Mintz

Sustainable Energy & Infrastructure CTA Updates — March 2025

FinCEN announced on February 27, 2025, that it will not impose fines or penalties for failures to file or update beneficial ownership information (BOI) reports in connection with the Corporate Transparency Act by the current…more

Beneficial Owner, Compliance, Corporate Transparency Act, Enforcement Actions, Filing Deadlines

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Best Practices for Clearances and Opinions

Last week, Mintz Member Lisa Adams moderated a panel discussion between in-house attorneys that covered best practices for conducting patent clearances and obtaining non-infringement and invalidity opinions. The panel…more

Claim Construction, Noninfringement, Patent Infringement, Patent Invalidity, Patent Litigation

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Court Holds Crime Policy Covers Business Compromise Email Loss

The “business compromise email” is what the FBI calls the “$5 billion scam,” but apparently an insurance company did not agree with an insured company that they had been the victim of a crime…more

Business E-Mail Compromise (BEC), Computer Fraud Insurance, Corporate Counsel, Crime Insurance Policies, Cyber Crimes

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Can a Consumer Plausibly Allege Your Product Labeling is False or Misleading Under California Law?

California’s consumer protection laws prohibit false advertising, as well as advertising that is “‘either actually misleading or which has a capacity, likelihood, or tendency to deceive or confuse the public.’” These claims are…more

Advertising, California, Consumer Protection Laws, Corporate Counsel, False Advertising

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Vacatur of an Arbitration Award in an FAA Case on Non-FAA Grounds

In an unusual decision in an unusual case—a dispute between sovereigns—a U.S. appellate court recently vacated a domestic arbitration award on grounds other than those provided in Section 10 of the Federal Arbitration Act…more

Arbitration, Arbitration Agreements, Arbitration Awards, Contract Interpretation, De Novo Standard of Review

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Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: December 2015

Trends & Analysis - We have identified 24 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of the 24 cases, five were filed within the past year, seven were filed in 2014, three were…more

Anti-Kickback Statute, False Claims Act (FCA), False Statements, Medicaid, Medicare

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SCOTUS Grants Certiorari to Hear NVIDIA Fraud Appeal on PSLRA Pleading Standard

Last week, the United States Supreme Court granted certiorari in NVIDIA Corp. v. E. Ohman J:Or Fonder AB., Case No. 23-970, to address two fundamental questions about how federal securities fraud cases must be pled to survive a…more

Appeals, Certiorari, Fraud, Motion to Dismiss, NVIDIA

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Mintz IRA Update — Fourth Edition: Q1 2025

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022 (IRA)…more

Drug Pricing, Inflation Reduction Act (IRA), Medicare, Medicare Part D, Pharmaceutical Industry

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A Typo to Remember: Erroneous Patent Number in Terminal Disclaimer Destroys Exclusive Rights

Co-authored by Sam Cohen, Summer Associate 2024. On May 29, 2024, the Western District of Oklahoma in SIPCO, LLC v. JASCO Prods. Co. dismissed the plaintiff SIPCO’s patent infringement claims against defendant JASCO because of a…more

Corporate Counsel, Obviousness, Obviousness-Type Double Patenting (ODP), Patent Infringement, Patent Litigation

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PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively…more

Compliance, Federal Trade Commission (FTC), Final Rules, Health Insurance, Healthcare

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FTC Complaint Against Rite Aid Signals New Paradigm for Evaluating AI Technology Use

Late last month, the Federal Trade Commission (FTC) filed a complaint for permanent injunctive relief and sanctions against Rite Aid, alleging that the pharmacy chain’s widespread use of facial recognition technology, deployed…more

Artificial Intelligence, Facial Recognition Technology, Federal Trade Commission (FTC), FTC Act, Injunctive Relief

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How Your Trade Secret Could Help to Defend Against Claims of Patent Infringement

For companies that need to protect their valuable intellectual property, the choice between trade secret and patent protection can be a difficult one. There are benefits to either approach..…more

Artificial Intelligence, Intellectual Property Protection, Machine Learning, Patent Infringement, Patent Prosecution

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New Amendments to the New York Labor Law Limit Certain Pay Frequency Claim Damages

New York State has resolved a recent judicial split regarding pay frequency violation remedies by amending the New York Labor Law (“NYLL”) to limit an employee’s ability to recover sizeable liquidated damages. New York employers…more

Appeals, Damages, Employee Rights, Employment Litigation, Liquidated Damages

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Hiring Across the 49th Parallel: Traps for the Unwary for Cross-Border US-Canada Hires

The United States and Canada have long been great trade partners, and not only with respect to hockey players. As commerce in general and employee mobility in particular increases, employers with operations in the United States…more

Canada, Cross-Border, Hiring & Firing, Jurisdiction

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Non-Debtor Substantive Consolidation: Do Recent Cases Signal a Judicial Preference for State Law Claims?

It is not unusual for a creditor of a debtor to cry foul that a non-debtor affiliate has substantial assets, but has not joined the bankruptcy. In some cases, the creditor may assert that even though its claim, on its face, is…more

Alter Ego, Commercial Bankruptcy, Non-Debtors, State Law Claims, Substantive Consolidation

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Not just for crypto – How blockchain technology will affect medical devices

Most people are familiar with blockchain technology because of its use in cryptocurrency, but its use is going to be far more widespread than just as a ledger for digital currency. As explained in a previous blog post,…more

Blockchain, Distributed Ledger Technology (DLT), Electronic Medical Records, Health Care Providers, Manufacturers

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What’s New in Wireless - May 2025

The wireless industry has revolutionized the way we connect, from facilitating teleworking, distance learning, and telemedicine to allowing the American public to interact virtually in almost all other aspects of their daily…more

FCC, Internet of Things, New Regulations, Proposed Rules, Rulemaking Process

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COVID-19 and Down-Round Financings

Although no one can predict the long-term economic impact of COVID-19, early indications show similarities to the last significant economic downturn that started in 2008. During that period, venture capital investment decreased…more

Breach of Duty, Capital Raising, Corporate Financing, Economic Downturn, Entire Fairness Standard

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Governor Healey State of the Commonwealth Address

On Tuesday, January 16, 2025, Massachusetts Governor Maura Healey delivered her second State of the Commonwealth Address. Below is a summary of some of the policy areas that she discussed during her nearly hour-long address to a…more

Affordable Housing, Artificial Intelligence, Child Care, Clean Energy, Education Reform

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USCIS Announces H-1B Cap Registration Period for March 2025

On Wednesday, February 5, 2025, US Citizenship and Immigration Services (USCIS) announced that the online registration period for H-1B quota selection for the upcoming fiscal year will begin on Friday, March 7 at 12:00 pm (noon)…more

Electronic Filing, Foreign Workers, Form I-129, H-1B, Immigration Procedures

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Need Prior Art? Here’s How to Search the PTO Database of Patents Like a Patent Examiner

A frequent pain point in the realm of patents is being unable to find pertinent patent publications quickly and efficiently. In an attempt to provide the public with better search tools, the United States Patent and Trademark…more

Patent Search, Patents, Prior Art, USPTO

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California Usury Law: A Search for Clarity around Compound Interest

California usury law is addressed in multiple places: the California Constitution, statutes, case law, and initiative measures. Due to the patchwork nature of this body of law, differing interpretations and ambiguity are…more

CA Supreme Court, Consumer Financial Products, Consumer Lenders, Disclosure Requirements, Financial Services Industry

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Maryland Employers: Amended Pay Transparency Law Requires Wage Range Disclosure in Job Postings

Maryland was one of the first states to implement a pay transparency law in 2020, and now it joins several states in broadening that law to require employers to disclose a wage range for open positions (Washington, D.C.’s pay…more

Compensation, Disclosure Requirements, Job Ads, Maryland, Pay Transparency

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Texas Has Been Busy Ramping up Privacy Protections with New Comprehensive Data Privacy Law and Stricter Data Breach Notification Requirements

Texas has joined the growing list of states enacting comprehensive consumer data privacy laws. On June 18, 2023, Governor Abbott (R) signed H.B.4, otherwise known as the Texas Data Privacy and Security Act (“TDPSA”). The TDPSA…more

Breach Notification Rule, Cybersecurity, Data Privacy, Data Protection, Families First Coronavirus Response Act (FFCRA)

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Supreme Court Narrows the Reach of Omission Liability Claims Under Section 10(b) of the Exchange Act

Last week, the U.S. Supreme Court, in Macquarie Infrastructure Corporation v. Moab Partners, L.P., held that omissions of supposedly material information allegedly required to be disclosed under Item 303 of SEC Regulation S-K…more

Certiorari, Investors, Item 303, Liability, Macquarie Infrastructure Corp v Moab Partners LP

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The Importance of Getting Inventorship Right: A Cautionary Tale in Two Cases

U.S. patent law elevates the importance of “the inventor” to an extent unseen in the rest of the world. Unlike many other countries, ownership of patent applications in the United States initially vests in the inventors listed…more

Appeals, Assignment of Inventions, Dismissals, Employment Contract, Former Employer

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Reduced Scope of March-in Rights Under Bayh Dole Rules Revisions

The Bayh Dole Act was enacted to provide incentives to promote commercialization of federally funded inventions and was designed to capitalize on the significant government investments in small business, university research, and…more

Bayh-Dole Act, Biden Administration, IP License, March-in-Rights, Patents

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Voluntary Self-Disclosure and Whistleblower Awards Initiatives Are Alive and Well in 2025: DOJ Issues White-Collar Enforcement Priorities for the New Administration

The first 120 days of the Trump administration have been characterized by dramatic changes in the realm of white-collar enforcement. However, in the midst of a period wrought with uncertainty over what the administration may do…more

Corporate Misconduct, Department of Justice (DOJ), Enforcement Actions, Enforcement Priorities, False Claims Act (FCA)

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Summary of Proposed Section 899 of the US Internal Revenue Code and Its Impact on Section 892 Benefits and Tax Treaties

Proposed Section 899, introduced as part of the “Defending American Jobs and Investment Act” (H.R. 591) and incorporated into the House Ways and Means Committee’s tax package titled “The One, Big, Beautiful Bill” (the “Bill”),…more

Corporate Taxes, Foreign Corporations, Internal Revenue Code (IRC), International Tax Issues, Proposed Legislation

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FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company with…more

Audits, Clinical Trials, Food and Drug Administration (FDA), Inspections, Pharmaceutical Industry

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Proposed Laws Are One Step Closer to the November 2022 Ballot

On Wednesday, September 1st, Attorney General Maura Healey certified 17 out of 30 ballot proposals filed in August to continue on the path to securing a spot on the 2022 ballot. Of the 17 proposals certified, 16 were initiative…more

Ballots, General Elections, Legislative Agendas, Pending Legislation, Proposed Legislation

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EO 11246 No More: Requirements for Federal Contractors Under President Trump’s Executive Order

Section 3 of President Trump’s Executive Order entitled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” addresses the federal contracting process and revokes Executive Order, EO 11246, a long-standing order…more

Affirmative Action, Department of Labor (DOL), Diversity and Inclusion Standards (D&I), Employment Discrimination, Executive Orders

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AI in Biotech and Synthetic Biology: What Can Be Protected? What Should Be Kept Secret?

Machine learning (ML), bioinformatics, artificial intelligence (AI), and other computational tools have become ubiquitous in the biotech and synthetic biology industries because such technology allows for rapid processing of a…more

Artificial Intelligence, Biotechnology, Intellectual Property Protection, Machine Learning, Patents

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Mintz On Air: Practical Policies – When Should You Hire an Employment Lawyer?

In the latest episode of the Mintz on Air: Practical Policies podcast, Member Jen Rubin discusses with colleague and Member Andrew Bernstein when the best time is to hire an employment lawyer. This episode is part of a series of…more

Acquisitions, Contract Negotiations, Contract Terms, Employee Rights, Employment Contract

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Trump Administration Withdraws Proposed Rebate Rule

In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate…more

Anti-Kickback Statute, Drug Pricing, Executive Orders, Medicaid, Medicare

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HHS, Treasury and Labor Issue More Guidance on the No Surprises Act

Title I of Division BB of the Consolidated Appropriations Act, 2021 (the “Act”), and interim final rules issued by the Departments of Health and Human Services, Treasury and Labor (the “Departments”) in July 2021 (see our post…more

Arbitrators, Consolidated Appropriations Act (CAA), Department of Health and Human Services (HHS), Department of Labor (DOL), Employer Group Health Plans

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Founder’s Stock – a Legal Fiction

In common usage, a founder is an individual who creates or helps create a company, but in legal terms, there is no such thing as a “founder” or “founder’s stock,” only early participants in a company’s organization and ownership…more

Board of Directors, Business Ownership, Certificates of Incorporation, Common Stock, Fair Market Value

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NLRB’s Newly-Proposed Joint-Employer Standard Puts Employers on Notice

The National Labor Relations Board (“NLRB”) has issued a notice of proposed rulemaking, which would significantly alter the standard to determine who is a “joint employer” under the National Labor Relations Act (“NLRA”). The…more

Biden Administration, Browning-Ferris Industries of California Inc., Fair Labor Standards Act (FLSA), Joint Employers, NLRA

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Massachusetts Supreme Judicial Court Allows Innovator Liability Claims to Proceed Under A Recklessness Standard

Today, the Massachusetts Supreme Judicial Court made an important ruling concerning innovator liability with respect to pharmaceuticals. Though precluding negligence and traditional product liability claims against brand-name…more

Failure To Warn, Food and Drug Administration (FDA), Generic Drugs, Innovator Liability, Manufacturers

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In re Weinstein and Mallinckrodt: Implications for Royalty Financings, M&A Earn-Outs, and Other Transactions Involving Future Payment Obligations

Deal structure matters, particularly in bankruptcy. The Third Circuit recently ruled that a creditor’s right to future royalty payments in a non-executory contract could be discharged in the counterparty-debtor’s bankruptcy. The…more

Acquisitions, Appeals, Asset Purchase Agreements, Bankruptcy Code, Bankruptcy Court

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Voluntary Self-Disclosure and Whistleblower Awards Initiatives Are Alive and Well in 2025: DOJ Issues White-Collar Enforcement Priorities for the New Administration

The first 120 days of the Trump administration have been characterized by dramatic changes in the realm of white-collar enforcement. However, in the midst of a period wrought with uncertainty over what the administration may do…more

Corporate Misconduct, Department of Justice (DOJ), Enforcement Actions, Enforcement Priorities, False Claims Act (FCA)

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Back to the Future: CFTC Emphasizes Existing Regulatory Standards for New Al Technologies

Advancements in artificial intelligence (AI) continue to reshape the financial services industry, with the growing popularity of generative Al (GenAl) tools prompting increased attention from US regulators. At the end of 2024,…more

Algorithms, Artificial Intelligence, CFTC, Commodity Exchange Act (CEA), Compliance

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VC Funds Warehousing Investments: Traps for the Unwary

One of the challenges facing venture capital firms is how to handle investments in portfolio companies prior to the initial close (“Initial Close”) of a new fund (“New Fund”). Typically, the investment advisor (“VC Advisor”), or…more

C-Corporation, Capital Raising, Exemptions, Investment, Investment Adviser

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OCR Proposes Sweeping HIPAA Security Rule Amendments

Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would…more

Compliance, Data Breach, Electronic Protected Health Information (ePHI), Food and Drug Administration (FDA), Hackers

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Delaware Bankruptcy Court Grants Derivative Standing to Creditors’ Committee to Sue Members and Officers of Delaware LLC

In early February, a Delaware bankruptcy judge set new precedent by granting a creditors’ committee derivative standing to pursue breach of fiduciary duty claims against a Delaware LLC’s members and officers. At least three…more

Bankruptcy Code, Bankruptcy Court, Breach of Duty, Corporate Counsel, Creditors

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Representations Made by a Patentee during Foreign Prosecution May Be Used in Claim Construction for U.S. Patents

Claim construction, the process by which a court interprets the scope and meaning of a patent’s claims, is a crucial part of patent litigation. In fact, claim construction can make or break a patentee’s case for infringement…more

Claim Construction, Foreign Jurisdictions, Foreign Patent Applications, Intellectual Property Protection, Patent Infringement

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Back to the Future: CFTC Emphasizes Existing Regulatory Standards for New Al Technologies

Advancements in artificial intelligence (AI) continue to reshape the financial services industry, with the growing popularity of generative Al (GenAl) tools prompting increased attention from US regulators. At the end of 2024,…more

Algorithms, Artificial Intelligence, CFTC, Commodity Exchange Act (CEA), Compliance

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Telephone and Texting Compliance News: Litigation Update — One-to-One Consent Eleventh Circuit Challenge Dead

One-to-One Consent 11th Circuit Challenge Dead - As we previously reported, after the Eleventh Circuit vacated the Federal Communications Commission’s much-anticipated one-to-one consent rule in Insurance Marketing Coalition…more

Appeals, Class Action, Consent, Enforcement Actions, FCC

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PTAB Continues Streak of IPR Denials

US Patent Trial and Appeal Board (PTAB) institution denials for inter partes review (“IPR”) and other post-grant review petitions have steadily risen from 13 percent in 2012 to 44 percent in 2020. In 2020, the institution rate…more

Burden of Persuasion, Denial of Institution, Inter Partes Review (IPR) Proceeding, Patent Litigation, Patent Trial and Appeal Board

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A Quantitative Analysis of Comment Letters Issued by the SEC Concerning Climate Change Disclosures: Further Developments

In June 2023, Mintz published an article entitled “A Quantitative Analysis of Comment Letters Issued by the SEC Concerning Climate Change Disclosures” (the June 2023 Article), which analyzed the comment letters related to…more

Climate Change, Corporate Governance, Disclosure Requirements, EDGAR, Enforcement Actions

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Issues in Chinese Foreign Direct Investment in U.S. Early Stage Biotechnology Companies

There has been a marked increase in the amount of money being invested by Chinese investors into U.S. early stage biotechnology companies since 2017, spurred on by direct encouragement from Beijing through its Made in China 2025…more

Acquisitions, Biotechnology, CFIUS, China, Federal Pilot Programs

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Impact of DEI-Related Executive Orders on Disclosures in Recent Public Company Annual Reports

President Trump’s executive orders aimed at Diversity, Equity and Inclusion (DEI) programs and policies, including the executive order titled “Ending Illegal Discrimination and Restoring Merit Based Opportunity” (Executive Order…more

Compliance, Department of Labor (DOL), Disclosure Requirements, Diversity and Inclusion Standards (D&I), Employment Discrimination

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Part Eight of the COVID-19 Roadmap Series: Avoiding COVID-19 Wage & Hour and Labor Law Pitfalls

In Part Eight of our Roadmap Series, we take a closer look at wage and hour compliance concerns that may arise during the COVID-19 pandemic, and what employers can do to minimize these pitfalls. Remember that wage and hour…more

Coronavirus/COVID-19, Department of Labor (DOL), Emergency Management Plans, Employer Liability Issues, Employment Policies

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Technical CCPA Violations Result in $345,178 Fine from California Privacy Protection Agency

The California Consumer Privacy Protection Agency (CPPA) Board has issued a Stipulated Final Order against Todd Snyder, Inc., a clothing retailer, ordering Todd Snyder to pay a $345,178 fine and implement various changes to its…more

California Consumer Privacy Act (CCPA), California Privacy Protection Agency (CPPA), Consent, Data Collection, Enforcement Actions

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2024 Pre-Election Analysis: Infrastructure

In this installment of ML Strategies’ Pre-Election Analysis series, we join with our partners in the Public Finance Practice at Mintz to discuss the potential implications of the 2024 general election for infrastructure policy…more

Climate Change, Department of Transportation (DOT), General Elections, Immigration Reform, Infrastructure

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Sustainable Energy & Infrastructure Connections — May 2025

A Note from the Editors - Sustainable Energy & Infrastructure Connections brings the latest developments in energy investing, legal insights, company activity, and industry events straight to your inbox. This month’s edition…more

Acquisitions, Climate Change, Energy Policy, Energy Sector, Inflation Reduction Act (IRA)

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Making “Material Adverse Change” Mean What You Choose It to Mean — Neither More nor Less

A recent decision by the Court of Chancery of Delaware provides a reason to pause before agreeing to standard, boilerplate “material adverse change” clauses in purchase agreements. In Osram Sylvania, Inc. v. Townsend Ventures,…more

Attorney's Fees, Breach of Contract, MACs, Material Adverse Effects, Purchase Agreement

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Deadline Approaching for Massachusetts Pay Data Reporting

In July 2024, Massachusetts passed into law An Act Relative to Salary Range Transparency (the “Act”)..…more

Compliance, Department of Labor (DOL), Disclosure Requirements, EEO, Equal Employment Opportunity Commission (EEOC)

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Waivers Of Obligations And Deadlines Under The Investors’ Rights Agreement

When a company’s founders agree to take on a sizable venture capital investment for the first time, they can be shocked by the volume of paper generated to memorialize the relationship between the company and its investors. A…more

Deadlines, Financial Statements, Purchase Agreement, Venture Capital, Waivers

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FERC’s Landmark Transmission Order: Takeaways for Clean Energy and Energy Storage Companies

On May 13, 2024, the Federal Energy Regulatory Commission (FERC or Commission) issued Order No. 1920,[1] its long-awaited Final Rule relating to long-term regional planning and regional cost allocation. This article summarizes…more

Clean Energy, Compliance, Energy Sector, Energy Storage, FERC

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Executive Orders, Administrative Court Orders, and Legislation: The Ever-Changing NY Landscape on Foreclosures, Evictions, and Out-of-State Travel

The landscape for foreclosures and evictions in New York State is constantly evolving. With the entire State of New York in Phase 4 of New York Forward, the courts have begun to reopen (at least virtually) and certain…more

Borrowers, Commercial Leases, Coronavirus/COVID-19, Eviction, Executive Orders

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Trump Administration Tariffs: Key Considerations for Private Equity Investors

President Trump’s return to the White House has been accompanied by an increasingly aggressive trade policy that seeks to restore global trading imbalances by imposing reciprocal tariffs on imported goods. While the…more

Acquisitions, Imports, International Trade, Investment, Investors

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First Circuit Adopts “But-For” Causation Standard for False Claims Act Cases Based on Anti-Kickback Statute Violations

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”…more

Anti-Kickback Statute, Causation, Compliance, Department of Justice (DOJ), Enforcement Actions

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Artificial Intelligence Executive Order: Workplace Implications

President Trump’s executive order entitled Removing Barriers to American Leadership in Artificial Intelligence (the “Trump AI Order”) seeks to create “a path for the United States to act decisively to retain global leadership in…more

Artificial Intelligence, Biden Administration, Department of Labor (DOL), Employment Discrimination, Employment Policies

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MSRB Addresses Selective Disclosure

On September 13, 2017, the Municipal Securities Rulemaking Board (the “MSRB”) published a market advisory on selective disclosure (the “Notice”). The stated purpose of the Notice is to “increase awareness” of selective…more

Material Nonpublic Information, MSRB, Municipal Securities Issuers, Municipal Securities Market, New Guidance

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Trump Signs Most-Favored-Nation Executive Order - Potential Impact on Drug Supply Chain

After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to…more

Department of Health and Human Services (HHS), Drug Pricing, Enforcement, Executive Orders, Manufacturers

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District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland and In re Cray

On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan…more

Abbreviated New Drug Application (ANDA), Bristol-Myers Squibb, Dismissals, FRCP 12(b)(3), Generic Drugs

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How NFTs and Blockchain Secure Digital Sports Collectibles

Today, there are new opportunities to own a bit of sports history. It is now possible to even own a digital collectible of your favorite athlete making a play during a game. NFTs (non-fungible tokens) are being used to provide…more

Artists, Athletes, Blockchain, Counterfeiting, Digital Assets

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New Amendments to the New York Labor Law Limit Certain Pay Frequency Claim Damages

New York State has resolved a recent judicial split regarding pay frequency violation remedies by amending the New York Labor Law (“NYLL”) to limit an employee’s ability to recover sizeable liquidated damages. New York employers…more

Appeals, Damages, Employee Rights, Employment Litigation, Liquidated Damages

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A Business Deal Could Kill Your Right to Challenge a Patent’s Validity

Last week, the Federal Circuit issued a decision holding that parties can contractually bargain away their rights to file petitions for Inter Partes Review (“IPR”) at the Patent Trial and Appeals Board (“the Board”). This…more

Confidentiality Agreements, Corporate Counsel, Forum Non Conveniens, Inter Partes Review (IPR) Proceeding, Patent Trial and Appeal Board

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PBM Legislation in the Reconciliation Bill is Far From Sweeping PBM Reform

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Medicaid, Medicare Part D, New Legislation

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New York State Releases Reopening Guidance for Phase 2 Businesses

New York State has issued industry-specific interim guidance for “Phase 2” businesses, which includes a number of “minimum requirements” certain businesses must meet before reopening their workplaces in light of COVID-19. The…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Governor Cuomo, New York

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How Can the Updated USPTO Guidance on Determining Obviousness Help You?

Recent guidance published in the Federal Register by the United States Patent and Trademark Office (USPTO) explains some of what is required by patent examiners in making an obviousness case under 35 U.S.C. § 103. Since it is…more

Intellectual Property Protection, Inventions, New Guidance, Obviousness, Patents

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He Got the MrBeast Blueprint… and a Trade Secret Lawsuit

Imagine getting your hands on the ultimate creator cheat code — the behind-the-scenes playbook MrBeast uses to dominate YouTube. Now imagine going viral not for using it, but for allegedly walking off with it. That’s exactly…more

Breach of Contract, Confidential Information, Data Security, Defend Trade Secrets Act (DTSA), Employer Liability Issues

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Do Patent Claims to Methods of Treatment Cover In Vivo Transformations?

Where an alleged infringer administers a substance A to a subject, and the substance is subsequently transformed to a therapeutic agent X inside the subject’s body, does the administration of the substance A constitute an act of…more

Claim Construction, Patent Infringement, Patent Litigation, Patents, Pharmaceutical Industry

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The 2019 Public Charge Rule Is Removed by DHS

On March 9, 2021 the Department of Homeland Security (DHS) announced that it will no longer enforce the Public Charge rule that originally took effect on February 24, 2020. Based on a number of recent U.S. Court of Appeals…more

Biden Administration, Department of Homeland Security (DHS), Final Rules, Immigration Procedures, Non-Immigrant Visas

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363 Sales as a Health Care M&A Tool, Part 2 – Pros and Cons for Buyers and Sellers

Over the summer, we wrote about why health care companies may want to consider buying assets out of bankruptcy, taking advantage of the Bankruptcy Code Section 363 sale process (a “363 Sale”). We are back with our second post,…more

363 Sales, Bankruptcy Code, Commercial Bankruptcy, Contract Terms, Due Diligence

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Early- and Growth-Stage Companies in Distress: What Directors Need to Know about their Fiduciary Duties

Most high-growth companies find themselves in a race against the clock, trying to use whatever capital they may have to achieve milestones prior to hitting their cash-out date. When markets are tight, as they have been over the…more

Confidential Information, Conflicts of Interest, Duty of Care, Duty of Loyalty, Fiduciary Duty

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FCC Proposes to Establish New Air-to-Ground Mobile Broadband Service for Airline Travelers

In a Notice of Proposed Rulemaking issued last week, the FCC proposed to establish a new, terrestrial-based, air-to-ground (“ATG”) mobile broadband service in the 14.0-14.5 GHz Ku-band, providing multi-gigabyte broadband…more

Airlines, Aviation Industry, Broadband, Competitive Bidding, FCC

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Managing State Law Risks of Employer-Sponsored Abortion-Related Travel Benefits Post-Dobbs

In previous posts (available here and here) we reported on some of the legal consequences from Dobbs v. Jackson Women’s Health Organization on employer-sponsored group health plan coverage of abortion-related travel benefits…more

Abortion, Commercial Insurance Policies, Corporate Counsel, Dobbs v. Jackson Women’s Health Organization, Due Process

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Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program (Negotiation…more

Administrative Procedure Act, Appeals, Centers for Medicare & Medicaid Services (CMS), Constitutional Challenges, Drug Pricing

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Private Equity Group and Hedge Fund Bills Continue Through the California Legislature

California legislative activity focused upon private equity group and hedge fund health care transactions continues notwithstanding California Governor Gavin Newsom’s veto last fall of California Assembly Bill 3129 (AB-3129). As…more

California, Health Care Providers, Healthcare, Hedge Funds, Hospitals

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US Department of Homeland Security Publishes H-1B Modernization Rule

On December 18, 2024, the Biden administration’s Department of Homeland Security published its final rule to overhaul several aspects of the H-1B visa program. This final rule, which takes effect 30 days after publication, is…more

Biden Administration, Department of Homeland Security (DHS), Exemptions, F-1 Visa, H-1B

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U.S. Citizenship and Immigration Services Streamlines Social Security Administration Applications for Form I-485 Permanent Resident Applicants

On Monday, August 9, 2021, the U.S. Citizenship and Immigration Services (USCIS) announced that applicants filing for permanent resident status may also apply for a Social Security number or replacement card as part of their…more

I-485 Applications, Social Security Administration (SSA), Social Security Numbers, USCIS

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Health Care Privacy and Security In 2024: Six Critical Topics to Watch

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the…more

Artificial Intelligence, Cybersecurity, Data Breach, Data Security, Department of Health and Human Services (HHS)

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Preparation for 2023 Fiscal Year-End SEC Filings and 2024 Annual Shareholder Meetings

A number of significant regulatory, legal, market, and ESG-related developments and issues will affect how public companies approach the upcoming year-end reporting process. As in past years, Mintz has prepared an in-depth…more

10b5-1 Plans, Artificial Intelligence, Chief Information Security Officer (CISO), Clawbacks, Climate Change

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Governor Healey State of the Commonwealth Address

On Tuesday, January 16, 2025, Massachusetts Governor Maura Healey delivered her second State of the Commonwealth Address. Below is a summary of some of the policy areas that she discussed during her nearly hour-long address to a…more

Affordable Housing, Artificial Intelligence, Child Care, Clean Energy, Education Reform

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Emerging Legal Trends AI: Can Israel Join the U.S. and Europe as a Leader in AI Protections?

The intersection of artificial intelligence (AI) and intellectual property invokes fascinating theoretical questions. For example, can a machine own an invention? Or be liable for the consequences of its actions? However, with…more

Artificial Intelligence, Computer-Related Inventions, Innovation, Intellectual Property Protection, Israel

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Ushering in a New Era: FDA Approves First Interchangeable Biosimilar

Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee…more

Biosimilars, Biosimilars Action Plan (BAP), Federal Trade Commission (FTC), Food and Drug Administration (FDA), Pharmaceutical Industry

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Restrictive Covenants in Private Equity Transactions

Restrictive covenants are unquestionably a significant deal consideration in M&A transactions. In the private equity context, a buyer is focused on restrictive covenants to protect its investment by binding the sellers and other…more

Confidentiality Agreements, Contract Terms, Due Diligence, Enforcement, Intellectual Property Protection

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USPTO Releases Final Rules on PTA Calculations in view of Supernus

On June 16, 2020, the U.S. Patent and Trademark Office (USPTO) released final rules (the “Rules”) implementing changes to how Patent Term Adjustment (PTA) is calculated in certain circumstances in view of Supernus Pharms., Inc…more

European Patent Office, Final Rules, Information Disclosure Statement, Patent Applications, Patent Litigation

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Trump Administration Tariffs: Key Considerations for Private Equity Investors

President Trump’s return to the White House has been accompanied by an increasingly aggressive trade policy that seeks to restore global trading imbalances by imposing reciprocal tariffs on imported goods. While the…more

Acquisitions, Imports, International Trade, Investment, Investors

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Massachusetts Appeals Court Upholds Liability Insurer’s Contractual Right to Settle

On Tuesday, December 12, 2017, the Massachusetts Appeals Court, applying New Hampshire law, held that a professional liability insurer did not breach the implied covenant of good faith and fair dealing by settling a New…more

Appeals, Breach of Contract, Covenant of Good Faith and Fair Dealing, Health Care Providers, Medical Malpractice

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A Review of the Affordable Care Act at 10 Years, Part 4: Alternative Payment and Delivery Models

Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few…more

Affordable Care Act, Antitrust Provisions, Centers for Medicare & Medicaid Services (CMS), CMMI, Healthcare Reform

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Lessons from Disney: The Exercise of the Corporate Voice is Protected Business Decision

In the ever-changing and divisive political climate facing our nation today, boards of directors and the companies they oversee face myriad pressures from numerous stakeholders to weigh in on specific political, cultural, and…more

Books & Records, Corporate Counsel, Disney, Environmental Social & Governance (ESG), Florida

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Federal Circuit Affirms PTAB’s Analysis Finding Product-by-Process Claim Narrowed During Prosecution Valid Over Prior Art

In a precedential opinion issued on March 4, 2025, in Restem, LLC v. Jadi Cell, LLC, No, 23-2054, the U.S. Court of Appeals for the Federal Circuit affirmed the PTAB’s claim construction and ruling that product-by-process claims…more

Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Obviousness, Patent Infringement, Patent Litigation

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How State Legislatures May Rock the World of Employee Compensation in Response to the Recent Federal Tax Law

Prior to the effective date of the tax bill recently signed by the President, Section 164 of the Internal Revenue Code permitted individuals who itemized deductions to deduct state and local income and other designated taxes…more

FICA Taxes, Income Taxes, IRS, Medicare Taxes, SALT

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SEC Approves Spot Bitcoin ETFs But Gensler Still Disapproves of Crypto

On January 10, 2024, the U.S. Securities and Exchange Commission (“SEC”) approved eleven applications for spot exchange-traded funds (“ETFs”) tracking Bitcoin. This landmark moment for the crypto asset industry has been over 10…more

Appeals, Bitcoin, Cryptoassets, Cryptocurrency, ETFs

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Health Law Diagnosed – Health Care Transaction Review Laws and the New Normal

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the evolving legislative and regulatory landscape impacting health care transactions, particularly for private equities and hedge funds..…more

Acquisitions, Antitrust Provisions, California, Healthcare, Mergers

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The Murky Waters of Wash Trading Digital Assets – DOJ Charges 18 Individuals and Entities

The United States Attorney’s Office for the District of Massachusetts recently unsealed what it described as the “first-ever criminal charges against financial services firms for market manipulation and ‘wash trading’ in the…more

Blockchain, Cryptocurrency, Department of Justice (DOJ), Digital Assets, Proposed Regulation

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Restrictive Covenants in Private Equity Transactions

Restrictive covenants are unquestionably a significant deal consideration in M&A transactions. In the private equity context, a buyer is focused on restrictive covenants to protect its investment by binding the sellers and other…more

Confidentiality Agreements, Contract Terms, Due Diligence, Enforcement, Intellectual Property Protection

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California Court Deals Blow to Employee Mobility

California employers and executives might view fixed term employment agreements in a new light following a California appellate court’s unpublished decision suggesting employers do not violate California’s long-established…more

Appeals, California, Employee Mobility, Fixed-Term Labor Contracts, Labor Code

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Alien Registration Rule and Evidence of Registration

On March 12, 2025, the Department of Homeland Security (DHS) issued an interim final rule (IFR) implementing an Alien Registration requirement. The rule takes effect on April 11, 2025. As previewed in our prior alert, this rule…more

Compliance, Criminal Prosecution, Department of Homeland Security (DHS), Enforcement Actions, Executive Orders

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Protecting Lawful Streaming Act Signed Into Law

One of the provisions included in the Consolidated Appropriations Act that President Trump signed into law on December 27, 2020 addresses the so-called “felony streaming” loophole in the Copyright Act and criminal code. …more

Copyright, Copyright Infringement, Criminal Code, Internet, Internet Streaming

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Energy & Sustainability Connections Newsletter — January 2025

Energy & Sustainability Connections brings the latest developments in energy investing, legal insights, company activity, and industry events straight to your inbox..…more

Acquisitions, Artificial Intelligence, Clean Energy, Climate Change, Department of Energy (DOE)

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Crunch Time for BIOSECURE Act

As the 118th Congress winds down, the House and Senate are in the throes of negotiating several packages of legislation before leaving Washington for Christmas recess. A bill to fund the government beyond December 20, a series…more

Biotechnology, Department of Defense (DOD), Farm Bill, Federal Contractors, Foreign Adversaries

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Attention Ontario Employers: There is a New Guide to Recent and Upcoming Employment Law Changes

The Province of Ontario recently introduced a guide (“Guide”) to help employers navigate recent and upcoming changes to the Employment Standards Act, 2000 (the “ESA”). We have highlighted some of the key upcoming changes below…more

Artificial Intelligence, Canada, Employee Rights, Employer Responsibilities, Job Ads

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A Typo to Remember: Erroneous Patent Number in Terminal Disclaimer Destroys Exclusive Rights

Co-authored by Sam Cohen, Summer Associate 2024. On May 29, 2024, the Western District of Oklahoma in SIPCO, LLC v. JASCO Prods. Co. dismissed the plaintiff SIPCO’s patent infringement claims against defendant JASCO because of a…more

Corporate Counsel, Obviousness, Obviousness-Type Double Patenting (ODP), Patent Infringement, Patent Litigation

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MintzTech Connect: All Things Technology — April 2025

Challenging times. The stock market is choppy, and uncertainty about the economy and politics is pervasive. That said, we have seen that venture capitalists with conviction are making big bets. History tells us that the biggest…more

Artificial Intelligence, Blockchain, Cryptocurrency, Digital Assets, FinTech

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US-Canada Critical Mineral, EV Battery, and Semiconductor Cross-Border Supply Chain Issues

The Inflation Reduction Act (“IRA”) has garnered criticism from the European Union (“EU”) due in large part to its domestic sourcing requirements. Some in Canada have echoed this criticism, including Michael Harvey, vice…more

Advanced Batteries, Canada, Defense Production Act, Department of Defense (DOD), Electric Vehicles

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NLRB Moves Away from Biden-Era Approach on Severance Agreements

As part of the Trump Administration’s significant efforts to roll back the Biden Administration’s policies, the Acting General Counsel of the National Labor Relations Board (the “NLRB”) recently rescinded, via Memorandum GC…more

Biden Administration, Compliance, Employment Contract, Employment Policies, Labor Reform

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The Trademark Modernization Act Establishes New Trademark Cancellation Procedures

On December 27, 2020, the Trademark Modernization Act of 2020 (“the Act”) became law as part of the Consolidated Appropriations Act, 2021. Among other changes, the Act includes important amendments to the Lanham Act..…more

Consolidated Appropriations Act (CAA), Corporate Counsel, Ex Partes Reexamination, Intellectual Property Protection, Irreparable Harm

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Zoom to Implement New Security Measures in Deal with NY Attorney General

Amidst multiple investigations into the privacy and security practices at Zoom Video Communications (“Zoom”), New York Attorney General Letitia James recently announced a settlement agreement with Zoom after the failings of the…more

Corporate Counsel, Cybersecurity, Data Privacy, Data Security, Department of Education

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Executive Orders, Administrative Court Orders, and Legislation: The Ever-Changing NY Landscape on Foreclosures, Evictions, and Out-of-State Travel

The landscape for foreclosures and evictions in New York State is constantly evolving. With the entire State of New York in Phase 4 of New York Forward, the courts have begun to reopen (at least virtually) and certain…more

Borrowers, Commercial Leases, Coronavirus/COVID-19, Eviction, Executive Orders

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Ahoy! ITC Welcomes SEP Holders Navigating for The Best Venue

Given the recent unanimous decision by a UK appellate court that Ericsson’s injunction efforts based on standard-essential patents (“SEPs”) were, essentially by their very nature, “hold-up” and “coercion” that violated…more

Antitrust Provisions, Competition, Enforcement Actions, FRAND, Intellectual Property Protection

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Losing Your International Shoe: Corporations May Waive Contacts-Based Personal Jurisdiction in Consent-by-Registration States

Late last month the Supreme Court of the United States opened the door to a potential sea change in personal jurisdiction over corporate entities. In Mallory v. Norfolk Southern Railway Company, the Court held that any…more

Commerce Clause, Constitutional Challenges, Due Process, Foreign Corporations, Fourteenth Amendment

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Take Aways from the 2024 MIT Climate and Energy Prize Semi-Final’s Panel on Paths to Scale an Early-Stage Venture

On March 8, 2024, I attended the MIT Climate and Energy Prize Semi-Final in Cambridge, Massachusetts, a climate-tech and energy startup competition for graduate students. At this event, innovators pitched their businesses –…more

Early Stage Companies, Investors, Startups, Venture Capital

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Navigating Changing Immigration Policies: Workplace Implications

President Donald Trump has swiftly signed several immigration-related executive orders and implemented other immigration initiatives since his inauguration. These executive orders and policy changes have the stated intent to…more

Audits, Compliance, Customs and Border Protection, Department of Homeland Security (DHS), Employment Policies

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Consolidated Appropriations Act of 2021 Amends Bankruptcy Code - Part 3: Congress Gives Suppliers and Landlords a Shiny New Arrow in their Quiver to Challenge Preference Actions

As discussed in previous posts, the Consolidated Appropriations Act of 2021 (the “Act”) was signed into law on December 27, 2020, largely to address the harsh economic impact of the COVID-19 pandemic. For bankruptcy litigators…more

Bankruptcy Code, Clawbacks, Commercial Leases, Commercial Property Owners, Commercial Real Estate Market

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DOJ Issues its Highly Anticipated Whistleblower Awards Pilot Program

In March 2024, at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (“DAG”) Lisa Monaco announced that the Department of Justice (“DOJ” or the “Department”) intended to create…more

American Bar Association (ABA), Audits, Bribery, Corporate Misconduct, Corruption

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CMS Announces Sweeping Changes to RADV Audits

On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced significant changes in its risk adjustment data validation (RADV) audits. The changes focus on speed, the volume of targeted contracts, and process…more

Audits, Centers for Medicare & Medicaid Services (CMS), Government Agencies, Health Insurance, Healthcare Reform

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PATENT 101: Key Considerations and Activities for Establishing a Patent Program (Part 2 of 3)

Tasked with starting an innovation protection and patent development program at your company but do not know where to begin? This three part series describes the key components to a patent development program for any company,…more

Competition, Exclusivity, Inventions, Inventors, Licenses

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Limiting Securities Litigation Risks in EB-5 Offerings: What Regional Centers and Issuers Need to Know

The flurry of federal suits filed by the U.S. Securities and Exchange Commission (SEC) in the past few months against several companies and individuals for alleged fraud and false statements in soliciting foreign investors under…more

Corporate Counsel, EB-5, Immigrant Investor Program, Material Misstatements, Securities and Exchange Commission (SEC)

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Phase 1 Construction Guidelines: Guidance for Real Estate Developers in New York City

On Monday New York City entered Phase 1 of re-opening. Phase 1 guidance provides specific guidelines relating to construction, manufacturing, whole trade and select retail (for curbside pickup only), agriculture, forestry and…more

Construction Industry, Coronavirus/COVID-19, Manufacturing Employers, New York, Re-Opening Guidelines

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The Federal Circuit Swings the Door to Anti-Suit Injunctions Back Open

In our blog, Another Implementer Hold Out Door Closes: The Death of the Anti-Suit Injunction? earlier this year, we suggested that a popular implementer patent hold out tactic may be off the table based on an order issued by…more

Anti-Suit Injunctions, FRAND, License Agreements, Popular

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[Podcast] Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Health Insurance, Medicare, Pharmacy Benefit Manager (PBM)

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MintzTech Connect: All Things Technology — April 2025

Challenging times. The stock market is choppy, and uncertainty about the economy and politics is pervasive. That said, we have seen that venture capitalists with conviction are making big bets. History tells us that the biggest…more

Artificial Intelligence, Blockchain, Cryptocurrency, Digital Assets, FinTech

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I Spy a Trade Secret: Conducting Proper Trade Secret Asset Management Review to Avoid Sufficiency Failure in Litigation

A recent trade secret matter pending in federal court in California shows the pitfalls of a company’s failing to do trade secret asset management before filing a trade secret lawsuit, and also highlights some important lessons…more

Asset Management, Defend Trade Secrets Act (DTSA), Intellectual Property Litigation, Intellectual Property Protection, Misappropriation

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An Emerging Split on the Applicability of the Inevitable Disclosure Doctrine Under the DTSA

Federal courts remain split on whether the Defend Trade Secrets Act (DTSA) allows for trade secret misappropriation claims brought under a theory of inevitable disclosure. Given this current patchwork of treatment of inevitable…more

Defend Trade Secrets Act (DTSA), Employment Policies, Inevitable Disclosure Doctrine, Jurisdiction, Misappropriation

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Heightened Risk for Banks as Account Fees Land on “Junk Fee” Agenda

Banks and financial institutions beware: an increased focus on so-called “junk fees” has litigants and regulators alike taking aim at checking and deposit account fees. Although recent political focus on “junk fees” has been…more

Banking Sector, Banks, Consumer Financial Protection Act (CFPA), Consumer Financial Protection Bureau (CFPB), FDIC

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Energy & Clean Tech Connections: Your Law Firm Link to Industry News -- January 2013

In the January edition of Energy & Clean Tech Connections, we’ve gathered recent information from a wide variety of sources in an effort to keep you abreast of what’s new in the world of clean energy. We draw your attention to…more

Biofuel, China, Clean Tech, Fiscal Cliff, Investment Tax Credits

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Part Two: To Pay, or Not to Pay (Rent) – California Landlord-Tenant Regulations During COVID-19

COVID-19 has flipped the landlord-tenant relationship on its head. Although evictions and recovering possession are off the table for now, landlords are eventually entitled to their full rent payments and are not necessarily…more

Business Interruption, Commercial Leases, Coronavirus/COVID-19, Eviction, Landlords

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Challenging the Legality of a Cruel Immigration Policy

ICE apprehended “Angela” and her husband in 2019 shortly after they crossed the border into the United States from Mexico. When the couple requested asylum, ICE placed them in the Migrant Protection Protocols (MPP) program, more…more

Appeals, Asylum, Human Rights, Immigrant Protection Laws, Immigration and Customs Enforcement (ICE)

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Picture Claims as an Effective Patent Strategy: Top 10 Reasons to Precisely Tailor Your Patent Claim

A “picture” claim refers to a patent claim precisely tailored to track a particular product’s important advantages and features. When drafting a patent application, one should describe various embodiments of the invention and…more

Enforcement, Fund-raising, Inventions, Patent Applications, Patent Validity

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Best Practices in Developing Winning IP Strategies for AI Companies

Intangible assets represent over 90% of the value of every AI company.  An effective IP strategy can help protect these assets and steer your Company to higher valuations and provide leverage in commercialization of your…more

Artificial Intelligence, Contract Terms, Digital Assets, Innovation, Intellectual Property Protection

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Summary of Proposed Section 899 of the US Internal Revenue Code and Its Impact on Section 892 Benefits and Tax Treaties

Proposed Section 899, introduced as part of the “Defending American Jobs and Investment Act” (H.R. 591) and incorporated into the House Ways and Means Committee’s tax package titled “The One, Big, Beautiful Bill” (the “Bill”),…more

Corporate Taxes, Foreign Corporations, Internal Revenue Code (IRC), International Tax Issues, Proposed Legislation

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Navigating Changing Immigration Policies: Workplace Implications

President Donald Trump has swiftly signed several immigration-related executive orders and implemented other immigration initiatives since his inauguration. These executive orders and policy changes have the stated intent to…more

Audits, Compliance, Customs and Border Protection, Department of Homeland Security (DHS), Employment Policies

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Restrictive Covenants in Private Equity Transactions

Restrictive covenants are unquestionably a significant deal consideration in M&A transactions. In the private equity context, a buyer is focused on restrictive covenants to protect its investment by binding the sellers and other…more

Confidentiality Agreements, Contract Terms, Due Diligence, Enforcement, Intellectual Property Protection

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Bay Area Office Landlords Get Further Clarity from Updated Shelter in Place Order

UPDATE: On March 24, we posted a summary of California’s “shelter in place” order issued on March 16, 2020, and in particular discussed the relationship between it and the Bay Area county orders already in effect at the time. As…more

Business Closures, Coronavirus/COVID-19, Emergency Management Plans, Executive Orders, Non-Essential Businesses

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2025 Private Equity Trends Outlook

In 2025, the private equity landscape will be shaped by several key trends, including the expansion of continuation vehicles as a vital liquidity tool, heightened regulatory scrutiny and antitrust pressures introducing both…more

Antitrust Provisions, Federal Trade Commission (FTC), Interest Rates, Private Equity, Regulatory Agenda

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Fighting for Access to Lifesaving HIV Medicine

Even with breakthrough medication that transformed the human immunodeficiency virus (HIV) from a near-certain fatal disease to a manageable but chronic illness, many with HIV still endure debilitating effects. For about…more

Affordable Care Act, Centers for Disease Control and Prevention (CDC), Chronic Care Managment (CCM), HIV, Medication-Assisted Treatment (MAT)

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FTC Chair Ferguson Tells Congress Agency Needs Extra Resources to Enforce AI Deepfake Act, and Trump Signs Nuclear Energy EO — AI: The Washington Report

On May 15, FTC Chair Andrew Ferguson testified to the House Appropriations Committee that his agency needs additional resources to fulfill its enforcement obligations under the TAKE IT DOWN Act, which bans AI-generated…more

Artificial Intelligence, Deep Fake, Department of Energy (DOE), Energy Projects, Enforcement Actions

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SEC’s Enforcement Authority Over Crypto Asset Transactions Upheld (Again) in Case Against Coinbase

On March 27, 2024, the SEC received a favorable—if at least somewhat split—decision when Judge Failla of the SDNY denied a motion by Defendants Coinbase, Inc. and Coinbase Global, Inc. (collectively, “Coinbase”) for judgment on…more

Coinbase, Crypto Exchanges, Cryptoassets, Cryptocurrency, Digital Assets

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A New Dawn (Maybe) for California Employers: State and Business Groups Strike Deal on PAGA Reform

On June 18, 2024, Governor Newsom, in collaboration with legislative leaders, unveiled a landmark agreement to reform the Private Attorneys General Act (PAGA). The agreement comes before California voters could weigh in on the…more

California, Compliance, Employment Litigation, Enforcement, Injunctive Relief

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The Prevailing Winds of Public Interest: Tailoring Injunctive Relief in Patent Litigation Through Carve Outs

Grants of permanent injunctions in U.S. district court patent litigation remain uncommon since the landmark decision in eBay v. MercExchange. LexMachina’s 2021 Patent Litigation Report highlights that courts grant fewer than…more

Carbon Emissions, Carve Out Provisions, Climate Change, Inflation Reduction Act (IRA), Offshore Wind

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Massachusetts Legislature Overhauls Public Records Law

Last week the Massachusetts Legislature adopted significant changes to the Massachusetts Public Records Law. These changes apply to all state agencies and municipalities and in theory are designed to improve the disclosure of…more

Attorney's Fees, Burden of Proof, Discovery, Municipalities, New Legislation

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Legal Shifts from the White House – What Employers Need to Know

Rapid changes across the federal government are creating tremendous ambiguity for the private sector, particularly around employment and immigration issues…more

Biden Administration, Department of Labor (DOL), Diversity and Inclusion Standards (D&I), Employment Policies, Equal Employment Opportunity Commission (EEOC)

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Fighting for Access to Lifesaving HIV Medicine

Even with breakthrough medication that transformed the human immunodeficiency virus (HIV) from a near-certain fatal disease to a manageable but chronic illness, many with HIV still endure debilitating effects. For about…more

Affordable Care Act, Centers for Disease Control and Prevention (CDC), Chronic Care Managment (CCM), HIV, Medication-Assisted Treatment (MAT)

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PE Opportunity in Litigation Financing

Litigation financing has quickly grown from a fledging concept into a robust industry. The concept is simple: in exchange for a share of any proceeds, a financing firm agrees to pay all or a portion of the plaintiff’s legal…more

Client Services, Due Diligence, Litigation Fees & Costs, Litigation Funding, Private Equity Firms

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USPTO Proposes Fee Increases for FY 2017

The USPTO has published its notice of proposed rulemaking for the FY 2017 patent fee schedule in the Federal Register. The USPTO proposes fee increases to recover its estimated costs for patent operations and achieve its…more

America Invents Act, Covered Business Method Proceedings, Federal Register, Inter Partes Review (IPR) Proceeding, Patent Fees

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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New EU-US Data Privacy Framework

The European Commission has published its long-awaited draft of the new EU-US Data Privacy Framework, available here. The Data Privacy Framework will replace the Privacy Shield decision that was invalidated in July 2020 by the…more

Biden Administration, Compliance, Data Privacy, EU-US Privacy Shield, European Commission

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Telephone and Texting Compliance News — April 2025

We are pleased to present our latest edition of Telephone and Texting Compliance News, providing insights and news related to the Telephone Consumer Protection Act (TCPA). In this month’s Regulatory Update, we cover the FCC’s…more

FCC, Robocalling, TCPA, Telemarketing, Text Messages

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Telephone and Texting Compliance News: Regulatory Update — Federal Communications Commission Proposes New Rules For Non-IP Caller ID Authentication

At its April Open Meeting, the Federal Communications Commission (FCC) adopted a Notice of Proposed Rulemaking (NPRM) aimed at closing the non-IP caller ID authentication gap. The NPRM is the next step in the FCC’s efforts to…more

FCC, Notice of Proposed Rulemaking (NOPR), NPRM, Proposed Rules, Regulatory Requirements

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Whose Profits Are These, Anyway? Who Constitutes The Defendant For Purposes of Disgorgement Of Profits In A Trademark Infringement Case

In a unanimous (and unsurprising) decision on Wednesday, the Supreme Court vacated an award of nearly $43 million in disgorged profits to a trademark infringement plaintiff because those profits were not attributable to the…more

Appeals, Corporate Governance, Damages, Dewberry Group Inc v Dewberry Engineers Inc, Disgorgement

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Supreme Court Confirms That the Federal Claims Act Applies to the FCC's E-rate Program

Last Friday, in Wisconsin Bell, Inc. v. United States ex rel. Heath, the Supreme Court unanimously held that requests for funding from the FCC’s E-rate program are “claims” for purposes of the False Claims Act (FCA), settling a…more

Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), FCC, Federal Funding

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SEC Harmonizes and Improves “Patchwork” Private Offering Framework

On November 2, the SEC adopted amendments designed to harmonize and simplify the existing, complicated framework of private offering exemptions—the primary method by which private companies raise capital. The amendments…more

Capital Formation, Crowdfunding, Exemptions, Investment, Private Offerings

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Attention Ontario Employers: There is a New Guide to Recent and Upcoming Employment Law Changes

The Province of Ontario recently introduced a guide (“Guide”) to help employers navigate recent and upcoming changes to the Employment Standards Act, 2000 (the “ESA”). We have highlighted some of the key upcoming changes below…more

Artificial Intelligence, Canada, Employee Rights, Employer Responsibilities, Job Ads

See all updates »

[Podcast] Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Health Insurance, Medicare, Pharmacy Benefit Manager (PBM)

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CPSC Adopts Final Rules for Button Cell and Coin Batteries with Sweeping Requirements

On September 11, 2023, the Consumer Product Safety Commission (CPSC) voted to adopt sweeping safety requirements, pursuant to Reese’s Law, for button cell and coin batteries and products containing these batteries or designed to…more

Batteries, Certifications, Compliance, Consumer Product Safety Commission (CPSC), Final Rules

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Governor Baker Signs Legislation Creating a Temporary Moratorium on Evictions: What Commercial Landlords Need to Know

Today, April 20, 2020, Governor Charles Baker signed into law an act providing for a moratorium on evictions and as well as foreclosures of residential property (the “Act”) during the pendency of Massachusetts’ COVID-19…more

Commercial Tenants, Coronavirus/COVID-19, Eviction, Foreclosure, Governor Baker

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Just as "Shall" Means "Shall", "Stay" Means "Stay"

To stay or to go (from the docket)? For decades, federal courts of appeal have disagreed on a fundamental procedural question: when a dispute filed in federal district court is subject to arbitration, should the court dismiss…more

Appeals, Arbitration, Dismissals, Dispute Resolution, Federal Arbitration Act

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Energy & Clean Tech Connections: Your Law Firm Link to Industry News -- January 2013

In the January edition of Energy & Clean Tech Connections, we’ve gathered recent information from a wide variety of sources in an effort to keep you abreast of what’s new in the world of clean energy. We draw your attention to…more

Biofuel, China, Clean Tech, Fiscal Cliff, Investment Tax Credits

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FTC Identifies Concerns With Plaintiff’s Lawyers Advertisements Concerning Risks Associated With Pharmaceutical Drugs

I suspect that we’ve all had this experience. You’ve finished a long day of work, had dinner, and have cozied up on the couch with a glass of wine to watch a re-run of your favorite TV show. The show goes to commercial and all…more

Advertising, Federal Trade Commission (FTC), Food and Drug Administration (FDA), Goods or Services, Pharmaceutical Industry

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Arbitration of SEP Disputes—A Growing Trend?

After years of litigating against each other in several jurisdictions around the world, Ericsson and Lenovo announced last week that they had entered into a global cross-licensing agreement involving 4G and 5G wireless…more

Arbitration, Dispute Resolution, FRAND, Intellectual Property Litigation, International Arbitration

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I Heart FTC: Proposed New York Bill Would Continue Biden FTC’s Antitrust Vision and Policies

After the FTC issued a replacement of the 2016 Antitrust Guidance for Human Resource Professionals on January 16, 2025, Commissioner – now Chair – Andrew N. Ferguson, joined by Commissioner Melissa Holyoak, punctuated his…more

Antitrust Division, Antitrust Provisions, Banking Sector, Competition, Consumer Financial Products

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Restrictive Covenants in Private Equity Transactions

Restrictive covenants are unquestionably a significant deal consideration in M&A transactions. In the private equity context, a buyer is focused on restrictive covenants to protect its investment by binding the sellers and other…more

Confidentiality Agreements, Contract Terms, Due Diligence, Enforcement, Intellectual Property Protection

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AI-Based Patent Applications: Recent History and the Future

The emergence of artificial intelligence (AI) as a field of technology has correlated with an increase in patent application filings on AI-related inventions over the past two decades. With more filings than ever, businesses and…more

Artificial Intelligence, EU, Google, IBM, Inventions

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Recentive Analytics v. Fox: The Federal Circuit Provides Analysis on the Patent Eligibility of Machine Learning Claims

On April 18, 2025, the Federal Circuit remained consistent with previous Alice decisions by holding that four machine learning patents involved in a dispute between Recentive Analytics, Inc. and Fox Corp. were ineligible under…more

Algorithms, Alice/Mayo, Appeals, Artificial Intelligence, Intellectual Property Litigation

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Back to the Future: CFTC Emphasizes Existing Regulatory Standards for New Al Technologies

Advancements in artificial intelligence (AI) continue to reshape the financial services industry, with the growing popularity of generative Al (GenAl) tools prompting increased attention from US regulators. At the end of 2024,…more

Algorithms, Artificial Intelligence, CFTC, Commodity Exchange Act (CEA), Compliance

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New for 2024: Compliance with the Corporate Transparency Act Necessary for Many Mintz Client

Clients with Limited Liability Companies, Corporations, and Other Entities Likely Impacted - Reporting requirements under the Corporate Transparency Act (CTA) are in effect beginning January 1, 2024. Under the CTA, many…more

Compliance, Corporate Transparency Act, Financial Institutions, FinCEN, Money Laundering

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Scalpels Out: Implications for Energy from the First Reconciliation Bill Committee Releases

Both the House Energy and Commerce Committee and the House Ways and Means Committee released their portions of the reconciliation bill over the last week. While not as far-reaching as some feared, these initial revisions would…more

Clean Energy, Department of Energy (DOE), Electric Vehicles, Energy Policy, Energy Tax Incentives

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Delaware Supreme Court Upholds Advance Waiver Of Statutory Appraisal Rights

The Delaware Supreme Court recently decided that an agreement (sometimes referred to as a “drag along”) to waive prospectively statutory appraisal rights is fully enforceable against the common stockholders who made such…more

Appeals, Appraisal Rights, DE Supreme Court, Investment, Investors

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What’s New in Wireless - May 2025

The wireless industry has revolutionized the way we connect, from facilitating teleworking, distance learning, and telemedicine to allowing the American public to interact virtually in almost all other aspects of their daily…more

FCC, Internet of Things, New Regulations, Proposed Rules, Rulemaking Process

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A Brief Summary of the SEC’s Proposed Climate-Related Rules

On March 21, 2022, the Securities and Exchange Commission (“SEC”) unveiled its long-anticipated proposed rules on climate disclosures, entitled “The Enhancement and Standardization of Climate-Related Disclosures for Investors.”…more

Biden Administration, Climate Change, Corporate Governance, Disclosure Requirements, Environmental Social & Governance (ESG)

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10 Millionth U.S. Patent Issues Today

Further to our previous blog post, the U.S. Patent and Trademark Office reported that the 10 millionth patent issued today with the new patent cover design…more

Covered Business Method Patents, Design Patent, Intellectual Property Protection, Inventions, Patent Applications

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CAUTION: Director Veto Rights in Financing Documents May Constitute “Disproportionate Voting”

Section 141(d) of the Delaware General Corporations Law (DGCL) allows the certificate of incorporation (COI) of a Delaware corporation to confer upon one or more directors voting powers greater than or less than those of other…more

Certificates of Incorporation, Corporate Governance, D&O Insurance, Delaware General Corporation Law, Individual Retirement Account (IRA)

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Understanding How to Patent Agentic AI Systems

Artificial intelligence is evolving beyond simple pattern recognition and content generation into autonomous decision-making. Agentic AI systems act independently—or with limited human supervision—to achieve specific objectives…more

Algorithms, Artificial Intelligence, Innovation, Intellectual Property Protection, Machine Learning

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In re Weinstein and Mallinckrodt: Implications for Royalty Financings, M&A Earn-Outs, and Other Transactions Involving Future Payment Obligations

Deal structure matters, particularly in bankruptcy. The Third Circuit recently ruled that a creditor’s right to future royalty payments in a non-executory contract could be discharged in the counterparty-debtor’s bankruptcy. The…more

Acquisitions, Appeals, Asset Purchase Agreements, Bankruptcy Code, Bankruptcy Court

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Energy & Sustainability Client Feature — Boston Metal

This month we are excited to feature Boston Metal, a company developing technology to fully decarbonize steel production. At the end of January 2023, Boston Metal announced the $120 million first close of Series C fundraising…more

Clean Energy, Energy Sector, Steel Industry, Sustainability

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Copy Cats II: Nexus of Copying Required to Substantiate Non-Obviousness

On January 28, 2021, the Federal Circuit affirmed the general principle that the mere fact of copying by an accused infringer is insufficient to rebut a charge of obviousness (L’Oreal USA, Inc. v. Olaplex, Inc.; appeal from…more

Confidential Information, L'Oreal, Obviousness, Patent Infringement, Patent Litigation

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PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively…more

Compliance, Federal Trade Commission (FTC), Final Rules, Health Insurance, Healthcare

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Overview of Recent U.S. Tax Reform Part I – Certain Significant Changes Impacting C-Corporations

On December 22, 2017, H.R. 1, the Tax Cuts and Jobs Act (the “Tax Act”) was signed into law. As the first comprehensive U.S. federal income tax reform in over thirty years, the Tax Act includes dramatic changes to tax provisions…more

Acquisitions, Alternative Minimum Tax, C-Corporation, Corporate Taxes, Income Taxes

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MintzTech Connect Industry News: Spotlight on Walkabout

Walkabout is tackling loneliness for the masses in a way that is deep, sustainable, and highly scalable, holding the potential to redefine community in today’s tech-enabled society. Unlike traditional social platforms that…more

Community Development, FinTech, Innovation, Shareholders, Small Business

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January 1, 2025 Deadline Is Fast Approaching for Compliance with the Corporate Transparency Act

The Corporate Transparency Act (CTA) requires entities, including corporations, limited liability companies, and limited partnerships, to file a beneficial ownership information (BOI) report with the Financial Crimes Enforcement…more

Beneficial Owner, Business Entities, Business Ownership, Compliance, Corporate Transparency Act

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Part Two: To Pay, or Not to Pay (Rent) – California Landlord-Tenant Regulations During COVID-19

COVID-19 has flipped the landlord-tenant relationship on its head. Although evictions and recovering possession are off the table for now, landlords are eventually entitled to their full rent payments and are not necessarily…more

Business Interruption, Commercial Leases, Coronavirus/COVID-19, Eviction, Landlords

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FinCen Publishes Final Rule on Beneficial Ownership Requirements - a Critical Step Towards Heightened Transparency in U.S. Financial System

On January 1, 2021, Congress passed the Corporate Transparency Act (“CTA” or the “Act”) to “better enable critical national security, intelligence and law enforcement efforts to counter money laundering, financing of terrorism,…more

Advanced Notice of Proposed Rulemaking (ANPRM), Beneficial Owner, Certification Requirements, Corporate Transparency Act, Exemptions

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Sustainable Energy & Infrastructure Connections — May 2025

A Note from the Editors - Sustainable Energy & Infrastructure Connections brings the latest developments in energy investing, legal insights, company activity, and industry events straight to your inbox. This month’s edition…more

Acquisitions, Climate Change, Energy Policy, Energy Sector, Inflation Reduction Act (IRA)

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Section 409A Valuations: Mastering the Art and Science in a Volatile Venture Market

Within the unpredictable landscape of start-ups and private companies, market volatility can significantly alter a company’s financial trajectory. An integral part of navigating this volatility is understanding the role and…more

Acquisitions, Benchmarking, Fair Market Value, Intellectual Property Protection, IRS

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Supreme Court: Parody Not a Shield from Trademark Infringement

In Jack Daniels Properties, Inc. v. VIP Products LLC, (slip. op. No. 22-148, June 8, 2023), the United States Supreme Court reversed the Ninth Circuit, ruling that a “Bad Spaniels” dog toy designed to look like a Jack Daniels…more

Cease and Desist, Dilution, First Amendment, Intellectual Property Protection, Jack Daniels Properties Inc v VIP Products LLC

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The Public Weighs In On How the SEC Should Regulate ESG Disclosures

The past several years has seen growing attention on climate change disclosures and other environmental, social, and governance (“ESG”) issues. In 2016, a variety of universities faced pressure as student bodies demanded…more

Biden Administration, Climate Change, Compliance, Corporate Governance, Disclosure Requirements

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Discretion Retained: USPTO Dodges Attack from Big Tech to Rein in Discretionary IPR Denials

The U.S. Patent and Trademark Office (USPTO) recently thwarted an attempt by big tech companies such as Apple, Cisco, Google, and Intel, to rid themselves of discretionary denials under the Fintiv factors. While these companies…more

America Invents Act, Big Tech, Inter Partes Review (IPR) Proceeding, Patent Infringement, Patent Ownership

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The State of Pay Transparency in 2025

Pay transparency laws have taken the country by storm over the last few years, and 5 additional states (Illinois, Minnesota, Massachusetts, New Jersey, and Vermont) have debuted or will debut their own versions in 2025.  These…more

Compensation & Benefits, Compliance, Disclosure Requirements, Employee Rights, Employment Discrimination

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Did you form an entity this year?! Is it exempt from reporting?! What actually goes in the BOIR?! It's time to focus on the CTA.

The CTA is on everyone's minds now, because entities formed prior to January 1, 2024 only have until the end of the year to file their Beneficial Ownership Information Reports (BOIRs), and, more urgently, entities formed since…more

Beneficial Owner, Corporate Transparency Act, FinCEN, Investment Funds, Joint Venture

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2024 Post-Election Analysis: US Tariffs on Canada and Mexico Take Effect Amid Trade Policy Shifts

During the 2024 presidential campaign, Donald Trump repeatedly promised to impose tariffs on imports from Canada, Mexico, and China. This was widely viewed as a negotiating tactic, especially concerning Canada and Mexico, the…more

Aluminum Sales, Canada, China, Executive Orders, Foreign Corporations

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Executive Compensation: Moving Forward in a COVID-19 World

Employers reacted in a variety of ways to cope with the unprecedented financial impact of COVID-19. Many of the initial executive compensation responses were designed as cost-cutting measures that would ease cash flow burdens…more

Board of Directors, Compensation & Benefits, Coronavirus/COVID-19, Employment Contract, Executive Compensation

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Crowdfunding Considerations For Early Stage Companies

The Securities and Exchange Commission (the “SEC”) amended and expanded its capital raising rules for Regulation Crowdfunding (“Regulation CF”) in November 2020, effective in March 2021, to increase the amount that a company can…more

Crowdfunding, Disclosure Requirements, Investors, Offerings, Resales Agreements

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Practical Policies: Discerning DEI Discrimination

In the latest episode of the Mintz on Air: Practical Policies podcast, Member Jen Rubin unpacks the recent EEOC guidance on DEI discrimination with fellow Employment Member, Geri Haight. Jen and Geri discuss the content and…more

Anti-Discrimination Policies, Audits, Department of Justice (DOJ), Diversity and Inclusion Standards (D&I), Employee Handbooks

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DOJ Speaks About More White Collar Enforcement, But It's More Interesting to Look at What Was Left Unsaid

Very interesting article from the Wall Street Journal talking about more upcoming white collar enforcement, particularly in the areas of sanctions and Foreign Corrupt Practices Act (FCPA) cases. But the interesting omission to…more

Bribery, Department of Justice (DOJ), Enforcement, Foreign Corrupt Practices Act (FCPA), Securities and Exchange Commission (SEC)

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Strengthen Software Claims Against Alice Challenges through Coined Terms and Depicting Technical Advantages in Figures

The Federal Circuit recently provided strategic guidance for defending software claims against Alice challenges that claims recite ineligible patent subject matter under 35 U.S.C. § 101. In Mentone Solutions LLC v. Digi…more

Abstract Ideas, Alice/Mayo, Patent Litigation, Patent-Eligible Subject Matter, Patents

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Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program (Negotiation…more

Administrative Procedure Act, Appeals, Centers for Medicare & Medicaid Services (CMS), Constitutional Challenges, Drug Pricing

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2025 Private Equity Trends Outlook

In 2025, the private equity landscape will be shaped by several key trends, including the expansion of continuation vehicles as a vital liquidity tool, heightened regulatory scrutiny and antitrust pressures introducing both…more

Antitrust Provisions, Federal Trade Commission (FTC), Interest Rates, Private Equity, Regulatory Agenda

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Action Items on Technology and Communication Policies in front of the Senate Commerce Committee

With the Senate set to flip to Democratic control in the 117th Congress, albeit by a razor thin margin, the policy priorities for the upper chamber are likely to significantly change. In so doing, the various Senate committees…more

Biden Administration, Communications Decency Act, Cybersecurity, Department of Justice (DOJ), FCC

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Straight EB-5 Extension in Proposed Omnibus Appropriations Bill

A provision to extend the current EB-5 Program until September 30, 2018 is contained in the proposed Consolidated Appropriations Act, 2018 (“Omnibus”). If passed by the Congress and signed into law by the President this week,…more

Appropriations Bill, EB-5, Federal Budget, Immigration Procedures, Legislative Agendas

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Noteworthy False Claims Act Settlement Demonstrates DOJ’s Continued Scrutiny of Arrangements Between Hospitals and Physician Practices

On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million (the Settlement Agreement) and…more

Anti-Kickback Statute, Department of Justice (DOJ), False Claims Act (FCA), Healthcare Facilities, Healthcare Fraud

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Twenty States Sue the Trump Administration for HHS Program Eliminations and Staff Layoffs

Nineteen states plus the District of Columbia filed a federal Complaint in U.S. District Court for the District of Rhode Island on May 5, 2025 alleging that the Trump Administration’s recent activities to downsize and…more

Administrative Procedure Act, Constitutional Challenges, Department of Health and Human Services (HHS), Federal Funding, Government Agencies

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Arkansas Law Takes Unprecedented Step to Prohibit PBM Ownership of Pharmacies

On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or…more

Acquisitions, Anti-Competitive, Competition, Drug Pricing, Healthcare

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FTC Chair Ferguson Tells Congress Agency Needs Extra Resources to Enforce AI Deepfake Act, and Trump Signs Nuclear Energy EO — AI: The Washington Report

On May 15, FTC Chair Andrew Ferguson testified to the House Appropriations Committee that his agency needs additional resources to fulfill its enforcement obligations under the TAKE IT DOWN Act, which bans AI-generated…more

Artificial Intelligence, Deep Fake, Department of Energy (DOE), Energy Projects, Enforcement Actions

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USPTO Takes a Hint from European Practice in Addressing Late Continuation Concerns

As expected, the United States Patent and Trademark Office (USPTO) is raising its fees this year, effective January 19, 2025. However, the USPTO is doing something a little unusual this time—they’re raising the cost of filing…more

Continuation Applications, European Patent Office, Fees, Filing Fees, Patents

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Energy & Clean Tech Connections: Your Law Firm Link to Industry News -- January 2013

In the January edition of Energy & Clean Tech Connections, we’ve gathered recent information from a wide variety of sources in an effort to keep you abreast of what’s new in the world of clean energy. We draw your attention to…more

Biofuel, China, Clean Tech, Fiscal Cliff, Investment Tax Credits

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Can a Consumer Plausibly Allege Your Product Labeling is False or Misleading Under California Law?

California’s consumer protection laws prohibit false advertising, as well as advertising that is “‘either actually misleading or which has a capacity, likelihood, or tendency to deceive or confuse the public.’” These claims are…more

Advertising, California, Consumer Protection Laws, Corporate Counsel, False Advertising

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Key Lessons from Patent Litigation for Drafting and Prosecuting Utility Patent Applications

In almost every U.S. patent suit, the patentee’s counsel considers how the case could have been facilitated had the patent at issue been drafted and prosecuted differently. These considerations demonstrate that patents should…more

Claim Construction, Corporate Counsel, Covered Business Method Patents, Patent Applications, Patent Litigation

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The Federal Circuit Swings the Door to Anti-Suit Injunctions Back Open

In our blog, Another Implementer Hold Out Door Closes: The Death of the Anti-Suit Injunction? earlier this year, we suggested that a popular implementer patent hold out tactic may be off the table based on an order issued by…more

Anti-Suit Injunctions, FRAND, License Agreements, Popular

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Massachusetts Supreme Judicial Court Upholds Trustee’s Adjustment from Principal to Income

Trustees have many duties, including the duty of loyalty, the duty to invest prudently, and the duty of impartiality to all beneficiaries. Trustees must also effectuate the wishes of the trust’s settlor. These duties often…more

Beneficiaries, Capital Gains, Duty of Loyalty, MA Supreme Judicial Court, Probate

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Frequently Asked Questions for Private Companies Considering a Reverse Merger

*This piece appears in PitchBook’s 2023 Annual US VC Valuations Report. We believe this is the wrong question—we view a reverse merger as "going public" during your cross-over round, rather than as an alternative to an IPO..…more

Initial Public Offering (IPO), Jurisdiction, Liquidity, Mergers, Nasdaq

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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California Assembly Passes Sweeping Age-Appropriate Privacy Legislation

California is leading the way on privacy regulation --- again. The California State Assembly has passed AB 2273, which, if approved by the California Governor, would require businesses that provide online services, products,…more

California, Civil Monetary Penalty, COPPA, Injunctive Relief, Privacy Laws

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Federal Circuit Rejects Google’s Bid To Shrink ITC Jurisdiction over Post-Importation Acts of Indirect Infringement

In the wake of the Supreme Court’s elimination of “Chevron deference” in the Loper decision, many commentators have suggested that the ITC’s authority over unfair imports under Section 337 might be curtailed. See Loper Bright…more

Chevron Deference, En Banc Review, Google, Imports, Indirect Infringement

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FTC Announces 2025 Thresholds for HSR Act Filings and Interlocking Directorates Violations

The Federal Trade Commission (FTC) announced Friday increased jurisdictional thresholds for (1) notifications under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), (2) the HSR Act filing fee schedule, and…more

Antitrust Division, Antitrust Provisions, Competition, Department of Justice (DOJ), Federal Trade Commission (FTC)

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A Quantitative Analysis of Comment Letters Issued by the SEC Concerning Climate Change Disclosures: Further Developments

In June 2023, Mintz published an article entitled “A Quantitative Analysis of Comment Letters Issued by the SEC Concerning Climate Change Disclosures” (the June 2023 Article), which analyzed the comment letters related to…more

Climate Change, Corporate Governance, Disclosure Requirements, EDGAR, Enforcement Actions

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Summary of Proposed Section 899 of the US Internal Revenue Code and Its Impact on Section 892 Benefits and Tax Treaties

Proposed Section 899, introduced as part of the “Defending American Jobs and Investment Act” (H.R. 591) and incorporated into the House Ways and Means Committee’s tax package titled “The One, Big, Beautiful Bill” (the “Bill”),…more

Corporate Taxes, Foreign Corporations, Internal Revenue Code (IRC), International Tax Issues, Proposed Legislation

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Preparation for 2024 Fiscal Year-End SEC Filings and 2025 Annual Shareholder Meetings

Every year, Mintz provides analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange Commission and their annual shareholder meetings…more

Artificial Intelligence, Cybersecurity, Disclosure Requirements, Environmental Social & Governance (ESG), Publicly-Traded Companies

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Trump Administration Will Replace the Biden Administration's Department of Labor Rule Permitting ESG Investing

3 Under the Biden Administration, the Department of Labor ("DOL") had issued a rule that permitted ESG factors to be considered when making investments on behalf of 401(k) plans. (This rule had replaced an earlier one from the…more

401k, Biden Administration, Department of Labor (DOL), Environmental Social & Governance (ESG), Federal Labor Laws

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Arbitration of SEP Disputes—A Growing Trend?

After years of litigating against each other in several jurisdictions around the world, Ericsson and Lenovo announced last week that they had entered into a global cross-licensing agreement involving 4G and 5G wireless…more

Arbitration, Dispute Resolution, FRAND, Intellectual Property Litigation, International Arbitration

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[Podcast] Mintz on Air: Practical Policies - Performance Evaluations: From Stellar to Subpar and Everything In Between

In the latest episode of the Mintz on Air: Practical Policies podcast, Member Jen Rubin hosts a conversation on performance evaluations, covering their importance, best practices, and legal significance. This episode is part of…more

Artificial Intelligence, Best Practices, Employee Rights, Employees, Employment Litigation

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Navigating the Legalization of Hemp under the 2018 Farm Bill Involves Changes to the Issuance of Federal Trademarks in the Cannabis Industry

Legalizing “hemp” under the Agricultural Improvement Act of 2018 (2018 Farm Bill) has triggered an important change for the examination of federal trademark applications concerning cannabis and cannabis-derived goods and…more

Agribusiness, Cannabidiol (CBD) oil, Controlled Substances Act, Corporate Counsel, Farm Bill

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May Madness: Montana’s New Consumer Data Privacy Law Follows the Leaders ... and we’re not talking about California!

Our May Madness series is getting you caught up on comprehensive privacy legislation passing state legislatures across the nation.  In April, governors signed legislation in Tennessee and Indiana, and this month ahead of their…more

Consumer Privacy Rights, Corporate Counsel, Cybersecurity, Data Privacy, Data Protection

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Mintz on Air: Practical Policies - Veteran Transitions to the Private Sector

In the latest episode of the Mintz on Air: Practical Policies podcast, Member Jen Rubin hosts a conversation on successful veteran transitions to the private sector. This episode is part of a series of conversations designed to…more

Compensation & Benefits, Diversity and Inclusion Standards (D&I), Employee Benefits, Employee Rights, Employee Training

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COVID-19: Prioritized Patent Application Examination and Patents 4 Partnerships

The United States Patent and Trademark Office (USPTO) has recently launched two new initiatives to support COVID-19 innovations: 1) a COVID-19 Prioritized Examination Pilot Program, and 2) Patents 4 Partnerships that provides a…more

Artificial Intelligence, Coronavirus/COVID-19, FDA Approval, Food and Drug Administration (FDA), Patent Applications

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A First-of-its-Kind Telemedicine Criminal Prosecution: Key Takeaways

The indictment, arrest, and arraignment of Ruthia He, the founder, CEO, and clinical president of Done Global (Done), and David Brody, clinical president of Done and the sole shareholder of Done Health, P.C. (PC) in connection…more

Criminal Prosecution, DEA, Department of Justice (DOJ), Healthcare Fraud, Mental Health

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Optimizing Data Centers to Meet the Needs of Cryptocurrency Miners

Data centers are the twenty-first century nexus between the commercial real estate and telecommunication business sectors. Owners, operators and developers of data centers face the difficult task of continually adapting to the…more

Blockchain, Commercial Real Estate Market, Cryptocurrency, Data Centers, Data Storage Providers

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Attention Ontario Employers: There is a New Guide to Recent and Upcoming Employment Law Changes

The Province of Ontario recently introduced a guide (“Guide”) to help employers navigate recent and upcoming changes to the Employment Standards Act, 2000 (the “ESA”). We have highlighted some of the key upcoming changes below…more

Artificial Intelligence, Canada, Employee Rights, Employer Responsibilities, Job Ads

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How Can the Updated USPTO Guidance on Determining Obviousness Help You?

Recent guidance published in the Federal Register by the United States Patent and Trademark Office (USPTO) explains some of what is required by patent examiners in making an obviousness case under 35 U.S.C. § 103. Since it is…more

Intellectual Property Protection, Inventions, New Guidance, Obviousness, Patents

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With Software Patents and Means-Plus-Function, “Structure” Takes On a New Meaning

Functional Claiming in Software Patents - Software patents are generally directed to a sequence of steps or rules, i.e., an algorithm, performed by a computer programmed to carry out the algorithm. Because algorithms are…more

Algorithms, Claim Limitations, Computer-Related Inventions, Indefiniteness, Intellectual Property Protection

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CMS’s 2026 Final Medicare Advantage Rule Focuses on Implementing the IRA and Deregulation

In April, CMS finalized its Contract Year (CY) 2026 Medicare Advantage and Part D Final Rule (Final Rule). With CMS releasing the 2026 Medicare Advantage and Part D Proposed Rule in December under the Biden Administration, the…more

Biden Administration, Centers for Medicare & Medicaid Services (CMS), Final Rules, Inflation Reduction Act (IRA), Medicare Advantage

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Energy & Sustainability Client Feature – Pascal

This month we are excited to feature our client Pascal, a technology company that has pioneered low-pressure solid refrigerants for use in heat pumps, air conditioners, refrigerators, and freezers. Pascal recently raised $8…more

Energy Sector, Greenhouse Gas Emissions, Pollution Control, Popular, Supply Chain

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Why companies may want to accelerate marketing approval for their patented drugs in Canada

Patent Term Extensions (e.g., in the United States), Supplementary Protection Certificates (e.g., in Europe), and other similar extensions compensate the owner of a patent covering certain approved medical products for the time…more

Canada, Certificates of Supplementary Protection (CSPs), CETA, EU, Marketing

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Mintz Levin Health Care Qui Tam Update - February 2019

Overview of Qui Tam Activity - We identified 49 health care-related qui tam cases that were unsealed in September and October 2018. The government intervened in whole or in part in 10 of those 49 unsealed cases, which is…more

Anti-Kickback Statute, Dismissals, False Claims Act (FCA), Former Employee, Fraud

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Preparing a VC-Backed Company for an Exit Event

Initial public offerings (IPOs) and M&A exits are the two most common means of achieving liquidity in a private company. This article addresses an acquisition transaction, which requires preparation and oversight that many…more

Acquisitions, Capital Raising, Early Stage Companies, Initial Public Offering (IPO), Investment

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Preparation for 2024 Fiscal Year-End SEC Filings and 2025 Annual Shareholder Meetings

Every year, Mintz provides analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange Commission and their annual shareholder meetings…more

Artificial Intelligence, Cybersecurity, Disclosure Requirements, Environmental Social & Governance (ESG), Publicly-Traded Companies

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An Arbitrator’s Power May Be Greater Than That of a Judge

Arbitration is a creature of contract, and an arbitrator’s powers are in effect defined by the parties’ arbitration agreement. Paradoxically, although an arbitration agreement can be written (double-spaced) on one side of a…more

Arbitration, Arbitration Agreements, Arbitration Awards, Arbitrators, Commercial Contracts

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In re Weinstein and Mallinckrodt: Implications for Royalty Financings, M&A Earn-Outs, and Other Transactions Involving Future Payment Obligations

Deal structure matters, particularly in bankruptcy. The Third Circuit recently ruled that a creditor’s right to future royalty payments in a non-executory contract could be discharged in the counterparty-debtor’s bankruptcy. The…more

Acquisitions, Appeals, Asset Purchase Agreements, Bankruptcy Code, Bankruptcy Court

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Has There Been A Sea Change in Eligible Domestic Industries at the ITC That Will Last?

For decades, the ITC’s jurisdictional requirement – known as the domestic industry requirement – effectively shut out innovators from availing themselves of the powerful remedies of the forum, in the form of an exclusion order…more

Administrative Law Judge (ALJ), Appeals, Appellate Courts, Design Patent, En Banc Review

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Court Vacates SEC’s New Share Repurchase Disclosure Rules

On December 19, 2023, the US Court of Appeals for the Fifth Circuit vacated the Securities and Exchange Commission’s (SEC) share repurchase disclosure rules, which were adopted in May 2023 and became effective on July 31, 2023…more

Administrative Procedure Act, Appellate Courts, Disclosure Requirements, Equity Securities, Repurchases

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Latest Installment of our Mintz Matrix!

Please visit here to visit our Mintz Matrix page with the latest edition of the Mintz Matrix, which is a 50-state resource we have maintained since 2009 to break down and summarize requirements of U.S. state data breach…more

Compliance, Corporate Counsel, Data Breach, Data Privacy, Data Protection

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Trump Administration Tariffs: Key Considerations for Private Equity Investors

President Trump’s return to the White House has been accompanied by an increasingly aggressive trade policy that seeks to restore global trading imbalances by imposing reciprocal tariffs on imported goods. While the…more

Acquisitions, Imports, International Trade, Investment, Investors

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January 1, 2025 Deadline Is Fast Approaching for Compliance with the Corporate Transparency Act

The Corporate Transparency Act (CTA) requires entities, including corporations, limited liability companies, and limited partnerships, to file a beneficial ownership information (BOI) report with the Financial Crimes Enforcement…more

Beneficial Owner, Business Entities, Business Ownership, Compliance, Corporate Transparency Act

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New York Department of Health Publishes Material Transactions Reporting Form

In our February 14, 2025 blog post, we detailed a proposed expansion of Article 45-A of New York’s Public Health Law (hereinafter, the Disclosure of Material Transactions Law) included in the proposed Fiscal Year 2026 New York…more

Acquisitions, Disclosure Requirements, Government Agencies, Healthcare, Hospitals

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PBM Legislation in the Reconciliation Bill is Far From Sweeping PBM Reform

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Medicaid, Medicare Part D, New Legislation

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Using Corporate Bylaws and Charters to Set the Rules for Shareholder Litigation

Recent court decisions, including the Delaware Supreme Court’s opinion earlier this month in ATP Tour, Inc. v. Deutscher Tennis Bund, have focused new attention on the use of corporate bylaws and charters to establish the ground…more

American Rule, ATP Tours, Attorney's Fees, Board of Directors, Bylaws

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USPTO Prepares to Celebrate the Issuance of the Ten Millionth U.S. Patent

The United States Patent and Trademark Office (USPTO) anticipates issuing the 10 millionth utility patent at some point during the summer 2018. According to the USPTO, “[t]his milestone of human ingenuity perhaps exceeds even…more

Design Patent, Inventions, Patent Applications, Patents, USPTO

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Trump Antitrust Enforcers Outline “America First” Antitrust Enforcement

Over the past few weeks, several Trump Administration antitrust enforcers at both the Federal Trade Commission (“FTC”) and U.S. Department of Justice Antitrust Division (“DOJ Antitrust”) have written or spoken about the…more

Acquisitions, America First Trade Policy, Antitrust Litigation, Department of Justice (DOJ), Diversity and Inclusion Standards (D&I)

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Governor Baker Signs Legislation Creating a Temporary Moratorium on Evictions: What Commercial Landlords Need to Know

Today, April 20, 2020, Governor Charles Baker signed into law an act providing for a moratorium on evictions and as well as foreclosures of residential property (the “Act”) during the pendency of Massachusetts’ COVID-19…more

Commercial Tenants, Coronavirus/COVID-19, Eviction, Foreclosure, Governor Baker

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New Year, New Laws: California Employment Law Updates for 2025

It’s that time of year again—California employers need to prepare for a raft of new laws that become effective in the new year.  Below is a brief overview of some of those laws and how employers should prepare for them.  All of…more

Anti-Discrimination Policies, Anti-Harassment Policies, California, FEHA, Freelance Workers

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Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have…more

Artificial Intelligence, Food and Drug Administration (FDA), Intellectual Property Protection, Life Sciences, Machine Learning

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[Podcast] Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Health Insurance, Medicare, Pharmacy Benefit Manager (PBM)

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Determining Entity Status Before the United States and Patent Trademark Office: Large, Small, or Micro?

At the time of filing any patent application with the United States and Patent Trademark Office (USPTO), patent applicants must designate their entity status. Selecting the correct entity status can significantly reduce costs,…more

America Invents Act, Fees, Higher Education Act, Micro Entity Status, Nonprofits

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Commercial Leases in the Age of COVID-19 - A Menu of Options for Landlords and Tenants

The interruption to business-as-usual in the commercial real estate industry brought about by the COVID-19 pandemic has been unprecedented and, while hopefully only temporary, the full extent of the impact may not be entirely…more

Abatement, Business Interruption, CARES Act, Commercial Leases, Commercial Property Owners

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Energy & Sustainability Legal Feature — The Recently Announced Federal-State Partnership to Accelerate the Development of Offshore Wind Projects

On June 23, the White House announced the launch of a Federal-State Offshore Wind Implementation Partnership to accelerate the development of US offshore wind projects. This partnership is a joint effort of the Biden…more

Biden Administration, Energy Sector, Investment, MARAD, NREL

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US Department of Homeland Security Terminates CHNV Parole Program

The US Department of Homeland Security (DHS) has published a notice in the Federal Register terminating the parole program for nationals of Cuba, Haiti, Nicaragua, and Venezuela (CHNV) effective April 24, 2025…more

Biden Administration, Department of Homeland Security (DHS), Executive Orders, Foreign Nationals, Immigration Enforcement

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ALERT: New COVID-19 Vaccine Paid Leave for New York Employees

As we enter the second year of the COVID-19 pandemic, New York employers must now grapple with another new paid leave requirement from New York State. A new law signed by Governor Cuomo on March 12, 2021 amends New York’s Labor…more

Coronavirus/COVID-19, Employer Liability Issues, Employment Policies, Governor Cuomo, Paid Leave

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2022 Amendments to the Bankruptcy Rules

The latest amendments to the Federal Rules of Bankruptcy Procedure (the “Bankruptcy Rules”) took effect on December 1, 2022. This collection of modifications may be broadly divided into two categories: (i) amendments and a new…more

Chapter 11, Chapter 12, Chapter 13, Chapter 7, Debtors

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FinCen Publishes Final Rule on Beneficial Ownership Requirements - a Critical Step Towards Heightened Transparency in U.S. Financial System

On January 1, 2021, Congress passed the Corporate Transparency Act (“CTA” or the “Act”) to “better enable critical national security, intelligence and law enforcement efforts to counter money laundering, financing of terrorism,…more

Advanced Notice of Proposed Rulemaking (ANPRM), Beneficial Owner, Certification Requirements, Corporate Transparency Act, Exemptions

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Spotlight On ESG Investing: The Importance of Understanding Environmental, Social and Governance Factors and Their Impact on Investing

The Corporation’s Role in Society - Today During the past several years, public companies have come under increasing pressure from investors and society at large to use their resources and influence for broad and meaningful…more

Business Plans, Climate Change, Corporate Governance, Corporate Social Responsibility, Environmental Social & Governance (ESG)

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The CARES Act: What Multifamily Owners with Federally Backed Mortgage Loans Should Know

In response to the COVID-19 outbreak, the United States, like many states has reacted by providing certain multifamily landlord and tenants with economic benefits during this unprecedented global pandemic. On March 27, 2020,…more

CARES Act, Coronavirus/COVID-19, Eviction, Federal Loans, Financial Stimulus

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New ESG Requirements for Banks that Hold Public Funds May Raise Challenging Compliance Issues

Much ink has been spilled about ESG laws and regulations targeted at the investment of public funds, and rightfully so.  Yet, there has been little discussion of novel requirements imposed on banks that simply hold state or…more

Banks, Compliance, Employment Discrimination, Environmental Social & Governance (ESG), Financial Institutions

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My Health, My Data! Washington State Enacts Broad Health Data Privacy Protection Law

Washington greatly expanded the protection for consumers’ identifiable health information by enacting the “My Health My Data Act” (MHMDA), in an effort to close the gap between HIPAA protections and the laws protecting the…more

Biometric Information Privacy Act, California Consumer Privacy Act (CCPA), Data Privacy, Disclosure Requirements, Employee Training

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Strategies to Unlock AI’s Potential in Healthcare Part 6: Commercialization of AI Tools in Healthcare – the Challenge of Securing Adequate Data Rights

As noted in previous posts in this series, AI tools hold great promise for applications in healthcare. To date, AI tools in healthcare primarily leverage machine learning technology – i.e., the machine’s ability to keep…more

Content Aggregators, Contract Terms, Cybersecurity, Data Collection, Data Privacy

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EnforceMintz — Tech Corner: Q&A with Mintz’s E-Discovery Pro Regarding Artificial Intelligence

Artificial intelligence (AI) is a phrase that we hear in many different areas of our e-data and discovery practice. But, as it relates to e-discovery, AI is not necessarily a new development..…more

Artificial Intelligence, Document Review, e-Discovery, Technology Sector, Technology-Assisted Review

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Over a Decade in the Making: CMS Releases Long-Awaited Medicaid Managed Care Rule

On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Managed Care Contracts, Medicaid

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Caremark Liability Following the SEC’s New ESG Reporting Requirements

Recent developments in the Court of Chancery concerning a corporate board’s duty to monitor and provide oversight over a corporation’s operations, so-called Caremark claims, are likely to intersect with the Securities and…more

Caremark claim, Climate Change, Corporate Governance, DE Supreme Court, Disclosure Requirements

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New York Proposes Regulatory Review and Approval of Material Health Care Entity Transactions

On February 1, 2023, New York Governor Kathy Hochul announced the Fiscal Year 2024 New York State Executive Budget (the Executive Budget). One component of the Executive Budget’s Health and Mental Hygiene Article VII Legislation…more

ACOs, Acquisitions, Anti-Competitive, Enforcement, Health Care Providers

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Genus Claims: Foiled again by Written Description

In late August of 2021, the Federal Circuit reversed a jury verdict of $1.2 billion in favor of Juno Therapeutics and Sloan Kettering Institute because the jury’s finding that four of the asserted patent claims did not lack…more

Patent Litigation, Patents, Pharmaceutical Patents, Reversal

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What’s New in Wireless - May 2025

The wireless industry has revolutionized the way we connect, from facilitating teleworking, distance learning, and telemedicine to allowing the American public to interact virtually in almost all other aspects of their daily…more

FCC, Internet of Things, New Regulations, Proposed Rules, Rulemaking Process

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EnforceMintz — Tech Corner: Q&A with Mintz’s E-Discovery Pro Regarding Artificial Intelligence

Artificial intelligence (AI) is a phrase that we hear in many different areas of our e-data and discovery practice. But, as it relates to e-discovery, AI is not necessarily a new development..…more

Artificial Intelligence, Document Review, e-Discovery, Technology Sector, Technology-Assisted Review

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OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a…more

Anti-Kickback Statute, Department of Health and Human Services (HHS), Department of Justice (DOJ), False Claims Act (FCA), Fraud

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Another One Bites the Dust – N.D. Tex. Dismisses Antitrust Claims re FRAND Commitments with Prejudice

In the latest decision addressing antitrust liability for FRAND commitments, Judge Barbara M. G. Lynn of the Northern District of Texas dismissed a complaint from Continental Automotive Systems, Inc. (“Continental”) alleging,…more

Anti-Competitive, Antitrust Violations, Bargaining Power, Breach of Contract, Declaratory Judgments

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Artificial Intelligence Executive Order: Workplace Implications

President Trump’s executive order entitled Removing Barriers to American Leadership in Artificial Intelligence (the “Trump AI Order”) seeks to create “a path for the United States to act decisively to retain global leadership in…more

Artificial Intelligence, Biden Administration, Department of Labor (DOL), Employment Discrimination, Employment Policies

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AbbVie’s Enforcement of its ‘Patent Thicket’ For Humira Under the BPCIA Does Not Provide Cognizable Basis for an Antitrust Violation

In a recent decision in In Re Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873, Judge Shah of the Northern District of Illinois dismissed a consolidated class action complaint filed by U.S. purchasers of AbbVie Inc.’s…more

Anti-Competitive, Antitrust Injuries, Antitrust Litigation, Biopharmaceutical, Biosimilars

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Beware Dark Patterns – What are They and What Should Your Business Do About Them?

While the term “dark patterns” is not new, it has recently been getting a more attention, not least because the newly passed California Privacy Rights Act (“CPRA”) will regulate dark patterns. In this article, we will focus on…more

California Privacy Rights Act (CPRA), Consumer Privacy Rights, Cybersecurity, Data Privacy, Data Protection

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Voluntary Self-Disclosure and Whistleblower Awards Initiatives Are Alive and Well in 2025: DOJ Issues White-Collar Enforcement Priorities for the New Administration

The first 120 days of the Trump administration have been characterized by dramatic changes in the realm of white-collar enforcement. However, in the midst of a period wrought with uncertainty over what the administration may do…more

Corporate Misconduct, Department of Justice (DOJ), Enforcement Actions, Enforcement Priorities, False Claims Act (FCA)

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Will New York Be Next to Regulate Specifically Personal Health Information to Further, and Possibly Re-Write, a New Paradigm of State-Level Health Data Regulation?

The New York legislature passed its version of Washington’s My Health My Data Act (“WA MHMDA”) on January 22, 2025. Currently awaiting action by Governor Kathy Hochul, the New York Health Information Privacy Act (“NY HIPA”)…more

Consent, Data Privacy, Enforcement, Health Insurance Portability and Accountability Act (HIPAA), Healthcare

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California’s Top Privacy Cop Issues First Enforcement Decision

The California Privacy Protection Agency (CPPA) has issued its first Order of Decision to American Honda Motor Co. in an enforcement action under the California Consumer Privacy Act (CPPA). Although the investigation arose from…more

California Consumer Privacy Act (CCPA), California Privacy Protection Agency (CPPA), Compliance, Consumer Privacy Rights, Data Privacy

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DOJ: ‘False Claims Act + Cybersecurity’ Is Here To Stay

Amid ongoing policy shifts in Washington, the federal government’s interest in pursuing civil cyber-fraud cases appears to be here to stay. In October 2021, the Department of Justice (DOJ) initiated its Civil Cyber-Fraud…more

Corporate Counsel, Cybersecurity, Defense Contracts, Department of Justice (DOJ), DFARS

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FTC Complaint Against Rite Aid Signals New Paradigm for Evaluating AI Technology Use

Late last month, the Federal Trade Commission (FTC) filed a complaint for permanent injunctive relief and sanctions against Rite Aid, alleging that the pharmacy chain’s widespread use of facial recognition technology, deployed…more

Artificial Intelligence, Facial Recognition Technology, Federal Trade Commission (FTC), FTC Act, Injunctive Relief

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Massachusetts Appeals Court Holds that Restrictive Covenants Created as Part of a Common Scheme May Be Extended Beyond Thirty Years Only if Explicitly Allowed in the Original Instrument

On December 5, 2017, the Massachusetts Appeals Court issued an important decision in Berger v. 2 Wyndcliff, LLC, No. 16-P-336 (Mass. App. Ct. Dec. 5, 2017), clarifying the extent to which land owners in a common-scheme…more

Land Developers, Land Owners, Local Ordinance, Property Owners, Real Estate Development

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How NFTs and Blockchain Secure Digital Sports Collectibles

Today, there are new opportunities to own a bit of sports history. It is now possible to even own a digital collectible of your favorite athlete making a play during a game. NFTs (non-fungible tokens) are being used to provide…more

Artists, Athletes, Blockchain, Counterfeiting, Digital Assets

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Key Considerations for Adopting Ephemeral Communications Tools

The combination of emerging technologies, information security risks and electronic discovery obligations continues to give rise to questions regarding best practices for adoption of modern ephemeral communication tools in lieu…more

Data Storage Providers, Discovery Costs, Duty to Preserve, Electronically Stored Information, Emerging Technology Companies

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Expanding Association Health Plans—Which Agencies Need to do What

On October 13th, President Trump signed an Executive Order directing various federal agencies to consider how to achieve three administration health reform objectives: (1) expand access to Association Health Plans (AHPs); (2)…more

Affordable Care Act, Association Health Plans, Centers for Medicare & Medicaid Services (CMS), Department of Labor (DOL), Employee Retirement Income Security Act (ERISA)

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Preparation for 2024 Fiscal Year-End SEC Filings and 2025 Annual Shareholder Meetings

Every year, Mintz provides analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange Commission and their annual shareholder meetings…more

Artificial Intelligence, Cybersecurity, Disclosure Requirements, Environmental Social & Governance (ESG), Publicly-Traded Companies

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SEC Provides Further Clarity in Rule 506(c) Offerings

On March 12, 2025, the Securities and Exchange Commission (the “SEC”) issued a No-Action Letter that provided guidance regarding the ways issuers can satisfy the accredited investor verification requirements of offerings made…more

Accredited Investors, Capital Markets, Disclosure Requirements, Investment, New Guidance

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Director Fiduciary Duties May Extend Post-Closing in Multi-Stage Transactions

A recent decision by the United States District Court for the Southern District of New York highlights directors’ fiduciary duty to evaluate all aspects of multi-stage transactions, including those portions to be effectuated…more

Aiding and Abetting, Breach of Duty, Business Judgment Rule, Fiduciary Duty, Motion to Dismiss

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IRA Update: IRS Releases Limited Guidance on Low-Income Community Adder and Establishes Allocation Program Needed to Make the Adder Available

On Monday, February 13, 2023, the Department of the Treasury (Treasury) and the IRS published Notice 2023-17 (the Notice), establishing the program for allocating environmental justice capacity limitations (the Allocation…more

Environmental Justice, Inflation Reduction Act (IRA), Investment Tax Credits, IRS, Low-Income Issues

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A New Age of Agency Rulemaking and Enforcement

As we prepare for the next Supreme Court term, we’d like to look back at some of the most significant opinions from the last session and their potential impact on corporate regulation. Of the dozens of opinions issued by the…more

Administrative Proceedings, Chevron Deference, Corporate Counsel, Enforcement, Loper Bright Enterprises v Raimondo

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[Podcast] Mintz on Air: Predictions and Practical Policies- Mandatory Metrics for NASDAQ Listed Companies

In the latest episode of the Mintz on Air: Predictions and Practical Policies Podcast, ESG Co-chair Jen Rubin hosts an in-depth discussion about mandatory diversity metrics and their relevance following the Fifth Circuit’s…more

Board of Directors, Capital Markets, Disclosure Requirements, Diversity, Diversity and Inclusion Standards (D&I)

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An Employee or an Independent Contractor?

The distinction between employees and independent contractors is often overlooked by emerging companies. However, the significance of this distinction in New York State cannot be overstated. As discussed further below, a…more

Employee Benefits, Employee Definition, Employer Liability Issues, Hiring & Firing, Independent Contractors

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With its Vanda Pharma and Berkheimer Memos, USPTO Provides Increased Clarity and Predictability in the Patent Eligibility Determination in a Further Boost for Stakeholders and Innovators in Personalized Medicine

In the time since the Federal Circuit issued its Vanda Pharma decision in April, Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. 887 F.3d 1117 (Fed. Cir. 2018), we have had more good news for the patent eligibility of claims…more

Intellectual Property Protection, Mayo v. Prometheus, Patent-Eligible Subject Matter, Patents, Personalized Medicine

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F-Reorgs: How Buyers’ and Sellers’ Favorite ‘F Word’ Optimizes M&A and Private Equity Transactions Involving S Corporations

In M&A and private equity transactions, buyers and sellers are consistently looking for ways to maximize value, which requires a critical focus on structuring the transaction in a tax-efficient manner. This pursuit of tax…more

Acquisitions, Asset Purchaser, Business Income, Buyers, C-Corporation

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PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends occurring…more

Abbreviated New Drug Application (ANDA), America Invents Act, Biologics, BPCIA, Food and Drug Administration (FDA)

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Ahoy! ITC Welcomes SEP Holders Navigating for The Best Venue

Given the recent unanimous decision by a UK appellate court that Ericsson’s injunction efforts based on standard-essential patents (“SEPs”) were, essentially by their very nature, “hold-up” and “coercion” that violated…more

Antitrust Provisions, Competition, Enforcement Actions, FRAND, Intellectual Property Protection

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Telephone and Texting Compliance News: Litigation Update — Courts Continue to Scrutinize Pleadings in TCPA Cases

A couple of recent district court decisions confirm that courts across the country continue to scrutinize and will dismiss complaints that contain conclusory and/or contradictory allegations without facts to support plaintiffs’…more

Facebook Inc v Duguid, Pleading Standards, Robocalling, TCPA, Telephone Service Providers

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Clean Edge 2014 Clean Energy Trends Report: Key Trends Emerging from 2013

We saw some key trends emerging and we are proud to be part of the Clean Edge 2014 Clean Energy Trends Report, released last week. The report highlights trends on the rise and provides a comprehensive glance back at 2013. Some…more

Clean Energy, Energy Sector, Solar Energy

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Private Equity Group and Hedge Fund Bills Continue Through the California Legislature

California legislative activity focused upon private equity group and hedge fund health care transactions continues notwithstanding California Governor Gavin Newsom’s veto last fall of California Assembly Bill 3129 (AB-3129). As…more

California, Health Care Providers, Healthcare, Hedge Funds, Hospitals

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NLRB Moves Away from Biden-Era Approach on Severance Agreements

As part of the Trump Administration’s significant efforts to roll back the Biden Administration’s policies, the Acting General Counsel of the National Labor Relations Board (the “NLRB”) recently rescinded, via Memorandum GC…more

Biden Administration, Compliance, Employment Contract, Employment Policies, Labor Reform

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Sustainable Energy & Infrastructure Connections — February 2025

The Mintz Sustainable Energy & Infrastructure Practice led record-size sustainable infrastructure projects over the past year and closed over 70 deals in 2024, helping clients raise over $4 billion. To support its explosive…more

Acquisitions, Artificial Intelligence, Clean Energy, Department of Energy (DOE), Energy Policy

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Scalpels Out: Implications for Energy from the First Reconciliation Bill Committee Releases

Both the House Energy and Commerce Committee and the House Ways and Means Committee released their portions of the reconciliation bill over the last week. While not as far-reaching as some feared, these initial revisions would…more

Clean Energy, Department of Energy (DOE), Electric Vehicles, Energy Policy, Energy Tax Incentives

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June Leader in the News: Axiom Exergy Closes $7.6 Million Series A with a New Thermal Storage Model for Grocery Stores

In May, Mintz Levin client Axiom Exergy closed an impressive $7.6 million Series A round to scale its cold-storage device for grocery stores, bringing its total fundraising to $12.5 million. Led by Shell Ventures and GXP…more

Battery, Electricity, Energy Efficiency, Energy Storage, Innovative Technology

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Benefits of Using Copyrights to Protect Artificial Intelligence and Machine Learning Inventions

We previously discussed which portions of an artificial intelligence/machine-learning (“AI/ML”) platform could be patented or protected under trade secret, such as related to biotech and synthetic biology. Equally important to…more

Artificial Intelligence, Copyright, Copyright Infringement, Inventions, Machine Learning

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Further Updates to the CPPA Proposed Regulations: Risk Assessments and Automated Decisionmaking Technology

After years of internal discussion, the Board of the California Privacy Protection Agency (CPPA), at their March 8th meeting, voted to progress toward formalizing the proposed regulations on risk assessments and automated…more

Artificial Intelligence, Automated Decision Systems (ADS), Bias, California Privacy Protection Agency (CPPA), Corporate Counsel

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New York Department of Health Publishes Material Transactions Reporting Form

In our February 14, 2025 blog post, we detailed a proposed expansion of Article 45-A of New York’s Public Health Law (hereinafter, the Disclosure of Material Transactions Law) included in the proposed Fiscal Year 2026 New York…more

Acquisitions, Disclosure Requirements, Government Agencies, Healthcare, Hospitals

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Staying Connected in the Busiest of Times

Adam Grant has published many good reads and I was reminded of his earlier work today ("Give and Take: Why Helping Others Drives Our Success"). So many lawyers across the legal industry are incredibly busy now and struggling to…more

Client Retention, Client Services, Law Firm Ownership, Law Practice Management, Relationship Development

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Preparing for an Exit: Selling Your Robotics Company

Robots are everywhere. Healthcare, logistics, manufacturing and other critical areas of the economy are being redefined by the robotics and artificial intelligence advances of today’s technology entrepreneurs. With this…more

Artificial Intelligence, Confidential Information, Drones, Emerging Technology Companies, Federal Acquisition Regulations (FAR)

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Supreme Court Declines to Weigh in on False Claims Act Pleading Requirements

The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims Act…more

False Claims Act (FCA), Federal Rules of Civil Procedure, Fraud, FRCP 9(b), Petition for Writ of Certiorari

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Supreme Judicial Court Affirms Award 0f $2,250,000 plus Interest Against Insurer for Breach of Duty to Defend and Settle — on $50,000 Policy

In Boyle v. Zurich American Insurance Company, SJC-11791 (Sept. 14, 2015), the Supreme Judicial Court (SJC) affirmed an award of $2,250,000 plus interest against an insurer for failing to defend its insured on a $50,000 policy…more

Breach of Duty, Commercial General Liability Policies, Damages, Denial of Insurance Coverage, Duty to Defend

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Treasury and IRS Release Final Tax Regulations for LIBOR Replacement Amendments

The lengthy saga of the transition to a post-LIBOR world reached a degree of finality on the tax side with the issuance by the Department of Treasury and Internal Revenue Service (IRS) of long-awaited final regulations (the…more

Alternative Reference Rates Committee (ARRC), Inter-Bank Offered Rates (IBORs), Internal Revenue Code (IRC), IRS, Libor

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Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the Anti-Kickback Statute Requires Knowledge that the Conduct is Unlawful

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the relator,…more

Anti-Kickback Statute, Corporate Misconduct, Criminal Prosecution, Dismissals, False Claims Act (FCA)

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Scalpels Out: Implications for Energy from the First Reconciliation Bill Committee Releases

Both the House Energy and Commerce Committee and the House Ways and Means Committee released their portions of the reconciliation bill over the last week. While not as far-reaching as some feared, these initial revisions would…more

Clean Energy, Department of Energy (DOE), Electric Vehicles, Energy Policy, Energy Tax Incentives

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First Circuit Adopts “But-For” Causation Standard for False Claims Act Cases Based on Anti-Kickback Statute Violations

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”…more

Anti-Kickback Statute, Causation, Compliance, Department of Justice (DOJ), Enforcement Actions

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Tenth Circuit Affirms Extraterritorial Reach of SEC Enforcement of the Federal Securities Laws

In the Traffic Monsoon litigation, the U.S. Court of Appeals for the Tenth Circuit held that the enforcement provisions of the Securities Act and the Exchange Act reach Traffic Monsoon’s sales to customers outside of the United…more

Cross-Border Transactions, Dodd-Frank, Enforcement Actions, Extraterritoriality Rules, Morrison v National Australia Bank

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[Podcast] Mintz on Air: Practical Policies - Can AI Make Good Decisions in the Workplace?

In the latest episode of the Mintz on Air: Practical Policies podcast, Member Jen Rubin hosts a conversation on the role of AI in human resources decision making in the workplace. This episode is part of a series of…more

Artificial Intelligence, Bias, Employer Liability Issues, Employment Discrimination, Employment Policies

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Five Tips For Every In-House Counsel Launching an Open Source Software Program

Used properly, Open Source Software (OSS) is an excellent tool. It saves your business time and money, enables interoperability of product platforms, and developers love it. But used improperly, it can be financially and…more

Bad Actors, Copyright, Copyright Infringement, Guidance Documents, Licenses

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Supreme Court in Jarkesy Limits the SEC’s Powers to Use In-House Administrative Courts

On June 27, the Supreme Court issued its decision in the closely-watched SEC v. Jarkesy, holding that the SEC could no longer seek civil monetary penalties for fraud in its in-house courts consistent with the Seventh Amendment,…more

Administrative Law Judge (ALJ), Article III, CFTC, Civil Monetary Penalty, Consumer Financial Protection Bureau (CFPB)

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Federal Circuit Affirms Delisting of REMS System Patent from FDA Orange Book

On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing Jazz…more

Abbreviated New Drug Application (ANDA), Appeals, Federal Food Drug and Cosmetic Act (FFDCA), Federal Trade Commission (FTC), Food and Drug Administration (FDA)

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Massachusetts Supreme Judicial Court Upholds Trustee’s Adjustment from Principal to Income

Trustees have many duties, including the duty of loyalty, the duty to invest prudently, and the duty of impartiality to all beneficiaries. Trustees must also effectuate the wishes of the trust’s settlor. These duties often…more

Beneficiaries, Capital Gains, Duty of Loyalty, MA Supreme Judicial Court, Probate

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EnforceMintz — False Claims Act Statistical Year in Review

Health Care Cases Spur Largest FCA Recoveries - Mintz’s annual report on False Claims Act case activity analyzes data from DOJ and the firm’s Health Care Qui Tam Database, and explores the 2024 record high in FCA case…more

Coronavirus/COVID-19, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Watch Your Language! Non-Pro Rata Uptier Transactions and the Serta and Mitel Decisions

Among the many financial innovations that came out of the COVID era, non-pro rata uptier transactions as a liability management exercise (“LMEs”) are among the more controversial. While lawsuits challenging non-pro rata uptier…more

Bankruptcy Court, Chapter 11, Corporate Restructuring, Creditors, Debt

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Understanding ESG Ratings: Legal Insights & Perspectives

With environmental, social, and governance (ESG) principles garnering increased attention in corporate circles in recent years, there has been an accompanying rise in demand for analytical products that evaluate companies’ ESG…more

Asset Management, Conflicts of Interest, Corporate Governance, Diversity and Inclusion Standards (D&I), Environmental Social & Governance (ESG)

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Multinational Patent Deal Complications

Entering into a patent purchase transaction is complicated.  Not surprisingly, purchasing assets that include Chinese originated technology is even more complicated.  Before signing a deal, make sure the diligence period allows…more

China, CNIPA, Exports, Foreign Entities, Multinationals

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Artificial Intelligence in the Employment Relationship: Friend or Foe?

Artificial Intelligence (“AI”) is no longer the stuff of sci-fi movies or alien invasions. The technology has permeated everyday life from Siri and Alexa to Facebook and Google.  While marketing teams have been relying on AI for…more

ADEA, Artificial Intelligence, Civil Rights Act, Employer Liability Issues, Equal Employment Opportunity Commission (EEOC)

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Second Circuit Clarifies the Circumstances in Which Presumptions Can Be Used To Support Federal Securities Fraud Class Action Lawsuits

On August 10, 2023, the U.S. Court of Appeals for the Second Circuit took an important step in Arkansas Teacher Retirement System v. Goldman Sachs Group toward clarifying the circumstances in which federal class action…more

Appeals, Basic v Levinson, Class Action, Class Certification, False Statements

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The OASB Annual Report to Congress for Fiscal Year 2020

In January 2019, the Office of the Advocate for Small Business Capital Formation (the “Office”) was formed “to advance the interests of small businesses and their investors at the SEC and in the capital markets.” These small…more

Capital Formation, Capital Markets, Coronavirus/COVID-19, Minority-Owned Businesses, Securities and Exchange Commission (SEC)

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2024 Post-Election Analysis

Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the popular…more

Affordable Care Act, Artificial Intelligence, Blockchain, Canada, Chevron Deference

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Section 409A Valuations: Mastering the Art and Science in a Volatile Venture Market

Within the unpredictable landscape of start-ups and private companies, market volatility can significantly alter a company’s financial trajectory. An integral part of navigating this volatility is understanding the role and…more

Acquisitions, Benchmarking, Fair Market Value, Intellectual Property Protection, IRS

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Energy & Sustainability Client Feature — FirstLight Power

This month we are excited to feature FirstLight Power, a leading clean power producer and energy storage company with operating and development assets in New England, Pennsylvania, New Jersey, and New York, including an…more

Clean Energy, Clean Power Plan, Energy Sector, Energy Storage, Investors

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Arbitration of SEP Disputes—A Growing Trend?

After years of litigating against each other in several jurisdictions around the world, Ericsson and Lenovo announced last week that they had entered into a global cross-licensing agreement involving 4G and 5G wireless…more

Arbitration, Dispute Resolution, FRAND, Intellectual Property Litigation, International Arbitration

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A Business Deal Could Kill Your Right to Challenge a Patent’s Validity

Last week, the Federal Circuit issued a decision holding that parties can contractually bargain away their rights to file petitions for Inter Partes Review (“IPR”) at the Patent Trial and Appeals Board (“the Board”). This…more

Confidentiality Agreements, Corporate Counsel, Forum Non Conveniens, Inter Partes Review (IPR) Proceeding, Patent Trial and Appeal Board

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The SJC Shocks Financial Services Industry by Taking Victory Away from Robinhood and Giving it to the Secretary of State

In a widely anticipated decision, the Massachusetts Supreme Judicial Court unanimously upheld the Massachusetts Fiduciary Duty Rule, which imposes a fiduciary duty standard on Massachusetts broker-dealers. The high Court’s…more

Broker-Dealer, Business Model, Enforcement, Fiduciary Duty, Fiduciary Rule

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Sustainable Energy & Infrastructure Connections — April 2025

A Note from the Editors Sustainable Energy & Infrastructure Connections brings the latest developments in energy investing, legal insights, company activity, and industry events straight to your inbox. This month’s edition…more

Acquisitions, Clean Energy, Energy Policy, Energy Sector, Infrastructure

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PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers…more

Competition, Cost-Sharing, Drug Pricing, Federal Trade Commission (FTC), Generic Drugs

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January 1, 2025 Deadline Is Fast Approaching for Compliance with the Corporate Transparency Act

The Corporate Transparency Act (CTA) requires entities, including corporations, limited liability companies, and limited partnerships, to file a beneficial ownership information (BOI) report with the Financial Crimes Enforcement…more

Beneficial Owner, Business Entities, Business Ownership, Compliance, Corporate Transparency Act

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Continuation Funds: Top 5 Considerations

For those who were unable to attend the recent Boston Private Equity Network (BPEN) panel and webinar on Continuation Funds – Moderated by Kari Harris, Investment Funds Chair at Mintz, and featuring Aly Champsi of DW Healthcare…more

Capital Raising, Credit, Infrastructure, Investment, Investment Adviser

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Phase 1 Construction Guidelines: Guidance for Real Estate Developers in New York City

On Monday New York City entered Phase 1 of re-opening. Phase 1 guidance provides specific guidelines relating to construction, manufacturing, whole trade and select retail (for curbside pickup only), agriculture, forestry and…more

Construction Industry, Coronavirus/COVID-19, Manufacturing Employers, New York, Re-Opening Guidelines

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PBM Legislation in the Reconciliation Bill is Far From Sweeping PBM Reform

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Medicaid, Medicare Part D, New Legislation

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Amendment to Delaware Law Permits Exculpation of Officers in Corporate Charters

Delaware has long permitted corporations to limit or eliminate monetary liability of directors from breach of fiduciary duty of care lawsuits. However, the same protections have not been afforded to a corporation’s officers…more

Board of Directors, Breach of Duty, Class Action, Corporate Counsel, Corporate Officers

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Telephone and Texting Compliance News: Litigation Update — One-to-One Consent Eleventh Circuit Challenge Dead

One-to-One Consent 11th Circuit Challenge Dead - As we previously reported, after the Eleventh Circuit vacated the Federal Communications Commission’s much-anticipated one-to-one consent rule in Insurance Marketing Coalition…more

Appeals, Class Action, Consent, Enforcement Actions, FCC

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Final Regulations Issued by Massachusetts Department of Family and Medical Leave – Health Maintenance During Leave

On January 6, 2023, the Massachusetts Department of Family and Medical Leave (DFML) published new Paid Family and Medical Leave (MAPFML) regulations (the 2023 Regulations). These regulations make changes to Section 458 CMR 2.16…more

Affordable Care Act, COBRA, Family and Medical Leave Act (FMLA), Final Rules, New Regulations

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Reduced Scope of March-in Rights Under Bayh Dole Rules Revisions

The Bayh Dole Act was enacted to provide incentives to promote commercialization of federally funded inventions and was designed to capitalize on the significant government investments in small business, university research, and…more

Bayh-Dole Act, Biden Administration, IP License, March-in-Rights, Patents

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Claimants Need Not Record Complaints to Enforce Lien Dissolution Bonds Under

In a recent decision, the Supreme Judicial Court of Massachusetts (SJC) has held that a contractor seeking to enforce a lien dissolution bond under G.L. c. 254 § 14 need not record an attested to copy of its complaint with the…more

Appeals, Construction Contracts, Deeds, Enforcement Actions, General Contractors

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FERC’s Landmark Transmission Order: Takeaways for Clean Energy and Energy Storage Companies

On May 13, 2024, the Federal Energy Regulatory Commission (FERC or Commission) issued Order No. 1920,[1] its long-awaited Final Rule relating to long-term regional planning and regional cost allocation. This article summarizes…more

Clean Energy, Compliance, Energy Sector, Energy Storage, FERC

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It’s Been a Long Time Coming: Massachusetts Health Care Market Review 2.0

The latest entrant in a national wave of policymakers enacting health care market oversight laws that have a significant impact on providers and investors, Massachusetts Governor Maura Healey has signed into law House Bill 5159,…more

Acquisitions, Compliance, Department of Justice (DOJ), False Claims Act (FCA), Health Care Providers

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TechConnect - Your Law Firm Link to Industry News - March 2017

Happy spring! This issue includes two articles that challenge conventional thinking. The first, called “Software is Still Patent Eligible,” makes the case that software patents can still be obtained. IP generally accretes in…more

America Invents Act, Equity, Innovator Liability, Liquidity, PaaS

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Key Considerations in Maximizing a Celebrity Brand

A celebrity should maximize the value of their brand by strategically monetizing every aspect of it. For example, one who becomes famous through the recording industry would consider a career in front of and behind a television…more

Advertising, Brand, Brand Registry, Celebrity Endorsements, Endorsements

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Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases…more

Clinical Laboratories, Diagnostic Imaging Services, Financial Conduct Authority (FCA), Healthcare, Hospitals

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California Supreme Court Upholds Employment Class Action Waivers, but Rejects Waivers of PAGA Claims

The California Supreme Court issued an important decision last week on the enforceability of employment class action waivers included in arbitration agreements. The result: private parties can contract for the waiver of the…more

Arbitration, Class Action, Class Action Arbitration Waivers, CLS Transportation, Employment Contract

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Public Benefit Corporations and the SPAC Surge

In Mintz’s recent article—“Public Benefit Corporations are Going Public,”—we predicted that, as Special Purpose Acquisition Companies (“SPACs”) reemerge as an alternative to initial public offerings (“IPOs”), Public Benefit…more

Corporate Governance, Environmental Social & Governance (ESG), Initial Public Offering (IPO), Public Benefit Corporation, Publicly-Traded Companies

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Part Two: To Pay, or Not to Pay (Rent) – California Landlord-Tenant Regulations During COVID-19

COVID-19 has flipped the landlord-tenant relationship on its head. Although evictions and recovering possession are off the table for now, landlords are eventually entitled to their full rent payments and are not necessarily…more

Business Interruption, Commercial Leases, Coronavirus/COVID-19, Eviction, Landlords

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Checklist for Foreign Companies Expanding into the US

You’re a foreign company looking to set up shop in the United States. You have weighed the pros and cons of expanding your business into the United States, c..onfirmed the compatibility of any products or services you offer with…more

Compliance, Employee Benefits, Foreign Corporations, Immigration, Labor Regulations

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U.S. Supreme Court Grants Cert in ADA “Tester” Case

In late March, the United States Supreme Court granted certiorari involving a case that could have a nationwide impact on lawsuits brought under Title III of the Americans with Disabilities Act (“ADA”). The case, titled Acheson…more

Americans with Disabilities Act (ADA), Appeals, Certiorari, Grants, Injunctive Relief

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Can a Consumer Plausibly Allege Your Product Labeling is False or Misleading Under California Law?

California’s consumer protection laws prohibit false advertising, as well as advertising that is “‘either actually misleading or which has a capacity, likelihood, or tendency to deceive or confuse the public.’” These claims are…more

Advertising, California, Consumer Protection Laws, Corporate Counsel, False Advertising

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Managing Multiple Bidders in the Sale of a Company

When selling a company through a competitive auction process, a seller may have multiple bidders seeking to purchase the target company. Having multiple bidders compete to purchase the target company can be advantageous to the…more

Auction, Buyers, Due Diligence, Purchase Agreement, Sellers

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Federal Circuit Clarifies That Secondary Considerations Must Be Considered Both Individually And As A Whole In An Obviousness Analysis

On August 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Volvo Penta of the Ams. LLC v. Brunswick Corp., Case No. 22-1765, vacated a Final Written Decision of the Patent Trial and Appeal Board (PTAB) holding all…more

Appeals, Inter Partes Review (IPR) Proceeding, Obviousness, Patent Infringement, Patent Trial and Appeal Board

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Third Time’s the Charm: Cal/OSHA’s Revised COVID-19 Prevention Emergency Temporary Standards (ETS) Is Effective Immediately

Cal/OSHA has approved revised Emergency Temporary Standards (ETS) and Governor Newsom has issued an executive order waiving the usual 10-day legal review and approval process by the Office of Administrative Law (OAL). This…more

Cal-OSHA, Coronavirus/COVID-19, Employer Responsibilities, Infectious Diseases, Office of Administrative Law

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Advance Regulatory Review of California Health Care Transactions by the New Office of Health Care Affordability to Begin in 2024

The health omnibus trailer SB-184, which created the Office of Health Care Affordability (OHCA), is set to usher in a significant change in California’s health care regulatory landscape. Beginning in 2024, certain health care…more

Anti-Competitive, California, Confidential Information, Health Care Providers, Healthcare

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The Value of Inclusive Leadership

A foundational component of corporate diversity, equity and inclusion programs is fostering an inclusive environment. A core question in building that environment and the corporate culture that supports it is: What is inclusive…more

Corporate Culture, Diversity, Diversity and Inclusion Standards (D&I), Equity, Leadership

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CCPA Breach Class Action Settlement About to Get “Minted”

Although the California Consumer Protection Act (“CCPA”) went into effect on January 1, 2020 and over 100 class actions referencing the CCPA have been filed to date, very few class actions have actually made their way to court…more

California Consumer Privacy Act (CCPA), Class Action, Class Action Settlement, Corporate Counsel, Cybersecurity

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Telephone and Texting Compliance News — February 2025

We are pleased to present our latest edition of Telephone and Texting Compliance News, providing insights and news related to the Telephone Consumer Protection Act (TCPA). In this month’s Regulatory Update, we cover the FCC’s…more

Compliance, Consent, Consumer Protection Laws, Enforcement Actions, FCC

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Consolidated Appropriations Act of 2021 Amends Bankruptcy Code - Part 3: Congress Gives Suppliers and Landlords a Shiny New Arrow in their Quiver to Challenge Preference Actions

As discussed in previous posts, the Consolidated Appropriations Act of 2021 (the “Act”) was signed into law on December 27, 2020, largely to address the harsh economic impact of the COVID-19 pandemic. For bankruptcy litigators…more

Bankruptcy Code, Clawbacks, Commercial Leases, Commercial Property Owners, Commercial Real Estate Market

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Offshore Wind Development May Get a Boost from Massachusetts

On October 13th, Gov. Charlie Baker filed legislation that would significantly enhance the support provided by Massachusetts for the development of offshore wind energy generation. His bill proposes that the state allocate…more

Offshore Wind, Proposed Legislation

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5 Key Takeaways | SI's Downtown 'Cats Discuss Artificial Intelligence (AI)

Recently, we brought together over 100 alumni and parents of the St. Ignatius College Preparatory community, aka the Downtown (Wild)Cats, to discuss the impact of Artificial Intelligence (AI) on the Bay Area business community…more

Artificial Intelligence, Business Development, Emerging Technologies, Innovation, Investment

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OCR Proposes Sweeping HIPAA Security Rule Amendments

Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would…more

Compliance, Data Breach, Electronic Protected Health Information (ePHI), Food and Drug Administration (FDA), Hackers

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FDA Places Two Food Orders on Restaurants’ Tables

The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the…more

Consumer Protection Laws, Coronavirus/COVID-19, Food and Drug Administration (FDA), Food Labeling, Food Safety

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Treasury and IRS Release Final Tax Regulations for LIBOR Replacement Amendments

The lengthy saga of the transition to a post-LIBOR world reached a degree of finality on the tax side with the issuance by the Department of Treasury and Internal Revenue Service (IRS) of long-awaited final regulations (the…more

Alternative Reference Rates Committee (ARRC), Inter-Bank Offered Rates (IBORs), Internal Revenue Code (IRC), IRS, Libor

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Restrictive Covenants in Private Equity Transactions

Restrictive covenants are unquestionably a significant deal consideration in M&A transactions. In the private equity context, a buyer is focused on restrictive covenants to protect its investment by binding the sellers and other…more

Confidentiality Agreements, Contract Terms, Due Diligence, Enforcement, Intellectual Property Protection