Mintz Levin

Third-Party Protections In Mass Tort Chapter 11 Cases

A defendant facing thousands of mass tort lawsuits in federal and state courts throughout the country often will seek to address the litigation by seeking Chapter 11 relief under the Bankruptcy Code. The Chapter 11 process…more

Automatic Stay, Bankruptcy Code, Chapter 11, Commercial Bankruptcy, Liability Insurance

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FCC Releases Declaratory Ruling Clarifying and Expanding the Reach of the Telephone Consumer Protection Act

On July 10, 2015 the Federal Communications Commission (“FCC”) released a Declaratory Ruling and Order clarifying its interpretation of the Telephone Consumer Protection Act (“TCPA”) and expanding its reach…more

Auto-Dialed Calls, Declaratory Rulings, FCC, Prior Express Consent, Revocation

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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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Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases..…more

False Claims Act, Healthcare, Medicare Part D, Pharmaceutical, Pharmacies

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Crowdfunding and IP in Health and Biotech Start-ups (Part 3): Potential Dangers

This is the third in a 3-part series about the use of crowdfunding in health and biotech start-ups. We started with the story of a tech start-up which set records for funding through a Kickstarter campaign, triggering the…more

Crowdfunding, Entrepreneurs, JOBS Act, Popular, Private Equity

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Federal Court Dismisses (Without Prejudice) CNA’s Cyber Insurance Lawsuit

We previously reported that CNA filed a lawsuit against its insured Cottage Health System seeking reimbursement of amounts that it previously paid under Cottage’s cyber liability insurance policy. On Friday, a federal district…more

CNA, Cyber Insurance, Mediation

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Comments on Proposed Rules Amendments (Rules 26, 34, and 37)

Mintz Levin compliments the Committee and supports the proposed amendments to the Federal Rules of Civil Procedure because, on balance, the proposals seek to reduce the costs of discovery and litigation of document preservation…more

Federal Rules of Civil Procedure, Proposed Amendments

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ACA Countdown to Compliance - 52 Week Series For Employers

In this volume, we have collected the 52 weekly blog posts that comprise the series entitled, The Affordable Care Act—Countdown to Compliance for Employers. The series appeared in the Mintz Levin Employment Matters Blog during…more

ADA, Affordable Care Act, Cafeteria Plans, EEOC, Employer Group Health Plans

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The PTAB Explores Estoppel in New Representative Decision

The Patent Trial and Appeal Board (PTAB) recently announced the addition of its March 26, 2015 decision in Dell, Inc. et al. v. Electronics and Telecomms. Res. Inst., IPR2015-00549 (“the ‘549 IPR”) to its online list of…more

Dell, Estoppel, Patent Trial and Appeal Board, Patents, Prior Art

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Suprema, Inc. v. ITC: En Banc Federal Circuit Confirms ITC’s Jurisdiction to Exclude Articles Based on Induced Infringement

On August 10, 2015, the full US Court of Appeals for the Federal Circuit issued its en banc opinion in Suprema, Inc. v. ITC, which overturned an earlier panel decision and confirmed, by a 6–4 vote, that the International Trade…more

Appeals, Chevron Deference, En Banc Review, Imports, Induced Infringement

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New York Becomes First State Raise Minimum Wage to $15 . . . For Fast Food Workers

A panel appointed by New York Governor Andrew Cuomo recommended a minimum hourly wage increase to $15 for fast food service workers on Wednesday. The recommendation comes just three months after Governor Cuomo tasked the…more

Fast-Food Industry, Governor Cuomo, Labor Commissioners, Low-Wage Workers, Minimum Wage

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The Latest Keyword Advertising Battle: The 10th Circuit Finds No Infringement Based on Use of Another’s Trademark to Generate Sponsored Advertisements

Over the past few years, numerous trademark infringement suits have been filed over keyword advertising. Last month, the 10th Circuit weighed in on this subject, issuing a decision with broad implications. In 1-800 Contacts,…more

Google, Infringement, Keyword Advertising, Keyword Search, SEO

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Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting…more

AMP v Myriad, Diagnostic Tests, DNA, Mayo v. Prometheus, Patent-Eligible Subject Matter

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Massachusetts Legislature Ends Active July with Budget Overrides

After a busy final few weeks of activity, the Massachusetts Legislature departed for its summer recess with a new budget and progress on several priority policy issues. In addition to overriding $97 million in Governor Baker’s…more

Ballot Measures, Carbon Emissions, Corporate Governance, Department of Revenue, Foreclosure

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Prepare for the Japanese Patent Opposition System Coming Soon

The Japanese Patent Act was revised on May 14, 2014 to provide for post-grant oppositions within one year of the rule change, i.e., by May 14, 2015 (the exact effective date has not yet been set). Under the new opposition…more

Intellectual Property Litigation, Japan, Patent Litigation, Patents, Post-Grant Review

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Ninth Circuit Upholds Judge Robart’s RAND Determinations in Microsoft v. Motorola

Late last month, the Ninth Circuit Court of Appeals issued its much-anticipated decision in Microsoft v. Motorola, a breach of contract action brought by Microsoft alleging that Motorola violated its commitment to license its…more

Anti-Suit Injunctions, Breach of Contract, Covenant of Good Faith and Fair Dealing, Damages, ITC

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California Update: New Laws Give Residential and Commercial Tenants Rights to Install EV Charging Stations and Streamline Residential Solar Permitting

Last month Governor Brown signed AB 2565, which gives residential and commercial tenants new rights to install electric vehicle (EV) charging stations, and AB 2188, which directs cities and counties to streamline permitting for…more

Auto Manufacturers, Automotive Industry, Commercial Leases, Commercial Tenants, Electric Vehicles

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Mintz Levin Alumni Profile — Flora Feng, Senior Director & Legal Counsel, Asia Pacific Region, PepsiCo

Narges Kakalia, a member in the litigation section in our New York office, recently sat down with Mintz Levin alumna Flora Feng, Senior Director & Legal Counsel, Asia Pacific Region for PepsiCo to discuss career transitions, the…more

Women in the Law

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Why Directors and Officers Should Demand a Separate Indemnification Agreement

Corporate directors and officers (“D&O’s”) face significant personal exposure whenever their corporation is involved in a dispute or investigation. For this reason, prudent D&O’s avail themselves of all available legal…more

Board of Directors, Bylaws, Corporate Charters, Corporate Officers, D&O Insurance

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CAFC Delivers Another Decision on Patentability of Myriad Patents

In Univ. of Utah Res. Foundation et al. v. Ambry Genetics Corp., No. 2014-1361 (Fed. Cir. Dec. 17, 2014), the Federal Circuit once again has weighed in on the patent eligibility of Myriad Genetics, Inc.’s patents related to…more

Ambry, AMP v Myriad, Genetic Materials, Myriad v Ambry, Patent Infringement

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The Legal and Regulatory Landscape for Wellness Plans: The Affordable Care Act and Beyond

The Patient Protection and Affordable Care Act (the ‘‘Act’’) generally encourages employers to adopt wellness plans and programs in conjunction with their group health plans. Wellness plan vendors tout these arrangements with…more

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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, FDA, Inspections, Pharmaceutical

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New Swap Business Conduct and Record-Keeping Regulations Kick in for Municipal Bond Issuers and Borrowers

Beginning May 1, 2013, many new business conduct regulations adopted by the Commodity Futures Trading Commission (“CFTC”) pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”) will begin to…more

Borrowers, CFTC, Dodd-Frank, End-Users, ISDA

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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, Solar Energy

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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

CMS, Healthcare Providers, Managed Care Contracts, Medicaid

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FCC Releases Declaratory Ruling Clarifying and Expanding the Reach of the Telephone Consumer Protection Act

On July 10, 2015 the Federal Communications Commission (“FCC”) released a Declaratory Ruling and Order clarifying its interpretation of the Telephone Consumer Protection Act (“TCPA”) and expanding its reach…more

Auto-Dialed Calls, Declaratory Rulings, FCC, Prior Express Consent, Revocation

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The Affordable Care Act’s Reporting Requirements for Carriers and Employers (Part 7 of 24): Mergers and Acquisitions

When it comes to mergers and acquisitions involving at least one applicable large employer (ALE), the substantive rules governing employer shared responsibility (under Internal Revenue Code § 4980H) and the corresponding…more

Affordable Care Act, Asset Purchaser, COBRA, Employer Group Health Plans, Final Rules

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The New Rule 506: a Useful Crowdsourcing Tool

When the JOBS Act was passed in the spring of 2012, all the “buzz” was about the imminent advent of “Crowdfunding.” But as legal practitioners, business persons, and pundits looked closer at the details under the Crowdfunding…more

Advertising, Crowdsourcing, Dodd-Frank, General Solicitation, JOBS 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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Potential Shareholder Liability Arising From Subsidiary WARN Act Violations

When a company begins experiencing financial difficulty, shareholders often ask whether they may be liable under the Federal Worker Adjustment and Retraining Notification (“WARN”) Act for violations by the company. When the…more

Employer Liability Issues, Involuntary Reduction in Force, Joint Employers, Joint Liability, Liability

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Obama Administration Outlines Religious Accommodations for Contraception Coverage Mandate

Last week, federal regulators released a Proposed Rule outlining accommodations for religious employers that object to the Affordable Care Act’s contraception coverage mandate. The Proposed Rule expands the range of employers…more

Affordable Care Act, Contraceptive Coverage Mandate, Exemptions, Reasonable Accommodation, Religious Institutions

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Data Breach Affects Millions of Current and Former Government Workers

The U.S. Office of Personnel Management (OPM) announced that hackers have stolen the personal information of approximately 4 million current and former federal employees, including names, birthdates and social security numbers. …more

Cyber Attacks, Cybersecurity, Data Breach, Data Protection, DHS

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Five Key Decisions for ACOs Looking to Participate in the 2015 MSSP

The Centers for Medicare & Medicaid Services (CMS) has announced the upcoming deadlines for the third round of new applications to the Medicare Shared Savings Program (MSSP). Accountable Care Organizations (ACOs) that…more

ACOs, Affordable Care Act, CMS, Healthcare

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New Swap Business Conduct and Record-Keeping Regulations Kick in for Municipal Bond Issuers and Borrowers

Beginning May 1, 2013, many new business conduct regulations adopted by the Commodity Futures Trading Commission (“CFTC”) pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”) will begin to…more

Borrowers, CFTC, Dodd-Frank, End-Users, ISDA

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Energy Technology Connections Newsletter: Your Law Firm Link to Industry News - June 2015

In This Issue: - Leaders in the News - Innovator Profile - Event Highlights - Washington Update - Energy Navigator - Upcoming Events - Excerpt from Leaders in the…more

DOE, Emerging Growth Companies, Emerging Technology Companies, Energy Projects, Energy Sector

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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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Washington Outlook for 2015

In This Issue: - Introduction - Agriculture, Food Safety, and Nutrition - Appropriations, Budget, and Debt Ceiling - Defense and National Security - Education - Energy and Environment - Financial…more

Appropriations Bill, Defense Sector, Department of Transportation, Energy Policy, Environmental Policies

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Applying for a Waiver From U.S. Manufacturing Requirements For Federally Funded Intellectual Property

Countless ideas and inventions are developed at U.S. universities every year, often with federal funding. Many of these important ideas could not be commercialized for the public’s benefit without the Bayh-Dole Act, which…more

Assignment of Inventions, Bayh-Dole Act, Federal Funding, Foreign Manufacturers, GAO

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Don’t Discount Computer-Related Inventions from Patentability

There is a general belief that it is not worth applying for patent protection for computer-implemented inventions and software in Europe because the legislation, at first glance, excludes computer programs and business methods…more

Computer-Related Inventions, Patent-Eligible Subject Matter, Patentability Search, Patents

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FCC Clarifies Rule Governing Foreign Ownership of Broadcast Stations

On November 14, 2013, the Federal Communications Commission (“FCC”) adopted a Declaratory Ruling (“Ruling”) clarifying its policies and procedures for reviewing applications or proposed transactions in the broadcasting industry…more

Consent, FCC, Filing Requirements, Foreign Ownership, Telecommunications

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New Swap Business Conduct and Record-Keeping Regulations Kick in for Municipal Bond Issuers and Borrowers

Beginning May 1, 2013, many new business conduct regulations adopted by the Commodity Futures Trading Commission (“CFTC”) pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”) will begin to…more

Borrowers, CFTC, Dodd-Frank, End-Users, ISDA

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Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date has…more

Biosimilars, FDA, Notification Requirements, Orange Book, Pharmacies

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IEEE Clarifies RAND Commitment for Standard-Essential Patents

On February 8, 2015, the Board of Governors of the Institute of Electrical and Electronics Engineers (“IEEE”) approved changes to the IEEE Patent Policy that provide additional specificity as to the nature of the obligation…more

DOJ, IEEE, Patents, RAND, Standards-Essential Patents

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Patentability of Software Post-Alice: How Do Courts Determine Whether an Idea is Abstract ?

Since the Supreme Court’s decision in Alice Corp. v. CLS Bank Int’l on patentable subject matter, courts have tried to follow the prescribed framework. Under Alice, patent claims are invalid if directed to “abstract ideas” and…more

Bilski, CLS Bank v Alice Corp, Mayo v. Prometheus, New Guidance, Patent-Eligible Subject Matter

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These Taxi Drivers Are Not Employees Says Massachusetts Supreme Judicial Court

We have been following the high-publicity battle between Uber and Lyft, on the one hand, and the drivers on the other, over whether the drivers are properly classified as independent contractors. Uber and Lyft argue they are…more

Drivers, Employee Definition, Independent Contractors, Leases, Lyft

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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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Effective September 12, 2014: New Fees for Some Nonimmigrant and Immigrant Visas

The Department of State (DOS) has revised certain nonimmigrant and immigrant visa fees. DOS has adjusted the visa fees in the following categories..…more

Department of State, Fees, Non-Immigrant Visas, Special Immigrant Visas, Visas

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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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UK High Court confirms jurisdiction to grant cross-border declaration of non-infringement

In Actavis Group HF v. Eli Lilly & Co. the UK High Court has granted a declaration of non-infringement in the UK, France, Italy and Spain. A jurisdictional challenge in relation to the French, Italian and Spanish jurisdictions…more

Actavis Inc., Cross-Border, EU, Foreign Jurisdictions, Jurisdiction

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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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A HYPOTHETICAL: Testimony of a U.S. Business Owner Before the U.S. House of Representatives Subcommittee on Immigration and Border Security

Mr. Chairman, I’m pleased to provide my testimony today as a follow-up to previous appearances before this committee. I’ve testified on two other occasions to explain the need for a more certain and predictable way to attract…more

Foreign Subsidiaries, Global Economy, Highly-Skilled Workers Visa, Visas

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Surprise! You Get to Arbitrate! Massachusetts Courts Continue to Permit Third Parties to Enforce Arbitration Agreements

Two Massachusetts decisions—including one from the state’s highest court—applied the same standard regarding enforcement of an agreement to arbitrate. In each case, plaintiffs signed arbitration agreements with another party. …more

Arbitration, Arbitration Agreements, Employment Contract, Ernst & Young

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Drug Pumps Are Vulnerable to Hacking, FDA Warns

Last Friday, the Food and Drug Administration (FDA) issued a statement warning that certain drug infusion pumps that administer medication to patients are vulnerable to being hacked. The statement focused on the Symbiq Infusion…more

Cyber Threats, Cybersecurity, Data Security, DHS, FDA

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Are “Personal Flamethrowers” Under the Jurisdiction of the CPSC?

Yes. You read that correctly. Two US companies are selling personal flamethrowers to the public. Once grisly weapons of war, the flamethrowers are now being marketed for more practical purposes such as clearing brush and snow,…more

ATF, CPSC

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The Supreme Court Takes the BIA to Task

Yesterday, in an opinion authored by Justice Ruth Bader Ginsburg, the U.S. Supreme Court brought a measure of hope to non-citizens facing deportation on the basis of certain minor criminal convictions. In Mellouli v. Lynch, the…more

BIA, Convictions, Deportation, Illegal Drugs, Immigrants

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Massachusetts Earned Sick Time Law Takes Effect July 1st

The Massachusetts Earned Sick Time Law, which requires nearly all Massachusetts employers to provide earned sick time to employees, goes into effect on July 1, 2015. Unless they qualify for the limited safe harbor provision…more

Earned Sick Time, Paid Leave, Safe Harbors, Sick Leave

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Energy & Environment Update - May 2015

In This Issue: - Energy and Climate - Congress - Administration - Department of Energy - Department of Interior - Environmental Protection Agency - Energy Regulatory Commission - Nuclear…more

Clean Energy, Energy Tax Incentives, EPA, Nuclear Regulatory Commission, Tax Reform

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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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Federal Court Rules That Issuers Face Strict Liability for Erroneous Statements About Legal Compliance in Registration Statements, Even if They Did Not Know the Statements Were False

A recent federal appeals court decision addressing pleading standards for shareholder suits under Section 11 of the Securities Act of 1933, as amended, highlights the potential dangers of giving broad assurances of legal…more

Biotechnology, Compliance, Derivative Suit, False Statements, Healthcare

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Crowdfunding and IP in Health and Biotech Start-ups (Part 3): Potential Dangers

This is the third in a 3-part series about the use of crowdfunding in health and biotech start-ups. We started with the story of a tech start-up which set records for funding through a Kickstarter campaign, triggering the…more

Crowdfunding, Entrepreneurs, JOBS Act, Popular, Private Equity

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FCC Releases Declaratory Ruling Clarifying and Expanding the Reach of the Telephone Consumer Protection Act

On July 10, 2015 the Federal Communications Commission (“FCC”) released a Declaratory Ruling and Order clarifying its interpretation of the Telephone Consumer Protection Act (“TCPA”) and expanding its reach…more

Auto-Dialed Calls, Declaratory Rulings, FCC, Prior Express Consent, Revocation

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FDA Denies Request to Make “Patent Dance” a Prerequisite for Biosimilar Approval

In a decision released on March 25, 2015, FDA denied a Citizen’s Petition that would have effectively made the information and patent exchange described in § 262 of the Biologics Price Competition and Innovation Act (“BPCIA”) a…more

Amgen, Biosimilars, BPCIA, FDA, Pharmaceutical Patents

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Washington Outlook for 2015

In This Issue: - Introduction - Agriculture, Food Safety, and Nutrition - Appropriations, Budget, and Debt Ceiling - Defense and National Security - Education - Energy and Environment - Financial…more

Appropriations Bill, Defense Sector, Department of Transportation, Energy Policy, Environmental Policies

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Pay Equity Legislation Aims to Eliminate Wage Disparities Between Genders in Massachusetts

In a hearing before the Joint Committee on Labor and Workforce Development on Tuesday, July 21, roughly two dozen lawmakers and a wide range of business officials, advocacy groups, non-profit leaders, and academics testified in…more

Attorney's Fees, Disparate Treatment, Employee Rights, Equal Pay, Gender Discrimination

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The Supreme Judicial Court Declares that Inexpensive Market-Rate Housing May Not Be Counted in Determining a Town’s Compliance with Chapter 40B

On Tuesday, in Zoning Board of Appeals of Lunenburg v. Housing Appeals Committee, the Supreme Judicial Court soundly rejected a zoning board of appeals’ argument that inexpensive market-rate homes may be counted toward a town’s…more

Affordable Housing, Land Developers

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MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,…more

Affordable Care Act, CMS, EHR, Electronic Health Record Incentives, Electronic Medical Records

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New Global Patent Prosecution Highways to Accelerate Examination of Patents

The Patent Prosecution Highway (PPH) gives applicants the opportunity to accelerate the examination of their patent applications in multiple countries once they have received a favourable report in one country. This is useful…more

Patent Litigation, Patent Prosecution, Patent Prosecution Highway, Patents

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FCC Clarifies Rule Governing Foreign Ownership of Broadcast Stations

On November 14, 2013, the Federal Communications Commission (“FCC”) adopted a Declaratory Ruling (“Ruling”) clarifying its policies and procedures for reviewing applications or proposed transactions in the broadcasting industry…more

Consent, FCC, Filing Requirements, Foreign Ownership, Telecommunications

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Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds

On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss a…more

ANDA, DaimlerChrysler v Bauman, Drug Manufacturers, Forum, Generic Drugs

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CMS Finally Releases Proposed Rules for Medicaid Managed Care

On Friday, Mintz Levin Health Law and ML Strategies posted an advisory on CMS’s proposed Medicaid Managed Care rules. This advisory provides contextual background, a helpful overview of the rule’s contents, and an in-depth…more

CMS, Health Insurance, Insurers, Managed Care Contracts, Medicaid

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Petitioners Must Present Sufficient Evidence to Establish Inherency

Last Friday the Patent Trial and Appeal Board (PTAB) denied four Sandoz Inc. petitions for instituting inter partes review (IPR) of U.S. 8,455,524 (IPR2015-00005), U.S. 7,612,102 (IPR2015-00006), U.S. 7,659,290 (IPR2015-00007),…more

Inter Partes Review Proceedings, Patent Trial and Appeal Board, Patents, Pharmaceutical Manufacturers, Pharmaceutical Patents

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Top Issues for Employers in 2013: Social Media & Independent Contractors

Employment lawyers anticipate that employers’ social media policies and their use of independent contractors will be hot button issues in the New Year, much like they were in 2012... …more

Independent Contractors, Misclassification, NLRA, NLRB, Social Media

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Forward-Publishing Patents: A Way to Tell Competitors “Stay Out”?

On March 10, 2014, Sonos announced it would forward-publish its patent applications before they would traditionally be available to the public. This has given rise to quite a bit of discussion in patent legal circles. What are…more

Forward Publishing, Patent Applications, Patents

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Breaking Down the DOJ Cybersecurity Unit’s Guidance on Responding to Cyberattacks

Another federal agency has weighed in with “guidance” on cybersecurity preparation and breach response. The Department of Justice (DOJ) is the latest to issue guidance on how companies should respond to data breaches. The…more

Corporate Counsel, Cyber Attacks, Cybersecurity, Data Breach, DOJ

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Data Dump! AshleyMadison.com Fallout Deepens

The Impact Team, the vigilante group behind the hacking of the infamous website AshleyMadison.com has followed through on its threat to leak the full database of the site’s users online. On Tuesday, August 18, 2015, an…more

Ashley Madison, Credit Cards, Data Breach, Data Protection, Hackers

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The SEC’s Common Sense Approach to Private Placements and General Solicitation

Earlier this month the SEC issued concurrently (i) the Citizen VC No Action Letter (in response to a request for guidance authored by Mintz Levin) relating to the use of 506(b) for a private placement online and (ii) a series of…more

CD&I, General Solicitation, No-Action Letters, Private Placements, Regulation D

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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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U.S. Supreme Court Decides Aereo Internet Broadcast Television Case

Yesterday, the U.S. Supreme Court released its widely-anticipated decision in American Broadcasting Cos., Inc. et al. v. Aereo, Inc., wherein it reversed and remanded for further consideration a decision by the U.S. Court of…more

Aereo, Broadcasting, Copyright, Copyright Infringement, Internet Streaming

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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, Solar Energy

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FLSA Collective Action: Supreme Court Holds Offer of Judgment Moots Claim

Does a “make whole” offer of judgment to the lead plaintiff in a wage and hour collective action put an end to the case? According to the US Supreme Court, the answer is “yes”- at least on the specific facts of the case before…more

Collective Actions, FLSA, Genesis HealthCare, Genesis Healthcare Corp. v. Symczyk, Mootness

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California Sick Leave Amendments Offer (Some) Needed Clarity for Employers

The California paid sick leave law provided a significant boon to employees not included under employers’ sick leave or paid time off policies, but it often created more questions than answers for companies. How do we calculate…more

Accrued Benefits, PTO, Sick Leave

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Newsflash, Politico: ‘Patent Death Squad’ Alive and Well

Politico, the popular political journalism publication, recently ran the story “Patent Reform Advocates: PTO Process Not Patent ‘Death Squad.’” The story was based on a blog post by patent reform advocate Unified Patents. …more

America Invents Act, Inter Partes Review Proceedings, Non-Practicing Entities, Patent Litigation, Patent Trial and Appeal Board

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Lyondell: Is the Safe Harbor Closed to Former Shareholders of LBOs?

In a recent decision by the United States Bankruptcy Court for the Southern District of New York, Weisfelner, v. Fund 1, et al. (In re Lyondell Chem. Co.), 2014 Bankr. LEXIS 159 (Bankr. S.D.N.Y. January 14, 2014), the Court…more

Fraudulent Transfers, Leveraged Buyout, Safe Harbors, Shareholders, Transfers

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First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained a…more

Commercial Speech, Drug Manufacturers, FDA, FFDCA, Free Speech

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Supreme Court Delivers Unanimous Decisions in Two Important Patent Cases: What Do This Week’s Limelight and Nautilus Decisions Mean for You?

Earlier this week, the United States Supreme Court delivered unanimous opinions in two separate cases addressing questions of patent law, Limelight Networks v. Akamai Technologies (on induced infringement) and Nautilus v. Biosig…more

Akamai Technologies, Claim Construction, En Banc Review, Induced Infringement, Limelight Networks

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The SEC’s Common Sense Approach to Private Placements and General Solicitation

Earlier this month the SEC issued concurrently (i) the Citizen VC No Action Letter (in response to a request for guidance authored by Mintz Levin) relating to the use of 506(b) for a private placement online and (ii) a series of…more

CD&I, General Solicitation, No-Action Letters, Private Placements, Regulation D

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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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Pay Equity Legislation Aims to Eliminate Wage Disparities Between Genders in Massachusetts

In a hearing before the Joint Committee on Labor and Workforce Development on Tuesday, July 21, roughly two dozen lawmakers and a wide range of business officials, advocacy groups, non-profit leaders, and academics testified in…more

Attorney's Fees, Disparate Treatment, Employee Rights, Equal Pay, Gender Discrimination

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Immigration-Related Documents and Information Not Discoverable in Wage and Hour Lawsuit

A New York federal court recently said that the plaintiff-employees involved in a wage and hour lawsuit are not required to produce their immigration documents and information. The case is important because it limits an…more

Corporate Counsel, Discovery, DOL, Employment Authorization Document, FLSA

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Carnegie Mellon University v. Marvell: $1.5 Billion at Stake at the Federal Circuit

Currently on appeal to the United States Court of Appeals for the Federal Circuit is Carnegie Mellon University’s (“CMU”) $1.535 billion judgment for patent infringement against Marvell Technology Group Ltd. and Marvell…more

Appeals, Carnegie Mellon, Colleges, Non-Practicing Entities, Patent Infringement

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Duty to Monitor Investments Extends Statute of Limitations for Fiduciary Breach Claim Says Supreme Court

The Supreme Court has decided an important statute of limitations issue in an ongoing fiduciary breach case, Tibble v. Edison International. Tibble has attracted attention up to this point for its substantive claim: that plan…more

401k, Benefit Plan Sponsors, ERISA, Fiduciary Duty, SCOTUS

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Survival of Reps and Warranties: Avoiding Unpleasant Surprises for Buyers

Survival of representations and warranties (“reps and warranties”) is among the staples of highly negotiated provisions in M&A purchase agreements. The length of the survival period limits the time during which claims may be…more

Breach of Contract, Breach of Warranty, Representations and Warranties, Statute of Limitations, Survival Clauses

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European patents to take effect in Morocco

From 1 March 2015, a new agreement will come into force that allows European patents to be validated in Morocco. This is the first time that a non-member country of the European Patent Organisation will have recognised European…more

EU, European Patent Office, Morocco, Patents

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Supreme Court Rewrites the Rules for Individual Campaign Contributions: McCutcheon v. Federal Election Commission

On April 2, 2014, the Supreme Court of the United States rendered the McCutcheon decision, addressing the facial validity of Section 203 of the Bipartisan Campaign Reform Act of 2002 (the “BCRA”). This case involved a challenge…more

FEC, McCutcheon v. FEC, Political Contributions, SCOTUS

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Paths to Dispute Resolution

In order to understand the best approach to solving a business dispute, counsel must understand the client's business objectives. A need to win at all costs will drive one particular strategy, while a need to resolve the dispute…more

Arbitration, Business Disputes, Business Litigation, Mediation

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Mintz Levin Health Care Qui Tam Update - July 2015

Trends & Analysis - ..We have identified 36 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of these cases, eight were filed within the last year. A number of…more

Anti-Kickback Statute, False Claims Act, Healthcare, Intervenors, Medicare

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EU Data Protection Regulation – Did you know there’s an app for that?

As EU data protection watchers know, the draft General Data Protection Regulation (which has been around long enough to be universally referred to by its acronym, GDPR) exists in three major versions, with a fourth version…more

Data Privacy, Data Protection, EDPS, EU, EU Council of Ministers

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Onward to Trial: Federal Court Rejects Vermont’s Motion to Dismiss GMA Lawsuit

Despite a stiff litigation challenge from the food industry, Vermont’s GMO-labeling campaign marches on. This week saw major developments in the suit brought by the Grocery Manufacturers’ Association and other food industry…more

Commerce Clause, First Amendment, Food Labeling, Food Manufacturers, GMO

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The Patchwork Solidifies: GMO Bill Moves Forward in the House

The proposed Federal regulation of GMOs is proceeding. Following the White House’s recent action on GMOs, Representative Pompeo’s “Safe and Accurate Food Labeling Act” (H.R. 1599) was passed by the House Agriculture Committee on…more

All Natural, Biotechnology, Department of Agriculture, Farms, FDA

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FCC Releases Declaratory Ruling Clarifying and Expanding the Reach of the Telephone Consumer Protection Act

On July 10, 2015 the Federal Communications Commission (“FCC”) released a Declaratory Ruling and Order clarifying its interpretation of the Telephone Consumer Protection Act (“TCPA”) and expanding its reach…more

Auto-Dialed Calls, Declaratory Rulings, FCC, Prior Express Consent, Revocation

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Cap Gap Expiration Approaching: Some Employees' Work Authorization May End on October 1, 2015

Fiscal year 2016 cap-subject H-1B petitions selected and approved by USCIS will be valid starting October 1, 2015. However, as October 1, 2015 approaches, many cap-subject H-1B petitions remain pending at both the California and…more

Employment Authorization Document, F-1, H-1B, Non-Immigrant Visas, USCIS

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Supreme Court Decides Qui Tam First-to-File Issues

Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss. Since…more

False Claims Act, Healthcare, KBR (formerly Kellogg Brown & Root), Kellogg Brown & Root, Qui Tam

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Supreme Court Rewrites the Rules for Individual Campaign Contributions: McCutcheon v. Federal Election Commission

On April 2, 2014, the Supreme Court of the United States rendered the McCutcheon decision, addressing the facial validity of Section 203 of the Bipartisan Campaign Reform Act of 2002 (the “BCRA”). This case involved a challenge…more

FEC, McCutcheon v. FEC, Political Contributions, SCOTUS

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

Trends & Analysis: ..We have identified 33 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. In addition, we have also identified one case in…more

Anti-Kickback Statute, Clinical Trials, False Claims Act, Hospitals, Medical Devices

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Registration Requirements Eased for Brokers and Financial Advisors in M&A Transactions

We are often asked whether a financial advisor or business broker may advise on mergers and acquisitions and similar business combinations of a privately held company in a stock transaction without having to register as a…more

Broker-Dealer, No-Action Letters, Registration, Securities Exchange Act

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New FINRA Rule 5123 Regarding Private Placements of Securities Effective December 3, 2012

In an effort to enhance oversight and investor protection over private placement activity of firms on behalf of other issuers, new Financial Industry Regulatory Authority, Inc. (FINRA) Rule 5123 became effective on December 3,…more

Commodity Pool, Exemptions, FINRA, Private Investment Funds, Private Placements

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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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FINRA Provides Guidance on the Applicability of the Suitability Rule to Broker-Dealers Marketing Private Placements in the EB-5 Context

In an interpretive letter to a broker-dealer dated August 26, 2013, FINRA (Financial Industry Regulatory Authority) interpreted the suitability requirements under Rule 2111 for recommendations to foreign nationals making…more

Broker-Dealer, EB-5, FINRA, Foreign Investment, Suitability Rule

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US Sanctions as Diplomacy Tools and Political Weapons: Complexities and Opportunities for the Business Community

Sanctions: Why So Hot Now? - In response to a number of foreign policy crises encountered over the past few years, the Obama Administration has sought a new and more aggressive approach to using sanctions to advance US…more

Cuba, Department of State, EU, Foreign Policy, Iran

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Preserving Net Operating Losses (NOL) Carryforward: What Are You Doing to Protect Your Company’s Valuable Tax Assets?

A company’s past NOLs can be used to offset taxable income in future years, subject to certain limitations. For companies that have operated at a significant loss and expect to turn a profit in the foreseeable future, the…more

Carry Forward, Corporate Taxes, Life Sciences, Net Operating Losses, Publicly-Traded Companies

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Financing Challenges for Small Cap Companies

Megan Gates explains the how rules implemented by the SEC and national securities exchanges make raising capital particularly challenging for small-cap companies…more

Emerging Growth Companies, Finance Lenders, Financing, Nasdaq, Publicly-Traded Companies

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Ninth Circuit Upholds Judge Robart’s RAND Determinations in Microsoft v. Motorola

Late last month, the Ninth Circuit Court of Appeals issued its much-anticipated decision in Microsoft v. Motorola, a breach of contract action brought by Microsoft alleging that Motorola violated its commitment to license its…more

Anti-Suit Injunctions, Breach of Contract, Covenant of Good Faith and Fair Dealing, Damages, ITC

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U.S. House Passes GMO Labeling Legislation

Today the Safe and Accurate Food Labeling Act of 2015 passed the House, in a vote of 275 to 150 (more information here). Still a hot-button issue, opposition to the Act is emotionally charged, with those opposed to the bill…more

All Natural, FDA, Food Labeling, Food Safety, GMO

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7 Key Roles of a Successful Startup CEO

In your experience, what’s the most important role that a startup CEO should fulfill? That’s the question we put recently to JD Supra contributors, many of whom have spent years working with successful entrepreneurs in various…more

Business Formation, CEOs, Legal Perspectives, Startups

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Fed Circuit Reverses PTAB Decision in IPR Proceeding

On June 16, the Federal Circuit issued its first-ever reversal of a Patent Trial and Appeal Board decision in an America Invents Act post-grant proceeding. The opinion, drafted by Chief Judge Prost and joined by CAFC Judge…more

America Invents Act, Inter Partes Review Proceedings, Microsoft, Patent Trial and Appeal Board, Patents

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Key Takeaways from OIG’s 2015 Work Plan

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to HHS…more

Affordable Care Act, CMS, Healthcare, Healthcare Reform, HHS

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SEC Proposes Disclosure Rules on Hedging Policies

On Monday, the Securities and Exchange Commission (the “SEC”) proposed rules requiring disclosure of companies’ policies with respect to hedging transactions, in order to implement Section 955 of the Dodd-Frank Wall Street…more

Dodd-Frank, Hedging, Proposed Regulation, Public Disclosure, Publicly-Traded Companies

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Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases: March 2015

Trends & Analysis - ..We have identified 19 health care–related qui tam cases unsealed in November and December 2014. Of those cases, 17 were filed from 2012 to the present. The remaining two cases were filed in April 2008…more

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SEC Finalizes the CEO Pay Ratio Rule – Additional Executive Compensation Disclosure for Public Companies Beginning in 2017

On August 5, by a vote of 3-to-2 with the SEC Commissioners voting along party lines, the SEC approved the final rule to implement the requirements of Section 953(b) of the Dodd-Frank Act, which instructed the SEC to amend…more

Cost-of-Living, Data Privacy, De Minimus Quantity Exemption, Disclosure Requirements, Dodd-Frank

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FCC Eliminates Foreign Competition Test for Certain International Telecommunications Authorization Applications

In an order released on April 22, 2014, the Federal Communications Commission eliminated its longstanding requirement that certain applications for authorization to provide international telecommunications services or for…more

FCC, Telecommunications, WTO

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More EPO Rule Reversals: Additional Searches Available During European Regional Phase

The EPO has announced rule changes that will provide applicants with the option to have additional searches carried out during the European regional phase of Euro-PCT applications…more

EPO, EU, Patent Applications, Patents, USPTO

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Health Care Update - March 2015 #4

In This Issue: - Permanent Medicare Doc-Fix Entering Critical Week - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional Initiatives - Other Health…more

Affordable Care Act, Congressional Investigations & Hearings, Healthcare, Healthcare Fraud, HHS

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Employment-Based Third Preference (EB-3) Cut-Off Dates Advance on the Visa Bulletin for All Countries Except India and the Philippines

The Visa Bulletin for July 2013 shows continual movement forward for immigrant visas in the employment-based third preference (EB-3) category for all countries except India and the Philippines…more

EB-3, India, Visa Bulletins, Visas

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Foreign Corrupt Practices Act (FCPA): Israel Beware – Trends in Enforcement

Intuitively, Israeli companies and their directors would likely assume that their businesses are immune to investigation and the assessment of penalties by US regulators that are separated by a vast ocean and located more than…more

Anti-Bribery, Anti-Corruption, Best Practices, Books & Records, Bribery

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On the Seventh Day of Privacy, federal agencies gave to me…..

Questions of Authority – who will be the federal regulatory cop on the privacy beat? FTC? FCC? Privacy, Data Security Jurisdiction Questions to the Forefront in 2015 - As privacy and data security gain more visibility…more

Data Protection, Enforcement, FCC, FTC, Jurisdiction

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House Judiciary Committee: Don’t Bank on Immigration Reform

On July 14, 2015, the House Judiciary Committee met to discuss oversight of the United States Department of Homeland Security (DHS). Immigration was a major topic alongside border security and global threats of terrorism,…more

Border Security, Cybersecurity, DHS, EB-5, H1-B

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Surprise! You Get to Arbitrate! Massachusetts Courts Continue to Permit Third Parties to Enforce Arbitration Agreements

Two Massachusetts decisions—including one from the state’s highest court—applied the same standard regarding enforcement of an agreement to arbitrate. In each case, plaintiffs signed arbitration agreements with another party. …more

Arbitration, Arbitration Agreements, Employment Contract, Ernst & Young

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FDA’s New Four-Letter Guidance on Biosimilars

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products. The…more

Biologics, Biosimilars, Comment Period, Draft Guidance, FDA

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Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient Drug…more

Affordable Care Act, Amarin, Caronia, CMS, Cybersecurity

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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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California Joins rest of Country in “Made in USA” Rules

California, the beacon of individualism and often marching to its own set of rules, has joined the rest of the country as Gov. Jerry Brown has signed SB 633 which revises California’s take on what constitutes “Made in USA”…more

Class Action, Governor Brown, Labeling, Made in the USA, Manufacturers

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How and Why Your Team Is Everything (And Other Essentials for Startup Success...)

The multi-faceted answer to our question: over the years working with entrepreneurs and inventors, what have you seen as an essential attribute to startup success?…more

Legal Perspectives, Startups

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Proxy Season Litigation Primer: Defending Shareholder Suits to Enjoin Annual Meetings for Allegedly Inadequate Disclosures Concerning Equity Compensation Plans

Over the past few years, as plaintiffs have found it increasingly harder to succeed in “say-on-pay” litigation, another type of litigation over proxy disclosures has been on the rise. These cases are generally brought as class…more

Board of Directors, Class Action, Equity Compensation, Executive Compensation, Fiduciary Duty

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Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health IT”),…more

FCC, FDA, FDASIA, Healthcare, ONC

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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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NLRB Adopts New Joint Employer Test: Companies That Kind of, Sort of, Maybe Someday Could Exercise Control Over Employees Can Be Joint Employers

The NLRB dropped a major bomb on businesses in subcontracting, franchising, and temporary staffing relationships yesterday, adopting a new—very, very broad—definition of joint employment. In Browning-Ferris Industries of…more

Browning-Ferris Industries of California Inc., Collective Bargaining, Franchises, Joint Employers, NLRA

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Are “Personal Flamethrowers” Under the Jurisdiction of the CPSC?

Yes. You read that correctly. Two US companies are selling personal flamethrowers to the public. Once grisly weapons of war, the flamethrowers are now being marketed for more practical purposes such as clearing brush and snow,…more

ATF, CPSC

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New York’s Nonprofit Revitalization Act: A Guide to the Law’s Key Provisions

Significant portions of the New York Nonprofit Revitalization Act (the “Revitalization Act” or the “Act”) went into effect in 2014. The Act represents the first overhaul in more than 40 years of laws applicable to nonprofit…more

Board of Directors, Charitable Organizations, Corporate Governance, Executive Compensation, General Solicitation

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Third Circuit Issues Bright-line Interpretation of FMLA’s “Overnight Stay” Rule

Early last month, the U.S. Court of Appeals for the Third Circuit held that a former employee’s hospital stay did not count as an “overnight stay” under the Family and Medical Leave Act, and thus did not trigger the FMLA’s…more

FMLA, Hiring & Firing, Retaliation, Termination, Wrongful Termination

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Federal Circuit Affirms Dismissal Where Co-Owner of Patent Refuses to Join Suit

The Federal Circuit recently denied en banc review of its prior decision dismissing a patent infringement suit where a co-owner of the patent-in-suit refused to join the case voluntarily and the court held that it could not…more

Co-Ownership, Dismissals, En Banc Review, Joinder, Patent Litigation

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Enlarged Board of Appeal referral – Challenging clarity of post-grant amendments

Lack of clarity is not a ground for opposition before the EPO, but can be raised against amendments filed during the opposition proceedings. In accordance with Article 101(3) EPC, any amendments made to a granted patent during…more

European Patent Convention, Patent Litigation, Patents, Post-Grant Review

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Bayer Given a Headache by Trial Court Decision in FLANAX US Trademark Dispute

On February 6, 2015, a US District Court issued a ruling which underscores the territorial nature of trademark rights and the need to seek formal protection for your marks where possible in all countries of interest. The US…more

Bayer, Lanham Act, Mexico, Paris Convention, Popular

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Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment

Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime. This past March, Governor Baker initiated a year-long review…more

Health Care Providers, Healthcare, Regulatory Agenda

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Fiscal Cliff Legislation Extends Tax Incentive to Invest in Small Businesses

As a result of the recent “fiscal cliff” legislation, otherwise known as the American Taxpayer Relief Act of 2012 (2012 Tax Act), many individual investors are expecting future tax increases, either in the form of higher capital…more

American Taxpayer Relief Act, C-Corporation, Capital Gains, Fiscal Cliff, Income Taxes

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Risk Management, Indemnification and D&O Coverage — Texas Wall Street Women Style

My colleagues Heidi Lawson, Dionne Lomax, and I just finished our tour of four Texas cities in as many days, meeting a lot of incredibly talented, smart, and fun Wall Street women (yes, and some men too) in San Antonio, Austin,…more

D&O Insurance, Indemnification, Liability Insurance, Risk Management

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First Circuit Hears Oral Arguments on Validity of Puerto Rico’s Recovery Act

A few reactions to today’s oral arguments before the U.S. Court of Appeals for the First Circuit regarding the validity of Puerto Rico’s Recovery Act..…more

Appeals, Bankruptcy Code, Chapter 9, Oral Argument, Puerto Rico

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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, FCA, Healthcare, Hospitals

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Health Care Reform Update -- April 2, 2013

In This Issue: Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups…more

Abortion, Affordable Care Act, CMS, Contraceptive Coverage Mandate, Health Insurance Exchanges

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ITC Sheds Light on Economic Prong of Domestic Industry Under Subsection 337(a)(3)(C) and Issues General Exclusion Order

On June 26, 2015, the ITC handed down its Commission Opinion in Certain Loom Kits for Creating Linked Articles, Inv. No. 337-TA-923, Comm’n Op. (Feb. 3, 2015) (hereinafter “Loom Kits ”), granting a general exclusion order. In…more

Bitcoins, China, Domestic Industry Requirement, ITC, Patent Infringement

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Beware the Ides of March at the US Patent and Trademark Office

Last March, the USPTO experienced an enormous spike in the typical number of application filings per week, as numerous US provisional and non-provisional patent applications were filed in advance of the March 16, 2013 effective…more

America Invents Act, Patent Reform, USPTO

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Third Circuit Joins Sister Courts in Finding Suspension with Pay is not an “Adverse Employment Action” Within Meaning of Discrimination Laws

In Precia Jones v. SEPTA, the Third Circuit Court of Appeals last week joined six sister courts in finding that a suspension with pay typically does not constitute an “adverse employment action” within the meaning of Title VII…more

Adverse Employment Action, Appeals, Employment Discrimination, Paid Leave, Retaliation

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DC Circuit Court Reaffirms Earlier Decision Partially Invalidating Conflict Minerals Rule On First Amendment Grounds

Pursuant to Section 1502 of the Dodd-Frank Act, which added new Section 13(p)(1) to the Securities Exchange Act of 1934, as amended, the SEC promulgated Rule 13p-1 (the “Conflict Minerals Rule”), which required that issuers that…more

Conflict Mineral Rules, Democratic Republic of Congo, Dodd-Frank, First Amendment, Petition For Rehearing

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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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Investment Fund Violates “Investment-Only” HSR Exemption

At the request of the Federal Trade Commission (“FTC” or “Commission”), the Department of Justice (“DOJ”) filed this week in federal court a proposed settlement to charges that an investment fund violated the Hart-Scott-Rodino…more

Board of Directors, DOJ, Enforcement Actions, FTC, Hart-Scott-Rodino Act

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Washington Outlook for 2015

In This Issue: - Introduction - Agriculture, Food Safety, and Nutrition - Appropriations, Budget, and Debt Ceiling - Defense and National Security - Education - Energy and Environment - Financial…more

Appropriations Bill, Defense Sector, Department of Transportation, Energy Policy, Environmental Policies

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West Virginia AG Clears Merger Creating Second Largest Hospital Chain in the State with Conduct Remedy

The federal antitrust enforcement agencies have trumpeted their preferences for structural, as opposed to conduct, remedies as the solution to potentially anticompetitive mergers. In contrast, State Attorneys General have been…more

Anticompetitive Agreements, Antitrust Provisions, Attorney Generals, FTC, Healthcare Providers

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OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees and…more

Advisory Opinions, Anti-Kickback Statute, CMS, Healthcare, Healthcare Professionals

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U.S. Customs and Border Protection Rolling Out Electronic Travel Records

In April 2013, U.S. Customs and Border Protection (CBP) introduced electronic Forms I-94, enabling nonimmigrants entering the U.S. via air and sea to easily access their Form I-94 Arrival/Departure Records online. As of May 1,…more

Customs and Border Protection, Electronic Records, Form I-94, H1-B, L-1 Visas

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Activism and Engagement: Yadda, Yadda, Yadda or a Useful tool (or a Little of Both)

Activism is on the rise and everyone's activism defense playbook includes engagement, engagement and more engagement as the principal response. The experts in the field are well versed in when to engage, who to engage and…more

Board of Directors, Corporate Governance, Regulation FD, Shareholder Activism, Shareholders

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Software Audits: Strategies for Licensees

Audits Have Become More Common - If you have received a software audit request from your software vendor or one of the industry trade groups representing software publishers, such as the Software & Information Industry…more

Audits, License Agreements, Software, Software Developers

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Health Care Reform Update -- April 15, 2013

In This Issue: Leading the News; Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups…more

Affordable Care Act, CMS, Federal Budget, Healthcare, HHS

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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

CMS, Healthcare Providers, Managed Care Contracts, Medicaid

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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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USPTO Issues Interim Guidance on Patent Eligibility Under §101: Framework for Considering Whether Patents Are Eligible for US patent Protection Significantly Improved

The United States Patent and Trademark Office (USPTO) has issued revised guidance to its examiners relating to determination of patent eligibility under 35 U.S.C. §101. This “Interim Guidance” provides more specific advice for…more

AMP v Myriad, CLS Bank v Alice Corp, Guidance Update, Mayo v. Prometheus, Patent-Eligible Subject Matter

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D&O Insurance and IPOs: Seven Issues You Need to Consider

As a company prepares for an IPO, the last thing to sometimes be considered is the potential of future litigation. Although going public can of course be a very good thing for a company, its directors, its initial investors and…more

Board of Directors, Compliance, D&O Insurance, IPO, Professional Liability

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PE Funds May Be Liable For Portfolio Company Pension Liabilities

Introduction - A recent decision by the U.S. Court of Appeals for the First Circuit increases the risk that a private equity fund could be liable for its portfolio company’s unfunded pension liabilities. Additionally, one…more

Employee Benefits, Employer Liability Issues, ERISA, Investment Portfolios, Pensions

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Privacy Tuesday – August 24, 2015 – FTC vs. Wyndham Update

Rather than our usual Privacy Monday “bits and bytes,” we have a breaking story relating to the ongoing Wyndham/FTC saga. Today, Wyndham Worldwide Corp. lost a critical round in the Third Circuit. Anticipated since April,…more

Best Practices, Credit Cards, Cybersecurity, Data Breach, Data Privacy

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USPTO Issues Newly Updated Guidance on Subject Matter Eligibility that Further Clarifies Examination Standards under 35 U.S.C. §101 in Light of Alice v. CLS Bank

Over the past few years, the Supreme Court’s decisions in Alice (Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347 (2014)) and Mayo (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)), and other cases…more

CLS Bank v Alice Corp, Guidance Update, Inventors, Mayo v. Prometheus, Patent Applications

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Why Directors and Officers Should Demand a Separate Indemnification Agreement

Corporate directors and officers (“D&O’s”) face significant personal exposure whenever their corporation is involved in a dispute or investigation. For this reason, prudent D&O’s avail themselves of all available legal…more

Board of Directors, Bylaws, Corporate Charters, Corporate Officers, D&O Insurance

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On the Second Day of Privacy, Plaintiffs’ Counsel Gave to Me . . .

. . . still more privacy litigation. In 2015, we are likely to see further development of the law in data breach class actions, continuing growth in statutory privacy claims, and increased risk of privacy-related claims arising…more

Data Breach, Data Protection, Popular, Right to Privacy, TCPA

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Africa Update - September 2015

Leading the News: South Sudan - On August 27th, emergency relief teams from the United Nations (U.N.) Children’s Fund (UNICEF) and the World Food Programme (WFP) reached more than 27,000 people in the town of Wau…more

Africa, AGOA, AIDS, Boko Haram, Burundi

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ACA Countdown to Compliance - 52 Week Series For Employers

In this volume, we have collected the 52 weekly blog posts that comprise the series entitled, The Affordable Care Act—Countdown to Compliance for Employers. The series appeared in the Mintz Levin Employment Matters Blog during…more

ADA, Affordable Care Act, Cafeteria Plans, EEOC, Employer Group Health Plans

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Massachusetts Appeals Court Set to Consider Scope of Employer Liability for Employee Data Breaches

Many of the highest-profile and headline-catching data breaches involve external breaches of a company’s electronic systems. But the reality that these headlines obscure is the fact that internal data breaches are generally more…more

Breach of Duty, Cyber Crimes, Data Breach, Data Privacy, Data Protection

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OIG Releases Semiannual Report to Congress

The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31,…more

DHS, DOJ, False Claims Act, Healthcare, HEAT

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REMINDER: Ultra Light Future Energy Forum Boston on September 25, 2013

On Wednesday, September 25, 2013, Ultra Light Startups is hosting its Future Energy Forum at Microsoft NERD in Cambridge, Massachusetts. The event is part of a series of startup pitch events that connects entrepreneurs,…more

Clean Energy, Clean Tech, Startups

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USPTO Guidance for Examiners Takes Expansive View of Myriad and Prometheus Decisions

On March 4, 2014, the U.S. Patent and Trademark Office (“USPTO”) issued a memorandum to the Patent Examining Corps with guidance for determining the patent eligibility of claims relating to products of nature and laws of nature…more

AMP v Myriad, Mayo v. Prometheus, Patent Litigation, Patent-Eligible Subject Matter, Patents

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US, Canada, and Mexico to Expand Trusted Traveler Programs

The Department of Homeland Security (DHS), Public Safety Canada, and the Secretariat of Governance of Mexico announced the planned expansion of the existing trusted traveler programs. This expansion is the first step toward the…more

Canada, Customs and Border Protection, DHS, International Travel, Mexico

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State Blue Sky Claims Under the Uniform Securities Act Can Be Won by Sellers, But at a Cost

An emerging tool for plaintiff-side securities litigators is the use of state claims under the Uniform Securities Act, such as Massachusetts’ so-called “Blue Sky” statute, Mass. Gen. L. c. 110A, § 410…more

Securities Litigation

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Energy & Environment Update - August 2015 #3

Energy and Climate Debate - Congress returns from the August recess after the Labor Day holiday next week, and the in the meantime, energy and environment issues continue to play a significant role on the national and…more

Carbon Emissions, China, Clean Energy, Clean Power Plan, Climate Change

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Investment Fund Violates “Investment-Only” HSR Exemption

At the request of the Federal Trade Commission (“FTC” or “Commission”), the Department of Justice (“DOJ”) filed this week in federal court a proposed settlement to charges that an investment fund violated the Hart-Scott-Rodino…more

Board of Directors, DOJ, Enforcement Actions, FTC, Hart-Scott-Rodino Act

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First Circuit Says Plaintiffs Cannot Prevail on Location-Based Discrimination Claims Based on a Disparate Impact Theory

Recently, the First Circuit Court of Appeals held that former employees of a FEMA call center could not proceed in their Title VII location-based disparate impact and retaliation claims against the agency. The case,…more

Adverse Employment Action, Call Centers, Corporate Counsel, Disparate Impact, FEMA

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7 Key Roles of a Successful Startup CEO

In your experience, what’s the most important role that a startup CEO should fulfill? That’s the question we put recently to JD Supra contributors, many of whom have spent years working with successful entrepreneurs in various…more

Business Formation, CEOs, Legal Perspectives, Startups

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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, Solar Energy

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5 Takeaways from the HHS OIG’s Guidance for Health Care Governing Boards

Tuesday, the HHS OIG, in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA), and the Health Care Compliance Association, released a guidance document entitled…more

AHLA, Chief Compliance Officers, Corporate Governance, Hospitals, Internal Audit Functions

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Federal Circuit Affirms Dismissal on Grounds of Patent Ineligibility

On June 23, 2015, the Federal Circuit affirmed the finding of the U.S. District Court for the Northern District of California (“District Court”) dismissing the complaints in four related actions for infringement of U.S. Patent…more

Abstract Ideas, Dismissals, Patent Infringement, Patent-Eligible Subject Matter, Patents

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Data: Big, Borderless and Beyond Control? Five Things You Can Do

There’s been a lot of talk about big data over the last few years and the breaches at Target and Neiman Marcus have many companies running in circles trying to figure out how to protect their systems and their data. So what are…more

Big Data, Cybersecurity, Data Breach, Data Protection, Neiman Marcus

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DOJ’s Endorsement of IEEE Patent Policy Takes Center Stage at IP Antitrust Conference

On April 14 in Washington, DC, Global Competition Review hosted its Second Annual IP & Antitrust USA conference. The conference covered various hot topics being closely followed by IP antitrust practitioners, including (1) the…more

Antitrust Litigation, DOJ, FRAND, IEEE, Patent Reform

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Energy & Environment Update - August 2015 #3

Energy and Climate Debate - Congress returns from the August recess after the Labor Day holiday next week, and the in the meantime, energy and environment issues continue to play a significant role on the national and…more

Carbon Emissions, China, Clean Energy, Clean Power Plan, Climate Change

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Health Care Update - July 2015 #3

ACA Repeal Votes Continue: As part of a rare Senate Sunday session to consider a bill to replenish the highway trust fund for six years, Majority Leader Mitch McConnell (R-KY) brought up an amendment to repeal the ACA—in…more

Affordable Care Act, CMS, Congressional Investigations & Hearings, Health Insurance, Health Insurance Exchanges

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Massachusetts Earned Sick Time Law Takes Effect July 1st

The Massachusetts Earned Sick Time Law, which requires nearly all Massachusetts employers to provide earned sick time to employees, goes into effect on July 1, 2015. Unless they qualify for the limited safe harbor provision…more

Earned Sick Time, Paid Leave, Safe Harbors, Sick Leave

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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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A Pick Off Play Strikes Out at the First Circuit, But There Are More Innings to be Played; the Debate Over Rule 68 Offers of Judgment Continues

Sorry, we couldn’t resist mixing our baseball metaphors. In Bais Yaakov of Spring Valley v. ACT, Inc., the First Circuit affirmed a district court decision refusing to dismiss a putative class action as moot based on an…more

Campbell Ewald v Gomez, Class Certification, Offer of Judgment, Putative Class Actions, Rule 68

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USCIS Resumes Premium Processing for H-1B Extensions

USCIS announced that beginning July 13, 2015, the agency will resume accepting premium processing requests for H-1B extension of stay applications. This provides an early cancellation of the previous USCIS directive suspending…more

Extensions, H-1B, Non-Immigrant Visas, Processing Fees, USCIS

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Newsflash, Politico: ‘Patent Death Squad’ Alive and Well

Politico, the popular political journalism publication, recently ran the story “Patent Reform Advocates: PTO Process Not Patent ‘Death Squad.’” The story was based on a blog post by patent reform advocate Unified Patents. …more

America Invents Act, Inter Partes Review Proceedings, Non-Practicing Entities, Patent Litigation, Patent Trial and Appeal Board

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Survival of Reps and Warranties: Avoiding Unpleasant Surprises for Buyers

Survival of representations and warranties (“reps and warranties”) is among the staples of highly negotiated provisions in M&A purchase agreements. The length of the survival period limits the time during which claims may be…more

Breach of Contract, Breach of Warranty, Representations and Warranties, Statute of Limitations, Survival Clauses

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Federal Circuit Clarifies Standard for Prior Art in Obviousness Analysis

Earlier this week, the Federal Circuit in Circuit Check Inc. v. QXQ, Inc. clarified the standard by which a reference may be considered prior art for the purposes of an obviousness determination. See No. 2015-1155, Slip. Op…more

Appeals, Corporate Counsel, Obviousness, Patent Infringement, Patents

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Did The Supreme Court Finally Explain Marathon And Stern? - Executive Benefits’ Impact on Bankruptcy Court Jurisdiction

The Supreme Court has spoken once again on the limited jurisdiction of the bankruptcy courts, adding to the understanding derived from Northern Pipeline Constr. Co. v. Marathon Pipe Line Co., 458 U.S. 50 (1982), Granfinanciera…more

Bankruptcy Code, Commercial Bankruptcy, Executive Benefits Insurance Agency v. Arkison, Jurisdiction, SCOTUS

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Green Chemistry Initiatives: An American Patchwork?

A growing number of states are passing Green Chemistry laws, e.g.; California, Connecticut, Maine, Minnesota, and Washington State. These laws present a challenge to manufacturers who distribute and sell products into the 50…more

Green Chemistry, Manufacturers

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Health Care Enforcement in 2013: A Year in Review

In 2013, the U.S. Department of Justice (“DOJ”), Health and Human Services Office of Inspector General (“HHS-OIG”), and other federal and state agencies continued to aggressively prosecute health care fraud and related offenses…more

Compliance, DOJ, Enforcement, Healthcare, Healthcare Fraud

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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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Mintz Levin Health Care Qui Tam Update - July 2015

Trends & Analysis - ..We have identified 36 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of these cases, eight were filed within the last year. A number of…more

Anti-Kickback Statute, False Claims Act, Healthcare, Intervenors, Medicare

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Writing on Her Own Behalf, Chairwoman Ramirez Takes a Position on FRAND

Federal Trade Commission (FTC) Chairwoman Edith Ramirez took the unusual step on July 13, 2015, of filing a written submission on her own behalf — and expressly not on behalf of her agency — in Investigation No. 337-TA-613,…more

Burden of Proof, Determination on Remand, Edith Ramirez, Exclusion Orders, FRAND

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Student Employees and the Affordable Care Act – Part 4 of 4: If students are employees, how are their hours counted?

In our prior installments, we determined that students who work at least 30 hours per week for their educational institutions are “full time” employees of those institutions under the Affordable care Act’s employer shared…more

Affordable Care Act, Educational Institutions, Health Insurance, Students, Universities

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Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient Drug…more

Affordable Care Act, Amarin, Caronia, CMS, Cybersecurity

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Privacy Tuesday – April 2015 #3

Some privacy & security bits and bytes to start your week: FCC to Hold Public Workshop on Broadband Consumer Privacy Tomorrow - Over the last several months, the Federal Communications Commission has taken on a…more

Broadband, Customer Proprietary Network Information (CPNI), Cybersecurity, Data Collection, Data Protection

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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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Big Win for Anti-GMO Groups as Federal Judge Upholds Jackson County GMO Ban

On Friday, Federal Magistrate Judge Mark D. Clarke partially dismissed a lawsuit brought by commercial alfalfa farmers seeking to overturn a Jackson County ordinance that banned the use of GMO seed stock (“It is a county…more

Farms, Genetically Engineered Seed, GMO, GMO Bans, Takings

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Federal Circuit Affirms ITC Jurisdiction for Non-Practicing Entities

On January 10, 2013, the Federal Circuit reaffirmed broad ITC jurisdiction for non-practicing patent enforcement entities by denying Nokia Corp.’s petition for rehearing of InterDigital Commc’ns, LLC v. Int’l Trade Comm’n (2010-…more

ITC, Jurisdiction, License Agreements, Nokia, Non-Practicing Entities

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Regulators Speak at IAPP Breakfast Meeting in NYC

Data Breach Incidents—Especially “Ransom” Incidents, are on the Rise—One panelist observed that the New York State Attorney General’s Office received reports of approximately 900 data breach incidents during the past year alone…more

Cybersecurity, Data Breach, Data Protection, DOJ, FOIA

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Class Action Waivers Enforced in Two Recent Second Circuit Decisions

The Second Circuit Court of Appeals recently issued two opinions each holding that class action waivers may be enforced by employers in cases brought under the Fair Labor Standards Act (FLSA). These decisions — Sutherland v…more

Class Action, Class Action Arbitration Waivers, Employer Liability Issues, FLSA, Wage and Hour

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CMS Releases Final Rule for the Medicare Shared Savings Program

On June 4, 2015, the Center for Medicare & Medicaid Services ("CMS") released the highly anticipated Final Rule ("Final Rule") updating the Medicare Shared Savings Program ("Shared Savings Program"). One of the few provisions in…more

ACOs, Beneficiary Designations, CMS, Medicare, Medicare Part A

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Federal Housing Administration Move on PACE Showcases Program’s Possible Impact

On August 24, President Obama directed the Federal Housing Administration (FHA) to allow homeowners to purchase and refinance properties with Property Assessed Clean Energy (PACE) loans when those loans are subordinated to an…more

Barack Obama, Clean Energy, Draft Guidance, Energy Efficiency, FHA

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Activism: An Overview from the Company Perspective

Increasingly, companies are being confronted with shareholders seeking to exercise power and influence over business activities. The term “activism” has become a buzzword to refer to shareholders seeking to make operational,…more

Best Management Practices, Board of Directors, Corporate Counsel, Corporate Governance, Proxy Advisors

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PTAB Issues ‘Quick Fix’ Rule Package, Effective Immediately

On March 31 we posted (here) about the Patent Office rolling out a series of rulemakings for improving post-grant proceedings, beginning with a first rule package of “quick fixes” this spring. This past Tuesday, May 19, 2015,…more

America Invents Act, Covered Business Method Patents, Discovery, Patents, Pleadings

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Employer Win in California – Say What??? Stress From Working Under Particular Supervisor is Not a Disability

Over the course of a career many workers experience the displeasure of dealing with a difficult supervisor — the type of individual whose mere presence in the workplace is a source of dread and whose name inspires feelings of…more

Disability, Disability Discrimination, Employee Rights, Employer Liability Issues, Failure to Accommodate

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U.S. Supreme Court Rules That Isolated Human Genes Are Unpatentable

Summary - On June 13, 2013 in a much-anticipated decision, the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, 569 U.S. __ (2013) unanimously held that claims for isolated DNA sequences are…more

AMP v Myriad, Biotechnology, DNA, Human Genes, Myriad

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Goodyear’s Settlement with the SEC Emphasizes the Importance of FCPA Due Diligence in M&A Transactions and of Having a Robust Anti-Corruption Policy

On February 24, 2015, Goodyear Tire & Rubber Co. agreed to pay more than $16 million to settle charges that two of its subsidiaries allegedly paid $3.2 million in bribes that generated $14,122,535 in illicit profits. The SEC…more

Bribery, Compliance, Corruption, Due Diligence, FCPA

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Delaware Bans Corporate Fee-Shifting Bylaws and Authorizes Delaware-Only Forum Requirement for Intra-Corporate Litigation

Delaware recently enacted new legislation to prohibit stock corporations from adopting fee-shifting bylaws and charter provisions, among other amendments to the Delaware General Corporation Law. The fee-shifting ban ends a…more

Attorney's Fees, Board of Directors, Breach of Duty, Bylaws, Certificates of Incorporation

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Director Liability for Cybersecurity Risks

If a corporation is the target of a cyberattack resulting in a data breach, its board may be the target of a shareholder derivative action claiming breach of fiduciary duty. A recent example is Palkon v. Holmes, No. 14-cv-01234…more

Board of Directors, Breach of Duty, Cyber Insurance, Cybersecurity, Data Protection

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FDA’s New Four-Letter Guidance on Biosimilars

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products. The…more

Biologics, Biosimilars, Comment Period, Draft Guidance, FDA

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Health Care Enforcement: The Impact on Private Equity Investments

Brian Platton provides an overview of enforcement trends that private equity investors should be aware of before entering into the health care space…more

Affordable Care Act, CMS, Enforcement, GDP, Healthcare

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Vapor Intrusion: New Rules by the EPA

This video provides background on the EPA’s new rules on vapor intrusion, or the intrusion of chemicals into the air inside buildings. The issue applies to any building constructed on a site that was previously used for…more

Construction Industry, EPA, Vapor Intrusion, Vapor Intrusion Guidance

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Overview of Certain Middle and Lower Middle Market Credit Trends

With heavier competition for bigger deals, larger private equity sponsors have increasingly turned to the middle market as a source for new acquisitions…more

Acquisitions, Middle Market, Private Equity

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Massachusetts State Court Holds Employee Cannot Recover Treble Damages on Late Wage Payments

Can an employer escape a treble damage award under the Massachusetts Wage Act where it makes a late payment of final wages to a fired employee after the employee filed a wage complaint with the state Attorney General but before…more

Attorney Generals, Employee Rights, Employer Liability Issues, Termination, Treble Damages

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Patentability of Software Post-Alice: How Do Courts Determine Whether an Idea is Abstract ?

Since the Supreme Court’s decision in Alice Corp. v. CLS Bank Int’l on patentable subject matter, courts have tried to follow the prescribed framework. Under Alice, patent claims are invalid if directed to “abstract ideas” and…more

Bilski, CLS Bank v Alice Corp, Mayo v. Prometheus, New Guidance, Patent-Eligible Subject Matter

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Health Care Update - October 2014 #2

In This Issue: - First Look at Pioneer ACO Data Reveals Murky Path Forward - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional Initiatives -…more

ACOs, Affordable Care Act, CDC, CMS, Healthcare

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Ebola Exclusions from Commercial Insurance Policies

Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses. This week we note that some business…more

Business Interruption, Commercial Insurance Policies, Ebola

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Work and Travel Guidance for F-1 Students with Pending H-1B “Change of Status” Applications and “Cap-Gap” Employment Authorization for FY16

This advisory summarizes key travel and employment issues if you are an F-1 student with Optional Practical Training (OPT) employment eligibility and an H-1B filing on your behalf has been accepted by US Citizenship and…more

Employment Authorization Document, F-1, H-1B, OPT, Students

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H-1B Alternative Series: Flexibility in Foreign Trade and Treaty Visas

Our series exploring alternatives to the H-1B continues with foreign trade and treaty visas. Was your petition one of the estimated 148,000 not selected in this year’s H-1B lottery? Is your client from one of the 79…more

Department of State, E-1, E-2, Free Trade Agreement, H-1B

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Current and Former SEC Officials Speak About Enforcement Issues Concerning Municipal Securities

Last week, the National Association of Bond Lawyers held its 13th Annual Tax and Securities Law Institute. Some of the panels included current and former employees of the SEC who spoke on several of the more notable recent…more

Control Person, Enforcement, Enforcement Actions, Municipal Securities Issuers, SEC

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Ninth Circuit Upholds Judge Robart’s RAND Determinations in Microsoft v. Motorola

Late last month, the Ninth Circuit Court of Appeals issued its much-anticipated decision in Microsoft v. Motorola, a breach of contract action brought by Microsoft alleging that Motorola violated its commitment to license its…more

Anti-Suit Injunctions, Breach of Contract, Covenant of Good Faith and Fair Dealing, Damages, ITC

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What to Make of a Diminished Thing: Tobacco Bond Defaults and Restructurings

There is little poetry in tobacco bonds these days. Cigarette consumption has declined beyond projections, and the advent of e-cigarettes may exacerbate the decline. Payments under the Master Settlement Agreement (MSA) are down,…more

Bond Financing, Bonds, Default, Manufacturers, Tobacco

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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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Cyber Extortion: What to Do When Your Data is Being Held for Ransom

Imagine you are the IT systems administrator of a large corporation. Coffee in hand, you sit down one morning and log in. You receive a message that there has been an intrusion into the corporate database, a large amount of…more

Corporate Counsel, Cyber Crimes, Data Theft, Extortion, Risk Assessment

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It’s Time to Prepare H-1B Visa Petitions for Fiscal Year 2015

This alert is a reminder of the rapidly approaching April 1, 2014 “deadline” for the filing of H-1B visa petitions for Fiscal Year 2015. Petitions for the new fiscal year, which starts on October 1, 2014, will be accepted by the…more

H-1B, Immigrants, USCIS, Visas

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Latest Medicare Fraud Strike Force Takedown Is The Most Significant To Date

As we discussed yesterday, the Medicare Fraud Strike Force’s eighth annual nationwide takedown resulted in charges in 17 districts against 243 individuals for approximately $712 in false billings. It is the most significant…more

DOJ, Enforcement, Enforcement Actions, False Billing, Medicare

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American Academy of Pediatrics Recommends Limits on Telemedicine

On June 29, 2015, the American Academy of Pediatrics (AAP) published a policy statement supporting the use of telemedicine in the practice of pediatrics as long as telemedicine technologies are used “in support of and integrated…more

American Academy of Pediatrics, American Medical Association, Healthcare, Healthcare Providers, Patient Centered Medical Homes

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Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health IT”),…more

FCC, FDA, FDASIA, Healthcare, ONC

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California Sets the Curve with New Regulations on Collection and Use of Student Data

When one thinks of the use of technology in school, often the first image that comes to mind is of students sending ill-advised Snapchats and making in-app purchases that line the pockets of the Kardashian family, rather than…more

Data Collection, FERPA, Popular, Student Records, Students

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Financial Services Legislative and Regulatory Update -- January 13, 2014

In This Issue: Leading the Past Week; Executive Branch; International; and Upcoming Hearings. Excerpt from Leading the Past Week - Last week closed with the long anticipated ability-to-repay and qualified…more

Ability-to-Repay, CFPB, FHFA, Financial Regulatory Reform, FOMC

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Corporate Practice of Medicine: An Old Doctrine Breathing New Life

New York is one of many states that prohibit the “corporate practice of medicine” (CPOM). The CPOM doctrine generally bars a business corporation from practicing medicine or employing a physician to provide professional medical…more

Corporate Practice of Medicine, Healthcare

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The Top 10 Obstacles to Litigating Securities Fraud Claims: Part I

Introduction: Congress passed the Securities Act of 1933, 15 U.S.C. §§ 77a et seq. (Securities Act), and the Securities Exchange Act of 1934, 15 U.S.C. §§ 78a et seq. (Exchange Act, collectively, the Acts) following the…more

Jurisdiction, Litigation Strategies, Material Misstatements, Securities Act of 1933, Securities Exchange Act

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What Does the Latest Uber Decision Mean for Your Gig Business?

If you tuned in to my appearance a few months ago on Bloomberg Law Radio, you heard me bemoaning our legal system’s failure to catch up with the gig economy. For those of you who don’t know, the term “gig economy” (also…more

Class Action, Class Certification, Contract Drafting, DOL, Independent Contractors

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SEC Adopts Rules Permitting General Solicitation in Private Offerings Limited to Purchases by Accredited Investors

On July 10, 2013, the Securities and Exchange Commission (the “SEC”) adopted rules that repealed a long-standing ban on the use of general solicitation for private securities offerings. These changes will be effective in…more

Accredited Investors, Advertising, General Solicitation, Marketing, Private Placements

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Ninth Circuit Clarifies Extraterritorial Reach of California Antitrust Laws

In AT&T Mobility LLC v. AU Optronics Corp., Ninth Circuit Case No. 11-16188 (Feb. 14, 2013), the Ninth Circuit held that California’s antitrust law, the Cartwright Act, could apply to a price fixing conspiracy of LCD panels even…more

AT&T Mobility, AU Optronics Corp, Cartwright Act, Conspiracies, Due Process

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Commil USA V. Cisco Systems: “I thought it was legal” is no defense to induced infringement under 35 U.S.C. § 271(b)

The United States Supreme Court’s recent decision in Commil v. Cisco held that a good-faith belief of a patent’s invalidity, standing alone, is insufficient to provide a defense to a claim of inducing another’s infringement of a…more

Cisco, Cisco v CommilUSA, Clear and Convincing Evidence, Good Faith, Honest Belief Defense

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CPSC Major ‘Repair Program’ Is Not Labeled A ‘Recall’

On July 22, 2015, the U.S. Consumer Product Safety Commission and major furniture company IKEA jointly announced a “repair program” to address the serious and complex hazard of furniture tip-over posed by 27 million chests and…more

Consumer Product Safety Improvement Act, Corrective Actions, CPSC, IKEA, Manufacturers

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Health Care Reform by Petition

A series of alternative proposed Initiative Petitions were filed Thursday, August 7, with the Office of the Attorney General of Massachusetts (the “AGO”) seeking primarily to establish specified limits on operating margins…more

CEOs, Executive Compensation, Healthcare Reform, Hospitals, Medicaid

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Washington Outlook for 2015

In This Issue: - Introduction - Agriculture, Food Safety, and Nutrition - Appropriations, Budget, and Debt Ceiling - Defense and National Security - Education - Energy and Environment - Financial…more

Appropriations Bill, Defense Sector, Department of Transportation, Energy Policy, Environmental Policies

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The Top 10 Obstacles to Litigating Securities Fraud Claims: Part I

Introduction: Congress passed the Securities Act of 1933, 15 U.S.C. §§ 77a et seq. (Securities Act), and the Securities Exchange Act of 1934, 15 U.S.C. §§ 78a et seq. (Exchange Act, collectively, the Acts) following the…more

Jurisdiction, Litigation Strategies, Material Misstatements, Securities Act of 1933, Securities Exchange Act

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Massachusetts Legislature Passes Minimum Wage Increase and Economic Development Package

In a previous article, “Massachusetts Legislature Considers Unemployment Insurance Reform and Minimum Wage Increase,” we outlined the Massachusetts House and Senate’s separate plans to increase the minimum wage and reform the…more

Economic Development, Legislative Agendas, Minimum Wage, New Legislation, Unemployment Insurance

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AB 1103 Update: Postponement of Certain Nonresidential Building Energy Use Disclosure Requirements

Under California Assembly Bill 1103 (“AB 1103”, codified as California Public Resources Code Section 25402.10), owners and operators of nonresidential buildings must disclose certain building energy performance data to a…more

Commercial Property Owners, Disclosure Requirements, Secured Lenders

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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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No One Told John Oliver About the America Invents Act: Last Week Tonight Stuck in 2012

The heady days of 2012 saw “Gangnam Style” dominate the U.S. music charts, Patricia Krentcil rocket to fame as the “New Jersey Tanning Mom,” and the New York Giants win the Super Bowl. That year also is the source of nearly all…more

America Invents Act, Attorney's Fees, CLS Bank v Alice Corp, Octane Fitness v. ICON, Patent Infringement

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PTAB Summer Package of Proposed Rule Changes Now Available and Open for Public Comment

On March 31 we posted about the Patent Office rolling out a series of rulemakings for improving post-grant proceedings before the Patent Trial and Appeal Board (PTAB) pursuant to public feedback to a Request for Comments…more

Additional Discovery, Claim Construction, Comment Period, Confidential Information, Expert Testimony

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California Update: New Laws Give Residential and Commercial Tenants Rights to Install EV Charging Stations and Streamline Residential Solar Permitting

Last month Governor Brown signed AB 2565, which gives residential and commercial tenants new rights to install electric vehicle (EV) charging stations, and AB 2188, which directs cities and counties to streamline permitting for…more

Auto Manufacturers, Automotive Industry, Commercial Leases, Commercial Tenants, Electric Vehicles

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SJC Issues Decision Concerning Recovery of Lost Profits Damages in Commercial Litigation

In a noteworthy recent decision addressing the parameters of damages in commercial litigation, the Massachusetts Supreme Judicial Court (SJC) affirmed an order excluding expert testimony concerning future lost profits damages…more

Expert Testimony, Lost Profits

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[Event] Massachusetts Employment Law Summit - May 13, Boston, MA

Employers and their HR departments are faced with a host of new issues and challenges. When you’re not navigating new state, federal, and local laws and making sure systems are in place to comply with them, you’re busy…more

Affordable Care Act, Bring Your Own Device, Chief Compliance Officers, Compliance, Employee Privacy Rights

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

Trends & Analysis - ..We have identified 67 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of those cases, 29 were filed before January 1, 2014, with seven in…more

Anti-Kickback Statute, False Claims Act, Health Care Providers, Healthcare, Medicare

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Suprema, Inc. v. ITC: En Banc Federal Circuit Confirms ITC’s Jurisdiction to Exclude Articles Based on Induced Infringement

On August 10, 2015, the full US Court of Appeals for the Federal Circuit issued its en banc opinion in Suprema, Inc. v. ITC, which overturned an earlier panel decision and confirmed, by a 6–4 vote, that the International Trade…more

Appeals, Chevron Deference, En Banc Review, Imports, Induced Infringement

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Another Shoe Drops in Washington: Ninth Circuit Expands Personal Jurisdiction over Willful Copyright Infringers

In Washington Shoe Co. v. A-Z Sporting Goods, Inc. (U.S. Court of Appeals – Ninth Circuit, No. 11-35166, Dec. 17, 2012), the Ninth Circuit expanded the exercise by Federal District Courts of personal jurisdiction over…more

Copyright, Jurisdiction, Long Arm Statute, Personal Jurisdiction

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The Troubled Track Record of the Proxy Strike Suit

The recent wave of proxy strike litigation, once thought to be on the rise in 2012 and 2013, has now gone two years without a significant court victory. After one notable early success, decision after decision has gone against…more

Class Action, Disclosure, Proxy Contests, Shareholder Activism, Shareholder Litigation

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KB Toys: Don’t Play with Clouded Claims

In a recent decision by the influential Third Circuit Court of Appeals, In re KB Toys Inc., 2013 U.S. App. LEXIS 23083 at *17 (3d Cir. Nov. 15, 2013), the Court decided that “the cloud on the claim” stemming from a preferential…more

Acquisitions, Chapter 11, Commercial Bankruptcy, Creditors, Debt Collection

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Fifth Circuit Continues to Permit Wage Claim Waivers in Private Settlements, But Only Where a Bona Fide Dispute Exists

A Federal Appeals Court recently confirmed that under certain circumstances, parties may privately settle and release claims under the Fair Labor Standards Act. A generic release contained in a settlement agreement won’t do it;…more

FLSA, Non-Compete Agreements, Over-Time, Settlement, Settlement Agreements

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Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting…more

AMP v Myriad, Diagnostic Tests, DNA, Mayo v. Prometheus, Patent-Eligible Subject Matter

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Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient Drug…more

Affordable Care Act, Amarin, Caronia, CMS, Cybersecurity

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Kissing Camels Antitrust Suit Against Health System Moves Past Another Hump in the Road

In June, an antitrust suit brought by plaintiff ambulatory surgery centers (“ASCs”) against a health system, health insurers, and a trade association survived a motion to dismiss. Last week, the ASCs’ case cleared the hump of…more

Ambulatory Surgery Centers, Anti-Competitive, Antitrust Conspiracies, False Statements, Insurers

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USPTO Issues Newly Updated Guidance on Subject Matter Eligibility that Further Clarifies Examination Standards under 35 U.S.C. §101 in Light of Alice v. CLS Bank

Over the past few years, the Supreme Court’s decisions in Alice (Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347 (2014)) and Mayo (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)), and other cases…more

CLS Bank v Alice Corp, Guidance Update, Inventors, Mayo v. Prometheus, Patent Applications

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Massachusetts Earned Sick Time Law Takes Effect July 1

Massachusetts’ Earned Sick Leave Law, which voters passed by ballot initiative last November, is set to become effective in less than two months on July 1, 2015. On April 27, Attorney General Maura Healy’s office released…more

Human Resources Professionals, Paid Leave, Proposed Regulation, Sick Leave, Wage and Hour

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New Hampshire Establishes Privacy Protections for Student Online Personal Information

California again has provided a model of privacy legislation for other states to follow. New Hampshire Governor Maggie Hassan recently signed into law House Bill 520 (the “Bill”), a bipartisan effort to establish guidelines for…more

Data Collection, Data Protection, De-Identification, Internet, Mobile Apps

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Just How Scary is the SEC? “Fear” Not Sufficient Grounds to Duck Administrative Subpoena

A witness testifying under oath before the SEC recently refused to answer any questions directed to him, not because of any privilege, but rather — as he said, sixty-eight different times – because he was “scared” and…more

Bitcoin, Fifth Amendment, Ponzi Scheme, SEC, Self-Incrimination

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Health Care Reform Update -- April 15, 2013

In This Issue: Leading the News; Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups…more

Affordable Care Act, CMS, Federal Budget, Healthcare, HHS

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Second Circuit Continues the Ebook Saga by Affirming Apple’s Role in an Unlawful Price Fixing Conspiracy

On June 30, 2015, the same day as the launch of Apple’s new streaming music service, the Second Circuit Court of Appeals coincidentally affirmed a district court ruling that Apple conspired with five of the country’s largest…more

Amazon, Apple, Collusion, Corporate Counsel, ebook

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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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Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided…more

Amarin, Commercial Marketing, Drug Manufacturers, False Claims Act, FDA

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A “Solution” in Search of a Problem? The Innovation Act of 2015 and Trends in Fee-shifting in Patent Litigation

On February 5, 2015, Rep. Robert Goodlatte (R-VA) introduced H.R. 9, entitled the “Innovation Act.” Among other things, the bill would direct courts to award attorneys’ fees and litigation-related expenses to prevailing parties…more

Attorney's Fees, Fee-Shifting, Innovation Act, Intellectual Property Litigation, Litigation Fees & Costs

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Kissing Camels Antitrust Suit Against Health System Moves Past Another Hump in the Road

In June, an antitrust suit brought by plaintiff ambulatory surgery centers (“ASCs”) against a health system, health insurers, and a trade association survived a motion to dismiss. Last week, the ASCs’ case cleared the hump of…more

Ambulatory Surgery Centers, Anti-Competitive, Antitrust Conspiracies, False Statements, Insurers

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IRS Revamps Proposed Issue Price Definition for Municipal Bonds

Treasury and IRS today announced a decision to withdraw the much-criticized portion of the notice of proposed rulemaking published in the Federal Register on September 16, 2013 (the “2013 Proposed Regulations”) related to the…more

IRS, Municipal Bonds, Tax-Exempt Bonds, U.S. Treasury

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Africa Update - September 2015

Leading the News: South Sudan - On August 27th, emergency relief teams from the United Nations (U.N.) Children’s Fund (UNICEF) and the World Food Programme (WFP) reached more than 27,000 people in the town of Wau…more

Africa, AGOA, AIDS, Boko Haram, Burundi

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FTC Check-Up on Health Care Trends Reveals New Competitive Wrinkles - Highlights from the FTC Workshop “Examining Health Care Competition”

The Federal Trade Commission (FTC or Commission) recently hosted a workshop exploring trends and innovation in the health care industry that may affect competition, marking at least 10 years since the antitrust agencies formally…more

Competition, FTC, Healthcare

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Expediting Patent Prosecution with the New Collaborative Search Pilot Program

Two new Collaboration Search Pilot Programs are or will soon be available to patent applicants. The Collaboration Search Pilot Program (CSP) between the United States Patent and Trademark Office (USPTO) and the Japan Patent…more

Collaboration, Federal Pilot Programs, Foreign Patent Applications, Japan, Japan Patent Office

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State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to…more

Attorney Generals, Disclosure Requirements, Drug Pricing, Fraud, Medicaid

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Back to School – HIPAA 101

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are four…more

Business Associates, C-Suite Executives, Cybersecurity, Data Breach, Data Privacy

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Energy & Environment Update - August 2014 #4

In This Issue: - Energy and Climate Debate - Congress - Administration - Department of Energy - Department of Interior - Department of State - Environmental Protection…more

Climate Change, Department of State, Department of the Interior, DOE, Energy

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