Mintz Levin

Ringing Off The Hook: TCPA Issues Still At Forefront As Calendar Turns To 2016

We may only be three weeks into 2016, but the Telephone Consumer Protection Act (“TCPA”) has already received a considerable amount of attention this year…more

Auto-Dialed Calls, Campbell Ewald v Gomez, Class Action, Declaratory Rulings, FCC

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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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When a Quirk of Copyright Law Creates a Christmas Classic: It’s a Wonderful Life and the Public Domain

George Bailey stands on a bridge begging for another chance at life. Upon being granted a second chance, he joyously runs home to embrace his family. As the community of Bedford Falls rallies around him and raises funds to save…more

Copyright, Derivative Works, Holidays, Movies, Public Domain

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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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Back to School – Avoiding Theft of Data and Money via the “Business Email Compromise” Scam

The FBI warned this summer that the “Business Email Compromise” (“BEC”) scam continues to grow, evolve, and target businesses of all sizes. As reported by the FBI in June, the scam had hit more than 22,000 victims for a combined…more

Business E-Mail Compromise (BEC), Cyber Crimes, Cybersecurity, Data Breach, Data Protection

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

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

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

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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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ITC Declines to File Petition for Certiorari – CAFC Holding that ITC Does Not Have Jurisdiction over Digital Imports Stands

The deadline has come and gone for the ITC and patentee Align to file petitions for certiorari seeking review by the Supreme Court of the Federal Circuit’s decision in ClearCorrect. On November 10, 2015, a panel of the Federal…more

Anti-Piracy, Appeals, CAFC, Digital Downloads, Digital Goods

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Pokémon Go in the Workplace: Oh Look There’s a Pikachu!

Did you know that the world is now inhabited by creatures called Pokémon? (Or maybe they’ve always been there?) Some run across the plains; others fly through the skies; and some live in the mountains….and some, yes, some, are…more

Data Security, Distracted Driving, Employee Engagement, Employee Handbooks, Games

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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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Mintz TechConnect - December 2015

Letter from the Editors - Welcome to the second issue of Mintz Levin’s TechConnect — our bi-monthly newsletter on “all things technology” in the legal and business world, from our perspective, of course. This issue contains…more

B Corporation, Broadcasting, Corporate Social Responsibility, Crowdfunding, Cybersecurity Information Sharing Act (CISA)

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What are the USPTO’s Patent Plans for Fiscal Year 2017?

The U.S. Patent and Trademark Office (USPTO) explains several patent prosecution trends, goals, and programs to justify proposed spending of its collected fees in its recently-issued Fiscal Year 2017 Congressional Justification…more

America Invents Act, Corporate Counsel, Examiners, Information Technology, Patent Applications

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Massachusetts State Legislature Takes Action on Major Employment Reform as Legislative Session Ends

In the final weeks before the end of the legislative session, the Massachusetts House and State both addressed major pieces of labor and employment legislation. However, although the legislature passed S.2119, an Act to…more

Anti-Discrimination Policies, Credit Checks, Equal Pay, FCRA, Gender-Based Pay Discrimination

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Supreme Court Makes It Harder for Willful Infringers to Escape Punishment

The Supreme Court has made it easier for patent owners to prove willful infringement and entitlement to enhanced damages. In a unanimous opinion issued yesterday in a pair of cases decided together, Halo Electronics, Inc. v…more

35 U.S.C. § 284, Abuse of Discretion, Enhanced Damages, Halo v Pulse, Judicial Discretion

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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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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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The DOL Releases Its Final Rule Updating the FLSA White-Collar Overtime Regulations

The wait is over! This morning, the Department of Labor announced its Final Rule, which is aimed at expanding overtime eligibility for millions of American workers. At its core, the final version of the rule doubled the…more

DOL, Final Rules, FLSA, Minimum Salary, Wage and Hour

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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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Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: April 2016

Trends & Analysis - ..We have identified 42 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. Included in that count is one proceeding (the…more

Class Action, Corporate Integrity Agreement, Fraud, HIPAA, Qui Tam

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Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s…more

Acquittals, Affirmative Defenses, Anti-Kickback Statute, Corporate Counsel, Criminal Prosecution

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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 Industry

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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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CMS Releases 2017 Advance Notice and Draft Call Letter

Last week, the Centers for Medicare & Medicaid Services (CMS) released its 2017 Advance Rate Notice and draft Call Letter (“2017 Draft Call Letter”) for the Medicare Advantage (“MA”) and Part D programs. With the final 2017…more

CMS, Employer Group Health Plans, Medicare Advantage, Medicare Part D, Prescription Drugs

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Monthly TCPA Digest - August 2016

In light of the continued compliance and litigation challenges presented by the Telephone Consumer Protection Act (TCPA), Mintz Levin’s TCPA and Consumer Calling Practice team have launched an inaugural newsletter to keep you…more

Article III, Bipartisan Budget Act, Debt Collection, Declaratory Rulings, Exceptions

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ACA Reporting on Forms 1094-C and 1095-C, AIRTN500 Error Messages, and Incorrect and Missing Taxpayer Identification Numbers (TINs)—What’s an Employer to Do?

Employer-sponsored group health plans and health insurance issuers (or carriers) are subject to information reporting requirements under the Affordable Care Act (ACA), including the obligation to report taxpayer identification…more

Affordable Care Act, Covered Employees, Form 1094, Form 1095, IRS

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TechConnect - Your Law Firm Link to Industry News - February 2016

As the Northeast begins (hopefully) to thaw out and we head into an early spring (so said the Groundhog), we are excited to deliver our new issue of TechConnect — our bimonthly newsletter on “all things technology” in the legal…more

Corporate Taxes, Drones, Private Equity, Protecting Americans from Tax Hikes (PATH) Act, Small Business

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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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Insider Loans Equitably Subordinated

In SGK Ventures, LLC, the Bankruptcy Court for the Northern District of Illinois ordered that the secured claims of two entities controlled by insiders of the debtor be equitably subordinated to the claims of unsecured…more

Bankruptcy Court, Closely Held Businesses, Creditors, Debtors, Equitable Subordination

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Statutory Liens vs. Consensual Liens: Why it Matters and When it may Not

While secured creditors are entitled to special rights in bankruptcy, those rights may differ depending on whether creditors have a statutory or consensual lien on their collateral. This is primarily because section 552(a) of…more

Bankruptcy Code, Chapter 9, Debtors, Liens, Municipal Bankruptcy

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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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“Your Money or Your PHI”: OCR Releases Guidance on Ransomware

On July 11, 2016, the Office for Civil Rights (OCR) released important new guidance on ransomware for hospitals and other healthcare providers and finally addressed the question of whether electronic protected health information…more

Breach Notification Rule, Covered Entities, Cyber Attacks, Data Breach, Employee Training

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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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Monthly TCPA Digest - August 2016

In light of the continued compliance and litigation challenges presented by the Telephone Consumer Protection Act (TCPA), Mintz Levin’s TCPA and Consumer Calling Practice team have launched an inaugural newsletter to keep you…more

Article III, Bipartisan Budget Act, Debt Collection, Declaratory Rulings, Exceptions

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“GMO” Labeling Food Fight: How Vermont’s Act 120 Is Pressuring An Entire Industry

On July 1, 2016, Vermont’s Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE). Unless Congress acts with…more

FDA, Food Labeling, Food Manufacturers, Genetically Engineered Seed, GMO

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What Questions Executives Should Be Asking About Their D&O Insurance Following The New DOJ Policies Issued Last Week

As was recently reported in the New York Times and elsewhere, the Justice Department issued new policies last week that place individual executives as the focus of their prosecution efforts, and encourage companies to cooperate…more

Board of Directors, C-Suite Executives, D&O Insurance, DOJ, Indemnification

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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 - August 2016

A Note from the Editors - Our August edition of Energy Technology Connections brings you recent industry highlights and features a list of upcoming energy industry events throughout the nation. In Leaders in the News, we…more

Clean Energy, Clean Tech, DOE, Electricity, 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 (DOT), Energy Policy, Environmental Policies

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Developers Who Elect Not to Pay Comprehensive Permit Fees in Full Proceed at Their Peril

The Massachusetts Appeals Court issued an opinion on August 29, 2016, that has significant ramifications for developers seeking Comprehensive Permits for affordable housing projects under chapter 40B of the Massachusetts General…more

Affordable Housing, Appeals, Filing Fees, Housing Developers, Safe Harbors

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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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Tackling Drug Prices: CMS and PhRMA Propose Steps to Promote Value-Based Purchasing

Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices. CMS proposed to tackle…more

CMS, Drug Pricing, Medicare Part B, PHRMA, Prescription Drug Coverage

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Apple (Finally) Enjoins the Sale of (Obsolete) Samsung Phones

In the latest development in the patent skirmishes between Apple and Samsung, on Monday, January 18, 2016, U.S. District Court Judge Lucy Koh of the Northern District of California entered a permanent injunction barring Samsung…more

Apple, Apple v Samsung, Patent Infringement, Patents, Permanent Injunctions

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Africa Update - March 2016 #4

Leading the News - Libya - On March 28th, Libya’s United Nations (U.N.)-backed unity government accused authorities in Tripoli of closing down the capital’s airspace to prevent it from travelling to Libya from Tunisia…more

Africa, Burundi, Ebola, Human Rights, Humanitarian Assistance

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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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2017 Diversity Visa Lottery Registration Begins Today

On October 1, 2015, the US Department of State will begin accepting requests to register for the 2017 Diversity Immigrant Visa Program (DV-2017), also known as the Green Card Lottery. The Diversity Lottery Program provides a…more

Adjustment of Status, Consulate, Diversity Lottery, Eligibility, Green Cards

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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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Design Patents – Unlocking the Value of The User Experience

The oft-overlooked design patent has seen somewhat of a revival recently (at least in the media) ever since a jury in California awarded Apple $399 million in damages — i.e., all Samsung profits from the sale of several of its…more

Apple, Damages, Design Patent, Lost Profits, Patent Infringement

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UK Immigration: SMS Request Premium Service Announced for Future Implementation

The UK Home Office has announced plans to offer an optional premium service for requests made through the Sponsor Management System (SMS). This service will allow Sponsors to pay a fee of £200 for expedited processing of certain…more

Immigrants, Licenses, UK, Visas

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Industrial Espionage and the Defend Trade Secrets Act

American corporations are facing an ever increasing threat of misappropriation of their valuable trade secrets through industrial espionage, defined as the theft of a company’s trade secrets by an actor intending to convert the…more

China, Confidential Information, Defend Trade Secrets Act (DTSA), Former Employee, Industrial Espionage

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Law Revamping Medicare ID Cards to Be Revived

Lawmakers are again eyeing ways to modernize the Medicare system, including a revamping of the identification cards used by Medicare beneficiaries. On Wednesday, the House Ways and Means’ health subcommittee held a hearing on…more

Electronically Stored Information, GAO, HHS, Medicare, Medicare Access and CHIP Reauthorization (MACRA)

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Second Circuit: Aluminum End Users Lack Antitrust Standing; Price Manipulation Claims Against Traders and Warehouses Foiled

Last week, in In re Aluminum Warehousing Antitrust Litigation, the US Court of Appeals for the Second Circuit (“Second Circuit”) rejected a claim by certain downstream end-users of aluminum that their price manipulation…more

Antitrust Violations, Civil Conspiracy, Class Action, Consumer Protection Act, Derivatives

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Immigration Relief for Foreign Entrepreneurs

On August 26, 2016, USCIS released the text of a proposed rule to be published in the Federal Register shortly, that provides temporary immigration relief to qualifying foreign entrepreneurs whose presence in the U.S. would be a…more

Corporate Counsel, Entrepreneurs, Foreign Investment, Parole Employment Authorization, Proposed Rules

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Handling Nondiscretionary Incentive Payments Under the New FLSA Overtime Rule

One of the few “wins” for employers under the DOL’s new overtime rule was that employers are now allowed to apply “nondiscretionary incentive payments” to meet up to 10 percent of the new salary threshold. This change could…more

Bonuses, Corporate Counsel, DOL, Exempt-Employees, FLSA

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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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Massachusetts State Legislature Takes Action on Major Employment Reform as Legislative Session Ends

In the final weeks before the end of the legislative session, the Massachusetts House and State both addressed major pieces of labor and employment legislation. However, although the legislature passed S.2119, an Act to…more

Anti-Discrimination Policies, Credit Checks, Equal Pay, FCRA, Gender-Based Pay Discrimination

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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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When a Quirk of Copyright Law Creates a Christmas Classic: It’s a Wonderful Life and the Public Domain

George Bailey stands on a bridge begging for another chance at life. Upon being granted a second chance, he joyously runs home to embrace his family. As the community of Bedford Falls rallies around him and raises funds to save…more

Copyright, Derivative Works, Holidays, Movies, Public Domain

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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 2016

Welcome to 2016 and our annual look at what’s in store for the United States Congress in the coming year. Here you will find a preview of the US legislative agenda as well as a look at the Obama Administration’s regulatory…more

Energy Policy, Federal Budget, Foreign Policy, International Tax Issues, Legislative Agendas

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Massachusetts State Legislature Takes Action on Major Employment Reform as Legislative Session Ends

In the final weeks before the end of the legislative session, the Massachusetts House and State both addressed major pieces of labor and employment legislation. However, although the legislature passed S.2119, an Act to…more

Anti-Discrimination Policies, Credit Checks, Equal Pay, FCRA, Gender-Based Pay Discrimination

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Louisiana Supreme Court Adopts Pro Rata Allocation of Defense Costs Among Insurers and Insured

On September 7, 2016, the Louisiana Supreme Court applied, for the first time, a pro rata allocation method to defense costs where commercial general liability policies provided coverage during a portion of the time of exposure…more

Insurance Industry, LA Supreme Court, Liability Insurance, Litigation Fees & Costs, Pro Rata Allocation Rule

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Supreme Court Adopts Implied False Certification Theory in Universal Health Services v. United States ex rel. Escobar But Imposes Limits

On June 16, 2016, a unanimous Supreme Court issued its long-awaited decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”). The Court ruled that under certain circumstances the theory of “implied…more

Conditions of Payment, False Claims Act (FCA), False Implied Certification Theory, Federal Contractors, Federal Pleading Requirements

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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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Fed. Cir. Defers to PTAB Finding of Obviousness in First Pharma IPR Reviews (Merck v. Gnosis)

On December 17, 2015, the Federal Circuit issued a precedential decision affirming a determination by the Patent Trial and Appeal Board (“PTAB”) that patent claims related to methods of treating elevated homocysteine levels were…more

America Invents Act, Corporate Counsel, Inter Partes Review Proceedings, Merck, Obviousness

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OIG Issues Favorable GPO Advisory Opinion

The OIG recently issued a favorable advisory opinion permitting a health system (the “Health System”) to become the sole owner of a Group Purchasing Organization (“GPO”), some of whose members were also owned by the Health…more

GPOs, OIG, Safe Harbors

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Federal Circuit Rules That “Same-Day Continuations” Are Proper

The Federal Circuit yesterday issued a decision that will make many patent owners and IP practitioners breathe easier. In Immersion Corp. v. HTC Corp. the Court reversed a district court holding that a continuation application…more

Filing Requirements, Patent Applications, Patents, Same-Day Continuations, USPTO

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Israel Connect - Legal Insight for Success in the US Market

We are excited to present you with the second issue of Israel Connect — our quarterly newsletter focused on forging new connections and strengthening existing bonds between Israeli businesses and the US market. In our second…more

Anti-Competitive, Biosimilars, D&O Insurance, DOJ, FDA

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Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for Average…more

Affordable Care Act, CMS, Drug Pricing, Fair Market Value, Final Rules

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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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A Novel Outcome at the International Trade Commission: Patent Claims Invalidated Under Alice in the 100-Day Pilot Program

On August 22, 2016, Administrative Law Judge David Shaw of the International Trade Commission (“ITC” or “Commission”) issued his final initial determination (“the ID”) in Certain Portable Electronic Devices and Components…more

ALJ, CLS Bank v Alice Corp, Corporate Counsel, Initial Determination (ID), ITC

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Various Ways to Raise Capital

The world of raising capital has been evolving over the last several years. Offerings of securities generally used to fall into two main buckets: (i) private placements under the old Rule 506 or (ii) a public offering. With the…more

Capital Raising, Crowdfunding, Crowdsourcing, IPO, 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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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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Political and Economic Conditions Shaping America’s Energy Future

America’s 10 year energy resurgence exhibits the difficulty of prediction. Unexpected global events, from the persistence of the U.S. fracking revolution to the impact (or lack thereof) of low natural gas prices on the business…more

Energy & Climate Debates, Energy Policy, Energy Sector, Global Economy, Legislative Agendas

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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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Pokémon Go in the Workplace: Oh Look There’s a Pikachu!

Did you know that the world is now inhabited by creatures called Pokémon? (Or maybe they’ve always been there?) Some run across the plains; others fly through the skies; and some live in the mountains….and some, yes, some, are…more

Data Security, Distracted Driving, Employee Engagement, Employee Handbooks, Games

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Federal Circuit: Go whole-hog on validity below if you want to contest an independent determination of invalidity on appeal

Think you’ve won on validity at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) and your claims are safe on appeal? “Not so fast,” says the Federal Circuit in Software Rights Archive, LLC v. Facebook…more

Facebook, Inter Partes Review Proceedings, Obviousness, Patent Trial and Appeal Board, Patent Validity

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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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Penalties For Health Care Law Violations Surge

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). Through an interim final rule, the…more

Civil Monetary Penalty, Deficit Reduction, DOJ, False Claims Act (FCA), Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015

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California Plaintiffs Say that Size Matters: Consumer Fraud Class Action Challenges Slack-Fill in Protein Products

According to named plaintiffs in a consumer fraud action filed in December in the Southern District of California, size matters when making it comes to making a purchase. In fact, Plaintiffs claim that the average consumer’s…more

Class Action, CLRA, Consumer Fraud, False Advertising, Food Manufacturers

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

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

Corporate Counsel, EB-5, Immigrant Investor Program, Material Misstatements, SEC

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TechConnect - Your Law Firm Link to Industry News - July 2016

Letter from the Editors - Dear Readers, One of the interesting facts that we have learned over the years is that there appears to be a correlation between the NASDAQ public market (which is heavily weighted with…more

Crowdfunding, E-SIGN, E-Signatures, Funding Portal, Intellectual Property Protection

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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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Baker Signs FY17 Budget, Issues Vetoes

Governor Charlie Baker signed a budget for FY17 on Friday, July 8, after vetoing $256 million in spending included in the plan approved by the legislature. The budget, which represents the second annual spending plan signed by…more

Budgets, Governor Baker, Governor Vetoes, State Budgets

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Back to Work from Travel Abroad? Check Your Form I-94!

As foreign national employees come back from summer vacations and travel abroad, one of the most overlooked immigration documents and pitfalls is Form I-94. If Form I-94 is issued for a shorter validity period than the maximum…more

Customs and Border Protection, Foreign Nationals, Form I-94, Forms, H-1B

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Failure to Update Infringement Contentions with New Reexamination Claims Fatal for Patentee

On April 22, 2016, a three judge panel of the United States Court of Appeals for the Federal Circuit, consisting of Judges Prost, Dyk and O’Malley, affirmed a district court’s decision to dismiss as moot a patent case involving…more

Mootness, Patent Infringement, Patent Litigation, USPTO

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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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Massachusetts Legislature Overhauls Public Records Law

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

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

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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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Federal Circuit Backs Finding of Inequitable Conduct in Reexamination of Prosthetics Patent

The Federal Circuit has affirmed a district court’s awarding of attorneys’ fees to Alps South (Alps) based on inequitable conduct by Ohio Willow Wood (OWW) during reexamination of its patent for gel-coated, cushioned socks that…more

Attorney's Fees, Evidence, Inequitable Conduct, Inter Partes Reexamination, Patent Infringement

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Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2016

Since our last issue, we have identified 31 recently unsealed health care-related whistleblower cases. In this Qui Tam Update, we analyze the trends and take an in-depth look at a few noteworthy cases…more

Certificates of Compliance, Constructive Trusts, Criminal Prosecution, DEA, False Billing

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Privacy Shield: The National Data Protection Authorities Hold Fire

The Article 29 Working Party (WP29) has released a brief updated statement on the final form of the Privacy Shield adequacy decision and supporting annexes. WP29 is an important advisory group made up of representatives of each…more

Article 29 Working Party (WP29), Binding Corporate Rules, Data Protection Authority, EU, EU-US Privacy Shield

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FDA Places Ban on Import of GE Salmon

Reversing course from the end of 2015, FDA recently announced an import ban on genetically engineered (GE) salmon until such a time as comprehensive labeling guidelines are introduced. Despite FDA’s approval of GE salmon in…more

FDA, Food Labeling, GMO Bans, Imports, Interstate Commerce

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Monthly TCPA Digest - August 2016

In light of the continued compliance and litigation challenges presented by the Telephone Consumer Protection Act (TCPA), Mintz Levin’s TCPA and Consumer Calling Practice team have launched an inaugural newsletter to keep you…more

Article III, Bipartisan Budget Act, Debt Collection, Declaratory Rulings, Exceptions

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A Preview of Business Immigration in 2016: H-4 EAD Reforms (Part 4/6)

From proposals to overhaul OPT to decreasing the number of H-1Bs, 2016 is already proving to be an interesting year for business immigration. In a series of posts, the Mintz Levin team will provide an overview of the cases,…more

DHS, Employment Authorization Documents (EAD), H-1B, H-4 Spouses, Motion for Summary Judgment

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Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”) Yates…more

Acquittals, CEOs, Corporate Executives, DOJ, False Claims Act (FCA)

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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

Federal Election Commission (FEC), McCutcheon v. FEC, Political Contributions, SCOTUS

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First Circuit Overturns SEC Commissioners’ Sanctions Order

As we have discussed before, the SEC’s increased use of in-house administrative proceedings in enforcement actions involving allegations of fraud has been a subject of considerable debate. Commentators have questioned the…more

Administrative Proceedings, Enforcement Actions, Materiality, Scienter, SEC

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Fund Manager Annual Update

The SEC brought a record number of enforcement actions against investment advisers in 2015, resulting in approximately $4.2 billion in sanctions.1 This alert highlights current issues for private equity, venture capital and…more

AIFMD, Blue Sky Laws, Cybersecurity, Enforcement Actions, Filing Deadlines

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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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Westlake Services v. Credit Acceptance: PTAB’s Precedential Decision to Apply Estoppel on a Claim-by-Claim Basis

The Patent Trial and Appeal Board recently designated as precedential its decision in Westlake Services, LLC v. Credit Acceptance Corp., CBM2014-00176, Paper 28 (PTAB May 14, 2015) addressing the scope of estoppel under 35…more

CLS Bank v Alice Corp, Covered Business Method Proceedings, Estoppel, Patent Litigation, Patent Trial and Appeal Board

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The Department of Labor’s 2016 Final Fiduciary and Conflict of Interest Regulations: The Principal Transactions Exemption

This post continues our examination of the Department of Labor’s suite of final fiduciary and conflict of interest regulations. Our prior posts discussed the newly expanded definition of “investment advice fiduciary” and the…more

Best Interest Contract Exemptions, Broker-Dealer, Conflicts of Interest, DOL, Employee Benefits

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Good News on “Bad Boy” Guarantees – IRS Reverts to Prior Position in Recent Legal Advice Memorandum

On April 15, 2016, the IRS released a generic legal advice memorandum (GLAM 2016-001) (the “April GLAM”) addressing the impact of so-called “bad boy” guarantees (also known as nonrecourse carve-out guarantees) on the…more

Bad Boy Liability, Carve Out Provisions, IRS, Non-Recourse Loans, Real Estate Market

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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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Preparation for 2015 Fiscal Year-End SEC Filings and 2016 Annual Shareholder Meetings

As our clients and friends know, each year Mintz Levin provides an analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange…more

Annual Meeting, Conflict Mineral Rules, Cybersecurity, Disclosure-Based Settlements, Executive Compensation

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Israel Connect - Legal Insight for Success in the US Market

We are excited to present you with the second issue of Israel Connect — our quarterly newsletter focused on forging new connections and strengthening existing bonds between Israeli businesses and the US market. In our second…more

Anti-Competitive, Biosimilars, D&O Insurance, DOJ, FDA

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Important Changes Resulting from New ALTA/NSPS Land Title Survey Standards

As a follow up to my colleague Allan Caggiano’s post on the new 2016 ALTA/NSPS Land Title Survey Standards, the Planning & Zoning Resource Company (PZR) has recently circulated an important advisory on the practical effects of…more

Land Titles, Urban Planning & Development, Zoning Laws

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Mintz TechConnect - December 2015

Letter from the Editors - Welcome to the second issue of Mintz Levin’s TechConnect — our bi-monthly newsletter on “all things technology” in the legal and business world, from our perspective, of course. This issue contains…more

B Corporation, Broadcasting, Corporate Social Responsibility, Crowdfunding, Cybersecurity Information Sharing Act (CISA)

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Israel Connect - Legal Insight for Success in the US Market

We are excited to present you with the second issue of Israel Connect — our quarterly newsletter focused on forging new connections and strengthening existing bonds between Israeli businesses and the US market. In our second…more

Anti-Competitive, Biosimilars, D&O Insurance, DOJ, FDA

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Supreme Court Makes It Harder for Willful Infringers to Escape Punishment

The Supreme Court has made it easier for patent owners to prove willful infringement and entitlement to enhanced damages. In a unanimous opinion issued yesterday in a pair of cases decided together, Halo Electronics, Inc. v…more

35 U.S.C. § 284, Abuse of Discretion, Enhanced Damages, Halo v Pulse, Judicial Discretion

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TechConnect - Your Law Firm Link to Industry News - February 2016

As the Northeast begins (hopefully) to thaw out and we head into an early spring (so said the Groundhog), we are excited to deliver our new issue of TechConnect — our bimonthly newsletter on “all things technology” in the legal…more

Corporate Taxes, Drones, Private Equity, Protecting Americans from Tax Hikes (PATH) Act, Small Business

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Monthly TCPA Digest - August 2016

In light of the continued compliance and litigation challenges presented by the Telephone Consumer Protection Act (TCPA), Mintz Levin’s TCPA and Consumer Calling Practice team have launched an inaugural newsletter to keep you…more

Article III, Bipartisan Budget Act, Debt Collection, Declaratory Rulings, Exceptions

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Renewable Energy Tax Credits: Recent IRS Notice Favorable to the Renewable Energy Industry

On May 5, 2016, the IRS released new guidance regarding the renewable energy production tax credit (“PTC”) and energy investment tax credit (“ITC”) which most in the renewable energy industry will find favorable…more

Investment Tax Credits, IRS, Production Tax Credit, Renewable Energy, Tax Credits

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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: Recently Unsealed Whistleblower Cases: October 2015

Trends & Analysis: ..We have identified 15 health care–related qui tam cases that were unsealed since our last Qui Tam Update. Of those, 12 were filed from 2012 to the present. All but two cases had been pending more than a…more

Anti-Retaliation Provisions, Corporate Integrity Agreement, Declination, DOJ, Employees

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Preparation for 2015 Fiscal Year-End SEC Filings and 2016 Annual Shareholder Meetings

As our clients and friends know, each year Mintz Levin provides an analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange…more

Annual Meeting, Conflict Mineral Rules, Cybersecurity, Disclosure-Based Settlements, Executive Compensation

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Medicaid Managed Care Transitions’ Impact On Brain Injury Waiver Populations

As of June 2015, 24 states utilize a traumatic or acquired brain injury waiver,1 as provided under section 1915(c) of the Social Security Act, which are designed to help individuals with traumatic brain injury (TBI) live in the…more

Affordable Care Act, Beneficiaries, CMS, HCBS Waivers, MCOs

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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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CISA Guidelines (Part 3): Guidance to Assist Non-Federal Entities

As we wrote previously, the federal government released several guidance documents last month implementing The Cybersecurity Information Sharing Act (CISA). Among these was the Guidance to Assist Non-Federal Entities to Share…more

Cyber Threats, Cybersecurity, Cybersecurity Information Sharing Act (CISA), DHS, DOJ

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EB-5 Will Likely Be Extended as Part of Continuing Resolution Through December 9, 2016

On September 23, 2016, a draft of the Continuing Resolution (CR) began circulating in Washington, DC. The CR, which Congress will likely pass early next week, will keep the federal government running through the November…more

Appropriations Bill, Continuing Resolution, EB-5, EB-5 Regional Centers

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What App Users Care About When Sharing Personal Data: Permissions

The latest Pew Research Center Report relayed useful information regarding application users’ concerns with sharing personal data. Ninety percent of app users indicated that how their personal data will be used is “very” or…more

Android, App Developers, Google, Google Play Store, Mobile Apps

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Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to the…more

Barack Obama, Biotechnology, EPA, FDA, Obama Administration

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Medicaid Managed Care Transitions’ Impact On Brain Injury Waiver Populations

As of June 2015, 24 states utilize a traumatic or acquired brain injury waiver,1 as provided under section 1915(c) of the Social Security Act, which are designed to help individuals with traumatic brain injury (TBI) live in the…more

Affordable Care Act, Beneficiaries, CMS, HCBS Waivers, MCOs

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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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House Passes GE Labeling Bill; Obama Expected to Sign

As a parting act before its seven-week recess, the House last Thursday passed by a vote of 306-117 Senator Pat Roberts’s (R-KS) legislation (S.764) requiring the labeling of genetically engineered foods. Already approved by the…more

Department of Agriculture, Food Labeling, GMO, GMO Bans, Preemption

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

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

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

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Practice Fusion and FTC Settle Complaint Over Deceptive Statements About the Privacy of Consumer-Generated Online Content

Last week, the Federal Trade Commission (FTC) announced (press release) that Practice Fusion, the largest cloud-based electronic health company in the United States, has agreed to settle FTC charges over deceptive practices…more

Cloud Computing, Disclosure Requirements, EHR, FTC, Patient Confidentiality Breaches

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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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FDA Concludes Two-Day Public Hearing on Human Cell and Tissue Product (HCT/P) Regulatory Paradigm

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level…more

Draft Guidance, FDA, PHSA, Public Hearing

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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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Where do the DOL’s New FLSA White-Collar Overtime Regulations Leave Non-Profits and Educational Institutions?

Over the course of this and next week, we will discuss the final overtime rule’s impact and address related workplace issues on which employers should focus in advance of its December 1st implementation date. Today we focus on…more

DOL, Educational Institutions, Final Rules, FLSA, Minimum Salary

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CPSC Chairman Kaye and Commissioner Adler: Current Civil Penalties Approach Works

Yesterday, CPSC Chairman Elliot Kaye and Commissioner Robert Adler issued a lengthy joint statement vigorously defending the Commission’s current approach to civil penalties against various criticisms voiced by Commissioners Joe…more

Civil Monetary Penalty, Consumer Product Safety Commission (CPSC), CPSC Commissioner

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A New Hope for Software Patents?

Software patents have been facing intense scrutiny under 35 U.S.C. § 101 for subject matter eligibility since the U.S. Supreme Court’s Alice v. CLS Bank decision in 2014. In the last two years, the patent ecosystem (including…more

Abstract Ideas, CLS Bank v Alice Corp, Microsoft, Patent-Eligible Subject Matter, Patents

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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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Renewable Energy Tax Credits: Recent IRS Notice Favorable to the Renewable Energy Industry

On May 5, 2016, the IRS released new guidance regarding the renewable energy production tax credit (“PTC”) and energy investment tax credit (“ITC”) which most in the renewable energy industry will find favorable…more

Investment Tax Credits, IRS, Production Tax Credit, Renewable Energy, Tax Credits

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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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U.S. Department of Defense Expands Telemedicine Access for Military Members

Last month, Jonathan Woodson, M.D., the Assistant Secretary of Defense for Health Affairs for the U.S. Department of Defense, issued a memorandum that effectively changes the Military Health System (“MHS”) policy on…more

Department of Defense (DOD), Military Service Members, Telemedicine

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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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Three Strikes and Recovery Act is Out

Today’s U.S. Supreme Court decision in Commonwealth of Puerto Rico v. Franklin California Tax-Free Trust puts an end to one of Puerto Rico’s multi-pronged efforts to deleverage itself. Given the comprehensiveness of the First…more

Bankruptcy Code, Commonwealth of Puerto Rico v Franklin California Tax-Free Trust, Contracts Clause, Debt Enforcement & Recovery Act (DERA), Preemption

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Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases…more

Clinical Laboratories, Diagnostic Imaging Services, Financial Conduct Authority (FCA), Healthcare, Hospitals

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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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In McRO, Federal Circuit Provides Further Guidance on Section 101

Two years after the Central District of California invalidated two 3-D animation patents under Section 101, the Federal Circuit reversed that court’s decision, finding that the lower court oversimplified the claims of a…more

Abstract Ideas, CLS Bank v Alice Corp, Computer-Related Inventions, Patent-Eligible Subject Matter, Patents

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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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Let’s talk about Networks of Things, baby. Let’s talk about you and me.

It is easy to see networks all around us. The printers at the office, your child’s videogame, the food ordering app on your phone, the fitness band or smart watch on your wrist, the electricity grid for your city, the…more

Chamber of Commerce, Internet of Things, Networks, NIST

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Summer Round-Up: Four States Bolster Data Breach Notification Laws and More Changes on the Way

As has become typical in the data security space, there was quite a bit of activity in state legislatures over the previous year concerning data breach notification statutes. Lawmakers are keenly aware of the high profile data…more

Attorney Generals, Breach Notification Rule, Data Breach, Data Security, Encryption

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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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Teladoc Receives Support from the Feds

Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board’s (the “Board”) appeal was inappropriate and…more

Amicus Briefs, Appeals, DOJ, FTC, Jurisdiction

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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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Second Circuit: Aluminum End Users Lack Antitrust Standing; Price Manipulation Claims Against Traders and Warehouses Foiled

Last week, in In re Aluminum Warehousing Antitrust Litigation, the US Court of Appeals for the Second Circuit (“Second Circuit”) rejected a claim by certain downstream end-users of aluminum that their price manipulation…more

Antitrust Violations, Civil Conspiracy, Class Action, Consumer Protection Act, Derivatives

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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 (DOT), Energy Policy, Environmental Policies

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What Have Merchants Gained from Payment Card Antitrust Litigation?

In recent years, federal antitrust enforcers and businesses that accept payment cards have been waging a slow war against payment card fees and the card network rules that protect them. The payment card industry’s antitrust…more

American Express, Anti-Steering Rules, Antitrust Violations, Appeals, ATMs

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Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”) Yates…more

Acquittals, CEOs, Corporate Executives, DOJ, False Claims Act (FCA)

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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, H-1B, 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, Health Care 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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(Trade)Marking Your Territory in the US: A Guide for Non-US Companies

Trademark rights exist on a country-by-country basis, and the laws in the United States differ in a number of significant ways from other markets. As a result, it is critical that before any non-U.S. company seeks trademark…more

Community Trademark, Foreign Corporations, Intellectual Property Protection, Intent-to-Use, Madrid Protocol

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September Privacy and Security Updates

Although National Cyber Security Month isn’t until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for Civil…more

Breach Notification Rule, Cyber Attacks, Cybersecurity, Cybersecurity Information Sharing Act (CISA), Health Care Providers

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The Impact of Recently Proposed Regulations on Ineligible Nonqualified Plans Under Internal Revenue Code § 457(f)

The Treasury Department and the Internal Revenue Service recently issued comprehensive proposed regulations governing nonqualified plans subject to tax under Internal Revenue Code § 457. Code § 457 prescribes the tax rules that…more

Deferred Compensation, Forfeiture, Income Taxes, Internal Revenue Code (IRC), IRS

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Federal Circuit: Go whole-hog on validity below if you want to contest an independent determination of invalidity on appeal

Think you’ve won on validity at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) and your claims are safe on appeal? “Not so fast,” says the Federal Circuit in Software Rights Archive, LLC v. Facebook…more

Facebook, Inter Partes Review Proceedings, Obviousness, Patent Trial and Appeal Board, Patent Validity

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New York Proposes First-Ever Cybersecurity Regulation for Financial Institutions

The New York Department of Financial Services recently announced a new proposed rule, which would require financial institutions and insurers to implement strong policies for responding to cyberattacks and data breaches. …more

Cyber Attacks, Cybersecurity, Data Breach, Financial Institutions, Financial Sector

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Latest Post-Alice Guidance from the Federal Circuit

On Thursday, May 12, 2016, the Federal Circuit reversed a lower court’s finding of invalidity under 35 U.S.C. § 101, as an unpatentable abstract idea, of a software patent concerning a “self-referential” database in Enfish v…more

CLS Bank v Alice Corp, Mayo v. Prometheus, Microsoft, Patent Litigation, Patent-Eligible Subject Matter

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Israel Connect - Legal Insight for Success in the US Market

We are excited to present you with the second issue of Israel Connect — our quarterly newsletter focused on forging new connections and strengthening existing bonds between Israeli businesses and the US market. In our second…more

Anti-Competitive, Biosimilars, D&O Insurance, DOJ, FDA

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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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Energy and Environmental Legislative Updates for Fall 2016

The House of Representatives and Senate returned September 6 from the long August recess that started in mid-July. The House is scheduled to be in session for four weeks and the Senate for five weeks before breaking again for…more

Bipartisan Budget Act, Clean Power Plan, Energy Sector, Greenhouse Gas Emissions, Lame Duck Session

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Staffing Firms, Educational Organizations, and Breaks-in-Service under the Affordable Care Act Employer Shared Responsibility Rules: Proposed Changes under Notice 2015-87

In Q&A format, recently issued Notice 2015-87 addresses a number of pressing issues that have arisen under the Affordable Care Act (ACA), including that law’s employer shared responsibility rules, information reporting…more

Affordable Care Act, Applicable Large Employers (ALE), Comment Period, Educational Institutions, Full-Time Employees

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Preparation for 2015 Fiscal Year-End SEC Filings and 2016 Annual Shareholder Meetings

As our clients and friends know, each year Mintz Levin provides an analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange…more

Annual Meeting, Conflict Mineral Rules, Cybersecurity, Disclosure-Based Settlements, Executive Compensation

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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 (FCA), 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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J-1 Site Visits

The Department of State’s Office of Private Sector Exchange Administration has announced that it will perform site visits to many J-1 Intern and Trainee host organizations beginning this month. Most individual participants and…more

Internships, J-1 Visas, Site Visit Program, US Department of State

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Massachusetts Legislature Overhauls Public Records Law

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

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

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FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical…more

Amarin, Animal Drugs, Biologics, FDA, FDCA

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Energy & Environment Update - March 2016 #3

Energy & Climate Debate: The Senate and the House of Representatives are both on Spring Recess, with the Senate returning on April 4 and the House scheduled to return on April 12. Before breaking for recess, the…more

Climate Change, DOE, Environmental Policies, EPA, Investment Tax Credits

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Teladoc Receives Support from the Feds

Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board’s (the “Board”) appeal was inappropriate and…more

Amicus Briefs, Appeals, DOJ, FTC, Jurisdiction

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National Labor Relations Board Grants Student Assistants the Right to Unionize at Private Colleges and Universities

In a setback to private colleges and universities, the National Labor Relations Board ruled on August 23, 2016 that student assistants have unionization and collective bargaining rights under the National Labor Relations Act. In…more

Brown University, Collective Bargaining, Colleges, Columbia University, Educational Institutions

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Monthly TCPA Digest - August 2016

In light of the continued compliance and litigation challenges presented by the Telephone Consumer Protection Act (TCPA), Mintz Levin’s TCPA and Consumer Calling Practice team have launched an inaugural newsletter to keep you…more

Article III, Bipartisan Budget Act, Debt Collection, Declaratory Rulings, Exceptions

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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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At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes

Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the…more

Clinical Laboratories, CMS, Final Rules, Laboratory Developed Tests, MCLFS

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What Type of Sale Constitutes an On-Sale Bar?

An invention cannot be patented if it was ready for patenting and was subject to a commercial offer for sale more than one year before the application was filed. This so-called “on-sale bar” can also be used to invalidate a…more

FDA, Hospira, On-Sale Bar, Patent Applications, Patent Invalidity

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FDA Finally Decides that “Evaporated Cane Juice” Is Misleading Consumers

Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized…more

Confusingly Similar, Evaporated Cane Juice, FDA, Final Guidance, Food Labeling

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Preparing for an Exit: Selling Your Robotics Company

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

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

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Keep Calm and IP On: Planning for UK IP Post-Brexit

This past Thursday the Brexit vote sent shockwaves around world, including the IP community and in particular with respect to IP rights in the UK and Europe. But concerns at the moment are speculative as nothing yet has changed…more

Community Designs, Copyright, EU, European Union Trade Mark (EUTM), Intellectual Property Protection

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

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

Breach of Duty, Commercial General Liability Policies, Damages, Denial of Insurance Coverage, Duty to Defend

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IRS Relaxes Restrictions on Management Contracts for Bond-Financed Facilities

The IRS on August 22, 2016 released long-anticipated Revenue Procedure 2016-44 (Rev. Proc. 2016-44), which substantially increases flexibility in, and provides a less formulaic approach to, the ability of a tax-exempt bond…more

501(c)(3), Hospitals, Internal Revenue Code (IRC), IRS, Management Contracts

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Fostering Financial Aid Literacy in Students: H.R. 3179

This is the sixth and final installment in a series examining five bipartisan bills advanced by the House Committee on Education and the Workforce on June 22, 2016 and approved by the full House of Representatives on July 11,…more

Bipartisan Agreement, Congressional Budget Office, Department of Education, Financial Aid, Higher Education Act

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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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U.S. Supreme Court Upholds Affirmative Action Program at University of Texas

On June 23, 2016, in its second time hearing Fisher v. University of Texas, the U.S. Supreme Court upheld the affirmative action admissions program at the University of Texas at Austin. The Court held that the program is lawful…more

Affirmative Action, College Admissions, Compelling Governmental Interest, Diversity, Equal Protection

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Sixth Circuit Rules That Theft of PII from Insurance Company Results in Article III Standing

In its recent decision in Galaria v. Nationwide Mut. Ins. Co., no. 15-3386 (6th Cir. Sept. 12, 2016). Co., No. 15-3386 (6th Cir. Sept. 12, 2016), a divided Sixth Circuit panel held that plaintiffs had standing to assert claims…more

Appeals, Article III, Clapper v. Amnesty International, Corporate Counsel, Data Breach

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Recent Developments in Petrobras Class Action Could Interfere with Trial Date

There have been several recent and interesting updates to the In re Petrobras Securities Litigation, 14-cv-9662 (S.D.N.Y.) that we have discussed several times on this blog. First, the Second Circuit has decided to accept…more

Class Action, Class Certification, Construction Contracts, Corruption, Institutional Investors

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2018 Green Card Lottery Registration

On October 1, 2016, the US Department of State will begin accepting requests to register for the 2018 Diversity Immigrant Visa Program (DV-2018), also known as the Green Card Lottery. The Diversity Lottery Program provides a…more

Diversity Lottery, Foreign Nationals, Green Cards, Immigrants, Permanent Residence Cards

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A New Hope for Software Patents?

Software patents have been facing intense scrutiny under 35 U.S.C. § 101 for subject matter eligibility since the U.S. Supreme Court’s Alice v. CLS Bank decision in 2014. In the last two years, the patent ecosystem (including…more

Abstract Ideas, CLS Bank v Alice Corp, Microsoft, Patent-Eligible Subject Matter, Patents

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Federal Circuit Flushes Appeal Relating to Infringement of Airline Toilet Patents; Waives-Off Challenge to Finding of Assignor Estoppel

On March 23, 2016, the Federal Circuit in MAG Aerospace Indus., Inc. v. B/E Aerospace, Inc., Nos. 2015-1370, -1426, upheld a decision concerning U.S. patents directed to vacuum toilets found on commercial aircraft. In its…more

Aerospace, Aircraft, Assignor Estoppel, Patent Infringement

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Revel: To Stay or Not to Stay? Third Circuit Reveals the Answer

On Sept. 30, 2015, the Third Circuit Court of Appeals in In re Revel AC Inc. issued a decision of significance to federal jurisprudence and bankruptcy practice. Hon. Thomas L. Ambro delivered the court’s opinion, reversing the…more

363 Sales, Appeals, Casinos, Chapter 11, Commercial Bankruptcy

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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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Supreme Court Decides Two Key Aspects of IPR in Cuozzo Speed Techs., LLC v. Lee

The U.S. Supreme Court ruled on June 20, 2016 in Cuozzo Speed Techs., LLC v. Lee that: (1) the statutory authority of the Patent Trial and Appeal Board (“Board”) in instituting an inter partes review (“IPR”) proceeding is final…more

Administrative Proceedings, America Invents Act, Appeals, Broadest Reasonable Interpretation Standard, Claim Construction

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Good News on “Bad Boy” Guarantees – IRS Reverts to Prior Position in Recent Legal Advice Memorandum

On April 15, 2016, the IRS released a generic legal advice memorandum (GLAM 2016-001) (the “April GLAM”) addressing the impact of so-called “bad boy” guarantees (also known as nonrecourse carve-out guarantees) on the…more

Bad Boy Liability, Carve Out Provisions, IRS, Non-Recourse Loans, Real Estate Market

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2018 Notice of Benefits and Payment: Proposed Updates to the HHS Risk Adjustment Model

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years. With several insurers…more

CMS, HHS, Prescription Drug Coverage, Prescription Drugs

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Could the Eastern District of Texas’s Reign Come to an End?

It has become a patent litigation trope, discussed at every Silicon Valley water cooler, that patent litigation is broken because all patent cases are tried in the plaintiff-friendly Eastern District of Texas. While this…more

Corporate Counsel, Kraft, Motion to Transfer, Patent Infringement, Patent Litigation

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Can Employees Commute Tax-Free on Uber or Lyft?

Uber, Lyft, and their competitors, offering handy apps, responsive drivers and competitive prices, are fast becoming a favored commuter option. Many employers either subsidize employee commuter expenses or allow employees to…more

Internal Revenue Code (IRC), IRS, Lyft, Uber

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Dutch Foundation Dismissed for Inadequate Safeguarding of Members’ Interests

On June 29, 2016, the Dutch Court of East Brabant dismissed a foundation’s claims against Rabobank Group for alleged unlawful selling of interest rate swaps because it failed to meet the requirement of the Dutch Claim Code that…more

Collective Actions, Corporate Executives, Dismissals, Dutch Claim Code, Founding Members

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Health Care Update - April 2016

FDA Reform Tops Spring Work Period Agenda - The next work period basically runs from April 4 to May 27, with a both chambers adjourning for a week long recess the week of May 2nd. Following this work period, there will be…more

Biosimilars, CMS, Drug Pricing, FDA, HELP

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FCC Broadband Privacy and Security Proposed Rulemaking Underway

As we reported last month, the FCC was preparing a proposed rulemaking (NPRM) to establish privacy and data security requirements for broadband internet access service (BIAS) providers. The FCC has now released that proposal…more

Customer Proprietary Network Information (CPNI), FCC, Net Neutrality, NPRM, Open Internet Rules

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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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Washington Outlook for 2016

Welcome to 2016 and our annual look at what’s in store for the United States Congress in the coming year. Here you will find a preview of the US legislative agenda as well as a look at the Obama Administration’s regulatory…more

Energy Policy, Federal Budget, Foreign Policy, International Tax Issues, Legislative Agendas

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In McRO, Federal Circuit Provides Further Guidance on Section 101

Two years after the Central District of California invalidated two 3-D animation patents under Section 101, the Federal Circuit reversed that court’s decision, finding that the lower court oversimplified the claims of a…more

Abstract Ideas, CLS Bank v Alice Corp, Computer-Related Inventions, Patent-Eligible Subject Matter, Patents

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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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Massachusetts Regulatory Overhaul: Hospitals, Clinics, Dialysis Units, and Medical Marijuana – Oh My!

The Massachusetts Department of Public Health (DPH) has released proposed amended regulations for the licensure of hospitals, clinics, and out-of-hospital dialysis units, proposed the rescission of separate birth center…more

Amended Regulation, Department of Health, Dialysis, Governor Baker, Hospitals

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After Adopting the “Fraud-on-the-Market” Presumption of Reliance, Australia is Poised to Become a Plaintiff-Friendly Venue

The United States is a popular location for securities class actions, due in large part to its reputation as a generally plaintiff-friendly system. A key contributor to that reputation is the acceptance of the…more

Australia, Class Action, False Statements, Fraud-on-the-Market, Liquidation

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Massachusetts Legislature Passes Compromise Energy Bill

Last Sunday, the Massachusetts Legislature passed a compromise energy bill to significantly increase electricity produced by renewable energy sources. The state’s utilities will be required to purchase power from on and offshore…more

Clean Energy, Dams, Electricity, Energy Sector, Energy Storage

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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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UPDATE: Subject Matter Eligibility under 35 U.S.C. § 101 – Abstract Ideas

All patent applications submitted to the United States Patent And Trademark Office (USPTO) are examined subject to the requirements set forth in 35 U.S.C. §§101, 102, 103, 112, which respectively address patent eligibility,…more

Abstract Ideas, CLS Bank v Alice Corp, Interim Guidance, Myriad-Mayo, Patent Applications

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Seventh Circuit Holds Title VII Does Not Prohibit Sexual Orientation Discrimination, But Acknowledges Inherent Flaws in Precedent Underlying its Holding

In a carefully reasoned but ultimately restrained opinion the Seventh Circuit held that Title VII does not prohibit discrimination in employment on the basis of sexual orientation. While declining to become the first circuit…more

EEOC, Gender Discrimination, Hiring & Firing, LGBT, Professors

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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