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

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

Federal Rules of Civil Procedure, Proposed Amendments

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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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ClearCorrect: ITC and Patentee Align Submit Petitions for Rehearing En Banc, Asking Federal Circuit to Reconsider Whether the ITC Has Jurisdiction Over Digital Imports

On January 27, 2016, the International Trade Commission (ITC) formally requested a rehearing en banc of a November 10, 2015, Federal Circuit panel decision in ClearCorrect Operating, LLC v. ITC. The Federal Circuit’s panel…more

Copyright, Corporate Counsel, Electronic Data Transmissions, Imports, ITC

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Employment Matters Monthly - February 2016

A Note from the Editors - If January was a harbinger of what's in store for 2016, it's sure to be a busy year for HR professionals and employment attorneys. And Employment Matters is certainly here to guide you along the…more

ADA, Affordable Care Act, Campbell Ewald v Gomez, Class Action, Class Representatives

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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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Prepare for the Japanese Patent Opposition System Coming Soon

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

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

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Governor Baker Files FY2017 Budget, Economic Development Bill; Speaker DeLeo Outlines Agenda

With Beacon Hill off and running in the new year, Governor Charlie Baker and House Speaker Robert DeLeo this week unveiled key parts of their policy agendas for 2016. As part of his second budget proposal since assuming office,…more

Corporate Taxes, Economic Development, Energy Policy, Governor Baker, Legislative Agendas

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Determining Damages for Standard Essential Patents: the Federal Circuit Provides Some Guidance in CSIRO v. Cisco

Late last week, in an opinion authored by Judge Prost, a panel of the Federal Circuit vacated a $16 million damages award won by Commonwealth Scientific and Industrial Research Organization (CSIRO) in its patent infringement…more

Apportionment, Cisco, Damages, Patent Infringement, Patent Royalties

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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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Employment Matters Monthly - February 2016

A Note from the Editors - If January was a harbinger of what's in store for 2016, it's sure to be a busy year for HR professionals and employment attorneys. And Employment Matters is certainly here to guide you along the…more

ADA, Affordable Care Act, Campbell Ewald v Gomez, Class Action, Class Representatives

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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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DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability

The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to…more

Cooperation, Corporate Crimes, Corporate Veil, Damages, DOJ

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

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

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

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The Affordable Care Act’s Reporting Electronic Backbone—The AIR System

For the last half of 2015, we spent a good deal of time explaining the Affordable Care Act reporting requirements that applied to carriers and large employers. This post examines the how of ACA reporting. In particular, it…more

Affordable Care Act, Applicable Large Employers (ALE), Electronic Filing, Employer Group Health Plans, Health Insurance

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A Balanced Approach to Founder's Equity

When accepting money from outside investors, entrepreneurs are generally asked to give up some degree of control over their start-up, exchanging equity in their company for cash. In an effort to minimize the control they…more

Common Stock, Entrepreneurs, Fund-raising, Startups

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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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Severance Payments May be Recoverable in a Company’s Bankruptcy

Working for the Queen of Hearts is a tough gig. A disappointing quarter and she’s quick to the chopping block. And the ‘severance’ she offers – “Off with their heads!” – no thanks…more

Clawbacks, Commercial Bankruptcy, Corporate Restructuring, Fidcuciary Liability, Layoffs

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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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HIPAA and Health Care Data Privacy – 2015 Year in Review

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015. Incredibly large data breaches became…more

Anthem Insurance, Cyber Attacks, Data Breach, HIPAA, HITECH

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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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“Just Mayo” Maker Convinces FDA That a Different Label Doesn’t Have to Include a Different Name

Back in September we blogged about the Warning Letter that FDA issued to Hampton Creek Foods, Inc. for its vegan food dressing and sandwich spread, “Just Mayo” and a similar product, “Just Mayo Sriracha.” In addition to several…more

FDA, Food Labeling, Misleading Impressions, Warning Letters

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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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Department of Energy Provides Major Funding Opportunities

The start of the new year has brought with it numerous opportunities for energy tech funding from the Department of Energy. Hundreds of millions of dollars have been or are being given out to companies and research institutions…more

Clean Energy, DOE, Energy Sector, Federal Funding, Power Grid

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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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Sophisticated Email Scams Targeting the Real Estate Industry

A sophisticated (and effective) wire-fraud scam targeting real estate (and other) transactions is on the rise, and mostly occurring in the United States…more

Data Security, Email, Fraud Alerts, National Association of Realtors, Popular

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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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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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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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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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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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2nd Circuit Court Requires I-140 Revocation Notice: Analysis

On December 30, 2015, the US Court of Appeals for the 2nd Circuit ruled that US Citizenship and Immigration Services (SUCIS) must notify either the beneficiary of an approved I-140 or successor employer, of any intent to revoke…more

Appeals, Beneficiaries, I-140, Permanent Residence Cards, Revocation

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

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

Arbitration, Arbitration Agreements, Employment Contract, Ernst & Young

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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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Update: Albany County Legislature Amends Controversial Toxic Toys Law

Last year, we wrote about a growing trend of local jurisdictions regulating children’s products, primarily toys and apparel. One such jurisdiction, Albany County, NY, enacted a far-reaching ordinance, “Local Law J of 2014,” that…more

Amended Legislation, Child Safety, Children's Toys, Consumer Product Safety Act (CPSA), FHSA

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A Preview of Business Immigration in 2016: OPT (Part 2/6)

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), OPT, Proposed Regulation, STEM

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UPDATE: OMB Says DOL May Publish Final White Collar Exemptions Overtime Rules in July 2016

July 2016. That’s when the final rule on the white collar overtime exemptions is expected to be published by the DOL – this according to the OMB’s Fall 2015 Unified Agenda and Regulatory Plan released last Thursday. Just one…more

DOL, Employer Liability Issues, Minimum Salary, Over-Time, Wage and Hour

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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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Governor Baker Files FY2017 Budget, Economic Development Bill; Speaker DeLeo Outlines Agenda

With Beacon Hill off and running in the new year, Governor Charlie Baker and House Speaker Robert DeLeo this week unveiled key parts of their policy agendas for 2016. As part of his second budget proposal since assuming office,…more

Corporate Taxes, Economic Development, Energy Policy, Governor Baker, Legislative Agendas

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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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Governor Baker Files FY2017 Budget, Economic Development Bill; Speaker DeLeo Outlines Agenda

With Beacon Hill off and running in the new year, Governor Charlie Baker and House Speaker Robert DeLeo this week unveiled key parts of their policy agendas for 2016. As part of his second budget proposal since assuming office,…more

Corporate Taxes, Economic Development, Energy Policy, Governor Baker, Legislative Agendas

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

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

Affordable Housing, Land Developers

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CMS Eases Regulatory Burdens and Creates New Exceptions in "Phase V" of the Stark Regulations

On November 16, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published the most significant changes to the physician self-referral law (“Stark Law” or “Stark”) regulations since 2008. Because this rulemaking is…more

CMS, Comment Period, Exceptions, MPFS, Physician Compensation Arrangements

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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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HIPAA and Health Care Data Privacy – 2015 Year in Review

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015. Incredibly large data breaches became…more

Anthem Insurance, Cyber Attacks, Data Breach, HIPAA, HITECH

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Tips for Responding to New Grounds of Rejection in an Examiner’s Answer

Filing an appeal brief with the Patent Trial and Appeal Board (PTAB) can be an effective way to advance prosecution and secure allowable claims. After an appellant’s filing of a PTAB appeal brief, an examiner may respond with an…more

Examiners, New Guidance, Patent Litigation, Patent Trial and Appeal Board, Patents

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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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Federal Circuit Reverses Punitive Exceptional Case Fee Award as Improperly Enhanced

On January 22, 2016, the Federal Circuit issued its opinion in Lumen View Technology LLC v. FindTheBest.com (Dkt. No. 15-1275), in which it vacated and remanded the lower court’s award of enhanced attorney fees under 35 U.S.C. §…more

Attorney's Fees, Enhanced Penalties, Exceptional Case, Patent Infringement, Patent Invalidity

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A Balanced Approach to Founder's Equity

When accepting money from outside investors, entrepreneurs are generally asked to give up some degree of control over their start-up, exchanging equity in their company for cash. In an effort to minimize the control they…more

Common Stock, Entrepreneurs, Fund-raising, Startups

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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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Truthful Terminations May Lead to Better Consequences

We are often asked what, if anything, employers should tell an employee about the reasons for the employee’s termination, especially if the termination is abrupt. We tell employers to tell the truth…more

Discrimination, Employer Liability Issues, Hiring & Firing, Pretext, Termination

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USPTO Implementation of AIA Does Not Violate Due Process: Federal Circuit Affirms the PTAB Panel Determining Institution of an IPR can also Issue the Final Written Decision

In Ethicon Endo-Surgery, Inc. v. Covidien LP, a 2-1 panel split of the Federal Circuit held that neither the American Invents Act (“AIA”) nor the Constitution precludes the same panel of the Patent Trial & Appeal Board (“PTAB”…more

Administrative Appeals, ALJ, America Invents Act, Covidien, Due Process

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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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OMB Finalizes Review of 60-Day Overpayment Rule

The Office of Management and Budget completed its review of the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the “60-day…more

60-Day Rule, Affordable Care Act, False Claims Act (FCA), Medicare Part A, Medicare Part B

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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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A Balanced Approach to Founder's Equity

When accepting money from outside investors, entrepreneurs are generally asked to give up some degree of control over their start-up, exchanging equity in their company for cash. In an effort to minimize the control they…more

Common Stock, Entrepreneurs, Fund-raising, Startups

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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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Governor Baker Files FY2017 Budget, Economic Development Bill; Speaker DeLeo Outlines Agenda

With Beacon Hill off and running in the new year, Governor Charlie Baker and House Speaker Robert DeLeo this week unveiled key parts of their policy agendas for 2016. As part of his second budget proposal since assuming office,…more

Corporate Taxes, Economic Development, Energy Policy, Governor Baker, Legislative Agendas

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Employers Must Withhold FICA Taxes for Students who Change Status to H-1B Starting October 1

As students and scholars’ status change from F-1, J-1 or other FICA exempt statuses to H-1B starting October 1, these employees will become subject to FICA taxes upon the effective date of their H-1B status…more

Adjustment of Status, Employer Liability Issues, Exemptions, FICA Taxes, Form F-1

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

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

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

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

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

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

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Survival of Reps and Warranties: Avoiding Unpleasant Surprises for Buyers

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

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

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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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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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Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann came…more

Anti-Corruption, Compliance, Corporate Counsel, Criminal Prosecution, Enforcement Actions

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Judicial Redress Act passes the House with the Senate Amendments

The amended Judicial Redress Act has passed the House and is on its way to the president to be signed into law. The Act, which we covered in an earlier blog post, gives citizens of foreign countries the same rights as US…more

Data Protection Authority, EU, EU-US Privacy Shield, International Data Transfers, Judicial Redress Act

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

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

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

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A Preview of Business Immigration in 2016: OPT (Part 2/6)

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), OPT, Proposed Regulation, STEM

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Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann came…more

Anti-Corruption, Compliance, Corporate Counsel, Criminal Prosecution, Enforcement Actions

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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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Beware of the Use of Derivatives in the Purchase and Sale of Private Shares

The SEC is examining the use of derivatives in the secondary market for shares of private companies. The trading of shares of private companies remains robust, and we are writing this alert to remind everyone that whether you…more

Buyers, Derivatives, Enforcement Actions, Initial Public Offerings, Private Company Shares

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

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

Cuba, EU, Foreign Policy, Iran, Obama Administration

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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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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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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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Excluding Your Gains on Small Business Investments

2016 promises to be another very good year to invest in start-ups because of the extension of significant tax breaks for investors who invest in early stage companies. Investors who invest in small businesses can exclude capital…more

Capital Gains, Early Stage Companies, Investment Funds, Protecting Americans from Tax Hikes (PATH) Act, Small Business

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Tax Law Changes Favorable to Venture Capital and Private Equity Investors

The “Protecting Americans from Tax Hikes” (PATH) Act was recently signed into law, and two provisions in particular benefit venture capital, private equity, and other investors owning or planning to purchase a corporation…more

Capital Gains, Corporate Conversions, Private Equity, Protecting Americans from Tax Hikes (PATH) Act, Qualified Small Business Stock

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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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Telemedicine Momentum Picking up Steam as New Legislation Introduced in U.S. Senate

On February 3, 2016, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under…more

Alternative Payment Models (APM), Healthcare Costs, Medicare, Medicare Access and CHIP Reauthorization (MACRA), Proposed Legislation

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FCC Eliminates Foreign Competition Test for Certain International Telecommunications Authorization Applications

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

FCC, Telecommunications, WTO

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

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

EPO, EU, Patent Applications, Patents, USPTO

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Health Care Update - March 2015 #4

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

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

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

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

EB-3, India, Visa Bulletins, Visas

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

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

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

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

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

Data Protection, Enforcement, FCC, FTC, Jurisdiction

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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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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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Reminder – Truthful Advertising Is Not Optional

We blog frequently about new regulatory developments coming from CPSC or FDA and about enforcement actions brought by those federal agencies as well as state counterparts and private plaintiffs. But we don’t very often discuss…more

Advertising Substantiation, Consumer Product Safety Commission (CPSC), False Advertising, FTC, FTC Endorsement Guidelines

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Telemedicine Momentum Picking up Steam as New Legislation Introduced in U.S. Senate

On February 3, 2016, a bipartisan group of Senators led by Senator Brian Schatz (D-HI) and Senator Roger Wicker (R-MS) have unveiled legislation that would expand the use of telemedicine and remote patient monitoring under…more

Alternative Payment Models (APM), Healthcare Costs, Medicare, Medicare Access and CHIP Reauthorization (MACRA), Proposed Legislation

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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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Knockout in Round One: Court Dismisses California Supply Chains Act Class Action

The first round goes to the industry: on December 9, 2015, the Central District of California dismissed the complaint in Barber v. Nestle USA, a key bellwether case in a new wave of class action litigation related to…more

Class Action, Corporate Counsel, Disclosure Requirements, Forced Labor, Nestle

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

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

Legal Perspectives, Startups

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

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

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

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Regulation of Health IT: A Risk-Based Approach

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

FCC, FDA, FDASIA, Healthcare, ONC

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

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

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

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DOL Issues Guidance on Joint Employment

The U.S. Department of Labor Wage and Hour Division weighed in last week on the hot topic of joint employment, issuing an Administrative Interpretation entitled “Joint employment under the Fair Labor Standards Act and Migrant…more

Administrative Interpretation, DOL, FLSA, Joint and Several Liability, Joint Employers

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CPSC Public Database: A 2011 Change to the Procedure for Filing Materially Inaccurate Information Claims that Can Easily be Overlooked

President Obama signed Public Law 112-28 (“PL 112-28”) into law on August 12, 2011. PL 112-28 amended numerous provisions of the Consumer Product Safety Improvement Act (“CPSIA”). One such amendment made a notable change to the…more

Amended Legislation, Consumer Complaint Database, Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Stays

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Federal Circuit Deems IPR Constitutional: The Patent Office Can Correct Its Own Mistakes

On December 9, 2015, the Federal Circuit ruled in MCM Portfolio LLC v. Hewlett-Packard Company that vesting the Patent Office with power to take back previously conferred patent rights through inter partes review does not…more

Article III, Hewlett-Packard, Inter Partes Review Proceedings, Patent Trial and Appeal Board, Seventh Amendment

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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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Tax Law Changes Favorable to Venture Capital and Private Equity Investors

The “Protecting Americans from Tax Hikes” (PATH) Act was recently signed into law, and two provisions in particular benefit venture capital, private equity, and other investors owning or planning to purchase a corporation…more

Capital Gains, Corporate Conversions, Private Equity, Protecting Americans from Tax Hikes (PATH) Act, Qualified Small Business Stock

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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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Telemedicine – 2015 Year in Review

As the year winds down, we look back on the significant developments in telemedicine in 2015 as well as look forward to what 2016 will bring. The number of providers offering telemedicine and telehealth services dramatically…more

Healthcare, Medical License, Medicare, Telehealth, 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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Que Certa, Certa: Supreme Court Creates Uncertainty with “Cert” Review of Puerto Rico Recovery Act

It is said that muddy water is best cleared by leaving it be. The Supreme Court’s December 4 decision to review the legality of Puerto Rico’s local bankruptcy law, the Recovery Act, despite a well-reasoned First Circuit Court…more

Certiorari, Chapter 9, Creditors, Debt Restructuring, Municipal Bankruptcy

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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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Judge Gilstrap awards Section 285 fees where Plaintiff’s Section 101 positions cross the “threshold of exceptionality.”

On December 17, 2015, Judge Rodney Gilstrap of the Eastern District of Texas (EDTX) ruled that, in light of Alice Corporation Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014) (“Alice”), a plaintiff’s position on the…more

Attorney's Fees, CLS Bank v Alice Corp, Covered Business Method Patents, Exceptional Case, Octane Fitness v. ICON

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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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NJ High Court Declines to Review “Borgata Babes” Case, Effectively Doubling Down on Appellate Court’s Acceptance of Atlantic City Casino’s Stringent Rules on Grooming, Dress and Weight Gain

The BorgataBabes Are Subject to Specific Personal Appearance Standards - The Borgata, which when it opened in 2003, marketed itself as Atlantic City’s first Las Vegas-style resort and distinguished itself in the…more

Adverse Employment Action, Appearance Policy, Atlantic City, Casinos, Corporate Counsel

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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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The Managed Care Industry – 2015 Year in Review

As we start a new year, let’s take a look back at a few hot topics that emerged in the managed care industry in 2015 and will likely be drivers of developments in 2016. Industry Consolidation – The Changing Landscape…more

ACOs, Affordable Care Act, Healthcare, Hospital Mergers, Managed Care Contracts

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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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FTC Increases HSR Jurisdictional Thresholds

The Federal Trade Commission (FTC) announced on January 21, 2016 increased jurisdictional thresholds for premerger notification filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act)…more

Federal Register, Filing Fees, FTC, Hart-Scott-Rodino Act, Jurisdiction

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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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FTC Increases HSR Jurisdictional Thresholds

The Federal Trade Commission (FTC) announced on January 21, 2016 increased jurisdictional thresholds for premerger notification filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act)…more

Federal Register, Filing Fees, FTC, Hart-Scott-Rodino Act, Jurisdiction

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Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory developed…more

Aetna, Anti-Kickback Statute, CIGNA, CLIA, CMS

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

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

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

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

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

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

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Software Audits: Strategies for Licensees

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

Audits, License Agreements, Software, Software Developers

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Health Care Reform Update -- April 15, 2013

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

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

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

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

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

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

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

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PE Funds May Be Liable For Portfolio Company Pension Liabilities

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

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

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Political Agreement Reached on US-EU Safe Harbor; Details “Hazy”

According to press reports, European Union and U.S. negotiators in Brussels finalized what is being called a “political agreement” on a new Safe Harbor transatlantic data transfer agreement. European Union justice commissioner…more

EU, EU Data Protection Laws, EU-US Privacy Shield, European Commission, European Court of Justice (ECJ)

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

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

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

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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 Bill the Focus of Congressional Debate

Congress has spent a significant chunk of the new year focused on a bipartisan energy bill, which, if passed, would be the first broad bipartisan energy package in nearly ten years. The Energy Policy Modernization Act of 2015…more

Clean Power Plan, CPUC, Energy Policy Modernization Act of 2015, EPA, Net Metering

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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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CBP releases FAQ on Visa Waiver Program: Rule Changes

On December 18, 2015, President Obama signed the “Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015” into law. On January 21, 2016, the Department of Homeland Security (DHS) and Department of State…more

Barack Obama, Customs and Border Protection, DHS, ESTA, International Travel

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A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from…more

Clinical Trials, Defamation, Disparagement, First Amendment, Scientific Research

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Energy & Environment Update - January 2016 #3

Energy and Climate Debate - The winter weather postponed much congressional and Administrative action on energy, environment, and other issues this week, but the Senate has now officially begun floor debate on the first…more

Canada, China, Climate Change, DOE, Energy & Climate Debates

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A Return to Evanston: FTC Revisits Old Ground in Yet Another Hospital Merger Challenge

Last week, the Federal Trade Commission (“FTC” or “Commission”) authorized staff to file an administrative complaint and to seek in federal court a temporary restraining order and a preliminary injunction to block the proposed…more

Anti-Competitive, Certificate of Need, FTC, Health Care Providers, Hospital Mergers

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Fifth Circuit Rejects Employee’s FLSA Off-the-Clock Claim; Highlights Importance of Overtime Authorization and Reporting Policies in Off-the-Clock Cases

The Fifth Circuit recently sided with an employer in an off-the-clock overtime case where the employee failed to comply with her employer’s overtime approval and reporting policies. For employers, this decision highlights the…more

FLSA, Over-Time, Policies and Procedures, Unpaid Overtime, Wage and Hour

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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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The Final 60-Day Rule Is Finally Here!

The Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days (the…more

60-Day Rule, CMS, Final Rules, Health Care Providers, Medicare Part A

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Federal Circuit Affirms Dismissal on Grounds of Patent Ineligibility

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

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

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

Trends & Analysis - Since our last Qui Tam Update, we have identified 39 health-related False Claims Act (“FCA”) qui tam cases that have been unsealed. Of those cases..…more

ACOs, Anti-Kickback Statute, Controlled Substances, False Billing, False Claims Act (FCA)

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U.S. International Trade Commission Publishes Proposed Changes to Procedural Rules of Practice

The International Trade Commission proposed a series of new procedural rules, which were published in the Federal Register on September 24, 2015. This blog post provides a summary of the more notable proposed changes to the…more

Abusive Discovery Strategies, Comment Period, Corporate Counsel, Evidentiary Hearings, Expert Witness

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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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Energy & Environment Update - January 2016 #3

Energy and Climate Debate - The winter weather postponed much congressional and Administrative action on energy, environment, and other issues this week, but the Senate has now officially begun floor debate on the first…more

Canada, China, Climate Change, DOE, Energy & Climate Debates

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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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Settlement Agreements with Students Are Protected Student Records But Must Be Disclosed in Redacted Form Under Public Records Law, Says Massachusetts Supreme Judicial Court

What is the responsibility of a public educational institution when it receives a public records request for material that it believes it must keep private under state and federal student records laws?…more

Educational Institutions, FERPA, Public Records, Redaction, Student Privacy

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The Problem With Data Security is not the Hardware or the Software, It’s the Wetware

Remember this? - “Wetware” – coder slang for biological life forms (i.e., people) – is the weak link in most companies’ data security protections, according to a new data security report issued by the Association of…more

Cybersecurity, Data Breach, Data Security, Employee Training, Popular

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Court in BP Oil Spill Litigation Denies Standing for Special Purpose Entities Created Solely for Litigation

A January 4, 2016 opinion in the Southern District of Texas by Judge Keith Ellison (“Op.”) in the In re: BP p.l.c. Securities Litigation, MDL No. 4:10-md-2185, has taken up the issue of whether plaintiffs can properly assign…more

Assignments, BP, Class Action, Corporate Counsel, Oil Spills

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CBP releases FAQ on Visa Waiver Program: Rule Changes

On December 18, 2015, President Obama signed the “Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015” into law. On January 21, 2016, the Department of Homeland Security (DHS) and Department of State…more

Barack Obama, Customs and Border Protection, DHS, ESTA, International Travel

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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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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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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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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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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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Judge Gilstrap awards Section 285 fees where Plaintiff’s Section 101 positions cross the “threshold of exceptionality.”

On December 17, 2015, Judge Rodney Gilstrap of the Eastern District of Texas (EDTX) ruled that, in light of Alice Corporation Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014) (“Alice”), a plaintiff’s position on the…more

Attorney's Fees, CLS Bank v Alice Corp, Covered Business Method Patents, Exceptional Case, Octane Fitness v. ICON

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Subsidizing Student Health Insurance With Stipends – New Agency Guidance and Relief

On February 5, 2016, the Departments of the Treasury, Labor, and Health and Human Services (the Departments) issued guidance addressing the application of market reforms and other provisions of the Affordable Care Act (ACA) to…more

Affordable Care Act, DOL, Educational Institutions, Health Insurance, HHS

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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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Wyndham and FTC Settle Case Over “Unfair” Data Security Practices

The years-long saga of the Federal Trade Commission’s suit against Wyndham Hotels over data breaches that occurred at least as early as April 2008 is finally coming to an end with a proposed settlement filed today with the…more

Data Breach, Data Security, FTC, FTC v Wyndham, Settlement

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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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Judge Gilstrap awards Section 285 fees where Plaintiff’s Section 101 positions cross the “threshold of exceptionality.”

On December 17, 2015, Judge Rodney Gilstrap of the Eastern District of Texas (EDTX) ruled that, in light of Alice Corporation Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014) (“Alice”), a plaintiff’s position on the…more

Attorney's Fees, CLS Bank v Alice Corp, Covered Business Method Patents, Exceptional Case, Octane Fitness v. ICON

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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 Health Care Reform – Full Speed Ahead; Health Policy Commission 2015 Cost Trends Report

The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings. The report contained 13 key recommendations across a wide range of health care…more

Alternative Payment Models (APM), Health Care Providers, Healthcare Costs, Healthcare Reform, Prescription Drugs

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CIBC v. Green: The Supreme Court of Canada Clarifies Key Provisions of the Ontario Securities Act and the Ontario Class Proceedings Act

A recent decision by the Supreme Court of Canada offers both clarity and further questions on the timing of secondary market misrepresentation claims brought under the Ontario Securities Act (the “Securities Act”). While we are…more

Canada, Institutional Investors, Limitation Periods, Misrepresentation, Ontario Securities Act

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Legislative Roundup on Energy from the New England States

On Thursday, September 10, The New England Clean Energy Council (NECEC) hosted its third annual Legislative Roundup. The event brought together clean energy advocates and technology developers from around the Northeast to…more

Clean Energy, Community Shared Solar, Department of Energy and Environmental Protection, Electric Vehicles, Energy Efficiency

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Activism: An Overview from the Company Perspective

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

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

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PTAB Issues ‘Quick Fix’ Rule Package, Effective Immediately

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

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

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DOL Issues Guidance on Joint Employment

The U.S. Department of Labor Wage and Hour Division weighed in last week on the hot topic of joint employment, issuing an Administrative Interpretation entitled “Joint employment under the Fair Labor Standards Act and Migrant…more

Administrative Interpretation, DOL, FLSA, Joint and Several Liability, Joint Employers

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

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

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

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

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

Bribery, Compliance, Corruption, Due Diligence, FCPA

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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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Director Liability for Cybersecurity Risks

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

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

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Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and…more

FDA, GAO, HELP, HHS, Hospitals

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Health Care Enforcement: The Impact on Private Equity Investments

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

Affordable Care Act, CMS, Enforcement, GDP, Healthcare

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Vapor Intrusion: New Rules by the EPA

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

Construction Industry, EPA, Vapor Intrusion, Vapor Intrusion Guidance

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Overview of Certain Middle and Lower Middle Market Credit Trends

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

Acquisitions, Middle Market, Private Equity

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Pick-Off Strategy Via a Rule 68 Offer of Judgment Suffers Stinging Defeat in the Supreme Court; But Can an Actual Payment to the Plaintiff Do the Trick?

An unaccepted Rule 68 Offer of Judgment for complete relief does not moot a plaintiff’s individual and class action claims said the Supreme Court on Wednesday. The decision in Campbell-Ewald Co. v. Gomez is welcome news for…more

Campbell Ewald v Gomez, Class Action, Class Representatives, FLSA, Injunctions

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

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

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

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Health Care Update - October 2014 #2

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

ACOs, Affordable Care Act, CDC, CMS, Healthcare

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Ebola Exclusions from Commercial Insurance Policies

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

Business Interruption, Commercial Insurance Policies, Ebola

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DHS Posts Final Rule to Amend Regulations for H-1B1 and E-3 Nonimmigrant Classifications

On Friday, January 15, 2016, the Department of Homeland Security (DHS) posted to the Federal Register the final rule revising regulations affecting highly skilled workers in the nonimmigrant classifications for specialty…more

DHS, E-3, Federal Register, H-1B1, Highly-Skilled Workers Visa

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The EEOC’s Proposed Revisions To The EEO-1 Report Could Create Legal and Administrative Headaches For Employers

The EEOC unveiled its proposed revisions to the Employer Information Report (EEO-1) last month. With the revisions, the EEOC hopes to gather additional data to help better discern pay discrimination. However, the revisions…more

Comment Period, EEO-1, EEOC, Pay Discrimination, Proposed Regulation

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DHS Submits New STEM OPT Rule for Comment

Today, October 19, the Department of Homeland Security submitted a proposed rule modifying the existing optional practical training (“OPT”) available to certain students with degrees in science, technology, engineering, or math…more

Accreditation, Comment Period, Department of Education, DHS, E-Verify

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

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

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

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Smartphone Wars – The Supreme Court Awakens: Samsung Files Petition for Certiorari in New Hope to Harmonize Design Patent Law

On December 14, 2015, in the latest episode of the smartphone wars, Samsung filed a petition for certiorari with the Supreme Court. Samsung is appealing a Federal Circuit decision that upheld a $399 million judgment against…more

Apple v Samsung, Damages, Design Patent, Disgorgement, Patent Infringement

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

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

Bond Financing, Bonds, Default, Manufacturers, Tobacco

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

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

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

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

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

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

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

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

H-1B, Immigrants, USCIS, Visas

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Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann came…more

Anti-Corruption, Compliance, Corporate Counsel, Criminal Prosecution, Enforcement Actions

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Telemedicine – 2015 Year in Review

As the year winds down, we look back on the significant developments in telemedicine in 2015 as well as look forward to what 2016 will bring. The number of providers offering telemedicine and telehealth services dramatically…more

Healthcare, Medical License, Medicare, Telehealth, Telemedicine

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Regulation of Health IT: A Risk-Based Approach

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

FCC, FDA, FDASIA, Healthcare, ONC

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

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

Data Collection, FERPA, Popular, Student Records, Students

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

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

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

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Corporate Practice of Medicine: An Old Doctrine Breathing New Life

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

Corporate Practice of Medicine, Healthcare

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Court Orders Plaintiffs to Pay Defendants’ $13.3 Million Appellate Costs in Lawrence E. Jaffe Pension Plan v. Household International

Recently, in Lawrence E. Jaffe Pension Plan v. Household International, Inc., the United States District Court for the Northern District of Illinois granted the defendants’ Rule 39 motion for appellate costs and ordered the…more

Class Action, Federal Rules of Appellate Procedure, Litigation Fees & Costs, Reversal, Securities Litigation

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Corporate Divorce Series: Do Fraudulent Credentials Annul Employment Contracts?

If you follow my corporate divorce series, you are familiar with my affinity for the employment-as-marriage metaphor. I’ve already examined how employment relationships end or should end. But I have yet to address an…more

Employment Application, Employment Contract, Fraud, Void Contracts

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

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

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

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ICYMI: Biosimilars and FDA Regulatory Webinar

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve…more

Biosimilars, BPCIA, FDA, FDA Approval, Pharmaceutical Industry

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Ninth Circuit Clarifies Extraterritorial Reach of California Antitrust Laws

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

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

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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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CPSC Public Database: A 2011 Change to the Procedure for Filing Materially Inaccurate Information Claims that Can Easily be Overlooked

President Obama signed Public Law 112-28 (“PL 112-28”) into law on August 12, 2011. PL 112-28 amended numerous provisions of the Consumer Product Safety Improvement Act (“CPSIA”). One such amendment made a notable change to the…more

Amended Legislation, Consumer Complaint Database, Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Stays

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Health Care Reform by Petition

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

CEOs, Executive Compensation, Healthcare Reform, Hospitals, Medicaid

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Washington Outlook for 2015

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

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

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The Debate Intensifies on the Best Strategy to Recover Foreign Securities Losses

Recent doubts have been raised as to the effectiveness of Dutch Foundations, which have become an important vehicle in foreign recoveries. While Dutch Foundations have negotiated settlements in some situations, some foreign…more

Collective Actions, Institutional Investors, Netherlands, Private Foundations, Securities Litigation

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Massachusetts Legislature Passes Minimum Wage Increase and Economic Development Package

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

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

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Proposed Prop 13 Reforms in California

Since February 2015, California state legislators have proposed several bills to modify the limitations on property tax increases established by Proposition 13 (Prop. 13). These bills include Senate Constitutional Amendment 5…more

Ballot Measures, Commercial Real Estate Market, Legislative Agendas, Property Tax, Proposition 13

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

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

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

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

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