Patterson Belknap Webb & Tyler LLP

OUCH! Now What? OSHA Creates New Rules for Reporting and Submitting Records of Workplace Injuries and Illnesses

On May 11, 2016, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued a Final Rule modifying workplace injury and illness reporting requirements. Certain employers will be subject to new…more

OSHA, Recordkeeping Requirements, Reporting Requirements, Workplace Injury

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

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Asset Protection Wake Up Call: Data Security Top Concern for High Net Worth Investors

A recent study asked high net worth investors which of the following issues they were most concerned about: terrorism, data security, or a major illness. The most prevalent response might surprise you. Seventy-two percent of…more

Cyber Attacks, Cyber Crimes, Cybersecurity, Data Security, Email

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Judge Nathan Grants Stay Pending Appeal of PTAB’s Inter Partes Review Decisions

On October 18, District Judge Alison J. Nathan (S.D.N.Y.) granted defendants Verizon Communications Inc.’s, Verizon Services Corp.’s, Verizon Business Network Services Inc.’s, and Cellco Partnership’s (collectively, “Verizon”)…more

Appeals, Consolidated Appeals, Motion To Stay, Patent Infringement, Patent Litigation

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Delaware Chancery Court Holds that a Reverse Triangular Merger Is Not an Assignment by Operation of Law

On February 22, 2013, the Delaware Chancery Court in Meso Scale v. Roche restored a degree of certainty to M&A planning by holding that the acquisition of a company through a reverse triangular merger (RTM) did not constitute an…more

Assignments, Reverse Triangular Mergers, Terms and Conditions

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Law Passed Amending NPCL

Over the summer, we posted about Bill No. A. 10365B/S. 7913, containing amendments to the New York Not-for-Profit Corporation Law (the “NPCL”) and the New York Estates, Powers and Trusts Law (the “EPTL”) here. After…more

Estate Planning, Legislative Amendments, Non-Profits, Trusts, Wills

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Action is Necessary: Designate Your Copyright Agent To Ensure Your DMCA Safe Harbor Protection Continues

Under the Digital Millennium Copyright Act (“DMCA”), an online service provider (“OSP”) – such as the owner of a website that allows users to post user content – may be eligible for a safe harbor from copyright infringement…more

Copyright, Copyright Infringement, Copyright Office, Designated Agent, DMCA

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International Cyber Recommendations for the Financial Market: Collaboration is the Name of the Game

On June 29, 2016, the Bank for International Settlements’ (BIS) Committee on Payments and Market Infrastructures (CPMI) and the Board of the International Organization of Securities Commissions (IOSCO) issued “Guidance on cyber…more

Banking Sector, BIS, Committee on Payments and Market Infrastructure (CPMI), Cybersecurity, Financial Markets

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

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New Rules on Section 83(b) Elections

Prior to a recent change, in order for a Section 83(b) election to be effective, the taxpayer had to: - File the Section 83(b) election within 30 days of the receipt of restricted property (typically, restricted stock) with…more

Equity Compensation, Filing Requirements, IRC Section 83(b), IRS, Restricted Stocks

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Hints of a Narrowing of the FTC’s Section 5 Authority Under a Trump Presidency

The transition of power from President Barack Obama to President-Elect Donald Trump is underway. Although President-Elect Trump did not lay out specific policy prescriptions about data privacy or consumer protection during his…more

Administrative Appointments, Barack Obama, Data Privacy, Data Protection, Donald Trump

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Supreme Court in Salman Says: “This One Is Easy,” Reaffirming Dirks and Rejecting Newman

The United States Supreme Court (Alito, J.) issued a unanimous decision today affirming the Ninth Circuit’s decision in Salman v. United States, an insider trading case concerning tippee liability. The Court held that the…more

Corporate Executives, Criminal Convictions, Dirks v SEC, Insider Trading, Personal Benefit

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China’s New Laws on Foreign and Domestic NGOs

Operating in China just became a bit more complex for foreign nongovernmental organizations (NGOs). China’s new “Law on the Management of Foreign Non-Governmental Organizations’ Activities within Mainland China”, which was…more

China, Domestic Corporations, Foreign Charities, Foreign Entities, NGOs

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AbbVie Submits Citizen Petition on Interchangeable Biosimilars

AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference product…more

AbbVie, Biologics, Biosimilars, Citizen Petitions, FDA

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Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two…more

ANDA, BPCIA, Commercial Marketing, Corporate Counsel, Forum Selection

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DHS Warns of New Ransomware Threats

The Department of Homeland Security (“DHS”) recently issued a joint alert with the Canadian Cyber Incident Response Centre warning of two new ransomware threats behind recent well-publicized attacks against healthcare companies…more

Bitcoin, Canada, Cybersecurity, Data Protection, DHS

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New Proposed Regulations for Section 457(f) Nonqualified Deferred Compensation Arrangements of Non-Profit and Governmental Entities

The Internal Revenue Service recently released long anticipated proposed regulations (the “Proposed Regulations”) governing deferred compensation arrangements maintained by tax-exempt organizations and governmental entities…more

457(b) Plans, Death Benefits, Deferred Compensation, Employee Benefits, IRS

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Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The…more

Actavis Inc., ANDA, Anti-Competitive, Antitrust Violations, Appeals

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Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent

It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the…more

Biologics, Genentech, Inter Partes Review (IPR) Proceeding, Joinder, Motion to Terminate

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Significant Changes Proposed to New York Estate and Income Tax Laws

The New York State Legislature is considering some significant proposed changes to the New York estate tax law, the tax treatment of gifts by New York residents, and New York income taxation of certain trusts. Some important…more

Estate Planning, Estate Tax, Generation-Skipping Transfer, Gift-Tax Exemption, Income Taxes

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New York’s Highest Court Rules that Yoga Instructors are Independent Contractors: But Can Other Employers Hold that Pose?

The New York State Court of Appeals and New York City recently provided additional guidance for – and imposed additional requirements on – New York employers that use independent contractors. In In re Yoga Vida NYC, Inc…more

Appeals, Control Test, DOL, FLSA, Freelance Workers

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The Federal Circuit Will Hear Apotex’s Appeal from a Preliminary Injunction Under the BPCIA in Early 2016

In Amgen v. Apotex, Judge Cohn of the Southern District of Florida recently enjoined Apotex from selling its proposed biosimilar of Amgen’s Neulasta for 180 days following FDA approval. In Amgen v. Sandoz, 794 F.3d 1347 (Fed…more

aBLA, Amgen, Apotex, Biosimilars, BPCIA

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NYS Cyber Crack Down Looms: What Every Financial Institution, Insurer and Their Board Must Know

With the public comment period closing in a few days, the New York Department of Financial Services (DFS) “first in the nation” cybersecurity regulation is one step closer to becoming law. The regulation – which covers a broad…more

Audits, Banks, Cybersecurity, Department of Financial Services, Financial Institutions

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U.S. Senators Want Answers: Yahoo’s Unacceptable Delay In Data Breach Announcement

The aftermath of Yahoo’s data breach has raised a number of questions from customers, law enforcement, and most recently six U.S. Senators. Yesterday, Senators Patrick Leahy, Al Franken, Elizabeth Warren, Richard…more

Breach Notification Rule, Cyber Attacks, Data Breach, Hackers, Yahoo!

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Law Firms and Vendors Mandated to Up Their Cyber Game: Final Installment in a 3-Part Series

This is our final installment in a three-part series examining the New York State Department of Financial Services (“DFS”) new cybersecurity regulation.  In this installment, we provide an overview of the regulation’s impact on…more

Banks, Cybersecurity, Data Security, Department of Financial Services, Encryption

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St. Louis Taxi Commission Not Immune From Uber’s Antitrust Suit

As we’ve written, Uber, the popular app-based car service, has been on the antitrust defensive, facing allegations that its algorithm for calculating prices restricts price competition. In Wallen v. St. Louis Metropolitan…more

Antitrust Provisions, Mobile Apps, Sharing Economy, Surface Transportation, Taxi Cabs

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Sunbeam Products, Inc. V. Chicago American Manufacturing, LLC

The U.S. Court of Appeals for the Seventh Circuit in Chicago has issued a decision with significant implications for licensees of trademarks whose licensors become debtors in bankruptcy. In Sunbeam Products, Inc. v. Chicago…more

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Fall into the GAAP: New Not-for-Profit Financial Reporting Standards Issued

As we previously reported, in April 2015 the Financial Accounting Standards Board (“FASB”) circulated a series of proposed changes to generally accepted accounting principles applicable to certain not-for-profit entities in…more

Accounting Standards, FASB, Financial Reporting, Financial Statements, GAAP

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FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept any…more

AbbVie, Anti-Competitive, Biosimilars, BPCIA, Citizen Petitions

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Sunbeam Products, Inc. V. Chicago American Manufacturing, LLC

The U.S. Court of Appeals for the Seventh Circuit in Chicago has issued a decision with significant implications for licensees of trademarks whose licensors become debtors in bankruptcy. In Sunbeam Products, Inc. v. Chicago…more

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Supreme Court Endorses Implied Certification Theory of Liability But Establishes “Demanding” Materiality Standard Under the False Claims Act

Yesterday, the United States Supreme Court decided Universal Health Services, Inc. v. United States ex rel. Escobar et al., holding that the so-called “implied certification” theory is viable under the False Claims Act (“FCA”),…more

Conditions of Payment, Failure To Disclose, False Claims Act (FCA), False Implied Certification Theory, Federal Contractors

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Merrick Garland on Efficiencies

Judge Merrick Garland, if he is confirmed, may become one of the Supreme Court’s foremost authorities in antitrust law. He taught antitrust law at Harvard, and he has published on the subject, so it’s fair to expect him to seek…more

Antitrust Provisions, Judicial Appointments, Market Participants, Merrick Garland, SCOTUS

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Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent…more

AbbVie, Amgen, Amgen v Apotex, Appeals, Biosimilars

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Galaria v. Nationwide: Data Breach Plaintiffs Standing Strong in the Sixth

This week, in the first post-Spokeo circuit court decision to address standing in a data-breach class action, the Sixth Circuit joined the Seventh Circuit in holding that plaintiffs whose sensitive personal information has been…more

Article III, Bailments, Class Action, Corporate Counsel, Data Breach

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U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies might…more

Affordable Care Act, Barack Obama, Biologics, BPCIA, Donald Trump

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

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Gold and Silver price fixing suits may be expensive for banks

The Southern District of New York recently denied motions to dismiss filed by several banks that allegedly conspired to manipulate the price of gold and silver. Only defendant UBS was successful in convincing the court that the…more

Antitrust Litigation, Banks, Failure To State A Claim, Metals, Motion to Dismiss

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NYSE Proposes Rule Changes Requiring Foreign Private Issuers to Submit Semi-Annual Financial Information to SEC

The New York Stock Exchange (NYSE) recently proposed amendments to the NYSE Listed Company Manual (Manual) to adopt a requirement that NYSE-listed foreign private issuers (FPIs) submit semi-annual unaudited financial information…more

Financial Statements, Foreign Private Issuers, NYSE, Proposed Amendments, Publicly-Traded Companies

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

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Impact of Nautilus on Biotech and Pharmaceutical Patents

In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), the Supreme Court rejected the Federal Circuit’s “insolubly ambiguous” standard for determining whether a patent claim meets the definiteness requirement…more

Claim Construction, Indefiniteness, Patent Litigation, Pharmaceutical Patents

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Banks Speak: LIBOR Plaintiffs Are Not Efficient Enforcers Of Antitrust Laws

As our loyal readers know, on May 23, 2016, the Second Circuit issued a decision in the In re: LIBOR-Based Financial Instruments Antitrust Litigation vacating the District Court’s prior decision dismissing one case in this…more

Antitrust Litigation, Banking Sector, Banks, Financial Instruments, Libor

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New Proposed Regulations for Section 457(f) Nonqualified Deferred Compensation Arrangements of Non-Profit and Governmental Entities

The Internal Revenue Service recently released long anticipated proposed regulations (the “Proposed Regulations”) governing deferred compensation arrangements maintained by tax-exempt organizations and governmental entities…more

457(b) Plans, Death Benefits, Deferred Compensation, Employee Benefits, IRS

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Second Circuit Reverses Conviction in Bond Market Misrepresentation Case, but Endorses Government Theory of Materiality

On December 8, 2015, the United States Court of Appeals for the Second Circuit reversed the conviction of Jesse C. Litvak, a securities broker and trader at Jefferies & Company. Litvak had been convicted of various counts of…more

Bonds, Convictions, Materiality, Misrepresentation, Reversal

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In re Capacitors Antitrust Class Action Update: Claims Slightly Narrowed, Parties Continue Discovery

When we last wrote in June 2015 about In re Capacitors Antitrust Litig., No. 14-03264-JD, consolidated putative class actions pending before Judge James Donato in the Northern District of California, the plaintiffs had just…more

Antitrust Litigation, Cartwright Act, Injury-in-Fact, Price-Fixing, Putative Class Actions

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New York Non-Profit Revitalization Act Reforms Governance Rules for Nonprofits

Signed into law in 2013, the New York Non-Profit Revitalization Act is designed to reform the statutory requirements for governance of nonprofit organizations (both not-for-profit corporations and wholly charitable trusts),…more

Audits, Charitable Organizations, Compensation & Benefits, Conflicts of Interest, Corporate Governance

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Sunbeam Products, Inc. V. Chicago American Manufacturing, LLC

The U.S. Court of Appeals for the Seventh Circuit in Chicago has issued a decision with significant implications for licensees of trademarks whose licensors become debtors in bankruptcy. In Sunbeam Products, Inc. v. Chicago…more

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A Closer Look At The Fallout From The Home Depot Data Breach

More than a year and a half ago, Home Depot announced that it had been a victim of one of the largest data breaches in U.S. history. Media outlets reported that the breach had affected Home Depot’s customers who had made…more

Article III, Banking Sector, Class Action, Corporate Counsel, Cyber Attacks

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Supreme Court Endorses Implied Certification Theory of Liability But Establishes “Demanding” Materiality Standard Under the False Claims Act

Yesterday, the United States Supreme Court decided Universal Health Services, Inc. v. United States ex rel. Escobar et al., holding that the so-called “implied certification” theory is viable under the False Claims Act (“FCA”),…more

Conditions of Payment, Failure To Disclose, False Claims Act (FCA), False Implied Certification Theory, Federal Contractors

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

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Remijas v. Neiman Marcus: Seventh Circuit Affords Broad Standing To Sue Over Consumer Data Breaches

When hackers breach a business’s systems, class actions are sure to follow. Often, however, these suits have faltered right out of the starting gate. Citing the Supreme Court’s 2013 decision in Clapper v. Amnesty International,…more

Appeals, Article III, Data Breach, Debit and Credit Card Transactions, Imminent Harm

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DOJ and FTC provide guidance on avoiding antitrust violations in Human Resources practices

The Department of Justice (DOJ) and the Federal Trade Commission (FTC) last week issued antitrust guidelines for human resources (HR) professionals. The guidelines highlight the most common antitrust violations, based on a…more

Antitrust Violations, Criminal Liability, DOJ, FTC, Human Resources Professionals

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Implications of the Supreme Court’s Windsor Decision on Estate Planning for Same-sex Couples

On June 26, 2013, the Supreme Court, in its decision in United States v. Windsor, overturned Section 3 of the Federal Defense of Marriage Act (“DOMA”). The Court ruled that the Federal government could not deny tax and other…more

DOMA, Estate Planning, Gift-Tax Exemption, Income Taxes, Lifetime Limits

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Draft Legislation Streamlines and Redefines Australia’s Competition Laws

On Monday, Australia’s Federal Government released new draft legislation after a panel conducted a review of Australia’s competition laws last year. The proposed revisions consolidate power and discretion with the Australian…more

Anti-Competitive, Australia, Competition, Corporate Counsel, Pending Legislation

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Proposed Legislation Would Allow Limited Political Campaign Activity for Charitable Organizations

Recently, we wrote about the absolute prohibition on political campaign activity by 501(c)(3) charitable organizations, and the importance of managing the use of social media to avoid violating these rules. This prohibition has…more

501(c)(3), Charitable Organizations, Donald Trump, IRS, Legislative Agendas

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Cybersecurity Advice from President Obama

We’re writing this week to highlight some of the ways in which President Obama’s evolving views on cybersecurity can help guide corporate governance of data security risks. In an interview with Wired Magazine, the President…more

Barack Obama, Cyber Attacks, Cybersecurity, Data Breach, Data Security

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Supreme Court Rejects the Government’s “Fishy” Interpretation of Sarbanes-Oxley Obstruction Statute

On February 25, the United States Supreme Court issued a decision in Yates v. United States.1 This case involved the interpretation of Title 18, United States Code, Section 1519, a statute that was added as part of the…more

Destruction of Evidence, Evidence, Sarbanes-Oxley, SCOTUS, US v Yates

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“Don’t retaliate! (We really mean it)”: EEOC and Second Circuit Crack Down on Workplace Retaliation

On August 25, 2016, the U.S. Equal Employment Opportunity Commission (EEOC) issued final enforcement guidance on employer retaliation (the “Guidance”). The Guidance addresses retaliation under each of the statutes enforced by…more

Civil Rights Act, Discrimination, EEOC, Employer Liability Issues, Retaliation

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Into the Cloud: New Guidelines for HIPAA Covered Entities and Business Associates

The advent of cloud computing has raised questions about how companies subject to HIPAA can take advantage of the technology while still complying with their privacy and security obligations under federal law. In response, the…more

Breach Notification Rule, Cloud Computing, Cloud Service Providers (CSPs), Electronic Protected Health Information (ePHI), HIPAA

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Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The…more

Actavis Inc., ANDA, Anti-Competitive, Antitrust Violations, Appeals

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Seventh Circuit (Again) Finds Consumers Have Standing To Sue Over Data Breaches

On April 14, 2016, the Seventh Circuit held in Lewart v. P.F. Chang’s that customers who may have had personal information compromised in a P.F. Chang’s data breach have standing, at the motion-to-dismiss stage, to sue the…more

Clapper v. Amnesty International, Class Action, Credit Monitoring, Data Breach, Injury-in-Fact

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New Rules on Section 83(b) Elections

Prior to a recent change, in order for a Section 83(b) election to be effective, the taxpayer had to: - File the Section 83(b) election within 30 days of the receipt of restricted property (typically, restricted stock) with…more

Equity Compensation, Filing Requirements, IRC Section 83(b), IRS, Restricted Stocks

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New York Non-Profit Revitalization Act Reforms Governance Rules for Nonprofits

Signed into law in 2013, the New York Non-Profit Revitalization Act is designed to reform the statutory requirements for governance of nonprofit organizations (both not-for-profit corporations and wholly charitable trusts),…more

Audits, Charitable Organizations, Compensation & Benefits, Conflicts of Interest, Corporate Governance

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Supreme Court Nixes Aereo TV, Holding That Internet Streaming of Broadcast TV to Subscribers Violates Copyright Law

On June 25, 2014, the United States Supreme Court decided ABC v. Aereo, one of the more important (and most closely watched) copyright cases of the digital era. The Court’s 6-3 decision that streaming-TV startup Aereo “publicly…more

ABC, ABC v Aereo, Aereo, Broadcasting, Copyright

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A New Tool for Anti-Bribery Compliance Program: ISO 37001

Recently, the International Organization for Standardization (ISO) adopted a new set of standards, designated as ISO 37001, to assist organizations in their ongoing fight against bribery. As a result of recent increases in the…more

Anti-Bribery, Anti-Corruption, Compliance, Corrective Actions, Due Diligence

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China’s Controversial New Cybersecurity Law

Earlier today, the Chinese government in Beijing approved a sweeping new cybersecurity law aimed at centralizing control over computer networks operating within China’s borders. The new law is broadly drafted and applies…more

Censorship, China, Computer Servers, Corporate Counsel, Critical Infrastructure Sectors

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A New Tool for Anti-Bribery Compliance Program: ISO 37001

Recently, the International Organization for Standardization (ISO) adopted a new set of standards, designated as ISO 37001, to assist organizations in their ongoing fight against bribery. As a result of recent increases in the…more

Anti-Bribery, Anti-Corruption, Compliance, Corrective Actions, Due Diligence

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Following the Money: The EEOC Requires Big Employers to Track Pay Data

The U.S. Equal Employment Opportunity Commission (“EEOC”) announced last week that, starting in March 2018, it will collect summary pay data from private employers (including federal contractors and subcontractors) with 100 or…more

Data Collection, EEO-1, EEOC, Federal Contractors, Filing Deadlines

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The “Cannibal Cop” and Protection of Computerized Data

In an unusual criminal case, the Second Circuit Court of Appeals recently weighed in on an important question at the intersection of employment law and data security. The decision will likely have implications wherever questions…more

Computer Fraud and Abuse Act (CFAA), Data Security, Trade Secrets, Unauthorized Access, Web Scraping

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Judge Oetken Holds that Amendments Made During Ex Parte Reexamination Are not Effective Until Grant of Reissue Patent

On September 26, 2016, District Judge Paul Oetken (S.D.N.Y.) denied defendant Jay Franco & Sons’ (“Franco”) motion to dismiss, granted plaintiff Infinity Headwear & Apparel’s (“Infinity”) motion for leave to amend to assert…more

Absolute Intervening Rights Doctrine, Appeals, Claim Construction, Ex Partes Reexamination, Leave to Amend

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Amgen v. Sandoz Biosimilar Litigation Update: Sandoz Follows the Patent Dance With Neulasta

Amgen v. Sandoz Biosimilar Litigation Update: Sandoz Follows the Patent Dance With Neulasta - Prominent among the first generation of U.S. biosimilar litigations under the Biologics Price Competition and Innovation Act…more

Biosimilars, BPCIA, Patent Dance, Patent Infringement, Patent Litigation

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Impact of Nautilus on Biotech and Pharmaceutical Patents

In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), the Supreme Court rejected the Federal Circuit’s “insolubly ambiguous” standard for determining whether a patent claim meets the definiteness requirement…more

Claim Construction, Indefiniteness, Patent Litigation, Pharmaceutical Patents

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When Using a Computer Becomes a Crime, Part Two: ACLU, Facebook Weigh In on Ninth Circuit’s Answer

The Electronic Frontier Foundation (“EFF”) and the American Civil Liberties Union (“ACLU”) have weighed in on Facebook’s high-profile dispute with a social media aggregation company over whether it had unlawfully accessed…more

ACLU, Appeals, Computer Fraud and Abuse Act (CFAA), Content Aggregators, Electronic Frontier Foundation

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Aetna and Humana Go to Battle With Regulators Over Multi-Billion Dollar Merger

The trial over Aetna and Humana's $37 billion proposed merger kicked off today in a Washington, D.C. federal court. At issue is whether the companies' merger would substantially lessen competition in the market for…more

Aetna, Affordable Care Act, Anthem Insurance, Bench Trial, CIGNA

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New Rules on Section 83(b) Elections

Prior to a recent change, in order for a Section 83(b) election to be effective, the taxpayer had to: - File the Section 83(b) election within 30 days of the receipt of restricted property (typically, restricted stock) with…more

Equity Compensation, Filing Requirements, IRC Section 83(b), IRS, Restricted Stocks

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Tough Choices Confront Trade Creditors When a Retailer Faces Bankruptcy

The Great Recession, which began in December 2007 and officially ended in September 2009, has been especially hard on U.S. retailers, and its impact likely will be felt for many more years. Retailers sustained record-breaking…more

Bankruptcy Code, Commercial Bankruptcy, Creditors, Debt Collection, Internet Retailers

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US Regulators Investigate Chinese Steelmakers for Hacking Trade Secrets

The U.S. International Trade Commission (“ITC”) last week launched an investigation into United States Steel Corporation’s (“U.S. Steel”) complaint that Chinese hackers stole trade secret information—including proprietary…more

ALJ, China, Hackers, Illegal Imports, ITC

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An Unforeseen Obstacle: Consultants Can Prevent Validity Challenges Through the Use of the Assignor Estoppel Doctrine

Imagine hiring a consultant who designs a process, only to find that the process infringes a patent invented by the same consultant owned by someone else. How much worse would it be if your use of that consultant prevented you…more

Assignor Estoppel, Consultants, Patent Infringement, Patent Litigation, Patents

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Supreme Court Clarifies Standing For False Advertising Cases

On March 25, 2014, the United States Supreme Court issued a unanimous decision resolving an important issue that has implications for companies seeking redress for false advertising and disparagement. In Lexmark International,…more

Copyright Infringement, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

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The Impact of the Supreme Court’s Recent Halliburton Decision on Securities Litigation

On June 23, 2014, the Supreme Court issued its long-awaited decision in Halliburton Co. v. Erica P. John Fund, Inc. In Halliburton, the Court declined to overrule Basic v. Levinson, but rather imposed limitations on the…more

Basic v Levinson, Class Certification, Fraud, Fraud-on-the-Market, Halliburton

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Third Circuit Grants FTC Injunction in Penn State Hershey-Pinnacle Merger, Overruling Lower Court

On September 27, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission a big win, overturning the Middle District of Pennsylvania’s denial of an injunction to block the proposed merger of Penn State…more

Anti-Competitive, Appeals, Burden of Proof, FTC, Hospital Mergers

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

See All Updates »

New Rules on Section 83(b) Elections

Prior to a recent change, in order for a Section 83(b) election to be effective, the taxpayer had to: - File the Section 83(b) election within 30 days of the receipt of restricted property (typically, restricted stock) with…more

Equity Compensation, Filing Requirements, IRC Section 83(b), IRS, Restricted Stocks

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Post-Spokeo Standing: An Evolving Landscape

Several recent federal court decisions have shed additional light on the still-unsettled question of when a plaintiff has Article III standing to sue based on a data breach or other data security or privacy event. These…more

Article III, Class Action, Data Breach, Data Protection, Data Security

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Supreme Court Clarifies Standing For False Advertising Cases

On March 25, 2014, the United States Supreme Court issued a unanimous decision resolving an important issue that has implications for companies seeking redress for false advertising and disparagement. In Lexmark International,…more

Copyright Infringement, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

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Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar…more

All Writs Act, Amgen, Appeals, Biologics, Biosimilars

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Judge Forrest Vacates Judge Scheindlin’s Prior Decision Invalidating TiVo Patents Under § 101

On November 29, 2016, District Judge Katherine B. Forrest (S.D.N.Y.) vacated the February 22, 2016 decision of Judge Shira A. Scheindlin, which had granted a motion to dismiss, brought by alleged infringers TNS Media Research,…more

Abstract Ideas, CLS Bank v Alice Corp, Motion to Dismiss, Motion To Reconsider, Patent Infringement

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China’s Controversial New Cybersecurity Law

Earlier today, the Chinese government in Beijing approved a sweeping new cybersecurity law aimed at centralizing control over computer networks operating within China’s borders. The new law is broadly drafted and applies…more

Censorship, China, Computer Servers, Corporate Counsel, Critical Infrastructure Sectors

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DFS Cyber Regulation: Part II – An Interview with Bay Dynamics’ Steven Grossman

This is the second installment in our interview with Steven Grossman, VP Strategy & Enablement at Bay Dynamics, the cyber risk analytics company. Here, Steven discusses the importance of aligning an institution’s risk profile…more

Banks, Board of Directors, CISO, Cyber Attacks, Cybersecurity

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New York Will Require Certain 501(c)(3) Organizations to Publicly Disclose Donors

Bill No. A. 10742/S. 8160, introduced during the final hours of the spring legislative session and signed into law by Governor Andrew Cuomo, requires 501(c)(3) organizations to publicly disclose the identities of certain donors…more

501(c)(3), 501(c)(4), Disclosure Requirements, Donations, Governor Cuomo

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New Proposed Regulations for Section 457(f) Nonqualified Deferred Compensation Arrangements of Non-Profit and Governmental Entities

The Internal Revenue Service recently released long anticipated proposed regulations (the “Proposed Regulations”) governing deferred compensation arrangements maintained by tax-exempt organizations and governmental entities…more

457(b) Plans, Death Benefits, Deferred Compensation, Employee Benefits, IRS

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Hints of a Narrowing of the FTC’s Section 5 Authority Under a Trump Presidency

The transition of power from President Barack Obama to President-Elect Donald Trump is underway. Although President-Elect Trump did not lay out specific policy prescriptions about data privacy or consumer protection during his…more

Administrative Appointments, Barack Obama, Data Privacy, Data Protection, Donald Trump

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Law Firms and Vendors Mandated to Up Their Cyber Game: Final Installment in a 3-Part Series

This is our final installment in a three-part series examining the New York State Department of Financial Services (“DFS”) new cybersecurity regulation.  In this installment, we provide an overview of the regulation’s impact on…more

Banks, Cybersecurity, Data Security, Department of Financial Services, Encryption

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New York District Court Allows Monopolization Claims Alleging Manipulation of Electricity Prices to Proceed Against Barclays

Last week, Judge Victor Marrero of the U.S. District Court for the Southern District of New York partially granted Barclays PLC’s motion to dismiss antitrust and unfair enrichment claims brought against it by Merced Irrigation…more

Barclays, Class Action, FERC, Price Manipulation, Sherman Act

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New York Non-Profit Revitalization Act Reforms Governance Rules for Nonprofits

Signed into law in 2013, the New York Non-Profit Revitalization Act is designed to reform the statutory requirements for governance of nonprofit organizations (both not-for-profit corporations and wholly charitable trusts),…more

Audits, Charitable Organizations, Compensation & Benefits, Conflicts of Interest, Corporate Governance

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AbbVie Submits Citizen Petition on Interchangeable Biosimilars

AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference product…more

AbbVie, Biologics, Biosimilars, Citizen Petitions, FDA

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New York’s Highest Court Rules that Yoga Instructors are Independent Contractors: But Can Other Employers Hold that Pose?

The New York State Court of Appeals and New York City recently provided additional guidance for – and imposed additional requirements on – New York employers that use independent contractors. In In re Yoga Vida NYC, Inc…more

Appeals, Control Test, DOL, FLSA, Freelance Workers

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Judge Forrest Vacates Judge Scheindlin’s Prior Decision Invalidating TiVo Patents Under § 101

On November 29, 2016, District Judge Katherine B. Forrest (S.D.N.Y.) vacated the February 22, 2016 decision of Judge Shira A. Scheindlin, which had granted a motion to dismiss, brought by alleged infringers TNS Media Research,…more

Abstract Ideas, CLS Bank v Alice Corp, Motion to Dismiss, Motion To Reconsider, Patent Infringement

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A New Tool for Anti-Bribery Compliance Program: ISO 37001

Recently, the International Organization for Standardization (ISO) adopted a new set of standards, designated as ISO 37001, to assist organizations in their ongoing fight against bribery. As a result of recent increases in the…more

Anti-Bribery, Anti-Corruption, Compliance, Corrective Actions, Due Diligence

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A Long Road Ahead: Data Privacy and the Self-Driving Car

America has had a longstanding love affair with the automobile, as a manifestation of innovation and independence. The next chapter is likely the advent of the (fully or partially) autonomous vehicle…more

Auto Manufacturers, Automotive Industry, Connected Cars, Cybersecurity, Data Privacy

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Data-Security Assessments? You’re Going to Want a Lawyer for That

These days, data breaches and cybersecurity attacks abound. With each news cycle, we’re confronted with stories about yet another big breach, at another big company, with the potential exposure of another big pool of…more

Attorney-Client Privilege, Confidential Information, Cybersecurity, Data Breach, Data Security

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Second Circuit Lays Out New Rules for Restitution

On February 6, 2015, the United States Court of Appeals for the Second Circuit decided an appeal, United States v. Cuti, which interpreted the restitution provisions of the Victims and Witnesses Protection Act (VWPA). The…more

Appeals, Attorney's Fees, Crime Victims, Restitution, SEC

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SEC Adopts Final Crowdfunding Rules under the JOBS Act

On October 30, 2015, the U.S. Securities and Exchange Commission (SEC) adopted final rules under Title III of the JOBS Act to enable U.S. companies to offer and sell securities through crowdfunding (Regulation Crowdfunding). …more

Crowdfunding, Funding Portal, Investors, JOBS Act, Offerings

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U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies might…more

Affordable Care Act, Barack Obama, Biologics, BPCIA, Donald Trump

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Supreme Court in Salman Says: “This One Is Easy,” Reaffirming Dirks and Rejecting Newman

The United States Supreme Court (Alito, J.) issued a unanimous decision today affirming the Ninth Circuit’s decision in Salman v. United States, an insider trading case concerning tippee liability. The Court held that the…more

Corporate Executives, Criminal Convictions, Dirks v SEC, Insider Trading, Personal Benefit

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Supreme Court in Salman Says: “This One Is Easy,” Reaffirming Dirks and Rejecting Newman

The United States Supreme Court (Alito, J.) issued a unanimous decision today affirming the Ninth Circuit’s decision in Salman v. United States, an insider trading case concerning tippee liability. The Court held that the…more

Corporate Executives, Criminal Convictions, Dirks v SEC, Insider Trading, Personal Benefit

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

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Lessons from LinkedIn: Privacy and Data Security Representations in the M&A Context

Microsoft’s blockbuster acquisition of LinkedIn earlier this month—a deal where concerns for privacy and data security loomed large—provides a glimpse into the growing trend of including separate privacy and data security…more

Contract Terms, Corporate Counsel, Due Diligence, FTC Act, LinkedIn

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Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use. The…more

Appeals, Biotechnology, Myriad-Mayo, Patent Invalidity, Patent-Eligible Subject Matter

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“Show Me the Money”: EEOC Seeks Pay Data from Large Employers

On January 29, 2016, the U.S. Equal Employment Opportunity Commission (“EEOC”) announced a proposal to begin collecting pay data from private employers with 100 or more employees and federal contractors. The EEOC currently…more

Data Collection, EEO-1, EEOC, Gender-Based Pay Discrimination, Reporting Requirements

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Supreme Court Clarifies Standing For False Advertising Cases

On March 25, 2014, the United States Supreme Court issued a unanimous decision resolving an important issue that has implications for companies seeking redress for false advertising and disparagement. In Lexmark International,…more

Copyright Infringement, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

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Some Welcome Relief and Clarification on Affordable Care Act for Employers

As the federal agencies continue to issue more guidance on the application of various provisions of the Affordable Care Act (the “ACA”) to employer-sponsored health coverage, there are some recent developments that we want to…more

Affordable Care Act, Cadillac Tax, Deadlines, Employer Group Health Plans, Form 1094

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New York Non-Profit Revitalization Act Reforms Governance Rules for Nonprofits

Signed into law in 2013, the New York Non-Profit Revitalization Act is designed to reform the statutory requirements for governance of nonprofit organizations (both not-for-profit corporations and wholly charitable trusts),…more

Audits, Charitable Organizations, Compensation & Benefits, Conflicts of Interest, Corporate Governance

See All Updates »

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a…more

Amgen, Biologics, Biosimilars, BPCIA, FDA

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New York Will Require Certain 501(c)(3) Organizations to Publicly Disclose Donors

Bill No. A. 10742/S. 8160, introduced during the final hours of the spring legislative session and signed into law by Governor Andrew Cuomo, requires 501(c)(3) organizations to publicly disclose the identities of certain donors…more

501(c)(3), 501(c)(4), Disclosure Requirements, Donations, Governor Cuomo

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The DOJ’s New Policy of Prosecuting Individuals

On September 9, 2015, Deputy Attorney General Sally Yates of the United States Department of Justice (“DOJ” or the “Department”) issued a new policy memorandum (the “Yates Memo”) entitled “Individual Accountability for Corporate…more

Corporate Crimes, Corporate Investigations, Criminal Investigations, Criminal Prosecution, DOJ

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Significant Changes Proposed to Rules for Valuing Interests in Family-Controlled Entities

Last week the IRS proposed new regulations that would, in many cases, prohibit the use of certain discounts customarily applied when valuing interests in family-controlled entities, such as corporations, partnerships and limited…more

Business Valuations, Estate Planning, Estate Tax, Family Businesses, IRS

See All Updates »

Aetna and Humana Go to Battle With Regulators Over Multi-Billion Dollar Merger

The trial over Aetna and Humana's $37 billion proposed merger kicked off today in a Washington, D.C. federal court. At issue is whether the companies' merger would substantially lessen competition in the market for…more

Aetna, Affordable Care Act, Anthem Insurance, Bench Trial, CIGNA

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New Proposed Regulations for Section 457(f) Nonqualified Deferred Compensation Arrangements of Non-Profit and Governmental Entities

The Internal Revenue Service recently released long anticipated proposed regulations (the “Proposed Regulations”) governing deferred compensation arrangements maintained by tax-exempt organizations and governmental entities…more

457(b) Plans, Death Benefits, Deferred Compensation, Employee Benefits, IRS

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In A Summary Order, Second Circuit Vacates 30-year Child Pornography Sentence on Substantive Reasonableness Grounds

In United States v. Sawyer, No. 15-2276, the Second Circuit (Jacobs, Pooler, Crawford) vacated and remanded for resentencing a case involving a conviction for possession of child pornography. The decision rested on a finding…more

Appeals, Child Pornography, Criminal Appeals, Criminal Convictions, Remand

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The Impact of the Supreme Court’s Recent Halliburton Decision on Securities Litigation

On June 23, 2014, the Supreme Court issued its long-awaited decision in Halliburton Co. v. Erica P. John Fund, Inc. In Halliburton, the Court declined to overrule Basic v. Levinson, but rather imposed limitations on the…more

Basic v Levinson, Class Certification, Fraud, Fraud-on-the-Market, Halliburton

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Supreme Court Clarifies Standing For False Advertising Cases

On March 25, 2014, the United States Supreme Court issued a unanimous decision resolving an important issue that has implications for companies seeking redress for false advertising and disparagement. In Lexmark International,…more

Copyright Infringement, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

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New Rules on Section 83(b) Elections

Prior to a recent change, in order for a Section 83(b) election to be effective, the taxpayer had to: - File the Section 83(b) election within 30 days of the receipt of restricted property (typically, restricted stock) with…more

Equity Compensation, Filing Requirements, IRC Section 83(b), IRS, Restricted Stocks

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Second Circuit Reverses Conviction in Bond Market Misrepresentation Case, but Endorses Government Theory of Materiality

On December 8, 2015, the United States Court of Appeals for the Second Circuit reversed the conviction of Jesse C. Litvak, a securities broker and trader at Jefferies & Company. Litvak had been convicted of various counts of…more

Bonds, Convictions, Materiality, Misrepresentation, Reversal

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Searching for Causation in ACTOS Complaint

How explicitly must a complaint sounding in antitrust allege causation? At oral argument last week, the Court of Appeals for the Second Circuit evaluated the sufficiency of the plaintiffs’ allegations that certain Takeda…more

Actos, Antitrust Violations, Appeals, Causation, Dismissals

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Law Passed Amending NPCL

Over the summer, we posted about Bill No. A. 10365B/S. 7913, containing amendments to the New York Not-for-Profit Corporation Law (the “NPCL”) and the New York Estates, Powers and Trusts Law (the “EPTL”) here. After…more

Estate Planning, Legislative Amendments, Non-Profits, Trusts, Wills

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Supreme Court Affirms Cuozzo – Leaving in Place BRI and Judicial Review Limitation for IPR Proceedings

In Cuozzo Speed Technologies, LLC v. Lee, No. 15-446, the Supreme Court affirmed the Federal Circuit’s holdings on claim construction and the scope of judicial review in an inter partes review (IPR) proceeding…more

Administrative Proceedings, America Invents Act, Appeals, Broadest Reasonable Interpretation Standard, Chevron Deference

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Choice-of-Law Rules Prevent Costco from Suing as Indirect Purchaser in California

In another development in the ongoing cathode ray tube (CRT) multidistrict litigation, Judge Tigar of the Northern District of California ruled that Costco could not recover any damages it sustained as an indirect purchaser of…more

Choice-of-Law, Costco, Damages, Electronics, Indirect Purchasers

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Action is Necessary: Designate Your Copyright Agent To Ensure Your DMCA Safe Harbor Protection Continues

Under the Digital Millennium Copyright Act (“DMCA”), an online service provider (“OSP”) – such as the owner of a website that allows users to post user content – may be eligible for a safe harbor from copyright infringement…more

Copyright, Copyright Infringement, Copyright Office, Designated Agent, DMCA

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FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The…more

Draft Guidance, Enforcement, FDA, Financial Conduct Authority (FCA), FTC

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The “Cannibal Cop” and Protection of Computerized Data

In an unusual criminal case, the Second Circuit Court of Appeals recently weighed in on an important question at the intersection of employment law and data security. The decision will likely have implications wherever questions…more

Computer Fraud and Abuse Act (CFAA), Data Security, Trade Secrets, Unauthorized Access, Web Scraping

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Judge Forrest Provides Litigants Guidance on Applying Alice

On August 3, 2016, S.D.N.Y. District Judge Katherine B. Forrest denied Defendant Lowe’s Companies, Inc. (“Lowe’s”) motion to dismiss Iron Gate Security, Inc.’s (“Iron Gate”) patent infringement claim. Iron Gate alleged that…more

Abstract Ideas, CLS Bank v Alice Corp, Motion to Dismiss, Myriad-Mayo, Patent-Eligible Subject Matter

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New York’s Highest Court Rules that Yoga Instructors are Independent Contractors: But Can Other Employers Hold that Pose?

The New York State Court of Appeals and New York City recently provided additional guidance for – and imposed additional requirements on – New York employers that use independent contractors. In In re Yoga Vida NYC, Inc…more

Appeals, Control Test, DOL, FLSA, Freelance Workers

See All Updates »

New York’s Highest Court Rules that Yoga Instructors are Independent Contractors: But Can Other Employers Hold that Pose?

The New York State Court of Appeals and New York City recently provided additional guidance for – and imposed additional requirements on – New York employers that use independent contractors. In In re Yoga Vida NYC, Inc…more

Appeals, Control Test, DOL, FLSA, Freelance Workers

See All Updates »

Supreme Court Clarifies Standing For False Advertising Cases

On March 25, 2014, the United States Supreme Court issued a unanimous decision resolving an important issue that has implications for companies seeking redress for false advertising and disparagement. In Lexmark International,…more

Copyright Infringement, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

See All Updates »

Proposed Legislation Would Allow Limited Political Campaign Activity for Charitable Organizations

Recently, we wrote about the absolute prohibition on political campaign activity by 501(c)(3) charitable organizations, and the importance of managing the use of social media to avoid violating these rules. This prohibition has…more

501(c)(3), Charitable Organizations, Donald Trump, IRS, Legislative Agendas

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Supreme Court Clarifies Standing For False Advertising Cases

On March 25, 2014, the United States Supreme Court issued a unanimous decision resolving an important issue that has implications for companies seeking redress for false advertising and disparagement. In Lexmark International,…more

Copyright Infringement, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

See All Updates »

Long and Wyndham Road: The Federal Trade Commission Extends Section 5 Unfairness to Regulate Data Security

In a surprising development, Wyndham Worldwide Corporation settled a long running dispute last week with the Federal Trade Commission that arose from three data breaches Wyndham suffered between 2008-2010. After an investigation…more

Audits, Cybersecurity, Data Collection, Data Security, FTC

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