McDermott Will & Emery

ICN Adopts New Guidance Focusing on Investigative Process and International Cooperation in Mergers

From April 28 through May 1, the International Competition Network (ICN) held its 2015 annual conference. The ICN is a network that unites 132 competition watchdogs from 119 jurisdictions, including the Antitrust Division of the…more

Competition, DOJ, Enforcement, European Commission, FTC

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Plain and Simple: Maryland Tax Court Holds Insurance Company is Exempt from Corporate Income Taxes

Although taxpayers often complain that complying with the tax laws imposed by the numerous state and local taxing jurisdictions that exist in the United States is a burdensome process, many of these tax statutes also provide…more

Corporate Taxes, Exempt Organizations, Insurance Companies, Insurance Industry, State Taxes

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Inside M&A - Winter 2015

Recent U.S. Cases Highlight Liability Risks to Executives in Mining, Heavy Industrial Transactions - Historically, corporate executives rarely faced personal or criminal liability resulting from mining or environmental…more

Africa, C-Suite Executives, COMESA, Compliance, Corporate Officers

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SEC Finalizes Rules Regarding Disclosure of CEO Pay Ratio—What They Require, What to Do and What’s Next

In yet another divisive 3-2 vote along party lines, on August 6, 2015, the U.S. Securities and Exchange Commission (SEC) adopted final rules requiring public companies (other than emerging-growth companies, smaller reporting…more

De Minimus Quantity Exemption, Dodd-Frank, Executive Compensation, Final Rules, Human Resources Professionals

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International News: Focus on International Private Client

In This Issue: Features - ..The UK Response to BEPS and Hybrid Mismatches ..Parental Liability for French Subsidiaries ..The Evolving US-Cuba Trade Landscape ..Amendments to Taiwan Fair Trade…more

BEPS, Cuba, Foreign Investment, Foreign Subsidiaries, France

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International News: Focus on Compliance

In This Issue - Welcome to the final issue of International News for 2014. As regulatory oversight of companies—from Sarbanes Oxley and the Dodd-Frank Act to the Foreign Corrupt Practices Act and the UK Bribery…more

Chief Compliance Officers, China, COMESA, Compliance, Disclosure Requirements

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1782 Discovery Applications Now Permitted in a ‘Reasonably Contemplated’ Foreign Judicial Proceeding

The U.S. Court of Appeals for the Eleventh Circuit recently affirmed a decision by the Southern District of Florida that substantially expanded a litigant’s ability to obtain discovery in aid of a foreign proceeding. The…more

Discovery, Foreign Corporations, Foreign Jurisdictions

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Pre-AIA Statute Did Not Give Patent Owner in an Ex Parte Reexamination the Right to Bring an Action in District Court

In re Teles AG Informationstechnologien - Addressing whether a patent owner involved in a pre-America Invents Act (AIA) ex parte reexamination, could challenge an adverse reexamination decision in a district court action…more

Appeals, Claim Construction, Ex Partes Reexamination, Obviousness, Patent Litigation

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Costs Sanctions For Failing to Respond to an Offer to Mediate: A Warning to Litigants in the UK

A recent UK Court of Appeal judgment demonstrates a clear and unequivocal endorsement of mediation and makes clear that a party who refuses to acknowledge or engage in an invitation to participate in mediation can face…more

Mediation, UK

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FTC Updates Guidelines for Making Proper Disclosures in Digital Advertising

The U.S. Federal Trade Commission (FTC) released updated guidance on how to make online advertising and marketing disclosures “clear and conspicuous” to avoid consumer deception. The guidelines affect the structure and format…more

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Affordable Care Act Reporting Penalties Significantly Increased

On June 29, 2015, President Barack Obama signed the Trade Preferences Extension Act (the Act) into law. In addition to containing several revenue offsets, the Act significantly increased penalties for incorrect information…more

1099s, Affordable Care Act, Corporate Counsel, Employer Liability Issues, Good Faith

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Maker’s Mark Defeats “Handmade” Class Action Lawsuit

Could consumers have plausibly believed that one of the country’s top-selling bourbon brands is “handmade”? Not according to one federal district court in Florida, which recently dismissed a class action alleging Maker’s Mark…more

Advertising, Class Action, Labeling, Wine & Alcohol, Young Lawyers

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Mexican Energy Reforms Bring E&P Opportunities and Much More

Last week the Mexican Congress approved legislation including Constitutional amendments that were approved by the required number of Mexican states on December 16 that will bring changes to the nation’s energy laws that…more

Energy, Energy Reform, Mexico, Oil & Gas

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Focus on Regulatory Law - December 2014

In This Issue: - Regulatory Authorities - Energy - Public Economy Law - Contracts - Public Health - Comparative Law - Excerpt from Regulatory Authorities: French…more

Competition Authorities, Energy Policy, EU

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IP Update, Vol. 16, No. 7, July 2013

“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the U.S…more

Advertising, ANDA, Antitrust Investigations, Arbitration Agreements, Claims Limitations Period

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IP Update, Vol. 16, No. 7, July 2013

“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the U.S…more

Advertising, ANDA, Antitrust Investigations, Arbitration Agreements, Claims Limitations Period

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Massachusetts: Proposing to Repeal Tax Credits Might Have Chilling Effect

During the rollout of his fiscal year 2016 budget proposal, Massachusetts Governor Charlie Baker proposed to repeal the state’s film tax credit in 2017. While this tax credit has drawn criticism for its goal of providing public…more

Film Tax Credits, Governor Baker, Repeal, State Budgets, Tax Revenues

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Non-Direct Competitors May Sue Under the Lanham Act, Doctrine of Prudential Standing Eliminated

The Supreme Court of the United States swept away the different standards for Lanham Act prudential standing previously applied by the courts of appeals, and expressly discarded the amorphous concept of prudential standing in…more

Corporate Counsel, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

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Use of § 325(d) Discretion Can Lead to Harsh Result - Samsung Austin Semiconductor, LLC v. Rembrandt Wireless Technologies, LP

The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) used its § 325(d) to dismiss a petitioner’s motion for joinder with an inter partes review (IPR) instituted on an earlier filed petition by the…more

Inter Partes Review Proceedings, Joinder, Patent Infringement, Patent Litigation, Patent Trial and Appeal Board

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In Chicago, Taxing the Cloud Will Wait (Mostly) Until 2016

The City of Chicago has announced that it will be delaying the effective date for its recent ruling under the Personal Property Lease Transaction Tax until January 1, 2016. Personal Property Lease Transaction Tax Ruling #12…more

City of Chicago, Cloud-Based Services, Personal Property Tax, Startups

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Exemptions for Energy Intensive Companies From Renewable Energy Surcharges: Commission Opens In-Depth State Aid Investigation Against France

The European Commission has opened an in-depth State aid investigation into a French scheme, under which energy intensive companies are exempted from renewable energy surcharges. The decision to open the formal investigation…more

Energy, Energy Policy, EU, Renewable Energy

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Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission confirmed…more

Africa, Anti-Spam Legislation, Canada, China, Cybersecurity

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Certificated Natural Gas Storage Capacity Is Based on Science Not Sales, FERC Rules

The Federal Energy Regulatory Commission (the Commission) issued an order on Thursday, March 19, 2015, refusing to allow the abandonment of certificated working gas capacity when the reason for the request was unrelated to the…more

Energy Storage, FERC, Mineral Leases, Natural Gas, Oil & Gas

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Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission confirmed…more

Africa, Anti-Spam Legislation, Canada, China, Cybersecurity

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IRS Releases Highly Anticipated Cash Balance Plan Regulations

The U.S. Department of the Treasury (Treasury) and Internal Revenue Service (IRS) recently released long-awaited final regulations (the Final Regulations) with respect to market rates of return and related Pension Protection Act…more

Equity Plans, Final Rules, Hybrid Plan, IRS, Pension Protection Act of 2006

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Challenges Facing “Narrow” Provider Networks on the ACA Health Care Insurance Exchanges

In This Issue: - The Driving Forces Behind the Trend Toward Narrower Networks - The Trade-Off - Regulatory, Legislative and Litigatious Responses to Narrower Networks Across the Nation - Judicial and CMS…more

Affordable Care Act, Health Insurance, Health Insurance Exchanges, Legislative Agendas, Medicare

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IRS Updates EPCRS Correction Methods and Procedures

Reflecting comments it requested, and others it received, the Internal Revenue Service (IRS) recently issued two updates which modify the Employee Plans Compliance Resolution System (EPCRS), which is the comprehensive system for…more

Corporate Taxes, Employee Contributions, EPCRS, IRS, Retirement Plan

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Contract Manufacturing Is a Commercial Transaction for Purpose of “On-Sale” Bar - The Medicines Company v. Hospira, Inc.

Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted patent were invalid based on an agreement, dated more than one year prior to…more

Appeals, FDA, Generic Drugs, Hatch-Waxman, On-Sale Bar

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Nearly Expired Is Not the Same as Expired: The Board Clarifies Claim Construction Standards for Inter Partes Review - Apple, Inc. v. PersonalWeb Techs., LLC

Addressing the standard to be applied for claim construction during inter partes review (IPR) proceedings, the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (PTAB or Board) declined to create an…more

Apple, Claim Construction, Expiration Date, Inter Partes Review Proceedings, Obviousness

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A New Concept in Cartel Fining: “Direct EEA Sales Through Transformed Products”

On 9 July 2015, the Court of Justice of the European Union (CJEU) issued its judgment in InnoLux Corp. v Commission C-231/14P, confirming the existence of a new concept in cartel fining: “direct European Economic Area [EEA]…more

Cartels, CJEU, EEA, EU, European Commission

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Did France Really Ban Work E-Mails After 6 p.m.?

Several international news sources recently reported that French law now prevents employees from answering their mobile phones or professional e-mails after 6.00 pm (see articles in the Guardian and USA Today, among others). The…more

CBAs, Email Policies, Employment Contract, France, Mobile Devices

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Lawmakers Reach Deal to End Government Shutdown, Raise Debt Ceiling

While the focus over the past 16 days has been on the shuttered government and the prospect of the United States defaulting on its debt obligations, there are subtexts that are relevant to the health care industry. This On the…more

Affordable Care Act, CMS, Debt Ceiling, Federal Budget, Government Shutdown

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New California LLC Law Requires Members To Reconsider Their Operating Agreement

On January 1, 2014, California limited liability company (LLC) law changes in several respects. Unlike other new laws regulating business entities, the new LLC law does not give existing LLCs a choice as to whether to be…more

Consent, Corporate Governance, Fiduciary Duty, LLC, Managers

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The New Normal: Big Data Comes of Age

On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing…more

Barack Obama, Big Data, Data Breach, Data Protection, ECPA

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Focus on Private Equity - April 2015

In This Issue: - The Use of Alternative Credit in Europe - Buying and Selling a Craft Brewery in the United States - Excerpt from The Use of Alternative Credit in Europe: As a result of the reduced…more

Breweries, Equity Financing, EU, Private Equity, Regulatory Standards

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New Developments in The UK Shale Gas Sector

The shale gas sector in the United Kingdom is still in its infancy, but the UK Government has announced recently new measures and incentives to encourage its growth. On 13 December 2012, the Government lifted a temporary…more

Fracking, Oil & Gas, Shale Gas

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Court Declines To Certify Damages Class in Baseball Blackout Suit

On May 14, 2015, the Southern District of New York issued two opinions in Laumann v. Nat’l Hockey League, No. 12-cv-1817, excluding plaintiffs’ damages expert under Daubert and denying plaintiffs’ motion to certify a damages…more

Broadcasting, Class Action, Daubert Ruling, Daubert Standards, Expert Witness

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Should Companies Adjust Their Incentive Strategies in Light of New Governmental Accounting Disclosure Requirements?

Earlier this month, the Governmental Accounting Standards Board (GASB) approved Statement No. 77, Tax Abatement Disclosures, which requires state and local governments to report on foregone revenue from tax abatement agreements…more

Clawbacks, Confidential Information, Confidentiality Agreements, Disclosure Requirements, Financial Reporting

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Fetal DNA Test Cannot Give Birth to a Patent - Ariosa Diagnostics, Inc., et al. v. Sequenom Inc., et al.

Addressing the issue of patent eligibility of a pre-natal testing invention, the U.S. Court of Appeals for the Federal Circuit unanimously affirmed the district court’s judgement of invalidity under 35 U.S.C. § 101 with respect…more

DNA, Mayo v. Prometheus, Patent Applications, Patent Invalidity, Patent Litigation

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Supreme Court Rejects “Presumption of Prudence,” Adopts New Pleading Standards in Fifth Third Bancorp v. Dudenhoeffer

The Supreme Court of the United States has issued its highly anticipated decision in Fifth Third Bancorp v. Dudenhoeffer, No. 12-751. In an opinion written by Justice Breyer for a unanimous court, the Supreme Court held that..…more

Duty of Prudence, Employee Benefits, ERISA, ESOP, FIfth Third Bancorp v Dudenhoeffer

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What Do We Do Now that the World Didn’t End in 2012?

The countdown to the launch of the new generic top-level domains, or gTLDs, and the surrounding uncertainty about whether the potential commercial benefits will outweigh the perceived burdens, has begun. Is your company ready?…more

Domain Names, gTLD, Trademarks

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The 'Super Powered' Rule of Stare Decisis Defeats Spider Man

The Supreme Court of the United States, in a 6-3 decision, left undisturbed the rule from its 51-year-old decision in Brulotte v. Thys Co. (1964), invoking stare decisis and rejecting arguments seeking to overturn the rule…more

Brulotte, Kimble v Marvel Enterprises, Law-of-the-Case, Marvel Comics, Patent Royalties

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Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission confirmed…more

Africa, Anti-Spam Legislation, Canada, China, Cybersecurity

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The Upcoming Implementation of the Italian Patent Box Regime

Several press articles in recent weeks have anticipated the upcoming enactment of the Ministerial Decree which will eventually implement the Italian Patent Box regime. The Ministry of Economics and Finance announced on 29 July…more

BEPS, Biotechnology, Capital Gains, Copyright, Corporate Taxes

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Focus on Tax Controversy - Summer 2015

The French 3 Percent Distribution Tax: Claiming a Refund - Since December 2012, French companies have been liable for a 3 percent tax on distributions to their shareholders (3 Percent Tax), but practitioners have widely…more

Corporate Taxes, Dividends, Double Taxation, EU, France

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Inside M&A - Summer 2013

A Closer Look at Leveraged Dividend Recapitalizations - With merger and acquisition activity down over the course of 2012 into 2013, and a weak market for initial public offerings (IPOs), many private equity firms have…more

Collateralized Loan Obligations, Debtors, Dividends, Financing, Leveraged Loans

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Have Employees In New York City? Earned Sick Time Act Requires Notice by TODAY, May 1

New York City’s Earned Sick Time Act (Act) requires all Covered Employers to provide all Covered Employees with written notice of the new law by today, May 1, 2014…more

Employee Rights, Paid Leave, Sick Leave

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FTC and DOJ Host Workshop Examining Health Care Competition - Updated 2015

The Federal Trade Commission (FTC) and the Antitrust Division of the U.S. Department of Justice (DOJ) held a public workshop on February 24–25, 2015, to examine recent trends and developments in health care provider organization…more

ACOs, Acquisitions, Affordable Care Act, Antitrust Division, DOJ

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No Copyright in Individual Contributions to a Film - 16 Casa Duse, LLC v. Merkin

Citing the U.S. Court of Appeals Ninth Circuit’s recent en banc decision in Garcia v. Google (IP Update, Vol. 18, No. 6), the United States Court of Appeals for the Second Circuit affirmed a summary judgment ruling that…more

Appeals, Authorship, Cease and Desist Orders, Copyright, Copyright Infringement

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New Board Compliance Guidance Prompts General Counsel Focus

Health care general counsel should review, and brief their internal clients on, the new Practical Guidance for Health Care Governing Boards on Compliance Oversight (Guidance), released on April 20, 2015. A joint effort by the…more

Chief Compliance Officers, Health Care Providers, Healthcare, Internal Audit Functions, Internal Controls

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Insights for Driving Value Through Operational Performance of Private Equity Investments

The 13th annual Beecken Petty O’Keefe & Company Private Equity Conference took place on Friday, February 21st. McDermott, a lead sponsor of the event, hosted a panel of leading, mid-market private equity (PE) funds to discuss…more

Private Equity Funds

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International News: Focus on Compliance

In This Issue - Welcome to the final issue of International News for 2014. As regulatory oversight of companies—from Sarbanes Oxley and the Dodd-Frank Act to the Foreign Corrupt Practices Act and the UK Bribery…more

Chief Compliance Officers, China, COMESA, Compliance, Disclosure Requirements

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Secret Practice of a Russian Invention on U.S. Soil Invalidates a Patent - Solvay, S.A. v Honeywell International

Affirming the federal district court, the U. S. Court of Appeals for the Federal Circuit concluded that a claim was invalid under § 102(g)(2), i.e., the invention was made in this country by another who had not abandoned,…more

Patents, Russia

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New Board Compliance Guidance Prompts General Counsel Focus

Health care general counsel should review, and brief their internal clients on, the new Practical Guidance for Health Care Governing Boards on Compliance Oversight (Guidance), released on April 20, 2015. A joint effort by the…more

Chief Compliance Officers, Health Care Providers, Healthcare, Internal Audit Functions, Internal Controls

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Focus on Private Equity - October 2014

Proposed EU Merger Review of Non-Controlling Minority Shareholding Acquisitions: Challenges and Opportunities for Private Equity - At present, the EU Merger Regulation [Council Regulation (EC) No 139/2004] (the Merger…more

EU, European Commission, European Merger Control Regulation, IPO, JOBS Act

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Litigants Challenging PTO Decisions in District Court Should Be Prepared to Pay PTO’s Attorneys’ Fees - Shammas v. Focarino

Addressing the issue of attorneys’ fees in connection with a district court challenge of the U.S. Patent and Trademark Office’s (PTO’s) decision to reject a trademark registration, the U.S. Court of Appeals for the Fourth…more

Attorney's Fees, Trademark Registration, Trademarks, USPTO

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IP Update, Vol. 16, No. 10, October 2013

No Case or Controversy in DJ Against Patentee Who Sued Manufacturer’s Customers: Cisco Systems, Inc. v. Alberta Telecommunications Research Center - In a non-precedential opinion addressing declaratory judgment…more

Cisco, Claim Construction, Copyright, FRAND, Offsets

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FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional Labeling

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and…more

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Focus on Tax Controversy - Summer 2015

The French 3 Percent Distribution Tax: Claiming a Refund - Since December 2012, French companies have been liable for a 3 percent tax on distributions to their shareholders (3 Percent Tax), but practitioners have widely…more

Corporate Taxes, Dividends, Double Taxation, EU, France

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Out-of-Market Divestiture Required to Resolve Competitive Concerns

On January 30, 2015, the Federal Trade Commission (FTC) announced a settlement of its investigation into Sun Pharmaceutical Industries Ltd.’s (Sun) acquisition of Ranbaxy Laboratories Ltd. (Ranbaxy) from Daiichi Sankyo Co., Ltd…more

Acquisitions, Drug Manufacturers, FTC, Generic Drugs, Multinationals

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Massachusetts DOR May Lose Staff This Summer

The Massachusetts Department of Revenue (DOR) likely will have significantly less employees starting July 1, 2015, due to a Massachusetts employee retirement incentive program. Governor Charlie Baker recently signed legislation…more

Department of Revenue, Pensions, Public Employees, Public Employers, Public Pension

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OCR to Begin Phase 2 of HIPAA Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) will soon begin a second phase of audits (Phase 2 Audits) of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA)…more

Audits, Best Management Practices, Business Associates, Chief Compliance Officers, Covered Entities

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Hospital and Health System M&A Series: Developing a Hospital Transaction Strategy and Process

Hospital transactions involve complex processes and carry significant ramifications for an institution and the communities it serves. This article outlines key steps that a hospital board and management team should take in…more

Charitable Purpose, Competition, FTC, Healthcare, Hospital Mergers

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Physicians Write Letter to FDA Regarding Biosimilar Naming Concerns

On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the…more

Biosimilars, BPCIA, FDA, Generic Drugs, Pharmaceutical

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What Constitutes a Covered Business Method Patent? - Square Inc. v. Protegrity Corp.

Addressing a request for rehearing and to expand the panel, the Patent Trial and Appeal Board (PTAB or Board) found that it did not abuse its discretion in instituting a covered business method (CBM) review and declined to…more

Covered Business Method Patents, Covered Business Method Proceedings, Patent Infringement, Patent Litigation, Patent Trial and Appeal Board

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Shifting Hospice Reimbursement – Moving in the Direction of Aligning Payment with Resource Concentration

The United States Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) published its update to the home health prospective payment system (HHPPS) for fiscal year (FY) 2016 in the August 6,…more

Bundled Payments, CMS, HHS, Home Health Care, Hospice

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The Immigration Accountability Executive Actions: Ramifications for Business

On November 20 and 21, 2014, President Obama announced his plan for executive action on the United States’ immigration problems, known as the immigration accountability executive actions. The actions represent the most…more

Barack Obama, Citizenship, DACA, DAPA, EB-2

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Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission confirmed…more

Africa, Anti-Spam Legislation, Canada, China, Cybersecurity

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New York Proposes Revised Regulations for Health Care Collaborations

Today, New York health regulators proposed revised rules that would allow health care providers to merge or cooperate with one another without being subject to federal or state antitrust scrutiny…more

Antitrust Provisions, Healthcare, Healthcare Providers, Hospital Mergers, Hospitals

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IRS Confirms that Flip Partnership Guidelines Do Not Apply to Solar Projects

The IRS has advised that the flip partnership guidelines under Rev. Proc. 2007-65, 2007-2 C.B. 967, do not apply to solar facilities or other projects claiming the Section 48 investment tax credit (ITC). The statement, made in…more

Capital Contributions, Energy Projects, Investment Tax Credits, IRS, Solar Energy

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CMS Issues Final ACO Rules: Key Legal Implications for Hospital & Health System ACOs

On June 4, 2015, the Centers for Medicare & Medicaid Services (CMS) released a final rule (Final Rule) containing changes to its Medicare Shared Savings Program (MSSP). Some of the changes codify informal guidance that the…more

ACOs, Board of Directors, Choice of Entity, CMS, Compliance

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International News: Focus on Mining and Metals

In This Issue: - Features ..Investors in Africa Benefit from Regional Trading Blocs ..Understanding the COMESA Merger Control Regime ..Protecting Your UK Business Against Departing…more

Africa, Brand, China, Coal, COMESA

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Whistleblowing in China and the United States

The Chinese Government’s wide-ranging bribery and corruption investigation into the pharmaceutical industry takes a new turn every week. Media reports contain numerous incidents of purported whistleblowers making allegations or…more

Bribery, China, Compliance, Corruption, Dodd-Frank

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CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D

In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of physicians…more

CMS, Data-Sharing, Healthcare, Medicare, Medicare Part D

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Post-Alice—Claims Directed to an Abstract Idea Must Have Meaningful Limitations

LinkedIn Corp. v. AVMarkets, Inc. - Addressing patent eligibility in a covered business method (CBM) patent review, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) concluded that the…more

Abstract Ideas, CLS Bank v Alice Corp, Covered Business Method Proceedings, LinkedIn, Patent Litigation

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IP Update, Vol. 16, No. 11, November 2013

Appellate Decision Sets Stage for Next Skirmish In The Apple vs. Samsung Smart Phone Wars - A unanimous panel of the U.S. Court of Appeals for the Federal Circuit has concluded that the district court was within its…more

Apple, Apple v Samsung, Fresenius, Patent Infringement, Patent Litigation

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IRS Extends Implementation of Certain FATCA Provisions, Eliminates 2013 Reporting

On July 12, 2013, the Internal Revenue Service (IRS) issued Notice 2013-43, which extended the implementation of certain provisions of the Foreign Account Tax Compliance Act (FATCA) by six months and eliminated reporting on U.S…more

FATCA, FFI, Foreign Banks, IGAs, IRC

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Should We Hack Back?

“No,” says U.S. Assistant Attorney General Leslie R. Caldwell. At the most recent Cybersecurity Law Institute held at Georgetown University Law Center in late May, the head of the U.S. Department of Justice’s (DOJ) Criminal…more

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

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ISS and Glass Lewis Update Proxy Voting Guidelines for 2015

Institutional Shareholder Services Inc. (ISS) and Glass, Lewis & Co., LLC, issued their respective annual updates to their proxy voting guidelines on November 6, 2014. As revised these guidelines have important implications for…more

Bylaws, Employee Stock Purchase Plans, Equity Compensation, Executive Compensation, Fee-Shifting

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Collective Redundancy Consultation: European Court Judgment is Good News for UK Employers

Background - UK legislation provides that, when a UK employer proposes to make redundant 20 or more employees at one establishment within a period of 90 days or less, the employer is required to collectively consult…more

Advocate General, Appeals, Collective Redundancy Consultations, Employee Rights, Employer Liability Issues

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Focus on Tax Strategies & Developments - November 2014

REIT Spin-Offs: Recent Transactions and IRS Rulings - Several recent corporate spin-offs in the United States have involved real estate investment trusts (REITs). Provided several requirements are satisfied, including…more

Corporate Taxes, FATCA, Income Taxes, Inversion, Mortgages

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Amendments to Virtual Representation Statute Take Effect on January 1, 2015

There is increasing interest among trustees and beneficiaries to resolve disputes and modify trust documents without going to court. For many years, the primary mechanism to accomplish that in Illinois has been the Virtual…more

Beneficiaries, Dependents, Minors, New Legislation, Non-Judicial Settlement Agreements

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No Induced Infringement Where Off-Label Use of a Drug Is Not “Inevitable” - Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp.

Finding that a drug label’s language did not rise to the level of “active encouragement” that would induce doctors to infringe, the U.S. Court of Appeals for the Federal Circuit upheld the district court’s denial of a…more

Appeals, Hatch-Waxman, Induced Infringement, Off-Label Use, Patent Infringement

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Expedited Patent Appeal Pilot Program

On June 15, 2015, the U.S. Patent and Trademark Office (USPTO) announced it was starting an Expedited Patent Appeal Pilot Program effective June 19, 2015. Under the Expedited Patent Appeal Pilot, an appellant can file a petition…more

Appeals, Certifications, Patent Applications, Patents, Request for Continued Examination

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FDA Announces Delay in Enforcing DSCSA Requirements for Dispensers

On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements…more

Drug Manufacturers, DSCSA, Enforcement, FDA, Pharmaceutical Manufacturers

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King v. Burwell Decision Upholds Subsidies in Federal Exchanges

On June 25, 2015, the Supreme Court of the United States ruled in King v. Burwell that the Affordable Care Act (ACA) requires premium tax credits to be made available in states that use a federal exchange. The case challenged an…more

Affordable Care Act, Chevron Deference, Health Insurance, Health Insurance Exchanges, Individual Mandate

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The New York Court of Appeals Considers the Consequences of a Liability Insurer’s Breach of the Duty to Defend

What are the consequences of a liability insurer’s breach of the duty to defend its insured against a potentially covered claim? Recent decisions from the New York Court of Appeals highlight differing views nationwide on…more

Breach of Duty, Commercial General Liability Policies, Duty to Defend, Insureds, Insurers

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Focus on China Compliance - Fall 2014

In This Issue: - Between a Rock and a Hard Place: Navigating Disclosures to U.S. Regulators Within the Framework of China’s State Secrets Law - Internal Investigations in China: Collecting and Reviewing Digital…more

China, Disclosure Requirements, Evidence, FCPA, Internal Controls

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Final Regulations Allow Retirement Plan Payments for Accident, Health and Disability Insurance

On May 9, 2014, the Internal Revenue Service finalized regulations that govern the tax treatment of payments made by retirement plans to pay accident or health insurance premiums. Under the final regulations, accident or health…more

Benefit Plan Sponsors, Defined Contribution Plans, Disability Insurance, Final Rules, Health Insurance

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Focus on Private Equity - April 2015

In This Issue: - The Use of Alternative Credit in Europe - Buying and Selling a Craft Brewery in the United States - Excerpt from The Use of Alternative Credit in Europe: As a result of the reduced…more

Breweries, Equity Financing, EU, Private Equity, Regulatory Standards

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Expert Testimony Not Always a Guarantee for Appellate Review with Deference - Shire Development v. Watson Pharmaceuticals; Teva Pharmaceuticals v. Sandoz

Addressing the impact of expert testimony used during claim construction, the U.S. Court of Appeals for the Federal Circuit in a case remanded by the U.S. Supreme Court, following its January 5, 2015 decision in Teva…more

Appeals, Claim Construction, Clear Error Standard, Expert Testimony, Patent Litigation

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Massachusetts: Proposing to Repeal Tax Credits Might Have Chilling Effect

During the rollout of his fiscal year 2016 budget proposal, Massachusetts Governor Charlie Baker proposed to repeal the state’s film tax credit in 2017. While this tax credit has drawn criticism for its goal of providing public…more

Film Tax Credits, Governor Baker, Repeal, State Budgets, Tax Revenues

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CMS Addresses Current Position on Supervision and Practitioner Qualifications Under ‘Incident-To’ Billing Rules

Among the proposed changes to Medicare regulatory requirements related to billing and coverage of physician services set forth in the 2016 Medicare Physician Fee Schedule Proposed Rule (the Proposed Rule), the Centers for…more

CMS, Healthcare Professionals, Healthcare Providers, Medicaid, Medicare

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Increase in UK Employment Protection Awards - May 2015

The compensation limits on Employment Tribunal awards and certain other amounts payable under UK employment legislation increased as of 6 April 2015. The key changes are set out below…more

Damages, Employment Tribunals, Termination, UK

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Hazardous Waste Recycling Regulations – the Latest Chapter

“A long time ago in a [May 19, 1980 Federal Register] far, far away [or so it seems],” the U.S. Environmental Protection Agency (EPA) declared its authority to regulate all hazardous secondary material, whether discarded or…more

EPA, Hazardous Substances, RCRA, Recycling, Waste Disposal

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IRS Confirms that Flip Partnership Guidelines Do Not Apply to Solar Projects

The IRS has advised that the flip partnership guidelines under Rev. Proc. 2007-65, 2007-2 C.B. 967, do not apply to solar facilities or other projects claiming the Section 48 investment tax credit (ITC). The statement, made in…more

Capital Contributions, Energy Projects, Investment Tax Credits, IRS, Solar Energy

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UK Court of Appeal: “Defaulting Shareholder” Provisions Are Unenforceable Penalties

Talal El Makdessi v Cavendish Square Holdings BV dealt with restrictive covenants in the context of a share sale. The UK Court of Appeal ruling indicates that contractual deterrents should not be used without careful…more

Default, Shareholder Litigation, Shareholders, UK

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Illinois Trust Taxation Deemed Unconstitutional

Ruling creates planning opportunities to minimize income taxes. In Linn v. Department of Revenue, the Illinois Fourth District Appellate Court reviewed the state’s statutory framework for taxing trusts. Linn v…more

Income Taxes, Property Tax, Trusts

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FTC Releases Section 5 Guidelines

On Thursday, August 13, 2015, the Federal Trade Commission (FTC) released a Statement of Enforcement Principles Regarding “Unfair Methods of Competition” Under Section 5 of the FTC Act. The statement was passed by a 4–1 vote,…more

Antitrust Investigations, DOJ, FTC, Rule-of-Reason Analysis, Section 5

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The Saga Continues: CMS Further Delays Enforcement of Medicare Enrollment Requirements for Prescribers of Part D Drugs

The Centers for Medicare & Medicaid Services (CMS) on June 1, 2015, published its “Medicare Part D Prescriber Enrollment Requirement Update” (Update). The Update further delays—until June 1, 2016—enforcement of the regulatory…more

CMS, Medicare, Medicare Part D, Prescription Drug Coverage, Prescription Drugs

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Non-Direct Competitors May Sue Under the Lanham Act, Doctrine of Prudential Standing Eliminated

The Supreme Court of the United States swept away the different standards for Lanham Act prudential standing previously applied by the courts of appeals, and expressly discarded the amorphous concept of prudential standing in…more

Corporate Counsel, False Advertising, Lanham Act, Lexmark, Lexmark v Static Control Components

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China Issues New Guiding Opinions for Public Hospital Reform

Recently, the General Office of the State Council published the Guiding Opinions on Pilot Comprehensive Reform of Urban Public Hospitals, which took effect on 6 May 2015. The Guiding Opinions give directions for the ongoing…more

China, Health Insurance, Healthcare, Hospitals, Prescription Drugs

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European Court of Human Rights Finds That Greater Protections Are Required For The Political Beliefs Of UK Employees

The European Court of Human Rights (ECtHR), in Redfearn v United Kingdom [2012] ECHR 1878, has held that employment law in the United Kingdom does not adequately protect individuals from dismissal as a result of their political…more

EU, Hiring & Firing, Political Expression, Termination

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Treasury Releases Guidance for Contributions of Appreciated Property to Partnerships with Related Foreign Partners

On August 6, 2015, 18 years after U.S. Congress authorized regulations under Internal Revenue Code Section 721(c), the U.S. Department of the Treasury and the Internal Revenue Service (IRS) released Notice 2015-54 announcing…more

Capital Gains, Cost-Sharing, Foreign Corporations, Intangible Property, IRC

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Focus on Private Equity - April 2015

In This Issue: - The Use of Alternative Credit in Europe - Buying and Selling a Craft Brewery in the United States - Excerpt from The Use of Alternative Credit in Europe: As a result of the reduced…more

Breweries, Equity Financing, EU, Private Equity, Regulatory Standards

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ANDA Update - July 2015

Supreme Court Holds Good Faith Belief of Patent Invalidity Is Not a Defense to Induced Infringement - Commil USA, LLC v. Cisco Systems, Inc. (Supr. Ct. May 26, 2015): Pharmaceutical patents commonly include claims…more

ANDA, Cisco v CommilUSA, Generic Drugs, Hatch-Waxman, Induced Infringement

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International News: Focus on International Private Client

In This Issue: Features - ..The UK Response to BEPS and Hybrid Mismatches ..Parental Liability for French Subsidiaries ..The Evolving US-Cuba Trade Landscape ..Amendments to Taiwan Fair Trade…more

BEPS, Cuba, Foreign Investment, Foreign Subsidiaries, France

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The New Balance of Power: What the 114th Congress Means for Business

As the now-lame-duck U.S. Congress convenes for its final legislative session of 2014, the 114th U.S. Congress is gearing up for action. Officeholders on both sides of the aisle are preparing for the shift to Republican control…more

Election Results, Legislative Agendas, Legislative Committees, Political Parties

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Taxpayer Victory Helps Trusts Holding Business and Real Estate Avoid Tax

One of the most vexing tax issues remaining unresolved since the 1986 enactment of the passive loss (PAL) rules is whether business or rental income earned by a trust can be active income and whether business or rental losses…more

Income Taxes, Passive Losses, Property Tax, Rental Income, Rental Property

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Seventh Circuit: Plaintiffs Lacked Standing to Challenge Tax Exemption for Ministerial Rental Allowances

In November 2013, the U.S. District Court for the Western District of Wisconsin declared unconstitutional Section 107(2) of the Internal Revenue Code, which excludes from gross income rental allowances paid to ministers as part…more

Churches, Establishment Clause, Federal Jurisdiction, Freedom From Religion Foundation, IRC

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Inside M&A - Summer 2013

A Closer Look at Leveraged Dividend Recapitalizations - With merger and acquisition activity down over the course of 2012 into 2013, and a weak market for initial public offerings (IPOs), many private equity firms have…more

Collateralized Loan Obligations, Debtors, Dividends, Financing, Leveraged Loans

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Teva Review Standard Controls Lighting Ballast on Remand - Lighting Ballast Control LLC v. Philips Electronics North America Corp.

In yet another post-Teva claim construction case (see discussion of Teva v. Sandoz, Shire Development v. Watson Pharmaceuticals, Kaneka Corp. v. Xiamen Kingdomway Grp. and TomTom, Inc. v. Adolph cases (this edition) the U.S…more

Appeals, Claim Construction, Clear Error Standard, De Novo Standard of Review, Extrinsic Evidence

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IRS Announces Major Changes to its Determination Letter Program for Individually Designed Retirement Plans

On July 21, 2015, the Internal Revenue Service (IRS) issued Announcement 2015-19 (the Announcement), which ends the five year remedial amendment cycles for individually designed plans effective January 1, 2017. For remedial…more

Benefit Plan Sponsors, Comment Period, Defined Benefit Plans, Defined Contribution Plans, Determination Letter

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DOJ Issues Business Review Letter Pertaining to SSO Policy on Standard-Essential Patents and RAND Commitments

On February 2, 2015, the Antitrust Division of the U.S. Department of Justice (DOJ) issued a business review letter stating that it would not challenge the Institute of Electrical and Electronics Engineers, Inc.’s (IEEE’s)…more

DOJ, IEEE, Manufacturers, Market Participants, Patents

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New CMS Proposed Rule Revises Long-Term Care Facility Requirements for Medicare and Medicaid Program Participation

On July 13, 2015, the Centers for Medicare & Medicaid (CMS) issued a long-awaited proposed rule (Proposed Rule) that would revise the requirements that long-term care (LTC) facilities must meet to participate in the Medicare and…more

Affordable Care Act, Binding Arbitration, CMS, Comment Period, Elder Abuse

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Focus on Tax Controversy - Fall 2014

Supreme Court to Hear Tax Injunction Act Case - On August 20, 2013, in Direct Marketing Association v. Brohl, the U.S. Court of Appeals for the Tenth Circuit held that the federal Tax Injunction Act (TIA) prohibited the…more

Certiorari, Direct Marketing Association, Discovery, Electronically Stored Information, Meal and Entertainment Expenditures

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FTC Consent Agreement with Par Petroleum Demonstrates Increased Agency Focus on Competitive Effects

On March 18, 2015, the Federal Trade Commission (FTC) ordered Par Petroleum Corporation to terminate its storage and throughput rights at a key gasoline terminal in Hawaii. This action will settle FTC charges seeking to prevent…more

Antitrust Provisions, Consent Agreements, FTC, Oil & Gas, Refineries

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Good Faith Belief in Invalidity No Defense to Active Inducement

The U.S. Supreme Court (Justice Kennedy writing for the majority) has now eliminated a defense that has been available to parties accused of actively inducing patent infringement under 35 USC § 271(b). The Court held that a…more

Cisco, Cisco v CommilUSA, Good Faith, Honest Belief Defense, Induced Infringement

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Elimination of Rule 84 and Form 18 Could Increase Pleading Standards in Patent Cases

In an order issued in late April of this year, the U.S. Supreme Court, without comment, adopted changes to the Federal Rules of Civil Procedure that were approved in September by the Judicial Conference of the United States. The…more

Federal Rules of Civil Procedure, Patent Litigation, Patents, Pleading Standards, SCOTUS

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Price Optimization in E-Commerce Not Patent Eligible - OIP Technologies, Inc. v. Amazon.com, Inc.

In the wake of the Supreme Court’s decision in Alice addressing patent-eligible subject matter (IP Update, Vol. 17, No. 7), the U.S. Court of Appeals for the Federal Circuit affirmed grant of judgment on the pleadings that a…more

CLS Bank v Alice Corp, Motion to Dismiss, Patent-Eligible Subject Matter, Patents, Pleadings

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King v. Burwell Decision Upholds Subsidies in Federal Exchanges

On June 25, 2015, the Supreme Court of the United States ruled in King v. Burwell that the Affordable Care Act (ACA) requires premium tax credits to be made available in states that use a federal exchange. The case challenged an…more

Affordable Care Act, Chevron Deference, Health Insurance, Health Insurance Exchanges, Individual Mandate

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California’s Harley-Davidson Decision Rides over Nexus Lines

On May 28 2015, The California Court of Appeals issued a decision in Harley-Davidson, Inc. v. Franchise Tax Board, 187 Cal.Rptr.3d 672; and it was ultimately about much more than the validity of an election within California’s…more

Appeals, Combined Reporting, Commerce Clause, Commercial Bankruptcy, Due Process

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New Ukraine-Related Sanctions Imposed on Russian Interests

On July 16, 2014, the Obama Administration responded further to developments in Ukraine by imposing another new round of sanctions on Russian, Ukrainian and Crimean parties. Importantly, for the first time, the United States…more

Foreign Policy, OFAC, Russia, Sanctions, Ukraine

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Inside M&A - Summer 2014

“Commercially Reasonable Efforts” Diligence Obligations in Life Science M&A" - More than 80 percent of all deals in the pharmaceutical, medical device and biotech industries include an earnout structure that provides some…more

Best Efforts Clauses, Biotechnology, Commercially Reasonable Efforts, Good Faith, Life Sciences

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IP Update, Vol. 16, No. 10, October 2013

No Case or Controversy in DJ Against Patentee Who Sued Manufacturer’s Customers: Cisco Systems, Inc. v. Alberta Telecommunications Research Center - In a non-precedential opinion addressing declaratory judgment…more

Cisco, Claim Construction, Copyright, FRAND, Offsets

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FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional Labeling

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and…more

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CMS Proposes Stark Law Amendments, Requests Comments on Whether Stark Law Is Barrier to Health Care Reform

On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law (the Proposed Rule). 80 Fed. Reg. 41,686,…more

CMS, Comment Period, FQHC, Healthcare, Healthcare Providers

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Independent Contractor and Exempt Employee Classification Review Should Include Joint-Employer Status

The U.S. Department of Labor’s (DOL) issuance last week of independent-contractor misclassification guidelines—as well as its recent issuance of proposed changes to the overtime rules—underscores that employers should be…more

Corporate Counsel, DOL, Independent Contractors, Joint Employers, Misclassification

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Focus on Tax Strategies & Developments - June 2015

In This Issue: - Distinguishing Between Captive Insurance and Related Party Derivatives: Chief Counsel Advice Memorandum 201511021 - Achieving Tax-Free ‘Rollover’ Treatment for Certain Shareholders in Acquisition of…more

Captive Insurance Company, Corporate Restructuring, Foreign Currency, IRS, Transfer Taxes

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Failure to Address All Graham Factors Dooms CBM Petition

Travelocity.com L.P. v. Cronos Technologies LLC - Addressing the showing required to institute covered business method (CBM) proceedings based on obviousness, the U.S. Patent and Trademark Office Patent Trial and Appeal…more

Covered Business Method Patents, Graham Factors, Obviousness, Patent Litigation, Patent Trial and Appeal Board

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IP Update, Vol. 16, No. 6, June 2013

Patents / Patent Eligible Subject Matter - Supreme Court to Myriad: Isolated DNA Sequences Are Not Patent-Eligible Subject Matter -- AMP et al. v. Myriad Genetics, Inc.: In a 9–0 decision the Supreme Court…more

Abuse of Discretion, AMP v Myriad, Burden of Proof, Copyright, Damages

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Washington Watch: House GOP Leadership and the ‘Fiscal Cliff’

An analysis of the year-end fiscal negotiations and their consequences. As the United States rapidly approached the “fiscal cliff,” negotiations between President Barack Obama and House Speaker John Boehner (R-OH) faltered,…more

Alternative Minimum Tax, American Taxpayer Relief Act, Capital Gains, Dividends, Estate Tax

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Inside the New York Budget Bill: Department Issues Guidance Regarding Investment Capital Identification Procedures

On July 7, 2015, the New York Department of Taxation and Finance issued guidance (TSB-M-15(4)C, (5)I, Investment Capital Identification Requirements for Article 9-A Taxpayers) on the identification procedures for investment…more

Capital Assets, Capital Gains, Capital Losses, Corporate Taxes, Internal Revenue Code

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Proposed Regulations Require Significant Entrepreneurial Risk for a Service Partner's Income to be a Distributive Share

On July 22, 2015, the U.S. Department of the Treasury and the Internal Revenue Service (IRS) released proposed regulations under Section 707(a)(2)(A) (the proposed regulations) which would treat certain partnership distributions…more

Distribution Rules, Fee Waivers, IRS, Management Fees, Partnerships

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