McDermott Will & Emery

General Court of the EU Upholds Cartel Fines of €131 Million Imposed on Toshiba and Mitsubishi Electric, Dismisses Arguments Based on Principle of Equal Treatment

By two judgments of January 19, 2015 (Case T-404/12 Toshiba v. Commission and Case T-409/12 Mitsubishi Electric v. Commission), the General Court of the European Union (GCEU) upheld the fines of €131 million imposed by the…more

Anti-Competitive, Cartels, EU, European Commission, European Court of Justice (ECJ)

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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 Industry, State Taxes, Tax Court

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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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IRS Guidance on Employee Benefits Implications of Supreme Court Obergefell Decision on Same-Sex Marriage

The Internal Revenue Service (IRS) recently issued Notice 2015-86, which provides some additional clarification, in the form of questions and answers, on the treatment of same-sex spouses under tax-qualified retirement plans and…more

Cafeteria Plans, DOMA, Employee Benefits, IRS, Obergefell v. Hodges

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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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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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Further Guidance on the ACA’s Cadillac Tax

The Affordable Care Act (ACA) added Code Section 4980I to the Internal Revenue Code. Effective for tax years beginning on or after January 1, 2018, an excise tax of 40 percent will be imposed on the cost of employer-sponsored…more

Affordable Care Act, Cadillac Tax, Comment Period, Employer Group Health Plans, Excise Tax

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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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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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International News: Focus on Private Equity

Our Focus on Private Equity provides a global perspective on some of the challenges being faced by PE firms and how these can be successfully addressed. It also examines some of the many opportunities available, e.g., by taking…more

Abuse of Dominance, China, Corruption, Data Privacy, Data Protection

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Illinois Appellate Court Upholds Finding of Consumer Fraud Act Violation in Sales Tax Overcollection Case

The Illinois Appellate Court recently affirmed a finding for a plaintiff individual, upholding the circuit court’s conclusion that defendant Sears, Roebuck and Co. (Sears) violated the Consumer Fraud and Deceptive Business…more

Appeals, Attorney's Fees, Consumer Fraud, Inadmissible Evidence, Misrepresentation

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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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Farewell ‘Safe Harbor,’ Hello ‘Privacy Shield’: Europe and U.S. Agree on New Rules for Transatlantic Data Transfer

After intense negotiations, and after the official deadline had passed on Sunday, 31 January 2016, the United States and the European Union have finally agreed on a new set of rules—the “EU-U.S. Privacy Shield”—for data…more

EU, EU-US Privacy Shield, European Commission, European Court of Justice (ECJ), FTC

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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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Farewell ‘Safe Harbor,’ Hello ‘Privacy Shield’: Europe and U.S. Agree on New Rules for Transatlantic Data Transfer

After intense negotiations, and after the official deadline had passed on Sunday, 31 January 2016, the United States and the European Union have finally agreed on a new set of rules—the “EU-U.S. Privacy Shield”—for data…more

EU, EU-US Privacy Shield, European Commission, European Court of Justice (ECJ), FTC

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IRS Announces Additional Changes in Determination Letter Program

The Internal Revenue Service (the IRS) recently issued Notice 2016-03 (the Notice) addressing three topics and expanding on its earlier announcement of major changes in the determination letter program for individually designed…more

Defined Contribution Plans, Determination Letter, Internal Revenue Code (IRC), IRS, Pre-approval

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International News: Focus on Private Equity

Our Focus on Private Equity provides a global perspective on some of the challenges being faced by PE firms and how these can be successfully addressed. It also examines some of the many opportunities available, e.g., by taking…more

Abuse of Dominance, China, Corruption, Data Privacy, Data Protection

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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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DOL Clarifies Fiduciary Duties for Defined Contribution Plan Sponsors Offering Annuity Contracts

The availability of annuity options under defined contribution plans has increased in recent years due to the shift from defined benefit to defined contribution plans. Fiduciaries, however, are often concerned with potential…more

Benefit Plan Sponsors, Breach of Duty, Defined Contribution Plans, DOL, Duty of Prudence

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Repeated Disparagement of the Prior Art in the Specification Can Operate as a Clear and Unmistakable Disavowal of Claim Scope - Openwave Systems, Inc., NKA Unwired Planet, Inc. v. Apple Inc. et al.

Addressing issues of claim construction, the United States Court of Appeals for the Federal Circuit affirmed the district court’s narrow construction based on a disclaimer in the specification. Openwave Systems, Inc., NKA…more

Apple, Claim Construction, Disclaimers, ITC, Patent Litigation

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Patent Owner Should Have Left “Good Enough” Alone - Belden Inc. v. Berk-Tek LLC

Addressing issues of obviousness and procedural issues related to the use of declarations, the U.S. Court of Appeals for the Federal Circuit affirmed in part and reversed in part a decision by the Patent Trial and Appeal Board…more

Appeals, Expert Testimony, Inter Partes Review Proceedings, Motion to Exclude, 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, EEA, EU, European Commission, European Court of Justice (ECJ)

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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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No Second Life for Fetal Test - Ariosa Diagnostics, Inc., et al. v. Sequenom, Inc., et al.

By a poll of active justices, the U.S. Court of Appeals for the Federal Circuit denied a petition for an en banc rehearing of Ariosa Diagnostics, Inc., et al. v. Sequenom, Inc. et al. and issued two concurrences and one dissent…more

Abstract Ideas, CLS Bank v Alice Corp, En Banc Review, Mayo v. Prometheus, 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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Thirty Years’ Use of Mark Is Not Enough to Prove Acquired Distinctiveness if Evidence Is Insufficient - In re Louisiana Fish Fry Products, Ltd.

Addressing the issue of distinctiveness, the Federal Circuit affirmed the Trademark Trial and Appeal Board’s (TTAB) decision to deny registration of a plaintiff’s mark due to the dearth of evidence supporting the plaintiff’s…more

Corporate Counsel, De Novo Standard of Review, Disclaimers, Evidence, Generic

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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, Marvel Comics, Patent Royalties, Patents

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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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Focus on Tax Strategies & Developments - January 2016

Protecting Americans from Tax Hikes Act of 2015—the Year-End Legislation f/k/a Extenders - Just in time for Christmas, Congress passed, with bipartisan support, and the President signed, the “Protecting Americans from Tax…more

Audits, Bipartisan Budget, FIRPTA, Holding Companies, International Tax Issues

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French Class Action Law Has Less Impact Than Expected

Since the entry into force on 1 October 2014 of the provisions of the “Hamon” law of 17 March 2014, which introduced class actions into French law in relation to consumer and competition law matters, only six class actions have…more

Anti-Competitive, Class Action, Competition, France

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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 Pennsylvania Attorney General Challenge Health System Combination

The Federal Trade Commission (FTC) and Pennsylvania Attorney General (AG) have challenged the proposed combination of The Penn State Hershey Medical Center (Hershey) and PinnacleHealth System (Pinnacle) in Harrisburg,…more

Administrative Proceedings, Advance Pricing Agreements, Anti-Competitive, Attorney Generals, FTC

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Federal Circuit: Disparagement Proscription of § 2(a) of the Lanham Act Unconstitutional

In the last several decades, the disparagement provision of § 2(a) of the Lanham Act has become a more frequent basis for rejection or cancellation of trademarks by the United States Patent and Trademark Office (USPTO) and the…more

Disparagement, En Banc Review, First Amendment, Lanham Act, Redskins

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HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and…more

Clinical Trials, Comment Period, Data Security, Exemptions, HHS

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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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International News: Focus on Tax - Issue 3, 2015

The breadth of the articles contained in our Focus on Tax this issue demonstrates the perennial importance of this topic to global businesses and international high net worth individuals. We examine topics ranging from…more

Anti-Bribery, China, Competition Appeal Tribunal, Double Taxation, EU

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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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CMS Finalizes Prior Authorization Program for Certain DMEPOS Items

On December 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published its final rule establishing a prior authorization program for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)…more

CMS, DMEPOS, Durable Medical Equipment, Final Rules, Medicare

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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 Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for managing…more

Cybersecurity, Draft Guidance, FDA, Health Care Providers, Health Information Technologies

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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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Massachusetts Department of Revenue Introduces Pilot Voluntary Disclosure Program

The Massachusetts Department of Revenue (the Department) released a draft administrative procedure introducing a pilot Voluntary Disclosure Program (the Program) for the settlement of uncertain tax issues for business taxpayers…more

Business Taxes, Department of Revenue, Publicly-Traded Companies, Settlement Offer, Voluntary Disclosure

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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 Industry

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Disclaimed Claims May Be Considered When Determining Eligibility for CBM Review - Compass Bank et al. v. Maxim Integrated Products, Inc.

Addressing the issue of whether disclaimed subject matter may be considered in determining if a patent is eligible for a covered business method (CBM) review, the Patent Trial and Appeal Board (PTAB or Board) found that a…more

America Invents Act, Broadest Reasonable Interpretation Standard, Claim Construction, Covered Business Method Proceedings, Patent Expiration

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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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Corporate Acquisitions and Employment Verification Issues

Under the Immigration Reform and Control Act of 1986 (IRCA), all employers are required to complete an Employment Eligibility Verification Form I-9 on the first day of employment for all hired employees. While most employers…more

Due Diligence, Hiring & Firing, I-9, ICE, IRCA

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California Supreme Court Denies BOE Petition for Review in Lucent Technologies

Last week, the California Supreme Court denied the State Board of Equalization’s (BOE’s) petition for review in Lucent Technologies, Inc. v. State Bd. of Equalization, No. S230657 (petition for review denied Jan. 20, 2016). This…more

AT&T, CA Supreme Court, Petition for Review, Sales Tax, State Tax Equalization Boards

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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, Health Care Providers, Healthcare, Hospital Mergers, Hospitals

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International News: Focus on Tax - Issue 3, 2015

The breadth of the articles contained in our Focus on Tax this issue demonstrates the perennial importance of this topic to global businesses and international high net worth individuals. We examine topics ranging from…more

Anti-Bribery, China, Competition Appeal Tribunal, Double Taxation, EU

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What Must Be Done for Wind and Solar Projects to Have “Begun Construction” under the New PTC and ITC?

With the recent extension of the federal income tax credits available for renewable energy projects, practitioners and industry participants have raised questions as to how the “begun construction” rules will apply under these…more

Begun Construction Test, Investment Tax Credits, IRS, Production Tax Credit, Renewable Energy Incentives

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CMS and OIG Finalize Waivers of Fraud and Abuse Laws Applicable to Medicare ACOs

On October 29, 2015, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) published a final rule regarding the waiver of several federal health care fraud and abuse laws with respect to…more

ACOs, CMS, Final Rules, Fraud and Abuse, Medicare Shared Savings Program

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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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HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and…more

Clinical Trials, Comment Period, Data Security, Exemptions, HHS

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No Review of PTAB Determination to Not Institute an IPR, Again - Achates Reference Publishing, Inc. v. Apple, Inc.

Addressing a decision by the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) to not institute inter partes review IPR proceedings, the U.S. Court of Appeals for the Federal Circuit concluded that…more

Apple, Covered Business Method Patents, Cuozzo Speed Technologies, Indemnification Clauses, Inter Partes Review Proceedings

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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, Internal Revenue Code (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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2016 Proxy Season Checklist – What You Need to Know

As we roll into a new year and a new public company reporting season, public companies should be aware of a number of rule changes and rulemakings, Securities and Exchange Commission (SEC) staff guidance, disclosure trends and…more

Corporate Governance, Cybersecurity, Disclosure Requirements, Dodd-Frank, Executive Compensation

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UK Employment Law Forthcoming Attractions in 2016

January - DATA PROTECTION: NEW EUROPEAN REGULATION - After four years of negotiation and lobbying, the new European General Data Protection Regulation has now been finalised. The Regulation will govern the…more

Collective Redundancy Consultations, Financial Conduct Authority (FCA), Gender-Based Pay Discrimination, General Data Protection Regulation (GDPR), Holiday Pay

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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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Propriety of a Certificate of Correction Requires Assessment of the Teachings of the Specification as a Whole - Cubist Pharms., Inc. v. Hospira, Inc.

In affirming that a certificate of correction may properly be used to correct a later-discovered error in a chemical diagram, the U.S. Court of Appeals for the Federal Circuit looked to the teachings of the specification as a…more

Patent Litigation, Patents, Pharmaceutical Patents, USPTO

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Special Circumstances Justify USPTO Release of Confidential Information About Pending Patent Applications - Hyatt v. Lee

The U.S. Patent and Trademark Office (USPTO) can release confidential information about pending patent applications under special circumstances the U.S. Court of Appeals for the Federal Circuit decided. Hyatt v. Lee, Case No…more

Administrative Procedure Act, Confidential Information, Patent Applications, Patent Litigation, Patents

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FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft guidance…more

Biologics, Biosimilars, Comment Period, Draft Guidance, Drug Safety

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2016 Proxy Season Checklist – What You Need to Know

As we roll into a new year and a new public company reporting season, public companies should be aware of a number of rule changes and rulemakings, Securities and Exchange Commission (SEC) staff guidance, disclosure trends and…more

Corporate Governance, Cybersecurity, Disclosure Requirements, Dodd-Frank, Executive Compensation

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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, Insurance Industry, Insureds

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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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2016 Proxy Season Checklist – What You Need to Know

As we roll into a new year and a new public company reporting season, public companies should be aware of a number of rule changes and rulemakings, Securities and Exchange Commission (SEC) staff guidance, disclosure trends and…more

Corporate Governance, Cybersecurity, Disclosure Requirements, Dodd-Frank, Executive Compensation

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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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MedPAC Votes to Recommend Changes to 340B Drug Payment Under Medicare Part B

For most of the past year, the Medicare Payment Advisory Commission (MedPAC) has been examining Medicare Part B payments to hospitals that participate in the 340B drug purchasing discount program in an effort to better align…more

Drug Pricing, Hospitals, Medicare Part B, MedPAC, Prescription Drugs

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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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What Must Be Done for Wind and Solar Projects to Have “Begun Construction” under the New PTC and ITC?

With the recent extension of the federal income tax credits available for renewable energy projects, practitioners and industry participants have raised questions as to how the “begun construction” rules will apply under these…more

Begun Construction Test, Investment Tax Credits, IRS, Production Tax Credit, Renewable Energy Incentives

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Wrong Defendant, Wrong Court: Plaintiff Wrongly Targets Government Contractors Instead of U.S. Government - Astornet Technologies Inc., v. BAE Systems, Inc. et al.

In a case addressing whether a patent holder can sue government contractors in district court, the U.S. Court of Appeals for the Federal Circuit upheld the dismissal of Astornet’s claims against three government contractors that…more

Direct Infringement, Exclusive Remedy, Federal Contractors, Indirect Infringement, Motion to Dismiss

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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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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 Released the Latest Classification Catalogue of Telecommunications Services (2015 Revision)

On December 28, 2015, the Ministry of Industry and Information Technology of China (the MIIT) released the newly revised Classification Catalogue of Telecommunications Services (2015 Catalogue) and the new Catalogue is due to…more

China, Cloud Computing, Digital Service Providers, Licensing Rules, Mobile Devices

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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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Focus on Tax Strategies & Developments - October 2015

Regulatory Developments Under § 367 Affecting Transfers of Appreciated Property to Foreign Corporations - Introduction: On September 14, the U.S. Department of the Treasury (Treasury) and the Internal Revenue Service…more

Administrative Procedure Act, Amended Regulation, BEPS, Clawbacks, Controlled Foreign Corporations

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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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There Is More than One Way to Slice the Apportionment Analysis - Commonwealth Scientific and Industrial Research Organisation v. Cisco Systems, Inc.

Addressing the application of the smallest salable patent-practicing unit analysis, as well as the impact of a patent’s standards essential status on apportionment and the relevance of prior licenses between the parties, the…more

Apportionment, Cisco, Damages, License Agreements, Patent Litigation

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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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National Transportation Safety Board Targets Impaired Driving

Industry professionals should remain aware of trends in policy and technology that may lead to changes in our nation’s laws to combat drunk driving. On January 13, 2016, National Transportation Safety Board (NTSB) Chairman…more

Drunk Driving, NHTSA, NTSB, Public Safety

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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, Internal Revenue Code (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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PTAB Denies Institution Where Claim Indefiniteness Precludes Application of Prior Art to the Claims

The Patent Trial and Appeal Board (PTAB or Board) denied institution of inter partes review (IPR) after determining that the challenged claims were indefinite and that therefore the Board could not apply the prior art to them…more

Claim Construction, Honda, Indefiniteness, Inter Partes Review Proceedings, Patent Litigation

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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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CMS Finalizes Controversial Changes to "2-Midnight Rule" for Inpatient Stays

On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released its final rule updating the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for Calendar…more

Ambulatory Surgery Centers, CMS, Final Rules, Hospitals, OPPS

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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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Notification Threshold Under the Hart-Scott-Rodino Act Increased to $78.2 Million

Notification Threshold Adjustments - Pursuant to the amendments passed by Congress in 2000, the FTC announced revised thresholds for HSR pre-merger notifications on January 21, 2016. These increased thresholds will become…more

FTC, Hart-Scott-Rodino Act, Mergers, The Clayton Act, Threshold Requirements

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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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What Is the Printed Matter Doctrine? - In re DiStefano

The U.S. Court of Appeals to the Federal Circuit addressed the obscure “printed matter doctrine,” concluding that a claim limitation should be considered as printed matter only if the claim pertains exclusively to the content of…more

Anticipation, Patent Invalidity, Patent Litigation, Patent Trial and Appeal Board, Printed Publications

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It Ends Not with a Bang but a Whimper - Commil USA, LLC v. Cisco Systems, Inc.

The patent case between Commil and Cisco, a case that made new law at the Supreme Court on the issue of the intent requirement in cases of induced infringement allegations, came to an end with a whimper on remand back to the…more

Cisco, Cisco v CommilUSA, Claim Construction, Determination on Remand, Direct Infringement

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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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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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New Legislation Extends Future Form 5500 and 990 Deadlines, Affects Veterans Health Benefits and Extends Excess Pension Asset Transfer Rules

On July 31, 2015, President Obama signed the Surface Transportation and Veterans Health Care Choice Improvement Act of 2015, temporarily extending the Highway Trust Fund to provide continued funding for federal transportation…more

Affordable Care Act, Barack Obama, Defined Benefit Plans, Employee Benefits, Employer Mandates

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CMS Finalizes Stark Law Amendments

On November 16, 2015, the Centers for Medicare and Medicaid Services (CMS) published the 2016 Medicare Physician Fee Schedule final rule with comment period in the Federal Register at 80 Fed. Reg. 70,886, which includes a final…more

Amended Regulation, CMS, Exceptions, Physician Compensation Arrangements, Physician-Owned Hospitals

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Illinois Supreme Court “Upgrades” Willful Misconduct Requirements in Unemployment Cases

The longstanding statutory definition of “willful misconduct” that would disqualify an unemployment insurance claimant has been “the deliberate and willful violation of a reasonable rule or policy of the employing unit,…more

Appellate Courts, Employer Liability Issues, IL Supreme Court, Termination, Unemployment

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Focus on Tax Controversy - December 2015

IRS Updates Administrative Appeals Process for Cases Docketed in Tax Court - In Notice 2015-72, the Internal Revenue Service (IRS) provided a proposed revenue procedure to update Rev. Proc. 87-24, 1987-1 C.B. 720, which…more

Administrative Appeals, Attorney-Client Privilege, Estate Tax, Good Faith, Income 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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PTAB Denies Institution Where Claim Indefiniteness Precludes Application of Prior Art to the Claims

The Patent Trial and Appeal Board (PTAB or Board) denied institution of inter partes review (IPR) after determining that the challenged claims were indefinite and that therefore the Board could not apply the prior art to them…more

Claim Construction, Honda, Indefiniteness, Inter Partes Review Proceedings, Patent Litigation

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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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NYS Tax Department Relaxes Investment Income Identification Rules

The New York State Department of Taxation and Finance has announced that it would extend the time for certain taxpayers to identify stocks as being held for investment so that income from those stocks would be tax-exempt [TSB…more

Corporate Taxes, Internal Revenue Code (IRC), Investment Funds, Net Investment Income

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Treasury Finalizes Regulations on the Varying Interests Rule Under Section 706

On August 3, 2015, the U.S. Department of Treasury (Treasury) and the Internal Revenue Service (IRS) issued final regulations under Section 706(d), providing rules for determining the partners’ distributive shares of partnership…more

Distribution Rules, Final Rules, Internal Revenue Code (IRC), IRS, New Regulations

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Illinois Appellate Court Upholds Finding of Consumer Fraud Act Violation in Sales Tax Overcollection Case

The Illinois Appellate Court recently affirmed a finding for a plaintiff individual, upholding the circuit court’s conclusion that defendant Sears, Roebuck and Co. (Sears) violated the Consumer Fraud and Deceptive Business…more

Appeals, Attorney's Fees, Consumer Fraud, Inadmissible Evidence, Misrepresentation

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Court of Justice of the European Union Holds that ISPs May Be Ordered to Block Customer Access to Websites Infringing Copyright

UPC Telekabel Wien GmbH v Constantin Film Verleih GmbH - On a reference from the Supreme Court of Austria, the Court of Justice of the European Union (CJEU) has held that ISPs may be ordered to block their customers’…more

Copyright Infringement, European Court of Justice (ECJ), Injunctions, Internet Service Providers (ISPs), Websites

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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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FTC and Pennsylvania Attorney General Challenge Health System Combination

The Federal Trade Commission (FTC) and Pennsylvania Attorney General (AG) have challenged the proposed combination of The Penn State Hershey Medical Center (Hershey) and PinnacleHealth System (Pinnacle) in Harrisburg,…more

Administrative Proceedings, Advance Pricing Agreements, Anti-Competitive, Attorney Generals, FTC

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Economic Justification in the Assessment of Abusive Terminations of Longstanding Commercial Relationships

International companies with operations in France, or those that conduct regular business with French commercial partners, should be aware that their longtime French commercial partners could be entitled to claim compensation…more

Breach of Contract, Damages, Economic Downturn, France, Layoffs

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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 Industry, State Taxes, Tax Court

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Recent Court Cases Highlight the Difficult Questions Related to Medically Assisted Procreation in France

Law No.2013-404 dated May 17, 2013, (the Law) allowed same-sex couples to get married and to adopt children, through either the mutual adoption of a child or the adoption of the same-sex spouse’s biological or adopted child…more

EU, Same-Sex Marriage

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IP Update, Vol. 16, No. 2, -- February 2013

In This Issue: Patents - Supreme Court: State Court Has Jurisdiction over a Legal Malpractice Claim; Nothing Non-Obvious About Applying Pre-Existing Technology to the Internet; The Federal Circuit Is Not the Place…more

Adverse Inference Instructions, America Invents Act, Assignor Estoppel, Attorney Malpractice, Commercial Bankruptcy

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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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CFTC Finalizes Exception for Swaps with Utility Special Entities

The Commodity Futures Trading Commission (CFTC) last week released a final rule excluding certain electricity and natural gas swaps with governmental agencies and municipalities from the lower de minimis threshold for swaps with…more

CFTC, Electricity, Final Rules, Municipalities, Natural Gas

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TTB Issues Ruling on Formulas for Beer

On June 5, 2014 the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued TTB Ruling 2014-4, exempting from TTB’s formula and pre-import approval (PIA) submission requirements beer made with dozens ingredients as well as beer…more

Breweries, TTB, Wine & Alcohol

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Italian Parliament Approves Final Rules on Changes to Feed-in Tariffs for Photovoltaic Plants

On 7 August 2014, the Italian Parliament approved the conversion into law of Law Decree no. 91 /2014 (the Decree) regarding, amongst other matters, “urgent measures … for the limitation of costs applied to electricity prices”…more

Energy, EU, Feed-in-Tariffs, Solar Energy, Tariffs

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Connecticut Limits New Tax Haven Law

In June of 2015, Connecticut passed legislation that implements combined reporting for tax years beginning on or after January 1, 2016. Part of the new regime, which is codified by Conn. Gen. Stat. P.A. 15-5, § 144 (2015),…more

Amended Legislation, Combined Reporting, Jurisdiction, Multistate Tax Commission, Tax Haven

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With No Federal Law in Sight, States Continue to Refine Their Own Data Privacy Laws

With no Congressional consensus to adopt a federal data privacy and breach notification statute, states are updating and refining their already-existing laws to enact more stringent requirements for companies. Two states…more

Breach Notification Rule, Credit Monitoring, Cybersecurity, Data Breach, Data Breach Plans

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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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Settle with All Stakeholders Before Trying to Terminate an IPR - Qualcomm Inc. v. Bandspeed, Inc.

In a case where the patent owner settled out of an IPR proceeding with the petitioners but not with a party seeking joinder, the Patent Trial and Appeal Board (PTAB or Board) instituted inter partes review of all the challenged…more

Inter Partes Review Proceedings, Joinder, Patent Ownership, Patent Trial and Appeal Board, Patents

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ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal…more

ANDA, Anti-Competitive, Antibiotics, Antitrust Conspiracies, Antitrust Injuries

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IP Update, Vol. 15, No. 12, December 2012

In This Issue: Patents - ..Federal Circuit Rules It’s Own Standards Apply When Considering Preliminary Injunctions ..Preliminary Testing of Medical Devices in Animals Enables Their Use in…more

America Invents Act, Claim Construction, Competition, Copyright, Infringement

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FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for managing…more

Cybersecurity, Draft Guidance, FDA, Health Care Providers, Health Information Technologies

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Rights of Job Applicants in Germany

The German Federal Labor Court made a very clear ruling regarding job applicants in Germany who are not offered the position for which such applicants applied. In the Federal Labor Court’s view, a rejected applicant has no…more

EU, Job Applicants

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IRS Announces Reduced VCP Compliance Fees

The Internal Revenue Service (IRS) has announced new general compliance fees for voluntary correction program (VCP) submissions under the Employee Plans Compliance Resolution System (EPCRS), effective February 1, 2016. EPCRS is…more

EPCRS, IRS, Retirement Plan, Revenue Procedure 2016-8, Voluntary Correction Program

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Inter Partes Review Is Not for Pending Claims - Ford Motor Co. v. Signal IP, Inc.

Addressing the issue of the utility of consolidating an inter partes review (IPR) with an ex parte reexamination proceeding, the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (PTAB or Board) denied a…more

Case Consolidation, Ex Partes Reexamination, Ford Motor, Inter Partes Review Proceedings, Patent Trial and Appeal Board