McDermott Will & Emery

Supreme Court Asked to Clarify the Reach of U.S. Antitrust Laws to Foreign Conduct

On March 16, 2015, AU Optronics Corporation America Inc. (AU Optronics) and Motorola Mobility LLC separately asked the U.S. Supreme Court to clarify the Foreign Trade Antitrust Improvements Act (FTAIA) and the extent to which…more

Antitrust Provisions, Electronics, FTAIA, Jurisdiction, Manufacturers

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Section 752 Proposed Regulations Regarding Partnership Recourse Liabilities and Rules for Related Persons

On December 13, 2013, the Internal Revenue Service and U.S. Department of the Treasury issued proposed regulations under Section 752 regarding recourse liabilities of a partnership and the special rules for related persons…more

IRS, Partnerships, Proposed Regulation, Risk of Loss, U.S. Treasury

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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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DOL Extends FMLA Spousal Leave Rights to Same-Sex Spouses in All States

On February 23, 2015, the U.S. Department of Labor (DOL) Wage and Hour Division published its final rule regarding the definition of “spouse” under the Family and Medical Leave Act (FMLA). Specifically, the rule recognizes all…more

DOL, DOMA, Employee Rights, Final Rules, FMLA

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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

28 U.S.C. §1782, 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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DOL Extends FMLA Spousal Leave Rights to Same-Sex Spouses in All States

On February 23, 2015, the U.S. Department of Labor (DOL) Wage and Hour Division published its final rule regarding the definition of “spouse” under the Family and Medical Leave Act (FMLA). Specifically, the rule recognizes all…more

DOL, DOMA, Employee Rights, Final Rules, FMLA

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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 Senate Explores “Nuclear Option” to Help Move Legislation

As of the first week of March 2015, several states are well into their legislative session. Committee hearings are underway, and significant legislation has passed both branches of government. In Massachusetts, however, a…more

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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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Petitioners Cannot Respond to Substantive Issue Raised in Preliminary Response - VTech, Inc. v. Spherix Inc.

Addressing whether a petitioner in an inter partes review (IPR) can respond to a patent owner’s preliminary response, the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (PTAB or Board) denied the…more

Inter Partes Review Proceedings, Patents, Prior Art, Supplemental Evidence

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Illinois Retailers Beware: Class Action Complaint Filed Against Grocer for Collecting Illinois Sales Tax on Manufacturers’ Coupons Lacking Specific Language

A class action complaint was filed in federal court last week against New Albertson’s, Inc. the operator of the Jewel-Osco grocery chain, alleging failure to deduct manufacturers’ coupons from the tax base on which sales tax was…more

Class Action, Coupons, Department of Revenue, Grocery Stores, Jewel-Osco

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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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IRS Releases Draft Revised Form 5300 and Instructions

The Internal Revenue Service (IRS) recently released a draft revised Form 5300 and its instructions. Form 5300, the Application for Determination for Employee Benefit Plan, is generally used to request an IRS determination that…more

Employee Benefits, IRS, Retirement, Section 401, Section 501

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In SEP Assertion Cases, Apportionment Trumps Entire Market Rule - Ericsson, Inc. v. D-Link Sys. Inc., et al.

Ericsson, Inc. v. D-Link Sys. Inc., et al. - The U.S. Court of Appeals for the Federal Circuit addressed a spectrum of issues surrounding industry standards for electronic devices that wirelessly access the internet,…more

Appeals, Apportionment, Ericsson, IP License, Patent Litigation

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Deposition of Declarants Is Limited after Routine Discovery

Valeo, Inc. v. Magna Electronics, Inc. - In an Order on Conduct of the Proceedings, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) denied a patent owner’s request to depose a…more

Depositions, Discovery, Inter Partes Review Proceedings, Patent Trial and Appeal Board, Patents

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Cooperation Agreement Between European Union and Switzerland in Competition Matters Enters into Force

The Cooperation Agreement between the European Union and Switzerland in competition matters, which entered into force on 1 December 2014, is the first “second generation” agreement concluded by the European Union with a third…more

Competition Act, Cooperation Agreement, EU, Switzerland

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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 - 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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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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Former Toyoda Gosei Executive Pleads Guilty to Price-Fixing, Bid-Rigging

On January 6, 2015, Makoto Horie of Toyoda Gosei North America pled guilty to the United States Department of Justice (DOJ) for conspiring to fix the prices of automotive hoses sold to U.S. companies. Mr. Horie was sales…more

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Captive Insurance Carve-Out: Illinois SB 1573 Amendment Proposed

Members of the Illinois General Assembly continue to make efforts to ameliorate the impact of Illinois’ new self-procurement tax on captive insurance. On March 10, 2015, Sen. William Haine (D-Alton) filed an amendment to Senate…more

Captive Insurance Company, Insurance Industry, Legislative Agendas, Proposed Amendments

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Combinations of Predictable Elements from the Prior Art Need Not Be Advantageous - Nuvasive, Inc. v. Warsaw Orthopedic, Inc.

Addressing the propriety of combining prior art in an obviousness analysis, U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (“PTAB” or “Board”) determined that a patent for a spinal implant for promoting…more

Medical Devices, Obviousness, Patent Trial and Appeal Board, Patents, Prior Art

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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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Skilled Nursing Facilities: Steps for Reducing FCA Liability

Several government agencies have voiced concerns related to the level of therapy services necessary to care for residents of Skilled Nursing Facilities (SNFs). The level of therapy services indicated for SNF residents affects…more

CMS, False Claims Act, Health Care Providers, Healthcare, OIG

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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 - March 2015

In This Issue: - U.S. International Tax Policy: 10 Questions for 2015 - The New UK Diverted Profits Tax - France Implements Horizontal Tax Consolidation - China’s New General Anti-Avoidance Rules: An…more

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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

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

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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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Eleventh Circuit Clarifies “Willfulness” Standard in Copyright Infringement Actions - Olem Shoe Corp. v. Washington Shoe Corp.

In an unpublished decision, the Court of Appeals for the Eleventh Circuit clarified its standard for willful copyright infringement when it affirmed the district court’s grant of summary judgment finding that the defendants…more

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OCR Issues Final Modifications to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules to Implement the HITECH Act

On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security…more

Business Associates, Covered Entities, Data Breach, Data Protection, Enforcement

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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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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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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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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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Taxpayer Overcomes New Jersey Amnesty Penalty

The Supreme Court of New Jersey recently affirmed a decision that amnesty and late-filing penalties did not apply to the taxpayers in United Parcel Serv. Gen. Servs. Co. v. Dir., Div. of Taxation, No. 072421 (N.J. Dec. 4,…more

Corporate Taxes, Tax Amnesty, UPS

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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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CBM Review Based on New Combinations of Prior Art - eBay Inc., v. Moneycat LTD.

Addressing an alleged abuse of discretion asserted by a patent owner in instituting a covered business method (CBM) patent review, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) concluded it…more

Covered Business Method Patents, eBay, Patents, Prior Art, USPTO

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CMS Finalizes 2015 Home Health Prospective Payment System Rule

The Centers for Medicare & Medicaid Services (CMS) published the annual final rule on the Medicare home health prospective payment system (HH PPS) rates for calendar year (CY) 2015 in the November 6, 2014, Federal Register…more

CMS, Final Rules, Patient Prospective Payment System

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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 Issues Additional Guidance on Beginning of Construction Rules for Renewable Projects

The Internal Revenue Service (IRS) issued Notice 2015-25 (Notice) on March 11, 2015, to provide further guidance on meeting the beginning of construction requirements for wind and other qualified facilities (biomass, geothermal,…more

Construction Project, Energy Projects, Energy Sector, Guidance Update, Investment Tax Credits

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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 Finalizes Proposal to Remove Continuing Medical Education Exclusion from Sunshine Act Regulations

On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations…more

CMS, Continuing Medical Education, Final Rules, Medicare, Pharmaceutical

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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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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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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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Free Fit For Work Service Begins Roll Out

The UK Government’s new, free occupational health service, Fit For Work (FFW) began its roll out on Monday this week. The aim of FFW is to provide assistance to employers and employees and reduce the amount of long term…more

Sick Leave, UK

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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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PTAB Rejects Attempts to Expand the Scope of CBM Review - Par Pharm., Inc. v. Jazz Pharm., Inc.

Addressing for the first time a request for covered business method (CBM) review by a generic drug maker facing an infringement suit under the Hatch-Waxman Act, the U.S. Patent and Trademark Office’s (PTO’s) Patent Trial and…more

Covered Business Method Proceedings, Generic Drugs, Hatch-Waxman, Jazz Pharmaceuticals, Par Pharmaceutical

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USPTO Releases Examples for Interim Examination Guidelines for Determining Patent Eligibility Under 35 U.S.C. § 101

On January 27, 2015, the U.S. Patent & Trademark Office (USPTO) released examples to supplement the 2014 Interim Guidance on Patent Subject Matter Eligibility (the interim guidelines), which were released in December 2014. The…more

Interim Guidance, Patent-Eligible Subject Matter, Patents, Software, USPTO

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FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical…more

Clinical Trials, FDA, HHS, Informed Consent, Medical Research

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U.S. Appeals Courts Issue Conflicting Decisions on Whether ACA Permits Tax Subsidies of Health Care Coverage Purchased Through Federal Exchanges

On July 22, 2014, three-judge panels of the U.S. Courts of Appeals for the District of Columbia and Fourth Circuits issued conflicting decisions regarding whether the Affordable Care Act (ACA) permits federal tax credits for…more

Affordable Care Act, Halbig v Burwell, Healthcare, IRS, King v Burwell

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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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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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Supreme Court: Claim Construction Is Subject to Hybrid Review - Teva Pharmaceuticals USA v. Sandoz, Inc.

In a 7–2 decision penned by Justice Breyer, the Supreme Court of the United States overturned the de novo standard as the sole standard of review issues arising in claim construction. Teva Pharmaceuticals USA v. Sandoz, Inc.,…more

Claim Construction, Clear Error Standard, De Novo Standard of Review, Federal Rules of Civil Procedure, Patent Litigation

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Massachusetts Senate Explores “Nuclear Option” to Help Move Legislation

As of the first week of March 2015, several states are well into their legislative session. Committee hearings are underway, and significant legislation has passed both branches of government. In Massachusetts, however, a…more

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New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services…more

Affordable Care Act, HHS, Hospitals, HRSA, Orphan Drugs

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Free Fit For Work Service Begins Roll Out

The UK Government’s new, free occupational health service, Fit For Work (FFW) began its roll out on Monday this week. The aim of FFW is to provide assistance to employers and employees and reduce the amount of long term…more

Sick Leave, 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 Issues Additional Guidance on Beginning of Construction Rules for Renewable Projects

The Internal Revenue Service (IRS) issued Notice 2015-25 (Notice) on March 11, 2015, to provide further guidance on meeting the beginning of construction requirements for wind and other qualified facilities (biomass, geothermal,…more

Construction Project, Energy Projects, Energy Sector, Guidance Update, Investment Tax Credits

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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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Parking Heater Manufacturer Pleads Guilty to Price-Fixing

On March 12, 2015, the U.S. Department of Justice (DOJ) announced that Espar Inc., pleaded guilty to one count of price-fixing under the Sherman Act in a scheme involving parking heaters for commercial vehicles that ran from…more

Antitrust Investigations, Corporate Criminal Fines, DOJ, Guilty Pleas, Manufacturers

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Sharp Questions Dominate Supreme Court Oral Arguments Regarding the Challenge to the Availability of ACA Premium Tax Credits

On March 4, 2015, the Supreme Court of the United States heard oral arguments in King v. Burwell, the highest profile challenge to the Affordable Care Act (ACA) since the Supreme Court’s 2012 decision to uphold the law. The oral…more

Affordable Care Act, Health Insurance, Health Insurance Exchanges, King v Burwell, Oral Argument

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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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Chinese Government Further Encourages, Regulates Multi-Site Practice by Physicians

The Opinions on Encouragement and Regulation of Multi-Sited Practices of Physicians demonstrate the Chinese government’s continued efforts to develop Chinese physicians’ ability to practise at multiple sites, and will provide…more

China, Healthcare, Healthcare Facilities, Hospitals, Physicians

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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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District Courts Must Follow Georgia-Pacific & Seagate’s Instructions - Aqua Shield v. Inter Pool Cover Team, et al.

Addressing the analysis required to support both damages and willfulness, the U.S. Court of Appeals for the Federal Circuit vacated a district court’s damages calculation and determination regarding willfulness. Aqua Shield v…more

Appeals, Calculation of Damages, Patent Infringement, Patent Litigation, Patents

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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

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

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The Apparently Never-Ending Story of Bard v. W.L. Gore - Bard Peripheral Vascular Inc. and C.R. Bard, Inc. v. W.L. Gore & Associates, Inc.

In a case centered about patent that matured from an application filed 40 years ago, a case that has been pending for 12 years and that just completed its fourth engagement at the appellate level, the U.S. Court of Appeals for…more

Appeals, Medical Devices, Patent Infringement, Patent Litigation, Patents

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White House Budget Proposal Includes Many Retirement-Related Provisions

On February 2, 2015, the White House released its Fiscal Year 2016 Budget, which includes a number of tax code changes targeting retirement savings. If enacted as presented, the proposals would have a significant effect on…more

401k, Federal Budget, IRA, Qualified Retirement Plans, Retirement Plan

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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 Proposes Recognition of Same-Sex Spouses

On December 12, 2014, CMS issued proposed regulations that would add recognition of same-sex spouses to the Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) relevant to patients in hospitals, ambulatory…more

CMS, Health Care Providers, Same-Sex Marriage

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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

Brohl, Certiorari, Direct Marketing Association, Discovery, Electronically Stored Information

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Increasing Antitrust Risk in Non-Reportable Transactions – DOJ Obtains Disgorgement of Profits in Tour Bus Settlement

The U.S. Department of Justice (DOJ) recently reached a settlement with Coach USA Inc. and City Sights LLC, breaking up their joint venture. The DOJ also employed the rarely used remedy of disgorgement to recover $7.5 million…more

Disgorgement, DOJ, Hart-Scott-Rodino Act, Joint Venture, Surface Transportation

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Supreme Court on Evaluation of Claims to Computer-Implemented Inventions under 35 U.S.C. § 101

On June 19, 2014, the Supreme Court of the United States issued its much anticipated decision in Alice Corporation Pty. Ltd. v. CLS Bank International et al., confirming that computer-implemented inventions, such as computer…more

Alice Corporation, Bilski, CLS Bank, CLS Bank v Alice Corp, Mayo v. Prometheus

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Allocation of Copyright Damages for Co-Owners - In re Isbell Records, Inc.

Addressing for the first time the issue of whether a partial owner of a copyright can be awarded infringement damages for his co-owner’s share, the U.S. Court of Appeals for the Fifth Circuit determined that a partial copyright…more

Co-Ownership, Copyright, Copyright Infringement, Damages, Music Industry

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PTAB Excludes Documents Corroborating Publication Date as Hearsay but Admits Librarian Testimony - Toyota Motor Corporation v. American Vehicular Sciences LLC

In a final written decision, the U. S. Patent and Trademark Office Patent (PTO) Trial and Appeal Board (PTAB or Board) granted in part the patent owner’s motion to exclude certain documents purporting to corroborate the…more

Automotive Industry, Inter Partes Review Proceedings, Patent Trial and Appeal Board, Patents, Prior Art

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2015 Notice of Benefit and Payment Parameters

The Centers for Medicare & Medicaid Services (CMS or the agency) kicked off a flurry of springtime regulatory activity for health insurance issuers with publication of the final Notice of Benefit and Payment Parameters for 2015…more

Affordable Care Act, CMS, Employee Benefits, Health Insurance Exchanges, Healthcare

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Inside the New York Budget Bill: Guidance Released Regarding Transitional Compliance and Qualified New York Manufacturers

On March 31, 2014, Governor Andrew Cuomo signed into law a budget bill containing major corporate tax reform. That new law resulted in significant changes for many corporate taxpayers, including a complete repeal of Article 32…more

Andrew Cuomo, Corporate Taxes, State Budgets, Tax Reform

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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, Contingent Payment Clauses, Good Faith

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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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Pressure Points: OCR Enforcement Activity in 2014

During 2014, the Office for Civil Rights (OCR) of the U.S. Department of Health & Human Services initiated six enforcement actions in response to security breaches reported by entities covered by the Health Insurance Portability…more

Business Associates, Covered Entities, Cybersecurity, Data Protection, Enforcement

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Inside M&A - Fall 2014

Managing Compliance Risks in M&A Transactions - Buyers can acquire unintended and potentially very damaging liabilities together with target business or assets. Analyzing the financial situation of a target company,…more

Compliance, DOJ, Due Diligence, FCPA, Integration

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IRS Clarifies Requirements for Establishing Non-Willful Conduct in Offshore Disclosure Cases

Voluntary disclosure programs exist for taxpayers that are not in compliance with their tax and information reporting obligations with respect to foreign bank accounts and assets. The Internal Revenue Service (IRS) recently…more

FBAR, Foreign Financial Accounts, IRS, Offshore Funds, OVDP

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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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NYS Tax Department Reverses Position on Statutory Residence Rule

The New York State Department of Taxation and Finance (the Department) has backed off from an aggressive position that it has been taking in cases involving New York residence issues…more

Income Taxes, Primary Residence, Residency Requirements

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Section 752 Proposed Regulations Regarding Partnership Recourse Liabilities and Rules for Related Persons

On December 13, 2013, the Internal Revenue Service and U.S. Department of the Treasury issued proposed regulations under Section 752 regarding recourse liabilities of a partnership and the special rules for related persons…more

IRS, Partnerships, Proposed Regulation, Risk of Loss, U.S. Treasury

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Louisiana Supreme Court Upholds Bundling Portable Toilet Leases and Cleaning Services, but Not Sure About True Object of Resulting Transactions

If you are ever waiting in line for portable toilet facilities at the St. Patty’s Day Parade and in need of something to think about, consider the property and service you are about to use: Is it the lease of tangible personal…more

Leases, Personal Property, Personal Services, Sales & Use Tax, Supreme Court of Lousiana

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Public Company Priorities for the New Year

Looking ahead to 2013, directors, executives and general counsel of public companies can take some solace from the fact that 2012 was not a year in which a large number of significant new disclosure rules or governance…more

Conflict Mineral Rules, Cybersecurity, Dodd-Frank, FCPA, Proxy Voting Guidelines

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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

CJEU, Copyright Infringement, Injunctions, ISPs, Websites

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Creeping Normality: IRS Releases Final Regulations Under Section 501(r)

In This Issue: - Community Health Needs Assessments (Code Section 501(r)(3)) - Financial Assistance Policies (Code Section 501(r)(4)) - Limitation on Charges (Code Section 501(r)(5)) - Billing and Collection…more

Community Health Systems, Final Rules, Healthcare, Hospitals, IRS

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Proposed Regulations Clarify Definition of “Real Property” for Real Estate Investment Trusts

On May 9, 2014, the Internal Revenue Service and U.S. Department of the Treasury issued proposed regulations (the Proposed Regulations) under Section 856 of the Internal Revenue Code (the Code) to clarify the definition of “real…more

Business Assets, C-Corporation, IRS, Private Letter Rulings, Proposed Regulation

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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 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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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

Abusive Terminations, Breach of Contract, Damages, Economic Downturn, France

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Inside the New York Budget Bill: Proposed Sales Tax Amendments

Governor Andrew Cuomo’s 2015–2016 New York State Executive Budget Bill proposes several significant changes to New York’s sales and use tax statutes. Several of these changes, while touted by Governor Cuomo as “closing certain…more

LLC, Non-Resident Income Taxes, Sales & Use Tax, State Taxes

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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, Medically Assisted Procreation, 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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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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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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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

Abusive Terminations, Breach of Contract, Damages, Economic Downturn, France

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What Constitutes a Covered Business Method Patent? - Groupon Inc. v. Blue Calypso Inc.

The U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB or Board) provided guidance as to what constitutes a patent subject to covered business method (CBM) review and what are “technological inventions”…more

Advertising, America Invents Act, Covered Business Method Patents, Groupon, Mobile Devices

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Old Compound + Known Purpose + Prior Art Concentrations = Obvious -- Galderma Labs L.P., et al v. Tolmar, Inc.

In a split panel decision, the U.S. Court of Appeals for the Federal Circuit reversed a district court concluding that the claims at issue were invalid as obvious because they were directed to the use of an old compound for a…more

Obviousness, Patent Litigation, Patents, Prior Art

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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 Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical…more

Clinical Trials, FDA, HHS, Informed Consent, Medical Research

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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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New IRS Rules on Direct Rollovers of Taxable and Non-Taxable Amounts Require Changes to Defined Contribution Plan Administration By January 1, 2015

The Internal Revenue Service (IRS) recently released guidance allowing participants to allocate the taxable and non-taxable portions of a single distribution from a defined contribution retirement plan into separate accounts. …more

Defined Contribution Plans, Distribution Rules, IRS, Retirement Plan

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PTAB Designates Recent Ruling as Information: Proposed Complaints Do Not Trigger the Time-Bar Under § 315(b) - TRW Automotive US LLC v. Magna Elecs., Inc.

In a ruling recently designated as informative, the U.S. Patent and Trademark Office’s (PTO’s) Patent Trial and Appeal Board (PTAB or Board) rejected a patent owner’s argument that the petitions were time-barred, finding the…more

Amended Complaints, Motion for Leave, Patent Trial and Appeal Board, Patents

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Skilled Nursing Facilities: Steps for Reducing FCA Liability

Several government agencies have voiced concerns related to the level of therapy services necessary to care for residents of Skilled Nursing Facilities (SNFs). The level of therapy services indicated for SNF residents affects…more

CMS, False Claims Act, Health Care Providers, Healthcare, OIG

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Focus on Tax Strategies & Developments - March 2015

In This Issue: - U.S. International Tax Policy: 10 Questions for 2015 - The New UK Diverted Profits Tax - France Implements Horizontal Tax Consolidation - China’s New General Anti-Avoidance Rules: An…more

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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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U.S. Appeals Courts Issue Conflicting Decisions on Whether ACA Permits Tax Subsidies of Health Care Coverage Purchased Through Federal Exchanges

On July 22, 2014, three-judge panels of the U.S. Courts of Appeals for the District of Columbia and Fourth Circuits issued conflicting decisions regarding whether the Affordable Care Act (ACA) permits federal tax credits for…more

Affordable Care Act, Halbig v Burwell, Healthcare, IRS, King v Burwell

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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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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, Contingent Payment Clauses, Good Faith

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Let the Training Begin: MTC Transfer Pricing Audits Draw Near

Deputy Executive Director Greg Matson (a nice guy at heart) announced this week that the Multistate Tax Commission (MTC) has hired its first transfer pricing training consultant and is scheduled to begin training state auditors…more

Arm's Length Principle, Auditors, Audits, Corporate Taxes, Multistate Tax Commission

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Failure to Name All Real Parties in Interest May Cause Termination of a Proceeding After Institution - Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc.

Addressing the issue of identification of all real-parties-in interest in a petition, the U.S. Patent and Trademark Office’s (PTO’s) Patent Trial and Appeal Board (PTAB or Board) vacated a decision to institute inter partes…more

Inter Partes Review Proceedings, Patents, Real Party in Interest, USPTO

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Employers with Group Health Plans: Have You Notified State Regulators of the Breach?

Data security breaches affecting large segments of the U.S. population continue to dominate the news. Over the past few years, there has been considerable confusion among employers with group health plans regarding the extent…more

Breach Notification Rule, Covered Entities, Cybersecurity, Data Breach, Data Breach Plans

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OIG Proposes Rule to Expand Civil Monetary Penalties and Solicit Comments on Penalty for Failure to Report and Return Overpayments

Department of Health and Human Services, Office of Inspector General’s (OIG) proposed rule expands the use of civil monetary penalties and solicits comments on the penalty for failure to report and return overpayments. …more

Civil Monetary Penalty, CMS, Healthcare, HHS, OIG

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FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the…more

Draft Guidance, FDA, Medical Device Accessories, Medical Devices

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Domicile Election for Non-UK Domiciled Spouses and Civil Partners

Non-UK domiciled individuals who have a UK domiciled spouse or civil partner now have the option to elect to be treated as domiciled in the United Kingdom for inheritance tax (IHT) purposes. This will enable them to receive…more

Domestic Partnership, Domicile, EU, Transfer of Assets

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Takeover Panel Takes a Wider Aim

From 30 September 2013, all AIM-listed companies registered in the United Kingdom, Channel Islands or the Isle of Man (relevant territories) will be subject to the United Kingdom’s Takeover Code. There are several implications…more

Takeover Code, UK

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Sixth Circuit Rejects Claim that Disgorgement of Profits Is Appropriate Remedy in ERISA Benefit Denial Action

On March 5, 2015, the U.S. Court of Appeals for the Sixth Circuit, sitting en banc in the matter of Rochow v. Life Insurance Company of North America, 2015 WL 925794 (6th Cir. Mar. 5, 2015), reversed the finding of a prior Sixth…more

Breach of Duty, Denial of Benefits, Disability Benefits, Disgorgement, Equitable Relief

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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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Claim Preclusion Bars Second Lawsuit on Reexamined Claims Previously Held Invalid

Senju Pharmaceutical Co., Ltd. v. Apotex Inc. - Addressing whether claim preclusion bars a second suit asserting reexamined claims against a defendant who was victorious on the merits on the original claims in a first…more

Claim Preclusion, Patent Infringement, Patent Litigation, Patents

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Tax Court Extends Implied Waiver of Privilege to Taxpayers’ State of Mind Penalty Defense

The U.S. Tax Court concludes in AD Investment 2000 Fund LLC v. Commissioner that a taxpayer’s assertion of a state of mind penalty defense waives the attorney-client privilege with respect to tax opinions provided to the…more

Attorney-Client Privilege, Privilege Waivers, Tax Court

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The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for…more

Clinical Trials, EEA, EU, International Harmonization, New Regulations

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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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Supreme Court: State Agencies Controlled by Active Market Participants Must Have Active State Supervision to Qualify for Antitrust Immunity

In a 6–3 decision issued February 25, 2015, the Supreme Court of the United States held in North Carolina State Board of Dental Examiners v. Federal Trade Commission that if active market participants control an entity—even a…more

Antitrust Litigation, Dentists, FTC, Immunity, Licensing Rules

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China to Implement New Personal Data Protection Rules

Effective March 15, 2015, China’s State Administration for Industry and Commerce (SAIC) will implement the new Measures for Penalties for Infringing upon the Rights and Interests of Consumers (Measures). The Measures clarify…more

China, Corporate Counsel, Data Collection, Data Protection, Personally Identifiable Information

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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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