Health Care and Pharmaceuticals INDUSTRIES

WilmerHale’s lawyers offer exceptional experience assisting health care providers, health care insurers and the companies that supply them with specialized products and services across a broad range of specialties. These specialties include fraud investigations and litigation; data protection and privacy; patent and trademark prosecution and litigation; transactions; antitrust; regulatory, legislative and public policy counseling; and commercial litigation. Our lawyers also include leading health care practitioners in the EU and China.

The health care industry accounts for nearly one-fifth of the US economy. In the EU, health care spending is expected to rise to nearly 15% of GDP by 2030. Our lawyers—who include the former general counsel of one of the largest health insurers in the country and senior in-house lawyers from an array of life sciences companies—know the industry from the inside.  

Experience

With the adoption of the Affordable Care Act, the US health care system—and the legal regime governing it—are undergoing dramatic changes. Major regulatory innovations are also advancing overseas. Our lawyers bring experience serving in senior roles in government and hands-on knowledge of how the government works in advising clients on the many issues affecting health care companies that have a government component. Our group includes individuals who have served in the Justice Department, including in its Antitrust Division, the Federal Trade Commission, the White House and on the staffs of Senators who have been the leading voices on health care policy issues.

Our health care group brings together specialists in many fields of greatest use to companies and organizations in the health care sector:

  • Health Care Investigations/Enforcement Litigation. WilmerHale has been involved in some of the most significant health care-related, criminal and civil investigations and litigation during the last decade. We frequently represent clients in investigations, leveraging the knowledge of our deep bench of former Justice Department officials, including two former Deputy Attorneys General, a former Assistant Attorney General in charge of the Civil Division, a former US Attorney and numerous Assistant US Attorneys.
  • Public Policy and Congressional & Executive Branch Investigations. Operating at the intersection of law, policy and politics, WilmerHale’s lawyers represent clients in high-stakes congressional and executive-branch investigations, help them shape legislation and regulations and guide them through the political and media mazes that often accompany public policy controversies.
  • Transactional and Corporate. WilmerHale’s lawyers are renowned for their work on mergers and acquisitions, IPO’s, private equity deals, strategic alliances and corporate governance matters both domestically and in the EU and China. We provide a one-stop source for solutions to the diverse array of corporate issues facing health care and life-sciences clients.
  • Patent and Trademark Prosecution and Litigation. WilmerHale’s patent litigation practice is second-to-none, garnering numerous national awards for consistently winning headline-grabbing cases. Our patent prosecution team has filed thousands of U.S. and foreign patent applications. And our trademark lawyers are equally adept at registration and litigation.
  • Data Security and Privacy. Our firm offers significant experience navigating the complex waters of data security and privacy laws, including HIPAA, the HITECH Act and FTC medical data breach notification requirements. From advising on domestic and global regulatory issues to litigating nuanced questions of first impression, to shaping compliance regimes, our lawyers provide soup-to-nuts counsel to our clients.
  • Antitrust. Our antitrust and competition lawyers counsel companies on the full spectrum of antitrust issues in jurisdictions across the United States and around the globe. Our deep knowledge of securing merger clearance should put us at the top of the list for any health care company facing acquisition decisions.
  • Commercial Litigation. Our philosophy is simple: Consistent courtroom excellence is essential to client satisfaction in the resolution of high-stakes commercial disputes like the ones we litigate. We have extensive experience litigating a wide variety of complex civil cases, including ERISA matters.
  • EU/Germany. Advising on regulatory, public policy, and legal strategy questions in the German health care arena as well as in the rest of the European Union, our partners offer pharmaceutical companies, producers of medical devices, associations of physicians and other health care clients a full-services approach to tackling questions of public law, privacy, transactional, licensing, and other types of law as well as public policy and legal strategy advice.
  • China. WilmerHale offers companies around the world extensive experience and understanding of the Chinese legal and policy systems and their impact on the health care, pharmaceuticals and medical device industries. We also handle a wide range of acquisitions and other corporate transactions and provide unparalleled insight on market access questions.

Publications & News

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April 4, 2014

Technical and Scientific Experience

Our ability to provide superior legal representation to technology companies is greatly enhanced by the academic and industry experience of our lawyers in a wide variety of technical and scientific fields.    

February 24, 2014

Fourth Circuit Holds cGMP Violations Do Not Create False Claims Under Medicare and Medicaid

In the first appellate decision of its kind, the U.S. Court of Appeals for the Fourth Circuit held on February 21, that because compliance with the Food and Drug Administration’s Current Good Manufacturing Practices (cGMP)  regulations is not a precondition for reimbursement under Medicare and Medicaid, violations of the cGMP regulations by themselves cannot form the basis for False Claims Act claims under those programs.

February 5, 2014

Global Anti-Bribery Year-in-Review: 2013 Developments and Predictions for 2014

The year 2013 witnessed several notable developments in the enforcement of the Foreign Corrupt Practices Act (FCPA). In 'Global Anti-Bribery Year-in-Review: 2013 Developments and Predictions for 2014', WilmerHale Partners Roger M. Witten, Kimberly A. Parker, Jay Holtmeier and Erin G.H. Sloane discuss notable trends and developments in 2013 corporate settlements and individual prosecutions, key FCPA legal developments, notable collateral litigation developments, and significant developments in international anti-corruption law.

January 23, 2014

US Supreme Court Holds That a Patentee Bears the Burden of Persuasion on the Issue of Infringement in a Declaratory Judgment Action

The US Supreme Court unanimously reversed a decision of the US Court of Appeals for the Federal Circuit and held that the patentee bears the burden of persuasion on the issue of patent infringement in a declaratory judgment action brought by a licensee.

January 21, 2014

Federal Circuit Finds Patentees Entitled to Additional Patent Term Adjustment

January 9, 2014

China’s New Anti-Corruption Policies in the Health Care Industry

December 6, 2013

House Passes Patent Litigation Bill

On December 5, 2013, the House of Representatives passed the Innovation Act (H.R. 3309) (the “Act”) by a vote of 325-91. The Act proposes several changes to the patent litigation system such as enhanced pleading requirements, fee shifting, discovery limits, patent ownership disclosures, and stays of customer suits.

September 26, 2013

Restrictions Governing International Trade in Genetic Resources Move Closer to Adoption

The European Parliament has approved a new Regulation to implement the "Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization" (“Nagoya Protocol” or “Protocol”).

September 13, 2013

New Post-Grant Patent Proceedings Exceeding Expectations

September 16 marks the second anniversary of the America Invents Act, which brought about the most significant changes in US patent laws in more than 50 years. One very significant change was the introduction of three new post-grant patent proceedings that permit third parties to challenge the validity of a patent in the US Patent and Trademark Office.

August 30, 2013

NIST Issues Discussion Draft of Preliminary Cybersecurity Framework