(WASHINGTON, D.C.) July 27, 2007 – Heller Ehrman earned another victory today for Merck KGaA, when the Court of Appeals for the Federal Circuit ruled in favor of the company in a major patent infringement case against Integra LifeSciences I, Ltd.  In June 2005, Heller Ehrman successfully represented German-based Merck KGaA before the U.S. Supreme Court, which handed down a unanimous decision in Merck KGaA v. Integra Lifesciences I, Ltd. The Supreme Court ruled that the so-called “FDA exemption” provides a broad safe harbor from patent infringement claims for pre-clinical research and development work on innovative investigational drug products.  The case was then remanded to the Federal Circuit, which issued its ruling today.

On behalf of Merck KGaA, Heller Ehrman’s position before the Federal Circuit was that, based on the Supreme Court’s decision, Merck KGaA is entitled to judgment as a matter of law if it was reasonable for Merck KGaA to believe (1) that the compounds being tested could stunt the growth of blood vessels; and (2) that every accused experiment would yield information relevant to efficacy, mechanism of action, pharmacokinetics, or pharmacology.  The Federal Circuit agreed, and held that Merck KGaA met the two-part test.  Judge Rader dissented in part, based on the view that some of Merck's patents were “research tools,” which should be subject to a different test.

The initial lawsuit arose in July 1996 from animal experiments on a drug candidate that appeared to kill cancer tumors.  The tests were conducted by Merck KGaA, in collaboration with The Scripps Research Institute, to generate data needed for FDA approval.  Integra LifeSciences sued Merck KGaA in the U.S. District Court for the Southern District of California, alleging that Merck KGaA was infringing a patent that Integra claimed encompassed the drug being tested.  In March 2000, a jury returned a verdict in Integra’s favor.

In 2003, when the Federal Circuit first heard the case on appeal, Merck KGaA contended the experiments were protected by the FDA safe harbor provision that immunizes research “reasonably related to the development and submission of information” to the FDA.  The Federal Circuit affirmed the district court’s decision to deny Merck KGaA’s motion for judgment as a matter of law, holding that the FDA safe harbor did not apply to preclinical studies.  The Federal Circuit held then that the exemption primarily covers generic drugs and only covers clinical trials on human patients, not the necessary precursor animal experiments.

Merck KGaA again appealed.  Before the U.S. Supreme Court, Merck KGaA was represented by an appellate team led by Heller Ehrman.  The Supreme Court reversed and rejected the Federal Circuit’s limited interpretation of the FDA exemption.  The Court also addressed the question of exactly how far back the exemption extended through the chain of drug development.  Justice Scalia, who authored the opinion on behalf of the unanimous Court, wrote that safe harbor “extends to all uses of patented inventions that are reasonably related to the development and submission of any information” to the FDA.  As a result, drug companies responsible for bringing safe and effective medications to the marketplace can now rely on the understanding that the FDA safe harbor exemption provides "a wide berth for the use of patented drugs in activities related to the federal regulatory process." 

In June 2006, one year after the Supreme Court’s decision in the case, Heller Ehrman represented Merck KGaA before the Federal Circuit, preparing the appellate briefs and handled oral argument.

About Heller Ehrman LLP

Heller Ehrman LLP has more than 700 attorneys and professionals in 13 offices worldwide – Anchorage, Alaska; Beijing; Hong Kong; London; Los Angeles; Madison, Wis.; New York; San Diego; San Francisco; Seattle; Silicon Valley; Singapore; and Washington, D.C.  Heller Ehrman represents a wide range of industry leaders, from entrepreneurial, technology-driven enterprises to established, multinational conglomerates.  The firm’s core values are Excellence, People, Teamwork, Innovation, Community and One Firm.