WASHINGTON, D.C. (April 1, 2005) — On April 20, 2005, lawyers from McDermott Will & Emery will appear before the U.S. Supreme Court on behalf of Integra LifeSciences Ltd. to argue a patent infringement case with far reaching implications for research and development in the biomedical, pharmaceutical and life science communities.
In a much anticipated case, the U.S. Supreme Court is being asked to clarify the circumstances under which researchers may use patented technology when conducting research for new drugs. In Integra LifeSciences Ltd. et al. v. Merck KGaA et. al., the issue before the Court is the scope of the so-called "FDA Exemption," a part of the Hatch Waxman Act of 1984, which provides a safe harbor from patent infringement liability for activities that are "reasonably related to the development and submission of information" under the Food and Drug Administration's drug approval process.
David Beckwith, now a McDermott Will & Emery partnera, successfully represented Integra LifeSciences and The Burnham Institute, winning a complex six-week trial in the U.S. District Court in San Diego in which the jury found that Merck had willfully infringed their client’s patents. In the appeal that followed, the U.S. Court of Appeals for the Federal Circuit affirmed the jury's decision that Merck's general biomedical experimentation did not fall within the FDA Exemption’s safe harbor. The Court of Appeals ruled that the safe harbor "simply does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process. The safe harbor does not reach any exploratory research that may rationally form a predicate for future FDA clinical tests." On appeal, Mr. Beckwith were joined by McDermott intellectual property partners Ray Lupo, Natalia Blinkova.
In interpreting the FDA Exemption, the U.S. Supreme Court may ultimately determine how far back in the chain of research activity and experimentation the safe harbor applies to provide immunity from patent infringement liability. This decision could substantially diminish the value of research tool patents, which are an important part of the biotechnology industry, typically providing the initial step in the chain of modern drug discovery.
The pioneering discovery that short amino acid sequences, called RGD peptides, were critical to a vast array of biological processes from wound healing to cancer was made by Drs. Erkki Ruoslahti and Michael D. Pierschbacher at The Burnham Institute in La Jolla, California. A number of patents relating to RGD peptides and their scientific and clinical uses were issued to The Burnham Institute and are now exclusively licensed to Integra LifeSciences. Without taking a sub-license from Integra, Merck KGaA supported research at the Scripps Research Institute, to identify particular RGD peptides as drug candidates that might inhibit angiogenesis, the process by which blood vessel develop to nourish tumors.