SAN DIEGO, CA — McDermott Will & Emery is pleased to announce that on December 3, 2003, the U.S. Court of Appeals for the Federal Circuit denied Merck KGaA’s petition for rehearing or rehearing en banc of the decision in Integra LifeSciences I Ltd. et al. v. Merck KGaA et al. In the original Federal Circuit opinion, the Court of Appeals upheld the jury determination that Merck infringed Integra’s patent, ruling on an issue of first impression that the FDA exemption to patent infringement (35 U.S.C. §271(e)(1)) is limited to exemptions related relatively directly to FDA review.
Merck petitioned for rehearing or rehearing en banc, arguing that the Federal Circuit had improperly limited the FDA exemption in contravening United States Supreme Court precedent. In addition to denying Merck’s petition, the Federal Circuit amended its original opinion. The Court’s amendments made clear that its original opinion was consistent with Supreme Court precedent.
The denial of the petition for rehearing reaffirms the intent of the legislature that the FDA exemption was to have minimal effect on patent rights, and should not impinge on the patent rights valuable to the research and development process. The Federal Circuit opinion further acknowledges that commercial market factors will ensure that technologies useful to the drug development process have access to the FDA exemption.
Integra was represented at trial by David Beckwith, who joined McDermott in March 2003. On appeal, David was joined in Washington, D.C. IP lawyers Ray Lupo and Natalia Blinkova.