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Supreme Court Broadly Interprets Safe Harbor Provision of Hatch-Waxman Act
On June 13, 2005, the Supreme Court issued its decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. ___, 2005 WL 1383624 (2005), a case involving the “safe harbor” provision of the Hatch-Waxman Act, 35 U.S.C. '271(e)(1).
At the trial level, a jury found that Merck had infringed Integra's patents by performing animal trials with a potential new cancer therapy. The U.S. District Court for the Southern District of California ruled that Merck's research was not protected by the safe harbor provision of 35 U.S.C. '271(e)(1). The Federal Circuit affirmed the district court's opinion, pointing to the fact that Merck's experiments did not provide information for submission to the FDA.
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