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Supreme Court to Rule on Experimental Use via the 'Safe Harbor' of 35 U.S.C. '271(e)(1)
On Jan. 7, 2005, the Supreme Court granted certiorari in Merck KGaG v. Integra LifeSciences I, Ltd., No. 03-1237. The question presented is whether the Federal Circuit erred in limiting the safe harbor exemption to clinical studies designed to provide information for Food and Drug Administration approval of a new drug.
At the trial level, Integra alleged that Merck had infringed its patents by performing animal trials with a potential new anticancer drug. After a jury trial, 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). On appeal, the Federal Circuit affirmed the district court's opinion that the safe harbor provision did not apply to Merck's activities. Integra LifeSciences I Ltd. v. Merck KGaA, 331 F.3d 860 (Fed. Cir. 2003) (Rader, J.). The Federal Circuit found that since Merck's research was not “solely for uses reasonably related” to tests for the FDA, it was not covered by the safe harbor provision. Oral argument is expected in April, and a decision is expected by the end of June.
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