Supreme Court Decision Curbs Rights of Patent Holders
IP Law Bulletin, June 13, 2005
3 Pages Posted: 26 Mar 2009
In June 2005, the U.S. Supreme Court in a unanimous decision in Merck v. Integra, No. 03-1237, broadly interpreted the scope of a rather ambiguously-worded provision of the U.S. patent statute, 35 U.S.C. 271(e)(1).
That provision provides a "safe harbor" from patent infringement liability for firms that, in the course of conducting tests and experiments needed to gather information for submission to the Food & Drug Administration (FDA), make or use inventions that are patented by others.
The Supreme Court held that the safe harbor protects not just generic manufacturers who are seeking FDA approval to market generic equivalents of branded drugs, but also protects innovator firms (research institutions as well as corporations) who conduct the clinical trials and pre-clinical tests required to seek FDA approval of new, "pioneer" drugs.
Keywords: patent infringement liability, safe harbor, Merck v. Integra, Supreme Court decision, interpretation, U.S. patent statute, 35 U.S.C. 271(e)(1), FDA approval, drugs, patent system, reform, research, experimentation, commercialization
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