A recent decision by the United States District Court for the Southern District of New York may have significant implications for the future of pharmaceutical research.
Indeed, Judge Robert Patterson’s Nov. 28, 2001 summary judgment decision in Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 2001 WL 1512597 (S.D.N.Y 2001), suggests that the safe-harbor afforded by 35 U.S.C. �271(e)(1) of the Patent Law – which was designed to expedite FDA approval of generic drugs by allowing generic drug manufacturers to perform development work and bioequivalency testing prior to patent expiration – is broad enough to protect research-based pharmaceutical companies conducting early stage research using patented tools from claims of infringement.
