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Federal Circuit Negative on Best-mode Defense

By John J. Molenda, Brian D. Coggio and Joseph Evall

The U.S. Court of Appeals for the Federal Circuit has taken an increasingly dim view of an accused infringer's attempt to invalidate the claims of a patent-in-suit by alleging that the patentee failed to satisfy the best-mode requirement.

Recent Federal Circuit decisions, such as Eli Lilly & Co. v. Barr Labs. Inc., 251 F.3d 955 (Fed. Cir. 2001), and Bayer A.G. v. Schein Pharms. Inc., 301 F.3d 1306 (Fed. Cir. 2002), have, with near uniformity, converted the best-mode analysis into a narrow, quasi-legal inquiry that focuses on the scope of the claimed invention, with careful attention to just what is claimed. The specification of all patents, including those claiming pharmaceutical inventions, must 'set forth the best mode contemplated by the inventor of carrying out his invention.' 35 U.S.C. 112, 1. As the Eli Lilly court stated, this best-mode requirement embodies a quid pro quo whereby a 'patentee must not receive the right to exclude others unless at the time of filing he has provided an adequate disclosure of the best mode.' The penalty for failure to satisfy this requirement is harsh: The patent claims covering the subject matter for which the best mode was not disclosed are rendered invalid. See Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1209 n.5 (Fed. Cir. 1991).

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