Helfgott & Karas, P.C. v. Sheffer

Bayer AG and Bayer Corporation (collectively, "Bayer") own United States Patent No. 5,264,446 (the "446 patent"). The 446 patent claims a pharmaceutical composition that contains nifedipine crystals of a defined specific surface area ("SSA"). The patent also claims the compositions method of preparation and a method of treatment using the composition. Bayer sued Elan Pharmaceutical Research Corporation and Elan Corporation, PLC (collectively, "Elan") in the United States District Court for the Northern District of Georgia alleging infringement by Elan of the 446 patent. Bayer alleged infringement under 35 U.S.C. § 271(e)(2)(A) based on Elans filing of an abbreviated new drug application ("ANDA") seeking approval by the Food and Drug Administration ("FDA") of a generic version of Bayers ADALAT CC, Bayers commercial embodiment of the pharmaceutical composition claimed in the 446 patent. The district court granted Elans motion for summary judgment on both literal infringement and infringement under the doctrine of equivalents and entered judgment for Elan. See Bayer AG v. Elan Pharm. Research Corp., 64 F. Supp. 2d 1295, 1304 (N.D. Ga. 1999). We affirm.