Merck & Co, Inc. v. Hi-Tech Pharmacal Co., Inc.

Merck & Co, Inc. v. Hi-Tech Pharmacal Co., Inc.

Fed. Cir. (2007)

On March 29, 2007, the Court of Appeals for the Federal Circuit affirmed the validity of the patent term extension, holding that the language of §156 is unambiguous and fulfills a purpose unrelated to and not in conflict with the terminal disclaimer statute, 35 U.S.C. §253. On April 25, 2006, Fitzpatrick attorneys obtained final judgment on behalf of client Merck that Hi-Tech had infringed U.S. Patent 4,797,413, by filing its ANDA’s which sought approval to market generic versions of Merck’s glaucoma eye drugs, TRUSOPT® and COSOPT®. The Honorable Mary L. Cooper granted a permanent injunction, enjoining Hi-Tech from the manufacture or sale of its generic products until the expiration of the ‘413 patent plus a six month period of pediatric exclusivity. On appeal, Hi-Tech’s sole argument was that the ‘413 patent had expired in 2004, and that its Hatch-Waxman term extension under 35 U.S.C. §156 was invalid due to the terminal disclaimer filed during prosecution to overcome an obviousness-type double patenting rejection.