Court Favors Merck in Patent Fight
By PETER LOFTUS
March 29, 2007 5:11 p.m.
A federal appeals court sided with Merck & Co. Thursday in the drug maker's effort to keep a generic version of its eye-disease drug Trusopt off the market until its patent expires next year.
Merck filed a patent-infringement lawsuit against Hi-Tech Pharmacal Co. in January 2006, following Hi-Tech's 2005 application for Food and Drug Administration approval to sell a generic version of Trusopt, an eye drop designed to treat patients with glaucoma or ocular hypertension.
Hi-Tech, Amityville, N.Y., had argued that the patent for Trusopt had already expired in 2004. But Merck argued that the patent's expiration had been extended by the U.S. Patent and Trademark Office until April 2008 based on the length of the FDA's review of Trusopt before granting approval, as well as a change in patent law in the 1990s.
In April 2006, a federal court in New Jersey ruled in Merck's favor in the case and ordered Hi-Tech not to begin selling a generic version of Trusopt until the patent expiration in April 2008. Hi-Tech appealed the ruling, leading to Thursday's decision in favor of Merck by the U.S. Court of Appeals for the Federal Circuit in Washington.
Merck, Whitehouse Station, N.J., has said it expects market exclusivity for Trusopt to expire in October 2008, following a six-month extension period of pediatric exclusivity that was granted by the FDA in 2004.
Merck's combined sales of Trusopt and a related drug, Cosopt, were $697 million for 2006, up 13% from $617 million in 2005.
Officials with both companies couldn't immediately be reached. |
