CollaGenex Pharmaceuticals Seeks Immediate Injunctive Relief to Enforce Its Patent Following Court's Decision Allowing FDA to Approve ANDAs Covering Generic Versions of Periostat
Thursday January 20, 8:55 am ET
NEWTOWN, Pa.--(BUSINESS WIRE)--Jan. 20, 2005--CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI - News) today announced that it intended to seek prompt injunctive relief to protect its patent and intellectual property rights following a decision by the United States District Court for the District of Columbia. The decision upheld the FDA's classification of Periostat® as an antibiotic drug which is not entitled to the patent and exclusivity protection otherwise available under the Hatch Waxman amendments to the Food, Drug, and Cosmetic Act. Periostat is the registered trademark of CollaGenex's proprietary 20mg tablets of doxycycline hyclate approved as the only systemic adjunct to scaling and root planing for the treatment of adult periodontitis.
CollaGenex is seeking a temporary restraining order and a preliminary injunction in the United States District Court for the Eastern District of New York. In that Court, CollaGenex recently filed a complaint for patent infringement against both IVAX Pharmaceuticals Inc. and CorePharma LLC ("Defendants"). CollaGenex alleges that the Defendants' submissions of Abbreviated New Drug Applications ("ANDA's") covering their 20mg tablets of doxycycline hyclate infringe United States Patent RE 34,656, of which CollaGenex is the exclusive licensee. CollaGenex seeks an injunction preventing the Defendants from introducing 20mg tablets of doxycycline hyclate into the market in the United States until its patent claims have been resolved.
"CollaGenex is the exclusive licensee of valid patents that cover, among other things, the use of doxycycline to treat adult periodontitis. We will vigorously pursue all legal avenues to defend our patent rights," said Colin Stewart, president and chief executive officer of CollaGenex.
In July 2003, the United States District Court for the District of Columbia had issued a preliminary injunction that had temporarily restrained the FDA from approving any ANDA for generic versions of Periostat. The injunction was ordered pending final resolution of CollaGenex's challenge to the FDA's classification of Periostat. Yesterday's decision dissolves that injunction and would permit the FDA to approve any otherwise eligible application to market a generic version of Periostat. CollaGenex will appeal this decision. |
