CLARKSBURG – Santarus, Inc., and Veloxis Pharmaceutical A/S are suing Mylan Pharmaceuticals, Inc., for allegedly attempting to sell a generic drug they hold patents on.

Veloxis Pharmaceuticals A/S is the owner of two patents titled “Solid Dosage Form Comprising a Fibrate” in which one is a ‘944 patent, issued on Feb. 9, 2010, and one is a ‘125 patent, issued on Feb. 28, according to a complaint filed Jan. 30 in the U.S. District Court for the Northern District of West Virginia.

Santarus, Inc., was granted the exclusive, royalty-bearing license under the ‘944 and ‘125 patents to market, import, use, sell, offer for sale and otherwise commercialize certain pharmaceutical products, including Fenoglide, in the United States.

The plaintiffs claim Santarus holds New Drug Application No. 22-118 for 40mg and 120mg fenofibrate orally disintegrating tablets and markets the tablets in the Unite States as Fenoglide.

The defendants are seeking FDA approval for the commercial manufacture, use and sale of generic 40mg and 120mg fenofibrate orally disintegrating tablets prior to the expiration of the ‘944 patent, according to the suit.

Mylan certified that the claims of the ‘944 patent are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of fenofibrate tablets pursuant to the Federal Food, Drug & Cosmetic Act, according to the suit. However, Mylan’s submission to the FDA constitutes the infringement of the ‘944 patent under U.S. code.

Santarus and Veloxis claim if Mylan commercially manufacture, uses, offers to sell, sells or imports any fenofibrate tablets, or induces or contributes to any such conduct, it would further infringe the ‘944 patent under U.S. code.

The defendants are aware of the existence of the ‘944 patent and were aware prior to filing for FDA approval, according to the suit.

The plaintiffs claim they were be irreparably harmed by the defendants’ infringing activities unless the Court enjoins the activities.

Santarus and Veloxis are seeking for the Court to declare its patents are valid and enforceable; that the defendants have infringed on the patents; and enjoin the defendants from commercially manufacturing, using, offering for sale or selling fenofibrate tablets within the United States prior to the expiration of the ‘944 and ‘125 patents. They are being represented by John Porco, James F. Companion, Rich Racine and Jennifer S. Swan.

The case has been assigned to District Judge Irene M. Keeley.

U.S. District Court for the Northern District of West Virginia case number: 1:13-cv-17




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