West Virginia Record

Saturday, December 14, 2019

Novartis alleges Mylan violated patent laws relating to prescription drug

Federal Court

By Kyla Asbury | Aug 12, 2019

Pl

WHEELING – Novartis Pharmaceuticals Corp. is suing Mylan Pharmaceuticals over alleged violations of patent laws related to the drug Gilenya.

Mylan notified Novartis on April 6, 2016, that it had submitted to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for Fingolimod, which is a generic version of Gilenya, according to a complaint filed in U.S. District Court for the Northern District of West Virginia.

"The purpose of Mylan’s submission of the ANDA was to obtain approval under the (Food, Drug and Cosmetic Act) to engage in the commercial manufacture, use, offer for sale, and/or sale of Mylan’s ANDA product prior to the expiration of the ‘405 patent," the complaint states.

Novartis alleges Mylan has committed an act of infringement by filing the ANDA with the intent to make, use, offer to sell, and/or sell the generic drug products that are the subject of the ANDA, which Novartis alleges will cause harm and injury to it.

The patent was issued to Novartis on Nov. 17, 2015, and Novartis has a New Drug Application (NDA) by the FDA for Gilenya, according to the suit.

Novartis claims by filing its ANDA, Mylan has necessarily represented to the FDA that its product will have the same active ingredient, method of administration, dosage form and dosage amount as Gilenya.

"Mylan’s ANDA submission seeking approval to engage in the commercial manufacture, use, offer to sell, or sale of its ANDA product, prior to the expiration of the ‘405 patent, constitutes infringement of one or some of the claims of the ‘405 patent under 35 U.S.C. §271 (e)(2)(A)," the complaint states.

Novartis is seeking for the court to enjoin Mylan from making, using, offering to sell or selling or importing its product until the expiration of the patent, as well as damages. It is represented by James F. Companion and Sandra K. Law of Schrader Companion Duff & Law.

U.S. District Court for the Northern District of West Virginia case number 1:19-cv-00128

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