West Virginia Record

Tuesday, September 17, 2019

Mylan sued for patent infringement

Lawsuits

By Kyla Asbury | Jun 9, 2019


WHEELING — A tobacco company is suing Mylan Pharmaceutical after it claims it infringed on one of its patents.

Japan Tobacco discovered the anti-viral compound known as elvitegravir and is the owner of a patent known as the '219 patent, according to a complaint filed in the U.S. District Court for the Northern District of West Virginia.

Japan Tobacco claims in the patent it has a method for treating an HIV infection in humans that uses elvitegravir, along with tenofovir disoproxil fumarate and emtricitabine, according to the suit.

In 2005, Japan Tobacco licensed patents involving elvitegravir to Gilead Sciences so that Gilead could develop drug products and the drug, Stribild, was approved by the U.S. Food and Drug Administration (FDA) in 2012. 

Before the expiration of the patent, Mylan submitted to the FDA an abbreviated new drug application involving elvitegravir, according to the suit.

Japan Tobacco claims Mylan has "taken and continues to take active steps toward the commercial manufacture, use, offer for sale, sale, and/or importation of Mylan’ s ANDA Product, including seeking approval of its ANDA Product under Mylan’s ANDA."

"There is a substantial and immediate controversy between Plaintiff and Mylan concerning the '219 patent," the complaint states. "Plaintiff is entitled to declaratory judgment under 28 U.S .C. §§ 2201and 2202 that Mylan will directly infringe, induce infringement of and/or contributorily infringe claims 1, 2 and 5 of the '219 patent."

Japan Tobacco claims its patent does not expire until 2030 and Mylan cannot manufacture or sell its product until after that date.

Mylan's drug will have the same purpose as the drug created by Gilead with Japan Tobacco's patent.

Japan Tobacco is seeking an injunction restraining and enjoining Mylan from manufacturing and selling its product. It is represented by James F. Companion of Schrader Companion Duff & Law.

U.S. District Court for the Northern District of West Virginia Case number: 1:19-cv-00012

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