MORGANTOWN -- A Delaware pharmaceutical corporation claims Mylan is illegally attempting to sell a generic form of a drug used to treat multiple sclerosis that the Delaware company patented.
Teva Pharmaceuticals, Teva Pharmaceutical Industries, Teva Neuroscience and Yeda Research and Developed Co. filed a lawsuit Nov. 4 in U.S. District Court for the Northern District of West Virginia against Mylan Pharmaceuticals, Mylan Inc. and Natco Pharma.
The plaintiffs claim Yeda developed a drug called Copaxone that reduces the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
Originally, Yeda's patent was issued on Nov. 9, 1999, and is set to expire on May 24, 2014, according to the complaint. Plaintiff Teva was issued the right to be the exclusive licensee of the drug's patent, the suit states.
However, Mylan is now seeking the right from the FDA to sell a generic version of the drug before Yeda's patent is set to expire, the complaint says.
"Upon information and belief, Mylan Pharmaceuticals also filed with the FDA a certification alleging that the claims of the patents in suit are invalid, unenforceable, and/or would not be infringed by the manufacture, use, importation, sale or offer for sale of Mylan's generic glatiramer acetate product," the suit states.
Defendant Natco helped Mylan develop the generic version of the drug, according to the complaint.
The plaintiffs contend Mylan should not be allowed permission to sell the generic drug because it will infringe on their patents and will cause them a loss in profits.
"Defendants' actions have created in Plaintiffs a reasonable apprehension of irreparable harm and loss resulting from Defendants' threatened imminent actions," the complaint says.
In the 14-count suit, the plaintiffs are seeking a declaration that their patents are valid and enforceable and that the defendants have infringed on their patents. They are also asking the court to not allow Mylan to sell a generic version of the drug until after Yeda's patent expires, to award monetary relief for all sales of the generic version of the drug before the patent's expiration and to award attorneys' fees and other relief the court deems just.
In the case that Mylan does obtain approval for the generic version of the drug, the plaintiffs are asking the court to prohibit Mylan from selling the drug before the patent's expiration.
James F. Companion and John Porco of Schrader, Byrd and Companion in Wheeling will be representing the plaintiffs. Steven J. Lee and Elizabeth J. Holland of Kenyon and Kenyon in New York and William G. James II of Washington, D.C., will serve of counsel.
U.S. District Court case number: 1:09-cv-152