Teva, Momenta, Mylan, Natco, Novartis autoimmune, generics news
The U.S. District Court for the Southern District of New York denied a motion by Teva for summary judgment of no inequitable conduct in its ongoing case seeking to block approval of generic versions of multiple sclerosis (MS) drug Copaxone glatiramer acetate injection. The court said there were "disputed issues of material fact" and scheduled a jury trial for July 11. In May, the U.S. Court of Appeals for the Federal Circuit ruled that to prove a patentee acted with inequitable conduct, a party must show with clear and convincing evidence the patent would not have been granted had the alleged conduct not occurred, and that the patentee acted with intent to deceive the U.S. Patent and Trademark Office (see BioCentury, May 30).
In March, Teva said the court set a trial date of Sept. 7 for the company's patent suit against Mylan, Natco, Novartis' Sandoz International GmbH generics unit and Momenta related to Copaxone. Momenta and Sandoz have submitted ANDAs for a generic version of Copaxone (see BioCentury, March 7 & May 23). ...