Cosmo Pharmaceuticals S.p.A., Jazz Pharmaceuticals, Shire, Hayman Capital Management autoimmune, neurology news

The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (PTO) instituted an inter partes review (IPR) petition from hedge fund manager Kyle Bass challenging a U.S. Patent No. 6,773,720 covering Shire’s ulcerative colitis drug Lialda mesalamine. The ‘720 patent covers controlled-release oral compositions containing 5-aminosalicylate (5-ASA) and is owned by Cosmo’s Cosmo Technologies Ltd. subsidiary. Shire markets Lialda, which is 5-ASA mesalamine formulated using Multi-Matrix system (MMX) technology from Cosmo. The board held that there is a reasonable likelihood that the coalition would prevail in showing that four claims of the patent are obvious based on prior art. PTAB also issued a scheduling order with deadlines for the parties to file responses and motions; it said oral arguments would occur June 24, 2016. The patent is the only Orange Book-listed patent for Lialda. It expires June 8, 2020. Bass filed the challenge April 1. Lialda, marketed in the EU as Mezavant, generated $306.4 million in worldwide sales during 1H15.

Separately, PTAB denied Bass’ IPR challenge of a patent covering Jazz’s narcolepsy drug Xyrem sodium oxybate. In its decision, PTAB disagreed that the petition had provided sufficient evidence that claims in U.S. Patent No. 7,895,059 were obvious based on publicly available prior art. PTAB also said the petition did not explain why it would have been obvious for a person of ordinary skill to combine disparate references from multiple documents cited as prior art. ...