BioCentury
ARTICLE | Company News

Biogen, Hayman Capital Management autoimmune news

October 5, 2015 7:00 AM UTC

Hedge fund manager Kyle Bass filed a third inter partes review (IPR) petition with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office challenging a patent covering Biogen’s Tecfidera dimethyl fumarate for multiple sclerosis. An entity associated with Bass filed the petition challenging U.S. Patent No. 8,399,514, which expires in 2028. The ‘514 patent is the last to expire among seven Orange Book-listed patents covering Tecfidera. The petition argues claims 1-20 of the ‘514 patent, which claim the specific dosage of 480 mg/day of dimethyl fumarate (DMF) to treat MS, are unpatentable on the grounds of obviousness.

In May, the entity filed a petition against the same claims of the ‘514 patent. PTAB dismissed the petition on Sept. 2 after concluding that the prior art documents used to support the entity’s challenge failed to establish that DMF would be useful in treating MS, which would have rendered the patent claims obvious. The new petition relies on different prior art. The primary reference provides results of a Phase II trial demonstrating DMF is effective in treating MS. Another IPR challenge filed by Bass is pending against U.S. Patent No. 8,759,393, which also covers Tecfidera and expires in 2019 (see BioCentury, April 27). ...