Mylan Wins District Court Decision against Biogen's Tecfidera Patent

Mylan announced the U.S. District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera® patent, U.S. Patent No. 8,399,514, for lack of written description. The ᾿514 patent claimed methods of treating multiple sclerosis (MS) using a dose of 480 mg/day of dimethyl fumarate delayed release capsules. This decision clears the way for Mylan's launch of its dimethyl fumarate product upon the receipt of FDA approval. The '514 patent could have otherwise delayed generic competition until 2028.

"Today's win is significant in that it brings Mylan one step closer to providing expanded treatment options for the thousands of Americans living with relapsing forms of MS. The District Court decision clears the legal pathway for us to bring our dimethyl fumarate product to market, and we are working with the FDA to accelerate our regulatory approval target action date, which currently is November 16. Once approved and launched, we believe our generic Tecfidera will potentially be the first generic of any MS treatment in an oral solid dosage form available to patients in the U.S., further advancing our commitment to provide a broad portfolio of central nervous system medicines, which already includes glatiramer acetate injection," Mylan CEO Heather Bresch said.

"Mylan continues to address unmet patient needs across the value chain. Bringing a product like generic Tecfidera to market requires not only our extensive scientific and commercial expertise, but also our unwavering commitment to access through overcoming potential legal barriers to reach patients. We look forward to bringing this important medicine to market as soon as possible, pending final FDA approval,” Mylan President Rajiv Malik said.

Tecfidera (dimethyl fumarate) delayed-release capsules are used to treat adults with relapsing forms of MS. Mylan believes it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Mylan's ANDA is pending with the U.S. Food and Drug Administration (FDA).

Biogen's total IQVIA sales in the U.S. for the 12 months ending April 30, 2020, were approximately $3.78 billion for Tecfidera.