District Court ruling on Tecfidera patent opens door for Mylan's generic

Mylan is closer to offering a generic treatment for patients with relapsing forms of multiple sclerosis. The U.S. District Court for the Northern District of West Virginia on Thursday invalidated Biogen's Tecfidera patent, U.S. Patent No. 8,399,514, for lack of written description. Biogen's patent claimed methods of treating multiple sclerosis using a dose of 480 mg/day of dimethyl fumarate delayed-release capsules.

The decision clears the way for Mylan's launch of its dimethyl fumarate product once the Food and Drug Administration approves it. Biogen's 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," said Heather Bresch, CEO of Mylan. "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 Nov. 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 United States, further advancing our commitment to provide a broad portfolio of central nervous system medicines, which already includes glatiramer acetate injection."

Mylan believes it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the United States upon final FDA approval.

"Mylan continues to address unmet patient needs across the value chain," Mylan president Rajiv Malik said,  "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."

Tecfidera had a market value of roughly $3.78 billion for the 12 months ended April 30, according to IQVIA.