Dutch generic drugmaker Mylan said that the US District Court for the Northern District of West Virginia has invalidated Biogen’s Tecfidera patent U.S. Patent No. 8,399,514 for lack of written description.

According to the company, the 8,399,514 patent claimed methods for the treatment of multiple sclerosis (MS) with a dose of 480 mg/day of dimethyl fumarate delayed release capsules. The court’s decision will clear the way for Mylan in launching its dimethyl fumarate product after the receipt of approval from the US Food and Drug Administration (FDA).

The 8,399,514 patent could have otherwise delayed generic competition until the year 2028, said Mylan.

Heather Bresch – Mylan CEO Heather Bresch said: “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.”

  Biogen, Heather Bresch, Multiple sclerosis, Mylan, Tecfidera, US Food and Drug Administration