Mylan reports that a US federal district court has invalidated a patent for Biogen’s Tecfidera (dimethyl fumarate), a drug to treat relapsing multiple sclerosis (MS), which opens a path for Mylan to launch a generic version of the drug upon regulatory approval. Tecfidera is the company’s top-selling drug with 2019 global sales of $4.4 billion.

Specifically, the US District Court for the Northern District of West Virginia invalidated Biogen’s patent (U.S. Patent No. 8,399,514) for lack of written description, according to information from Mylan. The ᾿514 patent claimed methods of treating MS using a dose of 480 mg/day of dimethyl fumarate delayed-release capsules. Mylan says the decision clears the way for Mylan’s launch of its dimethyl fumarate product upon the receipt of US Food and Drug Administration approval. The ‘514 patent could have otherwise delayed generic competition until 2028, according to information Mylan.

Mylan says it believes it is one of the first companies to have filed a substantially complete abbreviated new drug application (ANDA) with the FDA containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval. Mylan’s ANDA is pending with the FDA.

Source: Mylan