Biogen notches another Tecfidera patent win in Europe as officials revoke generic approvals

19 Dec 2023
www.fiercepharma.com
Patent InfringementDrug ApprovalPatent ExpirationBiosimilar
Biogen notches another Tecfidera patent win in Europe as officials revoke generic approvals
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Source: FiercePharma
The win in Europe follows a series of similar developments there. But in the U.S., it's a different story for Biogen's blockbuster.
Following a significant loss at the U.S. Supreme Court last October, Biogen’s Tecfidera patent odyssey continues to spin in the company’s favor overseas.
Tuesday, Biogen said the European Commission (EC) revoked marketing authorizations for generic versions of Tecfidera, also known as dimethyl fumarate, that are owned by copycat drugmakers Accord, Mylan, Neuraxpharm, Polpharma and Teva.
The EC has confirmed full data and marketing protection for Tecfidera in Europe, the company said. Under the latest ruling, Tecfidera is now girded by marketing protection until Feb. 3, 2025, making it the only dimethyl fumarate treatment for multiple sclerosis that can be legally placed on the European market before then, according to the Massachusetts-based drugmaker.
The company added that it’s kicked off legal action to defend its market protection rights. Biogen also says it has enough Tecfidera supply to provide the drug to the entire European market.
Biogen’s latest win marks a positive turn for the company in its ongoing Tecfidera patent odyssey.
The decision follows another win in Europe earlier this year. Back in May, the EC ruled that Biogen’s multiple sclerosis drug would have market protections until 2025. That outcome followed another March decision from the EU’s Court of Justice that went in Biogen’s favor and blocked generic versions of the company’s drug.
Things haven’t gone so smoothly for Tecfidera in the United States, where Biogen last year took its patent case all the way to the Supreme Court.
Stateside, Biogen’s exclusivity on Tecfidera originally wasn’t due to expire until 2028, but in 2020, a U.S. district court ruled that the med’s critical 514 patent was invalid. A November 2021 appeals court decision failed to revive the patent, which pushed Biogen to seek out a ruling from the High Court.
Last October, however, the Supreme Court declined to hear the case, clearing the way for Viatris to continue marketing its generic version of the drug, which launched back in 2020.
Tecfidera sales have been struggling since the generic launch in the U.S. The med's 2021 sales came in at $1.95 billion after reaching $3.84 billion the previous year, while in 2022, Tecfidera pulled in $1.4 billion.
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