Biogen triumphs over Mylan’s patent challenge

Biogen starts the year successfully by winning a patent challenge from Mylan over its multiple sclerosis drug Tecfidera. 

The challenge from Mylan focused on Biogen’s patent on Tecfidera (dimethyl fumarate) which is due to expire in 2028. The dispute was a significant one for Biogen – Tecfidera is its top-selling drug, bringing in $4.43bn in 2019, which was more than 30% of the company’s total revenues.

The Patent Trial and Appeal Board in the US determined that Mylan did not sufficiently demonstrate its claim and dismissed the challenge.

Responding to the ruling, Mylan said that it would investigate all grounds for appeal, with a spokesperson for the company saying that it “strongly disagrees with the decision”.

Although, Biogen has also been facing other challenges in the MS market from Novartis and Roche, it has its own next-generation MS treatment, Vumerity (diroximel fumarate), which was recently FDA approved for the treatment of relapsing forms of the disease. It is not currently registered in Australia.

For comparison, while Tecfidera is a billion-dollar product, the forecast sales of Vumerity are set to reach a modest $111m in 2024.

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