Biogen has scored its first major success of the year, winning a patent challenge from Mylan over its multiple sclerosis drug Tecfidera.
The challenge from Mylan focused on Biogen’s ‘514 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 – run by the US Patent and Trademark Office – determined that Mylan did not sufficiently demonstrate its claim and dismissed the challenge.
Following the overturned dispute, shares in Biogen were sent up 32%, as investors reacted to the positive news after somewhat of a rollercoaster year for the biotech.
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”.
“Mylan continues to believe, based on the law and the facts, that Biogen’s ‘514 patent is invalid and will continue its challenges in both the district court and the Federal Circuit to remove this patent from blocking generic competition to Tecfidera,” they added.
Its been a bumpy year for Biogen, whose shock turnaround of its Alzheimer’s drug aducanumab sent investors spiralling, mostly due to to the fact that the company had initially abandoned the drug after it reportedly failed in a phase 3 study.
After a re-analysis of the data, Biogen and partner Eisai revealed that the results from a subset of patients in the phase 3 ENGAGE study of the drug warranted taking it to the FDA for review.
These results, according to Biogen, showed that patients who received sufficient exposure to high doses of the drug experienced significant benefits on measures of cognition and function, including memory, orientation and language.
Although the patent dispute is an overwhelming win, Biogen has been facing other challenges in the MS market from new treatments, including Novartis’ newly-approved Mayzent and Roche’s Ocrevus.
Biogen does, however, have its own next-generation MS treatment – Vumerity (diroximel fumarate) – which was recently approved for the treatment of relapsing forms of the disease.
Despite being more tolerable than its predecessor, some analysts have raised concerns that patients who are stable on Tecfidera will be unwilling to transfer to Vumerity. That could spell trouble for Biogen, if it continues to face more patent challenges over its blockbuster treatment.
For comparison, while Tecfidera is a billion-dollar product, EvaluatePharma has forecast sales of Vumerity to reach a modest $111m in 2024.