Biogen investors have been on a wild ride over the last year, and on Wednesday they experienced their first major jolt in 2020. It was a welcome one.
The company prevailed in a high-stakes patent challenge from Mylan, giving Biogen a win as it continues defending its big-selling multiple sclerosis drug Tecfidera from would-be copycats.
Last year, Tecfidera pulled in $4.43 billion for the drugmaker, or about 30% of its global sales.
Mylan had challenged Biogen’s ‘514 patent on Tecfidera, which expires in 2028. Early last year, Biogen said the U.S. Patent and Trademark Office had decided to strike up an inter partes review.
In the decision this week, the patent judges determined that Mylan has “not demonstrated by a preponderance of the evidence the unpatentability of claims” it challenged.
A Biogen spokesman said the company is "pleased" with the decision, while a Mylan representative said the generics maker "strongly disagrees with the decision and plans to pursue all available options for appeal."
Aside from the inter partes review, Mylan is challenging the patent in West Virginia federal court, the company's spokeswoman said; that trial started Tuesday and is ongoing. Other companies are challenging the patent in Delaware federal court. Judgments in those cases are expected this year, according to Mylan.
"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," she added.
Biogen's shares jumped about 23% on the news Wednesday.
Meanwhile, Wall Street analysts and others are keeping a close eye on Biogen’s Alzheimer's drug candidate aducanumab, which the company had abandoned after it failed to show efficacy in late-stage trials last year. But then, in October, Biogen shocked the biopharma world when it said it planned an FDA submission based on a review of larger data sets. The company now plans a filing early this year.