Appeals Court Upholds Decision for Mylan Generic of Biogen MS Drug

Biogen_John Tlumacki/The Boston Globe via Getty

Courtesy of John Tlumacki/The Boston Globe via Getty Images

A decision made this week by the U.S. Court of Appeals for the Federal Circuit delivered a blow to Biogen, denying a second look into the patent dispute filed against Mylan Pharmaceuticals, Inc. This ruling upholds an appeal filed in 2021, in which Biogen argued the validity of its Multiple Sclerosis (MS) drug, Tecfidera.  

Last year’s appeal, as well as this bid to reopen the appeal, mark an attempt to intervene with Mylan’s launch and marketing of a generic of Biogen’s Tecfidera, arguing that a patent grants exclusivity. The root issue lies in the U.S. District Court’s 2020 decision to invalidate the patent.  

The decision was not unanimous, as three judges argued that the ruling left vague implications on what should be considered patent standardization. These three judges also expressed that a rehearing of the dispute should have been allowed, pointing out that a rehearing denial has not occurred since 1853.

The remaining seven judges voted to uphold the 2020 decision to invalidate Biogen’s patent number 8,399,514. The rationale for the initial 2-1 ruling was the patent's unclear treatment description, specifying which compounds will be delivered in what dosage.  

Mylan, a Viatris company, is based out of both Hertfordshire, England, and Pennsylvania. The company is aimed specifically at expanding patient access to medications globally. Its portfolio boasts 7,500 drugs currently being marketed in over 165 countries. Notably, Mylan’s HIV/AIDS retroviral drugs account for the treatment of 40% of diagnosed patients globally.  

Biogen took a hit in the stock market as a result of the Food and Drug Administration (FDA)’s decision to allow the generic, as shareholders anticipate a lower value being placed on the original drug. As Biogen’s best-seller, the company has fought to be able to hold its patent and market Tecfidera without competition. At the end of the fiscal year 2020, Biogen reported Tecfidera's net sales of $3.79 billion.  

The availability of a generic alternative to Biogen’s Tecfidera means increased access for patients who find themselves devoting a large portion of their budget to their medications. Biospace reported on the excitement felt by Mylan CEO Heather Bresch during the launch of their generic program.

“The launch of the first generic Tecfidera is yet another prime example of Mylan's fundamental commitment to bringing more access to patients worldwide," Bresch said.

This generic is the first orally-dosed solid medication to be launched specifically for the care of MS patients. To further dispute the generic competition, the only remaining option for Biogen is to graduate the case to the U.S. Supreme Court.  

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