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22 December 2020Americas

Fed Circuit refuses to revive Biogen’s MS drug dispute

Biogen has lost its long-standing fight to recover billions of dollars in royalties from the sale of a multiple sclerosis (MS) drug, after the US Court of Appeals for the Federal Circuit rejected Biogen’s request that it reconsider its own ruling on Friday, December 18.

The dispute dates back to 2010 when  Biogen accused Merck KGaA’s  EMD Serono and  Pfizer of infringing US patent number 7,588,755.

The patent, granted in 2009, covers a method of treating a viral condition by administration of a ‘pharmaceutically effective’ amount of a recombinant polypeptide related to human interferon-beta. It is central to Biogen’s MS treatment Avonex (interferon beta-1a).

According to Biogen, EMD Serono and Pfizer infringed the patent through the sale of Rebif (interferon beta-1a), which is also a treatment of MS. In 2018, at trial, Biogen sought more than $5.4 billion in damages, but a jury sitting at the US District Court for the District of New Jersey instead found that claims of the ‘755 patent were invalid as anticipated. It also found EMD Serono to be liable for contributory infringement, but not induced infringement.

However, the verdict was set aside after the judge determined that no reasonable jury could determine anticipation under EMD Serono’s interpretation of the ‘755 patent’s claims.Serono appealed against this decision. In September 2020, the Federal Circuit reversed the judge’s decision and instructed the New Jersey court to reinstate the jury verdict which had invalidated claims of Biogen’s ‘755 patent.

Biogen filed a combined petition for a rehearing and a rehearing en banc, asking the Federal Circuit to reconsider its decision.

However, on Friday, the Federal Circuit denied Biogen’s petition, as reported by  Bloomberg. As a result, the September decision stands and the verdict of the New Jersey jury—which found claims of Biogen’s ‘755 patent to be invalid—is reinstated. This is the latest in a series of blows for Biogen’s MS treatment portfolio. In September, the US District Court for the District of Delaware  held that Biogen’s last surviving patent covering MS drug Tecfidera (dimethyl fumarate) could not be revived following a lawsuit in West Virginia.

A spokesperson from EMD Serono told LSIPR:"We are pleased that after carefully weighing the evidence, the jury affirmed—and the appeals court reaffirmed— our position that Biogen’s patent is invalid and EMD Serono has no liability. EMD Serono adheres to all patent regulations and respects the valid intellectual property of other companies."

Earlier this year, the Federal Circuit  found that Banner Life Sciences’ bioequivalent version of Tecfidera did not infringe the section of another of Biogen’s patents which had been extended under the Hatch-Waxman Act.

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