Appeals court sides with Pfizer, Merck KGaA in $5bn suit
The US Court of Appeals for the Federal Circuit has sided with EMD Serono and Pfizer over the invalidation of a multiple sclerosis (MS) drug patent, in a defeat for biotech company Biogen.
Yesterday, September 29, the Federal Circuit concluded that a New Jersey judge had erred in setting aside a jury verdict which invalidated claims of Biogen’s patent, US number 7,588,755.
The ‘755 patent covers a method of treating a viral condition by administration of a ‘pharmaceutically effective’ amount of a recombinant polypeptide related to human interferon-beta.
Biogen had sued Merck KGaA’s unit EMD Serono and Pfizer in 2010, accusing the companies of infringement through the sale of Rebif, a recombinant interferon-beta product used for the treatment of MS. At trial, Biogen sought more than $5.4 billion in damages.
Following a five-week trial in early 2018, a jury at the US District Court for the District of New Jersey concluded that the ‘755 patent claims were invalid as anticipated and that Serono was liable for contributory infringement but not induced infringement.
However, Judge Claire Cecchi set aside the verdict and granted a new trial in the case, finding that no reasonable jury could find anticipation under Serono’s reading of the claims.
Serono subsequently appealed to the Federal Circuit and, yesterday, the Federal Circuit overturned the lower court’s decision.
Circuit Judge Richard Linn, on behalf of the court, explained that the New Jersey court had made determinations when evaluating the evidentiary record presented to the jury on the question of anticipation, which led to an “erroneous conclusion”.
One of these determinations was made by the New Jersey court when it declined to apply a product-by-process analysis to the claimed recombinant IFN-β source limitation.
“The district court, focusing on the process of making recombinant IFN-β, concluded that it need not analyse whether native IFN-β and recombinantly produced IFN-β were identical because” neither of the prior art references taught a method of treatment using re-combinant IFN-β, said the Federal Circuit.
The New Jersey court went on to reason that there was no binding precedent requiring it to apply a product-by-process analysis to a limitation contained in a method of treatment claim.
Linn added: “The district court’s refusal to consider the identity of recombinant and native IFN-β runs afoul of the longstanding rule that ‘an old product is not patentable even if it is made by a new process’.”
The Federal Circuit reversed the district court’s grant of judgment as a matter of law of no anticipation and the conditional grant of a new trial on anticipation, and remanded the case with instructions to reinstate the jury verdict on anticipation.
Mark Perry, partner at Gibson, Dunn & Crutcher and counsel for Serono and Pfizer, said: “The jury made the factual finding that recombinant interferon-beta was identical to naturally occurring interferon-beta, which had long been used for the same purposes. The court therefore reinstated the jury’s verdict of anticipation, recognising that this outcome ‘protects the public from attempts to excise old products from the public domain’.”
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