Patents4Life

So that I don’t have to explain the claims and the arguments presented by the parties, please read my posts on the Supreme Court’s opinion on Amgen v. Sanofi on May 22, 2023 and the Fed. Cir.’s opinion on February 13, 2021. In Amgen the Supreme Court affirmed the Fed. Cir.’s opinion, ruling that the disclosure of 26 antibodies did not enable the functional claims that encompassed millions of antibodies, because the effort to identify the other members of the genus would amount to undue experimentation. Earlier I wrote that “While Lourie tries to cabin the undue effort holding by writing ‘We do not hold that the effort required to exhaust a genus is dispositive’, he contradicts himself in the same paragraph by concluding that ‘no reasonable jury could conclude under these facts that anything but ‘substantial time and effort’ would be required to reach the full scope of the claimer embodiments.” The Supreme Court quoted the first sentence I quoted but ignored the second and wrote, “Instead the court stressed, the problem it saw was the same problem we see: Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’” So Sanofi succeeded in being found not-guilty of infringement of their antibody-based therapeutic simply by waiving the “at least millions of candidates” that would have to be screened for the recited bioactivity, and this effort involves “undue experimentation.”

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