Sanofi responds to patent spat with Amgen as Supreme Court arguments set for March

06 Feb 2023
endpts.com
Patent Infringement
The newest step in the saga between Amgen and Sanofi’s patent tug-of-war is in Sanofi’s court, just a matter of weeks before oral arguments. Just over a month after Amgen filed a response to the Supreme Court against Sanofi, the French pharma is countering Amgen’s claims that the Federal Circuit’s previous standard harms innovation. Sanofi said in its filing Friday that Amgen obtained additional patents to try and broadly claim the entire genus of PCSK9-blocking antibodies after Sanofi and Regeneron had already developed Praluent. On top of that, Sanofi claims that Amgen’s rationale that a Federal Circuit standard harms innovation is not entirely true. “Despite Amgen’s sky-is-falling lamentations, innovation has not been harmed by the decision below, as Amgen’s leading academic article ultimately concedes. Rather, the true threat to innovation comes from allowing companies to monopolize an entire functional genus that they have not enabled,” Sanofi wrote. Sanofi added even more bluntly: This case revolves around enablement, in which someone can make and use an invention, using information disclosed in the patent and with information known in the specific field or industry, “without undue experimentation,” according to the US Patent and Trademark Office. Sanofi is claiming that Amgen is attempting to patent a genus of antibodies that they have not themselves enabled. The Supreme Court is going to be hearing arguments on March 27 to review Amgen’s outstanding request to revive patents on Repatha, its blockbuster biologic PCSK9 inhibitorPCSK9 inhibitor — and block the sale of Sanofi/Regeneron’s similar, yet independently developed drug Praluent to reduce LDL cholesterol. While Amgen scored a win in 2019 in an initial trial, a federal judge reversed the decision in favor of Sanofi and Regeneron — which was later upheld by the Court of Appeals in 2021. Amgen then filed for writ of certiorari to the Court later that year. Amgen had claimed that the Federal Circuit decision requires patent owners — incorrectly, it added — to identify and make all or nearly all possible variations of the invention without “substantial time and effort.”
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