Supreme Court decision allows alirocumab to stay on US market
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Key takeaways:
- The U.S. Supreme Court ruled two patents held by Amgen related to PCSK9 inhibitor technology were invalid.
- The decision allows alirocumab to remain on the U.S. market.
The U.S. Supreme Court unanimously ruled in favor of Regeneron and Sanofi that two of Amgen’s patents for PCSK9 inhibitor technology were invalid, allowing alirocumab to stay on the U.S. market.
As Healio previously reported, in 2016 a U.S. District Court jury in Delaware decided that two patents related to monoclonal antibodies for PCSK9 inhibition held by Amgen, which makes evolocumab (Repatha), were valid and that Sanofi and Regeneron, which makes alirocumab (Praluent), infringed those patents. In January 2017, the U.S. District Court for the District of Delaware granted an injunction to prevent U.S. sales of alirocumab, but the injunction was suspended the following month pending completion of appeals. In October 2017, the U.S. Court of Appeals for the Federal Circuit overturned the permanent injunction and ordered a new trial. In that trial, the District Court and the Court of Appeals for the Federal Circuit sided with Regeneron and Sanofi, after which Amgen appealed to the Supreme Court.
According to the Supreme Court decision, written by Justice Neil Gorsuch, both companies received patents for their specific PCSK9 inhibitors in 2011, but the dispute revolved around two additional patents Amgen received in 2014. “These later-issued patents purport to claim for Amgen ‘the entire genus’ of antibodies that (1) ‘bind to specific amino acid residues on PCSK9,’ and (2) ‘block PCSK9 from binding to [LDL receptors].’ As part of its submission to the patent office, Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. Amgen then described two methods — one Amgen called ‘the roadmap’ and a second it called ‘conservative substitution’ — that scientists could use to make other antibodies that perform the binding-and-blocking functions described in the claims,” Gorsuch wrote.
The lower courts “correctly concluded that Amgen failed ‘to enable any person skilled in the art . . . to make and use the [invention]’ as defined by the relevant claims,” Gorsuch wrote.
“This Supreme Court decision protects access to this medicine and defends our industry and others against overreaching patent claims that cover an entire therapeutic category and could have a chilling effect on bringing life-saving medicines to people in need,” Leonard S. Schleifer, MD, PhD, founder and CEO of Regeneron, said in a press release issued by the company.
“This decision affirms the longstanding law on enablement and functional claiming, such that you need to enable the full scope of the claims without unreasonable experimentation,” Joseph J. LaRosa, executive vice president, general counsel and secretary at Regeneron, said in the release. “We’re gratified that the Supreme Court has affirmed the position we have held for nearly 10 years that Amgen’s PCSK9 patents were overly broad and inconsistent with established case law.”
Amgen issued the following statement by email to Healio:
“Amgen is disappointed in the outcome, but the Company will continue to fight for patent laws and policies that provide meaningful patent protection needed to foster breakthrough innovation.”
Reference:
- Amgen Inc. v. Sanofi, US No. 21-757, opinion. www.supremecourt.gov/opinions/22pdf/21-757_k5g1.pdf. Published May 18, 2023. Accessed May 18, 2023.
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