After Amgen last year asked the Supreme Court to take up its long-running PCSK9 patent feud with Sanofi and Regeneron, the High Court turned to the federal government to weigh in. Now, the Biden administration says the court should turn down the California drugmaker's request to take up the case.
In a Supreme Court brief (PDF), the U.S. Solicitor General, Elizabeth B. Prelogar, said Amgen's petition "should be denied.” After reviewing the case, the government backed an appeals court's ruling that Amgen's patent claims at issue are invalid because “undue experimentation” would be required to “enable their full scope.”
Amgen first sued Sanofi and Regeneron back in 2014, alleging patent infringement when the partners sought approval for their PCSK9 cholesterol drug Praluent. At the time, Amgen asked the court to back broader protections on antibody drugs such as its own PCSK9 medicine Repatha.
While Amgen scored some early wins in the saga, things have been going Regeneron and Sanofi's way lately. Last February, the U.S. Court of Appeals for the Federal Circuit invalidated two Repatha patents, prompting Amgen to request another hearing in June.
When the court shot down that request, the company either had to give up or turn to the Supreme Court.
Throughout the case, Amgen and its supporters have argued that without broader protections, me-too drugs could hit the scene and make minor changes to successful medicines without committing significant resources to research. Sanofi and Regeneron, for their part, have argued that Amgen's patent claims, if upheld, could allow companies to fend off entire classes of new drugs by making overly broad claims on their inventions.
Repatha generated $1.11 billion for Amgen last year, while Regeneron reported $421 million in Praluent sales. Sanofi also logged 218 million euros ($214 million) in Praluent sales.