US court backs Sanofi and Regeneron in Amgen suit
A US judge yesterday, August 28 ruled in favour of Sanofi and Regeneron in the pharmaceutical companies’ long-running patent dispute with Amgen over the cholesterol drug Praluent.
In February, a jury ruled that Amgen’s patents for its own cholesterol medicine, Repatha, were valid. The verdict was a blow to Sanofi and Regeneron, whose rival drug Praluent was adjudged to have infringed Amgen’s IP.
Both drugs function by binding to the PCSK9 gene, and in turn lowering cholesterol.
That verdict has now been set aside, following a request from Sanofi and Regeneron. In its opinion, the US District Court for the District of Delaware ruled that certain claims of Amgen’s patents for the drug were invalid as they were not enabled.
The court agreed with Sanofi and Regeneron’s argument that the patents would require undue experimentation by a person of ordinary skill in the art.
In its opinion, the court cited a ruling earlier this year in MorphoSys v Janssen when finding that, in order to obtain the antibodies disclosed in Amgen’s patents, a person of ordinary skill in the art would have to do “essentially the same amount of work as the inventors of the patents-in-suit."
In addition, there could still be a significant element of trial-and-error when seeking to obtain the antibodies according to the method disclosed by the patents.
As such, the court found that the patents were not particularly “instructive”.
Karen Linehan, executive vice president and general counsel at Sanofi, said that “it has been our longstanding belief that all of Amgen’s asserted US PCSK9 patent claims are invalid, and we are pleased today’s decision reaffirms this”.
Regeneron said the verdict confirmed the company’s position that Amgen’s patents were “overly broad and invalid”.
The latest decision marks a victory for Sanofi and Regeneron in a long-running saga in which both sides have at various points had the upper hand.
Last month, a German court ruled that Praluent infringed one of Amgen’s European patents.
The Düsseldorf Regional Court’s ruling followed a failed bid by Sanofi to have the case thrown out.
LSIPR has contacted Amgen for comment.
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