Deny Amgen’s ‘dangerous’ patent claims, Sanofi urges Supreme Court
French pharma firm urges US court not to allow ‘monopoly’ over market | Enablement issue at centre of antibody patent case could have wide implications for pharma and life sciences industries.
Sanofi has attacked Amgen’s “blatant attempt to corner the market” in a petition submitted to the US Supreme Court, as part of its argument that a ruling invalidating an Amgen patent should be upheld.
The document, released on February 3, details Sanofi’s standpoint that Amgen has claimed a monopoly “over far more than it has enabled”.
The Supreme Court granted a petition for a writ of certiorari in the case in November last year, which addresses the question of whether enablement is governed by the statutory requirement that the specification teaches those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation.
Amgen’s patents relate to monoclonal antibodies which bind to certain naturally-occurring proteins. The patents identify 26 antibodies which would bind as claimed, but millions of other antibodies might also do so.
A trial court and the US Court of Appeals for the Federal Circuit deemed Amgen’s claims to be invalid because there are too many possible solutions beyond what was disclosed by the patents.
Amgen has been working to overturn this ruling with many others weighing in on the debate as it has far-reaching consequences for the industry.
Market implications
Sanofi and Regeneron, who developed the PCSK9-blocking antibody Praluent (Alirocumab), are now embroiled in a Supreme Court battle with Amgen over the patents. They say that, after they developed Praluent, Amgen obtained additional patents that broadly claim the entire genus of PCSK9-blocking antibodies by function rather than structure, in an attempt to monopolise the market.
According to the petition, these claims are “not just invalid, but dangerous” as they could take medicines away from physicians and patients “and could allow someone without a clinically valid species to claim an entire genus of medically-vital antibodies they have not yet discovered”.
Sanofi argues that “the text of §112 and a host of this court’s precedents require the specification to enable the full scope of the invention, not leave skilled artisans where they started with no ability to make and use particular claimed antibodies with anything but trial and error using well-established techniques”.
Part of Amgen’s response to the argument is around the impact on innovation in the sector. An amicus brief by a group of law professors said without the ability to make broader claims, a competitor could make a minor change to the invention and avoid liability.
