MSD petitions SCOTUS over $2.5bn patent verdict
MSD subsidiary Idenix has urged the US Supreme Court to review the overturning of a record $2.5 billion verdict against Gilead Sciences.
Idenix, in a petition for a writ of certiorari filed on September 21 and docketed three days later, has asked the Supreme Court to decide whether genus claims can ever be enabled under section 112 of the Patent Act (which outlines enablement and written description requirements).
The patent in dispute—US number 7,608,597—claims a method of treating hepatitis C by administering nucleoside compounds that have a specific chemical and stereochemical structure.
Idenix had claimed that Gilead’s hepatitis C drugs Sovaldi (ledipasvir/sofosbuvir) and Harvoni (sofosbuvir) would infringe the ‘597 patent. Gilead, in its response, argued that the ‘597 patent was invalid for failure to meet the written description and enablement requirements.
A jury at the US District Court for the District of Delaware had originally awarded Idenix $2.54 billion in damages for patent infringement, the largest ever awarded in a US patent case.
But, in 2018, the award was reversed by District Judge Leonard Stark who, instead of finding that Gilead had infringed the patent, concluded that the patent was invalid.
This was later affirmed by the US Court of Appeals for the Federal Circuit in October 2019. The court subsequently denied Idenix’s petition for rehearing.
In its petition, Idenix alleged that the Federal Circuit’s decision conflicts with this Supreme Court’s treatment of section 112(a) generally and of genus claims specifically.
According to Idenix, the plain terms of section 112 encompass genus claims. Given the fact-intensive nature of the enquiry, it is the right of the jury to determine whether the specifications are precise enough to enable a person skilled in the art to make the invention, added Idenix.
“The Federal Circuit, however, has replaced this case-specific jury determination with two judicially invented bright-line rules that make it nearly impossible for genus claims to satisfy section 112(a),” warned the petition.
It added: “First, it has adopted a numbers-based enablement rule for genus claims based on the assumption that an artisan must be able to identify every covered compound—what that court calls the patent’s ‘full scope’—for the invention to be enabled.”
Second, said Idenix, the court developed a separate written description requirement, “under which a claim passes muster only if the inventor ‘had possession of the claimed subject matter’, including the infringing embodiment, as of the filing date”.
In addition to asking the Supreme Court to clarify whether genus claims can be enabled under section 112, the Merck subsidiary has also asked the court to clarify whether the section contains a separate possession requirement.
“This case is thus the ideal vehicle for this court to take up the two questions presented, which are two sides of the same coin. Together, they ask this court to ensure the vitality of genus claims by reinstating the singular, case-specific enablement standard that Congress and this court endorsed and entrusted to the jury,” concluded the petition.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
