Idenix $2.5bn ruling will impede innovation, says Amgen
Pharmaceutical company Amgen has asked a full US Court of Appeals for the Federal Circuit to review the overturning of a record $2.5 billion verdict against Gilead Sciences.
In an amicus brief filed Friday, January 31, Amgen said the Federal Circuit should review its precedential October 2019 decision which affirmed that Merck subsidiary Idenix’s hepatitis C treatment patent had failed to adequately explain how to make the treatment.
While a jury at the US District Court for the District of Delaware had originally awarded $2.54 billion in damages for patent infringement, the largest ever awarded in a US patent case, this was reversed by District Judge Leonard Stark in 2018.
Instead of finding that Gilead had infringed a patent held by rival Idenix through its HCV drugs Sovaldi (ledipasvir/sofosbuvir) and Harvoni (sofosbuvir), Stark concluded that the patent was invalid.
The Federal Circuit, in October 2019, affirmed Stark’s decision.
However, in early January, Idenix submitted a petition for an en banc rehearing of the dispute, arguing that the most recent decision effectively writes new enablement and description rules “with profound consequences for genus claims, long acknowledged as essential to developing and protecting new medical treatments and urgently needed cures”.
According to Idenix, the Federal Circuit’s panel held that the claims were non-enabled as a matter of law, because “the number of candidate compounds to be tested” was too large, despite finding that synthesis and screening in the patent’s art were both considered routine.
“For written description, it paradoxically concluded the patent contained too much disclosure without specifically disclosing the infringing product, rendering the infringing product ‘conspicuously absent’,” said Idenix.
Amgen’s brief
Late last week, Amgen sided with Idenix in its brief, claiming that the ruling will impede innovation in the medical field.
“Without the protection of genus claims, second-comers could easily appropriate the value of the invention and the investment of the innovator by piggy-backing off the blueprint the pioneer provides through its patent publication and do so with high confidence of success at a much lower cost and no contribution to the advancement of science,” warned Amgen.
The brief added that litigants are already arguing that Idenix prohibits any claim scope broader than the specific examples disclosed as a matter of law.
“Such a reading would clearly be in tension with precedent,” said Amgen.
It added: “Such a trend in enablement would narrow the available scope of patent protection for breakthrough innovations to the point where it fails to provide the marketplace protections necessary to support the large investments associated with such inventions and the early public disclosure that defines the patent bargain.”
According to Amgen, suggesting a requirement of greater numbers of working examples for a broad genus that encompasses “thousands and thousands” of species could pressure innovators to withhold their disclosures until they’ve amassed all of these examples.
“Resources that the entire industry will now feel forced to devote to synthesizing and screening such cumulative examples will be resources unavailable to discovering the next breakthrough medicine,” warned the brief.
Finally, Amgen claimed that it shares the industry-wide concern that if this “pendulum swings too far”, as the Idenix decision portends, it will have a “crippling effect” on the pace and breadth of scientific advancement in medicine in the US.
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