GSK, Amgen want SCOTUS to protect genus claims
Patent law experts and pharmaceutical companies have lent their support to Merck Sharp & Dohme (MSD) in its effort to confirm the patent-eligibility of genus claims at the US Supreme Court.
MSD’s Idenix has asked the country’s highest court to reverse a US Court of Appeals for the Federal Circuit decision which held genus claims in a Hepatitis C treatment patent to be ineligible for protection.
Idenix has now received the backing of Amgen and GlaxoSmithKline (GSK), as well as a group of 14 IP law professors, who have all filed amicus briefs in support of the MSD subsidiary.
Genus claims cover a group of related chemicals in a pharmaceutical product. MSD sued Gilead Sciences for allegedly infringing the genus claims in its patent by developing its own Hepatitis C treatment.
The Federal Circuit ruled that Idenix’s genus claims were ineligible under a part of US patent law known as section 112, which says the patent specification must include a written description of the invention.
“Genus claims are everywhere, and any patent lawyer will tell you they are critical to effective patent protection … without them, a competitor could make a minor change to the chemical the patentee invented and avoid liability while capturing the heart of the invention,” the IP professors argued.
The academics said the Federal Circuit had, in the Idenix and other decisions, effectively rewritten the law on genus claims in the chemical and pharmaceutical industries.
“The Federal Circuit now rejects claims as invalid because the genus contains thousands or millions of possible chemicals, unless the patent itself identifies exactly which of those myriad species will work. That is an impossible burden, and it is not one the law imposed until recently,” the professors’ amicus brief said.
GSK claimed the ruling, if upheld, could “devastate the incentives” for pharmaceutical companies to invest in researching chemical structures.
“Instead of focusing its efforts on developing the next groundbreaking drug, GSK would be forced to seek narrow patent claims that underrepresent the full breadth of its inventions and its true contributions to the scientific community,” GSK argued.
Amgen, meanwhile, agreed that the Federal Circuit’s position “makes it extremely difficult to defend justifiably broad patents on pathbreaking innovations”.
Gilead has waived its right to respond to Idenix’s petition asking the Supreme Court to review the Federal Circuit’s decision.
MSD is known as Merck & Co in the US and Canada.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
