Eli Lilly secures victory before Federal Circuit
The US Court of Appeals for the Federal Circuit affirmed a series of Patent Trial and Appeal Board (PTAB) inter partes reviews (IPRs), which upheld a patent owned by Eli Lilly late last week.
In a precedential decision handed down on Friday, April 26, the Federal Circuit rejected arguments from Neptune Generics, Mylan and Fresenius Kabi and affirmed the PTAB’s decisions.
The patent at issue, US number 7,772,209, relates to administering folic acid and a methylmalonic acid lowering agent, before administering pemetrexed disodium, a chemotherapy agent, in order to reduce the toxic effects of pemetrexed.
The patent covers the vitamin regimen for Alimta (pemetrexed for injection), a chemotherapy drug.
Neptune Generics, Mylan and Fresenius Kabi appealed against inter partes review decisions which found they hadn’t established that claims 1-22 of the ‘209 patent were unpatentable for obviousness.
The petitioners attempted to argue that the PTAB had erred in not considering Eli Lilly’s communications with the Food and Drug Administration during the clinical trials of pemetrexed.
In particular, they argued that in its communications with the FDA, Lilly “inform[ed] the FDA that the prior art suggested that pretreating with folic acid and B12 was a no-risk, predictable way to lower pemetrexed-induced fatalities by lowering pretreatment homocysteine levels”.
The trio claimed that even if the communications are not in the prior art, they reflect the background knowledge of a skilled artisan and are indicators of the level of ordinary skill in the art.
But the Federal Circuit concluded: “Because the board did not err in its obviousness analysis, substantial evidence supports its underlying fact findings, and subject matter eligibility is not properly before the court in an appeal from an IPR decision, we affirm.”
The petitioners also argued that the patent claims are not directed to patentable subject matter.
“It argues this issue is properly raised because eligibility is a question of law and in this appeal there are no factual issues that must be decided. We do not agree,” said Circuit Judge Kimberly Moore, on behalf of the court.
Moore added that the court may not address the issue on appeal of an IPR, before affirming the PTAB’s decisions.
Michael Harrington, senior vice president and general counsel for Eli Lilly, said: “We are pleased with today's ruling by the appeals court finding the claims of the Alimta vitamin regimen patent are valid.”
He added: “Lilly's extensive research to discover the Alimta vitamin regimen patent deserves IP protection, which has been confirmed in every validity challenge in the US to date.”
Did you enjoy reading this story? Sign up to our free newsletters and get stories like this sent straight to your inbox.
