NEPTUNE GENERICS, LLC, FRESENIUS KABI USA, LLC v. ELI LILLY & CO.

Before Moore, Wallach, and Hughes.  Appeal from the Patent Trial and Appeal Board

Summary:  Industry skepticism is a question of fact that weighs in favor of non-obviousness and can range on a scale, with the most weight afforded to skepticism that the subject matter is technically infeasible, unworkable, or impossible.

Neptune and Fresenius (“Petitioners”) requested three Inter Partes Reviews (“IPR”) of a patent owned by Eli Lilly for the administration of chemotherapy to cancer patients.  Before administering the chemotherapy agent, the patent claims require administering folic acid and a methylmalonic acid (“MMA”) lowering agent, such as vitamin B12, in order to reduce the toxic effects of the chemotherapy agent.  The Board found that the Petitioners did not establish that the claims at issue were unpatentable for obviousness.  The Board cited secondary considerations in support of its non-obviousness finding, including skeptical communications from the FDA regarding the clinical trials.

On appeal, the Federal Circuit affirmed the Board’s finding that the prior art did not provide a motivation for a skilled artisan to administer an MMA lowering agent.  In support, the Federal Circuit found that the Board did not err in its consideration of Eli Lilly’s FDA communications.  During clinical trials, the FDA stated that it did “not support adding vitamins to the ongoing . . . trial” and that “the addition of vitamins . . . is risky.”  The Petitioners argued that the FDA’s concerns did not support a finding of skepticism because the FDA allowed the trials to continue.  Petitioners argued that secondary considerations of “skepticism must be premised on whether it is ‘technically infeasible,’ ‘unworkable,’ or ‘impossible’ that the claimed subject matter would work for its intended purpose.”  However, the Federal Circuit found that Petitioners’ argument was not consistent with case law, which “recognize[d] a range of third-party opinion that can constitute skepticism.”  The Court held that “while evidence that third parties thought the invention was impossible might be entitled to more weight, that does not mean the Board erred in giving weight to the skepticism evidence here.”  

This case is: NEPTUNE GENERICS, LLC, FRESENIUS KABI USA, LLC v. ELI LILLY & CO.