A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

Neptune Generics, LLC, et al. v. Eli Lilly & Co., Nos. 2018-1257, -1258, -1288, -1290 (Fed. Cir. (PTAB) Apr. 26, 2019). Opinion by Moore, joined by Wallach and Hughes.

In a series of IPRs, the Petitioners challenged a patent directed to administering certain compounds to a patient in need of chemotherapy. The challenged claims cover, essentially, administering both folic acid and vitamin B12 before administering a chemotherapy agent in order to reduce the toxic effects of pemetrexed, an antifolate. The Patent Trial and Appeal Board determined that the claims were not unpatentable for obviousness.

The Federal Circuit affirmed, ruling that each step of the Board’s analysis was supported by substantial evidence. This included the Board’s findings that pemetrexed-induced toxicity correlated with folate deficiencies, but not vitamin B12 deficiencies; that the art did not provide a motivation for a skilled artisan to administer vitamin B12 in addition to folic acid; and that one of the prior art references “did not provide information as to how pretreatment with folic acid and vitamin B12 would impact toxicity effects.”

Next, the Federal Circuit addressed certain communications between the Patent Owner and the FDA that, according to the Petitioners, supported obviousness. For instance, the Patent Owner had told the FDA that “pretreating with folic acid and B12 was a no-risk, predictable way to lower pemetrexed-induced fatalities.” The challenged statements, however, were made five months after the critical date and were “made through the lens of what they had invented.” The Federal Circuit therefore ruled that the Board did not err by declining to read the prior art in view of these communications.

Finally, the Federal Circuit addressed the FDA’s expressed skepticism during clinical trials for pemetrexed, which the Board found supported its conclusion of nonobviousness. The FDA had identified concerns that adding vitamins along with folic acid was risky and not supported by the FDA medical officer. On appeal, the Petitioners argued that this sort of skepticism was irrelevant because skepticism for purposes of nonobviousness “must be premised on whether it is ‘technically infeasible,’ ‘unworkable,’ or ‘impossible’ that the claimed subject matter would work for its intended purpose.” The Federal Circuit disagreed because the court’s caselaw “recognizes a range of third-party opinion that can constitute skepticism.”

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