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Latest Federal Court Cases, 4/29/19

April 29, 2019



Neptune Generics, LLC v. Eli Lilly & Co., Appeal Nos. 2018-1257, et al. (Fed. Cir. Apr. 26, 2019)

The Federal Circuit issued only one precedential patent decision this week. The short, 11-page decision flowed from a series of IPRs concerning patents covering the administration of folic acid and vitamin B12 with a particular chemotherapy agent. The PTAB had held the patents not obvious, and the Federal Circuit found the PTAB’s conclusion to be supported by substantial evidence. Most of the Court’s opinion concerns specific fact finding concerning the patents at issue and the prior art, and are not worthy of repeating here.

However, there were two satellite issues worth noting. First, the patent office found industry skepticism as a factor supporting nonobviousness. During clinical trial the FDA stated that it did not support adding vitamin supplements to the clinical trial, and that it considered adding vitamins “risky.” The IPR petitioner challenged that this satisfied the requirements for “skepticism,” arguing that skepticism 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, holding that “a range of third-party opinion … can constitute skepticism.” The Court continued, “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.”

Second, the Petitioner argued on appeal that the claims are also invalid under Section 101. It argued that the Federal Circuit could address this issue because it is a pure question of law. The Federal Circuit disagreed:

Congress expressly limited the scope of inter partes review to a subset of grounds that can be raised under 35 U.S.C. §§ 102 & 103. The ground of patent eligibility arises under § 101. Accordingly, we may not address it on appeal of an IPR.

Having agreed with the PTAB on all relevant issues, the Court affirmed.

The opinion can be found here.

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