shutterstock_524795992In two recent companion cases, the Federal Circuit upheld the Board’s decision that claims related to administering a natural stereoisomer to treat symptoms of folate deficiency would have been obvious.

During the inter partes review, the Board considered two prior art references: a European patent application that discloses treating elevated levels of homocysteine, often associated with folate deficiency, with folate or a suitable active folate metabolite along with B vitamins. The second reference identified the stereoisomer recited in the claims at issue as a “natural metabolite” of folate. The Board then concluded that a person of ordinary skill would have been motivated to combine these references in order to arrive at the claimed invention.

During IPR, the Board also considered and rejected objective indicia of non-obviousness. Regarding commercial success of the products, the Board found that such success was not reasonably commensurate in scope with contested claims.

Regarding industry praise, the Court agreed with the Board that the praise was particularly directed to the use of a specific stereoisomer that was already known in the art. The Court concluded that the patent owner failed to connect the evidence of industry praise to the novel elements of the claims. Likewise, the inventors’ recognition that a subset of the population had difficulty processing folic acid was not adequately tied to the novel features of the claim. The Court also noted that the claims were not limited to a particular subpopulation.

Although the Court found that the Board erred in assessing the patent owner’s licensing evidence, it also found the error harmless. The Court stated the Board erred in considering whether the licensees’ product embodied the claimed invention, but rather should have considered whether the licensing activity arose out of recognition of the subject matter claimed in the patent. Nevertheless, the Court stated that even if the Board had correctly considered the evidence of licensing, that evidence was not enough to overcome the strong evidence of obviousness.

1 On December 17, 2015, the Federal Circuit decided on appeals from the PTAB decision in two companion cases, Merck & Cie v. Gnosis S.p.A., No. 14-1779 (Fed. Cir. Dec. 17, 2015) (Gnosis I) and South Alabama Medical Science v. Gnosis S.p.A., No. 14-1778 (Fed. Cir. Dec. 17, 2015) (Gnosis II).
2 See Gnosis II, at 3-4.
3 See Gnosis II, at 6.
4 See id.
5 See id. at 6-7 (“[E]vidence was not adequately tied to the novel features of the claimed invention.”).
6 See id. at 7-8 (The Court held that this error was “harmless” to the overall determination).