In Persion Pharmaceuticals LLC v. Alvogen Malta Operations LTD., [2018-2361] (December 27, 2019) the Federal Circuit affirmed the district court’s determination that the asserted claims of U.S. Patent No. 9,265,760 and 9,339,499, entitled “Treating Pain in Patients with Hepatic Impairment,” were obvious.

Persion raised four primary challenges to the district court’s obviousness conclusion. First, Persion contended that the district court improperly relied on inherency to conclude that the prior art discloses the pharmacokinetic limitations of the asserted claims. It is long settled that in the context of obviousness, the mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art. The Federal Circuit noted that the Supreme Court explained long ago that it is not invention to perceive that the product which others had discovered had qualities they failed to detect.

However, inherency is a high standard, that is carefully circumscribed in the context of obviousness. Inherency may not be established by probabilities or possibilities, and the mere fact that a certain thing may result from a given set of circumstances is not sufficient. Inherency renders a claimed limitation obvious only if the limitation is “necessarily present,” or is “the natural result of the combination of elements explicitly disclosed by the prior art.” The Federal Circuit said “inherency may supply a missing claim limitation in an obviousness analysis” where the limitation at issue is “the natural result of the combination of prior art elements,” and found that was the case here.

Second, Persion argued that the district court improperly relied on pharmacokinetic profiles from drugs other than extended-release single-active-ingredient hydrocodone formulations and from patients other than those with hepatic impairment in reaching its obviousness conclusion. The Federal Circuit found that the district court provided several reasons for its conclusion that a person of ordinary skill in the art would have considered other types of drug products in developing a hydrocodone-only extended-release formulation. In light of the record as a whole, we find no clear error in the district court’s findings on the relevance of combination product data to a person of ordinary skill considering the administration of a hydrocodone-only product.

Third, Persion contended that the district court erred by finding the asserted claims obvious before considering the objective indicia factors. The Federal Circuit found that the district court considered Persion’s evidence of objective indicia together with the other evidence presented at trial on the issue of obviousness. While the district court’s discussion of objective indicia followed its discussion of the asserted prior art, the Federal Circuit found that the substance of the court’s analysis makes clear that it properly considered the totality of the obviousness evidence in reaching its conclusion and did not treat the objective indicia as a mere “afterthought” relegated to rebutting a prima facie case. Overall, the Federal Circuit found no clear error with the district court’s assessment of the objective indicia evidence. Fourth, Persion argued that the district court’s factual findings concerning obviousness are inconsistent with its findings concerning the lack of written description support. The Federal Circuit found no such inconsistency, noting that Persion’s entire argument with respect to this issue is based on incomplete quotations from the district court’s opinion.