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Recently, the U.S. Court of Appeals for the Federal Circuit issued an opinion in <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-2361.Opinion.12-27-2019.pdf" target="_blank" rel="noopener"><em>Persion Pharm. LLC v. Alvogen Malta Operations Ltd.</em></a>, No. 2018-2361 (Dec. 27, 2019), affirming the district court’s decision that Persion’s asserted patent claims were invalid as obvious.

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Persion is the owner of U.S. Patents Nos. 9,265,760 and 9,339,499, both entitled “Treating Pain in Patients with Hepatic Impairment.” Both patents share a written description and priority date and cover methods of treating pain in patients with hepatic impairment through the use of hydrocodone. Persion sued Alvogen for infringement of both patents after Alvogen filed an Abbreviated New Drug Application seeking to market a generic version of Persion’s hydrocodone drug. The district court concluded that Alvogen would indirectly infringe the asserted claims because its product label would induce doctors and patients to administer the generic product in an infringing manner. However, the district court also concluded that the asserted patents were invalid as obvious over the Devane patent in light of the teachings of the Vicodin and Lortab drug labels. The district court determined that, in light of these labels, one of ordinary skill in the art would have been motivated to administer hydrocodone at an adjusted dose in accordance with the claims of the Persion patents, and that such person would have had a reasonable expectation of success in so doing. Persion appealed.

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The Federal Circuit affirmed, rejecting each of the four arguments raised by Persion concerning the district court’s obviousness holding. First, the Court held that inherency may supply a missing claim limitation even when not all claim limitations are taught by a single reference. Second, the Court found no error in the district court’s reliance on pharmacokinetic data from formulations and patient groups not covered by the asserted claims to inform its analysis. Third, the Court found no error in the district court’s consideration of objective indicia of non-obviousness. Specifically, the Court explained that, although these factors were discussed by the district court after discussing the asserted prior art, the district court’s analysis made clear that consideration of objective indicia was not a mere afterthought. Lastly, the Court found no inconsistencies between the district court’s determinations on obviousness, reasonable expectation of success, and written description. In view of the affirmance of the district court’s decision on obviousness, the Court declined to reach any of the remaining issues presented on appeal.

CAFC Affirms Obviousness Determination of Hydrocodone Method Patents

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