Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd., No. 18-2361 (Fed. Cir. 2019)Annotate this Case
Persion’s 760 and 499 patents, both entitled “Treating Pain in Patients with Hepatic Impairment” share a common written description and priority date and are directed to methods of treating pain in patients with mild or moderate compromised liver functionality, using extended-release hydrocodone-only formulations. Hydrocodone is an opioid, widely used to treat pain, and has been FDA-approved since 1943. The patents cover the formulation for Zohydro ER.4. Persion sued, alleging that Alvogen infringed the patents by filing an Abbreviated New Drug Application seeking to market a generic version of Zohydro ER.4. The Federal Circuit affirmed a finding that the patents are invalid as obvious. The district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims. Regardless of whether the court’s consideration of the FDA’s statement was proper, there was no clear error in the court’s finding that there was a motivation to combine prior art in light of the evidence as a whole. The district court considered Persion’s evidence of objective indicia together with the other evidence on the issue of obviousness and there is no inconsistency between the district court’s findings underlying its obviousness and lack of written description determinations.