A Belated Lesson In How To Avoid A Finding Of Obviousness Based Upon Inherent Disclosure

Decision: Persion Pharms. LLC v. Alvogen Malta Operations Ltd., No. 2018-2361 (Fed. Cir. Dec. 27, 2019) (REYNA, O'Malley, Chen)

Holding: The District Court of Delaware held Persion's claims invalid for obviousness and lack of written description. The Federal Circuit affirmed the obviousness determination, recognizing the proper application of inherent disclosure in an obviousness determination, and did not reach the written description issue.   

Background: Persion owns U.S. Patent Nos. 9,265,760 ("the ʼ760 patent") and 9,339,499 ("the ʼ499 patent) directed to treating pain associated with renal or hepatic impairment using hydrocodone-only formulations. The patents cover the commercial product Zohydro ER and share a common written description and priority date. When the FDA evaluated Zohydro ER, it required a clinical study that is described in Example 8. The results of this study led researchers to file patent applications that eventually issued as the '760 and