Persion’s Zohydro ER claims invalid for obviousness and lack of written description (“inherently result in the claimed [PK] parameters”, functional limitations too broad)

Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.

Docket Nos. 2018-2361
December 27, 2019

Brief Summary: DC findings of invalidity of Persion’s hepatic insufficiency claims related to Zohydro ER for obviousness and no WD affirmed.

Summary: Persion appealed DC decision finding US 9,265,760 and 9,339,449 relating to methods for treating pain in a “patient having mild or moderate hepatic impairment” using “extended release hydrocodone” (Zohydro ER, two of 17 OB patents) invalid as obvious and lacking written description (WD). The ‘760 and ‘449 patents share a common written description and priority date. The FC panel explained that “the FDA required the owner” (of Zohydro) “to conduct a clinical study” regarding hepatic impairment which showed the drug “did not result in substantially higher concentrations of hydrocodone” in the blood of subjects with hepatic impairment, and led to the ‘760 and ‘449 patents, the claims of which “are not limited to the use of the Zohydro ER formulation but instead cover methods of using any extended-release formulation” of hydrocodone. The FC panel separated the ‘760 and ‘449 claims into “non-adjustment” and “pharmacokinetic” (“does not increase average hydrocodone AUC0-inf” or “Cmax” (PK claims)) categories. The DC concluded the ‘760 and ‘499 claims are invalid as obvious in view of the prior art references (Devane, Jain and the Vicodin and Lortab labels), and for WD as lacking “guidance as to whether other formulations would satisfy the functional limitations of the claims”. Persion argued the DC improperly relied on inherency in its obviousness conclusions for the PK claims, but the FC panel disagreed (the prior art “taught the combination of elements that inherently result in the claimed [PK] parameters” (PAR, FC 2012 (inherency where “limitation is ‘necessarily present,’ or is ‘the natural result’”); also citing Santarus, FC 2012 (“an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations”), In re Kao, FC 2011 (“inherent [PK] property…‘add[ed] nothing of patentable consequence’”), In re Kubin, FC 2009 (“a property necessarily present in [the claimed protein]”), and In re Wiseman, CCPA 1979 (“‘not the law’ that ‘a structure suggested by the prior art…is patentable…because it also possesses an [i]nherent, but hitherto unknown, function”)). The FC panel also found no error with the DC’s consideration of data regarding non-hepatically impaired patients. The FC panel also found no error with the DC’s reliance on the FDA’s finding that safety data regarding a hydrocodone/ibuprofen combination product as part of the Zohydro ER NDA was not sufficient to support use for hepatically impaired patients since “[t]he standard to find a motivation to combine is far below what is sufficient to prove safety and efficacy to the FDA”. The DC’s reliance on other data regarding other products was similarly not found to be erroneous. Persion also unsuccessfully argued the DC did not properly consider secondary consideration evidence, but the FC panel disagreed (“clear that it properly considered the totality of the obviousness evidence” (Leo Pharm., FC 2013; Cyclobenzaprine, FC 2012). The FC panel also found no inconsistency in the DC’s obviousness and no WD conclusions since the patent only supported the claims as to the Zohydro ER formulation, but claimed much more functionally. The DC decision was therefore affirmed.

This entry was posted in Functional limitations, Inherency, Method claims, Obviousness, Obviousness (Secondary Considerations), Uncategorized, Written description. Bookmark the permalink.

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