Federal Circuit reverses DC and finds Horizon’s ‘907 and ‘285 Vimovo® Orange Book patents invalid for lack of written description

Nuvo Pharmaceuticals, Horizon Medicines LLC v. Dr. Reddy’s Labs. et al.

Docket No. 2017-2473, -2481, -2484, -2486, -2489, -2491-93
May 15, 2019

Brief summary: DC reversed as FC panel found found Nuvo/Horizon’s ‘907 and ‘285 claims to be invalid for lack of WD.

Summary: Dr. Reddy’s, Mylan, and Lupin (ANDA filers, “the Generics”) appealed DC final judgment finding Nuvo’s US 6,926,907 and 8,557,285 (shared specifications; two of ten Orange Book patents for the non-steroidal anti-inflammatory (NSAID) / proton pump inhibitor (PPI) combination product Vimovo®) non-obvious (§ 103), enabled (§ 112 enablement), and described (§ 112 written description (WD)). Nuvo and licensee Horizon appealed the DC’s grant of SJ of noninfringement to Dr. Reddy’s. Representative ‘907 claim 1 and ‘285 claim 1 are both directed to a “unit dosage form” …comprising” a PPI and an NSAID, where the NSAID is coated such to prevent release in a medium having a pH of 3.5 or higher (“in amount effective to reduce or eliminate pain or inflammation”, “therapeutically effective amounts”). The Generics argued that “the prior art taught away from” the claimed therapeutic effectiveness and therefore the WD “requires either supporting experimental data, or some reason, theory, or alternative explanation as to why the claimed invention is possessed by the inventor, and that mere recitation of the claim language in the specification cannot suffice.” The FC panel explained that the DC, “after finding that the specification lacks ‘information regarding the efficacy of uncoated PPIs,’ said it was enough that the specification described the immediate release of uncoated PPI and the potential disadvantages of enteric-coated PPI formulations.” The FC panel concluded, after “search[ing] the specification for [WD] support”, that the disclosure the DC “pointed to in no way provides support for the claimed efficacy of uncoated PPI”. For instance, the FC panel found that Novo’s expert testimony “recite[s] the claim limitations by simply calling generally for effective amounts of uncoated PPI, but our precedent clearly establishes that is not enough” (“it does not demonstrate that he actually invented what he claimed”) (Enzo, FC 2002 (WD not met just because claim language is in the specification), Centocor, FC 2011 (“[a] ‘mere wish or plan’” is not enough); but also citing Allergan, FC 2015; In re ‘318, FC 2009 (“testing need not be conducted”) and Univ. Rochester (FC 2004 (“invention does not actually have to be reduced to practice”)). Nuvo also argued that the effectiveness should be “a matter of inherency”, which the DC rejected as a ground for WD support, citing Alcon (FC 2014 (“it is enough that the patents teach making and using the claim combination drug formulation”)). The FC panel distinguished Alcon from this case since, in Alcon, the WD was “satisfied at least in part by accelerated stability testing showing the claimed effect”. The FC panel also explained that inherency can provide WD support (e.g., Allergan; Yeda, FC 2016 (“patent application…explicitly recites the invention’s inherent properties”)), but distinguished this case from Allergan (which demonstrated “a trend in their clinical effectiveness, even if the data were not specifically related to the exact formulation claimed”). Here, the FC panel found “there is no written disclosure that in any way relates to the efficacy of immediately released PPI” (“when the inventor expressly claims [a] result…that result must be supported”). Thus, the FC panel reversed the DC and found ‘907 and ‘285 claims to be invalid for lack of WD. The other arguments were not addressed, and Novo’s cross-appeal was dismissed.

This entry was posted in Generics / ANDA, Inherency, Written description. Bookmark the permalink.

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