Sanofi-Aventis Deutschland GMBH et al. v. Glenmark Pharmaceuticals Inc., USA et al.

Docket No. 2012-1489

April 21, 2014

Brief Summary: Jury verdict findings that Sanofi’s patent covering a combination of drugs for treatment of hypertension (Tarka®) is not invalid for obviousness (to try), Glenmark was not entitled to a new trial, and Abbott had standing were affirmed.

Summary: Glenmark appealed jury decision that Sanofi’s (with Aventis Pharma S.A., Abbott GmbH, Abbott Laboratories as owners or licensees) US 5,721,244 encompasing the combination of the angiotensin converting enzyme (ACE) inhibitor trandolapril and the calcium channel blocker (calcium antagonist) verapamil hydrochloride for hypertension (marketed as Tarka®) was not invalid for obviousness. Claim 1 encompasses a pharmaceutical composition comprising an ACE inhibitor and a calcium antagonist “wherein said ACE inhibitor and said calcium antagonist are present in said composition in amounts effective fo treating hypertension”. Disputed claim 3 is dependent on claim 1 and specifies the ACE inhibitor to be trandolapril. Glenmark argued that “if a combination of classes is already known, all selections within such classes are obvious to try, as a matter of law” (“the Tarka® product simply substituted one known ACE inhibitor for another…It is not invention merely to select something from a list of items in the prior art…even if the combination is later found to possess unexpected or advantageous properties.”) The opinion explains that the ACE inhibitors used in the prior art were “single-ring compounds” (enalapril and captopril) but that used in Tarka® is a “double-ring compound” which Glenmark’s expert testified was not “suggested for use in combination with a calcium channel blocker in any prior art reference” (although the expert disagreed with Sanofi’s expert that those of ordinary skill “generally believed that double-ring ACE inhibitors were not more effective than single-ring inhibitors to control hypertension”). However, the FC panel concluded that the jury “could reasonably have relied on the testimony of the Plaintiff’s expert, that persons skilled in the art in 1986 would not have predicted the longer-lasting hypertension control demonstrated by the double-ring structures of quinapril and trandolapril in combination with calcium antagonists, because of the widespread belief that double-ring inhibitors would not fit the pocket structure of the ACE” (discussing Eisai, FC 2008 (“in the medical arts ‘potential solutions are less likely to be genuinely predictable’…as compared with other arts such as the mechanical devices in KSR.”); Genetics Inst., FC 2011 (holding that inventors may rely on advantages appearing after the patent application was filed); In re Khelghatian, CCPA 1966 (reliance on an unexpected property not disclosed in the application may be entitled to weight if “directed to that which would inherently flow from what was originally disclosed”); Merck, FC 1989 and Richardson-Vicks, FC 1997 (combination obvious to try); Pozen, FC 2012 (combination of naproxen and sumatriptan not obvious because combination not suggested by prior art, longer-lasting efficacy shown)). Thus, the evidence supported “the verdict that obviousness had not been proved by clear and convincing evidence” and the judgment affirmed. Glenmark also argued it was entitled to a new trial and that no damages should be awarded to Abbott (US companies) (jury awarded damages of about $16 million) but the FC panel disagreed.

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