Combining Two Drugs Is Not Always Obvious

by McDermott Will & Emery

Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc.

Addressing the obviousness of combining two known hypertension medications, the U.S. Court of Appeals for the Federal Circuit upheld a ruling of non-obviousness where the prior art did not teach the drug combination and post-filing evidence showed unexpected benefits.  Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc., USA, Case No. 12-1489 (Fed. Cir., Apr. 21, 2014) (Newman, J.)

The plaintiffs sued Glenmark after the U.S. Food and Drug Administration (FDA) approved Glenmark’s abbreviated new drug application for a generic version of Tarka®, a hypertension drug.  The asserted patent relates to combining trandolapril (an ACE inhibitor) and verapamil (a calcium channel blocker) to treat hypertension.  Sanofi-Aventis, Aventis Pharma, Abbott GMBH, Abbott Laboratories (Abbott Labs) and Abbott Laboratories, Inc. (ALI) own or exclusively license the patent.  Abbott Labs owns the new drug application (NDA) for Tarka, and ALI is the exclusive distributor.  The plaintiffs sought damages due to Glenmark’s “at risk” launch of its generic drug.

Glenmark conceded infringement but challenged the patent as being obvious in a jury trial. According to Glenmark, combining ACE inhibitors with calcium channel blockers to treat pulmonary hypertension was well-known as of the priority date.  Thus, any hypertension treatment containing both drugs would have been “obvious to try” and, under KSR, invalid.  The jury rejected this argument, finding the patent was not invalid.  After the district court entered judgment on the verdict, Glenmark appealed.

The Federal Circuit upheld the ruling. Undisputed evidence showed that the prior art did not suggest using the claimed combination for hypertension. Moreover, the Court observed that the record showed there were hundreds if not thousands of potential combinations of ACE and calcium channel blocker combinations, and prior art did not suggest which might work.  The Court indicated that under those circumstances, Glenmark’s “obvious to try” argument failed.

In terms of objective evidence of non-obviousness, the Federal Circuit also found further support for the jury’s verdict in the form of Tarka’s unexpected superiority as a hypertension treatment over those in the prior art.  Glenmark argued that evidence of the drug’s unexpected benefits was discovered too late (after filing of the application) to be considered in an obviousness analysis.  The Court disagreed explaining “patentability may consider all of the characteristics possessed by the claimed invention, whenever those characteristics become manifest.”

Glenmark also asserted that co-plaintiffs Abbott Labs and ALI lacked standing, a prerequisite to recovering damages.  According to Glenmark, Abbott’s alleged ownership of the Tarka New Drug Application (NDA) arose before Abbott licensed the patent, those licensing rights were a prerequisite to owning the NDA and later attempts by the plaintiffs to paper over problem through a “Confirmatory Agreement” were ineffective for lack of consideration.

The Court rejected these arguments, agreeing with the district court’s finding that the parties evinced a mutual intent to transfer and vest in Abbot Labs exclusive rights to the patent.  This was revealed in Abbott’s ownership of the NDA, ALI’s exclusive distribution rights derived through Abbott, and other agreements between the parties.  Finally, the Court noted that all entities in the license chain joined the suit, which eliminated the risk of multiple infringement suits.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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