Case Name: Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms Inc., 748 F.3d 1354 (Fed. Cir. Apr. 21, 2014) (Circuit Judges Newman, Linn and Wallach presiding; Opinion by Newman) (Appeal from D.N.J., Cavanaugh, J.)

Drug Product and Patent(s)-in-Suit: Tarka^® (trandolapril/verapamil hydrochloride); U.S. Pat. No. 5,721,244 (“the ’244 patent”)

Nature of the Case and Issue(s) Presented:  The parties tried the issue of validity before a jury after Glenmark stipulated that its ANDA product would infringe the patent-in-suit. The jury found the ’244 patent valid and awarded Sanofi damages for Glenmark’s at risk launch. The trial court denied all post-trial motions and Glenmark appealed. Glenmark raised three arguments on appeal: (i) the ’244 patent was invalid; (ii) Glenmark was entitled to a new trial based on a prejudicial jury instruction on evidence spoliation; and (iii) that no damages should have been awarded due to lack of standing of the Abbott United States companies. The ’244 patent claims a pharmaceutical composition which is the combination of an angiotensin-converting enzyme inhibitor and a calcium antagonist. The asserted dependent claim identified the ACE inhibitor as trandolapril or quinapril. Glenmark argued that the jury finding could not stand because, as a matter of law, the claimed combination consisted of compounds that were already known and whose selection was obvious to try.

The Federal Circuit found substantial evidence to support the jury’s finding based on the structure of the ACE inhibitors. The district court concluded that Glenmark failed to preserve documents and instructed the jury to draw an adverse inference that electronic documents from 2005-2006 would have been unfavorable. Glenmark argued that the inference was improper because Sanofi did not make a showing that any deleted e-mails contained relevant evidence. The Federal Circuit was not persuaded because generic drug discussions occurred during the time period in question and found that the jury instruction was not an abuse of discretion. Finally, Glenmark challenged the standing of Abbott Laboratories (“Abbott”) and Abbott Laboratories, Inc. (“ALI”). Glenmark argued that since Abbott was not an exclusive licensee of the ’244 patent, it was not entitled to lost profits and price erosion damages. The Federal Circuit rejected this argument finding that the district court did not clearly err in finding that Abbott and ALI have exclusive rights in the United States under the ’244 patent.

Why Sanofi Prevailed:  The Federal Circuit rejected Glenmark’s obvious to try argument because of the structure of the ACE inhibitor. Trandolapril is a “double-ring” compound. At the time the patent was filed in 1986, the only FDA approved ACE inhibitors were single-ring inhibitors (enalapril and captopril). At trial, Glenmark’s expert testified that quinapril and trandolapril are in the double-ring class of ACE inhibitors and the prior art did not suggest using these compounds with a calcium channel blocker. The experts disagreed as to whether the ring structure mattered. Plaintiffs’ expert testified that generally one of skill in the art in 1986 would believe that the double ring was less effective than the single ring. But there was no disagreement that the prior art showed that ACE inhibitors and calcium blockers required more than once-a-day dosing and that the patented combination was more effective than the prior art. Glenmark argued that these results should not impact the obviousness analysis since they were discovered after the patent application was filed. The Federal Circuit rejected this argument outright noting that a patentability analysis may consider all of the characteristics of the invention, whenever they manifest. The Federal Circuit found that substantial evidence supported the jury’s finding of validity and that the jury could have relied on plaintiffs’ expert opinion that one of ordinary skill in the art would not have predicted longer lasting effects by double ring ACE inhibitors. The Federal Circuit also denied Glenmark’s motion for a new trial based on the spoilage jury instruction. The district court did not abuse its discretion with the adverse inference because the destroyed records were within an appropriate timeframe and there was no reasonable negation of the inference. Finally, the Federal Circuit affirmed the district court’s finding that Abbott and ALI have the exclusive right to market the brand name product and had standing to recover damages. The Federal Circuit noted that all of the entities in the license chain were joined in the suit and there was no danger of multiple suits. Abbott and ALI had an exclusive right to the patented product in the United States based on Abbott’s ownership of the NDA and relationships and agreements among the Plaintiffs.