Combination Is Not Obvious To Try Based On Later-Manifest Unexpected Benefits

In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharmaceuticals Inc., USA, No. 12-1489 (Fed. Cir. Apr. 21, 2014), the Federal Circuit, holding that it had appellate jurisdiction, affirmed the district court's rulings and judgment that the asserted patent was not invalid as obvious, that the jury instruction regarding evidence spoliation was not prejudicial, and that certain coplaintiff companies had standing.

The Court then remanded for an accounting of any postverdict damages.

U.S. Patent No. 5,721,244 ("the '244 patent") is directed to antihypertension drugs that utilize a combination of two active ingredients in a single dosage product: an angiotensin converting enzyme ("ACE") inhibitor and a calcium channel blocker. Claim 3 of the '244 patent claims the ACE inhibitors trandolapril and quinapril, both of which are "double-ring" compounds, as opposed to the "single-ring" compounds combined with calcium channel blockers in the prior art.

Sanofi-Aventis Deutschland GmbH, Aventis Pharma S.A., Abbott GmbH, Abbott Laboratories, and Abbott Laboratories Inc. (collectively "Plaintiffs") own or exclusively license the '244 patent, which covers the antihypertension drug Tarka®. Tarka® is a combination of trandolapril and the calcium channel blocker verapamil hydrochloride, and is longer lasting than previously known treatments with significant advantages, including improved kidney function and blood vessel structure. Plaintiffs sued Glenmark Pharmaceuticals Inc. and Glenmark Pharmaceuticals Ltd. (collectively "Glenmark") after Glenmark filed an ANDA with the FDA, seeking to market a generic version of Tarka®. Glenmark admitted infringement, and after the thirty-month stay under 21 U.S.C. § 355(j)(5)(B)(iii) expired and Glenmark launched its generic version of Tarka® "at-risk," a jury found that the '244 patent had not been proved invalid and awarded damages. Slip op. at 3. The district court denied posttrial motions and entered judgment on the verdict, retaining authority to assess postverdict damages if the Federal Circuit sustained the judgment. Glenmark appealed.

"As illustrated in In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988), it would not be 'obvious to try' when 'the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.'" Slip op. at 9.

On appeal, the Federal Circuit first held that the Court had appellate jurisdiction even though the...