Sanofi-Aventis Deutschland GmbH v. Glenmark Pharm. Inc., 2012-1489
| Decision Date | 21 April 2014 |
| Docket Number | 2012-1489 |
| Court | U.S. Court of Appeals — Federal Circuit |
| Parties | SANOFI-AVENTIS DEUTSCHLAND GMBH AND AVENTIS PHARMA S.A., Plaintiffs-Appellees, AND ABBOTT GMBH & CO. KG, AND ABBOTT LABORATORIES, Plaintiffs-Appellees, v. GLENMARK PHARMACEUTICALS INC., USA (now known as Glenmark Generics., Inc., USA) AND GLENMARK PHARMACEUTICALS LTD., Defendants-Appellants. |
Appeal from the United States District Court for the District of New Jersey in No. 07-CV-5855, Judge Dennis M. Cavanaugh.
JOHN ALLCOCK, DLA Piper LLP, (US) of San Diego, California, argued for all plaintiffs-appellees. With him on the brief were STUART E. POLLACK and STANLEY J.PANIKOWSKI, for Abbott GmbH & Co. Kg, et al. and BENJAMIN C. HSING and SAPNA W. PALLA, Kaye Scholer, LLP, of New York, New York, for Sanofi-aventis Deutschland GmbH, et al.
JAMES GALBRAITH, Kenyon & Kenyon LLP, of New York, New York, argued for defendants-appellants. With him on the brief were HUIYA WU, LEE B. SHELTON and MICHAEL S. CHANG.
Before NEWMAN, LINN, and WALLACH, Circuit Judges.
This patent infringement suit concerns the antihypertension drug having the brand name Tarka®. Tarka® is a combination of two active ingredients into a single dosage product: the angiotensin converting enzyme (ACE) inhibitor trandolapril, and the calcium channel blocker (also called "calcium antagonist") verapamil hydrochloride. The combination drug is covered by United States Patent No. 5,721,244 (the '244 patent) and is owned by or exclusively licensed to Sanofi-Aventis Deutschland GmbH (a company of Germany), Aventis Pharma S.A. (a company of France); Abbott GmbH (a company of Germany), and Abbott Laboratories and Abbott Laboratories Inc. (United States companies) (collectively "Plaintiffs").
The New Drug Application (NDA) for the Tarka® product was approved by the Food and Drug Administration in 1996 and acquired by Abbott Laboratories in 2001. In 2007 the defendants Glenmark Pharmaceuticals Inc. and Glenmark Pharmaceuticals Ltd. (collectively "Glenmark") filed an abbreviated new drug application (ANDA) for the generic counterpart of this product. Since the '244 patent had not expired, Glenmark filed a Hatch-Waxman "Paragraph IV Certification," leading to the filing by Plaintiffs of this infringement suit.
Launch of Glenmark's generic product was stayed for 30 months, as the statute provides. 21 U.S.C. §355(j)(5(B)(iii). After the stay expired in 2010, Plaintiffs moved for a preliminary injunction, which the district court denied. In June 2010 Glenmark launched its generic product "at-risk," while this litigation proceeded in the district court.
Trial was to a jury. Glenmark admitted infringement, and the jury held that the '244 patent had not been proved invalid. The jury awarded $15,200,000 in lost profits and $803,514 in price erosion damages. Post-trial motions were denied, and judgment was entered on the verdict. The district court retained authority to assess post-verdict damages if this court sustained the judgment on appeal.
Glenmark does not appeal the quantum of damages, but argues (1) that the '244 patent is invalid, (2) that Glenmark is entitled to a new trial based on a prejudicial jury instruction on evidence spoliation, and (3) that no damages should be awarded due to lack of standing of the Abbott United States companies. Plaintiffs defend the judgment, and also state that this court lacks jurisdiction to entertain this appeal because the district court's judgment was not final.
We conclude that jurisdiction is proper, and affirm the district court's judgment and related rulings.1
Within 30 days after the district court denied Glenmark's post-verdict motions, Glenmark filed a notice of appeal. Plaintiffs state that this appeal is premature because the district court did not issue a document entitled "final judgment" and retained authority to award post-judgment damages; thus Plaintiffs argue that there is no appellate jurisdiction.
Glenmark responds that on September 30, 2011 the district court entered an Order that disposed of every pending claim and defense except the final calculation of damages. The Order (1) denied Glenmark's pre-verdict Rule 50(a) motion, (2) denied Glenmark's motions for post-verdict judgment as a matter of law on the issues of standing and double patenting, and (3) granted Plaintiffs' request for an injunction. ECF No. 379. Glenmark timely filed a renewed motion for judgment as a matter of law under Rule 50(b), which the district court denied. ECF No. 410. Glenmark appealed within 30 days of that denial.
Glenmark points out that 28 U.S.C. §1292(c)(2) recognizes finality for purposes of appeal although the accounting of damages may not be complete. The statute assigns the Federal Circuit jurisdiction of:
§1292(c)(2)-- an appeal from a judgment in a civil action for patent infringement which would otherwise be appealable to the United States Court of Appeals for the Federal Circuit and is final except for an accounting.
In Robert Bosch, LLC v. Pylon Mfg. Corp., 719 F.3d 1305, 1317 (Fed. Cir. 2013) (en banc), this court reiterated that "an accounting" includes the determination of damages.
The jury found the damages for the period covered by the evidence at trial. The district court's issuance of an Order closing the case, with provision for an accounting of any additional damages that may accrue if the decision is affirmed on appeal, does not negate finality of a judgment that meets the terms of §1292(c)(2). No "magic words" are needed to confer final judgment. See Local Union No. 1992 of Int'l Bhd. of Elec. Workers v. Okonite Co., 358 F.3d 278, 285 (3d Cir. 2004) (); Hill v. Potter, 352 F.3d 1142, 1144 (7th Cir. 2003) (). Glenmark is correct that the judgment was final and ripe for appeal, and that this court is properly exercising jurisdiction.
Glenmark's principal challenge to validity is on the ground of obviousness.
The Tarka® product is a combination of two hypertension medications, trandolapril and verapamil hydrochloride. The combination is stated to provide longer-lasting control than previously known treatments. The product is stated to have significant advantages including improved kidney function and improved blood vessel structure without the need for multiple daily doses. There was evidence that these benefits were not known for prior art hypertension treatments.
Patent validity on the ground of obviousness is a question of law based on underlying facts. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). The factual components include the scope and content of the prior art, the differences between the prior art and the claimed invention, the level of skill in the art, and any objectiveevidence of nonobviousness. Id. at 17. When the question of obviousness is tried to a jury, on appeal we ascertain whether the jury was correctly instructed on the law, whether there was substantial evidence in support of factual findings necessary to the verdict, and whether the verdict was correct on the supported facts. The court must "accept implicit factual findings upon which the legal conclusion is based when they are supported by substantial evidence." Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1359 (Fed. Cir. 2012).
In suit is claim 3 of the '244 patent, shown with claim 1 from which it depends:
The jury was instructed on the presumption of validity, and that invalidity must be proved by clear and convincing evidence. The jury found that claim 3 had not been proved invalid on the ground of obviousness. Glenmark argues that the verdict cannot stand, as a matter of law, on the premise that if a combination of classes of components is already known, all selections within such classes are obvious to try, as a matter of law. Glenmark argues that it is irrelevant that the combination is ultimately found to have unpredicted or superior properties if those properties, though unknown in the prior art, could beattributed to one of the prior art components of the combination.
A
The trandolapril ACE inhibitor in the Tarka® product is distinguished from the class of previously known ACE inhibitors in that trandolapril is a "double-ring" compound, whereas the prior art had studied primarily "single-ring" compounds. At the time the '244 patent application was filed in 1986, the single-ring ACE inhibitors enalapril and captopril were the only ACE inhibitors approved by the FDA, and both of these drugs had a short duration of action. Captopril was typically dosed three or more times per day and enalapril was dosed twice per day. The dosage requirements of these drugs were unchanged in prior art studies involving combinations with calcium channel blockers.
Glenmark argued at trial, and repeats on this appeal, that the Tarka® product simply substituted one known ACE inhibitor for another. The Plaintiffs responded that there were hundreds if not thousands of potential combinations of ACE inhibitors and calcium antagonists in 1986, and that none of the available information pointed directly at the combinations claimed. The Plaintiffs pointed out that nothing in the art suggested the combination...
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