Sanofi-Avents Deutschland GmbH v. Glenmark Pharmaceuticals Inc.

821 F. Supp. 2d 681, 2011 U.S. Dist. LEXIS 112507, 2011 WL 4594205
CourtDistrict Court, D. New Jersey
DecidedSeptember 30, 2011
DocketCivil Action No. 07-CV-5855 (DMC-JAD)
StatusPublished
Cited by3 cases

This text of 821 F. Supp. 2d 681 (Sanofi-Avents Deutschland GmbH v. Glenmark Pharmaceuticals Inc.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sanofi-Avents Deutschland GmbH v. Glenmark Pharmaceuticals Inc., 821 F. Supp. 2d 681, 2011 U.S. Dist. LEXIS 112507, 2011 WL 4594205 (D.N.J. 2011).

Opinion

OPINION

DENNIS M. CAVANAUGH, District Judge.

This matter comes before the Court upon motions by Defendants Glenmark Pharmaceuticals, Inc., USA and Glenmark Pharmaceuticals, Ltd. (collectively, “Defendants”) for judgment as a matter of law that (1) Abbott Laboratories (“Abbott Laboratories”) and Abbott Laboratories, Inc. (“ALI”) (collectively, “Abbott Plaintiffs”) lack standing, (2) that Abbott Plaintiffs are not entitled to lost profits, (3) that U.S. Patent No. 5,721,244 (the “'244 patent”) is invalid for obviousness, and (4) that the '244 patent is invalid for obviousness type double patenting. Plaintiffs moved for a permanent injunction and accounting for supplemental damages. Pursuant to Federal Rule of Civil Procedure 78, no oral argument was heard. After considering the submissions of all parties, it is the decision of this Court for the reasons herein expressed that Defendants’ motions for judgment as a matter of law are denied, and the Plaintiffs’ motion for permanent injunction and supplemental damages is granted.

I. Background

As the Court has issued previous opinions in this case and writes solely for the parties, prior familiarity with the underlying factual and procedural history of this matter will be assumed. In short, this case concerns U.S. Patent No. 5,721,244 (the “'244 patent”), titled “Combination of Angiotensin-Converting Enzyme Inhibitors with Calcium Antagonists as well as their Use in Drugs[,]” issued on February 24, 1998, with a filing date of June 7, 1995 and a foreign application priority date of October 2, 1986. Claim 3 of the '244 patent, the only Claim at issue here, discloses and claims a “pharmaceutical composition” used to treat hypertension. The pharmaceutical composition contains an angiotensin-converting enzyme inhibitor (“ACE inhibitor”) having certain bicyclic or tricyclic ring systems and a calcium antagonist (also known as a calcium channel blocker or “CCB”) in “amounts effective for treating hypertension.” The parties agree that Claim 3 can be expressed as follows:

A pharmaceutical composition comprising:

(a) an angiotensin-converting enzyme inhibitor (ACE inhibitor) [which is] trandolapril or quinapril, or a physiologically salt thereof, and
(b) a calcium antagonist or a physiologically salt thereof; wherein said ACE inhibitor and said calcium antagonist are present in said composition in amounts effective for treating hypertension;
and with the proviso that when said calcium antagonist is ... felodipine, said angiotensin coverting enzyme inhibitor is not ... trandolapril.

Plaintiffs also obtained United States Patent 5,098,910 (the “'910 patent”) on March 24, 1992 with a filing date of May [686]*68630, 1989 and a foreign application priority-date of October 2, 1986. The '910 patent indicates that the “present invention relates to a combination of angiotensin-converting enzyme inhibitors (ACE inhibitors) with calcium antagonists as well as their use in drugs, especially in hypotensive drugs.” The '910 patent claims a pharmaceutical composition comprising of ramipril, an ACE inhibitor, and a calcium antagonist.

Abbott Laboratories is the owner of the New Drug Application (“NDA”) No. 20-591. Pursuant to the NDA approval, Abbott Laboratories, through ALI, sells drug products containing the trandolapril/verapamil hydrochloride combination in the United States under the trademark Tarka®. The '244 patent is listed in FDA publication titled “Approved Drug Products with Therapeutic Equivalence Evaluation” (“Orange Book”) as being applicable to Abbott Laboratories’ aforementioned NDA for its Tarka® tablets.

On July 24, 2007, Glenmark filed an Abbreviated New Drug Application (“ANDA”) No. 79-135 with the FDA for approval to market a generic version of the drug Tarka®. On October 24, 2007, Glen-mark notified Plaintiffs that it had made a “Paragraph IV” certification asserting that the '244 patent is invalid. On December 7, 2007, consistent with the provisions of the Hatch-Waxman Act, Plaintiffs initiated suit before this Court against Defendants for patent infringement.

On January 4-14, 2011, a jury trial was held to determine the validity of the '244 patent and the liability, if any, of the Defendants. The jury returned a verdict in favor of Plaintiffs on all counts. Specifically, the jury found that the '244 patent was not obvious and that Plaintiffs were entitled to damages for lost profits and price erosion. The jury also found that the '244 patent was not invalid based on obviousness type double patenting; however, as to this question the jury was advisory only.

Defendants moved for judgment as a matter of law that Abbott Laboratories and ALI lacked standing, that Abbott Plaintiffs are not entitled to damages for lost profits, and that the '244 patent is invalid for obviousness.1 Both parties moved for judgment as a matter of law regarding obviousness type double patenting. The Court reserved decision until after the jury rendered its verdict. Following the trial, both parties submitted briefs in support of their motions, findings of fact and conclusions of law with regard to obviousness type double patenting, and Plaintiffs moved for a permanent injunction. At the direction of the Court, the parties subsequently submitted supplemental briefs regarding the permanent injunction. The Court writes now to address these motions.

II. Motions For Judgment as a Matter of Law

A. Legal Standard

Judgment as a matter of law is appropriate when “the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue.” Fed. R. Civ. P. 50(a).

Patents are presumed to be valid. 35 U.S.C. § 282 (1994). Thus, “the burden is on an accused infringer to show by clear and convincing evidence facts supporting the conclusion that the patent is invalid.” Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1065 (Fed.Cir.1998). Accordingly, judgment as a matter of law may be granted in favor of a [687]*687party bearing the burden of proof “only where (1) the movant has established [its] case by evidence that the jury would not be at liberty to disbelieve and (2) the only reasonable conclusion is in [the movant’s] favor.” Id. (internal citations omitted) (emphasis added).

B. Standing

Defendants move for judgment as a matter of law that Abbott Laboratories and ALI (“Abbott Plaintiffs”) lack standing to sue for infringement of the '244 patent. Prior to trial, Defendants likewise moved to dismiss the Abbott Plaintiffs for lack of standing. This Court denied Defendants’ motion. In arguing they are entitled to judgment as a matter of law, Defendants rely on the briefs submitted in support of their prior motions.

In its earlier Opinion addressing the issue of standing, this Court found that Abbott Laboratories and ALI were exclusive licensees of the '244 patent and therefore had standing to sue for infringement. This finding is supported by the evidence that was presented at trial.

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821 F. Supp. 2d 681, 2011 U.S. Dist. LEXIS 112507, 2011 WL 4594205, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sanofi-avents-deutschland-gmbh-v-glenmark-pharmaceuticals-inc-njd-2011.