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Glaxosmithkline LLC v. Glenmark Generics Inc.

United States District Court, D. Delaware

April 22, 2015

GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs,
v.
GLENMARK GENERICS INC., USA, Defendant. GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs,
v.
TEVA PHARMACEUTICALS USA, INC., Defendant.

REPORT AND RECOMMENDATION

CHRISTOPHER J. BURKE, Magistrate Judge.

Presently pending in these two related patent infringement cases are Defendant Glenmark Generics Inc., USA's ("Glenmark") and Teva Pharmaceuticals USA, Inc.'s ("Teva") (collectively, "Defendants") motions to dismiss Plaintiffs GlaxoSmithKline LLC ("GSK") and SmithKline Beecham (Cork) Limited's (collectively, "Plaintiffs") First Amended Complaints ("FAC"), pursuant to Federal Rule of Civil Procedure 12(b)(6) (the "Motions"). (Civil Action No. 14-877-LPS-CJB, D.I. 18; Civil Action No. 14-878-LPS-CJB, D.I. 20)[1] For the reasons set forth below, the Court recommends that Defendants' Motions each be GRANTED-IN-PART and DENIED-IN-PART.

I. BACKGROUND

A. Factual Background

The patent-in-suit, U.S. Patent No. RE40, 000 (the "Asserted Patent" or the "000 Patent") relates to the chemical compound carvedilol. Carvedilol belongs to a class of chemical compounds known as beta-blockers, which are drugs that, among other things, may be used to treat patients with high blood pressure, or hypertension. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶ 8; Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶ 8) Approximately two decades ago, GSK filed New Drug Application ("NDA") No. 20-297 with the United States Food and Drug Administration ("FDA") on carvedilol tablets for management of hypertension, and in September 1995, it received approval to market the drug for that purpose. (Id. ) However, GSK did not launch carvedilol then, in part due to the "crowded hypertensive treatment market[.]" (Id. ) Instead, GSK pursued promising research suggesting that carvedilol could be used to successfully treat chronic heart failure ("CHF"); eventually, this led to the FDA's May 1997 approval of carvedilol for the treatment of CHF. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶¶ 8-17; Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶¶ 8-17) Thereafter, GSK began marketing and selling carvedilol 3.125 mg, 6.25 mg, 12.5 mg and 25 mg tablets (referred to herein as "carvedilol tablets") under the brand name COREG® ("COREG"). (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶ 18; Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶ 18)

By the year 2003, COREG had received FDA approval for multiple indications: for management of hypertension, for treatment of mild-to-severe CHF and for a third use-treatment of left ventricular dysfunction following myocardial infarction in clinically stable patients ("left ventricular dysfunction"). (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶¶ 8, 17, 22-24; Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶¶ 8, 17, 22-24) Despite this, GSK has only ever marketed COREG in the United States for the CHF indication (and has never marketed it for any other indication). (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶¶ 18, 25; Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶¶ 18, 25)

GSK also obtained United States Patent No. 5, 760, 069 ("'069 Patent"), issued in June 1998, on a method of treatment using carvedilol to decrease the risk of mortality caused by CHF. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶ 28; Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶ 28) In January 2008, that patent reissued as the Asserted Patent, which is listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") as covering COREG. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶¶ 28-33; Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶¶ 28-33) The key claim of the Asserted Patent (and its only independent claim) is claim 1, which reads:

1. A method of decreasing mortality caused by congestive heart failure in a patient in need thereof which comprises administering a therapeutically acceptable amount of carvedilol in conjunction with one or more other therapeutic agents, said agents being selected from the group consisting of an angiotensin converting enzyme inhibitor (ACE), a diuretic, and digoxin,
wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months.

(Civil Action No. 14-877-LPS-CJB, D.I. 14, ex. E ("'000 Patent"), col. 8:30-40 (emphasis in original)) The italicized portion of the claim above is the portion that was added to the claim during the reissue proceeding.

Teva holds Abbreviated New Drug Application ("ANDA") No. 76-373 for generic carvedilol tablets. (Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶ 44) Although Teva had originally submitted a Paragraph IV certification asserting that the '069 Patent was invalid, eventually Teva sought FDA approval under 21 U.S.C. § 355G)(2)(A)(viii) (a "Section viii carve out") to label its generic carvedilol tablets only for uses not covered by the patent-i.e., treating hypertension and left ventricular dysfunction. (Id. at ¶¶ 38-44; D.I. 22, ex. C)[2] Teva received this FDA approval on or about September 5, 2007 and launched its generic COREG tablets in the United States immediately thereafter. (Civil Action No. 14-878-LPS-CJB, D.I. 16 at ¶ 44) In May 2011, however, Teva amended its label to fully conform with and be identical (for all relevant purposes) to GSK's label for COREG, such that Teva's label now expressly included the CHF indication. (Id. at ¶¶ 45-46 & ex. G)

Glenmark holds Abbreviated New Drug Application ("ANDA") No. 78-251 for generic carvedilol tablets. (Civil Action No. 14-877-LPS-CJB, D.I. 14 at ¶ 40) It filed its application with a Section viii carve out, i.e., without those portions of the label relating to the CHF indication. (Id. at ¶ 42) On or about September 5, 2007, the FDA granted approval for Glenmark's ANDA, and Glenmark immediately launched its generic COREG tablets in the United States. (Id. ) Thus, at the time of this launch, Glenmark's label promoted use for two indications-treating hypertension and left ventricular dysfunction. (Id. ) However, it is alleged that at least between about August 2009 and about August 2010, Glenmark revised its label for generic carvedilol tablets to fully conform with and be identical (for all relevant purposes) to GSK's label for COREG, such that the label now expressly included the CHF indication. (Id. at ¶¶ 43-44 & ex. G) Thereafter, it appears that Glenmark switched back to the version of the label that it had utilized prior to about August 2009. ( Id.; see also D.I. 21 at 5)

B. Procedural Background

Plaintiffs commenced these actions on July 3, 2014, alleging indirect infringement claims against the Defendants concerning the Asserted Patent. (Civil Action No. 14-877-LPS-CJB, D.I. 1; Civil Action No. 14-878-LPS-CJB, D.I. 1) Soon after, Defendants moved to dismiss the Complaints for failure to state a claim, pursuant to Rule 12(b)(6). (Civil Action No. 14-877-LPS-CJB, D.I. 10; Civil Action No. 14-878-LPS-CJB, D.I. 10) In response, on September 22, 2014, Plaintiffs filed the FACs. (Civil Action No. 14-877-LPS-CJB, D.I. 14; Civil Action No. 14-878-LPS-CJB, D.I. 16) On October 16, 2014, Chief Judge Leonard P. Stark referred these cases to the Court to hear and resolve all pretrial matters, up to and including the resolution of case-dispositive motions. (Civil Action No. 14-877-LPS-CJB, D.I. 16; Civil Action No. 14-878-LPS-CJB, D.I. 18)

Defendants then filed the instant Motions, in lieu of answering the FACs, on October 23, 2014. (Civil Action No. 14-877-LPS-CJB, D.I. 18; Civil Action No. 14-878-LPS-CJB, D.I. 20) The Motions were fully briefed as of November 20, 2014. (Civil Action No. 14-877-LPS-CJB, D.I. 22; Civil Action No. 14-878-LPS-CJB, D.I. 25) On April 13, 2015, at the request of all parties, the Court heard oral argument on the Motions.[3] (Civil Action No. 14-877-LPS-CJB, D.I. 36 ("Tr.")) On April 15, 2015 and April 17, 2015, the parties filed supplemental ...


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