Glaxosmithkline LLC v. Glenmark Pharms. Inc.

GLAXOSMITHKLINE LLC andSMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs, v. GLENMARK PHARMACEUTICALS INC., USA, Defendant.

GLAXOSMITHKLINE LLC andSMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant.

Civil Action No. 14-877-LPS-CJB

Civil Action No. 14-878-LPS-CJB

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

May 23, 2017

REPORT AND RECOMMENDATION

In these two related actions filed by Plaintiffs GlaxoSmithKline LLC and SmithKline Beecham (Cork) Limited (collectively, "GSK" or "Plaintiffs") against Defendant Glenmark Pharmaceuticals Inc., USA ("Glenmark") and Teva Pharmaceuticals USA, Inc. ("Teva") (collectively, "Defendants"), GSK alleges induced infringement of United States Patent No. RE40,000 (the "Asserted Patent" or the "'000 patent"). Presently before the Court is Defendants' motion for summary judgment of no induced infringement (the "Motion"). (Civil Action No. 14-877-LPS-CJB (hereinafter "Glenmark Action"), D.I. 214; Civil Action No. 14-878-LPS-CJB (hereinafter "Teva Action"), D.I. 248)¹ The Court recommends that Defendants' Motion be DENIED.²

I. BACKGROUND

A. Factual Background

1. The Parties

GSK manufactures and sells the drug carvedilol under the trade name COREG®. (D.I. 60 at ¶¶ 8, 22) SmithKline Beecham (Cork) Limited is the owner, by assignment, of the '000 patent, and GlaxoSmithKline LLC is the patent's exclusive licensee. (Id. at ¶¶ 37-38)

Defendants are engaged in the business of developing, manufacturing, and distributing generic versions of branded drug products throughout the United States. (See, e.g., Glenmark Action, D.I. 61 at ¶ 47; Teva Action, D.I. 60 at ¶ 47; D.I. 105 at ¶ 47)

2. The Hatch-Waxman Act, FDA Requirements and the Orange Book

The Hatch-Waxman Act, codified as amended at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271 and 282, strikes a balance between the competing policy interests of "(1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market." Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1370-71 (Fed. Cir. 2002). A brand name drug manufacturer seeking approval from theUnited States Food and Drug Administration ("FDA") for a drug must submit a New Drug Application ("NDA") that includes, inter alia, a statement of the drug's components and proposed labeling describing the uses for which the drug may be marketed. 21 U.S.C. § 355(b)(1); Caraco Pharms. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 1676 (2012). A brand name drug may be approved for multiple methods of use—either to treat different conditions or to treat one condition in different ways. Caraco, 132 S. Ct. at 1676. Once a drug has been approved by the FDA, another company may seek permission to launch a generic version of the drug by filing an Abbreviated New Drug Application ("ANDA") with the FDA. 21 U.S.C. § 355(j); Caraco, 132 S. Ct. at 1676. The ANDA process circumvents the lengthy approval scheme in place for NDAs by permitting generic manufacturers to depend on the safety and efficacy studies completed for the previously-approved drug, so long as there is bioequivalency between the generic drug and the previously-approved drug. Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1318 (Fed. Cir. 2012).

When evaluating an ANDA seeking to market a generic drug, the FDA considers whether the proposed drug would infringe a patent held by the brand name manufacturer of the drug. Caraco, 132 S. Ct. at 1675. "[T]he Hatch-Waxman Act creates a mechanism that allows for prompt judicial determination of whether the ANDA applicant's drug or method of using the drug infringes a valid patent." Bayer, 676 F.3d at 1318. In line with its goals of protecting patentees and facilitating approval of generic drugs, the Act dictates that a brand name manufacturer's NDA must identify specific patent information with respect to which a claim of patent infringement could "reasonably be asserted . . . [due to] the . . . use . . . of the drug." 21 U.S.C. § 355(b)(1); see also Bayer, 676 F.3d at 1318. This requirement also applies to patentsthat issue subsequent to final approval of the NDA. 21 U.S.C. § 355(c)(2); see also Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1325 (Fed. Cir. 2003). The FDA lists these identified patents in the "Approved Drug Products with Therapeutic Equivalence Evaluations" publication (the "Orange Book"). Bayer, 676 F.3d at 1318.

If the brand name manufacturer holds a method of use patent that gives it exclusive rights over a particular method of using the drug subject to the NDA, FDA regulations require it to: (1) indicate "[w]hether the patent claims one or more methods of using the drug product for which use approval is being sought and a description of each pending method of use or related indication and related patent claim of the patent being submitted" and (2) provide "[i]dentification of the specific section . . . of the proposed labeling for the drug product that describes the method of use claimed by the patent submitted[.]" 21 C.F.R. § 314.53(c)(2)(i)(O)(1)-(2).³ The manufacturer's descriptions of the method-of-use patents are referred to as "use codes." Caraco, 132 S. Ct. at 1676. The FDA then publishes these use codes, along with the corresponding patent numbers and expiration dates, in the Orange Book. Id.

An ANDA applicant is required to consult the Orange Book and take action relating to all pertinent patents. Bayer, 676 F.3d at 1318. If a patent listed in the Orange Book is a method-of-use patent, a generic company can attempt to seek FDA approval to label its drug only for uses not covered by the patent by submitting a "section viii statement" with its ANDA. (D.I. 298 (hereinafter, "McCann Decl. Vol. I"), ex. 17 at ¶ 30); see also 21 U.S.C. § 355(j)(2)(A)(viii); Bayer, 676 F.3d at 1318. These statements are referred to as "carve-outs" or "section viii carve-outs" because they are said to "limit[] the scope of the generic manufacturer's ANDA to approved indications that are not claimed by valid patents listed in the Orange Book." Astrazeneca Pharms. LP v. Apotex Corp., Civil No. 10-338 (RBK/KW), 2010 WL 5376310, at *2 (D. Del. Dec. 22, 2010); see also Bayer, 676 F.3d at 1318.⁴ This process is meant to ensure that "one patented use will not foreclose marketing a generic drug for other unpatented ones." Caraco, 132 S. Ct. at 1682. If the section viii carve-out is approved, the FDA then requires the generic company to duplicate only the portions of the branded drug's label not protected by the applicable method-of-use patent, as identified in the patent use code (often referred to as a "skinny label"). (McCann Decl. Vol. I, ex. 17 at ¶ 31); see also AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1046 (Fed. Cir. 2010).⁵

The FDA takes the use code at face value—it does not independently assess the patent's scope or otherwise look beyond the use code description written by the brand. Caraco, 132 S.Ct. at 1677. The FDA has described its own role with respect to patent listing as "'ministerial[,]'" id. (internal citation omitted), as it "is not the arbiter of patent infringement issues[,]" AstraZeneca, 633 F.3d at 1061. Section viii statements do not require notice to the patent-holder and therefore foreclose automatic initiation of patent infringement litigation. In re Gabapentin Patent Litig., 649 F. Supp. 2d 340, 345 n.7 (D.N.J. 2009).

3. Discovery of Carvedilol as a Treatment for Congestive Heart Failure

Congestive heart failure (or "CHF"), which has been construed by the Court to mean "a condition that occurs as a result of impaired pumping capability of the heart and is associated with abnormal retention of water and sodium[,]" (D.I. 165 at 43), affects over 5 million people in the United States, (McCann Decl. Vol. I, ex. 2 at ¶ 23). More specifically, the hearts of people with CHF are diseased and/or damaged, thus impairing the ability of the left ventricle (i.e., the major pumping chamber) to fill with or eject blood. (Id. at ¶ 24) These patients' hearts are unable to deliver sufficient oxygenated blood throughout the body. (Id.) Symptoms of CHF include dyspnea (breathlessness), poor exercise intolerance, fatigue and edema (swelling of the legs). (D.I. 253, ex. A (hereinafter, "Rosendorff Decl.") at ¶ 28; McCann Decl. Vol. I, ex. 2 at ¶ 24) Historically, approximately half of the people that developed CHF died within 5 years of diagnosis. (See '000 patent, col. 1:55-57;⁶ McCann Decl. Vol. I, ex. 2 at ¶ 23) Before 1997, the only treatments approved by the FDA for heart failure were diuretics, certain angiotensin converting enzyme ("ACE") inhibitors and digoxin/digitalis. (McCann Decl. Vol. I, ex. 2 at ¶ 25) These drugs were used to treat the symptoms of heart failure. (Id.) Controlled clinical trialsdemonstrated that ACE inhibitors reduced the risk of mortality from heart failure by about 20%. (Id.)

Carvedilol has been a known beta blocker since at least 1978. (U.S. Patent No. 4,503,067; McCann Decl. Vol. I, ex. 2 at ¶ 29) Beta blockers are compounds that prevent stimulation of the adrenergic receptors responsible for increased heart rate and contractility, which can cause the heart to pump slower or with less force. (McCann Decl. Vol. I, ex. 2 at ¶ 27) Historically, beta blockers were contraindicated in the treatment of CHF because of the medical community's "widely-held concern" that this type of drug would further reduce the diseased and/or damaged heart's ability to pump blood through the body. (Id. at ¶¶ 27-28; see also D.I. 299 (hereinafter, "McCann Decl. Vol. II"), ex. 53 at 50, 55 (Glenmark's expert Sean C. Beinart, M.D. noting that when he was in medical school in the "mid-'90s" he was taught "capital letters, beta blockers are contraindicated [for CHF]"); '000 patent, col. 3:56-60) For example, guidelines published in 1993 regarding the treatment of high blood pressure indicated that beta blockers were "[r]elatively or [a]bsolute...