GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., C.A. No. 14–878–LPS–CJB

• Decision Date: 08 March 2018
• Docket Number: C.A. No. 14–878–LPS–CJB
• Citation: 313 F.Supp.3d 582
• Parties: GLAXOSMITHKLINE LLC and SmithKline Beecham (Cork) Limited, Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant.
• Court: U.S. District Court — District of Delaware

313 F.Supp.3d 582

GLAXOSMITHKLINE LLC and SmithKline Beecham (Cork) Limited, Plaintiffs,

v.TEVA PHARMACEUTICALS USA, INC., Defendant.

C.A. No. 14–878–LPS–CJB

United States District Court, D. Delaware.

Signed March 8, 2018

Douglas E. McCann, Elizabeth M. Flanagan, FISH & RICHARDSON P.C., Wilmington, DE, Michael J. Kane, William R. Woodford, Phillip W. Goter, FISH & RICHARDSON P.C., Minneapolis, MN, Juanita R. Brooks, Jonathan E. Singer, Michael A. Amon, Craig E. Countryman, Robert M. Yeh, FISH & RICHARDSON P.C., San Diego, CA, Attorneys for Plaintiffs GlaxoSmithKline and SmithKline Beecham (Cork) Limited.

John W. Shaw, Karen E. Keller, David M. Fry, SHAW KELLER LLP, Wilmington, DE, Ira J. Levy, Andrew E. Riley, GOODWIN PROCTER LLP, New York, NY, Daryl L. Wiesen, J. Anthony Downs, Christopher T. Holding, Elaine Herrmann Blais, Lana S. Shiferman, Robert Frederickson, III, Alexandra Lu, GOODWIN PROCTER LLP, Boston, MA, Attorneys for Defendant Teva Pharmaceuticals USA, Inc.

MEMORANDUM OPINION

STARK, U.S. District Judge:

Beginning on June 12, 2017, the Court held a seven-day jury trial in this patent infringement action (D.I. 457, 458, 459, 460, 461, 462, 463 (hereinafter, "Tr.") ), resulting in a verdict of: (1) willful induced infringement of claims 1, 2, and 3 of U.S. Patent No. RE40,000 ("the '000 patent") by Defendant Teva Pharmaceuticals USA, Inc. ("Teva") during the "skinny label" (also referred to as "partial label" or "carve-out") period; (2) no induced infringement of claims 6, 7, 8, and 9 of the '000 patent by Teva during the skinny/partial label period; (3) willful induced infringement of all asserted claims (claims 1–3 and claims 6–9) of the '000 patent by Teva during the "full label" (also referred to as "amended label") period; (4) no invalidity of the '000 patent ; and (5) an award to Plaintiffs GlaxoSmithKline and SmithKline Beecham (Cork) Ltd. ("GSK") of $234,110,000 in lost profits and $1,400,000 in reasonable royalty damages. (D.I. 448)

Pending before the Court are the parties' post-trial motions. Teva filed a renewed motion for judgment as a matter of law ("JMOL"), or in the alternative for a new trial, on five grounds: (1) no inducement of infringement of any claims at any time—that is, during either the skinny label or full label periods—and no lost profits; (2) no inducement of any claims during the skinny label period; (3) no inducement of claims 6 and 7 during the full label period; (4) no willful infringement; and (5) invalidity. (D.I. 464)¹ GSK filed a motion for enhanced damages, attorney fees, and pre-and post-judgment interest. (D.I. 466) Finally, Teva has moved to strike multiple exhibits GSK submitted in support of its post-trial motion that Teva contends were not part of the trial record. (D.I. 474)

The Court heard oral argument on October 26, 2017. Having considered the parties' briefing (D.I. 465, 467, 471, 472, 475, 476, 477, 478, 479) and letters regarding supplemental authority (D.I. 483, 485, 486, 487), and for the reasons discussed below, the Court will grant in part and deny in part Teva's JMOL motion (D.I. 464), and deny as moot both GSK's motion (D.I. 466) and Teva's motion to strike (D.I. 474).²

I. BACKGROUND

Congestive heart failure

("CHF") is a chronic condition that occurs when a diseased heart is unable to deliver sufficient oxygenated blood to the rest of the body. (See generally '000 patent ; Lukas Tr. at 359–60³ ) CHF affects over five million people in the United States, and half of those who develop CHF will die within five years of diagnosis. Prior to 1997, CHF treatment included limitation of physical activity, restriction of salt intake, and the use of a diuretic—a drug that decreases excess fluid—and digoxin —a drug that stabilizes heart rhythm. (See '000 patent ; Lukas Tr. at 361) Angiotensin converting enzyme ("ACE") inhibitors were also prescribed in conjunction with a diuretic, digoxin

, or both. (See '000 patent ) While ACE inhibitors caused an improvement in CHF mortality rates, doctors were still looking for other solutions. (Lukas Tr. at 362)

In the late 1980s, GSK and its research partner, Boehringer Mannheim GmbH, began researching the possibility of using carvedilol

to treat CHF. (Ruffalo Tr. at 1271–72) Carvedilol belongs to a class of chemical compounds known as beta-blockers, which are drugs used to treat high blood pressure or hypertension. In the early 1990s, beta-blockers, which slow the heart rate and depress the heart's contractility—that is, its ability to pump—were clinically contraindicated for CHF, as CHF patients are critically dependent on how well their heart pumps. (See Lukas Tr. at 357–58) Treating high blood pressure with beta-blockers worsened a patient's heart failure due to the beta-blocker's depressive effect on the heart's pumping function. (See id. )

GSK's research led to unexpected results showing that "the patients who were receiving carvedilol

were staying alive whereas the patients on placebo were the ones who were dying." (Id. at 364–67, 370–72; PTX–879) These results prompted GSK to file New Drug Application ("NDA") No. 20–297 with the U.S. Food and Drug Administration ("FDA"), seeking approval of carvedilol in combination with ACE inhibitors, diuretics, or digoxin to reduce the risk of mortality caused by heart failure, as well as an application for a patent on a method of using carvedilol to decrease the risk of mortality caused by CHF. (Lukas Tr. at 373, 379–81; PTX–229) In May 1997, the FDA approved carvedilol as the first beta-blocker for the treatment of CHF, leading to GSK's launch of Coreg ®, the brand name of its carvedilol tablets. (Lukas Tr. at 377) The patent issued in June 1998 as U.S. Patent No. 5,760,069 (the "'069 patent"), entitled "Method of Treatment for Decreasing Mortality Resulting from Congestive Heart Failure."

GSK ultimately received approval from the FDA to market Coreg

® for three indications: (1) hypertension ; (2) mild-to-severe CHF; and (3) left ventricular dysfunction ("LVD") following myocardial infarction (heart attack ) in clinically stable patients ("Post–MI LVD"). (See Lukas Tr. at 382–83) Despite receiving FDA approval for three indications, GSK only marketed Coreg® in the United States for the CHF indication. The FDA published the '069 patent in the Orange Book⁴ with use code U–233, "decreasing mortality caused by congestive heart failure." (See Pastore Tr. at 889)

GSK undertook further patent prosecution efforts, including to correct certain errors in the '069 patent. Consequently, on January 8, 2008, the '069 patent reissued as the '000 patent. (See Lukas Tr. at 373–74, 405, 409–10) Claim 1 of the '000 patent, the only independent claim, recites:

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.

(emphasis in original) After issuance of the '000 patent, the '069 patent was de-listed from the Orange Book, and the '000 patent was listed with the same use code, i.e., U–233, "decreasing mortality caused by congestive heart failure

." (Karst Tr. at 1042)

Meanwhile, back in March 2002, Teva had filed with the FDA Abbreviated New Drug Application ("ANDA") No. 76–373, seeking permission to market generic carvedilol tablets. (See Pastore Tr. at 442–43) Teva initially submitted a paragraph IV certification asserting that the '069 patent was invalid and requesting that its ANDA not be given final approval until a second Orange Book listed patent (one which covered the carvedilol compound) expired in March 2007.⁵ Then, however, in August 2007, Teva sought FDA approval of its ANDA pursuant to 21 U.S.C. § 355(j)(2)(A)(viii) —a "section viii carve out"—so that it could label its generic carvedilol

tablets as indicated only for uses not covered by GSK's '000 patent : that is, for treatment of hypertension and post-MI LVD. (See Pastore Tr. at 456–57; Lietzan Tr. at 534–37) At this point, since the '000 patent only claimed a method of using carvedilol for treatment of mild to severe CHF, Teva's position was that its "skinny label" generic product would not run afoul of the '000 patent because Teva's product would not be approved—or labeled as being approved—for the infringing use of treatment of CHF.

In 2007, with the expiration of the '067 patent, GSK's period of exclusivity with respect to carvedilol

ended and generic carvedilol entered the market. Fourteen companies marketed generic carvedilol, including Teva. (See Zusman Tr. at 1164; see also Pastore Tr. at 897–98; Hofmann Tr. at 1533) Specifically, on September 5, 2007, Teva received FDA approval of its generic tablets and launched its drug product with the carved out/skinny label—that is, excluding the CHF indication. (See Pastore Tr. at 461)

In April 2011, the FDA sent Teva a letter in response to the de-listing of certain GSK patents from the Orange Book, instructing Teva to "revise [its] labeling to include the information associated with [the de-listed] patent." (Id. at 461–63; PTX–15) One of the patents that had been de-listed was GSK's '069 patent, which had been reissued in 2008 as the '000 patent. (See PTX–15; Lukas Tr. at 352–53) Teva, therefore, amended its label in 2011 to be essentially a copy of GSK's full label, thereby covering all three indications: hypertension

, CHF, and post-MI LVD. (Pastore Tr. at 461–65) The '000 patent expired on June 7, 2015, the date the '069 patent was originally set to expire.

The following table is helpful for understanding the principal issues that were in dispute at...