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-MILVD"). (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:

(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-MILVD. (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 trial and are again presented by the pending motions.

Indications Implicated at Various Points

Indication       GSK's      GSK's        GSK's         GSK's           Teva's               Teva's Full
                 '000       FDA          Marketing     Orange          Skinny a.k.a.        a.k.a.
                 patent     Approval     of Coreg®     Book            Partial a.k.a.       Amended
                                                       Listing         Carve-Out            Label
                                                                       Label                (May 2011-June
                                                                       (Jan. 2008-April     2015)
                                                                       2011)

hypertension     No         Yes          No            No              Yes                   Yes

mild/severe      Yes        Yes          Yes           Yes (U-233)     No                    Yes
CHF

post-MI LVD      No         Yes          No            No              Yes                   Yes

As shown, GSK's patent-in-suit only claims a method of using carvedilol for the treatment of mild to severe CHF. (PTX-1; see Lukas Tr. at 352-54) Although GSK obtained FDA approval to market carvedilol as safe and effective also for the treatment of hypertension and post-MI LVD, it did not have patent protection on such uses, and it has never marketed its branded drug, Coreg®, to be used to treat anything other than CHF. (See Lukas Tr. at 350-52) The Orange Book listing for the '000 patent refers only to CHF, and not also to hypertension or post-MI LVD. (See Karst Tr. at 1040-44; Pastore Tr. at 888-90; Lietzan Tr. at 527-29, 566-67) When Teva initially launched and sold its generic carvedilol, during the skinny label period of January 2008 through April 2011, its label identified as approved indications only hypertension and post-MI LVD. (See Karst Tr. at 1027-28) It was not until the full label period, May 2011 through the expiration of the '000 patent in June 2015, that Teva's label also included the previously-patented method of use — treatment of CHF — as an approved indication for Teva's generic product. (See Pastore Tr. at 461-62; Zusman Tr. at 1229)

II. LEGAL STANDARDS

A. Judgment as a Matter of Law

Judgment as a matter of law is appropriate if "the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for [a] party" on an issue. Fed. R. Civ. P. 50(a)(1). "Entry of judgment as a matter of law is a sparingly invoked remedy," one "granted only if, viewing the evidence in the light most favorable to the nonmovant and giving it the advantage of every fair and reasonable inference, there is insufficient evidence from which a jury reasonably could find liability." Marra v. Phila. Hous. Auth., 497 F.3d 286, 300 (3d Cir. 2007) (internal quotation marks omitted).

To prevail on a renewed motion for judgment as a matter of law following a jury trial, the moving party "must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusions implied [by] the jury's verdict cannot in law be supported by those findings." Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed. Cir. 1998) (internal quotation marks omitted). "`Substantial' evidence is such relevant evidence from the record taken as a whole as might be accepted by a reasonable mind as adequate to support the finding under review." Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir. 1984).

In assessing the sufficiency of the evidence, the Court must give the non-moving party, "as [the] verdict winner, the benefit of all logical inferences that could be drawn from the evidence presented, resolve all conflicts in the evidence in his favor, and in general, view the record in the light most favorable to him." Williamson v. Consol. Rail Corp., 926 F.2d 1344, 1348 (3d Cir. 1991); see also Perkin-Elmer Corp., 732 F.2d at 893. The Court may not assess the credibility of witnesses nor "substitute its choice for that of the jury between conflicting elements of the evidence." Perkin-Elmer Corp., 732 F.2d at 893. Rather, the Court must determine whether the evidence reasonably supports the jury's verdict. See Dawn Equip. Co. v. Ky. Farms Inc., 140 F.3d 1009, 1014 (Fed. Cir. 1998); Gomez v. Allegheny Health Servs., Inc., 71 F.3d 1079, 1083 (3d Cir. 1995) (describing standard as "whether there is evidence upon which a reasonable jury could properly have found its verdict"); 9B Charles Alan Wright, Arthur R. Miller & Edward H. Cooper, Federal Practice & Procedure § 2524 (3d ed. 2008) ("The question is not whether there is literally no evidence supporting the party against whom the motion is directed but whether there is evidence upon which the jury properly could find a verdict for that party.").

B. New Trial

Federal Rule of Civil Procedure 59(a) provides in pertinent part, "[t]he court may, on motion, grant a new trial on all or some of the issues — and to any party — as follows: ... after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court." New trials are commonly granted where "the jury's verdict is against the clear weight of the evidence, and a new trial must be granted to prevent a miscarriage of justice," where "newly-discovered evidence exists that would likely alter the outcome of the trial," where "improper conduct by an attorney or the court unfairly influenced the verdict," or where the jury's verdict was "facially inconsistent." Zarow-Smith v. N.J. Transit Rail Operations, 953 F.Supp. 581, 584-85 (D. N.J. 1997) (internal citations omitted).

The decision to grant or deny a new trial is committed to the sound discretion of the district court. See Allied Chem. Corp. v. Daiflon, Inc., 449 U.S. 33, 36, 101 S.Ct. 188, 66 L.Ed.2d 193 (1980); Olefins Trading, Inc. v. Han Yang Chem Corp., 9 F.3d 282, 289 (3d Cir. 1993) (reviewing "district court's grant or denial of a new trial motion" under "abuse of discretion" standard). Although the standard for granting a new trial is less rigorous than the standard for granting judgment as a matter of law, in that the Court need not view the evidence in the light most favorable to the verdict winner, ordinarily a new trial should only be granted "where a miscarriage of justice would result if the verdict were to stand," the verdict "cries out to be overturned," or the verdict "shocks [the] conscience." Williamson, 926 F.2d at 1352-53.

III. DISCUSSION

A. The Jury Could Not Reasonably Find that Teva Caused Doctors to Infringe

The jury found that Teva induced infringement of claims 1, 2, and 3 of the '000 patent during the skinny label period and of claims 1-3 and 6-9 during the full label period. (D.I. 448 at 2-3) Teva moves for JMOL of no inducement or no lost profits damages on the basis that the jury could not reasonably have found that Teva caused doctors to infringe these claims of GSK's patent during the respective periods.6 (D.I. 465 at 4) Having reviewed the record under the appropriate standard, including by drawing all reasonable inferences in favor of GSK as the verdict winner, the Court concludes that substantial evidence does not support the jury's findings on inducement in either the skinny or full label period. Therefore, the Court will grant this portion of Teva's JMOL motion.

To prove inducement, GSK was required to prove by a preponderance of the evidence that, among other things, "Teva's alleged inducement, as opposed to other factors, actually caused the physicians to directly infringe." (D.I. 440 at 26) (emphasis added) The jury was instructed that "Teva cannot be liable for induced infringement where GSK does not show that Teva successfully communicated with and induced a third-party direct infringer and that the communication was the cause of the direct infringement by the third-party infringer." (Id. at 31) (emphasis added) Thus, the Court must now evaluate whether substantial evidence supports the jury's finding that Teva did cause the alleged infringement.7

Teva contends that the substantial uncontroverted evidence presented at trial showed that alternative factors caused doctors to infringe GSK's patent. Teva thus asserts that a reasonable jury could not conclude that even a single doctor — let alone the entire class of infringing doctors — was induced to infringe based on Teva's actions. Moreover, because GSK only asserted a "class" theory of liability — that is, that Teva induced doctors as a class to infringe — and failed to prove that theory, Teva's view is that GSK cannot now have the verdict upheld on an alternative theory of liability (i.e., the theory that "at least one" doctor was induced to infringe by Teva's actions). (See D.I. 465 at 1-2)

GSK responds that the jury's verdict should be sustained because GSK presented "ample evidence," including Teva's label and marketing materials, "from which [the jury] could infer Teva actually caused physicians to directly infringe." (D.I. 472 at 6) (internal quotation marks omitted) GSK argues that "JMOL of no inducement is only appropriate where the plaintiff fails to present sufficient evidence of even one act of direct infringement." (Id. at 9; see also Hr'g Tr. at 52 ("[T]he law doesn't require us to prove [inducement of the entire class]. What the law requires us to prove is just one of the class."); id. at 57 ("All we needed was circumstantial evidence of one doctor ...."); see generally D.I. 440 at 4.2.1 (instructing jury: "Proof of direct infringement may be based on circumstantial evidence.")) GSK contends that it provided substantial evidence through the testimony of its expert, Dr. Peter McCullough, permitting a reasonable factfinder to find that at least one doctor was induced to prescribe generic carvedilol by Teva's actions. (Id. at 71-72)

The Court agrees with Teva that neither sufficient nor substantial evidence supports the jury's finding of inducement. GSK failed to prove by a preponderance of the evidence that "Teva's alleged inducement, as opposed to other factors, actually caused the physicians [i.e., as a class or even at least one of them] to directly infringe," by prescribing generic carvedilol and to do so for the treatment of mild to severe CHF. (D.I. 440 at 26, 31) (jury instruction; emphasis added) Without proof of causation, which is an essential element of GSK's action, a finding of inducement cannot stand.8

GSK insists that Dr. McCullough identified himself as at least one doctor who was induced to prescribe generic carvedilol to a patient for the treatment of mild to severe CHF due to Teva's actions (or inactions), including Teva's label. (See Hr'g. Tr. at 52-53 (discussing GSK slide 4); id. at 69-72 (discussing GSK slides 32-33)) But the portion of Dr. McCullough's testimony to which GSK points (see McCullough Tr. at 631, 1659-63) does not show Dr. McCullough stating what GSK seems to think he said. Dr. McCullough merely said, in a conclusory manner, that Teva's labels (partial and full) "meet each and every limitation of claim 1" and a doctor performing the method of the claim would be the direct infringer. (See id. at 631) But even if the label were enough in a post-launch world, Dr. McCullough specifically stated that he did not read Teva's label prior to administering generic carvedilol, but "just assume[d] they were the same" based on the information the generic company provided. (See id. at 1659-63) As Dr. McCullough concedes that he did not read Teva's label, he cannot state, for instance, that he noticed or otherwise knew what (if anything) that label said about using carvedilol to treat CHF. Moreover, Dr. McCullough testified that he relied on various other sources, none of which are attributable to Teva, in deciding to prescribe carvedilol, both before and after generics entered the market. (See McCullough Tr. at 666-69, 676-78) GSK, therefore, has not met its burden to show inducement.

Below, the Court describes with more particularity its conclusion with respect to first the skinny label period and then the full label period.

1. The Skinny Label Period

The skinny label period, January 8, 2008 through April 30, 2011, is the period during which Teva's label carved out the CHF indication pursuant to 21 U.S.C. § 355(j)(2)(A)(viii) ("section viii"). The Court agrees with Teva that the record lacks substantial evidence that Teva's skinny label, in combination with other acts Teva took (or refrained from taking) during this period, caused of any physician's direct infringement. (See D.I. 465 at 13-25) Instead, as Teva argues, the record conclusively demonstrated — and a reasonable jury could only have found — that any infringing use by any physician during the skinny label period was caused by factors unrelated to Teva.

The unrebutted evidence presented at trial showed that Teva's skinny label omitted from its label the language contained on GSK's Coreg® label concerning the use of carvedilol to treat CHF. (See Lietzan Tr. at 539, 541; Zusman Tr. at 1190-91) It is further undisputed that Teva's generic carvedilol, during the skinny label period, was not approved for treatment of CHF, making such use an "off-label" use. Moreover, GSK's expert, Dr. McCullough, conceded that he would not prescribe generic carvedilol for CHF if it was not an approved use on the label. (See McCullough Tr. at 1660-61) The Court may, indeed must, consider unrebutted evidence presented at trial that supports the moving party on JMOL, in evaluating whether the jury had substantial evidence to support a reasonable finding against the moving party. See Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334, 1345 (Fed. Cir. 2007) ("The rule that a jury verdict is reviewed for support by `substantial evidence' does not mean that the reviewing court must ignore the evidence that does not support the verdict.... [T]he court should give credence to the evidence favoring the nonmovant as well as that evidence supporting the moving party that is uncontradicted and unimpeached.") (internal quotation marks omitted).

Teva's skinny label did not instruct doctors to prescribe generic carvedilol for an off-label use, i.e., treatment of CHF. See Warner-Lambert v. Apotex Corp., 316 F.3d 1348, 1364-65 (Fed. Cir. 2003) ("[T]he request to make and sell a drug labeled with a permissible (non-infringing) use cannot reasonably be interpreted as an act of infringement (induced or otherwise) with respect to a patent on an unapproved use, as the ANDA does not induce anyone to perform the unapproved acts required to infringe."). Similarly, Teva's skinny label identified the approved indications as being hypertension and post-MI LVD, which were not covered by GSK's patent, and which cannot be considered infringing uses. See id.9

While GSK's evidence of inducement during the skinny label period consisted principally of Teva's label (and testimony about it), GSK did present other evidence. In seeking to prove inducement, GSK relied on Teva's "AB rating" as well as Teva's 2008 and 2009 product catalogs and Teva's October 2009 Generic Product Reference Guide. (PTX-1208; PTX-1212; PTX-1226) These marketing materials trumpeted Teva's AB rating, without expressly stating that Teva's generic carvedilol was not approved for treatment of CHF. In the Court's view, even the totality of this evidence, taken in the light most favorable to GSK, and drawing all reasonable inferences in favor of GSK, cannot support a reasonable finding that Teva caused any infringement of GSK's '000 patent.

The jury was instructed that "[t]he fact that Teva obtained an AB rating for its generic product is not by itself a sufficient basis to find that Teva had an intent to infringe." (D.I. 440 at 29) GSK argues that Teva did something more than "obtain[] an AB rating;" Teva also listed and marketed Teva's generic carvedilol as AB rated to Coreg®, without specifying that Teva's generic carvedilol — unlike GSK's Coreg® — was not approved for the CHF indication. (See D.I. 472 at 5, 15) But this fact does not support a reasonable finding that Teva caused infringement. As both parties showed at trial, being AB rated signifies that a generic drug is therapeutically equivalent to a branded drug. (See Lietzan Tr. at 542; Karst Tr. at 1031-32) The undisputed evidence demonstrates that a generic drug cannot be listed as "AB rated" generally, as "AB rated" is a relative term; it necessarily requires a comparison between the generic drug and some branded reference drug. (See Lietzan Tr. at 534; see also Karst Tr. at 1031-32)

In addition, as GSK conceded, there is no FDA requirement that a generic drug company specify for which uses it is (or is not) AB rated. (See Lietzan at 577-78) Nor had either party's experts ever seen such a clarifying statement in any press release or product catalog. (See Lietzan Tr. at 548-49, 577-78; Karst Tr. at 1030)10 The Orange Book states that therapeutic equivalent determinations are not made for unapproved off-label indications. (See DTX-2171; Karst Tr. at 1035) GSK's expert, Professor Erika Lietzan, acknowledged that "the meaning of therapeutically equivalent of AB rating is if the generic drug is used in accordance with its label, you would expect it to have the same clinical effect in a person as if that person had taken the brand drug." (Lietzan Tr. at 534 (emphasis added); see also id. at 542 ("AB rating means ... if a patient took the generic carvedilol for one of the uses in its label, you would expect it to have the same clinical effect as if the patient is taking Coreg.")) Teva's skinny label, as addressed above, omitted substantial information regarding the CHF indication and, instead, stated that the product was approved for hypertension and post-MI LVD indications. Accordingly, there is not legally sufficient evidence to support a finding that Teva, by listing its carvedilol as AB rated to Coreg® in product catalogs and reference guides, encouraged infringement.

Additionally, a reasonable juror would had to have found, based on the record presented at trial, that in July 2007, prior to the launch of generic carvedilol (including by Teva), doctors deciding to write a prescription for carvedilol relied on various sources other than Teva's label and marketing materials. In addition to the knowledge and experience that ordinarily skilled cardiologists had acquired by July 2007 about the benefits of treatment with carvedilol, such doctors had access to American Heart Association and American College of Cardiology guidelines, carvedilol research studies published in the New England Journal of Medicine, The Lancet, and the British Heart Journal, GSK's own Coreg® label and product insert, and GSK's extensive promotional activity — totaling nearly $1 billion (See Vojir Tr. at 508-09) — which included sending doctors to hospitals, giving seminars, and detailing, marketing, and advertising Coreg®. (See D.I. 465 at 7-8; Vojir Tr. at 497-511; McCullough Tr. at 666-69, 676-77; Zusman Tr. at 1151, 1164-65; PTX-78; DTX-2655.4; PTX-534)

Further, Teva showed that once generic carvedilol entered the market in September 2007, and continuing beyond 2007, doctors continued prescribing carvedilol (be it Coreg® or a generic) in the same manner as they had prior to the generics' entrance, as they based their prescription decisions on the various factors addressed above without relying on Teva's — or any other generic manufacturers' — label. (See McCullough Tr. at 677-78) GSK's expert, Dr. McCullough, testified that he had not read Teva's generic label before he started writing prescriptions for carvedilol. (See id. at 1662-63)11 As GSK concedes, prior to the generics' entrance into the market in 2007, physicians already knew how to use carvedilol for treating CHF. (Hr'g Tr. at 85-86) Three cardiologists testified at trial — GSK's expert, Dr. McCullough, and Teva's experts, Drs. Zusman and Rosendorff — and all three agreed that even in September 2007, when generic companies (including Teva) began selling carvedilol, doctors relied on guidelines and research, as well as their own experience, in addition to GSK marketing. (See McCullough Tr. at 676-79; Zusman Tr. at 1164-72, 1176-77; Rosendorff Tr. at 1296-97) None viewed generic labeling, including Teva's label, as impacting prescribing behavior. (See id.)12 In this context, there was no reasonable basis for the jury to have found that anything Teva did — including selling generic carvedilol, giving it a "skinny label," and all aspects of how Teva marketed its carvedilol — caused even a single doctor to prescribe carvedilol for the treatment of CHF.

Teva's uncontroverted evidence of alternative factors that caused physicians to prescribe carvedilol in an infringing manner cannot be ignored. See Integra, 496 F.3d at 1345 ("The rule that a jury verdict is reviewed for support by `substantial evidence' does not mean that the reviewing court must ignore the evidence that does not support the verdict.... [T]he court should give credence to the evidence favoring the nonmovant as well as that evidence supporting the moving party that is uncontradicted and unimpeached.") (internal quotation marks omitted).

As Teva correctly notes, no direct evidence was presented at trial that any doctor was ever induced to infringe the '000 patent by Teva's label (either skinny or full). There was no direct evidence that Teva's label caused even a single doctor to prescribe generic carvedilol to a patient to treat mild to severe CHF. Hence, in order to uphold the verdict, the Court must find in the record substantial evidence to render it reasonable for the jury to have inferred that at least one doctor was so induced. GSK, as the verdict winner, is entitled to the benefit of all reasonable inferences that may be drawn from the evidence presented to the jury. The Court's determination, however, is that — given the dearth of evidence that doctors read and understand and are affected by labels, and given the vast amount of evidence that doctors' decisions to prescribe carvedilol during the relevant periods were influenced by multiple non-Teva factors — such an inference was an unreasonable one for the jury to have drawn. See McAnally v. Gildersleeve, 16 F.3d 1493, 1500 (8th Cir. 1994) ("[Courts] cannot accord the jury with the benefit of unreasonable inferences, or those at war with the undisputed facts.") (internal quotation marks omitted).13

GSK suggests that the Court cannot (or at least should not) grant Teva's JMOL because it denied Teva's motion for summary judgment. (See, e.g., D.I. 472 at 2) ("Teva's JMOL request should be denied because it repeats the same arguments the Court has rejected before trial, wrongly argues that GSK's evidence is insufficient even though the Court already concluded it could support a jury verdict, asks the Court to substitute its judgment for the jury's on disputed facts, and ignores the jury charge.") The Court disagrees. In connection with adopting Magistrate Judge Burke's recommendation to deny Teva's motion for summary judgment of non-infringement, the Court wrote:

(D.I. 411 at 5) (internal citations omitted) After reviewing the entirety of the record GSK actually created at trial, as well as the unrebutted trial evidence presented by Teva, the Court now concludes (as it is free to do, notwithstanding the assessment it made prior to trial), that the inference of causation that GSK asks be drawn is not reasonable, as it is not supported by substantial evidence in the trial record.

Considering the record as a whole, substantial evidence does not support a finding by a reasonable factfinder that even at least one doctor was induced to prescribe generic carvedilol to be used in an infringing manner due to Teva's actions, as opposed to the various other factors supported in the record, during the skinny label period.14 Therefore, the Court cannot uphold the verdict of infringement with respect to the skinny label period.

2. The Full Label Period

The full label period, May 1, 2011 through June 7, 2015, runs from when Teva amended its label to include the CHF indication until the '000 patent expired. In attempting to prove inducement during the full label period, GSK presented evidence of Teva's full label along with various other materials, including Teva's 2004 and 2007 press releases, Teva's 2011 product catalog, the 2012 and 2013 editions of Teva's Monthly Prescribing Reference ("MPR"), and Teva's AB rating (including as it was listed on Teva's website). (See PTX-1297; PTX-1301; PTX-1165; PTX-1203; PTX-1205; PTX-0860; McCullough Tr. at 635-36)

As addressed above, however, Teva presented substantial, unrebutted evidence of multiple factors unrelated to Teva that actually caused doctors to infringe the '000 patent. A reasonable factfinder could only have found that these alternative, non-Teva factors were what caused the doctors to prescribe generic carvedilol for an infringing use. Regardless of Teva's actions after it amended its label in May of 2011, including its elimination of the carve-out from its label, physicians were already prescribing generic carvedilol to treat CHF at that time. No substantial evidence was presented at trial to support a finding that anything about doctors' behavior — either as a class, or even a single doctor — was induced to change by Teva's label, or by anything else Teva did (or failed to do).15 GSK conceded that physicians' reasons for and methods of prescribing carvedilol did not change when generics entered the market. (See McCullough Tr. at 677-78) For all these reasons, a reasonable jury could not find that Teva caused any direct infringement and, therefore, Teva cannot be held liable for inducement of infringement.

In sum, substantial evidence does not support the jury's finding on causation, and therefore does not support its verdict that Teva is liable for induced infringement, during both the skinny and full label periods. The Court will grant Teva's JMOL. Without a finding of infringement, there is no liability, so Teva cannot be found to be a willful infringer and cannot be ordered to pay GSK any damages. Accordingly, the Court will grant Teva's JMOL motion on each of these grounds.16

B. Substantial Evidence Supports the Jury's Finding of No Invalidity

Teva additionally seeks JMOL of invalidity, or a new trial, on two grounds: (1) the Kelly reference anticipates the asserted claims; and (2) the asserted claims are obvious in light of Kelly and Garg. (See D.I. 465 at 27-29) The Court is not persuaded by Teva and will deny this aspect of Teva's JMOL motion.

Regarding anticipation, before trial, the Court identified three genuine disputes of material fact: (1) whether Kelly disclosed a maintenance period greater than six months; (2) whether Kelly's patient population was the same as that covered by the claims; and (3) whether Kelly was "too theoretical" to be considered enabling. (See D.I. 380 at 2-3, 5-6; D.I. 417 at 1-2 & n.1) On each of these factual questions, Teva contends that the jury's findings for GSK were unreasonable. (See D.I. 465 at 27-29) The Court disagrees.

GSK presented sufficient evidence to support a reasonable inference that the Kelly reference only taught treatment follow-up after six months, rather than continuing treatment for six months (see, e.g., McCullough Tr. at 1673, 1677-78, 1731-32) and that the study may have dealt with a different patient population, as more than one type of heart failure exists and Kelly did not specify which type of heart failure patients it was treating (see, e.g., id. at 1672-73, 1681-82). GSK also presented sufficient evidence to support the inference that Kelly was too theoretical, as the study had not yet begun and could require undue experimentation. (See, e.g., id. at 1678-79) Each of these factual disputes was for the jury to resolve, and its finding that Teva did not prove the contrary by clear and convincing evidence was reasonable based on the record.

Regarding obviousness, Teva contends that the questions left open by Kelly (as addressed above) were all answered by Garg. (See D.I. 465 at 29) Thus, Teva asserts that the claims are obvious and the jury's conclusion, even in light of GSK's evidence of secondary considerations of non-obviousness, was unreasonable. (See id. at 29-30) However, as GSK notes (and as the Court finds above), the jury's finding that Kelly did not disclose the three disputed claim elements was reasonable based on the record. Moreover, contrary to Teva's contention, GSK provided evidence through Dr. McCullough that Garg does not supply the duration element lacking in Kelly. (See McCullough Tr. at 1682) This evidence, in addition to GSK's evidence that the prior art taught away from and discouraged beta-blockers in heart failure, was sufficient to render the jury's finding that the patent was non-obvious reasonable. Therefore, the Court will deny Teva's motion for JMOL or a new trial on invalidity.

IV. CONCLUSION

For the reasons stated above, the Court will grant in part and deny in part Teva's motion for judgment as a matter of law. (D.I. 464) Because substantial evidence does not support a finding of induced infringement, there is no basis for enhanced damages, attorney fees, and interest. Accordingly, GSK's motion (D.I. 466) and Teva's motion to strike multiple exhibits GSK submitted in support of its motion (D.I. 474) will be denied as moot. An appropriate Order follows.

ORDER

At Wilmington, this 28th day of March, 2018:

For the reasons set forth in the Memorandum Opinion issued this date,

IT IS HEREBY ORDERED that:

1. Teva's motion for judgment as a matter of law, or in the alternative for a new trial (D.I. 464), is GRANTED IN PART and DENIED IN PART.

2. GSK's motion for enhanced damages, attorney fees, and interest (D.I. 466) is DENIED AS MOOT.

3. Teva's motion to strike (D.I. 474) is DENIED AS MOOT.

IT IS FURTHER ORDERED that the parties shall meet and confer and shall submit a joint status report, no later than April 2, 2018, advising the Court of any remaining order(s) it should enter in this case and how the case should now proceed.