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Vectura Limited v. Glaxosmithkline LLC

United States District Court, D. Delaware

September 10, 2019

VECTURA LIMITED, Plaintiff;
v.
GLAXOSMITHKLINE LLC and GLAXO GROUP LIMITED, Defendants.

          Kelly E. Farnan and Christine D. Haynes, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Dominick A. Conde, Christopher P. Borello and Damien N. Dombrowski, VENABLE LLP, New York, NY, attorneys for Plaintiff.

          Jack B. Blumenfeld and Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Martin J. Black, Kevin M. Flannery, Robert Ashbrook, Sharon K. Gagliardi, DECHERT LLP, Philadelphia, PA; Blake B. Greene, DECHERT LLP, Austin, TX; Katherine A. Helm, DECHERT LLP, New York, NY, attorneys for Defendants.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE

         Currently pending before the Court is Defendants' Motion for Judgment as a Matter of Law and New Trial or Remittitur.[1] (D.I. 336). The parties have fully briefed the issues. (D.I. 337, 343, 349). For the following reasons, I will deny Defendants' motion.

         I. BACKGROUND

         On July 27, 2016, Plaintiff Vectura Limited sued Defendants GlaxoSmithKline LLC and Glaxo Group Limited for direct and induced infringement of U.S. Patent No. 8, 303, 991 ("the '991 patent"). (D.I.I). The'991 patent relates to pharmaceutical compositions for inhalation. (D.I. 82 at 1). Before trial, Plaintiff narrowed their infringement case to assert direct infringement of claim 3 of the '991 patent ("the asserted claim"). (D.I. 307). Plaintiff also pursued a claim of willful infringement of the asserted claim. (D.I. 307 at 11). Defendants asserted a noninfringement defense and an invalidity defense under 35 U.S.C. § 103. (Id.; D.I. 320 at 2).

         Claim 3 of the '991 patent depends from claims 1 and 2. Together, the claims read as follows:

1. Composite active particles for use in a pharmaceutical composition for pulmonary administration, each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material, wherein the composite active particles have a mass median aerodynamic diameter of not more than 10 urn, and wherein the additive material promotes the dispersion of the composite active particles upon actuation of a delivery device.
2. Composite active particles as claimed in claim 1, wherein the additive material includes one or more of: an amino acid or derivative thereof; a peptide or derivative thereof, a phospholipid or derivative thereof, a surface active material; or a metal stearate and derivative thereof.
3. Composite active particles as claimed in claim 2, wherein the additive material includes magnesium stearate.

('991 patent, els. 1-3).

         After a five-day trial, the jury returned the following verdict: (1) Defendants infringed claim 3 of the '991 patent, (2) claim 3 was not invalid for obviousness, (3) Plaintiff was entitled to an ongoing royalty payment of three percent for a total sum of $89, 712, 069 through December 31, 2018, and (4) Defendants' infringement was willful. (D.I. 321). The parties have now filed post-trial motions. Defendants renew their request for JMOL of no infringement, invalidity for obviousness, and no willful infringement, or in the alternative, a new trial. Defendants also request a new trial on damages or remittitur.

         II. LEGAL STANDARDS

         A. Judgement 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, '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) (citation omitted).

         "To prevail on a renewed motion for JMOL following a jury trial, a party must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusion(s) 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) (alterations in original). "'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). The Court may "not determine the credibility of the witnesses [nor] substitute its choice for that of the jury between conflicting elements in the evidence." Perkin-Elmer, 732 F.2d at 893. Rather, the Court must determine whether the evidence 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, Federal Practice and 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 might reasonably find a verdict for that party.").

         Where the moving party bears the burden of proof, the Third Circuit applies a different standard. This standard '"requires the judge to test the body of evidence not for its insufficiency to support a finding, but rather for its overwhelming effect."' Fireman's Fund Ins. Co. v. Videfreeze Corp., 540 F.2d 1171, 1177 (3d Cir. 1976) (quoting Mihalchak v. Am. Dredging Co., 266 F.2d 875, 877 (3d Cir. 1959)). The Court '"must be able to say not only that there is sufficient evidence to support the finding, even though other evidence could support as well a contrary finding, but additionally that there is insufficient evidence for permitting any different finding.'" Id. at 1177 (quoting Mihalchak, 266 F.2d at 877).

         B. New Trial

         Federal Rule of Civil Procedure 59(a)(1)(A) provides, in pertinent part: "The court may, on motion, grant a new trial on all or some of the issues-and to any party- ... after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court . . . ." Among the most common reasons for granting a new trial are: (1) 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; (2) newly discovered evidence exists that would likely alter the outcome of the trial; (3) improper conduct by an attorney or the court unfairly influenced the verdict; or (4) the jury's verdict was facially inconsistent. See Zarow-Smith v. N.J. Transit Rail Operations, Inc., 953 F.Supp. 581, 584-85 (D.N.J. 1997).

         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 (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 new trial motion under the "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-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 where the verdict "shocks [the] conscience." Williamson, 926 F.2d at 1352-53.

         III. DISCUSSION

         A. Infringement

         A patent is infringed when a person "without authority makes, uses, offers to sell, or sells any patented invention, within the United States .. . during the term of the patent...." 35 U.S.C. § 271(a). A two-step analysis is employed in making an infringement determination. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and scope. See Id. The trier of fact must then compare the properly construed claims with the accused infringing product. See Id. at 976. This second step is a question of fact. See Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).

         "Literal infringement of a claim exists when every limitation recited in the claim is found in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). "If any claim limitation is absent from the accused device, there is no literal infringement as a matter of law." Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000).

         1. Judgment as a Matter of Law

         When an accused infringer moves for JMOL of noninfringement, such relief may be granted only if at least one limitation of the claim in question does not read on an element of the accused product. Bayer, 212 F.3d at 1247. I must give deference to the jury's factual findings and view the record in the light most favorable to the non-moving party, Plaintiff. Williamson, 926 F.3dat 1348.

         Defendants argue that JMOL of noninfringement is appropriate because (1) there is insufficient evidence to support a finding that the accused products satisfied the dispersion limitation and (2) Plaintiff failed to prove the presence of the claimed composite active particles ("CAPs"). (D.I. 337 at 2). Plaintiff asserts that it presented substantial evidence supporting the jury's infringement verdict. (D.I. 343 at 2). I agree with Plaintiff that the jury's infringement verdict is supported by substantial evidence.

         a. The Dispersion Limitation

         Defendants assert that there is insufficient evidence to supporting the jury's implied factual finding that the accused products satisfied the dispersion limitation. (D.I. 337 at 3-4). The dispersion limitation is found in the following claim language: "wherein the additive material promotes the dispersion of the composite active particles upon actuation of a delivery device." ('991 patent, cl. 1). I construed this limitation to mean "wherein a composition that contains one or more [CAPs] has increased dispersion of the active material upon activating a delivery device for inhalation into the lungs by a patient, as compared to the same composition wherein unmodified active particles are substituted for the [CAPs]." (D.I. 169 at 2). Defendants argue that to satisfy its burden, Plaintiff was required to present evidence isolating the impact of the CAPs on the overall dispersion of the composition as required by the Court's claim construction. (D.I. 337 at 3-4).

         The Federal Circuit has made clear that it does not require a party to show evidence of a direct comparison to satisfy its burden of proof on infringement even where the court's claim construction requires a comparison to satisfy the claim limitation. See Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1372-73 (Fed. Cir. 2009). In Martek, the Federal Circuit recognized that even where there is a functional claim limitation requiring comparison, "circumstantial evidence may be sufficient" to satisfy the patentee's burden of proof. Id. As the patentee had presented other evidence supporting the infringement verdict, the lack of direct comparative testing did not require JMOL of noninfringement. Id. Brigham & Women's Hosp., Inc. v. Perrigo Co., 761 Fed.Appx. 995 (Fed. Cir. 2019) does not state otherwise. In Brigham, clinical testing was the only evidence put forward to prove infringement; there was no other direct or circumstantial evidence in the record.[2] Id. at 1003-04. The Federal Circuit determined that the clinical testing did not measure the claim limitation and the patentee has not established a correlation between the claimed limitation and the metric tested. Id. (studies measured adequate relief beginning at fifteen minutes, rather than immediate relief starting within five to ten minutes).

         Here, Plaintiff submitted comparison testing and other circumstantial evidence to the jury. (D.I. 352 at 154:11-156:10; D.I. 353 at 317:7-327:10; PTX-185). Defendants assert that Study 2 cannot support the infringement verdict under Brigham. (D.I. 337 at 4-5). However, Defendants merely reiterate the same arguments made at trial. Defendants challenge the usefulness of Study 2 because it did not test the accused products and Plaintiff did not establish that the Study was representative of the actual products. (Id.). But Plaintiff did submit evidence that Blend 6 was representative of the accused products. (D.I. 353 at 316:12-327:10; PTX-185 at 4; PTX-129 at 21; PTX 123 at 12). And unlike Brigham, where the testing submitted did not test the appropriate metric, here, Study 2 does provide a comparison of dispersion between a formulation with C APs and a formulation without CAPs to show "increased dispersion of the active material ... as compared to the same composition wherein unmodified active particles are substituted for the [CAPs]". (PTX-185). There is more than a mere speculative correlation between the testing provided and the accused products. (D.I. 353 at 325:15-326:14, 390:12-391:3, 407:22-410:15). Defendants also challenged the representativeness of the Study and the blends in front of the jury. (Id. at 360:6-365:2, 404:5-406:21; D.I. 354 at 574:1-576:17). The jury was entitled not to credit this testimony. (D.I. 307 at 7-8). As is required on a motion for JMOL, I must give Plaintiff the benefit of all logical inferences that can be made from the evidence in the record. Here, a reasonable juror could have credited Dr. Zhou's testimony over that of Defendants' expert, Dr. Colombo, determined that Study 2 was representative of the accused products, and thus, concluded that the dispersion limitation was met.

         Defendants also challenge the sufficiency of the evidence with regard to the accused products with umeclidinium as the active ingredient. (D.I. 337 at 10). Dr. Zhou testified at trial that the results of Study 2, which tested only blends with the active ingredient vilanterol, were equally applicable to compositions using umeclidinium. (D.I. 353 at 324:16-23). The jury was entitled to credit this testimony, especially where there was an absence of any contradictory evidence.

         Thus, there is substantial evidence in the record supporting the jury's finding that the dispersion limitation was satisfied by the accused products.

         b. The CAPs Limitation

         Defendants assert that Plaintiff failed to prove that the accused products satisfy the CAPs limitation because Plaintiffs expert testimony established, at best, "co-association," which does not satisfy the claim construction. (D.I. 337 at 11). At claim construction, I construed the claim term "composite active particle[s]" to mean "[a] single particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material are fixed such that the active and additive particles do not separate in the airstream." (D.I. 169 at 1).

         Defendants continue to assert that "co-association" cannot show that the additive is "fixed" to the active particle. However, Defendants focus upon the wrong inquiry. As I stated, "fixed" is not a technical term. (Pretrial Hr'g Tr. at 21:17-18). Plaintiff was required to establish that the additive magnesium stearate was "fixed to the active particle such that it does not separate in the airstream." (D.I. 169 at 1). Plaintiff has done so. Plaintiff presented testimony of SEM-EDX, ToF-SIMS, and SPAMS testing to show that the accused products satisfy the CAPs limitation. (D.I. 352 at 188:19-190:10, 194:10-199:11, 201:12-204:23, 211:17-212:5; D.I. 353 at 327:12-335:12, 336:15-353:13, 379:8-11). Dr. Zhou repeatedly testified that magnesium stearate was sufficiently coated or fixed to the active particles such that the magnesium stearate and the active did not separate in the airstream. (D.I. 353 at 328:23-329:15, 341:11-22, 345:2-14, 350:2-19, 351:18-352:16). This is substantial evidence supporting the jury's implied factual finding that the accused products satisfy the CAPs claim limitation.

         Thus, there is substantial evidence supporting the jury's factual findings that the accused products satisfy each and every claim limitation, as construed by the Court. Therefore, ...


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