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Amarin Pharma, Inc. v. West-Ward Pharmaceuticals International Ltd

United States District Court, D. Nevada

October 28, 2019

AMARIN PHARMA, INC., et al., Plaintiffs,



         I. SUMMARY

         This is a consolidated patent infringement case brought under the Hatch-Waxman Act where Plaintiffs Amarin Pharma, Inc., and Amarin Pharmaceuticals Ireland Limited seek to prevent Defendants West-Ward Pharmaceuticals International Limited (“West-Ward”), Hikma Pharmaceuticals USA Inc. (“Hikma”), and Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (collectively, “DRL”) from launching generic competitor drugs to Plaintiffs' drug Vascepa. Before the Court are: (1) Plaintiffs' motion for partial summary judgment as to certain of Defendants' affirmative defenses and counterclaims (ECF No. 234 (“Plaintiffs' Motion”)); (2) Defendants' motion for summary judgment as to non-infringement (ECF No. 236 (“Defendants' Motion”)); and (3) motions to seal related to these motions (ECF Nos. 235, 246, 254, 261, 265).[1] As further explained below, the Court will grant Defendants' Motion as to Plaintiffs' contributory infringement theory, but deny it as to Plaintiffs' inducement theory. The Court will grant Plaintiffs' Motion to the extent it seeks to prevent Defendants from asserting a written description defense at trial, but deny it as moot as to the other challenged defenses and counterclaims because Defendants have withdrawn them. The Court will also mostly grant the pending motions to seal that accompanied the briefing on these motions, but will direct further briefing as to why certain exhibits should be sealed.


         A. The Hatch-Waxman Act

         “The Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act and the patent laws to enable generic drugs to be more easily approved and to respond to loss of effective patent life resulting from the requirement that drug products require premarket testing and then must undergo FDA review, actions that consume significant portions of a patent term.” Vanda Pharm. Inc. v. W.-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 1126 (Fed. Cir. 2018) (citation omitted). The Hatch-Waxman Act strikes a balance between the competing public policy interests of encouraging the development of innovative new drugs, while also enabling competitors to bring low-cost generic drugs to market. See id.

         As relevant here, the Hatch-Waxman Act, specifically 35 U.S.C. § 271(e)(2)(A) (“Section 271(e)(2)”), also created an artificial act of patent infringement-the filing of an Abbreviated New Drug Application (“ANDA”) if the brand-name drug is still patent-protected. See Vanda, 887 F.3d at 1122, 1126. ANDAs allow generic drug companies to get Food and Drug Administration (“FDA”) approval to bring generic drugs that are bioequivalent to already approved brand-name drugs to market without undergoing the extensive testing and certification new drugs must undergo before the FDA will allow them to be sold to the public. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1045-46 (Fed. Cir. 2010). ANDAs may be filed under certain circumstances, such as where the patents covering a brand-name drug have expired, or, as here, when the generic drug manufacturer files a certification with its ANDA under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”), stating that the applicable patents are either invalid or not infringed by the generic competitor drug. See Vanda, 887 F.3d at 1122.

         B. The Parties' Dispute[2]

         Plaintiffs market a drug called “Vascepa[, which] is a pharmaceutical comprised of a highly purified omega-3 fatty acid called ethyl-eicosapentaenoic acid [“EPA”].” (ECF No. 234 at 8.) “Vascepa is indicated ‘as an adjunct to diet to reduce triglyceride (“TG”) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.'” (Id.) Severe hypertriglyceridemia puts patients at risk of developing pancreatitis. (Id.) Plaintiffs own a family of related patents sharing the same specification that purportedly cover Vascepa.

         Defendants filed ANDAs including Paragraph IV Certifications based on Plaintiffs' drug Vascepa. (See, e.g., ECF No. 1 at 1-6.) ANDAs must include the proposed labelling that will accompany the generic drug-and that labelling must generally be substantially the same as the labelling that accompanies the brand-name drug. See AstraZeneca, 633 F.3d at 1045-46. Here, Defendants' proposed labelling is materially indistinguishable from Plaintiffs' labelling. (ECF Nos. 252 at 15, 245 (sealed).) Defendants also did not seek to omit anything from Plaintiffs' labelling. (ECF No. 252 at 15.)

         Defendants' filing of ANDAs allowed Plaintiff to sue them under Section 271(e)(2) in an attempt to block Defendants from bringing their competitor drugs to market. Plaintiffs allege Defendants infringe certain of the group of Vascepa-related patents' claims. Plaintiffs specifically assert infringement of “Claims 1, 13, and 16 of [U.S. Patent No. 8, 293, 728 (“the '728 Patent”)], Claim 14 of [U.S. Patent No. 8, 318, 715 (“the '715 patent”)], Claims 1, 7, and 8 of U.S. Patent No. 8, 357, 677 (“the '677 Patent”), Claims 1, 7, and 8 of U.S. Patent No. 8, 367, 652 (“the '652 Patent”), Claims 4, 7, and 17 of U.S. Patent No. 8, 431, 560 (“the '560 Patent”), and Claims 1 and 5 of U.S. Patent No. 8, 518, 929 (“the '929 Patent”).” (ECF No. 234 at 8 (collectively, “the Asserted Claims”).) These patents all cover a method of treating hypertriglyceridemia using EPA. See, e.g., the '728 Patent. Plaintiffs allege that Defendants either induce infringement of, or contributorily infringe, the Asserted Claims because Defendants cannot directly infringe them-as method claims, they can only be infringed if a doctor were to treat a patient using one of Defendants' ANDA drugs in line with Defendants' labelling in a way that infringes the Asserted Claims. (ECF No. 236 at 13.)

         Plaintiffs and Defendants agree about key elements of the Asserted Claims. Most notably, they agree that all 15 of the Asserted Claims “require[] administering icosapent [another name for EPA] to a patient with severe hypertriglyceridemia (TG ≥500 mg/dL) for at least 12 weeks.” (ECF No. 252 at 12-13 (internal quotation marks and emphasis omitted).) Further, they agree that “fourteen of the asserted claims further require at least one of the following effects: (i) a reduction in triglycerides that is statistically significant or of at least about 10%, 20%, or 25%; (ii) no increase, no substantial increase, no statistically significant increase, or no more than 5% increase in LDL-C levels; or (iii) a reduction in apolipoprotein B.” (Id. at 13 (internal quotation marks and punctuation omitted) (the “Other Health Benefit Claims”).) The parties also agree that “[f]our asserted claims require that the patient not receive concurrent lipid altering therapy, e.g., a statin.” (Id. (internal quotation marks omitted) (the “Excluding Statins Claims”).)

         The Court already construed certain disputed terms within the Asserted Claims. (ECF No. 135 (the “Claim Construction Order”).) The parties attended a settlement conference after the Court issued the Claim Construction Order, but the parties did not reach a settlement. (ECF No. 150.) This case is set for a bench trial scheduled to start January 13, 2020. (ECF No. 213.)


         “The purpose of summary judgment is to avoid unnecessary trials when there is no dispute as to the facts before the court.” Nw. Motorcycle Ass'n v. U.S. Dep't of Agric., 18 F.3d 1468, 1471 (9th Cir. 1994). Summary judgment is appropriate when the pleadings, the discovery and disclosure materials on file, and any affidavits “show there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law.” Celotex Corp. v. Catrett, 477 U.S. 317, 330 (1986). An issue is “genuine” if there is a sufficient evidentiary basis on which a reasonable fact-finder could find for the nonmoving party and a dispute is “material” if it could affect the outcome of the suit under the governing law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248-49 (1986). Where reasonable minds could differ on the material facts at issue, however, summary judgment is not appropriate. See Id. at 250-51. “The amount of evidence necessary to raise a genuine issue of material fact is enough ‘to require a jury or judge to resolve the parties' differing versions of the truth at trial.'” Aydin Corp. v. Loral Corp., 718 F.2d 897, 902 (9th Cir. 1983) (quoting First Nat'l Bank v. Cities Service Co., 391 U.S. 253, 288-89 (1968)). In evaluating a summary judgment motion, a court views all facts and draws all inferences in the light most favorable to the nonmoving party. See Kaiser Cement Corp. v. Fishbach & Moore, Inc., 793 F.2d 1100, 1103 (9th Cir. 1986).

         The moving party bears the burden of showing that there are no genuine issues of material fact. See Zoslaw v. MCA Distrib. Corp., 693 F.2d 870, 883 (9th Cir. 1982). Once the moving party satisfies Rule 56's requirements, the burden shifts to the party resisting the motion to “set forth specific facts showing that there is a genuine issue for trial.” Anderson, 477 U.S. at 256. The nonmoving party “may not rely on denials in the pleadings but must produce specific evidence, through affidavits or admissible discovery material, to show that the dispute exists, ” Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 1991), and “must do more than simply show that there is some metaphysical doubt as to the material facts.” Orr v. Bank of Am., 285 F.3d 764, 783 (9th Cir. 2002) (internal citations omitted). “The mere existence of a scintilla of evidence in support of the plaintiff's position will be insufficient.” Anderson, 477 U.S. at 252.

         Further, “when parties submit cross-motions for summary judgment, ‘[e]ach motion must be considered on its own merits.'” Fair Hous. Council of Riverside Cty., Inc. v. Riverside Two, 249 F.3d 1132, 1136 (9th Cir. 2001) (quoting William W. Schwarzer, et al., The Analysis and Decision of Summary Judgment Motions, 139 F.R.D. 441, 499 (Feb. 1992)) (citations omitted). “In fulfilling its duty to review each cross-motion separately, the court must review the evidence submitted in support of each cross-motion.” Id.


         Defendants seek summary judgment that they do not infringe any of the Asserted Claims. (ECF No. 236.) Defendants' lead arguments apply to all of the Asserted Claims, though Defendants also make arguments that apply to only a subset of the Asserted Claims-one set of arguments applies to the Other Health Benefits Claims, and the other applies to the Excluding Statins Claims. But while these arguments differ in application, they are very similar in substance. Defendants basically argue as to inducement that their proposed labelling does not encourage prescribing doctors to infringe the Asserted Claims, and argue as to contributory infringement that their proposed generic drugs may be used in substantial, non-infringing ways. (Id.) The Court addresses these arguments as to the Asserted Claims-and subsets of those claims-below, after first describing the applicable legal framework.

         A. Legal Framework for Establishing Infringement

         “Infringement is a two-step inquiry, in which a court must first construe disputed claim terms, and then compare the properly construed claims to the accused device.” Nazomi Commc'ns, Inc. v. Arm Holdings, PLC, 403 F.3d 1364, 1367-68 (Fed. Cir. 2005) (citation omitted). The first step as to Plaintiffs' allegations that Defendants' proposed products as they will be prescribed infringe the Asserted Claims is already complete-the Court has construed the disputed claim terms. (ECF No. 135.) Plaintiffs bear the burden of persuasion as to infringement and must therefore prove all facts necessary to support their infringement claim. See Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191, 198 (2014) (“It is well established that the burden of proving infringement generally rests upon the patentee.”). Further, “[i]nfringement is a question of fact.” Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1040 (Fed. Cir. 2016) (citation omitted).

         “Since the ultimate burden of proving infringement rests with the patentee, an accused infringer seeking summary judgment of noninfringement may meet its initial responsibility either by providing evidence that would preclude a finding of infringement, or by showing that the evidence on file fails to establish a material issue of fact essential to the patentee's case.” Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed. Cir. 2001) (citation omitted). “Summary judgment of noninfringement may only be granted if, after viewing the alleged facts in the light most favorable to the nonmovant and drawing all justifiable inferences in the nonmovant's favor, there is no genuine issue whether the accused device is encompassed by the patent claims.” Id.

         As noted supra, Plaintiffs assert two related but distinct infringement theories in this case-inducement and contributory infringement-that are both considered indirect infringement theories. (ECF No. 252 at 7.) The Court briefly describes below the requirements for finding liability under both an inducement and contributory infringement theory.

         In this type of Hatch-Waxman Act patent litigation, where Defendants have filed ANDAs, the question of whether Defendants may be held liable for inducing infringement turns on whether Defendants “have the specific intent, based on the contents of their proposed labels, to encourage physicians to use their proposed ANDA products” in a way that infringes the Asserted Claims. Grunenthal GMBH v. Alkem Labs. Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019) (citation omitted). In other words, the Court must ask “whether the label encourages, recommends, or promotes infringement.” Id. (citation omitted). And because the Asserted Claims are method claims, the “pertinent question is whether the proposed label instructs users to perform the patented method.” Id. (citation omitted).

         The test for contributory infringement is different. A defendant contributorily infringes a method patent when the defendant: (1) knows its product is “made or especially adapted for use in an infringement of” that method patent; and (2) the product is “not a staple article or commodity of commerce suitable for substantial non-infringing use.” Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1327 (Fed. Cir. 2009) (citing 35 U.S.C. § 271(c)) (emphasis in original). “[N]on-infringing uses are substantial when they are not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.” Id. (citation omitted). Thus, and as especially relevant to Defendants' Motion, contributory infringement can turn on whether there are substantial non-infringing uses, while inducement does not.

         B. 12 Week Limitation That Applies to All Asserted Claims

         Defendants first direct their arguments at the claim limitation admittedly present in all 15 of the Asserted Claims, which “requires administering icosapent [another name for EPA] to a patient with severe hypertriglyceridemia (TG ≥500 mg/dL) for at least 12 weeks.” (ECF Nos. 236 at 14, 252 at 12-13 (internal quotation marks omitted).) The Court first addresses the parties' arguments regarding this 12 week claim limitation as to inducement, and then contributory infringement.

         1. Inducement

         Defendants argue they will not induce infringement of the Asserted Claims because their proposed labelling, which mirrors Plaintiffs', does not encourage doctors to prescribe the drug for at least 12 weeks. (ECF No. 236 at 14-19.) Plaintiffs respond that the labelling does encourage doctors to prescribe the drugs for at least 12 weeks, primarily because the reported clinical results included in the labelling state that the clinical trial establishing Vascepa's effectiveness lasted for 12 weeks, further pointing to expert testimony supporting Plaintiffs' view that a doctor reading the labelling would understand she should prescribe the drug to patients for at least 12 weeks. (ECF No. 252 at 17-26.) Plaintiffs further argue that disregarding this expert testimony at the summary judgment stage would be improper. (Id. at 26.) The Court agrees with Plaintiffs on that point.

         Where, as here, there is expert testimony not inconsistent with the proposed labelling supporting the view that a doctor would understand she should prescribe the drug for at least 12 weeks, it would be inappropriate to disregard that expert testimony to grant Defendants summary judgment. Doing so would be tantamount to weighing the evidence or ...

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