Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.

Opinion

3 UNITED STATES DISTRICT COURT

4 DISTRICT OF NEVADA

5 * * *

6 AMARIN PHARMA, INC., et al., Case No. 2:16-cv-02525-MMD-NJK

7 Plaintiffs, ORDER

8 v.

9 WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED, et al., 10 Defendants. 11 12 I. SUMMARY 13 This is a consolidated patent infringement case brought under the Hatch-Waxman 14 Act where Plaintiffs Amarin Pharma, Inc., and Amarin Pharmaceuticals Ireland Limited 15 seek to prevent Defendants West-Ward Pharmaceuticals International Limited (“West- 16 Ward”), Hikma Pharmaceuticals USA Inc. (“Hikma”), and Dr. Reddy’s Laboratories, Inc. 17 and Dr. Reddy’s Laboratories, Ltd. (collectively, “DRL”) from launching generic competitor 18 drugs to Plaintiffs’ drug Vascepa. Before the Court are: (1) Plaintiffs’ motion for partial 19 summary judgment as to certain of Defendants’ affirmative defenses and counterclaims 20 (ECF No. 234 (“Plaintiffs’ Motion”)); (2) Defendants’ motion for summary judgment as to 21 non-infringement (ECF No. 236 (“Defendants’ Motion”)); and (3) motions to seal related to 22 these motions (ECF Nos. 235, 246, 254, 261, 265).1 As further explained below, the Court 23 will grant Defendants’ Motion as to Plaintiffs’ contributory infringement theory, but deny it 24 as to Plaintiffs’ inducement theory. The Court will grant Plaintiffs’ Motion to the extent it 25 26 1The Court has reviewed the various responses, replies and other documents 27 associated with these motions. (ECF Nos. 240, 247, 251, 252, 255, 262, 263, 264.) The Court also notes the parties requested oral argument, but those requests are denied 1 seeks to prevent Defendants from asserting a written description defense at trial, but deny 2 it as moot as to the other challenged defenses and counterclaims because Defendants 3 have withdrawn them. The Court will also mostly grant the pending motions to seal that 4 accompanied the briefing on these motions, but will direct further briefing as to why certain 5 exhibits should be sealed. 6 II. BACKGROUND 7 A. The Hatch-Waxman Act 8 “The Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act and 9 the patent laws to enable generic drugs to be more easily approved and to respond to loss 10 of effective patent life resulting from the requirement that drug products require premarket 11 testing and then must undergo FDA review, actions that consume significant portions of a 12 patent term.” Vanda Pharm. Inc. v. W.-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1126 (Fed. 13 Cir. 2018) (citation omitted). The Hatch-Waxman Act strikes a balance between the 14 competing public policy interests of encouraging the development of innovative new drugs, 15 while also enabling competitors to bring low-cost generic drugs to market. See id. 16 As relevant here, the Hatch-Waxman Act, specifically 35 U.S.C. § 271(e)(2)(A) 17 (“Section 271(e)(2)”), also created an artificial act of patent infringement—the filing of an 18 Abbreviated New Drug Application (“ANDA”) if the brand-name drug is still patent- 19 protected. See Vanda, 887 F.3d at 1122, 1126. ANDAs allow generic drug companies to 20 get Food and Drug Administration (“FDA”) approval to bring generic drugs that are 21 bioequivalent to already approved brand-name drugs to market without undergoing the 22 extensive testing and certification new drugs must undergo before the FDA will allow them 23 to be sold to the public. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1045-46 24 (Fed. Cir. 2010). ANDAs may be filed under certain circumstances, such as where the 25 patents covering a brand-name drug have expired, or, as here, when the generic drug 26 manufacturer files a certification with its ANDA under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) 27 1 (“Paragraph IV Certification”), stating that the applicable patents are either invalid or not 2 infringed by the generic competitor drug. See Vanda, 887 F.3d at 1122. 3 B. The Parties’ Dispute2 4 Plaintiffs market a drug called “Vascepa[, which] is a pharmaceutical comprised of 5 a highly purified omega-3 fatty acid called ethyl-eicosapentaenoic acid [“EPA”].” (ECF No. 6 234 at 8.) “Vascepa is indicated ‘as an adjunct to diet to reduce triglyceride (“TG”) levels 7 in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.’” (Id.) Severe 8 hypertriglyceridemia puts patients at risk of developing pancreatitis. (Id.) Plaintiffs own a 9 family of related patents sharing the same specification that purportedly cover Vascepa. 10 Defendants filed ANDAs including Paragraph IV Certifications based on Plaintiffs’ 11 drug Vascepa. (See, e.g., ECF No. 1 at 1-6.) ANDAs must include the proposed labelling 12 that will accompany the generic drug—and that labelling must generally be substantially 13 the same as the labelling that accompanies the brand-name drug. See AstraZeneca, 633 14 F.3d at 1045-46. Here, Defendants’ proposed labelling is materially indistinguishable from 15 Plaintiffs’ labelling. (ECF Nos. 252 at 15, 245 (sealed).) Defendants also did not seek to 16 omit anything from Plaintiffs’ labelling. (ECF No. 252 at 15.) 17 Defendants’ filing of ANDAs allowed Plaintiff to sue them under Section 271(e)(2) 18 in an attempt to block Defendants from bringing their competitor drugs to market. Plaintiffs 19 allege Defendants infringe certain of the group of Vascepa-related patents’ claims. 20 Plaintiffs specifically assert infringement of “Claims 1, 13, and 16 of [U.S. Patent No. 21 8,293,728 (“the ’728 Patent”)], Claim 14 of [U.S. Patent No. 8,318,715 (“the ’715 patent”)], 22 Claims 1, 7, and 8 of U.S. Patent No. 8,357,677 (“the ’677 Patent”), Claims 1, 7, and 8 of 23 U.S. Patent No. 8,367,652 (“the ’652 Patent”), Claims 4, 7, and 17 of U.S. Patent No. 24 8,431,560 (“the ’560 Patent”), and Claims 1 and 5 of U.S. Patent No. 8,518,929 (“the ’929 25 Patent”).” (ECF No. 234 at 8 (collectively, “the Asserted Claims”).) These patents all cover 26

27 2Plaintiffs originally brought four separate lawsuits against Defendants in this district, but those suits were consolidated into this case. (ECF No. 91.) 1 a method of treating hypertriglyceridemia using EPA. See, e.g., the ’728 Patent. Plaintiffs 2 allege that Defendants either induce infringement of, or contributorily infringe, the Asserted 3 Claims because Defendants cannot directly infringe them—as method claims, they can 4 only be infringed if a doctor were to treat a patient using one of Defendants’ ANDA drugs 5 in line with Defendants’ labelling in a way that infringes the Asserted Claims. (ECF No. 6 236 at 13.) 7 Plaintiffs and Defendants agree about key elements of the Asserted Claims. Most 8 notably, they agree that all 15 of the Asserted Claims “require[] administering icosapent 9 [another name for EPA] to a patient with severe hypertriglyceridemia (TG ≥500 mg/dL) for 10 at least 12 weeks.” (ECF No. 252 at 12-13 (internal quotation marks and emphasis 11 omitted).) Further, they agree that “fourteen of the asserted claims further require at least 12 one of the following effects: (i) a reduction in triglycerides that is statistically significant or 13 of at least about 10%, 20%, or 25%; (ii) no increase, no substantial increase, no 14 statistically significant increase, or no more than 5% increase in LDL-C levels; or (iii) a 15 reduction in apolipoprotein B.” (Id. at 13 (internal quotation marks and punctuation omitted) 16 (the “Other Health Benefit Claims”).) The parties also agree that “[f]our asserted claims 17 require that the patient not receive concurrent lipid altering therapy, e.g., a statin.” (Id. 18 (internal quotation marks omitted) (the “Excluding Statins Claims”).) 19 The Court already construed certain disputed terms within the Asserted Claims. 20 (ECF No. 135 (the “Claim Construction Order”).) The parties attended a settlement 21 conference after the Court issued the Claim Construction Order, but the parties did not 22 reach a settlement. (ECF No. 150.) This case is set for a bench trial scheduled to start 23 January 13, 2020. (ECF No. 213.) 24 III. LEGAL STANDARD 25 “The purpose of summary judgment is to avoid unnecessary trials when there is no 26 dispute as to the facts before the court.” Nw. Motorcycle Ass’n v. U.S. Dep’t of Agric., 18 27 F.3d 1468, 1471 (9th Cir. 1994). Summary judgment is appropriate when the pleadings, 1 the discovery and disclosure materials on file, and any affidavits “show there is no genuine 2 issue as to any material fact and that the movant is entitled to judgment as a matter of 3 law.” Celotex Corp. v. Catrett, 477 U.S. 317, 330 (1986). An issue is “genuine” if there is 4 a sufficient evidentiary basis on which a reasonable fact-finder could find for the 5 nonmoving party and a dispute is “material” if it could affect the outcome of the suit under 6 the governing law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248-49 (1986). Where 7 reasonable minds could differ on the material facts at issue, however, summary judgment 8 is not appropriate. See id. at 250-51. “The amount of evidence necessary to raise a 9 genuine issue of material fact is enough ‘to require a jury or judge to resolve the parties’ 10 differing versions of the truth at trial.’” Aydin Corp. v. Loral Corp., 718 F.2d 897, 902 (9th 11 Cir. 1983) (quoting First Nat’l Bank v. Cities Service Co., 391 U.S. 253, 288-89 (1968)). In 12 evaluating a summary judgment motion, a court views all facts and draws all inferences in 13 the light most favorable to the nonmoving party. See Kaiser Cement Corp. v. Fishbach & 14 Moore, Inc., 793 F.2d 1100, 1103 (9th Cir. 1986). 15 The moving party bears the burden of showing that there are no genuine issues of 16 material fact. See Zoslaw v. MCA Distrib. Corp., 693 F.2d 870, 883 (9th Cir. 1982). Once 17 the moving party satisfies Rule 56’s requirements, the burden shifts to the party resisting 18 the motion to “set forth specific facts showing that there is a genuine issue for trial.” 19 Anderson, 477 U.S. at 256. The nonmoving party “may not rely on denials in the pleadings 20 but must produce specific evidence, through affidavits or admissible discovery material, to 21 show that the dispute exists,” Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 22 1991), and “must do more than simply show that there is some metaphysical doubt as to 23 the material facts.” Orr v. Bank of Am., 285 F.3d 764, 783 (9th Cir. 2002) (internal citations 24 omitted). “The mere existence of a scintilla of evidence in support of the plaintiff’s position 25 will be insufficient.” Anderson, 477 U.S. at 252. 26 Further, “when parties submit cross-motions for summary judgment, ‘[e]ach motion 27 must be considered on its own merits.’” Fair Hous. Council of Riverside Cty., Inc. v. 1 Riverside Two, 249 F.3d 1132, 1136 (9th Cir. 2001) (quoting William W. Schwarzer, et al., 2 The Analysis and Decision of Summary Judgment Motions, 139 F.R.D. 441, 499 (Feb. 3 1992)) (citations omitted). “In fulfilling its duty to review each cross-motion separately, the 4 court must review the evidence submitted in support of each cross-motion.” Id. 5 IV. DEFENDANTS’ MOTION (ECF NO. 236) 6 Defendants seek summary judgment that they do not infringe any of the Asserted 7 Claims. (ECF No. 236.) Defendants’ lead arguments apply to all of the Asserted Claims, 8 though Defendants also make arguments that apply to only a subset of the Asserted 9 Claims—one set of arguments applies to the Other Health Benefits Claims, and the other 10 applies to the Excluding Statins Claims. But while these arguments differ in application, 11 they are very similar in substance. Defendants basically argue as to inducement that their 12 proposed labelling does not encourage prescribing doctors to infringe the Asserted 13 Claims, and argue as to contributory infringement that their proposed generic drugs may 14 be used in substantial, non-infringing ways. (Id.) The Court addresses these arguments 15 as to the Asserted Claims—and subsets of those claims—below, after first describing the 16 applicable legal framework. 17 A. Legal Framework for Establishing Infringement 18 “Infringement is a two-step inquiry, in which a court must first construe disputed 19 claim terms, and then compare the properly construed claims to the accused device.” 20 Nazomi Commc’ns, Inc. v. Arm Holdings, PLC, 403 F.3d 1364, 1367-68 (Fed. Cir. 2005) 21 (citation omitted). The first step as to Plaintiffs’ allegations that Defendants’ proposed 22 products as they will be prescribed infringe the Asserted Claims is already complete—the 23 Court has construed the disputed claim terms. (ECF No. 135.) Plaintiffs bear the burden 24 of persuasion as to infringement and must therefore prove all facts necessary to support 25 their infringement claim. See Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 26 191, 198 (2014) (“It is well established that the burden of proving infringement generally 27 1 rests upon the patentee.”). Further, “[i]nfringement is a question of fact.” Apple Inc. v. 2 Samsung Elecs. Co., 839 F.3d 1034, 1040 (Fed. Cir. 2016) (citation omitted). 3 “Since the ultimate burden of proving infringement rests with the patentee, an 4 accused infringer seeking summary judgment of noninfringement may meet its initial 5 responsibility either by providing evidence that would preclude a finding of infringement, 6 or by showing that the evidence on file fails to establish a material issue of fact essential 7 to the patentee’s case.” Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 8 (Fed. Cir. 2001) (citation omitted). “Summary judgment of noninfringement may only be 9 granted if, after viewing the alleged facts in the light most favorable to the nonmovant and 10 drawing all justifiable inferences in the nonmovant’s favor, there is no genuine issue 11 whether the accused device is encompassed by the patent claims.” Id. 12 As noted supra, Plaintiffs assert two related but distinct infringement theories in this 13 case—inducement and contributory infringement—that are both considered indirect 14 infringement theories. (ECF No. 252 at 7.) The Court briefly describes below the 15 requirements for finding liability under both an inducement and contributory infringement 16 theory. 17 In this type of Hatch-Waxman Act patent litigation, where Defendants have filed 18 ANDAs, the question of whether Defendants may be held liable for inducing infringement 19 turns on whether Defendants “have the specific intent, based on the contents of their 20 proposed labels, to encourage physicians to use their proposed ANDA products” in a way 21 that infringes the Asserted Claims. Grunenthal GMBH v. Alkem Labs. Ltd., 919 F.3d 1333, 22 1339 (Fed. Cir. 2019) (citation omitted). In other words, the Court must ask “whether the 23 label encourages, recommends, or promotes infringement.” Id. (citation omitted). And 24 because the Asserted Claims are method claims, the “pertinent question is whether the 25 proposed label instructs users to perform the patented method.” Id. (citation omitted). 26 The test for contributory infringement is different. A defendant contributorily 27 infringes a method patent when the defendant: (1) knows its product is “made or especially 1 adapted for use in an infringement of” that method patent; and (2) the product is “not a 2 staple article or commodity of commerce suitable for substantial non-infringing use.” Vita- 3 Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1327 (Fed. Cir. 2009) (citing 35 U.S.C. § 4 271(c)) (emphasis in original). “[N]on-infringing uses are substantial when they are not 5 unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.” Id. 6 (citation omitted). Thus, and as especially relevant to Defendants’ Motion, contributory 7 infringement can turn on whether there are substantial non-infringing uses, while 8 inducement does not. 9 B. 12 Week Limitation That Applies to All Asserted Claims 10 Defendants first direct their arguments at the claim limitation admittedly present in 11 all 15 of the Asserted Claims, which “requires administering icosapent [another name for 12 EPA] to a patient with severe hypertriglyceridemia (TG ≥500 mg/dL) for at least 12 weeks.” 13 (ECF Nos. 236 at 14, 252 at 12-13 (internal quotation marks omitted).) The Court first 14 addresses the parties’ arguments regarding this 12 week claim limitation as to inducement, 15 and then contributory infringement. 16 1. Inducement 17 Defendants argue they will not induce infringement of the Asserted Claims because 18 their proposed labelling, which mirrors Plaintiffs’, does not encourage doctors to prescribe 19 the drug for at least 12 weeks. (ECF No. 236 at 14-19.) Plaintiffs respond that the labelling 20 does encourage doctors to prescribe the drugs for at least 12 weeks, primarily because 21 the reported clinical results included in the labelling state that the clinical trial establishing 22 Vascepa’s effectiveness lasted for 12 weeks, further pointing to expert testimony 23 supporting Plaintiffs’ view that a doctor reading the labelling would understand she should 24 prescribe the drug to patients for at least 12 weeks. (ECF No. 252 at 17-26.) Plaintiffs 25 further argue that disregarding this expert testimony at the summary judgment stage would 26 be improper. (Id. at 26.) The Court agrees with Plaintiffs on that point. 27 1 Where, as here, there is expert testimony not inconsistent with the proposed 2 labelling supporting the view that a doctor would understand she should prescribe the drug 3 for at least 12 weeks, it would be inappropriate to disregard that expert testimony to grant 4 Defendants summary judgment. Doing so would be tantamount to weighing the evidence 5 or making credibility determinations, which the Court cannot do in considering summary 6 judgment. 7 That said, whether Defendants’ proposed labelling would induce doctors to 8 prescribe their proposed drugs for 12 weeks or more is a close call because the proposed 9 labelling does not have much to say about the duration of treatment. (See generally ECF 10 No. 245.) Plaintiffs point to only three instances in the 10 pages of labelling3 that relate to 11 the duration of treatment: (1) the clinical studies section of the labelling describes a clinical 12 trial (the “MARINE Trial”) in which patients were enrolled for 12 weeks (ECF No. 245 at 8- 13 9; (2) the nonclinical toxicology section of the labelling describes two studies done in rats 14 and mice, one that lasted 2 years and the other that lasted 6 months (id. at 8); and the 15 patient information section says “[d]o not change your dose or stop taking VASCEPA 16 without talking to your doctor” (id. at 11). (ECF No. 252 at 14-18.) None of these instances 17 explicitly tell doctors they should prescribe the drug for at least 12 weeks. Further, the 18 indications and usage section of the labelling, which both begins the labelling and is the 19 section one would expect to contain explicit instructions, does not specify a duration of 20 treatment. (ECF No. 245 at 4.) 21 However, Plaintiffs persuasively argue that no treating physician would view the 22 labelling in a vacuum—rather, they would bring their own knowledge and experience to 23 bear on the labelling in deciding the duration of treatment. (ECF No. 252 at 17-18.) 24 Plaintiffs also make the related argument that doctors know severe hypertriglyceridemia 25 is a chronic condition requiring indefinite treatment. (Id. at 18.) Therefore, Plaintiffs argue, 26

27 3Again, Defendants’ proposed labelling does not differ from Plaintiffs’ proposed labelling in any material way. 1 doctors would understand the labelling as requiring treatment for more than 12 weeks. (Id. 2 at 17-26.) The Court finds this argument intuitively persuasive—chronic conditions require 3 indefinite treatment. See Sanofi v. Glenmark Pharm. Inc., USA, 204 F. Supp. 3d 665, 684 4 (D. Del. 2016), aff’d sub nom. Sanofi v. Watson Labs. Inc., 875 F.3d 636 (Fed. Cir. 2017) 5 (finding after bench trial that the defendants’ labels induced infringement because of “the 6 description of the long-term treatment involved in the ATHENA trial in Defendants’ labels, 7 additional clues in the labels that suggest long-term treatment, and the experts’ testimony 8 that prescribing physicians generally intend to treat patients with dronedarone for longer 9 than 12 months[.]”). And more importantly, Plaintiffs support these arguments with expert 10 testimony. (ECF No. 252 at 17-26.) Plaintiffs’ proffered expert testimony creates a genuine 11 issue of material fact inappropriate for resolution at summary judgment as to “whether the 12 label encourages, recommends, or promotes infringement.” Grunenthal, 919 F.3d at 1339; 13 see also Bio Tech. Gen. Corp. v. Duramed Pharm., Inc., 325 F.3d 1356, 1361 (Fed. Cir. 14 2003) (reversing grant of summary judgment of noninfringement in part on an inducement 15 theory in part because the district court had disregarded expert testimony while explaining 16 that the evidence necessary to survive summary judgment need not be extensive provided 17 it is uncontradicted). 18 Defendants primarily rely on Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp., 19 785 F.3d 625, 632 (Fed. Cir. 2015) to argue that Plaintiffs’ proffered expert testimony is 20 insufficient to show inducement because the proposed labelling lacks specific statements 21 that encourage or will inevitably lead to infringement.4 (ECF No. 262 at 8-9.) The Court is 22 4The Court has reviewed Defendants’ supplemental authority (ECF No. 273-1), 23 HZNP Medicines LLC v. Actavis Laboratories UT, Inc., — F.3d. —, 2019 WL 5076226, *15-18 (Fed. Cir. Oct. 10, 2019), and finds it does not change the Court’s ruling on 24 inducement here. The asserted claims in HZNP Medicines required patients to: (1) apply a medicated lotion; (2) wait for it to dry; then (3) apply sunscreen or bugspray to the same 25 area. See id. at *16. But the labelling at issue merely warned users to let the medicated lotion dry before applying sunscreen or bugspray. See id. at *15-*16. Similar to Takeda, 26 the expert testimony in HZNP Medicines provided an implausible interpretation of the labelling in an attempt to show induced infringement of the asserted patent claims, 27 whereas here, Plaintiffs’ expert testimony offers a plausible interpretation of the labelling that suggests the Court could find induced infringement. See id. at *16-*18. Moreover, the 1 not persuaded. There is a meaningful distinction between the labelling in this case and the 2 labelling at issue in Takeda, where the plaintiff argued the statement “[i]f you have a gout 3 flare while taking [the drug], tell your healthcare provider,” in the labelling induced 4 infringement of claims directed to the treatment of acute gout flares, where the applicable 5 labelling only otherwise stated that the drug was indicated for prophylaxis of gout. Takeda, 6 785 F.3d at 630, 632-34. Here, the clinical studies section of the labelling mentions that 7 the study establishing the effectiveness of the Vascepa ran for 12 weeks, and the labelling 8 is otherwise mostly silent as to treatment duration. (ECF No. 245.) Therefore, Plaintiffs’ 9 proffered expert testimony supplements a plausible interpretation of the labelling, instead 10 of providing an explanation of the labelling not consistent with the labelling, like the expert 11 testimony did in Takeda.5 See 785 F.3d at 633. 12 2. Contributory Infringement 13 Defendants also argue they cannot contributorily infringe the Asserted Claims 14 because their drugs as described in the proposed labelling are capable of the substantial 15 non-infringing use of reducing triglycerides in less than 12 weeks. (ECF No. 236 at 19-23.) 16 As support, Defendants point to the content of their proposed labelling, Plaintiffs’ clinical 17 data showing reductions of triglycerides peaking around four weeks, the specifications of 18 the asserted patents claiming a reduction in triglycerides in as little as one week, 19 concessions from Plaintiffs’ infringement expert that probably 5% of his patients use 20 Vascepa for less than 12 weeks, and that it would not be ‘off-label,’ or prohibited by the 21 FDA, to prescribe Vascepa for less than 12 weeks. (Id.) Plaintiffs respond that this 22 evidence does not establish a substantial non-infringing use, especially because of other 23 relevant user in HZNP Medicines was a patient, and not, as here, a doctor. Thus, Plaintiffs’ 24 persuasive argument that a doctor would look at the clinical studies portion of the labelling because of that doctor’s medical training and experience would not apply in the situation 25 addressed in HZNP Medicines, where the court was considering whether a patient would infringe. 26 5Takeda also arose in a different procedural context, where a different legal 27 standard governed that court’s analysis. See 785 F.3d at 628-29, 634-35 (affirming the district court’s denial of a preliminary injunction). 1 testimony from Plaintiffs’ infringement expert showing that doctors understand 2 hypertriglyceridemia is a chronic condition necessitating ongoing, indefinite treatment to 3 maintain reductions in triglyceride levels. (ECF No. 252 at 35.) Plaintiffs further argue 4 short-term (less than 12 week) treatment would be therefore be unusual and contrary to 5 clinicians’ intent in treating hypertriglyceridemia. (Id.) 6 The Court agrees with Defendants. Even if it only happens about 5% of the time, 7 reducing triglycerides in less than 12 weeks using Defendants’ ANDA drugs would not be 8 “unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.” Vita- 9 Mix, 581 F.3d at 1327; see also In re Depomed Patent Litig., Case No. CV 13-4507 (CCC- 10 MF), 2016 WL 7163647, at *69 (D.N.J. Sept. 30, 2016), aff’d sub nom. Grunenthal, 919 11 F.3d 1333 (finding after trial that a use pattern of a drug the plaintiffs’ expert conceded 12 would occur less than 5% of the time was a sufficiently substantial use to defeat a 13 contributory infringement claim). 14 The material facts are undisputed as to this issue. First, it is undisputed that 15 prescribing Defendants’ potential ANDA drugs for fewer than 12 weeks is within the scope 16 of the FDA approval reflected in Vascepa’s labelling. (ECF No. 245 (providing no defined 17 duration of treatment).) Second, Plaintiffs agree with Defendants that “the specification in 18 the asserted patents states that TG reduction can occur in a shorter period of time than 19 12 weeks.” (ECF No. 252 at 13.) Third, Plaintiffs also agree with Defendants that Plaintiffs’ 20 MARINE study results show that “the maximum effect on fasting TG reduction occurred 21 by Week 4.” (Id.) Fourth, while he explained that he would normally prescribe Vascepa for 22 an indefinite period of time because severe hypertriglyceridemia is a chronic condition 23 (ECF No. 252 at 15), Plaintiffs’ infringement expert conceded that he treated patients with 24 Vascepa for less than 12 weeks about 5% of the time, which is consistent with Vascepa’s 25 labelling. (ECF Nos. 252 at 35, 241 at 74-75 (sealed).) Thus, there is no real dispute that 26 Vascepa—and therefore also Defendants’ ANDA drugs—are, and can be for legitimate 27 reasons, prescribed for fewer than 12 weeks. That means that reducing triglycerides in 1 less than 12 weeks using Defendants’ ANDA drugs is a substantial non-infringing use of 2 those drugs. Moreover, Plaintiffs proffer no evidence that directly contradicts any of the 3 evidence discussed above. (ECF No. 252 at 32-36.) 4 The existence of this substantial non-infringing use for Defendants’ ANDA drugs 5 therefore defeats Plaintiffs’ contributory infringement claim. See Vita-Mix, 581 F.3d at 6 1328 (affirming the district court’s grant of summary judgment of no contributory 7 infringement because there were substantial non-infringing uses for the accused 8 products). Because there is no genuine dispute of material fact on this issue, the Court 9 will grant Defendants summary judgment that they do not contributorily infringe Plaintiffs’ 10 Asserted Claims.6 11 C. Other Health Benefit Claims 12 Defendants next argue they will not induce infringement of the Other Health Benefit 13 Claims because their proposed labels do not specifically encourage use of their products 14 to achieve the claimed additional benefits. (ECF No. 236 at 24.) Plaintiffs respond that the 15 clinical studies section of the labelling describes how the additional benefits described in 16 this subset of claims occurred in the MARINE Trial, and proffer expert testimony to support 17 the view that doctors would consider these results in choosing to prescribe Vascepa over 18 other drugs—because the MARINE Trial shows they can reasonably expect a certain 19 amount of triglyceride reduction in their patients while those patients also receive other 20 health benefits. (ECF No. 252 at 26-31.) Thus, like the parties’ arguments as to all 21 6The Court therefore need not, and does not, reach the parties’ arguments as to 22 contributory infringement of the Other Health Benefit Claims and the Excluding Statins Claims—because they are subsets of the Asserted Claims. That said, the Court notes that 23 even Plaintiffs do not oppose Defendants’ Motion to the extent it argues that Defendants do not contributorily infringe the Excluding Statins Claims. (ECF No. 252 at 32 n. 17.) 24 Moreover, the Court is skeptical of Plaintiffs’ theory that Defendants contributorily infringe the Other Health Benefits Claims because there is no real dispute that Defendants’ 25 potential ANDA drugs could be used in accordance with their proposed labels without achieving the specific effects required by those claims, and Plaintiffs’ own clinical study 26 explicitly establishes that some patients received the triglyceride reductions required by all Asserted Claims without getting the other health benefits required by the Other Health 27 Benefits Claims—so at least some substantial non-infringing uses must exist. (ECF No. 262 at 24-25.) 1 Asserted Claims regarding the 12 week limitation, this dispute centers on whether the 2 clinical studies section of the labelling would encourage doctors to infringe the Other 3 Health Benefits Claims. And the answer again depends on whether the Court considers 4 Plaintiffs’ proffered expert testimony. At this stage, the Court must. 5 The Court will thus deny Defendants’ motion for summary judgment of 6 noninfringement as to Plaintiffs’ inducement theory regarding the Other Health Benefits 7 Claims because it simply cannot disregard Plaintiffs’ expert testimony to the effect that 8 doctors would look at the clinical study results in the labelling before deciding to prescribe 9 a drug, and would prescribe that drug for its additional benefits beyond its primary 10 indication. (Id. at 27.) The Court finds it more appropriate to consider expert testimony 11 from both sides as to whether induced infringement may be inferred from the labelling at 12 the upcoming bench trial, and resolve the meaning of the labelling at trial. See, e.g., 13 Grunenthal, 919 F.3d at 1339-40 (affirming the district court’s finding of no induced 14 infringement after a bench trial while looking to expert testimony to determine the meaning 15 of the labelling at issue). While there is no dispute that the clinical studies section of the 16 labelling reflects the findings of the MARINE Trial that are also embedded in the Other 17 Health Benefit Claims, a material factual dispute remains as to whether the labelling would 18 encourage doctors to prescribe Defendants’ ANDA drugs in a way that infringes the Other 19 Health Benefits Claims. (ECF Nos. 236 at 24-25, 252 at 26-31.) 20 Defendants also argue that “Defendants’ labels will not induce infringement of— 21 i.e., specifically encourage practicing—those claims that require controlling LDL-C and 22 Apo B levels, uses of icosapent that are not even approved by the FDA.” (ECF No. 236 at 23 25-27.) Defendants primarily rely on Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 24 1316 (Fed. Cir. 2012). (ECF No. 236 at 26-27.) In response, Plaintiffs point to expert 25 testimony to the effect that the additional health benefits discussed in the Other Health 26 Benefits Claims are merely “additional treatment effects that clinicians should expect when 27 administering the product in accordance with the approved label to reduce triglycerides in 1 patients with severe hypertriglyceridemia.” (ECF No. 252 at 29-30.) Plaintiffs also 2 distinguish Bayer for this reason, noting the Bayer court contrasted its finding that the 3 generic drug company defendants’ labels did not induce infringement of Bayer’s patent 4 with a hypothetical different case where “[t]he patent does not claim a method of achieving 5 a contraceptive effect in a patient in need of contraception in which the drug used to 6 achieve the contraceptive effect has two generally beneficial additional effects.” Bayer, 7 676 F.3d 1323. (ECF No. 252 at 30-31.) 8 The Court agrees with Plaintiffs. Again, the Court cannot ignore at this stage the 9 expert testimony Plaintiffs point to indicating that a doctor who administers Vascepa with 10 the primary purpose of reducing triglycerides, but also because there are additional 11 benefits, would still be using Vascepa in an ‘on label’ way. (Id. at 30.) And Bayer does not 12 require otherwise. The patent in Bayer was “narrowly focused on simultaneously achieving 13 three effects in premenopausal or menopausal patients in need of all three effects; as the 14 parties stipulated, the claim limitation referring to a ‘patient in need thereof’ means a 15 patient with a ‘perceived need for’ all three effects.” Bayer, 676 F.3d at 1323. The patents 16 at issue here are all focused on a method for reducing triglyceride levels in a particular 17 patient population by giving that patient a particular drug composition for at least 12 weeks. 18 See, e.g., Claim 1 of the ’728 Patent. The benefits described and claimed in the Other 19 Health Benefit Claims are merely additional benefits—nothing in the patent requires that 20 a doctor only prescribe a drug because a patient has a perceived need for both the primary 21 and additional benefits. Thus, the Court agrees with Plaintiffs that the patents at issue here 22 are more similar to the hypothetical situation described for contrast in Bayer, than the 23 patent claims at issue in Bayer. (ECF No. 252 at 30-31.) 24 In sum, the Court will deny Defendants summary judgment of non-infringement as 25 to Plaintiffs’ inducement infringement theory regarding the Other Health Benefits Claims. 26 /// 27 /// 1 D. Excluding Statins Claims 2 Defendants’ argument as to induced infringement of these four claims is similar to 3 the arguments described above as to the Asserted Claims more broadly. (ECF No. 236 at 4 29-30.) Plaintiffs’ response to Defendants’ argument is also similar. (ECF No. 252 at 31- 5 32.) In short, only the clinical studies section of the labeling refers to whether or not the 6 patient was on a statin during the MARINE Trial (some were, some were not), and 7 Plaintiffs’ proffer expert testimony to the effect that doctors would interpret this to mean 8 they could prescribe the drug to patients who were not also on a statin, while Defendants 9 argue the labeling itself does not encourage such an interpretation. For essentially the 10 same reasons as described above, the Court will deny Defendants summary judgment 11 that they do not induce infringement of the Excluding Statins Claims. 12 V. PLAINTIFFS’ MOTION (ECF NO. 234) 13 Plaintiffs seek to prevent Defendants from asserting any invalidity defenses at trial 14 under 35 U.S.C. § 102 and 35 U.S.C. § 112 because Defendants have only disclosed 15 evidence supporting Defendants’ view that Plaintiffs’ asserted patents are invalid as 16 obvious under 35 U.S.C. § 103. (ECF No. 234.) Defendants counter they only seek to 17 assert the defense that Plaintiffs Asserted Claims are invalid because they do not satisfy 18 the written description requirement. (ECF No. 247 at 6.) The Court will therefore address 19 below the other defenses Plaintiffs challenge in Plaintiffs’ Motion before addressing the 20 written description defense. 21 A. Other Challenged Defenses 22 Defendants write that they “are not asserting invalidity based on anticipation, 23 enablement, or indefiniteness, so [Plaintiffs’] motion with respect to those defenses is 24 moot.” (Id.) The Court therefore deems these defenses (and counterclaims) withdrawn. 25 B. Written Description 26 But Defendants would still like the option of raising the written description defense 27 (and counterclaim) at trial. (Id.) Plaintiffs respond that Defendants should not be allowed 1 to raise the written description defense because they did not raise it until their expert’s 2 reply report—that allowing Defendants to raise it now would be unfair and prejudicial. (ECF 3 No. 264 at 4-6, 7-13.) Plaintiffs further respond that Defendants’ written description 4 defense is deficient as a matter of law. (Id. at 13-21.) The Court agrees it would be unfair 5 and prejudicial to allow Defendants to assert a written description defense at trial, and 6 declines to address the merits of Plaintiffs’ argument. 7 One purpose of “the Federal Rules[] is to prevent unfair and prejudicial surprise[.]” 8 ATD Corp. v. Lydall, Inc., 159 F.3d 534, 550-51 (Fed. Cir. 1998) (affirming the district 9 court’s decision not to allow a party to present a particular patent as a prior art reference 10 at trial because that party did not produce the reference during the designated discovery 11 period). Experts are normally expected to include “a complete statement of all opinions 12 the witness will express and the basis and reasons for them” in their opening reports. Fed. 13 R. Civ. P. 26(a)(2)(B)(i). Moreover, “an expert’s rebuttal testimony may not introduce new, 14 alternative or previously unconsidered theories.” Tuuamalemalo v. Las Vegas Metro. 15 Police Dep’t, Case No. 2:16-cv-00619-JAD-VCF, 2017 WL 1550235, at *1 (D. Nev. Apr. 16 28, 2017) (denying motion to strike rebuttal expert report because it directly addressed the 17 same subject matter of the opening report). 18 Failure to comply with these rules triggers Rule 37(c)(1), which provides, in 19 pertinent part: 20 If a party fails to provide information or identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply evidence 21 on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless. 22 23 Fed. R. Civ. P. 37(c)(1). Thus, when a party fails to timely disclose a witness or information, 24 or supplement its disclosures, the default rule is the party cannot use the undisclosed 25 information or witness to supply evidence on a motion, at a hearing, or at trial. See, e.g., 26 Yeti by Molly, Ltd. v. Deckers Outdoor Corp., 259 F.3d 1101, 1106 (9th Cir. 2001) 27 (describing the sanction as “self-executing”). The exception is when failure to disclose is 1 substantially justified or harmless. See id. And the court retains discretion to fashion 2 appropriate relief in the event of a failure to disclose. See id. (stating that a district court 3 has “particularly wide latitude” over its discretion to issue sanctions under Rule 37(c)(1)). 4 “Several factors [] guide the determination of whether substantial justification and 5 harmlessness exist, including (1) prejudice or surprise to the party against whom the 6 evidence is offered; (2) the ability of that party to cure the prejudice; (3) the likelihood of 7 disruption of trial; and (4) bad faith or willfulness in not timely disclosing the evidence.” 8 Silvagni v. Wal-Mart Stores, Inc., 320 F.R.D. 237, 242 (D. Nev. 2017) (citations omitted). 9 Plaintiffs more specifically argue they would be prejudiced were Defendants 10 allowed to assert a written description defense at trial because their experts had no 11 opportunity to consider and rebut Defendants’ expert’s opinions as to written description 12 while expert discovery was still open. (ECF No. 264 at 9-10.) Plaintiffs also note that 13 Defendants obtained a two month extension of the deadline to exchange their opening 14 expert report, over Plaintiffs’ objection, “before committing to a final position on invalidity[,]” 15 but Defendants’ expert did not raise the written description defense in that opening report. 16 (ECF Nos. 173 at 5, 264 at 11.) In addition, Plaintiffs argue that this late disclosure of 17 Defendants’ written description defense would disrupt their preparations for the upcoming 18 trial were Defendants allowed to assert it. (ECF No. 264 at 12.) For these reasons, 19 Plaintiffs argue Defendants should be precluded from asserting a written description 20 defense at trial. (Id. at 12-13.) And while Plaintiffs’ Motion included a condensed version 21 of these fairness and prejudice arguments (ECF No. 234 at 15), Defendants did not 22 respond to them (ECF No. 247). 23 The Court is persuaded by Plaintiffs’ arguments. To start, there is no dispute that 24 Defendants did not indicate they intended to assert a written description defense in their 25 opening expert report as required by Fed. R. Civ. P. 26(a)(2)(B)(i). Thus, Defendants are 26 not allowed to assert that defense at trial unless their failure to disclose was substantially 27 justified or harmless. See Fed. R. Civ. P. 37(c)(1). Defendants do not even argue their 1 failure to disclose was substantially justified or harmless, instead focusing on the merits of 2 a potential written description defense. (ECF No. 247.) This weighs in favor of finding it 3 was not substantially justified or harmless. 4 Further, the factors outlined in Silvagni tip towards finding Defendants’ failure to 5 disclose was not substantially justified. See 320 F.R.D. at 242. The Court agrees with 6 Plaintiffs that the late disclosure of the written description defense in Defendants’ reply 7 expert report prejudices Plaintiffs. The Court also agrees it would be difficult for Plaintiffs 8 to cure the prejudice by moving to reopen expert discovery, and preparing a new expert 9 report to rebut the written description defense, all while preparing for the bench trial 10 scheduled to start in January. Moreover, the Court is concerned about potential disruption 11 of trial, especially considering that all parties seem to agree it is important the case actually 12 go to trial on the firm trial date it is currently set for. But all of this said, the Court will not 13 impute any bad faith or willfulness to Defendants for their untimely disclosure of their intent 14 to rely on the written description defense, as it sees no reason to do so. Even still, three 15 of the four Silvagni factors weigh in favor of finding Defendants’ late disclosure of their 16 intent to assert the written description defense was not substantially justified or harmless. 17 Thus, it was not. For all of these reasons, Defendants may not assert a written description 18 defense at trial. 19 In sum, the Court will deny Plaintiffs’ Motion as moot to the extent it attacks 20 Defendants’ anticipation, enablement, or indefiniteness defenses (and counterclaims) 21 because Defendants have withdrawn those defenses (and counterclaims). But the Court 22 will grant Plaintiffs’ Motion to the extent necessary to make clear Defendants may not 23 assert a written description defense at trial. 24 VI. MOTIONS TO SEAL 25 The parties filed redacted versions of their briefs and seek to seal certain exhibits— 26 so most briefs related to the motions discussed above were accompanied by a motion to 27 seal in accordance with LR IA 10-5. 1 In the Ninth Circuit there is “a strong presumption in favor of access to court 2 records.” Foltz v. State Farm Mut. Auto. Ins. Co., 331 F.3d 1122, 1135 (9th Cir. 2003). To 3 overcome this presumption, a party must articulate “compelling reasons” justifying 4 nondisclosure, such as use of the record to gratify spite, permit public scandal, circulate 5 libelous statements, or release trade secrets. Kamakana v. City of Honolulu, 447 F.3d 6 1172, 1179 (9th Cir. 2006). “The mere fact that the production of records may lead to a 7 litigant’s embarrassment, incrimination, or exposure to further litigation will not, without 8 more, compel the court to seal its records.” Id. (citation omitted). 9 In general, the parties seek to maintain under seal evidence designated as 10 confidential by the parties during discovery, which they contend contains proprietary and 11 confidential information that could subject them to commercial disadvantage were it to be 12 made public. The Court describes the content of each of these motions to seal, in turn, 13 below—and then provides the Court’s ruling as to the motions to seal. 14 A. Content of the Motions 15 1. ECF NO. 235 16 In this motion to seal, Defendants seek to maintain the redactions present in 17 Defendants’ Motion, and file exhibits 2, 4, 12, 13, 14, 15, and 16 to Defendants’ Motion 18 under seal. (ECF No. 235 at 2.) The redactions in Defendants’ Motion correspond to 19 material pulled from these exhibits. Exhibits 2 and 4 are excerpts from the depositions of 20 Plaintiffs’ experts, where they “discuss nonpublic and proprietary information concerning 21 [Plaintiffs’ branded product,” Exhibit 12 consists of “MARINE Study Report Excerpts,” 22 Exhibit 13 is the Vascepa label, Exhibit 14 is Hikma’s proposed label, Exhibit 15 is DRL’s 23 proposed label, and Exhibit 16 is a response letter from the FDA to Plaintiffs. (Id. at 2; see 24 also ECF No. 238 at 2.) 25 2. ECF No. 246 26 In this motion to seal, Defendants seek to maintain the redactions present in their 27 response to Plaintiffs’ Motion under seal, and file exhibits 1 and 2 to that response under 1 seal. (ECF No. 246 at 2.) The redactions in Defendants’ response to Plaintiffs’ Motion 2 correspond to material pulled from these exhibits. Exhibit 1 consists of excerpts from the 3 deposition of one of Plaintiffs’ experts, where he discusses “nonpublic and proprietary 4 information concerning Amarin’s branded product[,]” and Exhibit 2 consists of excerpts 5 from the reply expert report of one of Plaintiffs’ experts. (Id.) 6 3. ECF No. 254 7 In this motion to seal, Plaintiffs seek to maintain the redactions present in their 8 response to Defendants’ Motion, along with sealing portions of Exhibit 13, and file the 9 entirety of exhibits 5, 7, 9, and 10, under seal. (ECF No. 254 at 2.) Exhibits 5 and 7 are 10 excerpts of expert deposition transcripts “that have been marked ‘Confidential’ and that 11 discuss information Defendants have asserted constitutes competitively-sensitive 12 information concerning Defendants’ ANDA products.” (Id. at 3.) Exhibits 9, 10, and 13 are 13 Defendants’ expert reports. (Id.) 14 4. ECF No. 261 15 In this motion to seal, Defendants seek to maintain the redactions present in their 16 reply in support of Defendants’ Motion, where the redactions reference discovery material 17 that “is the type of technical and business information that is treated as confidential by 18 pharmaceutical companies generally.” (ECF No. 261 at 2.) “The disclosure of this 19 information would reveal the confidential details of Amarin’s technical and business 20 information and would give competitors an unfair advantage, causing Amarin to suffer a 21 commercial disadvantage.” (Id.) 22 5. ECF No. 265 23 In this Motion to Seal, Plaintiffs seek to file under seal “the entirety of Exhibit C to 24 the Reply Declaration of Michael N. Kennedy” filed with Plaintiffs’ reply in support of 25 Plaintiffs’ Motion. (ECF No. 265 at 2.) Exhibit C consists of excerpts of the deposition 26 transcript from one of the patents-in-suit’s named inventors, has been marked confidential, 27 and “discusses information that constitutes nonpublic competitively sensitive technical and 1 other confidential business information concerning Amarin’s Vascepa® product.” (Id. at 2- 2 3.) 3 B. Ruling on the Motions 4 The Court will grant in part, and deny in part, Defendants’ motion to seal the exhibits 5 accompanying Defendants’ Motion. (ECF No. 235.) The Court will grant the other pending 6 motions to seal. More specifically, the Court will allow the parties to file under seal exhibits 7 consisting of excerpts of expert deposition transcripts, and expert reports, in which the 8 experts discuss “proprietary, trade secret, and technical information which warrants 9 keeping [these exhibits] sealed.” Spectrum Pharm., Inc. v. Sandoz Inc., Case No. 2:12-cv- 10 00111-GMN, 2013 WL 6896975, at *2 (D. Nev. Dec. 31, 2013). The parties may also 11 maintain redactions in their briefs corresponding to material taken from those exhibits. 12 That means the parties may file under seal exhibits 2 and 4 discussed in ECF No. 235, 13 both exhibits discussed in ECF No. 246, all exhibits discussed in ECF No. 254, the 14 redactions present in Defendants’ reply in support of Defendants’ Motion discussed in ECF 15 No. 261, and the exhibit discussed in ECF No. 265. 16 However, the Court will direct Defendants to file a supplemental brief of not more 17 than five pages within 10 days of the date of entry of this order providing additional 18 argument as to why exhibits 12, 13, 14, 15, and 16 to Defendants’ Motion should be filed 19 under seal, along with the corresponding redactions. (ECF No. 235 at 2.) The Court will 20 then give Plaintiffs 10 days to file a response (subject to the same page limit) to 21 Defendants’ supplemental brief, though no response is required. No reply will be 22 permitted. 23 The Court is not convinced Defendants have articulated compelling reasons these 24 exhibits should be filed under seal.7 To reiterate, Exhibit 12 consists of “MARINE Study 25 7The Court notes its concern about the practice of moving to seal all potential trade 26 secret information, especially in cases involving pharmaceuticals, where the public has an important interest in the safety and efficacy of the drugs they take. While this case is of 27 course a patent case dealing with non-opioid drugs, the perils of the practice of arguably unthinkingly granting motions to seal materials containing purported trade secrets have 1 Report Excerpts,” Exhibit 13 is the Vascepa label, Exhibit 14 is Hikma’s proposed label, 2 Exhibit 15 is DRL’s proposed label, and Exhibit 16 is a response letter from the FDA to 3 Plaintiffs. (ECF No. 235 at 2; see also ECF No. 238 at 2.) The results of the MARINE study 4 are public. See, e.g., Bays HE, Braeckman RA, Ballantyne CM, Kastelein JJ, Otvos JD, 5 Stirtan WG, Soni PN. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on 6 lipoprotein particle concentration and size in patients with very high triglyceride levels (the 7 MARINE study). J Clin Lipidol. 2012 Nov-Dec;6(6):565-72. doi: 8 10.1016/j.jacl.2012.07.001. Epub 2012 Jul 24, available at 9 https://www.ncbi.nlm.nih.gov/pubmed/23312052?dopt=Abstract. The Vascepa label is 10 also public information. See, e.g., 11 https://www.accessdata.fda.gov/drugsatfda docs/label/2017/202057s019lbl.pdf. And 12 considering that Defendants’ proposed ANDA labels are virtually identical to the public 13 Vascepa label (ECF No. 252 at 15), it seems unlikely they contain any confidential 14 information. Finally, as to the FDA response letter, the Court finds Defendants have not 15 yet provided compelling reasons outweighing the policy favoring access to court records 16 that justify filing it under seal. 17 In sum, the motions to seal are mostly granted, subject to the exception discussed 18 above. 19 VII. CONCLUSION 20 The Court notes that the parties made several arguments and cited to several cases 21 not discussed above. The Court has reviewed these arguments and cases and determines 22

23 become apparent in products liability cases dealing with opioids, where harmful and revelatory information was kept hidden for years—information that could have been useful 24 to the public. See, e.g., Benjamin Lesser, Lisa Giron, and Jami Dowdell, How judges added to the grim toll of opioids, REUTERS (June 25, 2019, 1:00 PM), 25 https://www.reuters.com/investigates/special-report/usa-courts-secrecy-judges/. The Court therefore advises the parties to judiciously deploy motions to seal, remaining mindful 26 of the “strong presumption in favor of access to court records.” Foltz, 331 F.3d at 1135. Moreover, the Court may reconsider its sealing decisions at trial, ordering documents or 27 testimony unsealed if, for example, it becomes clear that evidence does not contain trade secrets. 1 that they do not warrant discussion as they do not affect the outcome of the motions before 2 the Court. 3 It is therefore ordered that Defendants’ motion for summary judgment (ECF No. 4 236) as to noninfringement is granted in part, and denied in part. It is granted to the extent 5 Plaintiffs assert a contributory infringement theory, but denied to the extent Plaintiffs assert 6 an inducement infringement theory. 7 It is further ordered that Plaintiff’s motion for partial summary judgment (ECF No. 8 234) is granted in part, and denied in part as moot. It is granted to the extent Defendants 9 may not assert a written description defense at trial, but denied as moot as to anticipation, 10 enablement, or indefiniteness because Defendants have withdrawn these defenses and 11 counterclaims. 12 It is further ordered that Defendants’ Motion to Seal (ECF No. 235) is granted in 13 part, and denied in part. It is granted as to exhibits 2 and 4 and their corresponding 14 redactions, but denied without prejudice as to exhibits 12, 13, 14, 15, and 16 and their 15 corresponding redactions. 16 It is further ordered that Defendants must file a supplemental brief or not more than 17 five pages within 10 days of the date of entry of this order providing additional argument 18 as to why exhibits 12, 13, 14, 15, and 16 to Defendants’ Motion should be filed under seal, 19 along with the corresponding redactions. (ECF No. 235 at 2.) These documents will remain 20 under seal pending the Court’s ruling on Defendants’ supplemental brief. 21 It is further ordered that Plaintiffs will have 10 days to file a response to Defendants’ 22 supplemental brief, though none is required. No reply will be permitted. 23 It is further ordered that Defendants’ Motion to Seal (ECF No. 246) is granted. 24 It is further ordered that Plaintiffs’ Motion to Seal (ECF No. 254) is granted. 25 It is further ordered that Defendants’ Motion to Seal (ECF No. 261) is granted. 26 /// 27 /// 1 It is further ordered that Plaintiffs’ Motion to Seal (ECF No. 265) is granted. 2 DATED THIS 28th day of October 2019.

4 MIRANDA M. DU 5 CHIEF UNITED STATES DISTRICT JUDGE 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27