1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 EDWARDS LIFESCIENCES Case No. 19-cv-06593-HSG CORPORATION, et al., 8 ORDER DENYING PLAINTIFFS' Plaintiffs, MOTION FOR PARTIAL SUMMARY 9 JUDGMENT AND GRANTING AND v. DENYING ASSOCIATED 10 ADMINISTRATIVE MOTIONS TO MERIL LIFE SCIENCES PVT. LTD., et al., SEAL 11 Defendants. Re: Dkt. No. 209, 210, 217, 225, 239, 243 12 13 Pending before the Court is Plaintiffs Edwards Lifesciences Corporation’s and Edwards 14 Lifesciences LLC’s (collectively “Edwards” or “Plaintiffs”) Motion for Partial Summary 15 Judgment, for which briefing is complete. Dkt. Nos. 210 (“Mot.”); 226 (“Opp.”); and 240 16 (“Reply”). The parties have also filed associated administrative motions to seal (“Motions to 17 Seal”) portions of their briefs and exhibits. Dkt. Nos. 209, 217, 225, 239, 243. For the following 18 reasons, Plaintiffs’ Motion for Partial Summary Judgment is DENIED and their Motions to Seal 19 are GRANTED and DENIED. 20 I. BACKGROUND 21 Because this case has been actively litigated, the Court limits its review of the factual and 22 procedural background to that relevant to the pending motions. Defendants Meril Life Sciences 23 Pvt. Ltd. and Meril, Inc. (collectively “Meril” or “Defendants”) are an India-based, global medical 24 device company that created a “Myval” branded transcatheter heart valve. Dkt. No. 98 at 1. 25 Plaintiffs supply medical devices for the treatment of heart disease, including artificial heart 26 valves. Id. at 2. Among their best-known products are “SAPIEN®” transcatheter prosthetic heart 27 valves. Id. 1 and Common Law Trademark Infringement in violation of 15 U.S.C. § 1114 and the common law; 2 (2) Unfair Competition in violation of 15 U.S.C. § 1125(a); and (3) Unfair Competition and False 3 Advertising in violation of §§ 17200 and 17500 of the California Business and Professions Code. 4 Dkt. No. 51 (or “FAC”) ¶¶ 96-111. In their statutory and common law trademark infringement 5 claim, Plaintiffs allege that Defendants infringed their PARTNER trademark by using the phrase 6 “Partner the Future” at the 2019 TCT Conference in San Francisco; at the 2019 EuroPCR 7 Conference in Paris, France; and in promotional materials related to those two events. Id. ¶¶ 20- 8 22, 49-52. In their Lanham Act and California unfair competition law (UCL) claims, Plaintiffs 9 allege that Defendants made several false or misleading statements associated with their presence 10 at cardiovascular conferences. Id. ¶¶ 41-52. Defendants allegedly made these statements at 11 various cardiovascular conferences and on the internet, including via their websites and social 12 media accounts on Facebook, YouTube, and LinkedIn, as well as numerous email “blasts.” See 13 Mot. at 5-6. 14 II. LEGAL STANDARD 15 Summary judgment is proper when a “movant shows that there is no genuine dispute as to 16 any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). 17 A fact is “material” if it “might affect the outcome of the suit under the governing law.” Anderson 18 v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). And a dispute is “genuine” if there is evidence 19 in the record sufficient for a reasonable trier of fact to decide in favor of the nonmoving party. Id. 20 But in deciding if a dispute is genuine, the court must view the inferences reasonably drawn from 21 the materials in the record in the light most favorable to the nonmoving party, Matsushita Elec. 22 Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587–88 (1986), and “may not weigh the evidence 23 or make credibility determinations,” Freeman v. Arpaio, 125 F.3d 732, 735 (9th Cir. 1997), 24 overruled on other grounds by Shakur v. Schriro, 514 F.3d 878, 884–85 (9th Cir. 2008). If a court 25 finds that there is no genuine dispute of material fact as to only a single claim or defense or as to 26 part of a claim or defense, it may enter partial summary judgment. Fed. R. Civ. P. 56(a). 27 III. DISCUSSION 1 A. Motion for Partial Summary Judgment 2 The elements of a Lanham Act false advertising claim are: (1) a false statement of fact by 3 the defendant in a commercial advertisement about its own or another’s product; (2) the statement 4 actually deceived or had the tendency to deceive a substantial segment of its audience; (3) the 5 deception is material, in that it is likely to influence the purchasing decision; (4) the defendant 6 caused its false statement to enter interstate commerce; and (5) the plaintiff has been or is likely to 7 be injured as a result of the false statement, either by direct diversion of sales from itself to 8 defendant or by a lessening of the goodwill associated with its products. See Southland Sod 9 Farms v. Stover Seed Co., 108 F.3d 1134, 1139 (9th Cir. 1997). 10 Plaintiffs appear to move for partial summary judgment as to the first and fourth elements 11 of their seventh and eighth claims for false advertising and unfair competition under the Lanham 12 Act. See Mot. at 1 (“[Plaintiff] move[s] the Court for partial summary judgment on the issues of 13 falsity and use in interstate commerce, the first and fourth elements of Edwards’ seventh and 14 eighth claims for false advertising and unfair competition under the Lanham Act”) and 2 15 (“Summary judgment on the issues of falsity and use in commerce, the first and fourth elements of 16 Edwards’ false advertising claims, is warranted with respect to the misrepresentations addressed 17 herein”). 18 i. Falsity 19 Although the first Lanham Act element requires “a false statement of fact by the defendant 20 in a commercial advertisement about its own or another’s product,” Plaintiffs’ motion fails to 21 address whether any or all of the statements in question qualify as “commercial advertisements.” 22 See Southland Sod Farms, 108 F.3d at 1139 (emphasis added). Instead, in response to 23 Defendants’ Opposition Brief, Plaintiffs devote a significant portion of their Reply Brief to 24 arguing, for the first time, that Defendants’ false statements are commercial advertisements. See 25 Reply at 2-6. 26 This is improper. Plaintiffs’ motion for partial summary judgment as to the first element 27 of the Lanham Act is denied because Plaintiffs’ Motion does not address whether Defendants’ 1 allegedly false statements were “in a commercial advertisement” and they cannot do so for the 2 first time in a reply brief. See Zamani v. Carnes, 491 F.3d 990, 997 (9th Cir. 2007) (“The district 3 court need not consider arguments raised for the first time in a reply brief.”). Having denied 4 Plaintiffs’ request for partial summary judgment as to the first element of the Lanham Act, the 5 Court finds it inefficient to use Rule 56 to engage in piecemeal summary disposition of the 6 remaining discrete and plainly disputed factual issues and therefore declines to do so.1 See Fed. R. 7 Civ. P. 56(g); Fed. R. Civ. P. 56
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1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 EDWARDS LIFESCIENCES Case No. 19-cv-06593-HSG CORPORATION, et al., 8 ORDER DENYING PLAINTIFFS' Plaintiffs, MOTION FOR PARTIAL SUMMARY 9 JUDGMENT AND GRANTING AND v. DENYING ASSOCIATED 10 ADMINISTRATIVE MOTIONS TO MERIL LIFE SCIENCES PVT. LTD., et al., SEAL 11 Defendants. Re: Dkt. No. 209, 210, 217, 225, 239, 243 12 13 Pending before the Court is Plaintiffs Edwards Lifesciences Corporation’s and Edwards 14 Lifesciences LLC’s (collectively “Edwards” or “Plaintiffs”) Motion for Partial Summary 15 Judgment, for which briefing is complete. Dkt. Nos. 210 (“Mot.”); 226 (“Opp.”); and 240 16 (“Reply”). The parties have also filed associated administrative motions to seal (“Motions to 17 Seal”) portions of their briefs and exhibits. Dkt. Nos. 209, 217, 225, 239, 243. For the following 18 reasons, Plaintiffs’ Motion for Partial Summary Judgment is DENIED and their Motions to Seal 19 are GRANTED and DENIED. 20 I. BACKGROUND 21 Because this case has been actively litigated, the Court limits its review of the factual and 22 procedural background to that relevant to the pending motions. Defendants Meril Life Sciences 23 Pvt. Ltd. and Meril, Inc. (collectively “Meril” or “Defendants”) are an India-based, global medical 24 device company that created a “Myval” branded transcatheter heart valve. Dkt. No. 98 at 1. 25 Plaintiffs supply medical devices for the treatment of heart disease, including artificial heart 26 valves. Id. at 2. Among their best-known products are “SAPIEN®” transcatheter prosthetic heart 27 valves. Id. 1 and Common Law Trademark Infringement in violation of 15 U.S.C. § 1114 and the common law; 2 (2) Unfair Competition in violation of 15 U.S.C. § 1125(a); and (3) Unfair Competition and False 3 Advertising in violation of §§ 17200 and 17500 of the California Business and Professions Code. 4 Dkt. No. 51 (or “FAC”) ¶¶ 96-111. In their statutory and common law trademark infringement 5 claim, Plaintiffs allege that Defendants infringed their PARTNER trademark by using the phrase 6 “Partner the Future” at the 2019 TCT Conference in San Francisco; at the 2019 EuroPCR 7 Conference in Paris, France; and in promotional materials related to those two events. Id. ¶¶ 20- 8 22, 49-52. In their Lanham Act and California unfair competition law (UCL) claims, Plaintiffs 9 allege that Defendants made several false or misleading statements associated with their presence 10 at cardiovascular conferences. Id. ¶¶ 41-52. Defendants allegedly made these statements at 11 various cardiovascular conferences and on the internet, including via their websites and social 12 media accounts on Facebook, YouTube, and LinkedIn, as well as numerous email “blasts.” See 13 Mot. at 5-6. 14 II. LEGAL STANDARD 15 Summary judgment is proper when a “movant shows that there is no genuine dispute as to 16 any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). 17 A fact is “material” if it “might affect the outcome of the suit under the governing law.” Anderson 18 v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). And a dispute is “genuine” if there is evidence 19 in the record sufficient for a reasonable trier of fact to decide in favor of the nonmoving party. Id. 20 But in deciding if a dispute is genuine, the court must view the inferences reasonably drawn from 21 the materials in the record in the light most favorable to the nonmoving party, Matsushita Elec. 22 Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587–88 (1986), and “may not weigh the evidence 23 or make credibility determinations,” Freeman v. Arpaio, 125 F.3d 732, 735 (9th Cir. 1997), 24 overruled on other grounds by Shakur v. Schriro, 514 F.3d 878, 884–85 (9th Cir. 2008). If a court 25 finds that there is no genuine dispute of material fact as to only a single claim or defense or as to 26 part of a claim or defense, it may enter partial summary judgment. Fed. R. Civ. P. 56(a). 27 III. DISCUSSION 1 A. Motion for Partial Summary Judgment 2 The elements of a Lanham Act false advertising claim are: (1) a false statement of fact by 3 the defendant in a commercial advertisement about its own or another’s product; (2) the statement 4 actually deceived or had the tendency to deceive a substantial segment of its audience; (3) the 5 deception is material, in that it is likely to influence the purchasing decision; (4) the defendant 6 caused its false statement to enter interstate commerce; and (5) the plaintiff has been or is likely to 7 be injured as a result of the false statement, either by direct diversion of sales from itself to 8 defendant or by a lessening of the goodwill associated with its products. See Southland Sod 9 Farms v. Stover Seed Co., 108 F.3d 1134, 1139 (9th Cir. 1997). 10 Plaintiffs appear to move for partial summary judgment as to the first and fourth elements 11 of their seventh and eighth claims for false advertising and unfair competition under the Lanham 12 Act. See Mot. at 1 (“[Plaintiff] move[s] the Court for partial summary judgment on the issues of 13 falsity and use in interstate commerce, the first and fourth elements of Edwards’ seventh and 14 eighth claims for false advertising and unfair competition under the Lanham Act”) and 2 15 (“Summary judgment on the issues of falsity and use in commerce, the first and fourth elements of 16 Edwards’ false advertising claims, is warranted with respect to the misrepresentations addressed 17 herein”). 18 i. Falsity 19 Although the first Lanham Act element requires “a false statement of fact by the defendant 20 in a commercial advertisement about its own or another’s product,” Plaintiffs’ motion fails to 21 address whether any or all of the statements in question qualify as “commercial advertisements.” 22 See Southland Sod Farms, 108 F.3d at 1139 (emphasis added). Instead, in response to 23 Defendants’ Opposition Brief, Plaintiffs devote a significant portion of their Reply Brief to 24 arguing, for the first time, that Defendants’ false statements are commercial advertisements. See 25 Reply at 2-6. 26 This is improper. Plaintiffs’ motion for partial summary judgment as to the first element 27 of the Lanham Act is denied because Plaintiffs’ Motion does not address whether Defendants’ 1 allegedly false statements were “in a commercial advertisement” and they cannot do so for the 2 first time in a reply brief. See Zamani v. Carnes, 491 F.3d 990, 997 (9th Cir. 2007) (“The district 3 court need not consider arguments raised for the first time in a reply brief.”). Having denied 4 Plaintiffs’ request for partial summary judgment as to the first element of the Lanham Act, the 5 Court finds it inefficient to use Rule 56 to engage in piecemeal summary disposition of the 6 remaining discrete and plainly disputed factual issues and therefore declines to do so.1 See Fed. R. 7 Civ. P. 56(g); Fed. R. Civ. P. 56(g) Advisory Committee Notes to 2010 Amendments (“If it is 8 readily apparent that the court cannot grant all the relief requested by the motion, it may properly 9 decide that the cost of determining whether some potential fact disputes may be eliminated by 10 summary disposition is greater than the cost of resolving those disputes by other means, including 11 trial.”); see also Robertson v. F. Martin, 2021 WL 545895, at *2 (C.D. Cal. Jan. 4, 2021) (“In the 12 present case, Plaintiff does not seek summary judgment, or summary adjudication, with respect to 13 any claim or defense or any part of any claim or defense. Rather, Plaintiff seeks an adjudication of 14 discrete, assertedly undisputed facts. The use of Rule 56 for this purpose is inappropriate.”). 15 ii. Interstate Commerce 16 Plaintiffs’ request for partial summary judgment as to the fourth Lanham Act element is 17 also denied because they have not met their burden of proving that Defendants’ statements made 18 solely at various cardiovascular conferences were necessarily made in interstate commerce. 19 The Lanham Act defines the word “commerce” to include “all commerce which may 20 lawfully be regulated by Congress.” 15 U.S.C. § 1127. Because Congress may regulate the 21 channels and instrumentalities of interstate commerce, and activities that substantially affect 22 interstate commerce, see United States v. Morrison, 529 U.S. 598, 608 (2000), Lanham Act 23 jurisdiction “attaches to use of a false statement in interstate commerce, or ‘intrastate commerce 24 which ‘affects’ interstate commerce.’” Jerome’s Furniture Warehouse v. Ashley Furniture Indus., 25 Inc., 2021 WL 1541649, at *6 (S.D. Cal. Apr. 20, 2021) (citing Thompson Tank & Mfg. Co. v. 26
27 1 To take just one example, Plaintiffs ask the Court to find as a matter of law that Defendants’ 1 Thompson, 693 F.2d 991, 992–93 (9th Cir. 1982)); see also Duncan v. Stuetzle, 76 F.3d 1480, 2 1489 n.14 (9th Cir. 1996); Stauffer v. Exley, 184 F.2d 962, 966 (9th Cir. 1950). 3 Plaintiffs contend that Defendants’ statements made at various cardiovascular conferences 4 or on the internet were indisputably made in interstate commerce and accordingly seek summary 5 judgment as to that element of their Lanham Act false advertising claim. See Mot. at 24. But as to 6 Defendants’ statements made solely at various cardiovascular conferences, Plaintiffs’ argument 7 rests almost entirely on one out-of-circuit case in which a district court held, without citing any 8 authority, that the defendant placed a product in interstate commerce by both “widely distributing” 9 the product to attendees at a trade show and sending the product to potential customers.2 See 10 Merck Eprova AG v. Gnosis S.p.A., 901 F. Supp. 2d 436, 451 (S.D.N.Y. 2012). The record here is 11 unclear as to how widely Defendants distributed any statements made solely at cardiovascular 12 conferences and, in any event, the Court is not inclined to rely on this out-of-circuit authority to 13 find that a trade show conference is necessarily a channel or instrumentality of interstate 14 commerce. Moreover, Plaintiffs’ Motion does not explain if or how these statements substantially 15 affected interstate commerce. See Mot. at 24-25. Plaintiffs’ request for partial summary judgment 16 as to the fourth element of the Lanham Act is accordingly denied. 17 Having denied that request, the Court again declines to engage in further summary 18 disposition of discrete issues, such as whether individual statements made on a website or in 19 emails were used in interstate commerce, for the reasons explained above. See Fed. R. Civ. P. 20 56(g) Advisory Committee Notes to 2010 Amendments (“Even if the court believes that a fact is 21 not genuinely in dispute it may refrain from ordering that the fact be treated as established. The 22 court may conclude that it is better to leave open for trial facts and issues that may be better 23 illuminated by the trial of related facts that must be tried in any event.”). 24 Accordingly, Plaintiffs’ motion for partial summary judgment as to the first and fourth 25 elements of the Lanham Act is DENIED. 26 27 B. Motions to Seal 1 The parties have also filed administrative motions to seal portions of their briefs and 2 exhibits related to Plaintiffs’ Motion for Partial Summary Judgment. Courts generally apply a 3 “compelling reasons” standard when considering motions to seal documents. Pintos v. Pac. 4 Creditors Ass’n, 605 F.3d 665, 678 (9th Cir. 2010) (quoting Kamakana v. City & Cty. of 5 Honolulu, 447 F.3d 1172, 1178 (9th Cir. 2006)). “This standard derives from the common law 6 right ‘to inspect and copy public records and documents, including judicial records and 7 documents.’” Id. (quoting Kamakana, 447 F.3d at 1178). “[A] strong presumption in favor of 8 access is the starting point.” Kamakana, 447 F.3d at 1178 (quotations omitted). To overcome this 9 strong presumption, the party seeking to seal a judicial record attached to a dispositive motion 10 must “articulate compelling reasons supported by specific factual findings that outweigh the 11 general history of access and the public policies favoring disclosure, such as the public interest in 12 understanding the judicial process” and “significant public events.” Id. at 1178–79 (quotations 13 omitted). 14 Records attached to non-dispositive motions must meet the lower “good cause” standard of 15 Rule 26(c) of the Federal Rules of Civil Procedure, as such records “are often unrelated, or only 16 tangentially related, to the underlying cause of action.” Id. at 1179–80 (quotation omitted). This 17 requires a “particularized showing” that “specific prejudice or harm will result” if the information 18 is disclosed. Phillips ex rel. Estates of Byrd v. Gen. Motors Corp., 307 F.3d 1206, 1210–11 (9th 19 Cir. 2002); see also Fed. R. Civ. P. 26(c). “Broad allegations of harm, unsubstantiated by specific 20 examples of articulated reasoning” will not suffice. Beckman Indus., Inc. v. Int’l Ins. Co., 966 21 F.2d 470, 476 (9th Cir. 1992) (quotation omitted). 22 The documents at issue in the pending motions to seal relate to Plaintiffs’ dispositive 23 motion for partial summary judgment so the Court will apply the “compelling reasons” standard. 24 i. Dkt. Nos. 209, 217 25 On September 16, 2021, Plaintiffs filed an administrative motion to file under seal certain 26 documents relating to Plaintiffs’ motion for partial summary judgment but did so based solely on 27 Defendants’ designation of the documents as confidential. See Dkt. No. 209. Because the parties’ 1 designations alone are insufficient to meet the compelling reasons standard, the Court denies this 2 request to seal. 3 On September 20, 2021, Defendants separately moved for administrative relief and 4 clarified that they seek to seal the expert report of Dr. Ramesh B. Daggubati (Ex. 1 to the 5 Declaration of Carlo F. Van Den Bosch In Support of Plaintiffs’ Partial Summary Judgment 6 Motion (“Van Den Bosch Decl.”)); limited portions of the deposition transcript of Dr. Daggubati 7 (Ex. 27 to Van Den Bosch Decl.); Meril’s discovery responses (Ex. 19 to the Van Den Bosch 8 Decl.); Meril’s regulatory submission to the Polish Center for Testing and Certification (Ex. 26 to 9 the Van Den Bosch Decl.); limited portions of the Partial Summary Judgment Motion that 10 describe these documents; and limited portions of the Van Den Bosch Declaration that describe 11 Meril’s raw clinical data. See Dkt. No. 217-1. 12 First, Defendants contend that Exhibits 1, 19, 26, and 27 to the Van Den Bosch Declaration 13 contain information regarding their clinical trial strategies or the raw medical data underlying 14 those trials, including for their Myval clinical trials. See id. The Court has already ordered certain 15 filings to be filed under seal in this case because they contained sensitive proprietary information 16 concerning Meril’s clinical and regulatory strategies for their Myval System and continues to find 17 compelling reasons to seal information for that basis. See Dkt. Nos. 66, 98; see also United States 18 ex rel. Ruhe v. Masimo Corp., 2013 WL 12131173, at *2 (C.D. Cal. Aug. 26, 2013) (internal 19 research studies and clinical tests for developing the accused device, and non-public data 20 submitted to the FDA in the course of regulatory approval, were “confidential, proprietary, and [ ] 21 valuable”); In re Incretin-Based Therapies Prods. Liab. Litig., 2015 WL 11658712, at *3 (S.D. 22 Cal. Nov. 18, 2015) (sealing confidential and proprietary information relating to the 23 “development, testing, and regulation” of proposed drugs, the disclosure of which would result in 24 “significant competitive harm”). 25 However, the Court is not convinced that Exhibit 1, the Expert Report of Ramesh B. 26 Daggubati, M.D., needs to be sealed in its entirety because portions of this report contain 27 information that is not confidential or proprietary but may nevertheless be valuable to the public. 1 order to seal that “inappropriately extended to non-confidential material”). Though the redactions 2 to this exhibit may be extensive, they need not be total. Accordingly, the Parties are directed to 3 file a narrowly tailored request that only seeks to seal the portions of Exhibit 1 that contain 4 information regarding the clinical trial strategies or the raw medical data underlying those trials. 5 Second, Defendants seek to seal portions of Plaintiffs’ Partial Summary Judgment Motion 6 that Defendants contend also contain references to their confidential clinical trial data. For the 7 foregoing reasons, the Court finds compelling reasons to seal the portions of Plaintiffs’ Partial 8 Summary Judgment Motion that contain information regarding clinical trial strategies or raw 9 medical data underlying those trials. In the Court’s view, however, this does not include the 10 motion’s general references to Defendants’ responses to Plaintiffs’ requests for admission. See 11 Dkt. No. 209-5 at i:8; 2:17-18; 8:10-12; 9:2; 12:13-15. Defendants’ clinical trial strategies and 12 underlying raw medical data are proprietary but their mere admission that they presented 13 inaccurate data is not. While this information may be embarrassing to Defendants, that alone is 14 insufficient to overcome the “strong presumption in favor of [public] access.” Psystar Corp., 658 15 F.3d at 1162. In short, data itself may be proprietary and protected, but a general admission that 16 data is inaccurate is neither. To summarize, and as further reflected below, Docket No. 209 is 17 DENIED, and Docket No. 217 is GRANTED IN PART and DENIED IN PART. 18 19 20 21 22 23 24 25 26 27 Docket No. Document Portion(s) Evidence Offered Ruling 1 Sealed/(Public) Sought to be in Support of 2 Sealed Sealing 3 4 217-5 / (217-4) Declaration of Carlo 6:20-27 Thakkar Granted F. Van Den Bosch in Declaration ¶¶ 3-4; 5 Support of Plaintiffs’ Tung Declaration Partial Summary ¶¶ 5-7 6 Judgment Motion (“Van Den Bosch 7 Decl.”) 8 209-7 / (210-5) Exhibit 1 to the Van Entire document. Thakkar DENIED Den Bosch Decl. Declaration ¶¶ 3-4; 9 Tung Declaration ¶¶ 5-7 10 209-10 / (211) Exhibit 19 to the Entire document. Thakkar Granted Van Den Bosch Declaration ¶¶ 3-4; 11 Decl. Tung Declaration 12 ¶¶ 5-7 209-13 / (211) Exhibit 26 to the Entire document. Thakkar Granted 13 Van Den Bosch Declaration ¶¶ 3-4; Decl. Tung Declaration 14 ¶¶ 5-7 15 217-7 / (217-6) Exhibit 27 to the 26:14-31:10 Thakkar Granted Van Den Bosch Declaration ¶¶ 3-4; 16 Decl. Tung Declaration ¶¶ 5-7 17 209-5 / (210) Plaintiffs’ Partial i:8; 2:17-18, 22; Thakkar Granted in Summary Judgment 8:10-12; 9:2; Declaration ¶¶ 3-4; part but 18 Motion 10:26-27; 12:13- Tung Declaration DENIED as 19 15, 26-28; 19:9- ¶¶ 5-7 to i:8; 2:17- 10; 20:21-22; 18; 8:10-12; 20 22:6, 10-12, 17- 9:2; 12:13- 22; 23:9-12 (as 15 21 designated by Plaintiffs) 22
27 ii. Dkt. No. 225 1 On September 30, 2021, Defendants filed an administrative motion to file under seal 2 certain documents relating to their Opposition to Edwards’ Motion for Partial Summary Judgment 3 (the “Opposition”). See Dkt. No. 205. Specifically, Defendants moved to seal: (1) the entirety of 4 Exhibit B to the Declaration of Melanie Mayer In Support of Meril’s Opposition to Edwards’ 5 Motion for Partial Summary Judgment (“Mayer Declaration”), which is the Myval-1 Clinical 6 Study Protocol; (2) portions of Exhibit F to the Mayer Declaration, which is an excerpt from the 7 transcript of the deposition of Edwards’ expert, Nimesh Desai, M.D., Ph.D.; (3) portions of 8 Exhibit G to the Mayer Declaration, which is an excerpt from the transcript of the deposition of 9 Edwards’ expert, Joseph Bavaria, M.D.; and (4) certain limited portions of Meril’s Opposition to 10 Edwards’ Motion for Partial Summary Judgment that quote from or summarize portions of 11 Exhibits F and G to the Mayer Declaration. Id. 12 As to the first request, the Court finds that the Myval-1 Clinical Study Protocol reflects 13 Meril’s clinical trial strategies for the Myval device, including information about the study’s 14 endpoints, the study design, and patient follow-up methodology and, for the reasons explained 15 above, finds compelling reasons to seal this document. However, the parties have not provided 16 compelling reasons to seal the following three exhibits. Defendants explain that they seek to seal 17 portions of Exhibits F and G, as well as portions of their Opposition that quote from or summarize 18 portions of Exhibits F and G, in accordance with their obligations under the Protective Order, 19 which in turn states that “a Party may not file in the public record in this action any Protected 20 Material . . . [w]ithout written permission from the Designating Party or a court order secured after 21 appropriate notice to all interested persons.” See Dkt. Nos. 151, 205. But because the parties’ 22 designations alone are insufficient to meet the compelling reasons standard, the Court denies this 23 request to seal. To summarize, and as further reflected below, Docket No. 225 is GRANTED IN 24 PART and DENIED IN PART. 25
27 Docket No. Document Portion(s) Evidence Offered Ruling 1 Sealed/(Public) Sought to be in Support of 2 Sealed Sealing 3 4 225-4/(226-4) Exhibit B to the Entire Thakkar Granted Declaration of Melanie document Declaration ¶¶ 4-5; 5 Mayer in Support of Mayer Declaration Meril’s Opposition to ¶¶ 4-7 6 Edwards’ Motion for Partial Summary 7 Judgment (“Mayer 8 Declaration”) 225-6/(226-8) Exhibit F to the Mayer 38:1-25 Thakkar DENIED 9 Declaration Declaration ¶¶ 4-5; Mayer Declaration 10 ¶¶ 4-7 225-8/(226-9) Exhibit G to the Mayer 102:1-25; Thakkar DENIED 11 Declaration 189:1-25; Declaration ¶¶ 4-5; 12 190:1-25 Mayer Declaration ¶¶ 4-7 13 225-10/(226) Meril’s Opposition to 8:9-10; 9:16- Thakkar DENIED Edwards’ Motion for 25; 10:2; Declaration ¶¶ 4-5; 14 Partial Summary 10:8-9 Mayer Declaration 15 Judgment ¶¶ 4-7 16 17 iii. Dkt. Nos. 239, 243 On October 7, 2021, Plaintiffs filed an administrative motion to seal in connection with 18 their Reply in Support of their Motion for Partial Summary Judgment (“Reply”). Dkt. No. 239. 19 Plaintiffs’ motion to seal identifies four documents containing confidential information: Exhibits 20 A, B, and C to the Hanle Declaration to be filed under seal in their entirety, and the Reply to be 21 partially sealed. Because the parties’ designations alone are insufficient to meet the compelling 22 reasons standard, the Court denies this request to seal. 23 Defendants separately filed a motion to seal stating that although they agree that Exhibit A 24 should be filed under seal in its entirety, they generally seek to seal more limited portions of 25 Exhibits B and C, and the Reply. See Dkt. No. 243. Consistent with Plaintiffs’ motion, 26 Defendants first seek to seal the entirety of Exhibit A, which Defendants contend contains 27 1 Id. at 1. The Court has already found that there are compelling reasons for filing this document 2 under seal and has ordered it sealed. See Dkt. Nos. 87, 98 at 18-19. For the same reasons, the 3 Court again finds compelling reasons to seal this document. 4 Defendants next seek to seal Exhibits B and C in their entirety. Defendants contend that 5 Exhibit B contains sensitive and proprietary information concerning Meril’s regulatory strategies 6 and regulatory submissions for the Myval transcatheter heart valve. See Dkt. 243 at 2. 7 Defendants separately contend that Exhibit C contains sensitive and proprietary information 8 concerning Meril’s clinical trials for the Myval transcatheter heart valve, including a discussion of 9 the Myval clinical data. Id. The Court agrees that these exhibits contain confidential and 10 proprietary information and, for the reasons explained above, finds compelling reasons to seal 11 them. Finally, Defendants seek to seal limited portions of the Reply. This request is derivative, as 12 it seeks to seal portions of the Reply that describe or reference the confidential information in 13 Exhibits A, B, and C. Accordingly, the Court also finds compelling reasons to seal the 14 descriptions or references of confidential information contained in the Reply. 15 To summarize, and as further reflected below, Docket No. 239 is DENIED, but Docket 16 No. 243 is GRANTED. 17 Docket No. Document Portion(s) Evidence Offered Ruling 18 Sealed/(Public) Sought to be in Support of 19 Sealed Sealing 20 21 239-2/(240-2) Exhibit A to the Entire Thakkar Granted Edwards’ Filing Declaration of Steven document Declaration ¶¶ 4-5; 22 Hanle in Support of Mayer Declaration Plaintiff’s Reply in ¶¶ 4-10 23 Support of its Motion for Partial Summary 24 Judgment (“Hanle 25 Declaration”) 239-3/(240-3) Exhibit B to the Hanle 198:1-15 Thakkar Granted 26 Edwards’ Filing Declaration Declaration ¶¶ 4-5; Mayer Declaration 27 243-5/(243-4) ¶¶ 4-10 I 239-4/(240-4) Exhibit C to the Hanle | 34:3-12; 34:15- | Thakkar Granted Edwards’ Filing | Declaration 16; 34:18; Declaration {fj 4-5; 2 34:20-23; Mayer Declaration 34:25; 71:1-3; | J] 4-10 3 243-7/(243-6) 71:6-13; 71:15- Meril’s Filing 25; 72:1-2; 4 72:5-10; 72:12- 5 21; 73:6-9; 73:20-24 6 239-5/(240-5) Plaintiff's Reply in 5:11-15; 9:2-4; | Thakkar Granted Edwards’ Filing | Support of Motion for | 11:3-6; 11:25- | Declaration 4-5; 7 Partial Summary 26; 12:7-15; Mayer Declaration 243-9/(243-8) Judgment 12:20-26: 14:n. | J] 4-10 8 || | Meril’s Filing 9 || Iv. CONCLUSION 10 For the reasons explained above, Plaintiffs’ Motion for Partial Summary Judgment is 11 DENIED. As to the associated Motions to Seal, Docket Nos. 209 and 239 are DENIED, Docket 12 || No. 243 is GRANTED, and Docket Nos. 217 and 225 are GRANTED IN PART and DENIED
13 IN PART. Within seven days of the filing of this Order, the parties shall file public versions of
14 || the documents identified above that comport with this Order. IT IS SO ORDERED. a 16 |! Dated: 11/10/2021
17 Alepwrel & Mbt □□□ HAYWOOD S. GILLIAM, JR. United States District Judge 19 20 21 22 23 24 25 26 27 28