Amarin Corp Plc (AMRN)

[Biobillionair]

Yep—-format sucks...

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Case 2:16-cv-02525-MMD-NJK
Document 316
Filed 01/02/20
Page 1 of 11
Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD. 10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135
Tel: [phone] / Fax: [phone] E-mail: [e-mail], [e-mail]
Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice)
Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice)
Han Park (admitted pro hac vice)
Jordan L. Moran (admitted pro hac vice) COVINGTON & BURLING LLP
One CityCenter, 850 Tenth Street, NW Washington, DC 20001
Tel: [phone] / Fax: [phone] E-mail: [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail]
Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
UNITED STATES DISTRICT COURT DISTRICT OF NEVADA
AMARIN PHARMA, INC. and AMARIN PHARMACEUTICALS IRELAND LIMITED,
Plaintiffs, v.
HIKMA PHARMACEUTICALS USA INC., et al.,
Defendants.
CASE NO.: 2:16-cv-02525-MMD-NJK
(Consolidated with 2:16-cv-02562-MMD-NJK)
AMARIN’S OPPOSITION TO DEFENDANTS’ MOTION IN LIMINE TO EXCLUDE EVIDENCE OR ARGUMENT REGARDING REDUCE-IT

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Case 2:16-cv-02525-MMD-NJK Document 316 Filed 01/02/20 Page 2 of 11
INTRODUCTION
Defendants’ Motion, ECF No. 310 (“Mot.”), mischaracterizes the record—specifically, the Court’s Order at the December 17 Pretrial Conference—as well as the applicable law. First, Defendants assert that Amarin failed to comply with its agreement at the Conference. Not so. Amarin has produced precisely what it offered: “[C]orrespondence with FDA discussing Amarin’s proposed labeling.” Defs.’ Ex. 5, ECF No. 310–6 at 28:1–22. Amarin produced this correspondence on December 19. To nonetheless accuse Amarin of producing only a “small subset” of the documents the Court ordered produced (Mot. at 3), Defendants refer to the Amended Minutes of Proceedings (not a Minute “Order,” as Defendants misleadingly label it), which refers to Amarin’s “agree[ment] to provide documents relating to the FDA communications.” ECF No. 309. But Amarin’s offer, read verbatim into the record at the Pretrial Conference by Defendants’ counsel, identified the FDA communications at issue as
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Second, Defendants seek to exclude all evidence and argument concerning REDUCE-IT, arguing that Amarin’s refusal to produce “documents relating to the FDA communications” justifies total exclusion of the REDUCE-IT trial from this case. But such a sanction is reserved for “extreme situations.” Silvagni v. Wal-Mart Stores, Inc., 320 F.R.D. 237, 243 (D. Nev. 2017) (quotation omitted), and Defendants cannot possibly justify seeking such a sanction here.
Nor is there any mystery as to why Defendants are willing to twist the record in an effort to exclude the REDUCE-IT trial results. Those results, first announced in late 2018, demonstrate
1 Defendants further confuse the issue by quoting their own statement at the Conference describing Amarin’s offer as “giving [Defendants] everything that [they’ve] asked for.” Id. at 22:7–9. Defendants cannot take their own contemporaneous acknowledgement that Amarin’s offer gave them what they were then asking for (labeling related correspondence), see Ex. 1, at 4, into a license to seek additional documents they now purport to want.
those concerning the revised labeling. Amarin thus followed the agreement to the letter. Additionally, as detailed in our Opposition to Defendants’ Motion to Compel (ECF No. 272), Amarin also fulfilled its agreements concerning production of REDUCE-IT documents, even in the face of Defendants’ belated and ever-shifting demands (id. at 6-8).
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Case 2:16-cv-02525-MMD-NJK Document 316 Filed 01/02/20 Page 3 of 11
that Vascepa® reduced major adverse cardiovascular events by 25% for patients already on statin therapy, changing preventative cardiovascular care. This dramatic result ran counter to scientists’ expectations for this closely-watched clinical trial. REDUCE-IT thus confirms real- world, unexpected, benefits of the claimed invention refuting Defendants’ obviousness defenses. See, e.g., Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1306-07 (Fed. Cir. 2015).
In any case, Defendants have already been provided a trove of information detailing the REDUCE-IT trial. In January 2019, Amarin produced the REDUCE-IT “Clinical Study Report,” which details the methods and results of the REDUCE-IT trial. This “CSR” also includes nearly 3,000 pages of tables and figures providing detailed analyses of the clinical trial results. Defendants sought and received a two-month extension of expert discovery to analyze this information (ECF No. 180) and took a March 2019 deposition of an Amarin employee concerning REDUCE-IT. Amarin also produced, months ago, key portions of the supplemental new drug application (“sNDA”) filed with FDA to obtain the new indication, as well as sNDA- related correspondence with FDA concerning issues such as the labeling. There is also publicly- available information detailing the REDUCE-IT results, some of which was published more than a year ago. Not surprisingly, then, Defendants’ experts have disclosed detailed opinions concerning REDUCE-IT’s relevance to this case, and Defendants have listed numerous REDUCE-IT related trial exhibits in the Pretrial Order.
Thus, even if Defendants could show a discovery default by Amarin—which they cannot—Defendants cannot show prejudice, much less prejudice that might justify the extreme sanction they seek. Defendants speculate that Amarin told FDA that the REDUCE-IT trial results were not actually unexpected, see Mot. at 6–7, 9, and that they cannot adequately respond to Amarin’s REDUCE-IT related contentions even if they receive the sought-after materials before trial, see id. at 3–9. But, Defendants’ Motion itself refutes any claim of prejudice—nearly half of Defendants’ 10-page submission advances Defendants’ (erroneous) merits arguments concerning REDUCE-IT. See Mot. at 1–2, 5–9. And the reason Defendants’ demands for additional documents were not resolved earlier is due to Defendants’ extraordinary delay in
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Case 2:16-cv-02525-MMD-NJK Document 316 Filed 01/02/20 Page 4 of 11
bringing their grievance to the Court (19 weeks by Amarin’s count, see ECF No. 272 at 12 tbl.1), combined with the Motion to Compel’s two-month pendency before being denied as moot.
“Courts universally recognize the strong preference for deciding cases on the merits whenever reasonably possible,” and courts prefer that discovery proceed “by the practical cooperation” of the parties, and seek to prevent the Federal Rules governing disclosure from being used “as procedural weapons through which parties seek to gain a tactical litigation advantage.” Silvagni, 320 F.R.D. at 243. These considerations apply with great force to Defendants’ Motion. The Court should not reward Defendants’ gamesmanship.
FACTUAL BACKGROUND
Last year, Amarin completed the REDUCE-IT study, a five-year clinical trial evaluating the effectiveness of Vascepa® as an add-on to statin therapy in reducing the first major cardiovascular event in a high-risk patient population. REDUCE-IT demonstrated a remarkable degree of cardiovascular risk reduction and benefits that were widely praised throughout the medical community. Defendants’ Motion is premised on the notion that, because Amarin has not provided certain correspondence between FDA and Amarin concerning the sNDA, Defendants would be prejudiced should Amarin be allowed to rely on REDUCE-IT at trial. As shown below, there is no basis to exclude REDUCE-IT from this case.
A. Defendants have received extensive discovery related to REDUCE-IT.
For months, Defendants have enjoyed access to substantial information concerning REDUCE-IT. Even before the results were available, Amarin produced documents detailing the trial’s design. ECF No. 272 at 3. After release of the full REDUCE-IT results in November 2018, Amarin sought to amend its validity contentions to rely on the REDUCE-IT results. As a result of the protracted negotiations and motion practice that ensued, Defendants requested and received (a) the REDUCE-IT CSR, produced in January 2019; (b) a deposition of an Amarin employee concerning said CSR, taken in March 2019; and (c) a two-month extension of the expert discovery schedule, specifically to give Defendants more time to analyze how the REDUCE-IT results would affect this case. During a January 14, 2019 hearing before
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Case 2:16-cv-02525-MMD-NJK Document 316 Filed 01/02/20 Page 5 of 11
Magistrate Judge Koppe, Defendants represented that the only additional REDUCE-IT document they were requesting was the CSR. See Ex. 2, Tr. of Mots. Hr’g at 7:22–9:16, 14:10–16:2; see also ECF No. 272 at 5.
B. Even after receiving the REDUCE-IT discovery they requested, Defendants make ever-shifting demands for additional REDUCE-IT related discovery.
Fact discovery closed in November 2018, with the limited exception of the supplemental REDUCE-IT related discovery described above. Despite this, throughout 2019 Defendants continually demanded more REDUCE-IT-related material. Amarin tried to address Defendants’ changing demands by agreeing to produce additional categories of documents, only for Defendants to ask for even more. This history is more fully set forth in Amarin’s Opposition to Defendants’ Motion to Compel (ECF No. 272 at 3-9), which the Court denied as moot at the Pretrial Conference—after Defendants’ counsel agreed that Amarin’s latest offer of compromise, made on December 13, provided Defendants with the materials they had sought in the Motion. See Defs.’ Ex. 5 at 22:4–9, 23:5–11, 28:1–24.
Defendants’ present Motion is premised on Amarin’s alleged failure to produce some of the FDA correspondence related to the sNDA. Mot. at 6–7. Defendants made their first request for “the sNDA” and “related documentation” on April 29, 2019—more than four weeks after the sNDA was filed, and six months after Amarin publicly stated its intention to file the sNDA. See Ex. 3; ECF No. 272 at 6. As Amarin reminded Defendants at the time, they could have asked for this information in January. See Ex. 4, at 3. After weeks of delay by Defendants, Amarin attempted to resolve the dispute by producing the table of contents for the sNDA, along with a request to explain why the sNDA was relevant and should be produced after fact discovery closed. See Ex. 5, at 1; ECF No. 272 at 6–7. Two weeks later, without providing the requested explanation, Defendants changed their demands again, now to include “FDA correspondence that accompanied the sNDA, such as the cover letter, and any prior or subsequent correspondence with FDA relating to the sNDA . . . [and] Modules 1 and 2 [of the sNDA].” Ex. 5, at 1.
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Amarin then proposed yet another compromise. Specifically, Amarin proposed to produce “Modules 1 and 2 of the sNDA (which include correspondence between Amarin and FDA regarding the REDUCE-IT clinical study between May 22, 2008 and September 25, 2018),” “the signed [CSR],” “the cover letter that accompanied the sNDA,” and “the final approved REDUCE-IT labeling when it becomes available.” See Ex. 6, at 12–13. Despite this offer, Defendants demanded that Amarin produce “all requested sNDA materials” by July 26. See Ex. 6, at 10–12. While not conceding that Defendants’ requests were appropriate, see Ex. 6, at 9–10, Amarin agreed that in addition to the above documents, it would produce FDA correspondence “concerning approval of the pending sNDA.”2 Id. Defendants agreed to this proposal but failed to confirm that they would not seek yet more documents. See Ex. 6, at 8–9. Amarin responded that it would abide by the parties’ agreement, but “d[id] not intend to entertain further requests.” Ex. 6, at 4.
Defendants then attempted to reinterpret the above agreement as requiring production of “all FDA correspondence relating to its pending sNDA”. See Ex. 6, at 3. In response, Amarin offered to produce yet more categories of documents, but Defendants continued to demand “all FDA correspondence that post-dates the submission of the pending sNDA.” See Ex. 6, at 1–3. In late August, Amarin notified Defendants that it would not further renegotiate the parties’ agreement. Ex. 6, at 1. Defendants moved to compel several weeks later, on October 4, 2019.
C. Amarin produces all the documents that Defendants told the Court would moot the pending Motion to Compel, but Defendants filed this Motion anyway.
While the Motion to Compel was pending, on December 13, 2019 FDA approved
2 Defendants now claim that they “understood this agreement to encompass all materials submitted to or received by Amarin relating to the approval of Amarin’s sNDA.” Mot. at 3. It is not clear how Defendants could have construed Amarin’s undertaking so broadly. In any event, any misunderstanding would have been corrected no later than July 17, 2019, when Amarin informed Defendants that it would not undertake the burden of producing all subsequent correspondence between Amarin and FDA. Ex. 6, at 12–13. Defendants did not file their Motion to Compel until October 4. Defendants’ misunderstanding of the agreement, combined with delay in seeking Court intervention, does not constitute prejudice inflicted on them by Amarin.
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Amarin’s sNDA and new labeling for Vascepa®. Within three hours, Amarin produced the final approval and labeling. See Ex. 1, at 2. In the email attaching these documents, Amarin further proposed, “in the interest of compromise, . . . to agree to collect and produce correspondence with FDA discussing Amarin’s proposed labeling if production of these document would resolve defendants’ pending motion to compel.” Id.
On December 17, 2019, the Court held the Pretrial Conference. Defendants asked leave to file this Motion “to seek . . . sanctions” for Amarin’s alleged failure to disclose REDUCE-IT correspondence. Defs.’ Ex. 6, at 22:25–23:4. Most relevant here, Defendants confirmed to the Court that Amarin’s December 13, 2019 proposal—read verbatim into the record by Defendants’ counsel—would moot the Motion to Compel, id. 28:1–22. See also id. at 22:4–9 (characterizing proposal as “giv[ing] [Defendants] everything . . . asked for.”) Id. Based on this representation, the Court denied the Motion to Compel as moot, and granted Defendants leave to file this Motion. See id. at 27:8–14. On December 19, Amarin produced the complete set of “correspondence with the FDA discussing Amarin’s proposed labeling,” which dates from November 27, 2019 through FDA approval on December 13. See Ex. 1, at 1–2. On Christmas Day, Defendants complained that Amarin’s production was inadequate. See Ex. 1, at 1. This Motion followed.
ARGUMENT
Rule 37(c)(1) “states that if a party fails to provide information . . . as required by Rule 26(a) or (e), the party is not allowed to use that information . . . at trial unless the failure was substantially justified or is harmless.” Martin v. Collier, No. 2:11-cv-00320, 2012 WL 2564890, at *2 (D. Nev. July 2, 2012) (quotation omitted) (emphasis added). “The party facing exclusion bears the burden of proving that failure to comply with Rule 26 was harmless or substantially justified.” Granados v. N. Nev. High Speed, LLC, No. 3:14-cv-00081, 2014 WL 5503118, at *3 (D. Nev. Oct. 30, 2014). Exclusion is not remotely supported by the record here. Amarin went above and beyond its obligations to provide Defendants’ with REDUCE-IT related materials over a period of months. Defendants can show no harm, much less harm sufficient to justify the
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drastic remedy of excluding REDUCE-IT from the trial.
A. Amarin complied with its Rule 26 obligations.
As detailed above, Amarin produced everything Defendants asked for in January 2019. (See supra at 2–4.) Then, when Defendants made additional, out-of-time, demands for more REDUCE-IT related materials, Amarin produced several additional categories of documents and reached multiple agreements with Defendants on the scope of discovery. (See supra at 4–6.) Moreover, Amarin produced new documents within the agreed-upon scope of production promptly as they were created. Cf. Fonseca v. Sysco Food Servs. of Ariz., 374 F.3d 840, 846 (9th Cir. 2004) (late disclosure of witness “substantially justified because it was made shortly after
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Abbott Labs. v. Syntron Biorsearch, Inc., No. 98-cv-2359, 2001 WL 34082555, at *2 (S.D. Cal. Aug. 24, 2001) (“The purpose of a discovery cutoff date is to protect the parties from a continuing burden of producing evidence and to assure them adequate time to prepare
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[plaintiff] learned of the” witness’s relevance).
Defendants’ Motion also ignores that fact discovery closed on November 8, 2018. See
immediately before trial.” (quotation omitted)).
fulfill Defendants’ original request of the CSR and a deposition witness, made before Judge Koppe in January 2019 (see supra at 3–4). Defendants’ motion elides the limited nature of their January request by asserting that “Amarin was thereby placed on notice of its obligation to provide fair discovery to Defendants concerning REDUCE-IT.” (Mot. at 5). Amarin was never required to provide open-ended discovery long after the fact discovery cutoff. Rather, Amarin’s obligation in January 2019 was to produce what Defendants asked for—the CSR and a deposition. Amarin did so.
There is no basis to find a discovery violation.
The only exception was Amarin’s agreement to
3 In the alternative, any failure to disclose by Amarin was substantially justified under the circumstances, given Amarin’s attempts to abide by Court direction and the parties’ agreements. See RRW Legacy Mgmt. Grp., Inc. v. Walker, 751 F. App’x 993, 997 (9th Cir. 2018) (lack of disclosure substantially justified where consistent with parties’ agreement adopted by court).
4 Defendants’ also point to Amarin’s responses to document requests served during the fact discovery period (Mot. at 8), but leave out objections Amarin lodged to those requests, including related to the time period of the documents Amarin would produce (ECF No. 272 at 15 n. 11).
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B. In any event, Defendants cannot show harm or prejudice.
At any rate, any purported Amarin violation was harmless because Amarin timely produced thousands of pages of data and details regarding REDUCE-IT that would enable Defendants—if they could—to challenge the relevance of REDUCE-IT’s results to the non- obviousness analysis. See supra at 2. Defendants also received a two-month extension of expert discovery, specifically to analyze this data. (ECF No. 180). Defendants have disclosed opinions from multiple experts concerning REDUCE-IT, deposed Amarin’s experts concerning REDUCE-IT, and have identified numerous REDUCE-IT related exhibits in the Pretrial Order. Given this record, any imagined disclosure failure was harmless. See RRW Legacy Mgmt., 751 F. App’x at 997 (harmless where party had ample “opportunity to depose the experts regarding” evidence); Silver State Intellectual Techs., Inc. v. Garmin Int’l, Inc., No. 2:11–cv–01578–GMN– PAL, 2015 WL 2152658, at *7 (D. Nev. May 7, 2015) (harmless where allegedly withheld evidence of non-infringing alternatives was included in expert reports before experts were deposed). Defendants’ repeated delays in responding to Amarin with respect to their ever- shifting requests, and then in seeking relief from the Court, see supra at 4, confirms the absence of harm. See Silver State, 2015 WL 2152658, at *7 (denying exclusion motion where party “waited nearly fifteen months to bring . . . [alleged disclosure] failure to the attention of the Court”).
Defendants speculate that Amarin made statements to FDA concerning the relationship between REDUCE-IT and a prior art study called JELIS that might be in tension with litigation positions. See Mot. at 3, 6–9. As an initial matter, any such statements would be of doubtful relevance. The unexpectedness of a claimed invention’s benefits must be judged from the perspective of a person of ordinary skill in the art as of March 2008, not that of Amarin (Vascepa’s developer) in 2019. It is an error to look at the inventor’s own expectations to determine unexpected results. See Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012) (“The inventor's own path itself never leads to a conclusion of obviousness; that is hindsight. What matters is the path that the person of ordinary skill in the art would have
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followed, as evidenced by the pertinent prior art.”). In any event, as Defendants’ Motion implicitly acknowledges, Amarin has already produced thousands of pages of correspondence with FDA, including discussions concerning the JELIS trial, ranging from 2014 to the recent, publically-broadcasted, FDA Advisory Committee convention to review the REDUCE-IT results in November 2019. Thus, Defendants have not been denied the category of documents they seek, and their belated assertion that Amarin should have searched for yet more such documents does not establish prejudice, let alone the sort of prejudice warranting the exclusion of highly- probative evidence such as the REDUCE-IT results. Silvagni, 320 F.R.D. at 243 (exclusion limited to “extreme situations”).
C. Exclusion is unwarranted even assuming a disclosure violation.
“Rule 37(c)(1) does not require the court, in all instances, to exclude evidence as a sanction for a late disclosure that is neither justified nor harmless.” Martin, 2012 WL 2564890, at *2. Instead, the court considers: “1) the public’s interest in expeditious resolution of litigation; 2) the court’s need to manage its docket; 3) the risk of prejudice to the defendants; 4) the public policy favoring disposition of cases on their merits; 5) the availability of less drastic sanctions.” Granados, 2014 WL 5503118, at *5 (quotation omitted). Here, even assuming arguendo that Amarin made a late disclosure that was neither justified nor harmless, the circumstances of this case would not justify exclusion. The parties have all relied extensively on Amarin’s voluminous REDUCE-IT related disclosures in preparing for trial, REDUCE-IT provides significant evidence on the merits of Amarin’s non-obviousness case, and the prejudice of excluding Amarin’s REDUCE-IT evidence vastly outweighs any possible prejudice to Defendants. Excluding the entirety of REDUCE-IT would be far out of proportion to the “information” underlying the alleged disclosure violation (some correspondence with FDA), and
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satisfy Defendants’ shifting requests, see supra at 4–5, refutes any finding of bad faith. “Absent
5 Even if the Court found a violation, it “may impose other sanctions, including payment of reasonable expenses . . . and any other appropriate sanction.” Silvagni, 320 F.R.D. at 242.
to which Rule 37’s exclusion rule actually applies.
Moreover, Amarin’s extensive attempts to
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a showing of bad faith or other misconduct, courts are leery of imposing the harsh sanction of exclusion absent a significant possibility of prejudice.” Silvagni, 320 F.R.D. at 243.
CONCLUSION
For the foregoing reasons, Amarin asks that the Court deny Defendants’ Motion in Limine.
DATED: January 2, 2020
Respectfully submitted,
/s/ Jason D. Smith
Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD.
10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135
Tel: [phone] / Fax: [phone] Email: [e-mail], [e-mail]
Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice)
Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice)
Han Park (admitted pro hac vice)
Jordan L. Moran (admitted pro hac vice) COVINGTON & BURLING LLP
One CityCenter, 850 Tenth Street, NW Washington, DC 20001
Tel: [phone] / Fax: [phone] Email: [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail], [e-mail]
Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
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