Amarin Corp Plc (AMRN)

[Biobillionair]

From Pacer:

MINUTES OF PROCEEDINGS - Telephonic Calendar Call held on 1/6/2020 before Chief Judge Miranda M. Du. Crtrm Administrator: Peggie Vannozzi; Pla Counsel: Jason Misth, Chroistopher Sipes, Megan Keane, Alaina Whitt, Adam Hosmer-Henner; Def Counsel: Claire Fundakowski, Eimeric Reig-Plessis, Charles Klein, West Allen (for Defendant Westward/Hickma); Beth Finkelstein, Constance Huttner, Caroline Sun, Michael Rounds, James Barabas (for Defendant DRL); Court Reporter: Kathy French; Time of Hearing: 1:10 PM - 1:25 PM; Courtroom: 5; Also present: Joe Kennedy, General Counsel for Plaintiff.
The Court advises counsel that it has reviewed Defendant DRL's motion in limine (ECF No. [31]), Plaintiff's response (ECF No. [316]) and the transcript of the 12/17/2019 hearing. The Court has also reviewed DRL's motion to seal (ECF No. [311].) For the reasons the Court has placed on the record, Defendant DRL's motion to seal (ECF No. [311]) is granted. Ms. Huttner and Mr. Sipes present argument. For the reasons the Court has placed on the record, Defendant DRL's motion in limine (ECF No. [310]) is denied.

The Court and counsel discuss the trial schedule. The trial will begin at 8:30 AM on 1/13/2020 in Reno Courtroom 5 before Chief Judge Miranda M. Du. The Court inquires as to whether it should be in session on 1/21/2020. Ms. Huttner and Mr. Sipes address the Court. The Court will keep 1/21/2020 open as a trial date.

The Court will not require counsel to divide their exhibits into small file sizes. Counsel may submit large files in total without dividing the files into smaller files.

(no image attached) (Copies have been distributed pursuant to the NEF - PAV)

Summary:
1) Defendants are granted motion to seal 311

2) Defendants are denied motion in limine 310***

Amarin gets to keep R-I in trial.





***full copy of motion 310
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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 1 of 14
W. West Allen
Nevada Bar No. 5566
HOWARD & HOWARD ATTORNEYS PLLC 3800 Howard Hughes Parkway, Suite 1000
Las Vegas, NV 89169
Telephone: [phone]
Email: [e-mail]
Attorneys for Defendants Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Limited
Michael D. Rounds (Nev. Bar No. 4734)
Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER SCHRECK, LLP 5371 Kietzke Lane
Reno, NV 89511
Tel: [phone]
Email: [e-mail]
[e-mail]
Attorneys for Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
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
DEFENDANTS’ MOTION
IN LIMINE TO EXCLUDE EVIDENCE OR ARGUMENT REGARDING REDUCE-IT

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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 2 of 14
I. INTRODUCTION
Defendants move in limine to exclude evidence or argument at trial related to Amarin’s “REDUCE-IT” clinical study, or in the alternative, to permit Defendants, but not Amarin, to rely on any documents relating to Amarin’s March 28, 2019 supplemental New Drug Application (“sNDA”) seeking approval for a cardiovascular disease (“CVD”) indication for Vascepa®.
As background, this case began after Defendants filed Abbreviated New Drug Applications (“ANDA”) seeking FDA approval to market generic versions of Amarin’s Vascepa® product. Vascepa® is a purified form of fish oil containing at least 96% eicosapentaenoic acid (“EPA”). At the time Defendants filed their ANDAs, Vascepa® was indicated solely as an adjunct to diet and exercise to reduce triglycerides in patients with severe hypertriglyceridemia (triglycerides greater than or equal to 500 mg/dL). Patients with triglycerides at this level are at an increased risk for pancreatitis. Accordingly, lowering triglycerides, not cardiovascular risk, is the medically recommended focus of their treatment.
On March 28, 2019, Amarin filed a Supplemental New Drug Application (“sNDA”) seeking a second indication for Vascepa® based on REDUCE-IT, which studied Vascepa®’s
1
effect on CVD risk in certain patients.
indication for Vascepa® based on Amarin’s sNDA – “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.”
On December 13, 2019, the FDA approved a second
Amarin asserts that Defendants’ generic products will infringe fifteen claims of six asserted patents. These claims all recite the same alleged invention: a method of reducing triglycerides by administering 4 g per day of purified EPA for at least 12 weeks to a patient with
1 Defendants’ labels for their ANDA products will not include the new CVD indication for Vascepa®. See AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1381 (Fed. Cir. 2012) (the Hatch-Waxman “Act permits generic manufacturers to file ANDAs directed to a subset of FDA-approved indications and even provides a mechanism for ANDA applicants to affirmatively carve out patented indications” from their labels).
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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 3 of 14
triglycerides of at least 500 mg/dL. Some claims further specify that this method must not increase a patient’s “LDL” (“bad” cholesterol), or must reduce blood levels of another particle called “apolipoprotein B” (“Apo B”). None of the asserted claims recite methods of reducing CVD risk, or even mention CVD.
Defendants deny infringement and contend that Amarin’s patents are invalid as obvious over the prior art, which disclosed all of the elements of the asserted claims. In an attempt to counter Defendants’ obviousness argument, Amarin and its experts rely heavily on “secondary considerations” (also called “objective evidence of non-obviousness”), including the results of Amarin’s recent REDUCE-IT clinical study, which Amarin claims were “unexpected.” The REDUCE-IT study does not concern the claimed methods of reducing triglycerides in patients with triglycerides of at least 500 mg/dL. Rather, REDUCE-IT only involved patients with triglyceride levels between 135 and 499 mg/dL, whose treatment is not covered by the asserted claims. And, unlike the patient population covered by the asserted claims, all patients in REDUCE-IT had additional risk factors for CVD and were on background statin therapy.
Defendants deny that the results of REDUCE-IT were “unexpected” compared to the closest prior art, which is the JELIS study that was conducted in Japan and published in 2007, two years before Amarin’s claims were allegedly invented. Like REDUCE-IT, JELIS showed that daily administration of purified EPA significantly reduced CVD risk in patients with abnormal lipid levels and on background statin therapy. In this litigation, Amarin and its experts have taken the position that JELIS was “flawed” and did not predict the positive outcome of REDUCE-IT. Their position here, however, is directly at odds with Amarin’s reliance on JELIS to support a prior sNDA for Vascepa®, which also sought a CVD indication. In that context, Amarin repeatedly argued to the FDA that JELIS was a
. Ex. 1, Feb. 27, 2014 Formal
Dispute Resolution Request, at AMRN00111741.
On information and belief, Amarin has continued to rely on JELIS in connection with its
current sNDA for Vascepa®. For example, during a November 18, 2019 public meeting with an 2

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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 4 of 14
FDA Advisory Committee (“AdCom”) relating to Amarin’s sNDA, Amarin’s Senior Vice President of Clinical Research & Development (whom Amarin has listed as a trial witness in this case) argued that “[p]rior to REDUCE-IT, there was one study . . . that supported the possibility that a higher dose of a purified omega-3 provides cardiovascular benefit. This is the JELIS study . . . .” Ex. 2, AdCom Transcript, at 27. It is also apparent from the public record that Amarin made written submissions to the FDA that likely commented or relied on the results of the JELIS study in relation to REDUCE-IT.
Defendants promptly sought production of these written submissions and related correspondence, which are directly relevant to their obviousness defense. Although Amarin initially refused to produce these materials, it eventually agreed to produce all “subsequent FDA correspondence concerning approval of the pending sNDA.” Ex. 3 at 6-7. Defendants understood this agreement to encompass all materials submitted to or received by Amarin relating to the approval of Amarin’s sNDA. Amarin, however, took the position that their production obligation was limited to the final FDA document granting or denying approval of its sNDA. Defendants were therefore forced to file their Motion to Compel. Ex. 4, ECF No. 268,
2
based on the understanding that Amarin was now “willing to compromise by now giving us the materials we’ve been asking for since April.” Ex. 5, Pretrial Conf. Tr. at 23:4-24:2; id. at 22:4-9. The Court’s Minute Order following the pretrial conference further confirmed that Amarin “agrees to provide documents relating to the FDA communications” that Defendants requested “by 12/23/2019.” ECF No. 309. Again, however, Amarin took a different view. On December 19, Amarin produced only a small subset of the documents Defendants had requested (299 pages in all), consisting solely of redline edits to the proposed label for Vascepa® between the FDA and Amarin from November 26, 2019 to December 13, 2019. Defendants received no further
2 The parties’ various exchanges concerning the production of documents relating to Amarin’s sNDA are discussed in detail in Defendants Motion to Compel at pp. 4-7, a copy of which is attached hereto as Exhibit 4.
Motion to Compel, dated October 4, 2019.
At the final pretrial conference, Defendants agreed that their Motion to Compel was moot
3

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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 5 of 14
documents by the December 23 deadline for production. Thus, on December 25, Defendants promptly sought a meet and confer for the morning of December 26. On this meet and confer, Amarin stated only that it has already produced a large quantity of its REDUCE-IT-related documents, which confirms that Amarin is continuing to withhold documents. Apparently, Amarin believes that it can selectively produce only those documents concerning REDUCE-IT that Amarin believes favor its litigation positions, while withholding any documents that may favor Defendants. Thus, despite Amarin’s representations at the pretrial conference and the Court’s subsequent Order, Amarin still has not produced all of its substantive communications with the FDA concerning its sNDA, forcing Defendants to file this motion.
Amarin’s failure to produce the materials it submitted to the FDA is highly prejudicial to Defendants. For example, these materials would likely provide further evidence of Amarin’s reliance on JELIS to support Vascepa’s new CVD indication, which is directly contrary to Amarin’s litigation positions. Moreover, several of Amarin’s experts and fact witnesses testified at the AdCom and may have submitted statements to the FDA on Amarin’s behalf concerning JELIS and other matters relevant to Defendants’ obviousness defense. Defendants are entitled to these documents, which may be useful in cross-examining Amarin’s experts at trial.
Because trial is less than three weeks away, the prejudice to Defendants can no longer be cured merely by ordering immediate production of all sNDA related correspondence. Defendants, therefore, seek an order precluding Amarin from relying on REDUCE-IT as objective evidence of non-obviousness at trial. In the alternative, at a minimum, the Court should order Amarin immediately to produce all of its FDA correspondence concerning its sNDA (excluding any confidential patient data); and direct that Defendants, but not Amarin, may rely on such documents at trial (with the exception of the small number of sNDA-related documents that Amarin produced to Defendants before the date of Defendants’ Motion to Compel, ECF No. 269).
II. APPLICABLE LAW
Judges have broad discretion to grant motions in limine. See Jenkins v. Chrysler Motors 4

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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 6 of 14
Corp., 316 F.3d 663, 664 (7th Cir. 2002). Even relevant evidence may be excluded if its probative value is substantially outweighed by a danger of unfair prejudice. See Fed. R. Evid. 402, 403. The Court has “particularly wide latitude” to issue sanctions under Rule 37(c)(1). Yeti by Molly, Ltd. v. Deckers Outdoor Corp., 259 F.3d 1101, 1106 (9th Cir. 2001) (citations omitted). “Courts have upheld the use of the sanction even when a litigant’s entire cause of action or defense has been precluded.” Id. (citations omitted). Courts have also excluded evidence that was not disclosed “until the very end of fact discovery, after all fact depositions were concluded,” and which should have been disclosed “prior to . . . deposition or, at the very least, early enough in the fact discovery period that [movant] could reasonably seek a second deposition to cover the newly disclosed information.” Baltimore Aircoil Co., Inc. v. SPX Cooling Techs. Inc., No. CCB-13-2053, 2016 US Dist. LEXIS 111934, at *60-*62 (D. Md. Aug. 22, 2016) (citing Woods v. DeAngelo Marine Exhaust, Inc., 692 F.3d 1272, 1282 (Fed. Cir. 2012) (quoting 8A Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 2049.1 (3d ed. 2011))).
III. AMARIN WITHHELD AND CONTINUES TO WITHHOLD HIGHLY RELEVANT EVIDENCE CONCERNING ITS sNDA AND REDUCE-IT
Amarin originally introduced the REDUCE-IT results into this case over Defendants’ objections as part of its supplemental validity contentions served on December 10, 2018. ECF No. 167. As a condition of allowing Amarin to introduce REDUCE-IT after the original fact discovery cut-off, the Court ordered Amarin to produce the REDUCE-IT results and extended the schedule by two months. ECF Nos. 180, 165. Amarin was thereby placed on notice of its obligation to provide fair discovery to Defendants concerning REDUCE-IT – an obligation that Amarin has utterly failed to meet.
As discussed above, Defendants strenuously dispute Amarin’s claim that the results of REDUCE-IT were “unexpected.” On the contrary, the prior-art JELIS study involved an identical purified EPA product and produced comparable CVD risk reduction in statin-treated patients. Defendants also contend that the results of REDUCE-IT fail to meet a “fundamental requirement that must be met before secondary considerations can carry the day. For objective
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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 7 of 14
evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention. Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” In re Huai- Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (quotation and emphasis omitted).
Here, REDUCE-IT lacks the necessary nexus to Amarin’s asserted claims, at least because (1) the CVD risk reduction in REDUCE-IT did not result from the methods of treating very high triglycerides described in the asserted claims; (2) none of the asserted claims require or recite a reduction in cardiovascular risk; (3) the asserted claims require reducing triglycerides, but the CVD benefits observed in REDUCE-IT occurred regardless of pre-existing or attained triglyceride levels; (4) the asserted claims require baseline triglyceride levels of at least 500 mg/dL, whereas patients enrolled in REDUCE-IT had baseline levels below 500 mg/dL; (5) the asserted claims require effects within 12 weeks, whereas the effects observed in REDUCE-IT did not occur for at least a year; and (6) all patients in REDUCE-IT were taking statin drugs,
whereas none of the asserted claims require statin drugs and some specifically exclude the use of statin drugs. Ex. 6, Heinecke Rebuttal Report at ¶ 159.
Thus, one of the relevant issues in determining whether REDUCE-IT provides objective evidence of non-obviousness of the claims asserted in this case is whether the results of REDUCE-IT were reasonably predictable based on the results of JELIS. Defendants’ experts have opined that “the REDUCE-IT results were expected in view of JELIS.” E.g., Ex. 6, Heinecke Rebuttal Report at ¶ 54. In contrast, Plaintiffs’ experts contend that
Ex. 7,
Mason Dep. Tr. at 88:3-5. Amarin’s experts also claim and they disagree that
Ex. 8, Toth Reply Report at ¶¶ 213, 60.
The arguments put forth by Amarin and its experts in this case are directly contrary to
Amarin’s statements to the FDA. For example, in connection with a prior sNDA application for 6

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a CVD indication for Vascepa®, Amarin argued that
Ex. 1, Feb. 27, 2014 Formal Dispute Resolution Request, at AMRN00111741 (emphasis
added). Amarin thus urged the FDA to
Id.
Defendants believe that Amarin and its experts may have made similar admissions about the significance of the JELIS study in its submissions to the FDA in support of its current sNDA. This belief is based, in part, on the public documents regarding the AdCom meeting where Amarin’s representatives told the FDA that JELIS reported (1) “a CV benefit with EPA consistent with REDUCE-IT,” Ex. 9, Amarin AdCom Presentation at 70; and (2) “a consistent benefit . . . in both the secondary prevention and primary prevention cohorts in this study.” Ex. 10, Amarin AdCom Briefing Document at 224. Defendants believe that Amarin’s written communications with the FDA likely contain similar admissions about JELIS and its relationship to REDUCE-IT. Thus, they are highly relevant to the parties’ dispute about the significance of the REDUCE-IT results to the obviousness issue in this case.
Another relevant issue is whether the CVD benefits reported in REDUCE-IT apply to the same patient population as the asserted claims. Again, it is highly likely that Amarin has correspondence with the FDA on this issue. Amarin’s sNDA broadly requested an indication
Ex. 11, Amarin Proposed sNDA Label. Yet the FDA only approved a CVD indication for patients with “established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.” Ex. 12, Amarin Approved sNDA label. The asserted claims are not limited to, and do not even mention, this narrow patient population. Given the difference between the broad indication in Amarin’s sNDA, and the narrow indication that the FDA ultimately approved, there must be correspondence between Amarin and the FDA discussing the scope of the reported CVD benefits, which bears directly on whether REDUCE-IT
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is relevant to the asserted claims. See Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) (“objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support”) (citation omitted).
The requested sNDA-related materials also fall squarely within Defendants’ previous document requests in this case, specifically Requests for Production Nos. 10, 13 and 15, which call for production of all documents and things relating to “NDA No. 202057 filed with the FDA for VASCEPA®, including, but not limited to . . . Supplemental New Drug Applications (sNDAs) . . . and correspondence to and from the FDA referring or relating to such application,” and “any communication or correspondence with the FDA relating to NDA No. 202057, or any supplement thereto, including, but not limited to, all internal documents relating to any correspondence with the FDA regarding NDA No. 202057 or any supplement thereto.” Ex. 13, Defendants’ Document Requests (emphasis added); see also id. at Request No. 15 (seeking production of “any communications between Amarin and the FDA regarding any product containing icosapent ethyl [i.e., the active ingredient in Vascepa®].”) (emphasis added).
In response to each of these previous requests, Amarin agreed to “undertake a limited search for, and produce, additional relevant, responsive, non-privileged, non-immune, discoverable documents created after April 21, 2014.” Id. Amarin had a continuing obligation to produce relevant documents responsive to these requests, which it failed to fulfill. See Fed. R. Civ. P. 26(e); Visa Int’l Serv. Assoc. v. JSL Corp., No. 2:01-cv-00294-LRH-LRL, 2006 U.S. Dist. LEXIS 77451, at *5 (D. Nev. Oct. 20, 2006). Yet instead of meeting its discovery obligations, Amarin’s production to date concerning its current sNDA has been limited to Amarin’s proposed CVD-related edits to the Vascepa® label, publicly available documents concerning the FDA approval date for the new CVD indication, a publicly available FDA press release about the approved label, the FDA’s publicly available response to a Citizen’s Petition relating to the sNDA, and several emails with the FDA discussing the FDA approval timeline. Amarin has not produced any communications with the FDA concerning the actual merits of its sNDA application, including the fact that REDUCE-IT’s reported CVD benefits were found only
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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 10 of 14
in a limited patient population, or its similarity to the prior-art JELIS study.
IV. DEFENDANTS HAVE BEEN HIGHLY PREJUDICED BY AMARIN’S REFUSAL TO PRODUCE CRITICAL REDUCE-IT-RELATED MATERIALS
For the reasons described above, Defendants believe that Amarin’s substantive communications with the FDA concerning its sNDA are likely to include information that will undermine Amarin’s reliance on REDUCE-IT as evidence of non-obviousness in this case— including positive statements about the JELIS study and statements by Amarin’s experts in this case comparing REDUCE-IT and JELIS. This evidence should have been produced to Defendants in a timely fashion after it was submitted to or received from the FDA. Amarin instead chose deliberately to conceal this information despite its extensive reliance on REDUCE- IT as objective evidence of non-obviousness in this case. See, e.g., Ex. 14, Ismail Opening Report at ¶ 38
Ex. 15, Mason Opening Report at ¶ 41
). Amarin’s experts also argue that others previously failed to achieve the REDUCE-IT results and were skeptical that they could be achieved. See
Ex. 16, Toth Opening Report at ¶ 208
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3
Amarin should not be rewarded for its malfeasance. Nor should Amarin be permitted to “cure” its prior misconduct by producing sNDA related documents now, on the eve of trial. The Court should instead preclude Amarin from relying on the REDUCE-IT study as objective evidence of non-obviousness in this case. This sanction appropriately addresses Amarin’s previous, repeated refusals to produce highly relevant material in a timely fashion. In the alternative, at a minimum, the Court should order Amarin immediately to produce all of its FDA correspondence concerning its sNDA (excluding any confidential patient data), and permit Defendants, but not Amarin, to rely on such documents at trial. See Baltimore Aircoil, No. CCB- 13-2053, 2016 US Dist. LEXIS 111934, at *60-*62 (excluding evidence not disclosed until the end of fact discovery).
V. CONCLUSION
For the foregoing reasons, Defendants respectfully urge the Court to grant Defendants’ Motion in Limine and bar Amarin from relying on REDUCE-IT as objective evidence of non- obviousness at trial. In the alternative, the Court should order Amarin immediately to produce all FDA correspondence concerning its sNDA (excluding any confidential patient data); and direct that Defendants, but not Amarin, may rely on such documents at trial (with the exception of any sNDA-related documents that Amarin produced to Defendants before the date of Defendants’ Motion to Compel, ECF No. 269).
DATED: December 26, 2019
/s/ Claire A. Fundakowski
W. West Allen (Nev. Bar No. 5566) HOWARD & HOWARD ATTORNEYS PLLC
3800 Howard Hughes Parkway, Suite 1000 Las Vegas, NV 89169
Tel: [phone]
Respectfully submitted,
/s/ Beth Finkelstein
Michael D. Rounds (Nev. Bar No. 4734) Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER
SCHRECK, LLP 5371 Kietzke Lane
Reno, NV 89511
3 Because Amarin has disclosed multiple experts
evidence or argument regarding REDUCE-IT would significantly shorten and simplify the trial.
who offer opinions on REDUCE-IT, excluding 10

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Case 2:16-cv-02525-MMD-NJK
Document 310 Filed 12/26/19 Page 12 of 14
Email: [e-mail]
Charles B. Klein (admitted pro hac vice) Claire A. Fundakowski (admitted pro hac
vice)
WINSTON & STRAWN LLP 1700 K Street N.W. Washington, D.C. 20006
Tel: [phone]
Email: [e-mail], [e-mail]
George C. Lombardi (admitted pro hac vice) WINSTON & STRAWN LLP
35 W. Wacker Drive
Chicago, IL 60601
Tel: [phone]
Email: [e-mail]
Eimeric Reig-Plessis (admitted pro hac vice) WINSTON & STRAWN LLP
101 California Street
San Francisco, CA 94111
Tel: [phone]
Email: [e-mail]
Attorneys for Defendants Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Limited
Tel: [phone]
Email: [e-mail], [e-mail]
Constance S. Huttner (admitted pro hac vice) Frank D. Rodriguez (admitted pro hac vice) James Barabas (admitted pro hac vice) Caroline Sun (admitted pro hac vice)
Beth Finkelstein (admitted pro hac vice) WINDELS MARX LANE &
MITTENDORF, LLP 1 Giralda Farms, Suite 100
Madison, NJ 07940
Tel: [phone]
Email: [e-mail], [e-mail], [e-mail], [e-mail], [e-mail]
Attorneys for Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 13 of 14
CERTIFICATE OF COMPLIANCE
Defendants Dr. Reddy’s Laboratories, Inc.; Dr. Reddy’s Laboratories, Ltd.; Hikma Pharmaceuticals U.S.A. Inc.; and Hikma Pharmaceuticals USA Ltd. hereby certify, pursuant to Local Rule 16-3(a), that the parties have participated in the meet-and-confer process and have been unable to resolve the matter without court action.
DATED: December 26, 2019
/s/ Claire A. Fundakowski
W. West Allen (Nev. Bar No. 5566) HOWARD & HOWARD ATTORNEYS PLLC
3800 Howard Hughes Parkway, Suite 1000 Las Vegas, NV 89169
Tel: [phone]
Email: [e-mail]
Charles B. Klein (admitted pro hac vice) Claire A. Fundakowski (admitted pro hac
vice)
WINSTON & STRAWN LLP 1700 K Street N.W. Washington, D.C. 20006
Tel: [phone]
Email: [e-mail], [e-mail]
George C. Lombardi (admitted pro hac vice) WINSTON & STRAWN LLP
35 W. Wacker Drive
Chicago, IL 60601
Tel: [phone]
Email: [e-mail]
Eimeric Reig-Plessis (admitted pro hac vice) WINSTON & STRAWN LLP
101 California Street
San Francisco, CA 94111
Tel: [phone]
Email: [e-mail]
Attorneys for Defendants Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Limited
Respectfully submitted,
/s/ Beth Finkelstein
Michael D. Rounds (Nev. Bar No. 4734) Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER
SCHRECK, LLP 5371 Kietzke Lane
Reno, NV 89511
Tel: [phone]
Email: [e-mail], [e-mail]
Constance S. Huttner (admitted pro hac vice) Frank D. Rodriguez (admitted pro hac vice) James Barabas (admitted pro hac vice) Caroline Sun (admitted pro hac vice)
Beth Finkelstein (admitted pro hac vice) WINDELS MARX LANE &
MITTENDORF, LLP 1 Giralda Farms, Suite 100
Madison, NJ 07940
Tel: [phone]
Email: [e-mail], [e-mail], [e-mail], [e-mail], [e-mail]
Attorneys for Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
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Case 2:16-cv-02525-MMD-NJK Document 310 Filed 12/26/19 Page 14 of 14
CERTIFICATE OF SERVICE
Pursuant to FRCP 5(b) and Section IV of the District of Nevada Electronic Filing Procedures, I hereby certify that I am an employee of BROWNSTEIN HYATT FARBER SCHRECK, LLP, and on this 26th day of December, 2019, I served the document entitled, DEFENDANTS’ MOTION IN LIMINE TO EXCLUDE EVIDENCE OR ARGUMENT REGARDING REDUCE-IT, on counsel of record through the CM/ECF system.
/s/ Jeff Tillison
Employee of Brownstein Hyatt Farber Schreck, LLP