APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEVADA, IN CASE NO. 2:16-CV-02525-MMD, JUDGE MIRANDA M. DU __________________________________________________________________
BRIEF AND APPENDIX VOLUME I, PAGES APPX1-APPX16 OF EPADI II AS AMICUS CURIAE IN SUPPORT OF PLAINTIFFS’-APPELLANTS’ COMBINED PETITION FOR PANEL REHEARING OR REHEARING EN BANC __________________________________________________________________
MICHAEL S. KASANOFF MICHAEL S. KASANOFF, LLC 9 STILLWELL STREET MATAWAN, NJ 07747 (908) 902-5900 Counsel for Amicus Curiae EPADI II
October 8, 2020
CERTIFICATE OF INTEREST
Counsel for Amicus Curiae EPA Drug Initiative II (“EPADI II”) certifies the following:
1. The full name of every party or amicus represented by me is:
EPA Drug Initiative II (“EPADI II”)
2. The name of the real party in interest (if the party named in the caption is not the real party in interest) represented by me is:
None
3. All parent corporations and any publicly held companies that own 10 percent or more of the stock of the party or amicus curiae represented by me are:
None
4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or are expected to appear in this court (and who have not or will not enter an appearance in this case) are:
None
5. The title and number of any case known to counsel to be pending in this or any other court or agency that will directly affect or be directly affected by this court’s decision in the pending appeal. See Fed. Cir. 4. 47.4(a)(5) and 47.5(b).
None
Dated: October 8, 2020 /s/ Michael S. Kasanoff Michael S. Kasanoff MICHAEL S. KASANOFF, LLC 9 Stillwell Street Matawan, NJ 07747 Telephone: (908) 902-5900 mkasanoff@att.net
Counsel for Amicus Curiae EPA Drug Initiative II (“EPADI II”)
TABLE OF CONTENTS
TABLE OF AUTHORITIES iii
INTEREST OF AMICUS CURIAE 1
INTRODUCTION 3
ARGUMENT 5
POINT I
DEFENDANTS HAVE COMMITTED A FRAUD UPON THE COURT BY INTENTIONALLY CROPPING THE KURABAYASHI TABLE AND THROUGH THE FALSE TESTIMONY OF THEIR MAIN EXPERT, DR. HEINECKE 5
POINT II
IF DEFENDANTS’ FRAUD UPON THE COURT IS NOT REMEDIED EN BANC, THIS CASE WILL DIRECTLY CONTRAVENE THIS COURT’S PRECEDENTS IN THERASENSE AND NOVO 11
CONCLUSION 12
CERTIFICATION OF COMPLIANCE
CERTIFICATION OF SERVICE
EPADI II APPENDIX VOLUME I
True Excerpts from the July 17, 2019 Deposition Transcript of Dr. Heinecke (ECF Document 264-3 filed 09/13/19) Appx1-Appx16
ADDENDUM
Cropped Kurabayashi Table 3 in Defendants’ Proposed Findings of Fact reproduced for the convenience of the Court Appx102826
Cropped Kurabayashi Table 3 in the District Court’s Opinion reproduced for the convenience of the Court Appx30
Uncropped Kurabayashi Table 3 in the actual Study reproduced for the convenience of the Court Appx88404
Hazel-Atlas Glass Co. v. Hartford Empire Co., 322 U.S. 238, 64 S.Ct. 997, 88 L.Ed. 1250 (1944) 9, 10
Heffernan v. City of Paterson, 136 S. Ct. 1412, 194 L. Ed. 2d 508 (2016) 5
Indianapolis v. Chase Nat. Bank, 314 U.S. 63, 62 S.Ct. 15, 86 L.Ed. 47 (1941) 5
Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 719 F.3d 1346 (Fed. Cir. 2013) 4, 5, 11
Sony Electronics, Inc. v. U.S., 382 F.3d 1337 (2004) 9, 11
Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 135 S.Ct. 831, 190 L.Ed.2d 719 (2015) 10
Therasense, Inc. v. Becton Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011)(En Banc) 4, 5, 9, 11
Watson v. Geren, 587 F.3d 156 (2d Cir. 2009) 9
INTEREST OF AMICUS CURIAE
EPADI II is an ad hoc group of physicians, patients, Amarin retail shareholders, iHub message board participants, and other concerned citizens1 bound by a common conviction. Specifically, that highly purified EPA as found exclusively within Amarin’s signature drug, Vascepa, has been shown to offer significant value in the prevention and treatment of cardiovascular disease, as well as systemic inflammation. EPADI II exists to promote education and awareness of Vascepa’s enormous cardiovascular and therapeutic benefits. EPADI II has a significant interest in the grant of en banc review. The District Court’s decision procured by Defendants’ fraud upon the Court, has basically destroyed the U.S. market for Vascepa. The issues and perspective raised in this Amicus Brief, have not been raised by any of the parties at any stage of this proceeding.
The invalidation of Amarin’s patents could potentially cost hundreds of thousands of American lives, as Amarin has been deprived of the incentive to promote Vascepa in the U.S., and Defendants can neither sell generic Vascepa to that patient population, nor promote generic Vascepa, as those activities would violate Amarin’s other patents. If the current Judgment stands, EPADI II’s entire existence will be severely undermined. EPADI II certifies that no counsel for a party authored this Brief in whole or in part, and no such counsel or party, nor any person other than Amicus or its counsel, made a monetary contribution intended to fund the preparation or submission of this Brief.2 This Brief is solely the work of EPADI II; it reflects the consensus view of EPADI II’s members, but not necessarily the views of any individual member. EPADI II further certifies that it is concurrently filing a motion for leave to file this Brief.
INTRODUCTION
Sunlight is said to be the best of disinfectants; electric light the most efficient policeman. Buckley v. Valeo, 424 U.S. 1, 67, 96 S.Ct. 612, 658, 46 L.Ed.2d 659 (1976). This Amicus Brief is being filed to illuminate the brazen fraud Defendants have perpetrated upon the Court. Because the District Court’s judgment declaring Amarin’s patents invalid on grounds of obviousness, was based largely upon tainted evidence submitted by Defendants, the District Court’s judgment cannot be sustained as a matter of law. Fraige v. American-National Watermatress Corp., 996 F.2d 295, 299 (Fed. Cir. 1993). One does not have to look any further than the Kurabayashi study which was central to the District Court’s decision. Because of Defendants’ egregious misconduct, the District Court erroneously concluded that in “light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA.” (Appx28-30). The District Court’s decision is both tainted and erroneous, because the District Court relied upon a “cropped” version of Kurabayashi Table 3, which omitted material information from the District Court. In fact, it is the same cropped table which Judge Du copied directly from Defendants’ Proposed Findings of Fact (Appx102826) before pasting it directly into her Opinion. (Appx30).
In order to appreciate the devious nature of Defendants’ fraud on the Court, one need only compare the cropped Table in Defendants’ Proposed Findings of Fact (Appx102826), with the identical cropped Table in Judge Du’s Opinion. (Appx30), with the uncropped Kurabayashi Table (Appx88404). (Addendum). It is absolutely stunning. As detailed below, Defendants intentionally cropped the Table to disingenuously bolster the misleading testimony from their expert, Dr. Heinecke, that is completely the opposite of the stated Kurabayashi statistical analysis. Defendants’ intentional cropping of the Table, is an act of ‘legal chutzpah’, defined as, “gall, brazen nerve, effrontery, incredible ‘guts’; presumption-plus-arrogance such as no other word, and no other language, can do justice to.” Chaffee v. Kraft Gen. Foods, Inc., 886 F.Supp. 1164, 1167 (D.N.J. 1995). But there’s more. Where, as here, a party has engaged in egregious, intentional misconduct designed to defraud the court, this Court has employed the “unclean hands doctrine” to remedy such egregious misconduct. Therasense, Inc. v. Becton Dickinson and Co., 649 F.3d 1276, 1287 (Fed. Cir. 2011)(En Banc); Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 719 F.3d 1346, 1358 (Fed. Cir. 2013). If en banc review is denied, and Defendants’ egregious misconduct goes unremedied, then this case will have deviated from Therasense and Novo.3 Notwithstanding the sound reasons advanced by Amarin, there are a multitude of reasons beyond those advanced by Amarin which support the grant of en banc review. ARGUMENT POINT I DEFENDANTS HAVE COMMITTED A FRAUD UPON THE COURT BY INTENTIONALLY CROPPING THE KURABAYASHI TABLE AND THROUGH THE FALSE TESTIMONY OF THEIR MAIN EXPERT, DR. HEINECKE “Litigation is the pursuit of practical ends, not a game of chess.” Indianapolis v. Chase Nat. Bank, 314 U.S. 63, 69, 62 S.Ct. 15, 17, 86 L.Ed. 47 (1941). This concept appears lost on Defendants, as their expert witness, Dr. Jay W. Heinecke misled the District Court by misrepresenting the real conclusions of Kurabayashi. In the Defendants’ Proposed Finding of Fact, they quote Dr. Heinecke, “In light of the statistically-significant differential effects reported between the EPA and control groups, a person of ordinary skill in the art would have attributed the reduction in Apo B to EPA.” (Appx102826). The District Court literally inserted Dr. Heinecke’s false conclusion into its Order verbatim. (Appx30). This inexplicably and inexcusably transpired despite being explicitly contradicted by Kurabayashi, “The apolipoprotein B level in the eicosapentaenoic acid group was significantly lower at week 48 compared with the baseline level, but there was no significant difference between the groups.” (Appx88402). Hence the cropped Table. Moreover, the Kurabayashi authors explicitly state how they compare groups to establish this conclusion of no difference between groups: “The significance of differences between the two groups was determined using Student unpaired test and that of differences in changes over time was determined by one-way repeated-measures analysis of variance. The statistical significance of intergroup differences was evaluated by two-way factorial analysis of variance followed by Fisher least significant difference method for multiple comparisons.” (Appx88401). It was this intergroup statistic that was non-significant in the ApoB analysis of Table 3 (See legend of “NS” for all time points between control and EPA arms illustrated below as p†). (Appx88401). The significance of the ANOVA variation in ApoB across time points for the EPA group was misrepresented to mean a difference in effects between EPA and control on ApoB. This is exactly the error Dr. Heinecke advanced, which the District Court then accepted as fact.
Defendants cropped the table to exclude the descriptive legend that clearly states that the NS refers to a comparison between the EPA and control arms, which renders Heinecke’s statement scientifically false. (Appx102826). By doing so, Defendants have hidden the fact that Dr. Heinecke’s conclusion is diametrically opposed to the stated Kurabayashi statistical analysis. The legend describing the lack of intergroup difference by student unpaired t-test for each time point was deliberately omitted. The legend should have been appended as the full Kurabayashi table includes the key intergroup difference statistic--the Students unpaired t-tests at each time point that definitively showed at every time point (NS) that “there was no significant difference between the groups” (Appx88402). What motivated Defendants to crop the Table and hide the legend? Defendants and Dr. Heinecke both knew or should have known that to make a statement on the EPA effect on ApoB, there needed to be an honest representation of the full Table including the critical statistical legend. The District Court was misled by a deliberate misrepresentation of the scientific truth, hidden behind a cropped Table and an omitted legend.
When Dr. Heinecke was deposed regarding the proper methodology for statistical analysis, and was asked how to interpret the LDL changes in the same cohort in Kurabayashi, it is obvious that Dr. Heinecke did not believe his own construct of appropriate statistical analysis for ApoB. (EPA Appx.9). In this context, we see why the tables were cropped as both Dr. Heinecke and Defendants knew this methodology of misrepresentation was deceptive. When asked at his deposition whether there was a difference in the LDL cholesterol effects of EPA and control groups, Dr. Heinecke acknowledges that he needs an intergroup comparison test–meaning the full Table, not the cropped one–to determine if there is a statistically significant, meaningful difference between the two groups. (EPA Appx9). This is exactly the same reasoning demanding the application of the intergroup statistical comparison test for assessing the differential ApoB effects of EPA versus control in Table 3. Regarding ApoB, Heinecke conveniently abandoned the comparison because it did not suit Defendants’ construct. Defendants then cropped out this non-significant statistical comparison (Appx102826), and then the District Court embraced this fraudulently cropped table in rendering its decision. (Appx30).
When a parties such as Defendants set the judicial machinery in motion, but violated conscience, good faith, or other equitable principle in their prior conduct, the doors of the courthouse are shut to those parties, as courts will refuse to interfere on their behalf, acknowledge their rights, or award them any remedies. Aptix Corp. v. Quickturn Design Systems, Inc., 269 F.3d 1369, 1375 (Fed. Cir. 2001). Where, as here, the misconduct is particularly egregious, it speaks for itself, and need not even be material. Theresasense, 649 F.3d at 1287. En Banc action is appropriate in cases involving a question of exceptional importance. Cascades Projection, LLC v. Epson America, Inc., 864 F.3d 1309, 1321 (Fed. Cir. 2017); Sony Electronics, Inc. v. U.S., 382 F.3d 1337, 1339 (2004). A question is of exceptional importance if it creates “important systemic consequences for the development of the law and the administration of justice.” Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333, 1370 (Fed. Cir. 2019)(Stoll dissenting) (quoting Watson v. Geren, 587 F.3d 156, 160 (2d Cir. 2009)). Defendants’ fraud on the Court undoubtedly renders this case as one presenting a question of substantial importance, as tampering with the administration of justice involves far more than an injury to a single litigant. Hazel-Atlas Glass Co. v. Hartford Empire Co., 322 U.S. 238, 246, 64 S.Ct. 997, 1001, 88 L.Ed. 1250 (1944). Defendants have wronged this Court–the most prestigious intellectual property dispute resolution forum the world has ever known– as an institution, where such fraud cannot be complacently tolerated. Id. Public policy demands that eminent institutions of public justice such as this Court “be not so impotent that they must always be mute and helpless victims of deception and fraud.” Id. This is so even if Amarin did not exercise the highest degree of diligence in uncovering the fraud. Id. Moreover, fraud in patent cases is a matter of public concern extending beyond the parties to the litigation. Fraige, 996 F.2d at 298 (citing Hazel-Atlas, supra). Indeed, fraud upon the court is especially troubling in patent cases as “patent law is a field where so much depends upon familiarity with specific problems and principles not usually contained in the general storehouse of knowledge and experience.” Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 328, 135 S.Ct. 831, 838, 190 L.Ed.2d 719 (2015). For all of these reasons, en banc action is most appropriate.
POINT II IF DEFENDANTS’ FRAUD UPON THE COURT IS NOT REMEDIED EN BANC, THIS CASE WILL DIRECTLY CONTRAVENE THIS COURT’S PRECEDENTS IN THERASENCE AND NOVO As noted in the Introduction, where, as here, a party has engaged in egregious, intentional misconduct designed to defraud the court, this Court has employed the “unclean hands doctrine” to remedy such egregious misconduct. Therasense, supra.; Novo, supra. En Banc action is likewise appropriate in order to maintain uniformity with this Court’s decisions. Cascade Projection, supra; Sony Electronics, supra. If en banc review is denied, and Defendants’ egregious misconduct goes unremedied, then this case will have deviated from Therasense and Novo. Accordingly, en banc action is required to maintain uniformity with this Court’s decisions in Therasense and Novo.
CONCLUSION For the reasons above, Amicus EPADI II respectfully requests that the Court rehear this case en banc.
Dated: October 8, 2020 /s/ Michael S. Kasanoff Michael S. Kasanoff MICHAEL S. KASANOFF, LLC 9 Stillwell Street Matawan, NJ 07747 Telephone: (908) 902-5900 mkasanoff@att.net
Counsel for Amicus Curiae EPA Drug Initiative II (“EPADI II”)
CERTIFICATE OF COMPLIANCE I hereby certify that: 1. This Brief complies with the type-volume limitation of Fed. R. App. P. 29(a)(5) because this Brief contains 2,139 words, excluding parts of the Brief exempted by Fed. R. App. P. 32(f). 2. This Brief complies with the typeface requirements of Fed. R. App. P. 32(a)(5) and the type style requirements of Fed. R. App. P. 32(a)(6) because this Brief has been prepared in a proportionally spaced font using Corel WordPerfect in 14 point Times New Roman.
Dated: October 8, 2020 /s/ Michael S. Kasanoff Michael S. Kasanoff MICHAEL S. KASANOFF, LLC 9 Stillwell Street Matawan, NJ 07747 Telephone: (908) 902-5900 mkasanoff@att.net
Counsel for Amicus Curiae EPA Drug Initiative II (“EPADI II”)
CERTIFICATE OF SERVICE In accordance with Fed. R. App. P. 25 and Fed. Cir. R. 25, I hereby certify that on October 8, 2020, I caused the foregoing to be filed with the Court electronically using the CM/ECF system, which will send a notification to all counsel of record.
Dated: October 8, 2020 /s/ Michael S. Kasanoff Michael S. Kasanoff MICHAEL S. KASANOFF, LLC 9 Stillwell Street Matawan, NJ 07747 Telephone: (908) 902-5900 mkasanoff@att.net
Counsel for Amicus Curiae EPA Drug Initiative II (“EPADI II”)
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