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Re: None

Thursday, 04/08/2021 8:02:42 PM

Thursday, April 08, 2021 8:02:42 PM

Post# of 427761
Reply Brief pasted out of my word processor:


MEMORANDUM OF POINTS AND AUTHORITIES
PRELIMINARY STATEMENT
Plaintiff Amarin “does not oppose either of EPADI II’s pending motions.” Defendants, on the other hand, have unilaterally decided that at this time, they need only file opposition to EPADI II’s Rule 24 motion, despite the absence of either an order from the Court, or even a Case Management Conference, authorizing bifurcation of the Rule 24 motion from the Rule 60 motion. Defendants have abjectly refused to respond to the Rule 60 motion even though they acknowledge that under LR 7-2(d), the failure to respond to a motion typically “constitutes a consent to the granting of the motion.”

Nevertheless, Defendants’ terse response is short on substance, but littered with ad hominem attacks on both EPADI II, whose members are labeled “disgruntled investors”, and EPADI II’s counsel, who is accused of filing frivolous litigation while advancing “concocted conspiracy theories.” Defendants’ ill-advised approach contravenes this Court’s stated preference that attorneys “demonstrate professionalism and respect for opposing counsel.” Instead, Defendants play right into the concern among the judiciary that the legal profession has “opened its doors to the ‘Rambo litigator’ which has spawned a generation of lawyers, too many of whom think they are more effective when they are more abrasive.” Glass Egg Digital Media v. Gameloft, Inc., 2020 WL 906714 at *7 (N.D. Cal. 2020).

One need not look any further than the very end of Defendants’ Opposition, where they “reserve all rights” to seek sanctions against EPADI II and its counsel pursuant to 28 U.S.C. § 1927. Defendants gallingly threaten EPADI II with sanctions despite knowing full well that such sanctions can only be awarded upon a showing of subjective bad faith on the part of an attorney acting “vexatiously”, meaning recklessly, plus something more such as frivolousness, harassment, or an improper purpose. Gonzalez v. Allied Collection Services, Inc., --- Fed. Appx. ----, 2021 WL 1174596 at *1 (9th Cir. 2021); Oracle USA, Inc. v. Rimini Street, Inc., 2021 WL 1224904 at *20 (D. Nev. 2021); Battle Born Munitions, Inc. v. Dick’s Sporting Goods, Inc., 2021 WL 40257 at *2 (D. Nev. 2021).

EPADI II petitions this Court having comprehensively briefed every legal issue while factually relying upon the expert report of a Cambridge professor, and a peer-reviewed paper published by two Harvard professors, and the top biostatistician at Duke. Win, lose, or draw, no rational person can reasonably conclude that EPADI II’s filing is either vexatious or frivolous.

This is especially true for Defendants’ sophisticated legal team quarterbacked by the National President of the Federal Bar Association. Defendants have both actual and constructive notice of the vexatiousness standard required for § 1927 sanctions, yet they haphazardly advance the threat anyway. Defendants’ intellectual recklessness on this issue, is emblematic of their Opposition--light on substance, but heavy on
bluster, threats, and condescending ad-hominem personal attacks.

Defendants seek to further besmirch EPADI II’s counsel through reference to other legal matters as if to say that those matters are dispositive of EPADI II’s current comprehensive Rule 60 motion. On that topic, it must be realized that the entry of the Judgment invalidating Amarin’s patents on March 30, 2020, caused a complete cratering of the stock price, which was an apocalyptic cataclysm for EPADI II, its members, its counsel, and countless others similarly situated.

The sting of this cataclysm has been geometrically magnified as EPADI II has since discovered that the Judgment was procured through some unholy combination of mistake, misrepresentation, fraud, fraud on the Court, unclean hands, and inequitable conduct. EPADI II’s counsel is committed to the pursuit of any and all viable legal remedies in order to achieve justice, accountability and restitution rectifying the manifest injustice which transpired on that fateful day. Each legal filing is but one step in that process.

Defendants’ Opposition is really an exercise in “we hope something sticks.” Assisted Living Assoc. of Moorestown, L.L.C. v. Moorestown Twp., 996 F.Supp. 409, 430 (D.N.J. 1998). Defendants want to make this about who is doing the filing, rather than what is actually being filed. But EPADI II has the highest confidence that the Court will see right through this facade, while focusing exclusively on what is being filed, rather than who is doing the filing.

The hard fact is that even if a court must make a decision that a court does not necessarily like, the court nevertheless makes the decision because it is right in the sense that the law compels such a result. Texas v. Johnson, 491 U.S. 397, 420–21, 109 S. Ct. 2533, 2548, 105 L. Ed. 2d 342 (1989) (Kennedy, J. Concurring). This is especially true considering that in the context of Rule 60, a failure to correct clear error, constitutes an abuse of discretion. McDowell v. Calderon, 197 F.3d 1253, 1255 n.4 (9th Cir. 1999)(en banc)(per curiam). EPADI II has the highest confidence that in the end, this Court will do the right thing because the facts and law compel the granting of EPADI II’s requested relief.

EPADI II has multiple interests justifying Intervention as of right pursuant to Rule 24(a). EPADI II asserts common questions of law and fact justifying permissive intervention pursuant to Rule 24(b). As a result of privity, and EPADI II’s allegations of fraud, EPADI II has standing to intervene in pursuit of Rule 60 relief.

In the words of Blackstone, “it is the business of the judges ... to suppress the mischief, and advance the remedy.” Royal Assoc. v. Concannon, 200 N.J. Super. 84, 93, 490 A.2d 357 (App. Div. 1985). EPADI II respectfully submits that this Court should suppress the mischief by rejecting Defendants’ non-opposition, and advance the remedy granting the relief requested by EPADI II.

ARGUMENT
POINT I
EPADI II HAS SATISFIED ALL OF THE CRITERIA FOR RULE 24(a) INTERVENTION AS OF RIGHT

A. The Motion is Timely
In a footnote, Defendants contend that EPADI II should be estopped from intervening due to the case being closed for a year. But the fact remains that EPADI II’s requests for relief under Fed. R. Civ. P. 60(b)(1) and 60(b)(3), are subject to a one-year deadline from the date of the entry of the original Judgment. Fed. R. Civ. P. 60(c)(1). Because this motion, as well EPADI II’s companion Rule 60 motion, are both being filed within the statutory one-year limitations period, this motion is per se timely.

In addition, EPADI II’s moving Brief chronicles the timeline demonstrating that EPADI II’s filing is both reasonable and timely:
March 30, 2020 The Judgment is entered.
April 2, 2020 Amarin appealed to the Federal Circuit, divesting this Court of jurisdiction.

September 3, 2020 The Federal Circuit issued its mandate affirming the Judgment.

November 4, 2020 Re-hearing en banc is denied.

November 9, 2020 The Silberberg Demand Letter is emailed to Amarin’s CEO.

February 9, 2021 90 days pass without any response to the Demand Letter.

March 19, 2021 EPADI II files its Rule 60 and Rule 24 motions.

The foregoing summarizes “the length and reason for any delay.” PEST Comm. v. Miller, 648 F. Supp. 2d 1202, 1212 (D. Nev. 2009), aff'd, 626 F.3d 1097 (9th Cir. 2010). The one-year statute of limitations and the above timeline both establish that this motion is timely.




B. EPADI II Need Not Own the Patents to Establish that it has a Protectable
Interest Relating to the Property or Transaction that is the Subject of this
Action

Once again, a significant protectable interest exists where the proposed intervenor asserts an interest protected under some law, and there is a relationship between the legally protected interest and the claims at issue. Arakaki v. Cayetano, 324 F.3d 1078, 1084 (9th Cir. 2003). For purposes of intervention, a sufficient interest will be found where the intervenor “will suffer a practical impairment of its interests as a result of the pending litigation.” Wilderness Soc. v. U.S. Forest Service, 630 F.3d 1173, 1179 (9th Cir. 2011).

Defendants erroneously and misleadingly proclaim that EPADI II “admits it does not own or have any legal interest in the patents-in-suit.” EPADI II acknowledges that it does not own the patents themselves, but it is a misrepresentation to proclaim that EPADI II has admitted that it does not have any legal interest in the patents-in-suit.

As Amarin shareholders, EPADI II has an ownership interest in the company which owns the patents. A corporation’s shareholders have a significant protectable interest justifying intervention as of right because “as owners of the corporation, shareholders have an interest in recovering damages suffered by the corporation.” In re Intel Corp. Shareholder Deriv. Litig., 2018 WL 5777138 at *3 (N.D. Cal. 2018). See Rothenberg v. Sec. Mgmt. Co., Inc., 667 F.2d 958, 960 n.3 (11th Cir. 1982)(Shareholders benefit indirectly from the increase in stock value that results from lawsuit recovery). See also Portnoy v. Kawecki Berylco Indus., Inc., 607 F.2d 765, 767 (7th Cir. 1979)(Because shareholders receive at least an indirect benefit in terms of increased shareholder equity, they have an adequate interest in vigorously litigating on behalf of the company).

Both Amarin and its shareholders have an interest in ensuring that EPADI II’s Rule 60 claims are fully investigated and litigated on their merits for purposes of obtaining the best possible recovery for Amarin and its shareholders, specifically the vacation of the Judgement and the restoration of the invalidated patents. In re Intel Corp. Shareholder Deriv. Litig., supra. Absent the grant of Rule 24 intervention and Rule 60 relief vacating the Judgement, resulting in the restoration of Amarin’s patents, the current disposition of the present litigation could bar restoration of the patents and permanently reduce the monetary value of Amarin’s stock price. U.S. v. Aerojet Gen. Corp., 606 F.3d 1142, 1152 (9th Cir. 2010). EPADI II has indeed stated a legal interest justifying intervention as of right.

POINT II
EPADI II ABSOLUTELY SHARES COMMON QUESTIONS OF LAW AND FACT WITH THE MAIN ACTION, JUSTIFYING RULE 24(b) PERMISSIVE INTERVENTION

Defendants erroneously claim that EPADI II has not articulated any claim or defense, let alone one that shares common questions of law and fact with the patent infringement claims in this case. Defendants are wrong.

EPADI II’s Rule 60 Motion seeks to vacate the Judgment invalidating Amarin’s patents on grounds of prima facie obviousness. In the underlying action, Amarin sought to uphold its patents on grounds that said patents were not void due to obviousness. EPADI II’s motion therefore shares common questions of law and fact with the main action–specifically upholding the integrity of the patents on grounds of non-obviousness. Nikon Corp. v. ASM Lithography B.V., 222 F.R.D. 647, 651 (N.D. Cal. 2004). Permissive intervention is appropriate.

POINT III
NO SEPARATE PLEADING IS REQUIRED UNDER RULE 24(c) AS EPADI II HAS MORE THAN SUFFICIENTLY APPRISED THE COURT OF THE GROUNDS FOR THIS MOTION

Defendants contend that EPADI II has not even filed a separate pleading as required by Rule 24(c). Defendants apparently missed the string cite in EPADI II’s moving Brief, noting that the courts in the Ninth Circuit routinely and emphatically approve intervention without a separate pleading where the court is otherwise apprised of the grounds for the motion. In re Molasky, 843 F.3d 1179, 1185 (9th Cir. 2016); Westchester Fire Ins. Co. v. Mendez, 585 F.3d 1183, 1188 (9th Cir. 2009); Beckman Indus., Inc. v. International Ins. Co., 966 F.2d 470, 474 (9th Cir. 1992); Arizonans for Fair Elections v. Hobbs, 335 F.R.D. 261, 268 n.1 (D. Ariz. 2020). It is unambiguously obvious from EPADI II’s papers that pursuant to Rule 60, EPADI II is seeking to vacate the Judgment invalidating Amarin’s patents on grounds of prima facie obviousness. EPADI II has complied with Rule 24(c).

POINT IV
EPADI II HAS STANDING TO FILE THE RULE 60 MOTION
A. EPADI II’s Privity with Amarin Provides the Basis for Standing

Defendants attempt to belittle EPADI II as nothing more than “disgruntled retail investors in Amarin stock.” Defendants’ hubris, however, actually constitutes an important admission, acknowledgment, and stipulation which completely undermines Defendants’ position that EPADI II lacks standing. EPADI II’s status as Amarin shareholders places EPADI II in privity with Amarin, which in turn, imbues EPADI II with Rule 60(b) standing.

Privity is a legal conclusion designating a person so identified in interest with a party to former litigation that he represents precisely the same right in respect to the subject matter involved. Headwaters, Inc. v. U.S. Forest Service, 399 F.3d 1047, 1053-54 (9th Cir. 2005). Privity arises from a “limited number of legal relationships in which two parties have identical or transferred rights with respect to the subject matter involved.” Id. at 1054. Those relationships include “corporations and their officers or shareholders.” Id.

A “party or a party’s legal representative” may bring an action pursuant to Rule 60(b). This allows one who is in privity with a party to move for relief, and constitutes an important exception to the general rule that a nonparty lacks standing to file a Rule 60(b) motion. In re La Sierra Fin. Serv., Inc., 290 B.R. 718, 728 (9th Cir. 2002); Eyak Native Village v. Exxon Corp., 25 F.3d 773, 777 (9th Cir. 1994). Thus EPADI II’s status as Amarin shareholders–disgruntled or otherwise–places EPADI II in privity with Amarin, thereby instilling Rule 60(b) standing upon EPADI II.

B. Because the Judgment Invalidating Amarin’s Patents was Procured
By Fraud, and EPADI II’s Interests have been Directly Affected,
EPADI II has Standing

If a non-party’s interests are directly affected, a non-party has standing to seek Rule 60 relief from a judgment procured by fraud. In re La Sierra Fin. Serv., supra, at 730; Eyak Native Village, supra. Furthermore, as long as the non-party’s interests are directly affected, there is no significant difference between whether the non-party seeks relief under Rule 60(b)(3), or any of the other Rule 60 provisions, meaning that where the non-party’s interests are affected, the non-party has standing to seek relief under any Rule 60 provision, including Rule 60(b)(1) on grounds of mistake. In re La Sierra Fin. Serv., supra.

As chronicled throughout this Brief, EPADI II’s interests will be adversely affected if the Judgment is not vacated. Id. Regarding the fraud itself, we need only compare the cropped Table in the Court’s Opinion, Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., 449 F.Supp.3d 967, 990 (D. Nev.), aff’d, 819 Fed. Appx. 932 (Mem) (Fed. Cir. 2020), with the identical cropped Table in Defendants’ Proposed Findings of Fact at 71, ¶280 (Feb. 14, 2020) (ECF No. 373), with the uncropped original Kurabayashi Table. Kasanoff Decl., Exh. “F”, at 3.

Then we get to Dr Heinecke, who literally does not believe his own statistical interpretation construct for ApoB in Kurabayashi. When questioned whether there was a difference in the LDL cholesterol effects between EPA and control groups in the same group of patients studied in Kurabayashi (Table 2), he acknowledged that he needed an intergroup comparison test to tell if there is a statistically significant, meaningful difference between the two groups. This is exactly the same reasoning that demands the application of the intergroup statistical comparison test for assessing the differential ApoB effects of EPA versus control illustrated in Table 3 Kurabayashi.


With specific regard to ApoB effects, Dr. Heinecke conveniently abandons the need for inter-group statistical comparison because it does not suit his construct, and quite tellingly, the Defendants cropped out evidence for this non-significant statistical comparison (clearly labeled as such) in the Table 3 legend prior to the post-trial submission of fact.

We illustrate the following deposition interchanges between Mr. Sipes and Dr. Heinecke as evidence of the analytical disingenuity:

(1) Dr. Heinecke unequivocally acknowledges that a comparison must be made directly between (and not within) the EPA and control groups to determine what the effect of EPA alone would have been on LDL. Excerpts from Transcript of July 17, 2019 Deposition of Dr. Heinecke at 8, 02:04 (Sept. 13, 2019) (ECF No. 264-3).

(2) Dr. Heinecke admits that sometimes variables can drift statistically significantly over time by random chance, a phenomenon well recognized by him and others and called “regression to the mean”. Hence the need for between group comparison. Excerpts from Transcript of July 17, 2019 Deposition of Dr. Heinecke at 8, 02:05 (Sept. 13, 2019) (ECF No. 264-3).

(3) Dr. Heinecke then falls on his own sword. He finally admits that the statistical description in the legend of Table 2 is correct as shown, and is vital to his interpretation regarding differences in LDL between EPA and control groups (a courtesy Defendants correspondingly denied this Court by cropping out the intergroup statistical comparison descriptors in the Table 3 legend, thereby obscuring the non-significant results (shown in the cropped Table 3 Kurabayashi as “NS”). Excerpts from Transcript of July 17, 2019 Deposition of Dr. Heinecke at 8, 02:06-02:07 (Sept. 13, 2019) (ECF No. 264-3).

Finally, Dr. Heinecke admits at 2:07 that there was NO statistical difference between the EPA and control groups with respect to LDL (despite individual reductions in both EPA and control groups that were both statistically significant) because the intergroups comparison that he made from the table statistics (using Student’s unpaired t-test comparisons -shown as †p in the Table 3 legend Kurabayashi) was NON-SIGNIFICANT. It becomes obvious that Dr. Heinecke does not believe that his own construct for ApoB analysis is the correct statistical technique.

Knowing this, the essential question remains why is this same statistical analysis of intergroups difference not employed in assessing ApoB effects of EPA vs. Control in Table 3? After all, this was the same group of patients subject to the same randomization assignments to EPA and EPA +E, analyzed for both ApoB and LDL changes. The inescapable conclusion is that it did not suit Defendants’ case construction for obviousness to employ the correct analysis, and thus the expert witness, Dr. Heinecke’s testimony, is tainted by deliberate misrepresentation through statistical manipulation.

Defendants proclaim that the above contentions are “outrageous and libelous”. Defendants need to remember, however, that truth is an absolute defense to defamation, especially where, as here, EPADI II has outlined the factual basis for the conclusions reached. Curtis Pub. Co. v. Butts, 388 U.S. 130, 151–52, 87 S. Ct. 1975, 1989–90, 18 L. Ed. 2d 1094 (1967); Price v. Stossel, 620 F.3d 992, 1004 (9th Cir. 2010); Oracle USA, Inc. v. Rimini St., Inc., 6 F. Supp. 3d 1108, 1131 (D. Nev. 2014). EPADI II has the truth on its side.

POINT V
EPADI II IS NOT RELITIGATING AMARIN’S FACTUAL ARGUMENTS ABOUT STATISTICAL SIGNIFICANCE, BUT RATHER, SEEKS TO VACATE THE
JUDGMENT ON GROUNDS OF MISTAKE PURSUANT TO RULE 60(b)(1)

Defendants erroneously claim that intervention is futile because EPADI II’s Rule 60 motion is attempting to relitigate Amarin’s factual arguments about statistical significance. Defendants are again wrong. Rather than relitigating Amarin’s factual arguments about statistical significance, EPADI II seeks to vacate the Judgment on grounds of Mistake pursuant to Rule 60(b)(1).

Not until after publication of the Judgment, did anyone learn that this Court mistakenly relied upon the conclusion in Mori that the increase in LDL-C with DHA compared with control and the non-significant increase in LDL-C with EPA compared with control imputed a difference between DHA and EPA effects on LDL-C. Amarin Pharma, 449 F.Supp.3d at 1007. The Court’s reliance upon Mori was mistaken, because the Mori authors made a common but fatal statistical mistake in failing to conduct the obvious and necessary direct comparison of the change in LDL-C between the EPA and DHA treatment groups. Mori did not include this critical comparison necessary to determine whether the effects of DHA and EPA on LDL cholesterol change were truly “differential”.

The Court also mistakenly relied upon Defense Expert Dr. Heinecke’s disingenuous interpretation of Kurabayashi in reaching the erroneous conclusion 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.” Id. at 990. The Court’s conclusion as well as its reliance upon Kurabayashi was mistaken because Dr. Heinecke’s interpretation of Kurabayashi (on which the Court relied) contained a fatal statistical error, which, if identified, would have contravened the erroneous conclusion that the lowering of Apo B by EPA was already demonstrated as obvious.

A District Court has the discretion to correct a judgment for mistakes made by the judge. Fid. Fed. Bank, FSB v. Durga Ma Corp., 387 F.3d 1021, 1024 (9th Cir. 2004); Kingvision Pay-Per-View Ltd. v. Lake Alice Bar, 168 F.3d 347, 350 (9th Cir. 1999); Bayview Loan Servicing, LLC v. Trejo, 2019 WL 6134471 at *1 (D. Nev. 2019); Finley v. Nevada, 2015 WL 8490928 at *1 (D. Nev. 2015). This includes both mistakes of law, and mistakes of fact. San Luis & Delta-Mendota Water Auth. v. U.S. Dep't of Interior, 624 F. Supp. 2d 1197, 1208 (E.D. Cal. 2009), aff'd sub nom. San Luis & Delta-Mendota Water Auth. v. United States, 672 F.3d 676 (9th Cir. 2012).

A mistake warranting vacation of a judgment occurs “where the court changes its mind because it made a legal or factual mistake in making its original determination.” U.S. ex rel. Guardiola v. Renown Health, 2017 WL 6886075 at *1 (D. Nev. 2017) (quoting Blanton v. Anzalone, 813 F.2d 1574, 1576 n.2 (9th Cir. 1987)). This is what EPADI II is pursuing, not relitigation of Amarin’s factual arguments about statistical significance.

CONCLUSION
For the reasons above, Intervenor EPADI II again respectfully requests that the Court permit EPADI II to intervene in this matter pursuant to Rule 24, for purposes of filing and adjudicating its companion Motion seeking to vacate the Judgment pursuant to Rule 60.

Dated: April 8, 2021 /s/ Michael S. Kasanoff
Michael S. Kasanoff, Esq. (pro hac vice pending
- attorney has complied with LR IA 11-2)
MICHAEL S. KASANOFF, LLC
9 Stillwell Street
Matawan, NJ 07747
Tel: (908) 902-5900
Fax: (732) 741-7528
E-mail: mkasanoff@att.net

Jakub Medrala, Esq. (Nev. Bar No. 12822)
THE MEDRALA LAW FIRM, PLLC
1091 South Cimarron Road - Suite A-1
Las Vegas, NV 89145
Tel: (702) 475-8884
Fax: (702) 938-8625
E-mail: jmedrala@medralalaw.com

Attorneys for Intervenor
EPA Drug Initiative II (“EPADI II”)
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