Replies to post #378110 on Amarin Corp Plc (AMRN)

[Meowza]

Here I'll paraphrase: there was a lot of numbers, it was a trial by combat of the experts, which is what we all should want after public market fortunes were risked on a groundbreaking therapy. The judge retconned all that with a lit review so quit being a sore loser.

[I didn't read the article, I'm speculating solely on marjac's "Hikma's spokesman" comment]

[marjac]

It's in there. Lower left corner. A PDF file. But here it is too:

Justices Told Fraud Tainted Vascepa Patent Invalidations
By
Dani Kass
Law360 (May 19, 2022, 6:54 PM EDT) -- A group made largely of Amarin shareholders has asked theU.S. Supreme Court to override the invalidation of patents covering the company's blockbuster cardiovascular drug Vascepa, claiming both a Nevada federal judge and the Federal Circuit allowed fraud within the case.
EPA Drug Initiative II's petition on Monday argues it was wrongly forbidden from intervening in the patent suit between Amarin and generic-drug makers Hikma and
Dr. Reddy's, and that its evidence of fraud during the litigation has not been sufficiently reviewed. The petition, docketed Wednesday, requests summary reversal, in the hopes of restoring Amarin's patents.
"Petitioner is not asking this court to grant certiorari for purposes of changing the law," the petition states, "Petitioner is not asking this court to grant certiorari for purposes of stretching the law. Petitioner is asking this court to grant certiorari for purposes of using its supervisory power to enforce the law. If this court enforces the law, then the grant of certiorari and the entry of a summary reversal, is the inevitable and just result."
The suit starts before EPADI II got involved, with Amarin in 2016 claiming Hikma's generic version of Vascepa would induce infringement of Amarin's patents, and then in 2018 making similar allegations against Dr. Reddy's.
In March 2020, Chief District Judge Miranda M. Du said the generic products would induce infringement, but that the patents are invalid as obvious.
The Federal Circuit summarily affirmed that ruling in September 2020 and refused rehearing.

EPADI II — which describes itself as an "ad hoc group of physicians, patients, Amarin retail shareholders, and other concerned persons" who want to promote the benefits of Vascepa — got involved in March 2021, asking to intervene and vacate the judgment. The district court denied that request, saying the group doesn't have standing, and the Federal Circuit agreed
.
The group claims the generic-drug makers "deliberately cropped" a table in post-trial documents "to disingenuously corroborate [an expert's] misleading expert testimony," according to the petition. The judge then copied that cropped table into her opinion. The fraud included a "a fatal statistical error, which, if identified, would have eviscerated the erroneous" obviousness finding, the group said.
EPADI II cites the U.S. Supreme Court's 1944 decision in Hazel-Atlas Glass Co. v. Hartford-EmpireCo., which deals with when a court can vacate a judgment due to a "fraud on the court."
"The Federal Circuit and the district court disregarded this court's Hazel-Atlas precedent, and allowed a fraud upon the court to go unremedied, on grounds of standing," the petition states. "But if a non-party's interests are directly affected, a nonparty has standing to seek [judgment] relief from a judgment procured by fraud."
The group claims it is financially impacted by a decrease in Amarin's stock price after the judgment, making a concrete injury that justifies standing. And since the group is largely company shareholders, they say they have a stake in the fight for the company to get money back.
"The court should grant certiorari in order to reinforce Hazel-Atlas, and exercise its supervisory power.by providing guidance to the lower courts emphasizing that this court's anti-fraud policies and precedents mean something, and are not to be so cavalierly disregarded, especially where there are devastating, wide-ranging real-world consequences," the petition states.
Alternatively, EPADI II urged the justices to hold that it has standing and remand to the Federal Circuit

Hikma on Thursday was confident about its chances.
"This meritless claim has previously been dismissed by both the district and circuit courts, and we are confident the U.S. Supreme Court will also deny plaintiff's baseless assertions," Hikma spokesperson Steven Weiss said in an email. "Most important, we are continuing to manufacture and provide this important medicine to the millions of patients who need it."
A spokesperson for Dr. Reddy's and counsel for EPADI II declined to comment Thursday. Corporate representatives for Amarin didn't immediately respond to a request for comment.
The patents-in-suit are U.S. Patent Nos.
8,293,728
;
8,318,715
;
8,357,677
;
8,367,652
;
8,431,560
;and
8,518,929
.
EPADI II is represented by Michael S. Kasanoff of Michael S. Kasanoff LLC and Gerald H. Bjorge.
Hikma was represented at the Federal Circuit by Charles B. Klein, Claire A. Fundakowski, Alison M.King and Eimeric Reig-Plessis of
Winston & Strawn LLP
.
Dr. Reddy's was represented at the Federal Circuit by Beth C. Finkelstein and Constance Huttner of
Windels Marx
.
The case is EPA Drug Initiative II v.
Hikma Pharmaceuticals USA Inc
., et al., case number
21-1458
, in the U.S. Supreme Court.
--Editing by Lakshna Mehta.