AMRN - Key Court Decisions Imminent
6/21/21 Update. As was predicted by Dr. Vacchiano in his article below on BPIQ.com, the Supreme Court DENIED AMRN's Petition for Cert. This means that the U.S. Supreme Court will not review the affirmation of the Federal Circuit of the Nevada District Court's ruling that AMRN's asserted patents were invalid. This is the end of the road and confirmed loss for AMRN for Case 1 and the patents asserted in the ANDA litigation. However, keep in mind that there is the very active recent patent infringement lawsuit of AMRN against Hikma and Health Net (Case 2 below) as well as the important case of GSK vs. Teva (Case 3 below), which has an imminent ruling on the rehearing.
ORIGINAL ARTICLE
There are two near-term decisions in pending patent lawsuits that are relevant to AMRN:
A) The Supreme Court decision of whether to review (i.e. grant cert) the appellate court's affirmance of the Nevada district court's decision that the AMRN patents were invalid, in the initial AMRN ANDA case against several generic manufactures for the initial severely elevated triglyceride indication; and
B) A decision and opinion(s) on the appellate court panel's rehearing of the GSK v. Teva case (AMRN is not a party to this litigation) that shares a number of facts with AMRN's recent Delaware litigation.
C) There is another decision that we now await too, which is the Delaware court's decision on whether to dismiss or sever AMRN's case against Health Net, after the oral hearing in late May. However, that decision is likely not as imminent as the Supreme Court and paten rehearing decisions noted above.
To step back, as we previously indicated, we are monitoring 3 cases that are relevant to AMRN and its ability to inhibit generic company's in their launch and marketing of generic icosapent ethyl. Below, we list those cases as well as their relevance to AMRN and our current thoughts on most likely outcomes.
CASE 1) The initial ANDA (generic drug) litigation of AMRN vs. various generic companies (Dr. Reddies and Hikma) in the District of Nevada (filed in 2019) where AMRN lost (held invalid) its asserted patents (a number of severely high triglyceride patents); AMRN's defeat was affirmed by a Federal Circuit appellate court panel;
STATUS: Pending decision by Supreme Court whether to review (i.e. grant cert) the decision in the case (For more info on the history of this case; See our 5/9/21 update HERE and our IQ Card for these litigations)
TIMING OF PENDING DECISION: Supreme Court cert decision above should be released on Monday morning, June 21 at 9:30 AM Easter1
IMPACT ON AMRN: If the Supreme Court granted cert for (agreed to review) the prior AMRN case, that would be great news for AMRN; This would likely be a major lift to AMRN's stock price; Then it would come down to how the Supreme Court decides in the future.
LIKELY OUTCOME: Highly unlikely that Supreme Court will grant AMRN's motion to review the case; To use a football analogy, I would consider this a hail Mary pass with time running out; In March, the Supreme Court requested that the generics file a Response, which was a bit surprising to me, but it is still highly unlikely that the Supreme Court will grant cert (agree to review) the prior decision in this case. See our prior BPIQ.com forum article HERE for our reasoning.
Case 2) The most recent lawsuit filed by AMRN against Hikma, the first generic drug company to launch generic Vascepa (icosapent ethyl), and Health Net, a health insurance provider;
STATUS: Pending decision by Delaware Court on whether to grant Hikma and/or Health Net's Motions to dismiss and/or sever the case against Health Net from the case against Hikma; See our 5/9/21 update HERE and our IQ Card for these litigations)
TIMING OF PENDING DECISION: We are currently unsure - initially we estimated July 26, 2021, 60 days from the oral hearing
IMPACT ON AMRN: If court granted either company's motion to dismiss that would be a bad defeat for AMRN unless it was on a technicality that AMRN could easily fix; If the court grants Health Net's motion to sever that would a be bad for AMRN because they could NOT continue to put the immediate pressure on Health Net in the courts, and a decision re: insurance companies activities in skinny label biopharma patent lawsuits would be delayed by years more
LIKELY OUTCOME: Extremely likely that AMRN wins against Hikma's Motion to Dismiss; and very likely that AMRN wins against Health Nets Motion to Dismiss and Motion to Sever: It is likely that AMRN has pled sufficient facts for its infringement theories, and thus it appears to pass this first very low bar to keep the case pending against Hikma (to use the analogy above against AMRN, this is a Hail Mary by Hikma); Regarding Health Nets motions, I think it is likely that Health Net loses, but this is a bit closer. The biggest challenge in this case for AMRN will be proving that Health Net meets the pretty strict legal requirements for induced infringement despite their skinny label (See my prior post on this litigation for more information); Regarding Health Net's motion to sever, although I have not reviewed the requirements for Motions to Sever recently, my current view is that the chances are slightly above their Motion to Dismiss, but both of these are NOT likely to succeed because the same patents are asserted and many of the facts are the same regarding the market use of Vascepa for their super high triglyceride indication vs. their the much larger reduce Reduce It cardiovascular risk reduction.
Case 3) A lawsuit filed by GSK against the generic company Teva, for its generic version of GSK's heart drug Coreg®, that shares a number of facts and legal theories to the AMRN Delaware case.
STATUS: Pending appellate Federal Circuit panel rehearing decision and likely precedential written opinion on whether jury had sufficient grounds to decide that Teva infringed GSK's patents, especially the '000 reissue patent during the "partial label period" (See our 5/9/21 update HERE and our IQ Card for these litigations). The initial decision yielded huge debate in biopharma patent law circles and many Amici briefs, which likely was a prime motivation for the grant of the Petition for rehearing, which is pretty rare;
TIMING OF PENDING DECISION: Since we are more than 3 months since the oral arguments (Feb 23, 2021), it is our understanding that this decision and associated opinion(s) could come out any day now;
IMPACT ON AMRN: There are a number of possible outcomes and each will have varying degrees of positive or negative impacts on AMRN.
Best outcome for AMRN; Judgment and opinion very similar to the initial judgment opinion to reinstate the jury's ruling in favor of GSK; In the initial Federal Circuit decision by this panel (which is now vacated (no precedence)) the 2 judge majority provided a very strong decision and opinion in favor of the patent holder (GSK), which was very good precedent for AMRN. It reinstated a jury's decision that GSK induced infringement of the GSK patents during Teva's generic's partial label and full label periods. The decision concluded that the jury had enough evidence given the legal infringement analysis to find that Teva's partial label, which did not list all the indications in GSK's label, along with their press releases, AV rating and other activities induced infringement of GSK's patents.
Worst outcome for AMRN: The jury's verdict is NOT reinstated, and the court holds that as a matter of law, Teva could not have induced infringement by its partial label, press releases, AD rating and other activities.
Possible more neutral decision for AMRN; The court clarifies that this is not a Skinny label case, but the fact that label taught all the claim limitations, was a key factor in again reinstating the jury's verdict.
LIKELY OUTCOME: This is a close call in my view but I give an advantage in favor of GSK. However, it is more possible that the majority opinion in favor of GSK might be similar to the neutral decision above, which is not nearly as favorable to AMRN as the original, now vacated decision. This is the same 3-judge panel (Judge Probst (chief judge of the court and disagreed with majority in initial now vacated. opinion/decision), Judge Newman (PhD judge who is very pro-pharma/science and wrote strongly favorable initial majority decision/opinion) and Judge Moore (cast the deciding vote in favor of GSK in initial decision). From the oral arguments, it is likely that Judge Newman votes again in favor of GSK, and likely writes an opinion that is similar to her initial opinion (which will at least be a dissenting opinion here that is highly favorable precedent for AMRN); The question is whether Chief Judge Probst or Judge Moore changes their decision from the now-vacated initial decision. The question on this appeal is whether the jury had substantial evidence to support its verdict that Teva infringed GSK's patents. Both Judge Probst and Judge Moore probed the party that was on the wrong side of their initial decision pretty hard at oral arguments. The fact that this could be qualified as NOT a skinny label case, but as a partial label case, I think will give Judge Moore more confidence to again decide in favor of GSK, and/or (less likely) will sway Judge Probst in that direction.
By Manny Vacchiano, JD, PhD
US registered patent attorney
This article is NOT legal advice or investment advice and is not the position of Double Helix Law, LLC. It provides some of the personal viewpoints of Dr. Vacchiano. Please use it as a starting point for your diligence.
Footnotes;
1) (Case was distributed for conference for June 17 (See Supreme Court docket for case HERE); Then see timing of announcement of Supreme Court conference decisions (See HERE); But note that there are some reasons that the Sup Ct may not make a cert decision on this date, although it seems very likely that they will.
#AMRN #Vascepa #Hikma #icosapentehtyl #GSK #HKMPF #RDY