6/21/21 Update. As was predicted by Dr. Vacchiano in his articles 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. Read below and our Forum post for subscribers for more info.
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. There is another imminent decision that is relevant to AMRN and a pending decision in AMRN's most recent litigation against Hikma (generic) and Health Net (insurance company). For our most detailed discussion of these, including likelihood of success for AMRN, see our forum post (HERE) (requires BPIQ.com subscription - see HERE for free 30-day trial (no credit card) and lock in introductory price under $20/month while it lasts).
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; BPIQ subscribers 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: see our forum post (HERE) (requires BPIQ.com subscription - see HERE for free 30-day trial (no credit card) and lock in introductory price under $20/month while it lasts).
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: see our forum post (HERE) (requires BPIQ.com subscription - see see HERE for free 30-day trial (no credit card) and lock in introductory price under $20/month while it lasts).
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);
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. For more details see our forum post (HERE) (requires BPIQ.com subscription - see home page for free 30-day trial (no credit card) and lock in introductory price under $20/month while it lasts).
LIKELY OUTCOME: See our forum post (HERE) (requires BPIQ.com subscription - see see HERE for free 30-day trial (no credit card) and lock in introductory price under $20/month while it lasts).
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.
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