Biotech General Discussion

On April 12, 2021 AMRN announced that its long-time president and CEO, John Thero, will retire on August 1, 2021. Thero will be replaced by Karim Mikhail, who joined AMRN in 2020 as head of commercial for Europe. Appointing the head of Commercial for Europe maybe sends a message about where AMRN sees the bulk of its future revenue. AMRN under Theros failed to this point, to successfully use its patents to block generic competition for Vascepa following its label expansion and highly successful Reduce-It trial.

Regardless, Karim inherits the almost completed/lost initial ANDA (generic drug) patent litigation related to Vascepa's initial indication of severe hypertriglyceridemia related to the Marine trial, and the more recent (Nov 2020) patent infringement lawsuit that AMRN filed against Hikma and now the insurance provider, Health Net. In the initial lawsuit, which AMRN lost at the district court and appellate court (Federal Circuit) level, the Supreme Court will almost certainly deny AMRN's request for them to review the case (writ of certiorari filed on 2/17/21) because the Federal Circuit panel did not even feel the case was close enough for them to issue a written opinion, and then the en banc (all active judges) Federal Circuit denied AMRN's request for en banc review.

As far as the second case (filed last November), in this patent infringement case, AMRN alleges that Hikma and now Health Net, infringe patents from a patent family that AMRN licenses from Mochida, a patent family related to the Reduce-It trial, and another family related to the Marine trial. While the filing of this second patent infringement lawsuit was not a surprise to me or the subscribers to my prior subscription service, this is a highly complex patent law situation. For investors interested in AMRN, I recommend that you check out my video presentation HERE, that explains the differences between the first patent litigation against generic companies, and the second AMRN patent litigation against the generic company Hikma.

It is quite an unusual patent lawsuit in my 20 yrs experience as a patent attorney, although I have not specifically researched the topic, in that a biopharma patent holder added an insurance company as a co-defendant in a biopharma method of use patent lawsuit. Indeed Health Net has filed a Motion to Dismiss alleging that it is simply a payor following federal and state laws regarding offering to pay for generic drugs, and AMRN did not plead sufficient facts that it actually induces anyone to infringe the asserted patents (See Health Net's Opening Brief dated March 18, 2021 in support of its motion to dismiss (attached)). A hearing is scheduling on Health Net's Motion and other motions (e.g. Hikma's Motion to Dismiss) in May. I plan to publish an article before that date regarding whether Health Net has a chance to win on this Motion and get out of this litigation without much cost/effort. Check out our Vascepa litigation IQ card for more litigation history, or the AMRN BPIQ company page for upcoming catalyst dates.

#AMRN #Vascepa #patent #patent_lawsuit #Hikma