Biotech General Discussion

There are two recent developments to report regarding Amarin’s fight to keep generic versions of Vascepa from launching. First, we now find a New Clinical Investigation Exclusivity for Vascepa’s expanded cardiovascular risk indication on Vascepa’s FDA Orange Book listing. This is the indication supported by the Reduce-It trial. It is our understanding that this provides 3 years of exclusivity in which time the FDA will not approve a generic Vascepa for this expanded cardiovascular risk reduction indication. Second, in its Hatch-Waxman (generic drug) Vascepa litigation related to its severe hypertriglyceridemia indication, yesterday, AMRN filed their initial Appeal Brief arguing against the district court invalidity ruling . This article provides a brief update on recent developments in this litigation for retail and institutional investors.

As a reminder, in late March the Nevada district court judge ruled in Amarin's favor that certain proposed generic products would induce infringement of Amarin's asserted patents, which focus on Vascepa's initial FDA-approved indication to treat patients with severe hypertriglyceridemia. However, the court ruled that all of Amarin's asserted patents are invalid over certain prior art. Therefore, this was a big loss for Amarin overall despite the favorable infringement ruling, because if the ruling stands and Amarin's asserted severe hypertriglyceridemia patents are invalid, Amarin could not use them to block these generic Vascepa products from entering the market.

As expected, Amarin appealed the ruling last month. The appeal will be heard by the Federal Circuit, the appellate court that hears all appeals of U.S. district court patent rulings. Amarin reported in its April 30, 2020 investor call, that they and the generic defendants, agreed to an expedited briefing schedule in the hopes of an expedited decision by the Federal Circuit. This could shorten the timeline for an appellate ruling considerably, down from the median 15-month timeline indicated in our previous article in our Amp investor forum. On their April 30, 2020 investor call, Amarin indicated that they expected a ruling in late 2020 or early 2021. We plan to investigate the likelihood that the court will go along with this timeline.

Since Amarin appealed the invalidity ruling, the 60-page brief focuses on only this aspect of the district court's ruling. In mid-June we expect to get the generic company defendant’s response to Amarin's arguments that the judge erred in holding the patents invalid. Next, Amarin will have an opportunity to file a Reply Brief, before a panel of Federal Circuit judges hears oral arguments and later rules on the case. As indicated in our prior article, the case might not end there, depending on the court's ruling, which might send the case back to the district court, and/or whether the parties seek and are granted further appellate review. Regarding a possible cross-appeal by the defendants, seeking review of the infringement ruling against them, from our search of the court dockets and understanding of appellate procedure, the defendants did not and cannot file a cross-appeal at this time because of the invalidity ruling.

Amarin's Appeal Brief that was filed with the Federal Circuit yesterday argues that the district court erred in two ways: 1) the mental process by which the court analyzed so-called secondary factors as part of the prior art obviousness analysis; and 2) the way the court performed its prima facie prior art obviousness analysis, improperly shifting the burden to Amarin. This latter argument focuses on whose burden it was, Amarin's or the defendant's, to establish whether or not a skilled artisan would have expected drugs to treat severe hyperglyceridemia to differently affect LDL-C levels, depending on whether they were administered to a patient with mild vs. severe hypertriglyceridemia.

We are currently analyzing the issues that Amarin raised (and did not raise) in its Appeal Brief, the strength of their arguments, and their likelihood of success. Our Amp tracking hedge fund and I, invest in Amarin and have kept our investment in Amarin despite the district court ruling. We plan to reassess the amount of our investment, after our deeper analysis of Amarin's Appeal Brief. From our initial read, we have NOT changed the amount of our investment. Feel free to contact us if you are interested in retaining our professional legal services, for additional analysis of this litigation.

Manny Vacchiano

U.S. Patent Attorney

Licensed in California and Illinois

Thanks to Dominic Vacchiano and Dr. Michael Mand for their research, and review of this article.

About Manny

Manny splits his professional time as a registered U.S. biotech patent attorney who has been practicing for over 20 years, and founder of AMP, where he leads a team in analyzing and investing in public biopharma companies.

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