Biotech General Discussion

Earlier today, AMRN filed a patent infringement lawsuit against Hikma who earlier this month launched their generic version of icosapent ethyl (Vascepa) (see header image below and complaint attached). In its complaint (attached), AMRN asserted 3 U.S. patents, 9,700,537 (exclusively licensed by AMRN from Mochida), 8,642,077 (owned by AMRN), and 10,568,861 (owned by AMRN). To any of our Amp Patent Investor+ subscribers (sign up here today, to get an experienced patent attorney's deep insights), this will not come as much of a surprise, since our October update, for example, indicated that our view was that it was not if, but when AMRN would file their next patent infringement lawsuit against Hikma, after they launched their generic version of icosapent ethyl. We also noted this future likelihood on our updates to our AMRN company pipeline page for free members of our site. See our AMRN page here: https://bit.ly/37hMSPu. See our freely available catalyst card for the AMRN generic litigation and generic sales monitoring here. Note that the original patent litigation of AMRN against generic companies including Hikma was an ANDA patent litigation asserted some of AMRN's patents covering use of icosapent ethyl to treat severe (>=500 mg/dL) hypertriglyceridemia, whereas this latest litigation is a patent infringement lawsuit (not an ANDA lawsuit per se), asserting some of AMRN's Orange Book patents that it added this year, which are not limited to severe hypertriglyceridemia. These patents were some of those added after Vascepa's cardiovascular risk reduction indication (Reduce-It trial) was added to its label in December 2019.

We have made all of my prior Patent Investor+ presentations about the prior AMRN vs. Hikma et al. ANDA litigation available to Amp users with a free sign-up so that you can learn from these and assess the quality of my analysis. I especially encourage you to check out my October update presentation/video (AVAILABLE HERE), which is now available on our site with free signup, to better understand why AMRN's loss of its initial ANDA litigation presented a difficult challenge for AMRN even with respect to patents like those asserted in the present lawsuit, as well as an introduction to the recent Federal Circuit Glaxo v. Teva decision that provides some hope to AMRN. Keep in mind that the present lawsuit is an induced infringement lawsuit where Hikma has a skinny label, which is intended to protect against induced infringement of indications that are not listed on the label. You can read AMRN's complaint (attached below) to see the initial evidence they point to in their assertion that Hikma is inducing infringement of the asserted patents.

I plan to provide another detailed update for Patent Investor+ subscribers this week, with my initial thoughts on this new patent litigation and more info on the recent Glaxo decision that investors need to understand. Patent litigation is extremely complex and AMRN's share price will likely continue to be greatly impacted by its patent litigation events/results. Thus, if you are an investor in AMRN, you should assure you get informed from an experienced patent attorney. Consider signing up for our Patent Investor+ subscription (HERE) to get my deep insights into this latest AMRN litigation, for a monthly fee that is less than an hour of a biotech patent attorney's time.

While you are on our Amp site, check out our free catalyst calendar (AVAILABLE HERE), now with catalysts for AMRN and over 100 other small and mid-cap biopharma companies, with more being added daily. And we include cards with a growing amount of information about the specific drug candidate too, to help expedite your diligence.

Best of luck to you in your investing in biopharma.

Manny