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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Julius Wong who wrote (51004)	7/28/2019 1:27:57 PM
From: quidditch	Respond to of 52153

Thanks, Peter, and (for your cheerleading! ): lol) Julius. Did some digging into AMRN 10-K. I find it well written and pretty comprehensive, esp. the Risk Factors, where the patent situation/regulatory framework for challenges under Hatch Waxman are laid out pretty clearly starting a p. 34 here: investor.amarincorp.com So it seems that January 20, 2020 or so in DCNV will be a watershed of sorts, unless proceedings are extended, relating to the 30-month stay and whether the Court concludes AMRN's patent position entitles Vascepa to continuing exclusivity and in effect renders the stay moot (if I have it right). The settlement entered into with TEVA under which it agrees to forego competition with its V generic until August 2029 is a positive; whether it is instructive for the continuing litigation reverts back to the patent portfolio and whether it builds a moat of exclusivity. The listing of AMRN patents is set forth below (sorry for the formatting), and this does not necessarily correspond with Orange Book Listing: it's way, way beyond my knowledge and abilities to piece together whether these claims collectively, let alone individually, entitle V to such exclusivity such as to prevail. We have prosecuted, and are currently prosecuting, multiple patent applications to protect the intellectual property developed during the Vascepa development program. As of the date of this report, we had 79 patent applications in the United States that have been either issued or allowed and more than 30 additional patent applications are pending in the United States. Such 79 allowed and issued applications include the following: • 2 issued U.S. patents directed to a pharmaceutical composition of Vascepa in a capsule that have terms that expire in 2020 and 2030, respectively; • 1 issued U.S. patent covering a composition containing highly pure EPA that expires in 2021; • 43 U.S. patents covering or related to the use of Vascepa in either the MARINE or ANCHOR populations that have terms that expire in 2030 or later; • 11 U.S. patents covering or related to the use of Vascepa in the REDUCE-IT population with terms expiring in 2033 or later; • 4 additional patents related to the use of a pharmaceutical composition comprised of free fatty acids to treat the ANCHOR patient population with a term that expires in 2030 or later; • 2 additional patents related to the use of a pharmaceutical composition comprised of free fatty acids to treat the MARINE patient population with a term that expires in 2030; • 3 additional patents related to the use of a pharmaceutical composition comprised of free fatty acids to treat the REDUCE-IT population expiring 2033; • 1 additional patent related to a pharmaceutical composition comprised of free fatty acids and uses thereof to treat both the MARINE and ANCHOR patient populations with a term that expires in 2030; • 1 additional patent related to the use of a pharmaceutical composition comprised of re-esterified EPA triglyceride to treat the REDUCE-IT population expiring 2033; • 3 additional patents related to a formulation of EPA/DHA and uses thereof with a term that expires in 2030; • 2 additional patents related to the use of Vascepa to treat obesity with a term that expires in 2034; • 2 additional patents covering a pharmaceutical composition comprised of EPA and a hydroxyl compound with a term that expires in 2034; and • 4 additional patents covering a new combination therapy comprised of EPA and another drug. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. A Notice of Allowance does not afford patent protection until the underlying patent is issued by the USPTO. No assurance can be given that applications with issued notices of allowance will be issued as patents or that any of our pending patent applications will issue as patents. No assurance can be given that, if and when issued, our patents will prevent competitors from competing with Vascepa. For example, we may choose to not assert all issued patents in patent litigation and patents or claims within patents may be determined to be invalid. We are the owner of the above-listed patents. We are also the exclusive licensee of certain patents owned by others covering products in development. To secure our debt under our outstanding royalty-like instrument, we have granted the holders of such instrument a security interest in our Vascepa-related patents.