Amarin Corp Plc (AMRN)

[cmm3rd]

Insurance companies will always insist on the generic no matter what the intent is simply because they don't care. Whatever is the cheapest. I'm also told that at least 29 states require generic substitution "no matter what". It's an uphill battle for sure.

In my (personal and unprofessional) opinion, Amarin should consider doing the following:

First, send carefully drafted letters to all generic manufacturers who are in line to market generic IPE demanding that they not facilitate infringement of Amarin's CVD risk reduction patents and that prudence and ordinary care require that they take various (specified), affirmative steps to avoid doing so. Those steps would include that all product literature, and their label, advise that generic IPE has been approved only for severe hypertriglyceridemia, and not for CVD risk reduction, and that under no circumstances should generic IPE be prescribed for CVD risk reduction, which indication is protected by a federally issued patent, with the consequences for doing so including potential liability for infringement damages (and enhancement, in the event of a willfulness finding).

Second, draft similar letters to all pharmacy companies/PBMs, adding that they should not dispense generic IPE unless the prescriber specifies that (1) the indication is for severe hypertriglyceridemia, and (2) the prescription authorizes generic substitution. I would also start researching whether a pharmacy and/or an insurance company could have legal exposure for its role in aiding in patent infringement once placed on notice that its conduct will facilitate such infringement.

Third, draft similar letters to all insurance companies demanding that they not facilitate patent infringement by insisting on generic substitution under circumstances where such substitution would likely result in patent infringement.

Fourth, prepare a draft complaint for filing in federal district court suing all states that have mandatory, broad generic substitution laws and seeking a declaratory judgment that such statutes would violate Art. VI, para 2, of the Constitution (and any applicable federal statute) as applied in the case of Vascepa because in 90% of instances such dispensing would violate federally issued patents.

Fifth, enlist the support of Pharma and other trade groups, including joining in prospective litigation against states that have broad, mandatory generic substitution laws that facilitate infringement.

Sixth, send 1-4 to Hikma's and Teva's counsel (and the other Vascepa ANDA filer's counsel) with a deadline for arriving at a suitable settlement that fairly reflects the anticipated market share of the MARINE indication, after which deadline, if no settlement has been reached, Amarin will proceed with whatever litigation it deems appropriate, and which may include, inter alia, filing of the complaint against the states seeking invalidation of their statutes to the extent such statutes facilitate violation of federally-issued patents.

Hikma, et al would have to make a judgment call. Settle (for what the law entitles them, given their "victory") or risk their business model.

I know it's not this simple, and that relationships with insurance companies and pharmacies are sensitive and important. But at a certain point, where the drug is in demand, pharmacies are going to want the business. I suspect the relevant legal considerations, and commercial and legal leverage points, are complex. But Amarin should carefully look at this, imo. It may be that relevant law would preclude some or all of the above, but I would want a thorough opinion re each.