Replies to post #294370 on Amarin Corp Plc (AMRN)

[HDGabor]

W-

Can you please elaborate on the "regulatory exclusivity" definition? Does it mean that only one company (i.e., Amarin) can sell pure EPA drug legally in the EU market? Or it's the exclusivity of the drug itself, i.e., pure EPA for the RIT indications regardless of which brand?

Only one company (i.e., Amarin) can sell pure EPA drug legally in the EU market for R-IT indication. Article 14(11) of Regulation (EC) No 726/2004:

Medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.

Data exclusivity = Period of time during which an applicant cannot rely on the data in support of another marketing authorisation for the purposes of submitting an application, obtaining marketing authorisation or placing the product on the market, i.e.: generics, hybrids, biosimilars cannot be validated by the Agency

Market protection = Period of time during which a generic, hybrid or biosimilar cannot be placed on the market, even if the medicinal product has already received a marketing authorisation.

I am not convinced that patents will be enough to protect Amarin in OUS IF this appeal is a loss for Amarin

Patents for OUS (both MARINE and R-IT) are independent from patents (MARINE) for the US ... but agree: I am not sure patents (for OUS) will not be invalidated ... especially if CAFC affirm DC.

Best,
G

ps: I did not checked / DD'd ... Could a Co. (other than Amarin) request EMA approval for MARINE indication based on MARINE trial / data or do not ...?