Replies to post #294381 on Amarin Corp Plc (AMRN)

[Will Lar]

HDG - thanks. Reading the EMA policy, I am still not very clear whether the exclusivity is applied to the product or the company. The paragraph starts wtih products. The only piece of info may make me to think it could be the company that gets the exclusivity is the phrase "the marketing authorisation holder", a singular not plural form. But it doesn't say explicitly that an/the entity can be the only one that markets the product exclusively. I thought policies like this should be very explicit on what can be done and what can not.

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.