Replies to post #89287 on Amarin Corp Plc (AMRN)

[HDGabor]

BB-

The FDA has clearly been defined as the gateway to patent infringement, this is new and is entirely based on Cooper decision.

It isn't new. FDA was always a gateway: ANDA should be received to trigger a Notice Letter (from generic to patent holder). Cooper decision: the case was dismissed due to any received ANDA ... nothing special ...

V will get extended exclusivity depending on when the FDA will receive ANDA referencing V. Generics could file paragraph iv's 6-26-2016...assuming they would be received

- V exclusivity will expire on July 26, 2017. It is independent from ANDAs.
- ANDAs could be filed after 7-26-2016. If the ANDA is complete, FDA does not have any basis to deny, ANDAs will be received -> Notice letter will be sent -> patent claim will be submitted by Amarin

I will file a complaint if "V" receives a paragraph iv prior to 6-2020, and my complaint will be received and acted on.

You could ... Good luck ... The law (again - the law) is very clear: the approval date of the RLD trigger the 4/5 years as the earliest ANDA submission date. The law does not deal with the date of the announcement [of the exclusivity].

Best,
G

ps.: Generics (inc. Watson) should not be informed about FDA no appeal, they could submit the appeal without this information also. btw: we (you) do not have any proof that ALL generics was informed, we know only that Watson received the info ... legally ... but it is history ...

[sts66]

Generic filers will first petition the FDA to receive their applications, prior to initiating legal actions against the FDA

.

What exactly are the steps generic filers have to take? How long does the FDA have to formally accept/receive an ANDA? I searched for the answer and came up blank. How does a filer know FDA is sitting on an ANDA instead of actually reviewing it?