Replies to post #230441 on Amarin Corp Plc (AMRN)

[rafunrafun]

A - Below are your quotes:

4) you, today:

There are two remaining CPs, one of which is related to the sNDA.

3) you, yesterday:

Currently, there are two citizen petitions still open that were submitted by MRC.

2) you, yesterday:

Again, the other two CP he submitted, one of which does pertain to the sNDA (submitted 7/17/19), are still pending.

1) you, yesterday:

The other two CP he submitted, one of which pertains to the sNDA (submitted 7/17/19), are still pending.

Is there a point that you are trying to push?

[sts66]

No, only one remaining unanswered CP from MRC, the one about MO - the one where he tried to get V classified as a DS was filed after a deadline had passed and was rejected. I don't seem to have saved the letter PDF from Janet (or can't find it), but I'm pretty sure BB knows where it can be found online. Might have been sent to another government agency and not to MRC.

Found it - but now I'm confused at why FDA issued a new CP denial letter over the '146 patent since Janet told the USPTO time to file a CP had elapsed:

https://www.regulations.gov/contentStreamer?documentId=FDA-2013-E-0780-0006&attachmentNumber=1&contentType=pdf

Patent No. 8,188,146
Docket No. FDA-2013-E-0780
The Honorable Andrei Iancu
Under Secretary of Commerce for Intellectual Property and
Director, United States Patent and Trademark Office
Mail Stop Hatch-Waxman PTE
JUL 05 2019

Dear Director Iancu:

This is in regard to the patent term extension application for U.S. Patent No. 8,188,146 filed by
Amarin Pharmaceuticals Ireland Limited under 35 U.S.C. § 156. The patent claims VASCEPA
(icosapent ethyl), a human drug product reviewed in new drug application (NDA) 202057.
In the February 13, 2018, issue of the Federal Register (83 Fed. Reg. 6192), the Food and Drug
Administration published its deterrnination of this product's regulatory review period, as required
under 35 U.S.C. § 156(d)(2)(A). The notice provided that on or before August 13, 2018, 180
days after the publication of the determination, any interested person could file a petition with
FDA under 35 U.S.C. § 156(d)(2)(B)(i) for a determination of whether the patent term extension
applicant acted with due diligence during the regulatory review period.

The 180-day period for filing a due diligence petition pursuant to this notice has expired and
FDA has received no such petition. Therefore, FDA considers the regulatory review period
determination to be final.

Please let me know if we can provide further assistance.

Sincerely yours,
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research