Amarin Corp Plc (AMRN)

[MedResCollab]

Citizen Petition Submission no.3

CITIZEN PETITION

Medical Research Collaborative, LLC submits this petition under 21 C.F.R. § 10.30 and 21 C.F.R. § 10.31 of the Federal Food, Drug, and Cosmetic Act (FDCA), to request that the Commissioner of Food and Drugs (Commissioner) take the actions identified in section A below.


A. Actions Requested

Medical Research Collaborative respectfully requests that the Commissioner have Amarin Corp.’s U.S. Patent No. 8,188,146 (the ‘146 patent) removed from the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, for being improperly listed therein.

B. Statement of Grounds

Title 21 U.S.C. § 355(c)(3)(D)(ii)(I) (for 505(b)(2) NDAs); id. § 355(j)(5)(C)(ii)(I) (for ANDAs), states that an applicant “may assert a counterclaim seeking an order requiring the [patent] holder to correct or delete the patent information submitted by the holder . . . on the ground that the patent does not claim either—(aa) the drug for which the application was approved; or (bb) an approved method of using the drug.” Amarin Corp.’s U.S. Patent No. 8,188,146 (the ‘146 patent) does not claim an approved method of using the drug, promotes unapproved uses, and in fact eschews the only approved use for icosapent ethyl (aka “Vascepa”), namely, to treat hypertriglyceridemia. Further, its claims describe a product that is impossible to make, relying on the judicial exception of an abstract idea, and is materially different from the manufactured and sold drug, “Vascepa.” ...

https://www.regulations.gov/document?D=FDA-2019-P-3265-0001

You may comment on the content of our petition submission by selecting the “Comment Now” button per the above link.

Regards,
-MRC Team