Replies to post #230632 on Amarin Corp Plc (AMRN)

[Atom0aks]

Has Congress ever provided the FDA ANY statutory authority to decide questions related to patent validity, with its decision to be final and subject to appeal to the Federal Judiciary?

I always thought Congress gave/deposited such statutory authority ( Per Article I, Section8 , clause 8, of the U.S. Constitution) solely within the PTO, with jurisdiction provided to the Federal judiciary to review said PTO decision. I am familiar with the more recent Patent Acts enacted after the 1952 Patent Act, 35 U.S.C. 101-103 et al, as well as 35 U.S.C. 141-146, 271 et al and amendments thereto.

I am aware of one statutory provision whereby the PTO may request the FDA for an opinion on certain questions arising under 35 USC 101 and/or 112. I am not aware/convinced you have complied with requisites of that statutory provision. Any FDA recommendation to the PTO under that provision is not a final decision; it is not binding on the PTO, in any event.

I am also aware that the ITC( the old Tariff Commission)has been provided with ALJ and Commission jurisdiction to decide questions related to patent validity and infringement. As above, I also am not aware you have complied with the requisites of those provisions; are you asserting you are an unnamed agent of the parties currently before the Supreme Court?

Under the circumstances, what difference does it make what docket of FDA your CP is under? The 2013 CP was filed late; do you assert the 2019 CP asks for relief materially different from the 2013 CP and also complies with any statutory requisite that necessitates/obliges an answer from FDA?

I am reminded of actions taken by patent trolls in the past. Remedies to those aggrieved by actions of such trolls do exist.

Sorry, I am not a lawyer. Are you sure you are responding to the right post?

[Biobillionair]

North-

Remedies to those aggrieved by actions of such trolls do exist.

There are several remedies that can be taken for someone the submits a Citizen Petition under false pretenses; especially when the filer provides false information.

BB

[sts66]

Not quite sure why you kept referring to "you", as if A-0aks was involved in the CPs himself - he's not, he just posted links to CPs filed by others.

Per "do you assert the 2019 CP asks for relief materially different from the 2013 CP", not sure he mentioned that either - but I sort of did. The 2013 CP was filed by AMRN asking for a patent extension - MRC's 3 CPs were filed against AMRN, and IIRC AMRN even responded to one of them in some manner, although it's up to the FDA to make the decisions on how to respond, and they've already denied the CP (on procedural grounds) in which MRC wanted them to remove the '146 patent from the Orange Book - the CP process is not the correct avenue to challenge Orange Book patents:

Because your request disputes the appropriateness of listing the ’l46 patent and urges FDA to
remove it from the Orange Book, your request is subject to the procedures and requirements set
forth in our regulations at § 314.53(f). Submission of your request to FDA in a citizen petition
does not comply with those procedures, and we are unable to resolve your concerns in a citizen
petition response. Therefore, your citizen petition is denied without comment on the merits of
the petition’s statements regarding the ’ 146 patent. 13