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?