Amarin Corp Plc (AMRN)

[north40000]

Sleven, here is my partial answer to your question. I would file a complaint in a Federal District Court against a generic with two counts:

I. Patent infringement

2. Violation of statutory exclusivity

In FDA.gov, you will find a monograph or infograph entitled “Exclusivity and generic drugs: What does It Mean?”

“Initial Exclusivities for New Drugs

Exclusivity is a period of time when a brand-name drug is protected from generic drug competition. There are different exclusivities for different situations. Exclusivity is designed to promote a balance between new drug innovation and generic drug competition....

A brand-name drug with active ingredient that has been approved before may be awarded a three-year exclusivity in certain circumstances, such as...a different disease or condition the drug can treat is identified. To get this approved, the drug company may conduct new clinical studies in humans......

After exclusivities no longer block generic approval, generics can join the market if:

...Patent protection no longer blocks generic approval.”


Note particularly the portion of the FDA infograph “Orange Book Frequently Asked Questions”, items 1-19, that reference sections of the FD&C Act and 21 C.F.R.

The last sentences of the FDA citation above appear to literally embrace what we are discussing: two exclusivities, one of which has expired, with patent protection remaining for a further indication or condition.

Simple, eh? But I found no explicit answer to the question you pose “Who do you sue.” Above is the only research I have done on the question. Obviously, that research is incomplete.

I will try to find some time to investigate treatises and my litigation boxes where files relating to numerous patent civil actions are stored. I testified in numerous suits between patentees and generics; my files contain copies of the complaints. I do not recall now the content/text of any particular complaint.