Replies to post #262907 on Amarin Corp Plc (AMRN)

[rmitra]

From a scientific point of view I think

[rmitra]

From a scientific point of view I think there is not much you can say about a small number of individuals with tg>500 in that population. Legally I think the defense was trying to make the point that people with Tg>500 had been given pure EPA in the past (which is the Marine indication).

[mc1988]

If my recollection is correct, the patent examiner relied partially on the presence of patients with TGs >500 mg/dL as prima facie evidence of obviousness in the prior art in his preliminary assessment. (Amarin's patent was limited to patients with high triglycerides, those >500 mg/dL.)

Amarin was later able to overcome the examiner's rejection by explaining that there is an important medical/science-related difference between patients with very high TGs vs those are not. Amarin argued that just because some patients in the prior art have a slight overlap with the range >500 mg/dL, it does not provide sufficient grounds for rejecting its patent application. I'm not sure if the patent examiner agreed with Amarin's argument, but he eventually approved the patent application, on the grounds that Amarin overcame prima facie obviousness by showing (1) unexpected outcome, and (2) long felt unmet medical need.

(Again, I'm going with my recollection, so it is best to check my recollection against the patent examiner's notes, e.g. here https://www.courtlistener.com/recap/gov.uscourts.nvd.118340/gov.uscourts.nvd.118340.89.27.pdf)

I suppose the judge wanted to highlight the presence of patients with TGs >500 mg/dL in Hayashi––just as the patent examiner did––to establish prima facie obviousness.