Amarin Corp Plc (AMRN)

[lettruthringout]

Curfman pushing the CV patent obviousness defense today

Even if Amarin can show infringement, to prevail in this lawsuit, it will have to face an invalidity challenge. The challenge will most likely focus on the JELIS study. That study purportedly suggested that purified EPA could reduce cardiovascular risks in patients with abnormal lipid levels who were on statin therapy.

During the prior Nevada lawsuit, the parties debated the relevance of the JELIS study. Amarin argued that the JELIS study was flawed, whereas the generics argued that Amarin had previously relied upon the JELIS study in its bid to the FDA for a cardiovascular indication Vascepa®. Either way, JELIS presents a validity challenge to the patents now asserted by Amarin, and this will likely form a focal point of the case.

Amarin appears to have contemplated this in selecting patents to assert against Hikma. One very interesting patent is the ‘537 patent. This is not a homegrown Amarin patent. Rather, this patent is owned by the Japanese company, Mochida Pharmaceutical, which is the manufacturer for Epadel, another EPA drug. (This is likely why Mochida is a plaintiff in this lawsuit.) Even though Amarin does not own this patent, it has an exclusive license, which permits it to bring suit.

The ‘537 patent has an earlier priority date than the other two asserted patents. During prosecution, the ‘537 patent also appears to have preliminarily overcome considerable prior art related to JELIS in the process of being granted by the Patent Office. Moreover, the patent is based upon the Saito article, which studied the use of EPA in patients enrolled in JELIS with no history of cardiovascular events. Therefore, the ‘537 patent is likely to be very important to this case.

https://blog.petrieflom.law.harvard.edu/2021/09/23/fish-oil-patent-battle/#more-30373