The prior post on the carve-out issue that was illuminated by the Sanofi ruling is what this is going to hinge on. Either Hamoa or HDG provided that, I believe. Thanks - that is the scenario & logic that will be tested here.
Judge stated she was thinking of high TG's as chronic condition and leaning towards assuming LT treatment needed as a result (certainly >12 weeks).
Generics appear to frame many instances where TG's >500mg can be reduced via short-term (<12 weeks) IPE treatment and diet/exercise. (Thanks to whoever posted that partially redacted document, #333, it is a must read).
Seems those differences of impression/opinion on TG treatment duration are going to be slugged out in court. It appears that generics do not violate any patents if prescribed for <12 weeks. Whoever at Amarin filed that patent with a minimum duration of dosing should be shot, as the MARINE trial itself showed a distribution of TG reductions, not a step function at 12 weeks. The Amarin patents provide no protection for <12 wks of treatment, as Amarin has stipulated.
So, it comes down to the indirect inducement question. Judge said R-IT results don't matter much to that (as someone else posted)? I hope they do, because that is the obvious incentive to push generic IPE and pursue this litigation to the ends of the earth. It's not the size of the well-supplied hyper-TG market. Unfortunately, I don't think intent to access the vastly larger CV market can be proven here, absent the discovery of some internal generics document that points to the off-generic-label CV opportunity. In fact, this litigation started before R-IT results emerged.
Hamoa is completely correct about the primacy of strong IP protection to stimulate innovation. However, the judge will rule on the narrow facts & circumstances of this case, guided by precedent. If there has been inadequate development of the patent estate for a given endeavor, that is the company's problem, not the Judge's. She will rule on how the explicit patent language is applied rather than the societal costs of losing patent challenges. Which takes us right back to Sanofi and how that bears on Amarin vs. Generics.
There is that old saying: "The law is an ass". Sometimes it truly is. It is tough to take much comfort in the possiblity that the Judge wants to reward Amarin simply due to the momentousness of the impact of Vascepa for CV disease, and the heck with many of the surrounding details. If their filings prove to not be in order, Amarin has a problem. But the key issue leads back to the Sanofi carve out precedent for the back door to the massive CV market.
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