Replies to post #380105 on Amarin Corp Plc (AMRN)

[Number sleven]

HDG, I agree in part, and disagree in part. FDA has the authority to regulate the approval of Drugs, but no authority to tell doctors how to use them. That falls under the practice of medicine.
There was a period of time that Teva did explicitly promote the drug for use. That was during the time that the '000 patent had expired. The primary argument in that case was that the carve out itself was invalid. No clear separation between the patented indication an the carve out. So an explicit act is not required if you argue that the carve out is improper. This is a new take on HW. If you like I can find and post the ruling.
Sleven,

[ilovetech]

HDG - This case is rife with complexity. Unfortunately, the correlation between high trig's and CVD had not been settled before the correlation between high trig's and pancreatitis was. As more support for the CVD correlation grew, but not settled, Amarin wanted to pivot to CVD, but data did not exist to prove it.

After Reduce-it, Amrn established the CVD - Trig correlation, but the two disease states "remain" distinct morbidities for trageted therapies. The medical establishment has failed to blend the two targets together. Poor Trig lowering treatments along with Lovaza are still written in substantial numbers. So I don't know if we can compare our case with other carve-out cases. There's seems to be more complexity than meets the eye. IMO, the "best defensive wall" against competition would be a combo pill, with the added benefit of increased compliance. A combo may have been Amarin's long game all along. At some point Amarin accepted failure to market Vascepa in the U.S, regardless of losing the patents. So Amarin decided to allow the ROW to dominate growth, while simultaneously perfecting the combo.

So that gives us exclusive growth in ROW until 2039. Meanwhile, a first generation combo pill patent can come at "any time" to launch in the US. Only this time, the acquiring BP will do one hell of a job marketing it.

ILT

[north40000]

It is helpful to remember, HDG, that Judge Du found Hikma to infringe the 6 patents in suit in Nevada before she found those 6 VHT(Marine) patents invalid on:
1) fabricated and misleading evidence and argument presented to her by defendants, and 2) statistical mistakes as later pointed out by Curfmann and Bhatt et al.(include Jarvis as well).

Like most folks here, I also wait to see whether the S.Ct. asks for a response to the petition for certiorari now pending since May 14.

My PCP prescribed Vascepa for me in April 2013 because of family history of CVDs, plaque in my carotid arteries and T1 Diabetes(since 1956-7).