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Number sleven

06/12/22 8:07 AM

#380104 RE: HDGabor #380103

HDG, I agree that an appropriate use of a PA could insulate insurance companies from obvious infringment. I don't know if the lack of a PA would provide protection.
Hikma is not an impossible position. That is why the magistrate recommend that the case proceed. Take a look at the ruling in GSK v Teva. This ruling blurred the law on infringment. The legal issue that I see is the validity of the carve out. How do you separate VHTG from CVD. I don't see them as two distinct and separate indications. The FDA position on off label prescriptions has nothing to do with patent law.
Sleven,
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ziploc_1

06/12/22 9:20 AM

#380109 RE: HDGabor #380103

HDG...QUOTE..." I am not aware of the full details of the Hikma case, so could not say or deny it is the "same" or different situation but I am sure an "explicit" promotion by Hikma should be exist to win the case."

This turns on what is meant by "explicit"...Hikma bragged in 2020 in a public a meeting of financial analysts that.... "Company forecasts sales as high as $700m after regulator grants broad label."

This figure could not be realistically achieved by selling gV solely for Rx for the high triglyceride indication, which is only 7% of the Vascepa market...It is a very "explicit' statement of Hikma's intention to infringe on Vascepa's CVD indications, which are 93% of the market.

This evidence was introduced at the Amarin vs. Hikma and Healthnet trial. and was convincing enough for magitrate judge Hall to find for Amarin.