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Re: alm2 post# 304982

Wednesday, 10/14/2020 12:05:51 PM

Wednesday, October 14, 2020 12:05:51 PM

Post# of 429202
alm2. quick notes .

The refusal by the court to even accept the Amicus brief ...was the final straw for me. Yes chances of success were slim ...but to be even denied a chance shows me how closed the courts are regarding our case .
Theres no Amicus brief and there will be no En Banc .....and no Supreme Court is going to hear our case ...so our legal options are done .

Re Hikma launching ... reading todays FDA law blog ...thx to whoever posted it

In no uncertain terms, the Federal Circuit held that the “criteria of induced infringement are met” based on the “ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides.”
Mainly, the evidence consisted of materials in which Teva had noted that its product was a “generic of Coreg” and “AB rated” without any reference to specific indications.
Notably, the Court implied that the labeling alone may have been enough, as “[p]recedent has recognized that the content of the product label is evidence of inducement to infringe.”



This is a roadmap on what NOT to do for Hikma . Their attorneys will be all over this ....and if they were smart enough to beat Singer ( supposedly the finest patent lawyer in the land ) chances are they can ensure Hikma doesn't fall into the same trap as Teva.
We will know soon enough ....Mid Nov launch to protect their 180 day marketing exclusivity

Re EU and the ROW .....if you read Pharmadudes posts you will see that for govt run health plans ...Canada , most of the EU etc ...Vascepa is over priced . In Canada from memory by up to 40% above what their govt calculates .

So AMRN will have to lower prices to gain market access or accept a low market share .
ROW is worse ...Vascepa is an expensive drug for most of the world .

Bottom line ..no huge upside and better opportunities elsewhere

Good luck
Kiwi
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