Monday, October 12, 2020 8:52:05 PM
However, I do not (could not) read the Opinion as the mere knowledge of possible infringement by others amounts to inducement ... as it is opposite the case law.
Teva did not simple had a knowledge but (actively) marketed the infringed use.
"skinny" label period:
Teva was not liable because of the label but because of specific intent and action to induce infringement was proven.
"Assuming" that generic V has knowledge of the ruling, it defies common sense to expect that generic V will actively promote the sale of its approved icosapent for a use that infringe Amarin's patent.
The decision is essentially a roadmap of what not to do. The generics will design any promotional materials, activities or references to their generic drug in a manner to avoid the pitfalls made by Teva.
Hikma and Dr. Reddy’s will likely modify (if necessary) any promotional materials, either press releases or product catalogues or communications to the doctors, to specify that any mention of their generic formulation for Vascepa is not indicated for, and not encouraged for treatment of, the cardiovascular indication. That type of simple modification within any promotional materials more likely be enough to avoid infringement of any of Amarin’s R-IT patents.
"full" label period: I do not see any reason to presume that Hikma or Dr. Reddy’s will request or be required by the FDA to do it.
Too much ado about nothing ...
Best,
G
re.
Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.
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