Replies to post #437192 on Amarin Corp Plc (AMRN)

[north40000]

"court can't mandate a label change."  But: 

1) per Hazel-Atlas, 322 U.S. 238(1944)(the Court exercised its equitable power to order reversal of the judgment of the 3rd Circuit in light of fraud committed in connection with evidence that was relied on to support the opinion accompanying that judgment). Bottom line--Hartford Empire business disappeared to the extent it relied on fraudulently obtained/maintained patents responsible for or originating/forming/supporting that business and business model.

2) FDA can withdraw approval of ANDA(s) and corresponding labels, per its unchallenged authority/power vested by FDA Compliance Policy Guide (CPG) 120.100, when FDA finds fraudulent actions by any company(s) that omitted material information accompanying its request for approval of those ANDAs/labels. Bottom line--generic company business will disappear to the extent it relied on fraudulent evidence to invalidate patents of competitors to subsequently obtain ANDAs and labels to originate/support their business. Dr. Reddy's icosapent ethyl product and label disappeared from CVS/Caremark formulary on or before July 1, 2025. Hikma's  and other generics'  products and labels must also have disappeared in like manner from CVS/Caremark formulary if, as noticed,  Vascepa from Amarin (website) is exclusive and only.on CVS/Caremark formulary. 

[JRoon71]

Sleven, I believe the court can provide tailored injunctive relief, by preventing further marketing of a product until/unless the label is modified.

I am not saying it's a "label change" in the scientific sense. I am saying it's corrective measures on the language used.

And I'm not saying this will happen. I'm just saying that there is a lot of discussion about how this case is open and shut, and Amarin can't possibly lose (or will not have "less serious" damages awarded). We've seen how anything can happen when you get a small panel of judges (or a jury).