Yes. I am aware of the case where infringing use was 95%, non-infringing use was 5% and the non-infringing use was determined as significant ... the case is Amarin Pharma, Inc. v. Hikma Pharmaceuticals
Do you know any precedent/case other than Amarin Pharma, Inc. v. Hikma Pharmaceuticals?
If the amount of prescription is unusual(ly high) it confirms existence of substantial non-infringing use
How does it confirm that those prescription is not for infringing use, but for non-infringing use?
"Unnecessary. The existence of direct infringement is not a question. But it is not enough, specific action should be proved also. "
So manufacturing of generic icosapent ethyl is not "specific action" but encapsulation, packaging and importation then ultimately consumption by patients with the reduce-it indication, is? Or is not?
I keep going back to production limits. If jointly the generic icosapent ethyl manufacturers produce more generic icosapent ethyl than is required to treat patients with triglycerides >500, the excess production is intended for sale to patients with the reduce-it indication.