Ram, but if a doctor is prescribing off-label, then where is the infringement? (assuming another party is not inducing infringement)
Therein lies the problem - there is no law prohibiting a doctor from prescribing generic IPE for anything. Actually prescribing and fulfilling a generic IPE script for CVD is NOT infringing.
Look, I'm just playing devil's advocate here. I don't like this one bit. But the system is structured in such a way that can make it virtually impossible to prevent this. Look at the Hikma suit - if they had simply written in their PR "for high-triglycerides" (or whatever the language needs to be), then we wouldn't even be having this discussion. Hikma could continue to manufacture and distribute without retribution.