HDG, in your reply, you stated” Hikma does claim that they had no knowledge that their product would be used in an infringing manner”.That is the definition of willful blindness. Of course they knew. They’re fully aware of how the system works and the perceived loophole in HW and skinny labels.
I later stated that Hikma knows how the system works and knows that their product will be and is being sold in an infringing manner. You replied “ all of these are true but none of them a proof of inducement( which require a specific action. A mere knowledge is not enough). This contradicts the first statement saying that Hikma claims they have no knowledge their product would be used in an infringing manner.
Having knowledge of the system and the high probability of infringement and doing the bare minimum to attempt to make sure it doesn’t happen, omitting language from the label regarding CVD, adding AB rating to your literature, and supplying IPE in excess of the Marine indication market, is an act(s) of contributory infringement.
Either way, we agree that Hikma knew and know their product would be used in an infringing manner, and I believe they acted in ways to ensure it would.
As far as a specific act to induce infringement, there is several. Omitting parts of the Marine label, advertising AB rating, and other debatable actions or lack of actions that contribute to inducement.
All generic manufactures are aware of how the system is gamed to allow infringement outside of the skinny label. Therefore to reduce any chance of liability for contributing to infringement, I believe it’s incumbent upon those that want to sell into a skinny label, to do everything in their power to discourage and prevent infringing uses. i.e use the strongest possible warnings on the label. Like stating” only to be used for patients with trigs >500, not intended or authorized for CVD risk reduction , CVD risk reduction is a patent protected indication and our product is not intended or authorized for this use. Additionally they should communicate with PBM’s and pharmacies, in writing, that their product should have a PA requiring trigs to be >500 to avoid infringement liability and that Hikma will not provide any GV to those that attempt to substitute GV for any patient requiring CVD risk reduction or with trigs <500. Anything short of this makes them equally guilty of inducing infringement and that’s the risk they take when launching a copy of a patent protected medicine with a skinny label. They don’t do any of this because they intend to infringe as much as possible claiming willful blindness or ignorance.
Playing dumb should not shield the generics from liability. It’s not only about what they say and do but what they don’t say and do that contributes to the inducement and infringement. All IMHO
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