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Number sleven

11/01/25 5:45 AM

#440386 RE: rosemountbomber #440380

RMB, I'm not entirely sure what you are trying to work through. I will give my best effort to summarize everything I understand about our legal challenge. Hatch Waxman introduced the concept of the "skinny label". Generic drugs marketed with a label carve out, can't be sued based solely on their label. In order for the branded company to get past the pleading stage, an overt act of inducement must be alleged. In our case the active step was Hikma advertising their generic product for the HTG indication. That mistake put Hikma in court. Removing Hikma from the market doesn't solve our problems. Our lawyers need to prove that the label itself is inducing infringement. The Hatch Waxman act prevents a direct challenge of the label. Once you get past the pleading stage, the label can be challenged. The strategy for the challenge is laid out in GSK v Teva. Supreme Court interference is the last major legal hurdle for us to get past. The ruling from the circuit of appeals prevents the district court judge from dismissing this case based on matters of fact. Hikma will still try. As long as the current state of the law remains unchanged they won't succeed. That brings us to the jury.
Sleven,