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« Amicus Briefing in Amgen v. Sanofi: The Rest of the Story - Part III | Main | Senate Once Again Tries to Address Drug Pricing »

May 15, 2023


Thank you for this post. I confused about this case though and would like to understand the regulatory issues better because it seems like the problem for Teva was really caused by the FDA requiring Teva to change the generic label to recite the infringing use. Once a label recites an infringing use, a finding of infringement seems inevitable. Could Teva have done anything to prevent that change to the label? If not, wasn't going ahead with sales anyway just a business decision by Teva to market the generic and hope that damages are limited to infringing uses, and not enhanced by any finding of willful infringement? Or at least that damages would just be a cost of doing business and they would still come out ahead in sales for non-infringing uses?

I think the hope is that the Federal Circuit's decision will be cabined by exactly these facts. The majority seems to have identified the possibility for shenanigans and ruled accordingly.

There was a case where the drug had an indication for 98% of the patients and another one for the remaining 2%. The first filer decided they would file a section viii carve-out for the 2% indication and the judge went ballistic, agreeing to keep the case on her docket so plaintiffs could return if there was any evidence of off-label use (and encouragement of such use by any of the defendants).

Not always the case but frequently enough to generate the issue.

Thanks for the comment

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