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Saturday, 10/03/2020 9:52:51 AM

Saturday, October 03, 2020 9:52:51 AM

Post# of 425930
I agree the case yesterday was a big deal. It makes the generics take pause. Here is a footnote from the first trial.

In a footnote, Judge Stark distinguished the instant case from typical ANDA cases in that this case involves an at-risk launch. Cases such as Sanofi v. Watson Laboratories Inc., 875 F.3d 636, 646 (Fed. Cir. 2017) involve the ordinary Hatch-Waxman framework, “where a claim of induced infringement is filed before the generic has launched its product, and necessarily, before the generic has even attempted to communicate with any direct infringer.” (D.I. 411 at 3). In those cases, “the focus must be on intent, rather than actual inducement.” Id. In this case, GSK filed its case almost seven years after generic product launch. Therefore, GSK’s inducement claims “are not based on a hypothetical, but instead must be supported by sufficient evidence as to what actually happened during the relevant time period.” (Id. at 3-4). Reliance on a label and speculation about what may occur in the future cannot substitute for actual evidence about what actually occurred in the past.

This case will likely be appealed.

Now the intent will be in the supplier agreement. They will have to agree to buy a ton more then the marine label. Huge issue for them and now with the lost yesterday. Interesting times for sure.

PT


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