Drugmakers Exposed to Antitrust Probes if Patent Cache Added
Member Vanessa Yen and Special Counsel Evan Diamond spoke with Bloomberg Law on the US Patent and Trademark Office’s proposed rule that would require parties to file settlement agreements for patent challenges with the Patent Trial and Appeal Board — even when such agreements are entered before the PTAB institutes full proceedings.
Vanessa commented on the implications of the USPTO connecting this change to an Executive Order regarding antitrust law that President Biden signed in July 2021, saying, “By mentioning the EO, there’s an implication they’re making this change because there’s something wrong with the settlements . . . But honestly, the opposite is true, because settlements can avoid burdening the PTAB, and can include clauses that allow generics or biosimilar entries years in advance of patent expiration.”
Evan stated, "There was already existing anxiety about the lack of clarity around agreement confidentiality, and the [USPTO's proposed] expansion of the [filing] requirement doubled that concern."
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