Short Summary
Amgen’s request for Director Review of IPR denial is rebuffed by Bristol‑Myers Squibb, which argues the petitioner offers no credible basis and that European prosecution does not affect settled expectations for the U.S. patent.
Detailed Summary
In its authorized response to Amgen’s request for Director Review, Bristol‑Myers Squibb contends that the petitioner has failed to identify any credible grounds to overturn the Board’s discretionary denial of institution for IPR on U.S. Patent No. 9,856,320. The patent owner emphasizes that foreign prosecution does not unsettle settled expectations, that the petitioner’s changed‑circumstances and policy arguments are irrelevant and waived, and that the constitutional challenge is unsupported. Consequently, the patent owner urges the Board to deny the Director Review request, maintaining the validity of the ’320 patent.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before local courts. Understanding the court's reasoning in Amgen Inc. et al. vs Bristol-Myers Squibb Company is valuable context for structuring arguments or assessing risk in similar proceedings.
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