Short Summary
BPI Labs requests Director Review of the PTAB’s denial to institute an IPR against Eli Lilly’s tirzepatide patent (US 9,474,780). The petitioner argues the denial misapplies § 325(d), ignores material prosecution errors, and violates APA rulemaking requirements. Consistency with a related pending IPR is also urged.
Detailed Summary
In a petition for Director Review, BPI Labs challenges the PTAB’s decision to deny institution of IPR2025‑01346, which targets Eli Lilly’s US 9,474,780 patent covering the diabetes drug tirzepatide. The petitioner alleges that the discretionary denial improperly relied on 35 U.S.C. § 325(d) despite material errors in prosecution, notably Lilly’s failure to disclose its own prior application (Alsina‑Fernandez) that taught a key claim feature. The petition further contends that the Director’s new institution memo constitutes a substantive rule adopted without the notice‑and‑comment process required by the APA, rendering the denial procedurally defective. Consistency with the pending Director Review in IPR2025‑01024 is emphasized to avoid contradictory outcomes. BPI Labs seeks vacatur of the denial and a merits institution determination.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before local courts. Understanding the court's reasoning in BPI Labs, LLC et al. vs Eli Lilly & Co. is valuable context for structuring arguments or assessing risk in similar proceedings.
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