Biocon Biologics Limited et al. v. Regeneron Pharmaceuticals, Inc.
Patent Trial and Appeal Board
Holding
The Director denied institution of Biocon’s PGR challenging claims 1–38 of Regeneron’s biologics/pharmaceutical Patent No. 12,168,036 because the petition was filed more than nine months after patent issuance and therefore was barred by 35 U.S.C. § 321(c). The Director held that § 325(c) joinder requires a petition to be “properly filed” and that 37 C.F.R. § 42.222(b)’s one-month joinder-request deadline cannot override the statutory nine-month PGR filing deadline; no prior Board merits decision was reversed or affirmed.
Why It Matters
PGR petitioners seeking joinder cannot wait until after lead-case institution if doing so pushes the petition outside the nine-month statutory window. Practitioners should file the PGR petition and joinder motion before the § 321(c) deadline, even if the lead PGR has not yet been instituted.
- Fed. Cir. · Oct. 6, 2026Inari Agriculture, Inc. v. Corteva Agriscience LLC
- Fed. Cir. · Oct. 5, 2026O'Reilly Winship LLC v. SnapRays LLC
- Fed. Cir. · Oct. 1, 2026Satius Holding, LLC v. Samsung Electronics Co., Ltd.
- Fed. Cir. · Sept. 30, 2026WSOU Investments LLC v. Salesforce, Inc.
- Fed. Cir. · Sept. 30, 2026TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY