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.
How this summary was made: Drafted with AI from the Board's or the Director's decision. Read the document itself before relying on the summary. Editorial policy
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