Sun Pharmaceutical Industries, Inc. v. Biofrontera Inc.
Patent Trial and Appeal Board
Holding
The Director denied institution of the PGR challenging Biofrontera’s Patent 12,280,146 B2 in the pharmaceutical/biotech space because Sun failed to establish that it identified all real parties in interest. Applying Corning Optical, Tianma, and Worlds, the Director held that RPI status turns not only on actual funding or control, but also on the ability to control the proceeding; Sun’s evidence addressed only SPI Inc.’s actual funding/control and did not negate parent SPI Ltd.’s ability to control.
Why It Matters
Practitioners should treat parent/subsidiary RPI disputes as requiring affirmative evidence negating the parent’s ability to control, not merely declarations about who is actually funding or directing the case. Adding an omitted RPI can force a new filing date, which is fatal for a PGR filed near or after the 9-month window, and there is no mechanism to convert a PGR into an IPR.
- Written description, enablement and indefiniteness (§ 112) →
- PTAB discretionary denial →
- PTAB Director Review →
- Fed. Cir. · Oct. 7, 2026In re Gamble
- Fed. Cir. · Oct. 2, 2026Pioneer Hi-Bred International, Inc. v. Inari Agriculture, Inc.
- Fed. Cir. · Oct. 1, 2026Satius Holding, LLC v. Samsung Electronics Co., Ltd.
- Fed. Cir. · Sept. 30, 2026TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY
- Fed. Cir. · Sept. 30, 2026Wang v. Viking Drill & Tool, Inc.