Biofrontera Inc., Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, and Biofrontera AG v. Sun Pharmaceutical Industries, Inc.

The Director granted Patent Owner's request for review, vacated the Final Written Decision, and dismissed the Petition. The ITC had already decided, on the same claims, prior art and obviousness grounds, that the claims were not shown invalid as obvious. The Board did not adequately explain why it reached a different outcome. Its reasons were that the ITC determination was "not final," that new expert testimony was before the Board, and that the burdens of proof differed. The Director found none of these reasons sufficient, under the September 16, 2025 Memorandum on prior findings of fact and conclusions of law. When the ITC has already adjudicated the same claims, art and grounds, the Board must give a detailed explanation for any contrary result. Under this decision, a missing or insufficient explanation can lead the Director to vacate a final written decision and dismiss the petition, even after trial. Petitioners should put "critical" evidence in the petition rather than the reply. They should expect the ITC's outcome to be weighed heavily, including an initial determination that is still under Commission review. Decision under review: the Board's Final Written Decision (Paper 53) holding the challenged claims obvious. Patent Owner argued it was inconsistent with the ITC's determination that the same claims were not shown invalid as obvious over the same prior art and substantially the same evidence. Legal framework: under the Sept. 16, 2025 Memorandum, the Board must consider prior findings and conclusions, and a more detailed explanation is required when the same or substantially the same evidence or arguments were presented to the ITC. Whether the explanation is sufficient is committed to the Director's discretion and bears on whether a proceeding is instituted, maintained or dismissed. Finality: an ITC initial determination can still favor terminating a co-pending IPR, citing Hydrafacial. The ITC's determination is also no longer initial, because a May 6, 2026 Commission Opinion affirmed the ID's no-invalidity finding despite reviewing the Board's contrary Final Written Decision. The Director stressed avoiding inconsistent results and duplicative expense in an overlapping patentability dispute. Technical findings and burden of proof: the ITC found Petitioners failed to show Lundahl and Larsen teach the "uniformly illuminate" limitation, and that their analysis was not free of improper hindsight. The Board found Larsen discloses uniform illumination by a preponderance of the evidence. The differing standards of proof do not, without more, explain the discrepancy. The Director also questioned, but did not resolve, whether the Board departed from the parties' agreed claim construction without notice. Reply evidence: the "critical" Supplemental Declaration of Dr. Grove first appeared with Petitioners' Reply. The record suggests Petitioners used it to backfill gaps in the Petition and to address shortcomings the ALJ later identified in the same obviousness theory. The Director held that critical evidence belonged in the Petition. The order grants Director Review, vacates Paper 53, dismisses the Petition and terminates the proceeding. KEY QUOTE: "Here, the Board failed to adequately explain why it was reaching a different outcome than the ITC." (Paper 58, p. 6)