The director of the United States Patent & Trademark Office (USPTO) vacated a Patent Trial and Appeal Board final written decision finding challenged claims obvious where the US International Trade Commission, considering the same patent, parties, and obviousness theory, had reached the opposite conclusion. The director found that the Board had not adequately justified departing from the Commission’s analysis. Biofrontera Inc. v. Sun Pharmaceutical Industries Inc., IPR2024-01312 (USPTO Dir. July 29, 2026) (Squires, Dir.)
Biofrontera petitioned for inter partes review (IPR) of a Sun Pharmaceutical patent directed to a photodynamic dermatology device. The Board instituted review and ultimately found all challenged claims unpatentable as obvious.
The same patent was also at issue in a Section 337 investigation before the Commission. Sun Pharmaceutical had accused Biofrontera of importing certain photodynamic therapy systems that infringed two patents. An administrative law judge (ALJ) found infringement and recommended an exclusion order. The ALJ also found that Biofrontera had not shown the claims of the patent at issue in the IPR to be obvious.
Before the Board, Biofrontera argued that the ALJ’s determination did not warrant deference because it was not yet final, remained subject to Commission review, and was based on a different evidentiary record and burden of proof. The Board agreed and reached the opposite conclusion on obviousness.
On Director Review, the director rejected the Board’s explanations and vacated the final written decision. The director concluded that the Board had not identified a sufficient basis for reaching a patentability determination inconsistent with the Commission’s assessment of the same obviousness theory.
The director first rejected the Board’s reliance on the non-final status of the ALJ’s determination. By the time of Director Review, the full Commission had upheld the ALJ’s conclusion that Biofrontera had not shown the claims obvious, eliminating the finality concern on which the Board had relied. The director further explained that even a non-final ALJ determination may remain relevant when the Board considers whether parallel proceedings justify terminating or otherwise declining to continue an IPR.
The director also found that differences in the evidentiary records did not adequately explain the conflicting results. Although the IPR included expert testimony that had not been presented at the Commission, the Board did not sufficiently explain why that testimony warranted reaching a different conclusion on the same prior art combination.
Nor did the differing burdens of proof resolve the inconsistency. The director acknowledged that an IPR applies the preponderance-of-the-evidence standard, while a Commission respondent challenging patent validity faces a higher burden. But the difference in standards, standing alone, did not explain why the two tribunals reached conflicting factual conclusions regarding the same claim limitation and prior art combination.
Finding no adequate justification for the divergence, the director vacated the Board’s final written decision and dismissed the IPR petition rather than remanding for further proceedings.
Practice Note: Parties litigating patent validity in parallel Board and Commission proceedings should expect prior findings from one forum to receive meaningful consideration in the other, particularly where the same parties, prior art, and invalidity theories are involved. A different burden of proof or a modestly expanded evidentiary record may not, without more, justify inconsistent outcomes. Parties should clearly identify any material factual or evidentiary differences that support a different result.
