What happens when the PTAB and the ITC reach opposite conclusions on the same patent claims? The ITC found that the claims had not been shown obvious. The PTAB found them obvious. Because of the PTAB’s decision, the ITC suspended enforcement of an exclusion order. The USPTO Director then vacated the PTAB’s decision, and the ITC allowed the exclusion order to take effect. The Director’s decision shows that the USPTO is not waiting for its proposed “one collective bite” rules to take effect. It is already applying that principle, even after a final written decision, with consequences extending beyond the PTAB.
Two Forums, Two Different Results
The dispute involved U.S. Patent No. 11,697,028, which covers a photodynamic dermatology device. Sun Pharmaceutical asserted the patent against Biofrontera at the ITC. Biofrontera challenged the asserted claims as obvious before the ITC while also pursuing an IPR based on the same claims, prior art, and obviousness grounds.
The two proceedings produced opposite results. An ITC administrative law judge concluded that Biofrontera had not shown the asserted claims invalid as obvious. In February 2026, the PTAB reached the opposite conclusion and issued a final written decision finding all challenged claims unpatentable.
On May 6, the ITC affirmed the finding that the claims had not been shown invalid and found a violation of Section 337. It issued a limited exclusion order and cease-and-desist orders but suspended enforcement as to the ’028 patent because of the conflicting PTAB decision.
Sun sought Director Review. On July 29, USPTO Director John Squires vacated the PTAB’s final written decision, dismissed the petition, and terminated the IPR. He concluded that “there was no justifiable reason for the Board to have reached a different patentability determination than the ITC.”
Sun then asked the ITC to lift the suspension. On Sept. 1, the Commission did so, making its remedial orders fully enforceable as to the ’028 patent.
The public record does not establish formal coordination between the agencies. But their successive actions produced a consistent result. The Director vacated the PTAB’s obviousness decision based on the ITC’s earlier determination. The ITC then lifted its suspension and gave full effect to its remedial orders.
An IPR Is an Alternative, Not an Additional Forum
The USPTO has proposed rules that would limit parties to one collective opportunity to challenge patent validity. Among other things, the rules would require the Office to deny institution when a claim already has been tested and upheld in another forum or when another proceeding is likely to resolve validity first. They also would require a petitioner to forgo certain invalidity challenges in other forums if the IPR is instituted.
Biofrontera goes further. The proposed rules focus on whether an IPR should be instituted. Here, the IPR had proceeded through trial, and the Board had issued a final written decision. The Director nevertheless vacated that decision and dismissed the proceeding.
Squires grounded his decision in the purpose of AIA review. Quoting an earlier precedential decision, he explained that AIA review is “to provide a quick and cost-effective alternative” to litigating validity in other forums, not another forum for simultaneously litigating the same dispute.
The Director did not hold that the PTAB is bound by an ITC patentability determination or establish categorical issue preclusion between the agencies. Instead, he concluded that the Board must meaningfully account for an earlier adjudication involving the same or substantially the same claims, evidence, and arguments. A different result requires an adequate explanation.
The Board had identified three principal reasons for reaching a different result. The IPR included supplemental expert testimony. And the forums applied different burdens of proof.
The Director found none to be sufficient. An ITC initial determination, he explained, may support terminating an overlapping IPR before Commission review is complete. By the time the Director acted, the Commission also had affirmed the finding that Biofrontera failed to prove obviousness.
The supplemental expert testimony also appeared to backfill gaps in the petition. Biofrontera did not submit it until its reply, after shortcomings in the same obviousness theory had emerged in the ITC proceeding. If the evidence was critical, the Director reasoned, it should have been included in the petition.
Finally, the different burdens of proof did not, “without more,” explain the conflicting technical findings. The ITC credited evidence concerning the difficulty of achieving uniform illumination and rejected Biofrontera’s theory. The PTAB reached the opposite conclusion without adequately explaining the discrepancy.
The decision places a substantial burden on a party seeking a different result from the PTAB after another tribunal has considered materially the same challenge. The PTAB’s lower burden of proof, standing alone, may not be enough.
The One-Bite Principle Already Has Teeth
Parties should not assume that the PTAB’s lower burden of proof guarantees another opportunity to litigate an unsuccessful validity challenge. When the PTAB and another tribunal consider the same claims, prior art, grounds, and substantially the same evidence, the first adjudication may affect whether the PTAB proceeding survives. Even a final written decision may be vacated if the Board fails to justify a different result.
The consequences can extend beyond the PTAB. Here, vacating the Board’s decision cleared the way for the ITC to enforce its remedial orders. Forum selection and timing therefore may affect both whether an IPR survives and when an ITC remedy takes effect.
The Director framed AIA review as an alternative to litigating validity in another forum, not another opportunity to pursue the same challenge. Biofrontera shows that the USPTO is willing to enforce that view even after the PTAB issues a final written decision. The one-bite principle already has teeth.
