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In Sinclair Pharma Limited v. Hydrafacial LLC, the USPTO Director de‑instituted an already‑instituted IPR after full briefing, underscoring the increasing risk that parallel adjudications—particularly at the ITC—can derail an IPR even after institution. IPR2025-00145, Paper 41 (USPTO Feb. 12, 2026) ("Sinclair IPR"). In the Sinclair IPR, after institution and Sinclair's reply to the patent owner's response, the Director sua sponte raised Director review of the Board's institution decision and stayed the proceeding based on an ITC Initial Determination ("ID") in a parallel investigation. Nearly two months later, and without additional briefing, the Director de-instituted the proceeding based on the ID's invalidity-related findings, including that (i) prior art grounds raised at the ITC, which were substantially similar to those in Sinclair's IPR, failed to render unpatentable certain claims and (ii) patent owner's commercial success supported a finding of non-obviousness. Notably, Sinclair was not a party in the ITC case.
The Procedural Background
A. Parallel ITC Investigations and IPR Filings
In mid‑2024, the patent owner filed two ITC complaints asserting U.S. Patent No. 11,865,287 ("'287 patent"): one against Sinclair (Inv. No. 337‑1416) and another against different respondents (Inv. No. 337‑1408). In response, Eunsung filed an IPR petition in September 2024 (IPR2024‑01491), followed by Sinclair's petition in November 2024 (IPR2025‑00145). Both petitions raised substantially similar invalidity grounds. In February 2025, the patent owner withdrew its ITC complaint against Sinclair.
B. PTAB Institution Decisions and Director Review Requests
In April 2025, the PTAB discretionarily denied Eunsung's petition under Fintiv based on the ongoing ITC investigation. By contrast, in Sinclair's IPR, the patent owner waived its preliminary response, and the Board instituted review in June 2025 after finding a reasonable likelihood that Sinclair would prevail on at least one challenged claim. Sinclair IPR, Papers 11–12. The institution decision did not address Fintiv, and Acting Director Coke later denied the patent owner's request for Director Review seeking post-institution Fintiv review. Id., Papers 15, 20.
C. ITC Adjudication and Final Disposition of the Sinclair IPR
In August 2025, the ITC issued an Initial Determination ("ID") rejecting similar prior art challenges to certain '287 patent claims and crediting evidence of commercial success. Sinclair's IPR challenged those same claims, as well as additional claims not addressed by the ITC. After the patent owner submitted the ID to the PTAB, the Director sua sponte initiated Director Review and stayed the IPR in December 2025. Id., Paper 40. In January 2026, the ITC Commission declined review of the invalidity and commercial success findings, and the following month the Director vacated institution and denied Sinclair's IPR based on the ITC's prior adjudication. Id., Paper 41.
Parallel Litigation and the Impact on Petitioners
This decision highlights a broader risk associated with parallel adjudications generally, felt most acutely with the ITC. Here, the Director de-instituted an already-instituted IPR based on a determination reached in another forum that was not legally binding on the PTAB, involved a different party than the IPR petitioner, did not resolve all of the claims challenged in the IPR, and was based on a different statutory framework and standard of proof.
At the same time, the outcome illustrates how determinations in parallel proceedings may nonetheless influence PTAB discretion even after institution, underscoring the potential for later‑issued determinations in other forums to affect the trajectory of an IPR despite differences in parties, jurisdiction, scope, and governing standards.
In parallel litigation settings more broadly, late‑stage discretionary decisions of this kind can leave petitioners without a merits determination after substantial investment, while also narrowing practical opportunities to pursue alternative challenges—particularly where petitioners are not parties to the parallel litigation and would otherwise have had a basis to participate in or appeal the outcome of that proceeding.
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