The U.S. Patent and Trademark Office convened the first of three planned listening sessions on March 30, 2026, to examine the Patent Trial and Appeal Board’s role in life sciences patent disputes. The session brought together representatives from the pharmaceutical patent owner community and the generic drug industry, and it quickly laid bare a fundamental divide over how the PTAB’s inter partes review process should function—and whether it has damaged the predictability of pharmaceutical patent rights.
The PTAB was established under the America Invents Act of 2012 and adjudicates patent validity through administrative proceedings including inter partes review (IPR) and post-grant review (PGR). Since its creation, the board has been credited by some with correcting improperly granted patents, while patent-intensive industries—particularly pharmaceuticals—have argued that it introduces structural uncertainty that undermines investment in innovation.
Speaking on behalf of the pharmaceutical patent owner community, Bristol Myers Squibb Chief IP Counsel Henry Hadad and Senate Judiciary Committee IP Policy Director Peter-Anthony Pappas presented data and arguments focused on the PTAB’s IPR invalidation rate. Hadad cited 2023–2024 figures showing that roughly 70% of instituted IPR petitions resulted in patent invalidity findings, arguing that this rate creates untenable uncertainty for R&D-intensive companies whose drug development programs depend on reliable patent protection over decades-long timeframes.
Hadad also highlighted what he described as a fundamental structural asymmetry in multi-venue patent validity challenges: patent owners must prevail on all validity issues across every forum—the USPTO, federal district courts, the PTAB, and the Federal Circuit—while challengers need only succeed on a single issue in a single forum to defeat a patent. This asymmetry, he argued, is compounded by the availability of serial and parallel proceedings that allow repeated attacks on the same patents.
Pappas argued that any proposed restrictions on patent rights should be grounded in demonstrated need and reliable data. Both Pappas and Hadad challenged the data underlying frequent claims that pharmaceutical companies engage in “patent thicketing” to block generic entry. They pointed to a June 2024 joint USPTO-FDA report that disputed the I-MAK dataset commonly cited in support of the patent thicket narrative, noting that the dataset includes abandoned applications and patents on drugs that have already faced generic competition, inflating the apparent scale of the problem.
Association for Accessible Medicines President Robert Cerwinski presented the opposing view, defending the IPR and PGR mechanisms as tools that support generic and biosimilar market entry. Cerwinski cited examples of brand-name drugs with more than 40 listed patents, arguing that the volume of patents associated with certain products creates practical barriers to competition that the PTAB is designed to address.
A central legislative focus of the pharmaceutical patent community is the PREVAIL Act—the Promoting and Respecting Economically Vital American Innovation Leadership Act. The bill would impose limits on serial and duplicative IPR petitions, strengthen patent owners’ procedural rights in PTAB proceedings, and address the composition of the PTAB’s administrative patent judges. Passage of the PREVAIL Act, or administrative action toward similar ends, would substantially reshape the reexamination landscape for pharmaceutical patents.
The session’s significance lies not in any immediate policy outcome but in its role as a formal input mechanism for USPTO’s ongoing evaluation of PTAB operations. The agency’s choices in this space will directly affect how pharmaceutical companies structure their patent portfolios, how generic manufacturers time their market entry strategies, and how Hatch-Waxman litigation plays out in practice.
USPTO has scheduled two additional sessions: a second covering high-tech industries and the PTAB in April 2026, and a third on PTAB administration and reform in May 2026. IP practitioners across sectors should monitor the cumulative record from all three sessions, as the body of submissions is likely to inform future USPTO rulemaking and guidance on PTAB proceedings.
Reference information: USPTO Life Sciences PTAB Listening Session, Session 1, March 30, 2026. Key speakers: Henry Hadad (Bristol Myers Squibb), Peter-Anthony Pappas (Senate Judiciary Committee), Robert Cerwinski (Association for Accessible Medicines). Applicable statutes: 35 U.S.C. §§ 311 et seq. (IPR proceedings), Hatch-Waxman Act. Upcoming sessions: April 2026 (PTAB and High Tech), May 2026 (PTAB Administration and Reform).
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