One Forum. One Fight. One Shot.

October 21, 2025

On October 17, 2025, the USPTO issued a Notice of Proposed Rulemaking that could reshape the architecture of post-grant practice. Nicknamed the “one-and-done” rule, the proposed changes to 37 C.F.R. Part 42 would substantially limit serial and parallel IPR challenges.

This is more than procedural streamlining. It’s a strategic realignment that tilts the balance between challengers and patent owners, tests the boundaries of 35 U.S.C. § 314(a) discretion, and may redefine how — and how often — patent validity can be contested.

How We Got Here: AIA’s “Streamlined Alternative” Became a Second Front

When Congress enacted the Leahy-Smith America Invents Act in 2011, it positioned IPR as “a quick and cost effective alternative to litigation” (H.R. Rep. No. 112-98, pt. 1, at 48). The PTAB was intended to offer a targeted forum to challenge patents under 35 U.S.C. §§ 102 and 103.

In practice, however, petitioners—particularly large, repeat filers—turned IPR into a parallel battlefield. Serial petitions, staggered challenges, and overlapping litigation became common. PTAB developed discretionary denial tools like Apple Inc. v. Fintiv, Inc., IPR2020-00019 (PTAB Mar. 20, 2020) (precedential), but those case-by-case approaches often felt unpredictable and burdensome.

Meanwhile, patent owners endured years of procedural churn, defending the same claims on the same art multiple times across multiple forums. What was meant to provide clarity began to undermine it.

The “one-and-done” proposal is the USPTO’s structural answer: stop managing the sprawl at the margins and change the ground rules entirely.

One Fight, One Forum: The Core of the Rule

The proposed rule rests on three pivotal pillars:

1. Mandatory stipulations. If an IPR is instituted, the petitioner must stipulate to forgo § 102 and § 103 invalidity challenges in district court or the ITC. What was optional under Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019 (PTAB Dec. 1, 2020), becomes mandatory.

2. No second bite at surviving claims. If a challenged claim (or parent claim) has already been upheld in prior proceedings, PTAB will deny institution absent extraordinary circumstances.

3. PTAB defers to parallel proceedings. If a parallel court or ITC case is likely to reach a validity decision first, PTAB can decline institution to avoid duplication.

The “extraordinary circumstances” carve-out is narrow: new prior art or legal theories won’t suffice. This is a bright-line shift away from Fintiv-style balancing and toward categorical bars.

Power Shift: Finality Moves to the Front End

The statutory foundation for this shift is § 314(a), which gives the Director broad discretion to deny institution even when a petition meets the threshold showing of “reasonable likelihood.” The Supreme Court confirmed the breadth of this discretion in Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016), and the Federal Circuit reinforced it in Mylan Labs. Ltd. v. Janssen Pharmaceutica, N.V., 989 F.3d 1375 (Fed. Cir. 2021).

That discretion has always existed in tension with § 311(a), which grants broad access to challengers. The new rule decisively tips the scale toward finality.

It also operationalizes the estoppel principles in § 315(e), which the Federal Circuit described in XY, LLC v. Trans Ova Genetics, LC, 890 F.3d 1282 (Fed. Cir. 2018), as designed to prevent “two bites at the apple.” Under this proposal, the second bite never happens at all.

Implications for Patent Owners: Real Finality, Not Just Theoretical

For patent owners, the implications are profound. A single validity determination could effectively lock out future IPRs. Once a claim survives in court or at PTAB, the rule cuts off serial petitioners, creating a stability that has long been missing from the AIA regime.

That stability has cascading effects. Portfolio valuation could rise for “battle-tested” claims. Licensing negotiations could occur from a position of strength. Early wins could deter further challenges altogether. Patent owners may adjust their enforcement strategies to prioritize securing a first validity ruling in a favorable forum — knowing it could be the only one that matters.

This shift could be especially consequential for life sciences companies, universities, and startups, whose patents often face waves of post-grant challenges designed to delay investment or erode market confidence.

Implications for Petitioners: A Compressed and Riskier Playbook

For petitioners — particularly large technology companies and generics — the proposal compresses strategic maneuvering into a single shot.

No follow-on petitions to refine arguments. No hedging between PTAB and district court. No dual-track invalidity campaigns. The first petition must be the best petition.

This will demand heavier up-front investment in prior art searches, expert declarations, and procedural planning. Forum selection becomes binding: filing at PTAB forecloses § 102 and § 103 defenses in court, while opting for litigation forfeits the speed and technical focus of PTAB.

The risk profile of challenging patents shifts. A single failed IPR could foreclose future defenses entirely, fundamentally changing the economics of litigation strategy in tech and pharma disputes.

Legal Flashpoints: The Rule Will Be Tested

A rule this aggressive will not go unchallenged. Petitioners are likely to contest it on several grounds:

• Statutory overreach. Petitioners will argue that categorical bars exceed § 314(a) discretion and conflict with the broad access rights in § 311(a).

• Retroactivity. If applied to ongoing disputes, challengers may raise Landgraf v. USI Film Products, 511 U.S. 244 (1994), due process objections.

• APA claims. The Administrative Procedure Act will require the USPTO to justify why bright-line rules are superior to existing discretionary tools.

Although Oil States Energy Servs., LLC v. Greene’s Energy Grp., LLC, 138 S. Ct. 1365 (2018), upheld IPR’s constitutionality, restricting access too severely could reignite delegation or due process challenges.

Policy Context: Finality as Innovation Strategy

The proposed rule also fits into a broader policy turn toward patent stability. Federal agencies and courts have grown less tolerant of serial validity attacks that stretch disputes for years. Lawmakers increasingly frame IP certainty as essential to domestic innovation and investment.

For the USPTO, this is also an institutional management decision. Serial petitions and overlapping litigation have strained resources. A one-and-done framework simplifies the docket and brings PTAB practice closer to traditional principles of judicial economy.

Strategic Next Steps: Getting Ahead of the Curve

Although the comment period runs through November 17, 2025, sophisticated actors are already adapting.

Patent owners should:

• Identify patents with prior favorable validity outcomes or strong litigation posture.

• Position key assets for early adjudication in favorable forums.

• Revisit portfolio valuation and licensing strategies in light of increased stability.

Petitioners should:

• Front-load prior art analysis and expert development before filing.

• Reassess forum selection strategy—there will be no second swing.

• Prepare for higher stakes and potentially longer lead times before filing.

These adjustments are not optional. They will define who thrives and who miscalculates in a post–one-and-done landscape.

The End of the Two-Bite Era

The USPTO’s “one-and-done” proposal marks a philosophical and strategic pivot in U.S. patent practice. It moves the decisive moment in patent validity challenges to the very beginning, closing off the backdoors that defined the last decade of PTAB strategy.

For patent owners, it’s a long-awaited measure of stability and leverage. For challengers, it’s a compressed and higher-stakes game. And for the entire innovation ecosystem, it signals that finality—not flexibility—is becoming the governing value of post-grant practice.

Whether the rule survives statutory and constitutional scrutiny remains to be seen. But its gravitational force is already shaping how sophisticated parties plan their next moves.