The PREVAIL Act Is Back. Will It Prevail This Time?

On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The reintroduced bill is substantively unchanged from the prior version introduced in July 2023. Generally, it is aimed at bringing Patent Trial and Appeal Board (PTAB) procedures in line with those of District Courts, as well as further reducing potential overlap between proceedings in both forums. Its key provisions include:

• Adding a standing requirement to bring an inter partes review (IPR) or post-grant review (PGR) petition
• Imposing a presumption of validity and requiring a showing of invalidity by “clear and convincing” evidence
• Precluding defendants in District Court proceedings and respondents in International Trade Commission (ITC) proceedings from later bringing IPR challenges at the PTAB
• Attaching estoppel upon the filing of an IPR or PGR petition
• Limiting multiple challenges against the same patent

For more information on the PREVAIL Act’s terms, please see “Eleven Ways the PREVAIL Act Would Alter PTAB Practice” and our 2024 Post-Grant Annual Report.

How we got here

The PREVAIL Act was originally introduced in July 2023 by the same sponsors as the 2025 version. In its legislative findings, the bill states that the 2011 America Invents Act (AIA) has had “unintended consequences,” including the filing of post-grant proceedings to “depress stock prices and extort settlements,” the filing of repetitive petitions that have the effect of “harassing patent owners,” and the “unnecessary duplication of work” by District Courts and the PTAB. The bill couches the need for PTAB reform partially in national security terms, stating that China is “leveraging and exploiting intellectual property as a critical tool within its national strategies for emerging technologies” and that the U.S. has failed to reform its patent laws in response. Proponents have noted that the Act is needed to ensure “quiet title” to intellectual property rights.

The 2023 bill was debated in the Senate Judiciary Committee for over a year. In one hearing, several senators on the committee expressed concerns that the bill’s standing requirement would negatively impact the ability of patient advocacy groups and generic drugmakers to challenge branded drug patents at the PTAB. To address those concerns, Senator Coons introduced a manager’s amendment to relax the standing requirement for nonprofit organizations, which could include patient advocacy groups. While that amendment was sufficient to assuage some skeptical legislators, several voted “no” on the bill despite the amendment, expressing continued concern about its impact on generic drug prices. Senator Ted Cruz (R-TX) proposed an amendment that would allow small businesses to opt out of PTAB proceedings. While that amendment failed, several senators expressed support for the general concept of allowing small business opt-outs.

Ultimately, the bill was voted out of committee and onto the Senate floor by a vote of 11-10 in December 2024, whereafter it stalled upon the conclusion of the 118^th Congress. The bill was then reintroduced in May 2025.

Where we’re going

The bill is currently before the Senate Judiciary Committee. If the prior version of the bill is any indication, objections are likely to focus on the bill’s impact on the pharmaceutical industry, including concerns that its standing requirements could bar challenges by generic drugmakers and nonprofit patient advocacy groups. If these and other Judiciary Committee concerns are sufficiently addressed, the bill will pass out of the Judiciary Committee and onto the Senate floor for further consideration, where it could be passed as-is, further amended, or killed. If the bill passes the Senate, it would then head to the House of Representatives, where a similar process would play out. If the bill passes both the Senate and the House, a conference committee would work out significant differences between the Senate version and the House version. (Conference committees typically are appointed by the Senate Majority Leader and the House Speaker, and they are composed of members of committees within the Senate and House that originally considered the bill.) If each house passes the finalized bill, it would then be presented to the President to be signed into law or vetoed. While it’s unclear how long this process will take, the bill must either become law or fail by the end of the 119^th Congress in January 2027.

Reactions

Reactions to the PREVAIL Act have been mixed.

A recent endorsement came from John Squires, President Trump’s nominee for USPTO Director, in a hearing before the Senate Judiciary Committee on May 21. Asked by Senator Chris Coons (D-DE) whether the PTAB needs reform and whether the PREVAIL Act would help, Squires answered both questions in the affirmative. Much of Squires’ testimony before the committee focused on his support for various legislative patent reform initiatives, including the PREVAIL Act, as tools to boost U.S. competitiveness in the global market.

In a letter to Congress, the PTAB Bar Association examined the impact of several features of the bill. The letter recognized the potential for supporting “just, speedy, and inexpensive resolutions” with measures that reduce duplication of efforts across proceedings in District Court and the PTAB and increased transparency and autonomy in panel selection and decision-making. However, the letter expressed concerns regarding other features of the bill. For example, it noted that proposed limitations to multiple petitions could have unintended consequences, each unrelated to whether implicated patents are valid under the law, such as where petitioners have good cause to file multiple petitions due to the length or complexity of the challenged patent; that the standing requirement may limit access to just, speedy, and inexpensive resolutions; and that restrictions on joinder and the new estoppel rules may paradoxically encourage duplicative challenges. Among other concerns, the letter noted that the Act precludes clearance of invalid patents before proceeding with domestic investments and fails to account for the litigation behavior of plaintiffs. Due to these key areas of concern, the Association’s position is that the bill should not be enacted in its current form.

Likewise, while generally indicating support for legislative efforts to improve the implementation of the AIA, a letter from the American Intellectual Property Law Association (AIPLA) encouraged several amendments to the PREVAIL Act, including clarifications related to the standing requirement (§ 4(a)), the single forum previsions (§ 4(c)(1)(C)), the estoppel provisions (§4(c)(1)(F)), and the provision related to the effect of an ITC determination (§ 4(c)(1)(G)). The AIPLA shares the PTAB Bar Association’s concern that the bill’s limitations on multiple petitions could stymie parallel petitions filed for good cause.

Several inventor advocacy organizations, including US Inventor and the Innovation Alliance, also express a desire for change of the type advanced through the bill, although US Inventor notes that the bill in its current form does not go far enough to address “perverse incentives” and proposes a strengthening amendment. The Association for Accessible Medicines, a generic and biosimilar advocacy group, opposes the bill, arguing that it will make it more difficult for generics and biosimilars to challenge drug patents.