# 2025-11039: FDA Patent Clock Advances for VOWST, a Human-Derived Biologic

2025-11039, Determination of Regulatory Review Period for Purposes of Patent Extension; VOWST, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Anyone with knowledge that any of the dates as published are incorrect must submit either electronic or written comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 15, 2025.; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11039
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11039
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; VOWST
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25341
- Published: 2025-06-16
- Effective: Anyone with knowledge that any of the dates as published are incorrect must submit either electronic or written comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 15, 2025.
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Patent Clock Advances for VOWST, a Human-Derived Biologic

## Summary

The FDA has officially set the review period for VOWST, a special human biological product, so its patent can be extended. This affects the company behind VOWST, giving them more time to protect their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they must act by August 15 or December 15, 2025.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOWST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

## Effects PRIA read

- VOWST regulatory review period set: benefit, high. FDA determined the regulatory review period for VOWST is 2,941 days total, consisting of 2,697 days in the testing phase and 244 days in the approval phase. The testing phase began April 9, 2015; the biologics license application was submitted August 26, 2022; and the BLA was approved April 26, 202…
- Applicant seeks 1,177-day patent extension: benefit, high. The patent applicant (Seres Therapeutics, Inc.) filed for patent term restoration seeking 1,177 days of patent term extension for patents U.S. Nos. 9,011,834; 9,180,147; and 9,446,080. The USPTO will apply statutory limitations in calculating the actual extension.
- Deadlines to challenge dates or due diligence: benefit, low. If you believe any published dates are incorrect you must request redetermination by August 15, 2025. Any interested person may petition FDA regarding whether the applicant acted with due diligence during the regulatory review period by December 15, 2025. Petitions must meet 21 CFR 60.30 requiremen…
- VOWST approved for preventing CDI recurrence: benefit, medium. FDA approved VOWST (fecal microbiota spores, live-brpk) to prevent recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI; the BLA approval date was April 26, 2023.

## Related documents

- [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13
- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27

## Sources
- [2025-11039 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11039/determination-of-regulatory-review-period-for-purposes-of-patent-extension-vowst)
- [2025-11039 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11039.pdf)

## Related
- [Previous: 2025-11038, Determination of Regulatory Review Period for Purposes of Patent Extension; ZEV…](https://policyrisk.com/federal-register/2025-11038)
- [Next: 2025-11040, Determination of Regulatory Review Period for Purposes of Patent Extension; RIV…](https://policyrisk.com/federal-register/2025-11040)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11039 (as of 2026-11-02).