FDA Patent Clock Advances for VOWST, a Human-Derived Biologic
Published Date: 6/16/2025
Notice
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.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
VOWST regulatory review period set
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, 2023. This determination establishes the maximum potential length of a patent extension.
Applicant seeks 1,177-day patent extension
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.
VOWST approved for preventing CDI recurrence
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.
Deadlines to challenge dates or due diligence
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 requirements and be filed as specified.
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