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Exclusive Patent License for PEDF Peptides and Retinal Degeneration Treatment

Favicon for www.federalregister.gov FR: National Institutes of Health
Published April 1st, 2026
Detected April 1st, 2026
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Summary

The National Eye Institute, part of the NIH, has published a notice of its intent to grant an Exclusive Patent License to Perpetual Biosciences, Inc. (New York, NY) covering PEDF (Pigment Epithelium-Derived Factor) peptides for treating retinal degeneration. The license would cover multiple patent applications and issued patents across US, Australia, Canada, European, and Japanese jurisdictions. The public comment period closes on April 16, 2026.

What changed

The NIH's National Eye Institute is contemplating granting an exclusive patent license to Perpetual Biosciences, Inc. for a family of patents and applications relating to Pigment Epithelium-Derived Factor (PEDF) peptides used in treating retinal degeneration. The intellectual property portfolio includes US Provisional Application 63/430,251, PCT Application PCT/US2024/064947, and issued Australian Patent No. 2023390868, among others. HHS Reference Nos. E-028-2023-0-US-01, E-028-2023-0-PCT-01, and related applications are included in the contemplated license.

Interested parties have until April 16, 2026 to submit written comments or competing license applications to NCI's Technology Transfer Center. Parties with relevant competing interests in retinal degeneration therapeutics or PEDF peptide technology should evaluate whether to challenge the exclusive license grant. Requests for copies of patent applications and inquiries should be directed to Geoffrey E. Ravilious, Ph.D. at the contact information provided.

What to do next

  1. Submit written comments by April 16, 2026 if you have concerns about the exclusive license grant
  2. Contact NCI Technology Transfer Center if seeking competing license rights for the PEDF peptide technology
  3. Review patent portfolio (HHS Reference E-028-2023 series) for potential overlap with your own intellectual property

Source document (simplified)

Notice

Prospective Grant of an Exclusive Patent License: Pigment Epithelium-Derived Factor (PEDF) Peptides and Use for Treating Retinal Degeneration

A Notice by the National Institutes of Health on 04/01/2026

  • This document has a comment period that ends in 15 days.
    (04/16/2026) View Comment Instructions

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  • Public Inspection Published Document: 2026-06283 (91 FR 16205) Document Headings ###### Department of Health and Human Services
National Institutes of Health

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

( printed page 16206)

SUMMARY:

The National Eye Institute, an institute of the National Institutes of Health, United States Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Perpetual Biosciences, Inc., a company located in New York, NY.

DATES:

Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center, representing the National Eye Institute, on or before April 16, 2026 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Geoffrey E. Ravilious, Ph.D., NCI Technology Transfer Center, Telephone: 240-276-6391; Email: geoffrey.ravilious@nih.gov.

SUPPLEMENTARY INFORMATION:

Intellectual Property

  1. United States Provisional Patent Application No. 63/430,251 filed December 5, 2022, entitled “PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND USE FOR TREATING RETINAL DEGENERATION” [HHS Reference No. E-028-2023-0-US-01];

  2. International Patent Application PCT/US2024/064947 filed March 24, 2023, entitled “PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND USE FOR TREATING RETINAL DEGENERATION” [HHS Reference No. E-028-2023-0-PCT-01]; and

  3. Australian Patent No. 2023390868 issued June 5, 2025, entitled “PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND USE FOR TREATING RETINAL DEGENERATION” [HHS Reference No. E-028-2023-0-AU-01];

  4. Canadian Patent Application No. 3,275,801 effective filing date of June 3, 2025, entitled “PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND USE FOR TREATING RETINAL DEGENERATION” [HHS Reference No. E-028-2023-0-CA-01];

  5. European Patent Application No. 23720018.3 filed July 1, 2025, entitled “PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND USE FOR TREATING RETINAL DEGENERATION” [HHS Reference No. E-028-2023-0-EP-01];

  6. Japanese Patent Application No. 2025-555099 effective filing date of June 4, 20125, entitled “PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND USE FOR TREATING RETINAL DEGENERATION” [HHS Reference No. E-028-2023-0-JP-01];

  7. United States Patent No. 19/135,668, entitled “PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND USE FOR TREATING RETINAL DEGENERATION” [HHS Reference No. E-028-2023-0-US-02].

  8. United States Provisional Patent Application No. 63/604,026 filed November 29, 2023, entitled “MODIFIED PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND METHODS OF USE” [HHS Reference No. E-028-2023-0-US-01]; and

  9. PCT Patent Application No. PCT/US2024/057784 filed November 27, 2024, entitled “MODIFIED PIGMENT EPITHELIUM-DERIVED FACTOR PEPTIDES AND METHODS OF USE” [HHS Reference No. E-028-2023-0-PCT-01];

  10. any and all other U.S. and ex-U.S. patents and patent applications claiming priority to any one of the foregoing, now or in the future.

The patent rights in these inventions have been assigned to the Government of the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be limited to the following:

“Peptide therapeutics for human ophthalmological diseases that may include but not be limited to retinitis pigmentosa, glaucoma, or age-related macular degeneration.”

This technology describes chemically synthesized peptide fragments derived from PEDF, a naturally occurring neurotrophic factor that is produced by retinal pigment epithelia. The biological roles of PEDF suggest that peptide fragments of PEDF have the potential to treat multiple diseases that fall within the Field of Use. Efforts to utilize native PEDF for therapeutic effect, as well as many invasive gene therapy approaches, have had minimal effect on outcomes for patients with ophthalmic diseases that result from neurodegeneration or retinal cell death. The subject invention potentially addresses the limited efficacy of approved therapeutic treatments for ophthalmic diseases that result from neurodegenerative pathologies and/or retinal cell death.

This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Eye Institute, receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

Dated: March 30, 2026.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.

[FR Doc. 2026-06283 Filed 3-31-26; 8:45 am]

BILLING CODE 4140-01-P

Published Document: 2026-06283 (91 FR 16205)

Classification

Agency
Health and Human Services Department
Published
April 1st, 2026
Comment period closes
April 16th, 2026 (15 days)
Compliance deadline
April 16th, 2026 (15 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Consultation
Change scope
Minor
Document ID
91 FR 16205

Who this affects

Applies to
Pharmaceutical companies
Industry sector
3254.1 Biotechnology 3254 Pharmaceutical Manufacturing
Activity scope
Patent Licensing Biotechnology Research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Legal
Topics
Intellectual Property Pharmaceuticals

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