2024-16594. Prospective Grant of an Exclusive Patent License: Adeno-Associated Virus Vector-Mediated Gene Delivery of Human Aquaporin-1 To Prevent Radiation-Induced Salivary Hypofunction

Document Headings

Document headings vary by document type but may contain the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

See the Document Drafting Handbook for more details.

Department of Health and Human Services

National Institutes of Health

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Institute of Diabetes and Digestive and Kidney Disease and National Institute of Dental and Craniofacial Research, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Australian, Brazilian, Canadian, Chinese, European, Hong Kong, Israeli, Japanese, South Korean, Mexican, Malaysian, New Zealand, Philippines, Singapore, United States, and South African Applications listed in the Supplementary Information section of this notice to MeiraGTx, LLC, located in New York City, New York, USA.

DATES:

Only written comments and/or applications for a license that are received by the National Institute of Diabetes and Digestive and Kidney Disease's Technology Advancement Office on or before August 13, 2024 will be considered.

ADDRESSES:

Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Vladimir Knezevic, MD, (Senior) Advisor for Commercial Evaluation, Technology Advancement Office, Building 12A, Room 3011, Bethesda, MD 20817-5632 (for business mail), Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intellectual Property

I. ARIPO Patent Application AP/P/2024/015557 filed on February 28, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-AP-01).

II. Australian Patent Application 2022325158 filed on February 26, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-AU-01).

III. Brazilian Patent Application BR112024002194-7 filed on February 7, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-BR-01).

IV. Canadian Patent Application 3227584 filed on January 31, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-CA-01).

V. Chinese Patent Application 202280058429.9 filed on February 27, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-CN-01).

VI. Eurasian Patent Application 202490372 filed on March 1, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-EA-01).

VII. European Patent Application 22786210.9 filed March 1, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-EP-01).

VIII. Hong Kong Patent Application entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-HK-01) with the priority filing date of August 4, 2021.

IX. Israeli Patent Application 310485 filed on January 29, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-IL-01).

X. Japanese Patent Application 2024-506727 filed on February 2, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-JP-01).

XI. South Korean Patent Application 10-2024-7007179 filed on February 29, 2024, published as 10-2024-0049295 on April 16, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-KR-01).

XII. Mexican Patent Application MX/a/2024/001577 filed on February 1, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-MX-01).

XIII. Malaysian Patent Application PI2024000751 filed on February 2, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-MY-01).

XIV. New Zealand Patent Application 808619 filed on February 26, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-NZ-01).

XV. Philippines Patent Application 1-2024-550312 filed on February 2, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-PH-01).

XVI. Singapore Patent Application 11202400787X filed on February 2, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-SG-01).

XVII. United States Patent Application 18/294,048 filed on January 31, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-US-02).

XVIII. South African Patent Application 2024/01677, filed on February 27, 2024, entitled “AQP1 Gene Therapy To Prevent Radiation-Induced Salivary Hypofunction” (HHS Reference Number E-129-2021-0-ZA-01).

The patent rights for these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide and in fields of use that may be limited to use of adeno-associated virus 2 vector-mediated gene delivery of human aquaporin-1 for the prevention of radiation-induced xerostomia (`dry mouth' syndrome).

The above-listed patent portfolio covers inventions directed to gene therapy and specifically, expression vector and therapeutic method of using such vector in the prevention of radiation-induced xerostomia.

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. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the 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.

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: July 23, 2024.

Vladimir Knezevic,

Senior Advisor for Commercial Evaluation, Technology Advancement Office, National Institute of Diabetes and Digestive and Kidney Disease.