2024-05878. Prospective Grant of an Exclusive Patent License: Manufacturing of Anti-Malaria Monoclonal Antibody L9LS in Transgenic Cows and Sheep

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Taurgen Malaria, Inc. (“Taurgen”), headquartered in Logan, UT. Taurgen Malaria, Inc. is a wholly-owned subsidiary of Taurgen Therapeutics, LLC, which is also headquartered in Logan, UT.

DATES:

Only written comments and/or applications for a license which are received by the National Institute of Allergy and Infectious Diseases' Technology Transfer and Intellectual Property Office on or before April 4, 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: Wade Green, Ph.D., Lead Technology Transfer and Patent Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intellectual Property

1. United States Provisional Patent Application No. 62/842,590, filed May 03, 2019, titled “Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use” [HHS Reference No. E–087–2019–0–US–01];

2. International Patent Application No. PCT/US2020/031345, filed May 04, 2020, titled “Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use” [HHS Reference No. E–087–2019–0–PCT–01];

3. European Patent Application No. 20727798.9, filed May 04, 2020, titled “Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use” [HHS Reference No. E–087–2019–0–EP–02]; and

4. United States Patent Application No. 17/608,381, filed October 02, 2021, titled “Neutralizing antibodies to Plasmodium falciparum circumsporozoite protein and their use” [HHS Reference No. E–087–2019–0–US–03].

The patent rights in these inventions have been assigned and/or exclusively licensed 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:

“Production of the L9LS monoclonal antibody in transgenic bovine and ovine species.”

The E–087–20219 patent family is primarily directed to (1) compositions of matter of the L9LS monoclonal antibody, (2) methods of treating and preventing infection with Plasmodium falciparum using the L9LS monoclonal antibody, and (3) methods of manufacturing the L9LS monoclonal antibody. The exclusive field of use which may be granted to Taurgen applies to only manufacturing of the L9LS monoclonal antibody in transgenic bovine and ovine species. Accordingly, the proposed scope of rights which may be conveyed under the license covers only a portion of total scope of the E–087–2019 patent family and only a subset of the possible methods of manufacturing the L9LS monoclonal antibody.

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 Institute of Allergy and Infectious Diseases 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.

Complete license applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from 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 14, 2024.

Surekha Vathyam,

Acting Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.