Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       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 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 Leyden Laboratories B.V., located at Emmy Noetherweg 2, 2333 BK Leiden, the Netherlands to practice the inventions embodied in the patent applications listed in the                         **SUPPLEMENTARY INFORMATION**                         section of this notice.                    

# DATES:

Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before November 3, 2023 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: Dawn Taylor-Mulneix, Technology Transfer and Patent Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Suite 2G, MSC 9804, Rockville, MD 20852-9804, phone number 301-767-5189, or                         *dawn.taylor-mulneix@nih.gov.*

# SUPPLEMENTARY INFORMATION:

The following represents the intellectual property to be licensed under the prospective agreement: U.S. provisional application (63/308,898), filed on February 19, 2022, and the PCT application (PCT/US2023/062324), filed on February 9, 2023, entitled “Human Monoclonal Antibodies that Broadly Target Coronaviruses” (HHS Reference No. E-047-2022). All rights in these inventions have been assigned to the Government of the United States of America.

                    The prospective exclusive patent commercialization license territory may be worldwide, and the field of use may be limited to: Prevention and treatment of coronavirus infection, illness, and transmission through mucosal delivery                           ( print page 72089)                        to the respiratory tract of products, comprised of COV44-62 (fusion peptide), COV44-79 (fusion peptide), COV89-22 (stem helix), and/or COV72-37 (stem helix), including products that may be obtained from the genetic sequence of the same and derivatives thereof. The prospective exclusive patent commercialization license may include two products (preventative and therapeutic) in the field of use.                

                    An abstract for this invention was published in the                     **Federal Register**                     on June 10, 2022. The family of coronaviruses cause upper respiratory tract disease in humans and have caused three major disease outbreaks in recent history: the 2003 SARS outbreak, the 2012 MERS outbreak, and the current SARS-CoV-2 pandemic. There is an urgent need for strategies that broadly target coronaviruses, both to deal with new SARS-CoV-2 variants and future coronavirus outbreaks.                

Scientists at NIAID have developed several novel human monoclonal antibodies that bind to conserved parts of the SARS-CoV-2 spike protein. These antibodies can neutralize SARS- CoV-2 variants of concern including Omicron BA.1 and BA.2, as well as neutralize at least one other betacoronavirus. Further, these antibodies limit disease in animal models. Broadly reactive antibodies against coronaviruses are useful tools to identify conserved sites on the coronavirus spike protein, which could be investigated for the development of broad coronavirus vaccines that aim to prevent future pandemics. Potent neutralizers that target these sites could also be useful for prevention of disease caused by diverse coronaviruses, including those that may emerge in the future.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing, and 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.

                    Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization license. Comments and objections submitted in response to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the                     *Freedom of Information Act,*5 U.S.C. 522.                

Surekha Vathyam,

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

[FR Doc. 2023-23030 Filed 10-18-23; 8:45 am]

BILLING CODE 4140-01-P