NIH to Grant Exclusive Patent License for Ebola Neutralizing Monoclonal Antibody

Strategic Insights -

The National Institute of Allergy and Infectious Diseases (NIAID) is considering granting an exclusive patent license to Ridgeback Biotherapeutics, L.P. for the development, production, and commercialization of an Ebola neutralizing monoclonal antibody, mAb114, for the treatment of Ebola virus disease in humans. This license would cover the use of the antibody as a single therapy, not in combination with other monoclonal antibodies. The potential license would be royalty-bearing and could be granted unless objections are received within 15 days of the published notice.

Key Takeaways:

  • The NIAID is contemplating granting an exclusive patent license to Ridgeback Biotherapeutics, L.P. for an Ebola neutralizing monoclonal antibody, mAb114.
  • The license would cover the development, production, and commercialization of the antibody for the treatment of Ebola virus disease in humans.
  • The patent and patent application rights in the 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 fields of use may be limited to the specified treatment for Ebola virus disease.
  • The license would be royalty-bearing and may be granted unless objections are received within 15 days of the published notice.
  • Interested parties can submit comments or objections, but applications for a license will be treated as confidential.
  • The Freedom of Information Act will govern the release of information from license applications.

Statistics:

  • The license would cover the use of mAb114, a single monoclonal antibody, for the treatment of Ebola virus disease in humans.
  • The patent and patent application rights in the 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.
  • 35 U.S.C. § 209 and 37 CFR 404 govern the grant of the prospective exclusive patent commercialization license.

Sources:

  • 35 U.S.C. § 209
  • 37 CFR 404
  • United States Provisional Patent Application No. 62/087,087, filed 3 December 2014 (HHS Reference No. E-045-2015-0-US-01)
  • International Patent Application No. PCT/US2015/060733, filed 13 November 2015 (HHS Reference No. E-045-2015-0-PCT-02)
  • European Patent Application No. 15797815.6, filed 13 November 2015 (HHS Reference No. E-045-2015-0-EP-03)
  • United States Patent No. 10,273,288, issued 30 April 2019 (HHS Reference No. E-045-2015-0-US-05)