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Exclusive Patent License for Engineered Tumor Infiltrating Lymphocytes for Cancer Therapy

Strategic Insights

— 2 min read

The National Cancer Institute has announced its intention to grant an exclusive patent license to practice inventions related to engineered tumor-infiltrating lymphocytes for cancer therapy to Iovance Biotherapeutics, Inc. This license would allow Iovance to develop, manufacture, distribute, sell, and use autologous tumor-infiltrating lymphocyte (TIL) adoptive cell therapy products for cancer treatment.

Key Takeaways:

  • The National Cancer Institute is contemplating the grant of an exclusive patent license to Iovance Biotherapeutics, Inc. for inventions related to engineered tumor-infiltrating lymphocytes for cancer therapy.
  • The license would cover the use of autologous TIL adoptive cell therapy products for cancer treatment, excluding products genetically engineered to express a chimeric antigen receptor and/or T cell receptor.
  • The patent 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 field of use would be limited to the treatment of cancer.
  • The license would be royalty-bearing and would not be granted if within 15 days of the published notice, the National Cancer Institute receives evidence and argument establishing that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
  • Iovance would need to submit license applications to the National Cancer Institute, which would be treated as confidential.

Statistics:

  • The patent applications listed in the Supplementary Information include US Provisional Patent Application 61/174,046, filed on April 30, 2009, and International Patent Application PCT/US2010/031988, filed on April 22, 2010.
  • The inventions are primarily directed to recombinant constructs for the inducible expression of Interleukin-12 (IL-12).
  • IL-12 has been reported to be an important immunostimulatory cytokine, but its clinical utility has been constrained by dose-limiting toxicity following systemic administration.
  • The subject invention potentially addresses this limitation by operatively associating a nuclear factor of activated T cells (NFAT) promoter with the coding sequence for IL-12.
  • The prospective exclusive license would be granted unless the National Cancer Institute receives written evidence and argument establishing that the grant would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
  • The National Cancer Institute has announced that public comments or objections may be submitted in response to the Notice, but would not be treated confidentially.

Sources:

  • Notice of Intent to Grant Exclusive Patent License, National Institutes of Health, HHS, Federal Register, 2022-08795, April 25, 2022.
  • US Provisional Patent Application 61/174,046, filed on April 30, 2009.
  • International Patent Application PCT/US2010/031988, filed on April 22, 2010.
  • United States Patent 8,556,882, issued on October 15, 2013.

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