(Update: The NIH provided a response to our comments on November 15, 2019)
On Friday October 18, 2019, Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) submitted comments on the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer” (84 FR 52890)by the National Institutes of Health (NIH) National Cancer Institute (NCI) to Ziopharm Oncology, Inc. located in Boston, MA. The proposed license would grant Ziopharm the worldwide, exclusive rights to the development, manufacture, and commercialization of autologous blood T cell therapy products for the treatment of human cancers.
The technology to be licensed includes two T-cell therapies, one which targets mutations in the Kirsten rat sarcoma viral oncogene homolog (KRAS) gene and one which targets mutations in the p53 tumor protein. The KRAS gene and p53 mutations are expressed in a wide variety of cancers, including: lung cancers, endometrial cancer, colon cancer, rectal cancer, ovarian cancer, glioblastoma, uterine cervical cancer, head and neck cancer, breast cancer, pancreatic cancer, bladder cancer, cholangiocarcinoma, and melanoma. With such a broad range of potential applications, the NIH must carefully evaluate both the necessity of an exclusive license in the technology, as well as the company receiving the license.
KEI and UACT outlined the following objections to the exclusive license:
- KEI’s correspondence with the National Institutes of Health (NIH) concerning the prospective license indicates that the NIH has not faithfully applied the criteria in 35 U.S.C. § 209 and 37 C.F.R. § 404.7;
- The NIH has not been completely transparent about the license, impeding the public’s right to comment under 35 U.S.C. § 209(e); and
- The NIH apparently has not sought the antitrust advice of the U.S. Attorney General regarding the license, as required by 40 U.S.C. § 559.
KEI and UACT note that Drew Deniger, a former NIH scientist who discovered at least one of the subject inventions, joined Ziopharm in July 2019. An inventor can play an important role in bringing an invention to practical application, by bringing passion, vision and expertise to the endeavor. That said, when an NIH employee who discovers an invention in his or her capacity as an NIH researcher is soon after employed by the company to which the NIH licenses the invention, it is particularly important for the NIH to demonstrate that it properly evaluated the criteria for granting exclusive patent licenses, located at 35 U.S.C. § 209, which includes a responsibility to protect the public’s interests in the inventions it financed.
A PDF of the full comments is available here: KEI_UACT_Comments_NIH_Exclusive_License_Ziopharm_18Oct2019