Note: There is an update on this issue, here: https://www.keionline.org/23454, noting that the University filed a correction to each of the five patents, reporting federal funding of the inventions.
Knowledge Ecology International has conducted an investigation into the patents held by the University of Pennsylvania with regard to chimeric antigen receptor t-cell (CAR T) therapy, and has reason to believe that five of these patents fail to disclose the fact that they were developed with federal funds.
The Bayh-Dole Act requires that companies disclose when public funds are used to create an invention. These disclosures should be made on the application for the patent and printed on the patent in a “Statement Regarding Federally Sponsored Research Or Development.”
Companies which fail to disclose federal funding, and thus federal rights in their patents can forfeit patent rights.
KEI focused on thirteen patents which mention “chimeric antigen receptor” which are assigned to the Trustees of the University of Pennsylvania, and which had the exact same five inventors and the exact same earliest priority date for each patent.
Of the thirteen patents, five patents, filed between August 2014 to December 2014, did not make a statement regarding federal funding.
KEI reviewed the patent claims for each of the five patents that failed to disclose federal funding, and also reviewed academic papers related to the inventions. In addition to several relevant academic papers that reported the NIH funding, the National Institutes of Health has itself identified three NIH grants which were related to each of the five undisclosed patents.
The first CAR T therapy, Kymriah, was approved by the FDA in August of 2017 and released by Novartis with a $475,000 price tag. Kymriah was developed with the University of Pennsylvania NIH funded CAR T research.
When the federal government has rights in a patent, there are opportunities for it to require less restrictive licensing, and an obligation to make the invention “available to the public on reasonable terms.”
KEI has asked the Department of Health and Human Services to conduct an investigation into these patents and to seek remedies for the non-disclosure.