[Ip-health] KEI finds University of Pennsylvania failed to disclose government rights in five CAR T patents

James Love james.love at keionline.org
Tue Oct 17 06:15:10 PDT 2017


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

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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