[Ip-health] KEI Letter to NIH regarding UPenn/ James Wilson et al. Failure to Disclose Federal Funding in 7 patents relating to gene therapy
james.love at keionline.org
Thu Sep 19 06:34:05 PDT 2019
On September 3, 2019, KEI submitted a request to the NIH that it
investigate an apparent failure to disclose federal funding in patents in
adeno-associated viral (AAV) gene therapies. A failure to disclose federal
funding is a violation of the Bayh-Dole Act (35 U.S.C. §§ 200 et seq) and
if confirmed, carries several possible remedies, including the remedy that
the government take title of the patents in question. The request concerns
7 patents assigned to the Trustees of the University of Pennsylvania
(UPenn) that list 3 inventors: Guangping Gao, James M. Wilson, and Mauricio
KEI’s current request concerns patents that expand on the technologies in
Luxturna, a gene therapy that treats a type of blindness. Luxturna is
currently sold by Spark Therapeutics at a price of $425,000 per eye.
For more on KEI’s work on non-disclosure of federal funding in medical
technology patents, please see:
(Update: KEI also separately filed a request to the NIH regarding further
AAV-related patents assigned to the University of Pennsylvania that failed
to disclose federal funding, concerning another set of inventors, Jean
Bennett, Therese Cronin, and Luk Vandenberghe.)
A PDF version of the request is available here, and the full text of the
request follows below.
September 3, 2019
Ms. Michelle G. Bulls
Office of Policy for Extramural Research Administration (OPERA)
National Institutes of Health
Via E-mail: MICHELLE.BULLS at NIH.GOV
Dear Ms. Bulls,
I am writing to request an investigation into apparent non-disclosure of
federal funding for several patents assigned to the Trustees of the
University of Pennsylvania.
KEI has been investigating federal funding of certain gene therapies. In
this instance, we are writing in regards to seven patents that were issued
to the same three inventors and assigned to the Trustees of the University
of Pennsylvania that do not disclose federal funding.
The three inventors are:
James M. Wilson, and
All seven patents that did not report federal funding are related to
adeno-associated virus (AAV) sequences. The patent numbers, filing dates
and patent titles are listed in Table 1.
Table 1: Seven patents related to AAV sequences with the same three
inventors and no federal funding disclosures.
The seven which do not disclose federal funding in the U.S. PTO database or
in the NIH RePORTER database, can be compared to the following ten patents
in Table 2 that have the same three inventors and also pertain to AAV
sequences, but do report federal funding in the patents.
Table 2: Ten patents relating to AAV sequences with the same three
inventors and federal funding disclosures.
In addition, there are three other patents that have the same title as the
patents in Table 2 and have the same three inventors, plus a fourth
inventor (Luk H. Vandenberghe), and which also disclose federal funding
involving the same two grants.
Table 3: Three patents related to AAV sequences with the same three
inventors as in Table 1 and 2, plus Luk Vandenberghe, with disclosures of
Also, we note that James Wilson is listed as the principal investigator for
109 projects and 90 subprojects at Penn involving $105.5 million in NIH
funding from seven different NIH institutes/centers, from 1992 to 2019,
indicating that public funding has played a significant role in supporting
We would like to speak with you or the appropriate contact in your office
about this and other related cases of non-disclosures of federal funding in
James Love. Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
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