[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 james.love at keionline.org
Thu Sep 19 06:39:04 PDT 2019


One correction to this post, which was a mistake in editing.  The Wilson
patents are not limited to treatments blindness.

Jamie

On Thu, Sep 19, 2019 at 9:34 AM James Love <james.love at keionline.org> wrote:

> https://www.keionline.org/31682
>
> 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
> Alvira.
>
> 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:
> https://www.keionline.org/bayh-dole/failure-to-disclose
>
> (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
> Director
> 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:
>
> Gao Guang-ping,
> James M. Wilson, and
> Mauricio Alvira.
> 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.
>
> .............. snip..........
>
> 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.
>
> ..............snip..............
>
> 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
> federal funding.
>
> .............snip................
>
> 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
> his research.
>
> 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
> patents.
>
> .................
>
>
>
> --
> James Love.  Knowledge Ecology International
> U.S. Mobile +1.202.361.3040
> U.S. office phone +1.202.332.2670
> http://www.keionline.org <http://www.keionline.org/donate.html>
> twitter.com/jamie_love
>


-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


More information about the Ip-health mailing list