[Ip-health] University of Pittsburgh Failure to Disclose Federal Funding for Patents on Vizamyl

Claire Cassedy claire.cassedy at keionline.org
Fri May 18 10:45:10 PDT 2018


https://www.keionline.org/27865

University of Pittsburgh Failure to Disclose Federal Funding for Patents on
Vizamyl
Posted on May 18, 2018 by Claire Cassedy

On May 18, 2018 KEI requested that the Department of Health and Human
Services (HHS) investigate the failure to disclose National Institutes of
Health (NIH) funding in four patents on Vizamyl (INN flutemetamol F 18),
which is used to evaluate possible cases of Alzheimer’s disease and other
causes of cognitive decline. The patents are assigned to the University of
Pittsburgh, and all list the same three inventors, William Klunk, Chester
A. Mathis, Jr., and Yanming Wang.

Together, the inventors have received more than $66 million in NIH grants
for projects for which they are listed as Principal Investigators.

-According to the NIH RePORTER database, from 1988 to 2018, William Klunk
was the principal investigator for grants obtained from the NIH consisting
of 52 projects, 35 sub-projects and a total funding amount of $47,209,483.
-From 1986 to 2018, Chester A. Mathis, Jr. received NIH grants consisting
of 31 projects and 12 subprojects with a total funding amount of
$14,936,292.
-From 2003 to 2013, Yanming Wang was listed as the principal investigator
for 19 NIH projects involving $4,116,038 of funding.

In published papers that describe the inventions in Vizamyl, the
inventors/authors, acknowledge NIH and Department of Energy (DOE) finding
of their work, but did not report the grants on the patents themselves, and
the patents do not appear in the NIH RePORTER database.

KEI is asking HHS, as a remedy to this failure to disclose federal funding,
to take title to the patents.  Taking possession of the patents is a remedy
available to the government in cases of non-disclosure of federal funding,
as laid out in the Bayh-Dole Act.

Below are the materials submitted to HHS regarding this request:

-Vizamyl Failure to Disclosue Federal Funding in Patents:
https://www.keionline.org/wp-content/uploads/2018/05/Vizamyl-patent-memo-UofPittsburgh-Klunk-Mathis-Wang-18May2018.pdf
-KEI Cover Letter Regarding Vizamyl Patents:
https://www.keionline.org/wp-content/uploads/2018/05/Azar-KEI-CoverLetter-Vizamyl-patents-18May2018.pdf
-Annex: KEI Briefing Note 2018:1:
https://www.keionline.org/wp-content/uploads/2018/05/KEI-Briefing-Note-2018-1.pdf

---------------------------------------------------------------------------------

The cover letter to Secretary Azar follows:

May 18, 2018

The Honorable Alex Azar
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Via email: secretary at hhs.gov

Re: Investigation into the failure disclose NIH funding in inventions
patented by the University of Pittsburgh for flutemetamol F 18),

Dear Secretary Azar:

We are writing to ask the Department of Health and Human Services (HHS) to
investigate and if applicable, to remedy a failure to disclose National
Institutes of Health (NIH) funding in four inventions patented by the
University of Pittsburgh. The four inventions are identified in the FDA
Orange Book as patents for Vizamyl (INN flutemetamol F 18), used to
evaluate possible cases of Alzheimer’s disease or other causes of cognitive
decline. Access to the tests is currently restricted, including
restrictions on reimbursements by Medicare.

Knowledge Ecology International (KEI) asks that HHS take title to the four
patents. The legal basis for the proposed remedy is set out in the attached
memorandum, Bayh-Dole Obligations to Disclose Federal Funding in Patented
Inventions. One of the possible remedies for non-disclosures, as set out in
35 U.S.C. § 202(c)(1) and 37 C.F.R. § 401.14, is for the federal government
to take possession of the patent title.

We believe this is an egregious case of non-disclosure. The same three
inventors are listed for each of the four patents. Collectively they were
the principal investigators in NIH grants involving more than $66 million.

-According to the NIH RePORTER database, from 1988 to 2018, William Klunk
was the principal investigator for grants obtained from the NIH consisting
of 52 projects, 35 sub-projects and a total funding amount of $47,209,483.
-From 1986 to 2018, Chester A. Mathis, Jr. received NIH grants consisting
of 31 projects and 12 subprojects with a total funding amount of
$14,936,292.
-From 2003 to 2013, Yanming Wang was listed as the principal investigator
for 19 NIH projects involving $4,116,038 of funding.

This actually understates the amount of federal funding involved, since the
inventors have also received NIH research contracts and funding from the
Department of Energy for this research.

The inventors have made references to NIH and DOE funding of their work in
papers describing the inventions, but did not report the grants on the
patents, and the patents do not appear in the NIH RePORTER database.

The patents were subsequently licensed to GE Healthcare. We believe the
public interest would be served if the patents were licensed on a
non-exclusive basis, permitting more competition in the use of the
inventions, resulting in greater innovation and lower prices. Lower prices
for flutemetamol F 18 may expand access to the test, which, as Medicare
describes, “may be clinically useful in the work up and management of
patients with cognitive impairment who are being evaluated for possible
Alzheimer’s disease or other causes of cognitive decline.”

Finally, we note that this one of several letters we have sent to the HHS
and/or the NIH, regarding failure of NIH grant recipients to disclose
federal funding. We are still waiting to hear the conclusions of
investigations regarding Cold Spring Harbor patents on nusinersen (trade
name Spinraza), the Pharmasset/Gilead patent on sofosbuvir, the Dana Farber
Cancer Institute patents on midostaurin (Trade name Rydapt), multiple
institutions’ (including an NIH-funded project at a foreign university)
patents on Exondys 51, and the University of Pennsylvania patents on
Lomitapide (trade name Juxtapid). We are making these inquiries as a public
service, to ensure the public has the opportunity to benefit from the
safeguards and public interest provisions in the Bayh-Dole Act, including
the obligation by patent holders to make the inventions available to the
public on reasonable terms, the ability of the NIH to ensure broad use of
inventions for research purposes, and the requirements in the Bayh-Dole Act
for domestic manufacturing of products, among other requirements.

Sincerely,

James Love, Director, KEI
james.love at keionline.org
+1.202.332.2670

Attachments:

Vizamyl (INN flutemetamol F 18): Failures to disclose NIH funding for four
patents in the FDA Orange Book invented by William Klunk, Chester Mathis,
Jr., and Yanming Wang, and assigned to the University of Pittsburgh.
Knowledge Ecology International, May 18, 2018.
KEI-Briefing-Note-2018-1

Cc:

Dr. Francis Collins, Director, the National Institutes of Health:
Francis.Collins at nih.hhs.gov

The Honorable Daniel R. Levinson, Inspector General, Office of Inspector
General (OIG), HHS, Dan.Levinson at oig.hhs.gov

Ann M. Hammersla, J.D., Director, Division of Extramural Inventions and
Technology Resources
Office of Policy for Extramural Research Administration,
hammerslaa at od.nih.gov

Rep. Tom Cole, Oklahoma, Chairman, Labor, Health and Human Services,
Education, and Related Agencies, Committee on Appropriations, House of
Representatives.

Rep. Rosa DeLauro, Connecticut, Ranking Member, Subcommittee on Labor,
Health and Human Services, Education, and Related Agencies, Committee on
Appropriations, House of Representatives.

Roy Blunt, Chair, Labor, Health and Human Services, Education and Related
Agencies, Committee on Appropriations, U.S. Senate

Patty Murray, Ranking Member, Labor, Health and Human Services, Education
and Related Agencies, Committee on Appropriations, U.S. Senate


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