[Ip-health] HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals' Spinraza

Zack Struver zack.struver at keionline.org
Thu Mar 16 08:32:56 PDT 2017


HHS Office of Inspector General Declines to Investigate Failure to Disclose
Federal Funding in Ionis Pharmaceuticals' Spinraza

Submitted by Zack Struver on 16. March 2017 - 10:39

The Department of Health and Human Services Office of Inspector General
(OIG) informed KEI that it would not move forward with an investigation
into whether Isis Pharmaceuticals, now known as Ionis Pharmaceuticals,
failed to report federal funding in patents on Spinraza.

In a letter dated March 13, 2017, Matthew Charette, the Special Agent in
Charge of the Investigations Branch of OIG, explained that OIG counsel
believes that OIG has limited authority, and that the obligation to
"monitor[] invention reporting and remedy[] noncompliance" "rests with
NIH's Office of Policy for Extramural Research Administration (OPERA)."

On January 18, 2017, KEI submitted a 22-page letter to OIG
<http://keionline.org/node/2710> containing evidence that the patents on
Spinraza benefited from federal grants. KEI did not just ask OIG to
investigate Isis' alleged failure to report this funding, in violation of
the Bayh-Dole Act and federal regulations, but also urged the OIG "to
investigate whether the National Institutes of Health failed to conduct
proper oversight in administering its grants" and to "recommend appropriate
action to remedy the situation in line with the statute and prior decisions
with regard to failure to disclose a subject invention."

Spinraza is used to treat Spinal Muscular Atrophy (SMA), a debilitating
illness that largely affects very young children. Biogen, which
collaborates with Ionis, sells Spinraza for a price of $750,00 for the
first year of four injections, and $375,000 for every year thereafter. As
explained in KEI's original letter to OIG, Ionis worked with researchers at
Cold Spring Harbor Laboratories who received federal funding for their work
on a treatment for SMA. We also noted that failure to disclose federal
funding affects the ability of the government to use march-in rights or its
royalty-free rights in patents under the Bayh-Dole Act.

The letter from is available as a pdf
and transcribed below.

Mr. Andrew Goldman
Legal Counsel
Knowledge Ecology International
1622 [sic] Connecticut Avenue, NW, Suite 500
Washington, DC 20009
Dear Mr. Goldman:

I am responding to your letter dated January 28, 2017, concerning potential
violations of the Bayh-Dole Act by Isis Pharmaceuticals, now known as Ionis
Pharmaceuticals, and Cold Spring Harbor Laboratory. You requested that the
Inspector General investigate whether two inventions patented by Isis and
Cold Spring Harbor are Federally-funded subject inventions that should have
been disclosed to the National Institutes of Health (NIH) and, if so,
recommend an appropriate remedy. We have consulted with our counsel and, as
explained below, we believe your requets is better handled by NIH.

Under the Inspector General Act of 1978 (IG Act), OIG may conduct
investigations relating to fraud, waste, abuse or other misconduct in
connection with programs and operations of HHS. However, OIG's authority is
limited. To preserve OIG's independence and objectivity, OIG may not assume
responsibility for the operation of a Departmental program. See §§ 4 and
9(a) of the IG Act. Here, the responsibility for administering and
overseeing extramural research grants rests with NIH's Office of Policy for
Extramural Research Administration (OPERA). This responsibility includes
monitoring invention reporting and remedying noncompliance. For this
reason, OIG must decline your request.

We did, however, contact representatives from NIH in connection with your
letter. We provided NIH with a copy of your letter, and we were informed
that NIH/oPERA is currently addressing your concerns. We recommend that you
contact NIH/OPERA for further information about this matter.

We hope that this information is useful to you. If you have additional
questions, please do not hesitate to contact me or Peter Taschenberger,
Senior Counsel at Peter.Taschenberger at oig.hhs.gov [4] or (202) 205-8896.

Matthew Charette
Special Agent in Charge
Investigations Branch

cc: James Love, Director
Zack Struver, Research Associate
Diane Singhroy, Scientific Advisor

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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