[Ip-health] Six University of Pennsylvania and Daniel J. Rader patents on Juxtapid (lomitapide) failed to discuss multiple NIH grants

Andrew Goldman andrew.goldman at keionline.org
Mon Mar 19 06:57:34 PDT 2018


https://www.keionline.org/27300

Six University of Pennsylvania and Daniel J. Rader patents on Juxtapid
(lomitapide) failed to discuss multiple NIH grants

Posted on March 19, 2018 by KEI Staff

On March 29, 2018, KEI asked the NIH to investigate the failure of the
University of Pennsylvania and Daniel J. Rader to report NIH funding
relating to 6 patents in the FDA Orange Book for the drug Juxtapid (INN
lomitapide).

A copy of the memorandum describing drug, the patents and the related
grants is available here:

Juxtapid patents: Memo on the failure to disclose Penn/Daniel Rader NIH
Grants, March 19, 2018 [
https://www.keionline.org/wp-content/uploads/2018/03/Juxtapid-Failure2disclose-Daniel-Rader-19Mar2018.pdf
]

The introduction of the memorandum read as follows:

Knowledge Ecology International (KEI) asks the Department of Health and
Human Services (DHHS) to investigate under-reporting of NIH research
funding on six patents granted to Daniel J. Rader as the sole inventor, and
assigned to a single entity, the Trustees of the University of
Pennsylvania, and to remedy the non-disclosure of NIH funding for the six
inventions.
The six patents all have the same priority date of March 5, 2004 and are
six of the eight patents listed in the FDA Orange Book for the drug
Juxtapid (INN lomitapide), a treatment for Homozygous Familial
Hypercholesterolemia (HoFH).

The Rader patents extend the monopoly on Juxtapid by seven years and six
months. The current price of Juxtapid is $1,380 per day, an increase of 70
percent since 2013. The University of Pennsylvania has played a significant
role in the development of this drug, acquiring two of the patents as a
donation from Bristol-Myers Squibb (BMS), relicensing the BMS and the Penn
patents to Aegerion Pharmaceuticals in 2006, and filing five of its six
patents after the Aegerion license and four after Juxtapid was approved by
the FDA.

Since 1996, Daniel Rader has been the principal investigator for NIH grants
involving $72 million. The KEI has focused on four grants the were
specifically related to BMS-201038, a compound now named lomitapide and
sold in the United States under the brand name Juxtapid.

Aegerion has been involved in several controversies, including a 2017
criminal conviction in the United States for violations of FDA laws
regarding the marketing and promotion of Juxtapid.

KEI is asking the NIH to take title to the patents, which is a remedy
available under the Bayh-Dole Act for non-disclosure of federal funding of
patented inventions. At a minimum, the Department of Health and Human
Services should require the University of Pennsylvania to correct the
failure to disclose the NIH grants and acknowledge the federal government
rights in the patent.

The cover letter to the NIH was as follows:

March 19, 2018

Karen Rogers, Acting Director
Office of Technology Transfer
National Institutes of Health
rogersk at mail.nih.gov

Jill Roering, Acting Deputy Director
Office of Technology Transfer
National Institutes of Health
roeringj at mail.nih.gov

Bruce Goldstein, JD, MS, Assistant Director, Monitoring & Enforcement,
Office of Technology Transfer
National Institutes of Health
goldsteb at mail.nih.gov

Dear Karen Rogers, Jill Roering and Bruce Goldstein:

I am forwarding a memorandum that describes six patents granted to Daniel J
Rader and assigned to the Trustees of the University of Pennsylvania, each
with the same title:

Methods for treating disorders or diseases associated with hyperlipidemia
and hypercholesterolemia while minimizing side effects.

All six patents are listed in the FDA Orange Book for the drug Juxtapid
(INN lomitapide). None of the six patents disclose federal funding. We
believe all six patents were based upon research funded by the NIH,
including but not limited to 4 NIH projects that include in their title
“BMS-201038,” the name of the compound now known as Juxtapid.

The memorandum provides more details on the relationship between the six
patents and the four grants, and asks the NIH to take title to the patents
as a remedy for the failure by Daniel Rader to acknowledge the NIH funding
in the patent application.

We were surprised that the University of Pennsylvania, which received more
than $68 million in grants from the NIH for which Daniel J. Rader was the
principal investigator, failed to disclose the NIH funding in the patent
application as required by law.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legal Affairs
andrew.goldman at keionline.org

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

Cc: The Honorable Daniel R. Levinson, Dan.Levinson at oig.hhs.gov

--
Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670 <(202)%20332-2670>
www.keionline.org


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