Update: In a letter dated March 28, 2018, Robert Firestone wrote to the NIH on behalf of Penn, stating that the NIH grants were infrastructure grants that did not give the NIH rights in the inventions.
2018-03-28-Penn-Response-juxtapid-Rader
On March 19, 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
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 following two pdf files list 158 NIH funded projects at the University of Pennsylvania, for which Daniel Rader as the PI.
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@mail.nih.gov
Jill Roering, Acting Deputy Director
Office of Technology Transfer
National Institutes of Health
roeringj@mail.nih.gov
Bruce Goldstein, JD, MS, Assistant Director, Monitoring & Enforcement,
Office of Technology Transfer
National Institutes of Health
goldsteb@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@keionline.org
James Love, Director, KEI
james.love@keionline.org
+1.202.332.2670
Cc: The Honorable Daniel R. Levinson, Dan.Levinson@oig.hhs.gov