On March 21, 2018, KEI asked the NIH to investigate the failure of James Griffin, the Dana-Farber Cancer Institute and Novartis to disclose millions of dollars in NIH grants related to two patents for the leukemia drug midostaurin, marketed by Novartis as Rydapt. KEI has asked the NIH to take title to the two patents, as a remedy to the failure to disclose the NIH funding.
Midostaurin was first synthesized in 1986, and the Dana-Farber NIH funded research has been used to create a monopoly on its use.
The 2017 price for Rydapt was $133.84 for each 25mg capsules. The recommended dose for a patient with acute myeloid leukemia (AML) is 4 capsules per day, and for advanced systemic mastocytosis (ASM), 8 capsules per day. The annual costs for AML is $195,405 per year, and for ASM, $390,811 per year.
Griffin has been working in the field of leukemia research since 1985 and has received over $44 million in funding for 71 projects (and subprojects) where he was the principal investigator. Many of these NIH grants were during the time period of and on topics related to the patents at issue, including over $15 million in grants between 1996-2001, leading up to the priority date of both patents, and over $8 million in grants between 2009-2011, leading up to the filing date of the second patent. Griffin was the co-author of papers that describe the invention, refer specifically to midostaurin, and disclose NIH funding.
Commenting on the Griffin patents, KEI director James Love said:
“It was either a remarkable case of amnesia to forget these NIH grants when the patents were filed, or something else. Griffin is the inventor or co-inventor for 10 US patents. The first five, filed from 1987 to 1991, disclosed federal funding. The next five, filed from 2002 to 2015, did not, despite receiving millions of dollars for research on leukemia. Dana-Farber and Novartis were both keenly aware of the NIH funding for Griffin’s research, and share responsibility for the failure to disclose the role of the federal funding in the Rydapt patents. We are asking the NIH to take title to the patents, a sanction that would send a signal to all NIH grant recipients that the requirements to report the federal funding of inventions are being taken seriously, and enforced.”
A copy of the March 21, 2018 KEI memo to the NIH is available here:
A copy of the KEI cover letter to the NIH is available here.
The Annexes to the memorandum are as follows: