WHA71: KEI intervention on Global strategy and plan of action on public health, innovation and intellectual property

At the 71st World Health Assembly, KEI will deliver the following intervention regarding the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property: 11.6 Global strategy and plan of action on public health, innovation and intellectual… Continue Reading

WHA71: KEI intervention on Addressing the global shortage of, and access to, medicines and vaccines

21 May 2018 Knowledge Ecology International (KEI) intends to deliver the following statement on Addressing the global shortage of, and access to, medicines and vaccines. 11.5 Addressing the global shortage of, and access to, medicines and vaccines Documents A71/12 and… Continue Reading

University of Pittsburgh Failure to Disclose Federal Funding for Patents on Vizamyl

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… Continue Reading

Six organizations ask HHS Secretary Azar to take title of 5 patents on Exondys 51, as remedy to failure by inventors to disclose NIH funding

FOR IMMEDIATE RELEASE April 5, 2018 kim.treanor@keionline.org (202)-332-2670 Six organizations are asking Department of Health and Human Services Secretary Alex Azar to take actions to lower the price of eteplirsen, a drug sold under the brand name Exondys 51, to… Continue Reading

James Griffin, Dana-Farber Cancer Institute and Novartis failure to disclose NIH funding for patents on leukemia drug midostaurin (Trade name Rydapt)

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… Continue Reading

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

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,… Continue Reading

Reasonable Pricing Clause

1994. The 1994 NIH Report on CRADAs and the Reasonable Pricing Clause 1994. September 8. James Love. Pricing of Drugs Developed with Public Funds. Comments Presented to the Second NIH CRADA Forum. 1995. April 11. NIH Notice Rescinding the Reasonable… Continue Reading