Open letter asking 37 WTO Members to declare themselves eligible to import medicines manufactured under compulsory license in another country, under 31bis of TRIPS Agreement

Background In 2001, the World Trade Organization (WTO) began negotiations on the rules regarding patents and access to medicine. While several issues were clarified and resolved in the November 2001 “Doha Declaration on TRIPS and Public Health”, the negotiations took… Continue Reading

KEI and Public Citizen letter to Congress regarding Costa Rica proposal for WHO COVID-19 pool of rights in technology and data

The following is a letter that KEI and Public Citizen sent to Congressional leadership on March 26, 2020, supporting the proposal by the President of Costa Rica to the World Health Organization to create a pool for rights in technology… Continue Reading

Open letter to the World Health Organization (WHO) and its Member States on the proposal by Costa Rica to create a global pool for rights in the data, knowledge and technologies useful in the prevention, detection and treatment of the coronavirus/COVID-19 pandemic

March 27, 2020. We are writing to ask the WHO and its Member States to support the proposal by Costa Rica for the creation of a global pooling mechanism for rights in the data, knowledge and technologies useful in the… Continue Reading

President and Minister of Health of Costa Rica ask WHO to create global pool for rights in COVID-19 related technologies

(KEI blogs and other work on COVID-19 are here: https://www.keionline.org/coronavirus) A letter from Costa Rica, signed by Carlos Alarado Quesada, the President, and Dr. Daniel Salas Peraza, the Minister of Health, to Dr. Tedros Adhanom Ghebreyesus, was sent this evening… Continue Reading

FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease

Today the FDA granted Gilead Orphan Drug status for remdesivir for the treatment of COVID-19, on grounds this is a rare disease. The morning of the designation, the U.S. had confirmed, through testing, more than 35 thousand cases, including 8,477… Continue Reading

Three areas in Section 202 of the Bayh-Dole Act that require action to ensure sufficient rights in patents on coronavirus relevant inventions

For more on KEI’s work on COVID-19, see keonline.org/coronavirus. As the US and other governments begin to expend large amounts of money on research and development related to the control, prevention and treatment of the coronavirus pandemic, there are important… Continue Reading

Unreasonable pricing and the “Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020”

For more on KEI’s work on COVID-19, see keonline.org/coronavirus. The “Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020’’ will provide welcome funding to deal with the expanding COVID-19 pandemic. The current language on affordability (this Draft text), however, is worse… Continue Reading

KEI Comments to NIST on Interagency Edison System for Reporting Federally Funded Inventions, 84 FR 68128, Docket No. 191126-0092

Filed in 84 FR 68128, Docket No. 191126-0092. KEI-NIST-RFC-iEdison, 27Jan2020 January 27, 2020 Dr. Courtney Silverthorn Deputy Director, Technology Partnerships Office, National Institute of Standards and Technology Technology Partnerships Office 100 Bureau Drive, MS 2200, Gaithersburg, MD 20899, mailto:courtney.silverthorn@nist.gov Re:… Continue Reading

Joint comments on the NIH license to patents on CAR therapies to CJ Healthcare

Joint Comments Regarding “Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies[,]” 85 FR 328 On January 21, 2020 five groups and two individuals filed comments… Continue Reading