Request for Amendment to add Risdiplam for Spinal Muscular Atrophy (SMA) to Schedule 1 of the Canadian Patent Act

On March 1st, Knowledge Ecology International sent a letter to The Hon. Mark Holland, Ministry of Health, and The Hon. François-Philippe Champagne, Minister of Innovation, Science, and Industry, urging the prompt consideration of adding risdiplam, a drug to treat spinal… Continue Reading

NIST Draft Guidance on Exercising March-in Rights

The National Institute of Standards and Technology (NIST) issued a Request for Information on December 8, 2023 regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). The request follows a nearly year-long interagency… Continue Reading

WTO: Prospects to adopt proposed decision text on the extension of the 17 June 2022 Ministerial Decision to Covid-19 therapeutics and diagnostics appear grim

On 4 December 2023, the World Trade Organization (WTO) published a document (WT/GC/W/913, IP/C/W/694/Rev.1) entitled, “Decision text on extension of the 17 June 2022 Ministerial Decision to COVID-19 therapeutics and diagnostics”. This document is a communication from Bangaldesh, The Plurinational… Continue Reading

WIPO CDIP 31: Opening statement of Brazil

On Monday, 27 November 2023, Brazil delivered the following general statement at WIPO’s Thirty-First Session of the Committee on Development and Intellectual Property. The statement was delivered by Ambassador Guilherme Patriota, one of the architects of WIPO’s Development Agenda. General… Continue Reading

USITC avoids taking sides in 497 page report on WTO limited patent extension of exceptions for COVID 19

The USITC has issued a 497 page report on the WTO negotiations over TRIPS and COVID. https://www.usitc.gov/publications/332/pub5469.pdf The USITC release states: The U.S. International Trade Commission (USITC) today released a report about COVID-19 diagnostics and therapeutics and certain flexibilities under… Continue Reading

Letter to FDA on the Cost to the Public of the Pediatric Trial Exclusivity Extension

Today, Knowledge Ecology International (KEI) submitted a letter to the Commissioner of the Food and Drug Administration (FDA) regarding the mismatch between the cost to perform pediatric extension trials and the cost to the public of the six month extension… Continue Reading