On March 11th 2021, Biolyse Pharma (“Biolyse”) issued a statement publicly indicating their capacity to manufacture a COVID-19 vaccine and their intent to apply for a compulsory license in Canada. Biolyse is a Canadian manufacturer of cancer drugs based out… Continue Reading
The USTR Special 301 Committee presented KEI with four questions in follow-up to our earlier comments. Below are the questions and KEI’s responses, also available as PDF: KEI-Responses-to-Hearing-Questions-2025-Special-301 KEI Responses to Hearing Questions – 2025 Special 301 Review (docket number… Continue Reading
Introduction In January 2025, the National Institutes of Health (NIH) introduced a new NIH Intramural Research Program Access Planning Policy (“IRP Access Planning Policy” or “Policy”). An NIH web page provides links to several documents describing the policy: https://osp.od.nih.gov/policies/innovation-and-translation#tab1/ The… Continue Reading
On December 26, 2024, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Anti-KK-LC-1 T Cell Receptors for the Treatment of Cancer” (89 FR 99888) to StraightLine… Continue Reading
On December 17, 2025, Knowledge Ecology International (KEI) provided comments to the National Institutes for Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Vaccine Augmented Tumor Infiltrating Lymphocytes for the Treatment of Cancer” (89 FR 95224) to… Continue Reading
On December 5, 2024, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) on the “Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Peptides and Peptide Microarrays for Detection and Differentiation of Antibody Responses to Ebola… Continue Reading
On November 1, 2024, Knowledge Ecology International (KEI) submitted a proposal for the addition of risdiplam to the World Health Organization’s (WHO) Model List of Essential Medicine (EML). You can access the full proposal here: risdiplam2WHOEML1Nov2024 The EML, updated every… Continue Reading
Comment on proposal by several countries to add language clarifying references to MAT or VMAT on the transfer of technology or know-how is without prejudice to other measures KEI Briefing Note 2024:2A James Love Knowledge Ecology International (KEI) May 21,… Continue Reading
On October 3, 2023, Knowledge Ecology International (KEI) sent a letter to the FDA asking the agency to publish its historical Orange Book data. The Orange Book identifies patent and exclusivity data for FDA approved drug products. The FDA publicly… Continue Reading
On Thursday, 12 September 2024, non-State actors in official relations and relevant stakeholders were invited to join a “brief open session at the beginning of the day.” In advance of Thursday’s discussions on Article 13 (Supply chain and logistics) and… Continue Reading