Canada based Biolyse Pharma Seeks to Manufacture COVID-19 Vaccines for Low-Income Countries, may test Canada’s compulsory licensing for export law

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

KEI Submits FOIA Regarding FDA Orphan Products Grant Program

On July 28, 2025, Knowledge Ecology International (KEI) submitted a Freedom of Information Act request for records concerning the Food and Drug Administration (FDA) Orphan Products Grant Program. The program (administered by the FDA’s Office of Orphan Products Development (OOPD))… Continue Reading

KEI Comments on NIH Prospective License To Chan Zuckerberg Biohub

On July 17, 2025, KEI submitted comments regarding the prospective Exclusive, Inter-Institutional Agreement-Institution Lead for the development and commercialization of engineered commensals to generate antigen-specific T and B cells (90 FR 29028), which is set to be given to CZ… Continue Reading

KEI Comments on NIH Exclusive License to Capstan for CAR T Autoimmune Treatment

On July 18, 2025, KEI submitted comments regarding the prospective exclusive licensing by the NIH of “The Development of an in vivo Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment or Prevention of B Cell Mediated Autoimmune Diseases” (90 FR… Continue Reading

Request for issuance of authorization and consent to use federal rights in three patents to supply enzalutamide to patients in government programs

This is a PDF copy of the letter June 13, 2025 Robert F. Kennedy, Jr. Secretary U.S. Department of Health and Human Services 200 Independence Ave SW, Washington, DC 20201 RE: Request for issuance of authorization and consent to use… Continue Reading

KEI Comments on NIH Exclusive License to Neurala for Central Nervous System Disorders

On June 2, 2025, Knowledge Ecology International (KEI) offered comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: c-Abl Tyrosine Kinase Inhibitory Compound Embodiments and Methods of Making and Using the Same”… Continue Reading

KEI Comments on NIH Exclusive License to Sangam Lifesciences for Drug Delivery Platform

On May 7, 2025, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Size-Dependent Brain and Lymphatic Distribution of Macromolecular Drug Delivery Platform” (90 FR 16878) to… Continue Reading