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

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

rfkjr-kei-13June2025-xtandi 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 federal rights in three patents to supply… 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

KEI Responses to Questions from HHS, USTR, Copyright Office and USPTO, Following Testimony at the 2025 Special 301 Review Hearing (docket number USTR-2024-0023)

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

The New NIH Intramural Research Program Access Planning Policy

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

KEI Comments to the NIH on Cancer Treatment License to Straightline Bio

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

KEI Comments on NIH Exclusive License to Iovance for T-cell Vaccine for Cancer Treatment

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

KEI Comments on NIH Exclusive License to Columbia for Ebola Technology

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