On Thursday, 24 July 2025, the United Kingdom published the text of the Comprehensive Economic and Trade Agreement (CETA) between the United Kingdom of Great Britain and Northern Ireland and India and associated documents. The agreement consists of 30 chapters… 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
Annually, the Office of the United States Trade Representative spearheads the Special 301 review process, whose goal is to produce a report that names-and-shames countries that have committed perceived offenses against intellectual property rights. The USTR solicits written comments from… 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 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 14 May 2024, the Pharmaceutical Accountability Foundation (PAF) had their first hearing in their case against Abbvie at the Amsterdam District Court. The case concerns Abbvie’s pricing practices for its blockbuster drug Humira (adalimumab), one of the world’s best-selling… Continue Reading
Comments by Knowledge Ecology International, Regarding: Request for Comments: Unlocking the Full Potential of Intellectual Property by Translating More Innovation to the Marketplace, Notice by the Patent and Trademark Office on 03/15/2024, Document Citation: 89 FR 18907, Agency/Docket Number: Docket… Continue Reading
PDF version is available here: KEI.MutuallyAgreedTerms.A_INB_9_3Rev1.22April2024draft KEI comments on six references to “mutually agreed terms” in the WHO pandemic agreement negotiating text: A/INB/9/3 Rev.1, 22 April 2024 James Love Knowledge Ecology International April 28, 2024, revised April 29, 2024 Introduction… Continue Reading
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
KEI submitted comments to the National Institute of Standards and Technology (NIST) in response to the Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) concerning Bayh-Dole rights and the… Continue Reading