KEI publishes research and commentary in a variety of journals, periodicals, books and other independent publishing platforms.
In-house, KEI presents information in blogs, correspondence and reports, as well as in occasional KEI research notes and papers.
Timelines
KEI Policy and Briefing Notes
2025
2025-2 KEI Research Note: The cost of trials used to support the initial FDA approval of risdiplam (Evrysdi)
2025:1 KEI Research Note: Timeline: Development of Risdiplam.
2024
2024:7 KEI Briefing Note: KEI Comments on NIH Proposal to Require License Holders to Provide Access Plans.
2024:6 KEI Briefing Note: Note on the origins of the Bayh-Dole Act, the definitions of practical application in competing bills from 1977 to 1980.
2024:5 KEI Briefing Note: Notable 1984 amendments to Section 202 and 203 of the Bayh-Dole Act.
2024:4 KEI Briefing Note: Notable changes to Section 209 of the Bayh-Dole Act in 2000.
2024:3 KEI Briefing Note: What measures do US competition authorities refer to in technology transfer mandates.
2024:2 KEI Briefing Note: Examples of US competition cases that mandate transfer of technology and know-how.
2024:2A KEI Briefing Note: 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.
2024:1 KEI Briefing Note: Anti-Obesity Drugs: Patents and Pipeline.
2023
2023:4 KEI Briefing Note: Notes on the Preclinical Development of Imbruvica (Ibrutinib).
2023:3 KEI Briefing Note: KEI Notes on the Clinical Studies for Imbruvica (Ibrutinib).
2023:2 KEI Briefing Note: Mismatch between the Cost to Perform Pediatric Extension Trials and the Cost to the Public of the FDA PED Monopoly Extension.
2023:1 KEI Briefing Note: The NIH has radically reduced the time for the public to comment on exclusive licenses.
2023:1 KEI Research Note: Submission to FDA: Video Ads for Prescription Drugs and Vaccines that use Distracting Images or Music when Risks are Presented.
2022
2022:3 KEI Briefing Note: Selected differences between Article 30, 31 and 44 of the WTO TRIPS Agreement as regards non-voluntary use of patented inventions.
2022:2: KEI Briefing Note: U.S. federal government FAR 52.227-1 authorizations (for non voluntary use of patents) disclosed in 173 SEC exhibits.
2022:1 KEI Briefing Note: Selected U.S. Government COVID Contracts with Authorization and Consent to Non-Voluntary Use Of Third Party Patents.
2021
2021:3 KEI Briefing Note: The number of standard and material CRADAs Executed by the NIH from 1985 to 2020 and the relationship to NIH reasonable pricing clause.
2021:2 KEI Briefing Note: Canadian Experience with Compulsory Licensing under the Canadian Access to Medicines Regime.
2021:1 KEI Briefing Note: Comments on the Proposal to Eliminate Unreasonable Prices as a Standalone Basis for March-in Rights (Modify 37 CFR § 401.6)
2021:1 KEI Research Note: US government COVID contracts and the definition of practical application.
2020
2020:4 KEI Research Note: Research Mandates.
2020:4 KEI Briefing Note: Selected Government Definitions of Orphan or Rare Diseases.
2020:3 KEI Research Note: Moderna failures to disclose DARPA funding in patented inventions.
2020:3 KEI Briefing Note: Other Transaction Agreements: Government Contracts that May Eliminate Protections for the Public on Pricing, Access and Competition, Including in Connection with COVID-19
2020:2 KEI Research Note: Role of Private Sector, Governments and Charities in Funding Research and Development Related to Tocilizumab.
2020:2 KEI Briefing Note: The Federal Government’s Authority to Restrict or Eliminate Contractors’ Rights to Federally-Funded Inventions in “Exceptional Circumstances”.
2020:1 KEI Research Note: Government funding related to the cobas Liat Analyzer PCR testing device.
2020:1 KEI Briefing Note: Role of the U.S. Federal Government in the Development of GS-5734/Remdesivir.
2019
2019:1 KEI Briefing Note: International Reference Pricing.
2018
2018:1 KEI Briefing: Bayh-Dole Obligations to Disclose Federal Funding.
2017
2017:2 KEI Briefing Note: Lexmark: The Supreme Court’s patent exhaustion case and parallel trade in drugs.
2017:1 KEI Briefing Note: Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents.
2016
2016:2 KEI Briefing Note: 2015-2016 Pharmaceutical Transparency Legislation.
2016:1 KEI Briefing Note: Transparency of Patent Landscapes.
2015
2015:4 KEI Briefing Note: Conflicts with US legal norms and TPP Article QQ.H.4: {Civil Procedures and Remedies / Civil and Administrative Procedures and Remedies}.
2015:3 KEI Briefing Note: Comparison of key indicators between LDC, Non-LDC and OECD countries.
2015:2 KEI TPP Briefing Note: The Evolution of the Article on Patents/Patentable Subject Matter in the Trans-Pacific Partnership Intellectual Property Chapter.
2015:1 KEI TPP Briefing Note: Compulsory licenses on patents and the 3-step test.
2014
2014:2 KEI Policy Brief: Freedom/Restrictions as regards exports to countries outside of the licensed territory for Gilead’s 2014 HCV voluntary license.
2014:1 KEI Policy Brief: Nonvoluntary use of patents for drugs to treat the Hepatitis C Virus in the United States: Mechanisms available to the Federal Government, State Governments and Private Actors. July 18, 2014.
2014:1 KEI Research Note: Recent European Union Compulsory Licenses. March 1, 2014.
2014:2 KEI Research Note: Recent United States Compulsory Licenses. March 7, 2014.
2014:3 KEI Research Note: Elizabeth Rajasingh, Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results. 17 November 2014.
2013
2013:1 KEI Research Note. James Love. Notes on the Blur Banff proposal, February 1, 2013.
2012
2012:1 KEI Research Note: Berne Convention revisions, and the evolution of its limitations and exceptions to copyright. August 11, 2012.
2011
2011:1 KEI Policy Brief White House and European Commission trade official oppose waiver of drug patents for Least Developed Countries (LDCs).
2011:2 KEI Research Note: Tedmund Wan. Survey of drug prices for 14 drugs with US government rights in patents listed in the FDA Orange Book.
2011:1. KEI Research Note: Paul Miano. Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines.
2010
2010:5 KEI Research Note: James Love. Differences in ratio of deaths to new cases for 6 cancer types in 14 WHO regions, with reference to income of region.
2010:4 KEI Research Note: Anne Mira Guha, Prices for Abbott’s Norvir (generic name Ritonavir) as a Standalone Product in 2010.
2010:3 KEI Research Note: Molly Redfield Ward, Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs).
2010:2 KEI Research Note: Public and Private Sector Funded Research in Fabry’s Disease.
2010:1 KEI Research Note: James Love, Comments on ACTA Provisions on Injunctions and Damages.
2008
2008:3 KEI Research Note: Jacqueline Lee, Research and Development Related to dasatinib (Sprycel-tm).
2008:2 KEI Research Note: An Annotated Bibliography of Scholarly and Technical Articles and Books on Innovation Prizes.
2008:1 KEI Research Note: Selected Innovation Prizes and Reward Programs.
2007
2007:6 KEI Research Note: David Serafino. Survey of Patent Pools Demonstrates Variety of Purposes and Management Structures.
2007:5 KEI Research Note: James Love. Compulsory licensing of copyright under Article 44.2 of the TRIPS, in light of eBay.
2007:4 KEI Research Note: Judit Rius. Organización Mundial de la Salud — Grupo de Trabajo Intergubernamental sobre Salud Pública, Innovación y Propiedad Intelectual (IGWG).
2007:3 KEI Research Note: IGWG Briefing Paper on Patent Pools.
2007:2 KEI Research Note: James Love. Recent examples of the use of compulsory licenses on patents.
2007:1 KEI Research Note: Benjamin Krohmal. Prominent Innovation Prizes And Reward Programs (A newer and much expanded version is available as KEI Research Note 2008:1).
2007:1. James Love and Tim Hubbard The Big Idea: Prizes to Stimulate R&D for New Medicines.
2006
2006:1. Judit Rius Sanjuan, James Love and Robert Weissman, Protection of Pharmaceutical Test Data: A Policy Proposal.