KEI Publications

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

(several) Timelines regarding privileges (such as patents or copyrights) for the commercialization and use of knowledge

KEI Policy and Briefing Notes

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 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