KEI Comments on NIH Proposal to Require License Holders to Provide Access Plans
KEI Briefing Note
KEI Comments to CMS Regarding Imbruvica (INN:Ibrutinib) R&D (regarding Medicare pricing negotiations)
On October 2, 2023, Knowledge Ecology International submitted written comments to the Centers for Medicare & Medicaid Services (CMS) in conjunction with the Medicare Price Negotiation public consultation process. CMS is hosting a series of patient-focused listening sessions this fall,… Continue Reading
KEI Notes on the Clinical Studies for Imbruvica (Ibrutinib)
Notes on the Preclinical Development of Imbruvica (Ibrutinib)
Mismatch between the Cost to Perform Pediatric Extension Trials and the Cost to the Public of the FDA PED Monopoly Extension
KEI Comment on the Reduction of Number of Days the Public Can Comment on a Prospective NIH Exclusive Patent License
The National Institute of Health (NIH) recently held an all-day workshop titled, “Transforming Discoveries Into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.” KEI Director James Love participated in the July 31st workshop, speaking on the panel on “How NIH… Continue Reading
KEI Briefing Note 2021:2 Canadian Experience with Compulsory Licensing under the Canadian Access to Medicines Regime
KEI Briefing Note 2021:1 Comments on the Proposal to Eliminate Unreasonable Prices as a Standalone Basis for March-in Rights (Modify 37 CFR § 401.6)
Comments on the Proposal to Eliminate Unreasonable Prices as a Standalone Basis for March-in Rights (Modify 37 CFR § 401.6) KEI Briefing Note 2021:1 March 18, 2021 James Love (Note: The contents of this briefing note were submitted to the… Continue Reading
KEI Briefing Note 2017:1. Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents
Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents KEI Briefing Note 2017:1 When the United States federal government funds research that results in patents, it obtains rights, either directly or through contracts,… Continue Reading