KEI Comments Regarding NIH Proposed License T Cell Cancer Therapy to Moonlight Bio

On October 12, 2023, Knowledge Ecology International (KEI) filed comments regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Engineered T Cell Therapies for the Treatment of Cancer” by the National Institutes of Health (NIH) to… Continue Reading

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 Comments on NIH License to EnZeta Immunotherapies for Solid Tumors

On August 28, 2023, Knowledge Ecology International (KEI) provided comments to the National Institutes of Health (NIH) objecting to the “Prospective Grant of an Exclusive Patent License: Manufacture, Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid Tumors” (88 FR… Continue Reading

KEI August 18, 2023 Comments to the NIH licensing practices highlight failure to enforce Section 209 restrictions on exclusivity, transparency concerns, and KEI’s past engagement

As a part of the workshop hosted by the National Institutes of Health (NIH) on July 31, 2023 on the topic of, “Transforming Discoveries Into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer,” the NIH solicited public comments. In addition… Continue Reading

KEI Exchange with the NIH Regarding April 2023 EnZeta Prospective License Notice

KEI recently submitted comments to the National Institutes of Health (NIH) regarding its drastic cuts in the length of public comment periods for proposed exclusive licenses. In our comments, KEI discussed reasons that a longer comment period is important for… Continue Reading

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

NGO Letter to Biden Administration in Support of Xtandi Appeal

Today, eight non-governmental organizations sent the Biden Administration a letter of support for the administrative appeal of the request for the Department of Health and Human Services (HHS) to use its rights in the patents on the prostate cancer drug… Continue Reading

Reference Pricing in US Government COVID-19-related Contracts

Knowledge Ecology International conducted a review of contracts entered into by the US government concerning COVID-19-related treatments, diagnostics, vaccines, and other countermeasure-related technologies, regarding reference pricing clauses in the agreements. Of the 104 contracts reviewed, it is difficult to say… Continue Reading

KEI Oral Statement for US ITC Investigation on COVID-19 and TRIPS Agreement Flexibilities

NOTE: KEI also submitted a 16-page in depth written submission to this investigation on March 20, 2023. The US International Trade Commission (ITC) will hold a hearing on March 29-30, 2023 on COVID–19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS… Continue Reading

Response to Questions to KEI from Trade Policy Staff Committee in Docket No. USTR-2022-0016, Special 301

In 2023, the Office of the US Trade Representative (USTR) has elected to continue conducting its Special 301 Review process virtually, with no in-person hearing, as in the years prior to 2020. In this virtual process, after stakeholders have submitted… Continue Reading