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

25 Members of Congress Ask HHS Secretary to Act on Xtandi Request

On January 10, 2023, twenty-five Members of Congress sent a letter to HHS Secretary Xavier Becerra urging him to act on the Xtandi request, and to use the Bayh-Dole Act to lower the price of Xtandi (enzalutamide) for US patients.… Continue Reading

NIH Questioned about Xtandi and March-in Rights during Congressional Hearing

On Wednesday May 11, 2022, the National Institutes of Health (NIH) was asked about Xtandi and march-in rights during a Congressional hearing. The House Appropriations Committee held a hearing on the FY2023 Budget Request for the NIH, and Representative Mark… Continue Reading

Xtandi Petitioners Highlight Pfizer Practice of Reference Pricing in US Government Contracts

Following the publication of the US government contract with Pfizer for the COVID-19 therapeutic Paxlovid, the petitioners of the Xtandi government use request wrote to the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH)… Continue Reading