On September 9, 2019, KEI submitted a second request to the NIH that it investigate an apparent failure to disclose federal funding in patents in adeno-associated viral (AAV) gene therapies assigned to the Trustees of the University of Pennsylvania (UPenn).… Continue Reading
KEI Briefing Note 2019:1 International Reference Pricing August 22, 2019 International Reference Pricing, often referred to as External Reference Pricing (ERP), is the practice of using a price in a foreign market as a benchmark for an acceptable price in… Continue Reading
Open letter on NIST Draft Green Paper on Bayh-Dole Act Policies and Regulations 5 April 2019 FMI: Claire Cassedy, claire.cassedy@keionlineorg +1.202.332.2670 Washington, 5 April 2019 – Eleven non-governmental organizations have sent a letter to members of the US Congress, highlighting… Continue Reading
For a general timeline of the Bayh-Dole Act, see this page. 1980. December 12. The Bayh-Dole Act was enacted into law as part of Public Law 96-517, including Section 203 that provide march-in rights. 1984. November 8. The Bayh-Dole statute was… Continue Reading
(UPDATE: The NIH provided a response to our comments on February 26, 2019) On February 22, 2019, KEI submitted comments to the Federal Register notice 84 FR 2555 on the “Prospective Grant of an Exclusive Patent License: Virus-Like Particles Vaccines… Continue Reading
Today KEI asked the Department of Commerce National Institute of Standards (NIST) to publish a notice in the Federal Register inviting comments on their Special Publication 1234, Draft Green Paper on Return on Public Investment, with an extended deadline. The… Continue Reading
KEI filed comments on the NIST Draft Green paper on the return from investment on federally funded R&D (See: https://www.keionline.org/29518). We expect the comment period to be extended, but filed this on January 9, 2018, as an initial submission. KEI-comments-NIST-SP-1234-ROI-9Jan2018… Continue Reading
In December 2018, the Department of Commerce National Institute of Standards (NIST) published NIST Special Publication 1234, “Return on Investment Initiative for Unleashing American Innovation” as a draft Green Paper. According to the initial release, before the government shutdown, comments… Continue Reading
Below are the comments filed by Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) regarding a prospective grant of an exclusive license of NIH-owned patents to the California-based company Midissia Therapeutics. The prospective exclusive license is… Continue Reading
Attached are comments from 8 health and fair groups regarding a prospective grant of an exclusive license to NIH owned patent, for the development of an Anti-Mesothelin Chimeric Antigen Receptor (CAR) for the treatment of human Cancer, to Atara Biotherapeutics… Continue Reading