KEI Comments to the NIH License on Gene Therapy to Marble Therapeutics

Today Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Vaccine Augmented Adoptive Cell Therapy for the Treatment of Cancer” (89 FR 8438). The wordwide, exclusive license… Continue Reading

KEI Comment to NIST on the Bayh-Dole Letter to the Washington Post and the Legislative History of the Act

KEI submitted comments to the National Institute of Standards and Technology (NIST) issued a Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) regarding the 2002 Bob Dole and Birch… Continue Reading

KEI Comment to NIST on “Available to the Public on Reasonable Terms”

On February 6, 2024, KEI submitted comments to the National Institute of Standards and Technology (NIST) regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (88 FR 85593). This set of comments outlined that the draft… Continue Reading

KEI Comment to NIST on Bayh-Dole Rights and Cases of Mixed Patent Landscapes

KEI submitted comments to the National Institute of Standards and Technology (NIST) in response to the Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) concerning Bayh-Dole rights and the… Continue Reading

KEI Comments on the Implications of Access and Benefit Sharing Commitments/Regimes and Other Proposed Commitments in the WHO Pandemic Agreement

On January 29, 2024, KEI submitted comments in response the Federal Register notice posted by the Department of Health and Human Services (HHS) concerning, “the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under… Continue Reading

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