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

Letter to FDA on the Cost to the Public of the Pediatric Trial Exclusivity Extension

Today, Knowledge Ecology International (KEI) submitted a letter to the Commissioner of the Food and Drug Administration (FDA) regarding the mismatch between the cost to perform pediatric extension trials and the cost to the public of the six month extension… Continue Reading

Senator Tillis Letter to FDA and USPTO Asking for a Study of Relationship between Patents and Drug Prices

In a January 31, 2022 letter to Drew Hirshfeld, the Commissioner for Patents for the USPTO, and Janet Woodcock, the Acting Commissioner of the FDA, Senator Thom Tillis provides extensive criticism of the empirical work of the group I-MAK and… Continue Reading

KEI comments to FDA on Prospective Exclusive Patent License for Diagnostic for SARS, SARS-CoV-2, Other Viruses, Bacteria and Bacterial Serovar, to Advion

To: Ken Millburne Technology Transfer Program Food and Drug Administration Via email: Kenneth.millburne@fda.hhs.gov From: James Love Knowledge Ecology International 1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009 https://keionline.org Date: November 30, 2020 Re: Prospective Grant of an Exclusive Patent… Continue Reading

Comments of Knowledge Ecology International Regarding “Purple Book Enhancement; Establishment of a Public Docket; Request for Comments” (FDA-2020-N-0437)

May 4, 2020 Comments of Knowledge Ecology International Regarding “Purple Book Enhancement; Establishment of a Public Docket; Request for Comments” (FDA-2020-N-0437) Knowledge Ecology International (KEI) provides the following comments regarding the Food and Drug Administration [FDA]’s Purple Book Enhancement. Our… Continue Reading

FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status Application is ‘Confidential’

On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan designation from the US Food and Drug Administration (FDA) for the treatment of COVID-19. Remdesivir has been reported to be one of the candidates to potentially treat COVID-19, which the… Continue Reading