KEI Comments on Medicare Programs: International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Knowledge Ecology International (KEI) is a non-profit organization that focuses on the management of knowledge goods, including new drugs, vaccines and other medical therapies. Much… 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
Office of Research and Technology Applications, Naval Postgraduate School, Research and Sponsored Programs Office, NPS Code 41, 699 Dyer Road, Bldg. HA, Room 226, Via. Ms. Deborah Buettner, Director, Research and Sponsored Programs Office, email: dbuettne@nps.edu Dear Deborah Beuttner, We… Continue Reading
Jaime M. Greene Senior Licensing and Patenting Manager NCI Technology Transfer Center Email: greenejaime@mail.nih.gov December 16, 2018 Re: Comments on “Prospective Grant of an Exclusive Patent License: Agonist/Antagonist Compositions and Methods of Use for certain inventions” (83 FR 61659) Dear… Continue Reading
KEI has received Pfizer and USTR emails and a Pfizer briefing memo to USTR from September 2017, asking the USTR to block a Malaysia Requirement to disclose drug prices. The documents were obtained under a Freedom of Information request to… Continue Reading
The attached document is a 78 page PDF file obtained from USTR under the Freedom of Information Act (copy here), regarding communications between Gilead and USTR, over Malaysia’s decision to grant a compulsory license on patents for HCV treatments. This… Continue Reading
This will be discussed next week at the SCCR 37 Standing Committee on Copyright and Related Rights (SCCR) Thirty-Seventh Session Geneva, November 26- 30, 2018 PROPOSAL OF THE UNITED STATES OF AMERICA ON THE SCOPE AND IMPLEMENTATION OF RIGHTS, WIPO… Continue Reading
KEI has filed a pre-hearing statement for the International Trade Commission, “On the United States-Mexico-Canada Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors Investigation (No.TPA-105-003)” KEI-Pre-hearing-statement-ITC-USMCA-30Oct2018 The submission covers the following topoics: Patentable subject matter for… Continue Reading
On Monday, October 15, 2018, Judge Peter J. Messitte of the United States District Court, District of Maryland, convened a hearing on a motion by the NIH to dismiss a lawsuit (Case 8:18-cv-01130-PJM) by KEI regarding the decision by the… Continue Reading
The United States-Mexico-Canada Agreement (USMCA) provisions on the term of protection of test data for new pharmaceutical products has received considerable attention, and in some cases, some inaccurate reports on the agreement have conflated the term for test data protection… Continue Reading