This is a note on Gilead run or funded programs that are available for patients residing in the United States.
Recently, Gilead’s new hepatitis C drug, Sovaldi, has received much attention and criticism for its high price of $1000 a day.
Attached are two annexes from our 2014 USTR Special 301 comments Continue Reading
On 14 January 2013, Knowledge Ecology International (KEI), the University of California (San Francisco), Universities Allied for Essential Medicines (UAEM), Third World Network (TWN) and Young Professionals Chronic Disease Network: YP-CDN submitted a Proposal for the Inclusion of Trastuzumab in the WHO Model List of Essential Medicines for the Treatment of HER2-Positive Breast Cancer to WHO’s Exper Continue Reading
As part of a partial response to FOIA request, USTR has provided KEI with copies of 13 letters sent by members of Congress, from July 27, 2011 to August 8, 2013, on the topic of biologic drug test data provisions in the TPP negotiation. We had obtained several but not all of these letters earlier from a variety of sources, including from PhRMA’s web page — where some had been proudly displayed. (See link below).
Were there letters on the other side? Yes, three. (see below).
With the FOIA request, we have also obtained the responses to the letters.
On July 24, 2014, the Medicines Patent Pool announced welcome modifications and expansions of their licensing agreement with Gilead. Among the significant changes were the addition of a new drug, tenofovir alafenamide (TAF), formerly known as GS-7340. TAF is a nucleotide reverse transcriptase inhibitor, and a prodrug of tenofovir. TAF is considered to have similar antiretroviral efficacy to tenofovir disoproxil fumarate (TDF), the drug it may replace in use, but can be administered with smaller doses and with less adverse effect on kidneys and bones.
KEI is creating a timeline for various events relating to the discovery and the development of diagnostics, vaccines and drugs for Hepatitis. A working draft of the timeline is available here. Continue Reading
The Assemblies of the Member States of the World Intellectual Property Organization (WIPO) convenes its Fifty-Fourth Series of meetings in Geneva from 22 September 2014 to 30 September 2014. These Assemblies include, inter alia, meetings of the WIPO General Assembly, the WIPO Coordination Committee, the Paris Union Assembly, the Berne Union Assembly, the Madrid Union Assembly, the Lisbon Union Assembly, the Patent Cooperation Treaty Assembly, the WIPO Copyright Treaty (WCT) Assembly and the WIPO Performances and Phonograms Treaty (WPPT) Assembly. Continue Reading
To get a quick look at who is holding patents on the Hepatitis C Virus, I did some searches of the USPTO database. In each search, I looked for the term HCV in the field for patent claims (ACLM). Note this is fairly arbitrary, and I get different (and higher) numbers if I include HCV in the Abstract. In any case:
There were 1164 patents that have the term HCV in the patent claim.
Attached is policy briefing note that sets out possible mechanisms to overcome the exclusive rights of patents for drugs to treat the Hepatitis C Virus (HCV), in the United States. Each approach involves leadership from different actors. Each has advantages and disadvantages, including legal and practical risks. (Available here)
Table of Contents
1. The Federal Government use of HCV patents, without permission from right holder
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At 12:50 AM on 5 July 2014, the World Intellectual Property Organization’s (WIPO) 28th Standing Committee on Copyright and Related Rights concluded without reaching agreement on recommendations to the WIPO General Assembly on the following two topics: 1) Protection of Broadcasting Organizations and 2) Limitations and exceptions: libraries and archives. Continue Reading