In May 2014, the World Health Organization's (WHO) 67th World Health Assembly (WHA67) passed decision WHA67(15) setting the stage for the creation of a new pooled funding mechanism for R&D.
OMB's Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards, and CommissionsSubmitted by James Love on 15. August 2014 - 8:58
Following litigation by several lobbyists, OMB is revising its guidance on the appointment of lobbyists to federal advisory committees, boards, and commissions. Now, lobbyists can serve on these committees, including the USTR advisory boards. Money quote:
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
January 2013: Proposal for the inclusion of trastuzumab in WHO EML for treatment of HER2-Positive Breast CancerSubmitted by thiru on 5. August 2014 - 11:47
On 14 January 2013, Knowledge Ecology International (KEI), the University of California (San Francisco), Universities Allied for Essential Medicines (UAEM), and the Third World Network (TWN) 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 Expert Committee on the Selection and Use of Essentia
Money speaks: USTR releases letters from Congress backing PhRMA on exclusive rights biologic test data in TPPSubmitted by KEI Staff on 4. August 2014 - 13:29
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.
WIPO General Assembly 2014: Hard Decisions on the Design Law Treaty and Treaty for Protection of Genetic ResourcesSubmitted by thiru on 24. July 2014 - 9:24
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.
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
SCCR28: Chair’s Conclusions (No recommendations on broadcasting or limitations and exceptions for libraries and archives)Submitted by thiru on 18. July 2014 - 4:42
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.
I had not seen this lawsuit filed by Gilead against AbbVie and Abbott before. It is an interesting read. According to Gilead:
Abbott executives and “inventors” conspired and carried out the initial steps of the company’s scheme by filing serial fraudulent patent applications asserting that Abbott had invented methods of treating HCV using PSI-7977 as well as the Gilead Combination (as well as thousands of combinations of Abbott’s other competitors’ HCV compounds). The first of these applications is dated October 21, 2011.
KEI asks FTC to investigate Shire decision to abandon efforts to compete in US market for Fabry’s disease treatmentsSubmitted by James Love on 15. July 2014 - 5:43
July 15, 2014
Knowledge Ecology International (KEI) asks the FTC to investigate Shire decision to abandon efforts to compete in US market for Fabry’s disease treatments. Letter to FTC provides evidence of possible conspiracy to segment markets, involving licensing of an NIH funded invention for use in Europe, in return for abandoning efforts to enter US market.
For More Information:
James Love, Knowledge Ecology International
New UK Parliamentary report on Global TB urges the United Kingdom to explore a WTO Agreement on the Provision of Public GoodsSubmitted by thiru on 14. July 2014 - 5:32
On 8 July 2014, the United Kingdom of Great Britain and Northern Ireland's All-Party Parliamentary Group on Global Tuberculosis (APPGTB) released a seminal report entitled, "Dying for a Cure: Research and Development for Global Health." The APPGTB is co-chaired by Andrew George MP (St Ives, Liberal Democrat), Rt Hon Nick Herbert MP (Arundel and South Downs, Conservative) and Virendra Sharma MP (Ealing Southall,