- NIH rulemaking on transparency of clinical trials
- UACT sends letter to Tufts President, Chairman of Trustees, asking questions about R&D cost study
- The Winning Bet
- KEI comment on the new Tufts Study on Drug Development Costs
- What to look for in the new Tufts study on drug development costs. 10 issues.
- Research note on oncology drugs, including trial size and orphan drug status
- KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
- Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund's Equitable Access Initiative
- WIPO patent committee engaged in heated talks on work sharing, limitations & exceptions, client confidentiality
- WIPO patent committee (SCP21): Intervention of KEI on Patents and Health
In 2012, as a member of the Senate Finance Committee, Senator Ron Wyden was a strong advocate for providing the public with access to the TPP negotiating text. Now, as Chairman, the Senator has been silent on the public's right to the text. This is an example of Wyden in 2012. Has his position changed?
Timestamp and notes on Wyden comments on need for transparency in TPP
WIPO General Assembly 2014: Hard Decisions on the Broadcast Treaty and work program on copyright limitations and exceptionsSubmitted by thiru on 3. September 2014 - 7:50
In the piece, WIPO General Assembly 2014: Hard Decisions on the Design Law Treaty and Treaty for Protection of Genetic Resources (22 July 2014), KEI highlighted the hard decisions awaiting the WIPO General Assembly (22 September 2014 to 30 September 2014) with respect to the Design Law Treaty, the imminent revision of the Lisbon Agreement to include geographical indications and WIPO's work to conclude an instrument for the protection of genetic resources, traditional knowledge and folklore.
13 May 2014: WHO Technical Consultation on Innovative Models for New Antibiotics’ Development and PreservationSubmitted by thiru on 27. August 2014 - 3:32
In a concerted bid to contain the emerging threat posed by antibiotic resistance, in May 2014, the World Health Organization's (WHO) 67th World Health Assembly (WHA) passed WHA resolution 67.25 on "Antimicrobial resistance" instructing the WHO to "develop a global action plan to combat antimicrobial resistance" by May 2015 (Source: WHO page on Draft Global action plan on antimicrobial resistance).
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:
CPTech's 2003 reports for the RSA Competition Commission, in Hazel Tau et al.v GSK, Boehringer, et alSubmitted by KEI Staff on 13. August 2014 - 8:15
On August 13, 2014, the Republic of South Africa (RSA) Competition Commission (CC) released the redacted versions of the reports provided to the CC by CPTech in 2003 in the TAC competition case involving GSK and Boehringer Ingelheim. A complete set of the documents is available here, and links to individual documents are listed below.
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
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.