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KEI welcomes the Gilead HCV licenses, as a step to expand access to treatments. Notes challenges that remain

Today Gilead announced it will provide seven generic drug manufacturers licenses to make and sell two drugs that are used in combination to treat the Hepatitis C Virus (HCV) in 91 developing countries.

Senator Wyden in 2012, on access to the TPP text

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
https://www.youtube.com/watch?v=dUYCSSdhEC8

WIPO General Assembly 2014: Hard Decisions on the Broadcast Treaty and work program on copyright limitations and exceptions

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 Preservation

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).

TDR and the Pooled Fund for R&D: WHO demonstration projects and CEWG follow-up

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 Commissions

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 al

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.

Gilead's US patient access programs for Sovaldi

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.

Some recent cancer drug prices

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 TPP

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.

Gilead's MPP license for tenofovir alafenamide (TAF) patents

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.

Hepatitis research and development timeline

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 Resources

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.

Hepatitis C Virus patent assignments: patents with HCV in the patent claim

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.

KEI Policy Brief: Non-Voluntary use of HCV patents in the United States

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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