On Monday, September 15, 2014, Gilead announced licensing agreements with 7 generic drug manufacturers, for two of the HCV drugs, including sofosbuvir, which is currently the most important HCV drug, and the basis for Gilead’s value to shareholders. KEI's statement from Monday, and links to other NGO comments are here: http://www.keionline.org/node/2082.
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.
Oral Question posed by French MEP Michelle Rivasi (Greens)
Access to medicines has repeatedly made the headlines in many EU countries over the past 3 months (in France, the UK, Spain, Greece, etc.). The reason for that is the price charged for Sofosbuvir, a drug that can cure hepatitis C. It is sold by the pharmaceutical firm Gilead, which charges generally between 50 000 and 60 000 euros per patient for a 12 weeks course in the Eurozone.
The situation with Sofosbuvir is urgent, but unfortunately it is not an isolated case. This level of prices not only is a new trend but it is becoming a new norm for serious diseases. As a consequence, we, for example, see how it is becoming harder and harder to ensure access to drugs to cancer patients in Europe. It is happening with Kadcyla® a drug for breast cancer, for Nexavar® a drug for kidney and liver cancer. And we are all affected, or soon will be.
The less innovation the pharmaceutical industry brings to the market, the more it prices the new drugs. Abuses of monopoly rights and patents is harming innovation and crushing health systems. We are seeing doctors and medical authorities forced to compromise their professional code of ethics and to invent false reasons of cost-effectiveness to justify sentencing people to death.Nothing in the chain of development of these drugs justifies these prices.
Rationing of life saving medicines in Europe is not acceptable. It is high time to reform a system that is increasingly dysfunctional, and to honestly address the issue of the research and development model we need for medical innovation.
Today 10 to 15% maximum of the price of a medicine will go towards research. Is that really the most effective way to proceed? Instead of paying 100 euros to endure that 10-15 euros will go to research, citizens, communities or States could pay directly the same share for research without having to bear the cost of monopoly.
France raised the issue of Sofosbuvir at the Council and before the Commission during the Summer. What are the Council and the Commission planning on doing to break this deadlock which is becoming deadly for an increasing number of EU citizens? When will we seriously discuss options that do not necessarily please a handful of multinationals but would serve the EU public interest, such as funding mechanisms and financial incentives that are not tied to the granting of exclusive rights and monopolies? When will we impose price caps on medicines the same way we were able to do for roaming?
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 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).
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:
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 Cancer
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 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.
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 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.
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)
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 treatments
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