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
New UK Parliamentary report on Global TB urges the United Kingdom to explore a WTO Agreement on the Provision of Public Goods
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,
In "Compulsory License as a Remedy for Trade Secret Misappropriation, Dennis Crouch writes* about a July 1, 2014 decision in Sabatino Bianco, M.D. v. Globus Medical, 2:12-cv-00147 (E.D. Tex 2014). The decision by Judge Bryson, a U.S. Circuit Judge in the Eastern District of Texas, concerns trade secrets which:
"consisted of ideas for the design of a medical device known as an adjustable intervertebral spacer or implant. Intervertebral spacers are used in spinal surgery to replace damaged discs in patients’ spines."
The Declaration on Patent Protection: Regulatory sovereignty under TRIPS was drafted under the auspices of the Max Planck Institute for Innovation and Competition in Munich. It is the result of two decades of intensive research and prepared with the support of scholars all over the world. It has been issued in the context of the 20th anniversary of the establishment of the WTO and the adoption of the TRIPS Agreement on 15 April 1994.
The purpose of the Declaration indicates the interpretive scope of the TRIPS norms. Overall, it remains neutral – it is neither directed at states with a specific level of development nor does it aspire to provide recommendations for legal action. It only points out the regulatory discretion that national legislators enjoy when it comes to implementing their own patent systems.
According to the drafters
“Sovereign states should retain the discretion to adopt a patent system that best suits their technological capabilities as well as their social, cultural and economic needs and priorities, with the proviso that the exercise of such discretion must remain within the boundaries of international law. Taking into account the customary principles of interpretation of international law, this Declaration seeks to shed light on these boundaries. The purpose is to clarify the policy space that the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) leaves to national legislators and judicial authorities with regard to the implementation and administration of their patent systems.”
The Declaration deals accordingly with the following aspects of patent law: a) general principles; b) differentiation of fields of technology; c) patentability and disclosure; d) scope of protection; e) exhaustion issues; f) exceptions to the scope of protection; g) compulsory licence; h) government use; i) undisclosed information; j) enforcement; k) goods in transit; and l) criminal measures.
The Declaration on Patent Protection shows that it is possible to design a patent system that reflects both the interest of inventors and right holders as well as the national public interest, without infringing the international obligations of WTO members and taking advantage of the TRIPS Agreement flexibilities.
You can access the document here
Improving technology transfer flows and arrangements directed towards developing countries and LDCs has emerged as an important priority in a number of international forums such as the WTO, WIPO and beyond. It has also been a shared interest in the research agendas of ICTSD and the Centre for Global Development (CGD).
In this context, this expert meeting will discuss the draft of a new CGD paper entitled: ‘Europe Beyond Aid: Evaluating Europe’s contribution to the transfer of technology and knowledge to developing nations’ developed in cooperation with Walter Park (American University) and Owen Barder (CGD) who will present the paper at the dialogue. Beyond Europe, the meeting will also examine the status of current technology transfer discussions at both WTO and WIPO.
Multilateral intellectual property (IP) negotiations face multiple challenges in an increasingly complex global innovation landscape. From climate change to biodiversity and access to medicines, IP has become a cross-cutting issue with important public policy implications. Regional/bilateral trade agreements and plurilateral initiatives have also become a key feature of this global landscape.
In this context, what are the present realities and future challenges facing these negotiations? How can traditional differences be bridged to reach consensual outcomes? How to ensure coherence across the variety of international forums where IP issues are raised? These are some of the questions to be addressed in this dialogue which will bring together capital-based officials to interact with Geneva based IP negotiators, who will provide a practical perspective on how IP negotiations are conducted at forums such as the WTO and WIPO.