- Rep. Lloyd Doggett keynote address at CAP drug pricing event highlights Xtandi, federal funding of pharmaceutical R&D
- China: as PCT patent filings increase, GDP growth has decreased
- Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries
- KEI comment on USTR's 2016 Special 301 report
- Transparency of patents on medicines and other technologies
- WHO releases program of work and progress report in advance of Consultative Expert Working Group on R&D (2-4 May 2016)
- 2015 Oct 16 version: RCEP draft text for investment chapter
- Letter to HHS and NIH regarding impact of high prices on cost effectiveness of Xtandi
- 2015 Oct 15 version: RCEP IP Chapter
- Global pharmaceutical sales, by region, 2013-2015
On March 3, 2016, KEI filed a comment with the U.S. Copyright Office in Docket No. 2015-8, regarding 17 U.S.C. § 1201.
The comment made specific recommendations regarding changes to the rulemaking procedure, the anti-trafficking provisions, and permanent exemptions, and also suggested requiring a registration and application process, as well as payment of a fee, for the DRM/TPM seeking legal protection under the law.
11 February 2016: 5 groups express concerns over WIPO statements relating to UN High-Level Panel on Access to MedicinesSubmitted by thiru on 4. March 2016 - 5:10
On Thursday, 11 February 2016, five groups including Knowledge Ecology International (KEI), Oxfam, Stop AIDS, Third World Network (TWN) and Treatment Action Campaign (TAC) sent a letter to Dr. Francis Gurry, Director-General of the World Intellectual Property Organization (WIPO) highlighting our concerns with statements expressed by WIPO relating to the United Nations Secretary General’s High-Level Panel on Access to Medicines (HLP). To date, we have yet to hear any formal response from WIPO.
Andrea Carolina Reyes Rojas informs us that a committee appointed to consider a request for a compulsory license on the leukemia drug Imatinib has decided that there are public interest reasons to do so.
Some press reports about the decision:
Colombia Technical Committee Recommends Declaration that a Compulsory License on Imatinib (Gleevec) Would Be in Public InterestSubmitted by Andrew Goldman on 3. March 2016 - 13:46
In Colombia, a technical committee has issued a recommendation that a declaration be made that a compulsory license on imatinib (Gleevec) would be in the public interest. Under Colombian law, this is an important intermediary step prior to the actual grant of a compulsory license.
Attached below are the four submissions for which KEI was the lead author to the UN Secretary General's High Level Panel (HLP) on Access to Medicine.
- "The Need for Global Negotiations on Agreements to Fund R&D within the Context of a Progressive De-linking of R&D Costs from Product Prices". Supported by 12 organizations; 1 individual; 3 Members of European Parliament.
- "Increasing the Transparency of Markets for Drugs, Vaccines, Diagnostics and other Medical Technologies". Supported by 17 organizations; 2 individuals; 3 Members of European Parliament.
DHHS has declared a public health emergency over the Zika viru, and authorized emergency use of diagnostic tests. (Copy here)
(An expanded, edited and better version of this is available in our March 4, 2016 reply comment to USTR, available here: http://www.keionline.org/node/2440)
These were my notes from my testimony for KEI at today's USTR Special 301 hearing
Big market puts countries on the #special301 watch list
The dearth of recent compulsory licenses out of India has led to speculation that the Government has made an agreement not to issue such licenses.
On reviewing submissions for the Office of the United States Trade Representative's upcoming 2016 Special 301 Review, several industry documents confirm that such an agreement exists.
KEI is one of the non-government entities speaking at the USTR Special 301 hearing on Tuesday. We each get 7 minutes of testimony and 3 minutes of questions. (The schedule is here).
KEI intervention: TTIP Stakeholder events Round 12, Brussels (24 February 2016)
A Positive Agenda for TTIP - What we would like to see in the TTIP that would expand access to knowledge?
1) Marrakesh Treaty ratification
The TTIP should include an obligation to ratify and to implement the WIPO Marrakesh Treaty for Persons Who Are Blind for Otherwise Disabled, in order to expand access to accessible works to persons with disabilities in the European Union and the United States, as well as in other countries.
2016: KEI comments on NIH proposal for exclusive licenses for vitro diagnostics patents to AltraTechSubmitted by KEI Staff on 23. February 2016 - 1:30
Other KEI comments on NIH licenses are found here: http://keionline.org/nih-licenses
February 22, 2016
Patrick McCue, Ph.D.
Senior Licensing and Patenting Manager
Technology Advancement Office
The National Institutes of Diabetes and Digestive and Kidney Diseases
12A South Drive
Bethesda, MD 20892
via email: email@example.com
Dear Dr. McCue:
I am in a meeting of the Equitable Access Initiative (EAI), which is considering new ways of measuring development and/or health needs, in the context of the priority setting by donors. I am a member of the Expert Panel, and this was my intervention in the morning session:
The presentations by John McArthur and Dominik Zotti were excellent, and the work of the four expert groups is a very useful contribution for those struggling with the challenge of setting priorities for aid.
5 questions about NIH licenses to patents on Production of Attenuated Respiratory Syncytial Virus VaccinesSubmitted by James Love on 22. February 2016 - 0:59
The NIH has a notice for comments on proposed licenses of several patents relating to the "Production of Attenuated Respiratory Syncytial Virus Vaccines". See: https://federalregister.gov/a/2016-03486
We asked Peter Soukas, a Senior Technology Licensing Specialist in the Technology Transfer and Intellectual Property Office, at the National Institute of Allergy and Infectious Diseases (NIAID), these questions:
- What provisions exist in the license to protect US residents against excessive or unreasonable pricing?
Submission of Knowledge Ecology International
U.S. Copyright Office Docket No. 2015-6
This is the submission of Knowledge Ecology International (KEI) in response to the U.S. Copyright Office request for public comment on “software-enabled consumer products” (U.S. Copyright Office Docket No. 2015-6).
Knowledge Ecology International is a non-governmental organization with offices in Washington, DC, and Geneva, Switzerland, that searches for better outcomes, including new solutions, to the management of knowledge resources.
This submission covers these topics:
Obama Administration Recommends Senate Ratify Marrakesh Treaty for the Blind; Implementation Language Would Limit ExportsSubmitted by Claire Cassedy on 12. February 2016 - 14:35
CONTACT: Zack Struver
+1 (202) 332-2670
Obama Administration Recommends Senate Ratify Marrakesh Treaty for the Blind; Implementation Language Would Seriously Limit Exports