- A few reactions to the USTR Special 301 Hearing
- KEI comments at February 24, 2015 USTR Special 301 Hearing
- WTO TRIPS Council (February 2015): Bangladesh statement (on behalf of LDC Group)- Extension of the 2016 transitional period
- WTO TRIPS Council (February 2015): LDC Group statement on Non-Violation and Situation Complaints
- WTO TRIPS Council (February 2015): LDC request for extension of the transitional period for pharmaceutical products
- WTO Trade Policy Review of the United States: USTR deflects questions from India on compulsory licensing (December 2014)
- Human Rights Council Social Forum 2015: Intervention of Knowledge Ecology International
- Save the Date- 19 February 2015- Fire in the Blood- Screening co-sponsored by KEI/MSF-Access Campaign
- 16-18 February 2015 WIPO Expert Forum on International Technology Transfer to examine Alternatives to the Patent System
- Regional Comprehensive Economic Partnership, Japan IPR proposals, October 3, 2014
The NIH has a notice about a proposed rule that "clarifies and expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database." Comments are due on or before February 19, 2015. We may ask the NIH to consider expanding the trials registry to include more information on the economics of clinical trials.
Here is a link to the Regulations.Gov docket for the proposed rule:
On November 24, 2014. the Union for Affordable Cancer Treatment (UACT) sent a letter to Anthony P. Monaco, Office of the President, Tufts University, with copies to Michael Baenen, the Tufts Chief of Staff, and Peter Dolan, Chairman of the Board of Trustees for Tufts University, regarding the Tufts University press conference to announce an estimate of $2.6 billion as the R&D costs for new drugs.
Leading up to the release of Professor Joe DiMasi's latest study of the cost of drug development, KEI offered $50 to the individual who could most accurately predict the new cost for drug R&D.
We received 26 guesses, ranging from $1.157 billion to $5 billion.
Joel Lexchin's estimate ($2.47 billion) was the closest to DiMasi's number ($2.558 billion). It was also the 5th largest estimate.
A complete list of submissions is below.
Name & Guess
Charles Clift - 1.157 billion
Nicole H - 1.2 billion
Ronald Rader - 1.55 billion
Wouter Deelder - 1.655 billion
The Tuft Center for Study of Drug Development (CSDD) has just concluded a press conference, and issued a press release about their new study of drug development costs. The key number is $2.558 billion.
When the new Tufts study on the costs of R&D for development of a new drug is released Tuesday at 10AM, here are 10 things to look for:
We will be sharing some data on 2005 to 2014 oncology approvals, including the size of the trials cited in the medical review, and the orphan status.
The spreadsheet we are working on updating is published here:
KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary resultsSubmitted by James Love on 17. November 2014 - 11:50
A copy of the research note is also available here as a pdf file: http://keionline.org/sites/default/files/kei-rn-2014-3.pdf
KEI Research Note 2014:3
Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
November 17, 2014
On 14 March 2014, KEI published "Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules" in which we provided an analysis of the Global Fund's plans to create a global framework for tiered pricing enforced by the rules of the World Trade Organization (WTO).
WIPO patent committee engaged in heated talks on work sharing, limitations & exceptions, client confidentialitySubmitted by thiru on 6. November 2014 - 11:38
6 November 2014
The following intervention on patents and health was delivered by KEI during the 21st session on WIPO's Standing Committee on the Law of Patents (SCP). Part 1 was delivered on 4 November 2014 during discussions of the Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents. Part 2 was delivered on 5 November 2014 during general discussions on patents and health.
Statement of Knowledge Ecology International (KEI)
Item 7: Patents and health
On Wednesday, 5 November 2014, Pakistan delivered the following intervention on patents and health.
Agenda 7 Statement on patents and health
1. General statement
I will make this statement in national capacity,
WIPO Standing Committee on the Law of Patents (SCP 21): Intervention of Pakistan on Opposition SystemsSubmitted by thiru on 4. November 2014 - 13:29
On Tuesday, 5 November 2014, Pakistan delivered the following intervention on opposition systems.
The agenda item on quality of patents also include another item on "opposition systems" which was not discussed by the Committee. I want to make a small statement on opposition systems.
WIPO patent committee (SCP21) to discuss International Nonproprietary Names and Exceptions and Limitations to Patent RightsSubmitted by thiru on 3. November 2014 - 5:55
In the words of the International Bureau of the World Intellectual Property Organization (WIPO), the WIPO Standing Committee on the Law of Patents (SCP) was created,
created in 1998 to serve as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law.
WTO TRIPS Council (October 2014): Statement of India on the Review of the Paragraph 6 system (compulsory licensing for export)Submitted by thiru on 29. October 2014 - 11:49
On 28 October 2014, India delivered the following intervention at the WTO TRIPS Council's annual review of the Paragraph 6 system (designed to facilitate compulsory licensing for export of pharmaceuticals).
In particular, India noted that
Obama officials seek end of WIPO program on limitations and exceptions to patent rights in developing countriesSubmitted by Staff on 24. October 2014 - 8:21
During the WIPO 2014 General Assembly's discussions of patents and health in the context of the work of the Standing Committee on the Law of Patent (SCP), the Obama Administration embraced an aggressive position against WIPO technical assistance on the use of patent limitations and exceptions.