- The Winning Bet
- KEI comment on the new Tufts Study on Drug Development Costs
- What to look for in the new Tufts study on drug development costs. 10 issues.
- Research note on oncology drugs, including trial size and orphan drug status
- KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
- Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund's Equitable Access Initiative
- WIPO patent committee engaged in heated talks on work sharing, limitations & exceptions, client confidentiality
- WIPO patent committee (SCP21): Intervention of KEI on Patents and Health
- WIPO patent committee (SCP21): Intervention of Pakistan on Patents and Health
- WIPO Standing Committee on the Law of Patents (SCP 21): Intervention of Pakistan on Opposition Systems
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.
India's Department of Industrial Policy and Promotion creates IPR Think Tank to Draft National IPR PolicySubmitted by thiru on 24. October 2014 - 6:05
On Friday, 24 October 2014, India's Department of Industrial Policy and Promotion (DIPP) announced the creation of an IPR Think Tank to Draft National Intellectual Property Rights Policy.
The composition of the think tank follows:
Justice Prabha Sridevan, Chairperson, IPR Think Tank;
Ms. Pratibha Singh, Advocate, Singh & Singh Associates, Member;
Ms. Punita Bhargava, Advocate, Inventure IP, Member;
Dr. Unnat Pandit, Cadila Pharmaceuticals Limited, Member;