Blogs

What to look for in the new Tufts study on drug development costs. 10 issues.

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:

Research note on oncology drugs, including trial size and orphan drug status

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 results

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

Elizabeth Rajasingh
November 17, 2014

Introduction

Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund's Equitable Access Initiative

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 (SCP21): Intervention of KEI on Patents and Health

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

Part 1

WIPO patent committee (SCP21): Intervention of Pakistan on 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

Mr. Chair,

I will make this statement in national capacity,

WIPO Standing Committee on the Law of Patents (SCP 21): Intervention of Pakistan on Opposition Systems

On Tuesday, 5 November 2014, Pakistan delivered the following intervention on opposition systems.

Mr. Chairman,

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 Rights

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)

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 countries

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.

hamamoto_lee_22sep2014_wipoga.jpg

India's Department of Industrial Policy and Promotion creates IPR Think Tank to Draft National IPR Policy

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;

Rajasingh on India-US dispute over patents on dasatinib, a drug to treat leukemia

link to video: https://www.youtube.com/watch?v=vU-JLDq02CE See also: http://keionline.org/node/2109.

Video script:

My name is Elizabeth Rajasingh.

I want to talk about a trade dispute between India and the United States, involving patents on a drug for leukemia.

Comments to USTR on the Out-of-Cycle Review for India due October 31, 2014.

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Ambassador Michael Froman wants to block compulsory licenses on drug patents in India

New leak of TPP consolidated text on intellectual property provides details of pandering to drug companies and publishers

For more information:
James Love, Knowledge Ecology International
email: james.love@keionline.org, +1.202.361.3040

The May 16, 2014 version of the consolidated negotiating text for the Intellectual Property Chapter for the Trans-Pacific Partnership (TPP) agreement is a long, complex document that taken as a whole is designed to expand and extend monopolies on knowledge goods, including in particular publisher-owned copyrights, patents on inventions, and monopoly rights in data used to register new drugs, vaccines and agricultural chemical products.

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