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KEI Special 301 supplemental comments: Compulsory Licensing not restricted to "Emergencies" or "Measure of Last Resort"

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

KEI's supplemental comments in USTR 301: Online pharmacies, parallel trade and counterfeit drugs

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

KEI's Feb 27, 2015 Supplemental Comments to USTR Regarding Research and Development

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

KEI 2015 Special 301 Comments (filed February 6, 2015)

Attached are KEI's February 6 comments to USTR on the 2015 Special 301.

Our 7 page submission begins with this:

KEI comments on India IP strategy

Attached are KEI's January 30, 2015 comments on the India IP Policy.

http://keionline.org/sites/default/files/KEI_30Jan2015_Comments_India_IPR_Policy.pdf

This is how the comments begin:

Knowledge Ecology International (KEI) has reviewed the document entitled “National IPR Policy” prepared by the IPR Think Tank. The document is surprisingly lacking in several key areas. In particular:

SEPTA class action suit on excessive pricing of Sovaldi, U.S. District Court for the Eastern District of Pennsylvania

Attached are:

1. The SEPTA the law suit.

2. A pessimistic 2011 OECD working paper on the weak competition remedies for excessive pricing in the United States.

3. A 2012 report on a 2011 OECD policy roundtable on excessive pricing

KEI intervention, SCCR 29, December 9, 2014

Below is a cleaned up version of the transcript, from my rambling intervention for KEI on the broadcasting treaty definitions.

Thank you, Mr. Chairman. My comments would be initially on the definitions.

It is our position that it's more appropriate to provide protection for free services that are traditionally provided by radio and television and less appropriate for pay services,

Broadcasters make sweeping demands on scope and rights in new WIPO treaty

To understand the negotiations this week at the WIPO SCCR 29, it is helpful to review an April 2014 document, endorsed by several broadcasting organizations.

The attached document* is a joint statement by 12 broadcasting organizations, on "THE OBJECTIVES, SPECIFIC SCOPE AND OBJECT OF THE PROPOSED WIPO BROADCASTERS' TREATY".

The new Medicines Patent Pool license with AbbVie: good news for children living with HIV

The Medicines Patent Pool (MPP) has signed a new license with AbbVie, to expand access to pediatric formulations of lopinavir (LPV) and ritonavir (r). The details of the licenses are available here:

NIH rulemaking on transparency of clinical trials

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:

http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003

UACT sends letter to Tufts President, Chairman of Trustees, asking questions about R&D cost study

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.

KEI comment on the new Tufts Study on Drug Development Costs

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.

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

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