Blogs

Equitable Access Initiative (EAI), 1st intervention

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 Vaccines

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:

  1. What provisions exist in the license to protect US residents against excessive or unreasonable pricing?

KEI comments to Copyright Office on software-enabled consumer products

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).

Introduction

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 Exports

CONTACT: Zack Struver
zack.struver@keionline.org
+1 (202) 332-2670

Obama Administration Recommends Senate Ratify Marrakesh Treaty for the Blind; Implementation Language Would Seriously Limit Exports

WTO TRIPS Council (March 2016) to discuss Intellectual Property and Innovation: Education and Diffusion

The World Trade Organization (WTO) will convene its Council for TRIPS (TRIPS Council) from Tuesday, 1 March 2016 to Wednesday, 2 March 2016. Australia, the European Union, Switzerland and the United States of America have submitted a written request for the item "Intellectual Property and Innovation: Education and Diffusion" to be placed on the proposed agenda.

WTO/AIR/IP/6
5 FEBRUARY 2016

SUBJECT: COUNCIL FOR TRIPS

THE NEXT MEETING OF THE COUNCIL FOR TRIPS WILL BE HELD IN THE CENTRE WILLIAM RAPPARD ON 1-2 MARCH 2016. THE MEETING WILL START AT

Obama asks the Senate to ratify the Marrakesh treaty for the blind

This is the announcement.

For Immediate Release February 10, 2016

TO THE SENATE OF THE UNITED STATES:

With a view to receiving the advice and consent of the Senate to ratification, I transmit herewith the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled, done at Marrakesh on June 27, 2013 (Marrakesh Treaty). I also transmit, for the information of the Senate, a report of the Secretary of State with respect to the Marrakesh Treaty that includes a summary of its provisions.

NIH acknowledges KEI/UACT request to use royalty-free or march-in rights on Xtandi

On February 8, 2016, the National Institutes of Health (NIH) responded to Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment’s (UACT) letter requesting that the federal government exercise its authority under the Bayh-Dole Act to break patents on an expensive prostate cancer drug.

Feasibility study on a TDR pooled fund for R&D to be released on 20 February 2016

In May 2014, the 67th World Health Assembly (WHA) of the World Health Organization (WHO) passed Decision WHA67(15) providing WHO the mandate to explore the feasibility of creating a voluntary pooled fund fund on R&D hosted by the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR). The Decision outlined three principles guiding the consideration of the pooled fund:

SAVE THE DATE - 26 January 2016: Implications of the TPP and RCEP on Universal Health Coverage

Implications of the Trans Pacific Partnership (TPP) and Regional Comprehensive Economic Partnership (RCEP) on Universal Health Coverage

Knowledge Ecology International

26 January 2016
9 AM to 12:30 PM
Lotus Suite 3. 22nd Floor
Bangkok Convention Centre
Bangkok, Thailand

Xtandi 2016 March-In Request

Today Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) petitioned the Department of Health and Human Services, the Department of Defense, and the National Institutes of Health, asking that they exercise either their royalty-free, non-exclusive license or federal "march-in" rights to end the monopoly on an expensive prostate cancer drug, enzalutamide, marketed as Xtandi by Astellas, a Japanese pharmaceutical company.

Xtandi was invented at UCLA on federal grants from the NIH and DoD.

Knowledge Ecology International joins amicus brief on non-copyrightability of model laws and statutes

Washington, DC — On January 11, 2016, Knowledge Ecology International joined Public Knowledge and the American Library Association in an amicus curiae brief that argued that the contents of model laws, once enacted into statute, cannot be protected by copyright. The brief was filed with the U.S. District Court for the District of Columbia in the case of ASTM International v. Public.Resource.Org.

51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices

This was the release from Representative Doggett's office:

FOR IMMEDIATE RELEASE
January 11, 2016

Contact:
Leslie Tisdale, (202) 225-4865
Over 50 Members of Congress to Obama Administration:
Help End Drug Price Gouging Now

WHO's evaluation of the global strategy and plan of action on public health, innovation and intellectual property

In May 2008, the 61st World Health Assembly (WHA) of the World Health Organization (WHO) adopted the seminal global strategy and plan of action on public health, innovation and intellectual property.

As stated in its aim, the global strategy on public health, innovation and intellectual property serves to

FDA approves 45 new drugs. 47 percent qualify for 50 percent Orphan Drug tax credit

In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This is a large number of approvals.

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