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

Knowledge Ecology International - Wed, 03/02/2016 - 09:42

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:

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

Knowledge Ecology International - Wed, 20/01/2016 - 11:04

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

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Xtandi 2016 March-In Request

Knowledge Ecology International - Wed, 13/01/2016 - 23:45

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 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.

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

Knowledge Ecology International - Wed, 13/01/2016 - 17:14

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.

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

Knowledge Ecology International - Mon, 11/01/2016 - 17:51

This was the release from Representative Doggett's office:

January 11, 2016

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

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

Knowledge Ecology International - Mon, 11/01/2016 - 10:36

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

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

Knowledge Ecology International - Tue, 05/01/2016 - 12:44

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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KEI's December 19, 2015 submission to the US ITC regarding the TPP

Knowledge Ecology International - Wed, 30/12/2015 - 13:53

Attached here is a KEI submission to the US ITC for the January hearing of the

Washington, DC
Investigation No. TPA-105-001
Trans-Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors

Our earlier, related testimony on trade agreements was here: http://keionline.org/node/2370

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The UK's rebates on drug sales, and introducing the budget constraint into pricing models

Knowledge Ecology International - Tue, 22/12/2015 - 18:05

Under the UK's Pharmaceutical Price Regulation Scheme (PPRS), drug companies will make rebates of about £550 million in 2016, according to this story.

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SAVE THE DATE - 16 December 2015 - KEI breakout session on A WTO Agreement on the Supply of Social Goods

Knowledge Ecology International - Tue, 15/12/2015 - 12:45

On Wednesday, 16 December 2015, at the Fourth Global Congress on Intellectual Property and the Public Interest (National Law University, Delhi, India), Knowledge Ecology International (KEI) will convene a breakout session (led by Jamie Love, Director, KEI) on a WTO Agreement on the Supply of Social Goods.

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SCCR 31 Chair's Conclusion

Knowledge Ecology International - Fri, 11/12/2015 - 17:46

Chair's Conclusions

MICHELE WOODS: Standing Committee on Copyright and Related Rights, 31st session, Geneva, December 7 to 11, 2015. Summary by the Chair.

Agenda item 1. Opening of the session. The 31st session of the Standing Committee on Copyright and Related Rights SCCR or Committee was opened by Mr. Francis Gurry, Director General who welcomed the participants and opened agenda item 2.
Ms. Michele Woods, WIPO, acted as secretary.

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SCCR 31 Chair's proposal for future work and conclusions

Knowledge Ecology International - Fri, 11/12/2015 - 16:34

The Chair proposed an intersessional on broadcasting and regional meetings regarding Libraries and Archives. This was supported by Asia, Grulac and Africa (but Africa wanted to include education and research institution) and rejected by Group B. The decision will be made at the next SCCR, SCCR 32 possibly May 9-13 2016.

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SCCR 31: KEI Statement on Droit de Suite/Resale Rights

Knowledge Ecology International - Fri, 11/12/2015 - 15:41

Day 5 of SCCR 31, December 11, 2015

Thank you Mr Chair.

We welcome the proposal tabled by Senegal and the Congo to include the droit de suite, the artist resale right, in this Committee’s agenda for future work.

I would like to refer to the Directive mentioned by the Commission, Directive 2001/84/EC which came into force on 1 January 2006:

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US Industry pressure against any IPR concessions at Paris Climate Talks on green technology

Trans Atlantic Consumer Dialogue - Fri, 11/12/2015 - 10:10

December 7, 2015
The Honorable Michael Froman
Office of the United States Trade
600 17th Street, NW
Washington, DC 20508
Fax: (202) 395-4549
The Honorable Penny Pritzker
United States Department of Commerce
1401 Constitution Ave., NW
Washington, DC 20230
Fax: (202) 482-2741
The Honorable John Kerry
United States Department of State
2201 C Street, NW
Washington, DC 20520
Fax: (202) 647-2283
Re: U.S. IPR and the COP21 Climate Negotiation


Dear Secretary Kerry, Ambassador Froman, and Secretary Pritzker:
As the COP21 UNFCCC meeting in Paris progresses, we ask for your continued
leadership in rejecting the ongoing demands of a small group of foreign governments and NGOs
that UNFCCC member governments weaken the protection of climate change-related patents and
other Intellectual Property Rights (IPR), or that they agree to measures or provisions that would
otherwise undermine existing global IPR standards. Any such outcome would not only
undermine previously agreed global IPR standards as reflected in the WTO Agreement on Trade-
Related Intellectual Property Rights (TRIPS) in particular, but would be counterproductive from
a perspective of addressing the effects and underlying causes of global climate change (for which
innovation and continued dissemination and deployment of clean technologies is needed), and
have serious negative consequences for U.S. industry, U.S. exports, and U.S. jobs.
Over the years, several countries and NGOs have sought to insert references to IPR in
UNFCCC decisions and other negotiating outcomes. This has ranged from overt schemes like
compulsory licensing, veiled references to “flexibilities” and “balancing” IPRs, to proposals to
create UN- or foreign government-led bodies to buy up and effectively redistribute American
and other IPRs and their related technologies.
We urge you to avoid all references to IPR, positive or negative, in the agreement or
decision text. This is particularly critical with respect to references that relate to IPR and
finance, which could be viewed as an institutional mechanism to engage in compulsory
There are several reasons why these and other IPR-related proposals are so harmful:
? First, U.S. firms are currently among the world’s leaders in the development and production
of cleaner, more efficient technology, goods, and services. Enhancing this leadership
position will help create and maintain high-paying jobs in America and sustain future U.S.
economic growth, exports, and trade. Failing to do so means losing the battle for
competitiveness and jobs to China, India, and other nations, all of whom are investing in
these key growth markets and have aggressive industrial policies in place that are targeted at
U.S. technology and U.S. innovation. Continued strong global IPR protection is key.
? Second, failure to protect clean technology IPR would also undermine the very climate
change action that the Administration (and the UNFCCC) is aiming to pursue. The evidence
shows, for example, that strong IPR protection encourages private sector investment in new
technologies and innovation, helps companies market and thus monetize their competitive
technological edge, yet at the same time rewards the sharing of knowledge and inventions,
rather than inhibiting or punishing it.1 A wide body of economic and policy literature also
confirms that IPRs help facilitate both the development of new clean technology solutions,
and their adoption and deployment on the ground.2 As such, patents and other forms of IPR
protection are a tried-and-tested tool to achieve global climate change-related objectives, as
well as sustainable development and investment in some of the world’s poorest and most
vulnerable nations. Indeed, in most developing countries it is not the existence of IPR
protection that is the problem, but rather its absence.

Finally, no matter how carefully crafted, failure to keep IPR issues out of a UNFCCC or
other UN climate change or sustainable development agreement or decision will result in
significant legal, institutional and practical confusion precisely because such IPR issues are
already well-regulated at the WTO and elsewhere. Even worse, any kind of compromise
language on or references to IPR in a climate change or other UN agreement or decision,
risks undermining this Administration’s own recent negotiating efforts in the Transpacific
Trade Partnership (TPP) Agreement and elsewhere, and would send mixed signals to our
negotiating partners around the world. It would send a confusing signal and be harmful not
just for the U.S. economy, innovation, exports, and jobs, but for the very climate changerelated
objectives that the UNFCCC COP21 negotiation is purporting to pursue.

1 See, e.g., PriceWaterhouseCoopers, Innovation: Government’s Many Roles in Fostering Innovation (2010).
2 See, e.g., Kristina M. Lybecker and Sebastian Lohse, WIPO Global Challenges Report, Innovation and Diffusion
of Green Technologies: The Role of Intellectual Property and Other Enabling Factors, WIPO: Geneva (2015); U.N.
Conference on Trade and Development, Foreign direct investment, the transfer and diffusion of technology, and
sustainable development (2011), available at http://unctad.org/en/docs/ciiem2d2_en.pdf.

As the COP21 enters its final stages, we urge you to continue standing up for American
jobs, American exports, and American innovative businesses and entrepreneurs and to continue
rejecting any and all references to IPR in a COP21 agreement or decision, including more
indirect references or openings for future discussions about IPR, such as those mentioned above
and previously discussed with your teams.
We recognize the evolving nature of these negotiations and urge you continue to support
an environment where IP rights facilitate technology development and dissemination. We will
continue to communicate with your representatives on the ground in Paris from State, USTR, and
Commerce as a follow up to this letter.

Yours sincerely,
Alliance for Clean Technology Innovation
Biotechnology Industry Association
Business Council for Sustainable Energy
Corn Refiners Association
Information Technology Industry Council
National Association of Manufacturers
National Foreign Trade Council
Northeast Clean Energy Council
U.S. Chamber of Commerce
United States Council for International Business
CC: The Honorable Michelle Lee
United States Patent and Trademark Office
USPTO Madison Building
600 Dulany Street
Alexandria, VA 22314
Fax: (571) 273-8300
CC: Ms. Caroline Atkinson
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20006
Fax: (202) 456-2461
CC: The Honorable Stefan Selig
United States Department of Commerce
1401 Constitution Ave., NW
Washington, DC 20230
Fax: (202) 482-2741

Categories: Front page

SCCR 31 KEI Statements on Legal Deposit and on Lending

Knowledge Ecology International - Fri, 11/12/2015 - 08:28

Topic 3 is Legal Deposit.

KEI ‘s question is the following: should these designated deposit systems --national archives or libraries-- be mandated or encouraged as I believe it is described in the US principles)?

We're not even sure this is a copyright issue and to what extent this is essential for libraries.

However, as the IFLA Statement underlined, Legal deposit was the original limitation on copyright, embedded in the Statute of Anne and we believe it could be discussed in the form of a model law intended to ensure the preservation of works at a national level.

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SCCR 31: Statement of SAA Representative re Reproduction and Safeguarding Copies

Knowledge Ecology International - Thu, 10/12/2015 - 16:23

Statement of SAA Representative to WIPO Standing Committee on Copyright and Related Rights 31 December 2015 by
William J. Maher (w-maher at illinois.edu)

TOPIC TWO: Reproduction and Safeguarding Copies

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SAVE THE DATE - 16 December 2015 - KEI workshop on a WTO Declaration on the TRIPS Agreement and the copyright 3-step test

Knowledge Ecology International - Thu, 10/12/2015 - 15:30

On Wednesday, 16 December 2015, at the Fourth Global Congress on Intellectual Property and the Public Interest (National Law University, Delhi, India), Knowledge Ecology International (KEI) will convene a workshop entitled a "WTO Declaration on the TRIPS Agreement and the Three-Step Test for Copyright and Related Rights."

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In favour of Public Libraries´ role for preservation, reproduction and access to culture

Trans Atlantic Consumer Dialogue - Thu, 10/12/2015 - 15:12

Oral Statement at World Intellectual Property Organization copyright committee (sccr 31)


Millions of consumers in Europe and the United States represented by TACD are in favour of the role public libraries in providing access to knowledge, research and preservation.

Recently we have commemorated 800 years of the Magna Carta and the Charter of the Forest that safeguarded the use and access of the common good from unreasonable, private enclosure. It limited the power of the monarchy to exercise its complete power over its properties. Today we are facing many attempts to enclose the digital and cultural sphere to prevent access to what should be the immaterial knowledge commons. International instruments for exceptions and limitations could prevent this.

Preservation of our cultural heritage should be a global public good and a part of our global knowledge commons.

Archives provide researchers with copies, aid scientific endeavors and preserve our cultural legacy. To ignore that we are in a digital age that can reinforce and enrich common knowledge is neither rational nor morally acceptable. It is not an alternative to impose cumbersome and expensive licensing schemes.

The right to reproduction is also needed for supplying copies for use, repair, lending and sharing between libraries and for individuals. Why deny exceptions and create barriers to this public non-profit service that helps many and hurts no one? There is no empirical objective evidence of substantial “negative unintended consequences.” by library activities.

It is quite surprising that the European Union that has recently presented a proposal for a reform of its copyright laws, with clear proposals for exceptions and limitations for text and data mining, disabilities and other areas but at the same time it is not willing to extend these initiatives to the rest of the world.

EU´s new copyright proposal that has just been released to reform the existing 2001 Information Society Directive. It states:

The EU exception authorizing libraries and other institutions to allow on-screen consultation of works for research and private study only applies to terminals on the libraries’ physical premises, which does not take into account today’s technological possibilities for remote consultation. Lastly, the EU exception on preservation activities by cultural heritage institutions also needs attention, notably because Member States often do not take digital formats into account when implementing the exception at national level.25 The Commission will take action to ensure that the EU framework on exceptions that is relevant for access to knowledge, education and research is effective in the digital age and across borders.

To allow public interest research organizations to carry out text and data mining of content they have lawful access to, with full legal certainty, for scientific research purposes;

? provide clarity on the scope of the EU exception for ‘illustration for teaching’, and its application to digital uses and to online learning;

? provide a clear space for preservation by cultural heritage institutions, reflecting the use of digital technologies for preservation and the needs of born-digital and digitized works;

? support remote consultation, in closed electronic networks, of works held in research and academic libraries and other relevant institutions, for research and private study;

Why can´t the EU enter into a parallel discussion here at WIPO about similar exceptions and limitations could be enacted for the libraries of the world?

What is acceptable for the European Union needs to be extended to the rest of the world for universal access to culture, education and science.

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