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IP-Watch interns talk about their Geneva experience in summer 2013. 2:42.

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The Politicization Of The US Patent System

The Washington Post story, How patent reform’s fraught politics have left USPTO still without a boss (July 30), is a vivid account of how patent reform has divided the US economy, preempting a possible replacement for David Kappos who stepped down 18 months ago. The division is even bigger than portrayed. Universities have lined up en masse to oppose reform, while main street businesses that merely use technology argue for reform. Reminiscent of the partisan divide that has paralyzed US politics, this struggle crosses party lines and extends well beyond the usual inter-industry debates. Framed in terms of combating patent trolls through technical legal fixes, there lurks a broader economic concern – to what extent ordinary retailers, bank, restaurants, local banks, motels, realtors, and travel agents should bear the burden of defending against patents as a cost of doing business.


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    WHO Expert Group To Recommend Binding R&D Treaty Negotiation

    Published on 14 December 2011 @ 4:21 pm

    By , Intellectual Property Watch

    A World Health Organization expert group has narrowed proposals under consideration for ways to finance research and development for diseases predominately affecting poor populations. Among the remaining recommendations is that WHO members launch negotiations for a binding treaty.

    “This group is going to recommend to member states to consider initiating negotiations” of an R&D convention, Zafar Mirza, coordinator in the WHO Department of Public Health, Innovation and Intellectual Property, said recently. “The group thinks its time has come.”

    The preliminary recommendation of the Consultative Expert Working Group on Research and Development: financing and coordination (CEWG) was announced on 18 November, at the end of its third meeting.

    A progress report will be given to the annual January WHO Executive Board meeting, and the group hopes to finalise the report by February, making it public in March in the six UN languages.

    The first draft of the CEWG report is to be presented to the annual World Health Assembly in May 2012. At the November meeting, the group discussed ways to improve the report, according to Mirza. The discussion will be incorporated into the report.

    The group decided that six out of 15 proposals under consideration best fit the agreed criteria of the group, according to slides of 18 November presentation. The six are: a globally binding instrument for R&D and innovation for health; direct grants to companies in developing countries; equitable licensing; patent pools; pooled funds; precompetitive R&D platforms / open source and access; and prizes. Few details are available on the latest versions of the proposals.

    The remainder found to fit the criteria less well or to be not directly related to R&D were: green intellectual property; the Health Impact Fund; orphan drug legislation; priority review voucher; purchase or procurement agreements; tax breaks for companies; transferable IP rights; regulatory harmonisation; and removal of data exclusivity.

    The chair of the 21-member CEWG is John Arne Røttingen, director general of the Norwegian Knowledge Centre for Health Services, and vice chair is Claudia Inês Chamas of Brazil. The group’s work arose from the 2008 WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.

    Binding Convention

    The CEWG reaffirmed its commitment to further develop thinking on a global binding instrument on R&D funding, he said. In July, the group made a preliminary recommendation to start negotiations for a possible R&D treaty (IPW, WHO, 5 July 2011).

    Since then, their thinking has evolved to call for a “global binding instrument,” sources said. Loosely, the concept is to create a new binding global instrument, negotiated under the WHO. A government signing the instrument would commit to rules that regulate which – and how much – health R&D is undertaken in order to ensure adequate financing is available for “needs-driven” health R&D.

    The convention, which the WHO general counsel said falls under Article 19 of the WHO constitution, would address R&D related to Type II and Type III diseases (predominately affecting poor populations), and the specific R&D needs of developing countries in relation to Type I diseases (also occurring in developed countries), according to the 18 November presentation.

    The binding instrument is seen as necessary because “current funding is insufficient and global coordination is necessary to find solutions to the global disease burden,” it said.

    At the November meeting there was discussion of possible principles and objectives for a global binding instrument, Mirza said.

    The principles behind the binding instrument include: open knowledge innovation, de-linkage, competition, access and strengthening innovative capacity in developing countries; a global coordination mechanism; a call for increased public investment; a mechanism for redistributing resources; and the pooling of funds to meet these aims, according to the presentation.

    Among the option and principles the group discussed in November, according to sources, was that governments should consider different forms of revenue generation to match the proposed funding commitments, and that taxes on activities harmful to populations health, such as tobacco or alcohol, might be appropriate and would be earmarked for health R&D. Other possibilities were that if member states introduce any international indirect tax increase such as the financial transaction tax, a portion of the revenues would be dedicated to global health R&D; and that there could be more encouragement of voluntary private funding toward a pooled funding mechanism.

    It is unclear how the treaty proposal will be received by developed countries such as the United
    States, according to sources.

    No Threat to IP System

    A key point made by meeting chair was that the instrument is not aimed at replacing the existing IP-based system, Mirza said.

    “CEWG thinks it works when it works,” he said. But when it doesn’t work, the alternative is to develop a system in which governments make binding financial commitments to provide funding for R&D for diseases disproportionately affecting developing countries.

    Other Favoured Proposals

    Among the “best-fit” group, equitable licensing, patent pools, precompetitive R&D platforms / open source and access, and prizes (in particular milestone prizes) were clustered under “open knowledge innovation” in draft recommendations. The other recommendations are the direct grants, pooled funding, the R&D convention, coordination mechanisms, and strengthening capacity in and technology transfer to developing countries, the presentation said.

    Equitable licensing is aimed at ensuring that intellectual property-protected technology and medicines that arose from public funding or in public sector institutions such as universities should be licensed in a way that makes affordable versions available in resource-limited countries.

    Under patent pools, patent holders to license their patents to a pool based on negotiated terms. This allows generic manufacturers to use licenses from the pool under special restrictions.

    Pooled funds, meanwhile, provide funding to research organisations, including product development partnerships, on a long-term, secure basis. Pooled funds are managed by a board or facility, and can be generated from new sources such as taxes or bonds, or improved management of existing funds. There are a variety of proposals to the CEWG on pooled funds.

    Prizes are typically in the form of rewards for developing a product (an end prize) or for completing a step in the R&D process (a milestone prize).

    With direct grants to companies in developing countries, the funds are given to small and medium-sized companies to develop a product to the stage where they can more easily find other funders to take it to later stages of development.

    A report [pdf] on the CEWG to an October European Congress on Tropical Diseases and International Health gave an indication of the kinds of questions raised and answers provided about the CEWG process and proposals.

    The full CEWG membership is as follows:

    Prof John-Arne Røttingen, Norway, Chair, EURO region
    Prof Claudia Chamas, Brasil, Vice-Chair, PAHO region

    Mr L.C. Goyal, India, Rapporteur, SEARO region
    Ms Hilda Harb, Lebanon, Rapporteur, EMRO region
    Dr Leizel Lagrada, Philippines, Rapporteur, WPRO region
    Prof Bongani Mayosi, South Africa, Rapporteur, AFRO region

    Dr Kovana Loua, Guinea
    Prof Jean de Dieu Rakotomanga, Madagascar
    Dr Samuel Okware, Uganda
    Prof Carlos Correa, Argentina
    Prof Steven Morgan, Canada
    Prof Laksono Trisnantoro, Indonesia
    Dr Pichet Durongkaveroj, Thailand
    Dr Meri Koivusalo, Finland
    Prof Paul Herrling, Switzerland
    Prof Albrecht Jahn, European Union
    Prof Hossein Malekafzali, Islamic Republic of Iran
    Dr Rajae El Aouad Berrada, Morocco
    Mr Peilong Liu, China
    Mr Shozo Uemura, Japan

    William New may be reached at wnew@ip-watch.ch.

     

    Comments

    1. WHO Board Considers Reform, Director Re-Election, Key IP-Related Issues | Intellectual Property Watch says:

      [...] Meanwhile, the proposed negotiation of a treaty on financing and coordination of R&D for neglected diseases and other medical products may test the WHO’s ability to provide a forum for member states to reach agreement on sticky issues. A consultative WHO expert group in November agreed to recommend the negotiation of a binding treaty (IPW, WHO, 14 December 2011). [...]

    2. EU Health Cooperation: Room For Improvement | Intellectual Property Watch says:

      [...] considerations apply to the operational models the WHO has called for to finance R&D for diseases of the poor and ensure long-term access to medicines. They encompass direct grants, equitable licensing, pooled [...]

    3. Inside Views: WHO Performance Undermined By Inadequate EU Collaboration | Intellectual Property Watch says:

      […] considerations apply to the models the WHO has called for to finance R&D for diseases of the poor and ensure long-term access to medicines. There is seemingly poor attention by the EU, apart from […]

    4. Global Health 2035 Report: Flawed Projections | Intellectual Property Watch says:

      […] models the WHO has called for to finance R&D for diseases of the poor and ensure long-term access to medicines have been overlooked in the Lancet Report. This comes as […]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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