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    Developing Countries Urged To Beat Biopiracy With Patent Examination, Regulatory Frameworks

    Published on 7 February 2014 @ 10:22 am

    By , Intellectual Property Watch

    While World Intellectual Property Organization members seek ways to address the issue of biopiracy, speakers at a side event to this week’s negotiations said the phenomenon is widespread. According to them, very few patent applicants source the origin of the resources they have used and on which they seek claims. Some measures can be taken by countries within the intellectual property system to stem the problem, they said.

    The side event, entitled, Tackling Bio-piracy: Policy and Legal Options, was organised by the South Centre and the Third World Network (TWN) on 5 February.

    The WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) is meeting from 3-7 February.

    Edward Hammond, a researcher specialised in policy issues related to biodiversity, agriculture, infectious disease, and IP rights, presented on two items: some details of recently identified cases of possible misappropriation, and the results of disclosure analysis of 187 recent international patent applications claiming genetic resources.

    Among the recently identified cases is a barley gene used by Sapporo, a Japanese brewer, to give its beer a longer shelf life. The patent application dating from 2004 simply referred to the gene as coming from a “landrace” without identifying the country of origin. The gene appears to have come from India.

    Another case is an African microbe, a strain of Sorangium cellulosum, that “has yielded a fairly important new cancer drug, which has gained regulatory approval in the United States for use in breast cancer,” he said. The drug “Ixempra” is sold by Bristol Myers Squibb, which showed a US$120 million annual sale for it.

    There are also candidate drugs derived from the same microbe under development by Bayer and Novartis, he underlined. This is a case of a microbe “which has yielded lead compounds for three different pharmaceutical companies, all of them large.”

    There are now more than 600 international patent applications mentioning this drug in their claims, he said. Although a lot of those patents relate to the administration of the drug, not to the compounds themselves, only five of them “gave any indication of the origin of this microbe.”

    The ones which did, asserted that it was “collected on the bank of the Zambezi river,” he said, a river that crosses a large territory and several countries such as Namibia and Mozambique. It appears, according to Hammond, the sample of the microbe may in fact have been collected on a family farm in Orange State, South Africa.

    He gave other examples such as a patent from Pioneer Hi-bred International (WO2012112411), which claims a root-specific promoter gene from sorghum. In the patent application, he said the source was identified as BTX623, with no indication on the country of origin or access and benefit sharing measures.

    According to Hammond, it appears that BTX623 refers to a cross made in Texas between an Ethiopian sorghum and one “likely” from South African origin.

    Study Shows Poor Rate of Disclosure

    Hammond also disclosed the results of a study soon to be published by TWN, on 187 international patent applications relating to claims on genetic resources. The search was restricted to a specific class of patents (C12N “Micro-organisms or enzymes”), published from 2010 to 2013.

    Using a conservative approach that considered as disclosure any cases where scientific names of species included geographic references, he found that close to three-quarters of the applications contained no disclosure at all.

    Improving Search and Application Process

    Margo Bagley, professor at the University of Virginia School of Law, said a key issue for developing countries is to improve their search and application process in patent offices. A set of tools could help countries with the issue of misappropriation, she said.

    In particular, developing countries should include a requirement for information (RFI) provision in their legislation to require information from applicants, such as the location of origin of genetic material.

    Another important tool, she said, is involving third parties. This involves publishing pending applications promptly and inviting third party submissions of prior art, through the education of the public and incentives such as crowd-sourcing initiative Article One Partners (IPW, Innovation, 5 March 2013).

    She also advised to enhance the examination of patent applications. Work-sharing, such as “patent prosecution highways,” can be useful, but using other office examination should be considered a floor, not a ceiling, she said. This is because there is no way to know what happens to patents at a collaborating office after examination. For example, she said, some 60 percent of challenged European Patent Office patents were revoked or narrowed, and US courts decisions invalidate “thousands of patents”.

    She noted WIPO CASE (Centralized Access to Search and Examination) as a useful tool for developing country patent offices. An initiative born in 2008 between the IP offices of the United Kingdom, Canada and Australia, it is now open to any patent office as accessing office, depositing office, or both, she said.

    Also of importance, she said, is the patent claim format in order to avoid claims that are too broad and in some cases, can circumvent restrictions on patentability. She cited the recently challenged Syngenta patent on an insect resistant sweet pepper (IPW, IPW Briefs, 3 February 2014).

    Treaties Useful but Institutional Framework Key

    According to Biswajit Dhar, director general of the Research and Information System for Developing Countries in New Delhi, very few countries signatory to the Convention on the Biological Diversity have put into place a specific legislation.

    He said India for this purpose has enacted the Biological Diversity Act, but this does not prevent commercial entities – which are supposed to get permission from Indian’s national biodiversity authorities – from operating and accessing resources in any other mega-diverse country.

    A major problem, he said, is that in mega-diverse countries there is substantial use of bio-resources commercially, in particular in the area of traditional medicines. The challenge is to check these cases of accession without proper rules being followed.

    The key issue is the setting up of regulatory structures, he said. Treaty obligations and policies are widely discussed but the implementation is overlooked, he said.

    India has a lot of experience to share, he said, and it will be useful for member states to look at countries like India, Brazil and South Africa, which have been making efforts to put into place these kind of legislations to see how the problem of biopiracy can be addressed.

    “Adding new instruments will not take us very far unless … you take real serious steps to get the right institutions in place,” he said.

    TWN published a book [pdf] in August titled “Biopiracy Watch,” authored by Hammond, presenting a compilation of recent biopiracy cases.

     

    Catherine Saez may be reached at info@ip-watch.ch.

     

    Comments

    1. Leo Saldanha says:

      Esg has brought Monsanto to face criminal charges of biopiracy in India. Will be happy if we are included in these deliberatons.


    Leave a Reply

    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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