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IP-Watch Interns Summer 2013

IP-Watch interns Brittany Ngo (Yale Graduate School of Public Health) and Caitlin McGivern (University of Law, London) talk about their Geneva experience in summer 2013. 2:42.

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    Expiring GMO Patents Raise Regulatory Issues; Private Sector Takes Measures

    Published on 5 February 2013 @ 11:37 am

    By , Intellectual Property Watch

    A number of patents on genetically modified organisms (GMOs) in agriculture will expire in the coming years and this could be a problem for the biotechnology industry in terms of regulatory authorisations. A private sector initiative has recently been launched to address the issue.

    In the United States, the Biotechnology Industry Organization (BIO), along with the American Seed Trade Association (ASTA), started an initiative in 2010 to “address the opportunity and the challenges associated with patent expiration.” They jointly developed a framework, called “the Accord,” which is “a private-sector driven mechanism that provides for the transition of regulatory and stewardship responsibilities for biotechnology events, after patent expiration,” according to the Accord website.

    The website states: “The first genetically engineered row crop was commercialized in 1996.” It further says that “currently, nearly ninety-percent of cotton, corn and soybean acreage in the United States is planted with seed varieties containing biotechnology events [traits].”

    “Grain from these crops is traded globally, accounting for over $40 billion annually, making the United States the largest producer and exporter of crops and grain derived from biotechnology globally,” the site says.

    The first of the commercial biotechnology traits are going off patent in 2015, and the Accord seeks to find a solution to the maintenance of global regulatory authorisations for those traits.

    It includes two agreements: the Generic Event Marketability and Access Agreement (GEEMA), open for signature on 31 October 2012, and the Data Use and Compensation Agreement (DUCA), which is expected to be open for signature in 2013. According to the website, the GEEMA has five signatories: BASF Plant Science, Bayer CropScience, Dow AgroSciences, Dupont Pioneer, and Monsanto.

    After patents expire, they fall into the public domain and can be used widely. Under the GEEMA, according to Matthew O’Mara, director of international affairs, food and agriculture at BIO, holders of the proprietary regulatory property (PRP, companies that have developed proprietary regulatory information supporting authorisations for biotechnology traits), have three options.

    These options are: they can maintain the authorisation independently and therefore at no cost to the generic producer (a seed company that accesses the generic event to incorporate into its seed products); they can attempt, via negotiations, to share these costs and responsibilities; or they can choose to discontinue regulatory responsibilities, starting a seven-year clock, he told Intellectual Property Watch.

    Under this scenario the originator steps away, and if no other signatory steps forward to negotiate for access to the PRP, then all signatories that are using the generic event free of cost must discontinue use, O’Mara said.

    The GEEMA does not, however, address variety patents, O’Mara said, but focusses on single biological trait patents. The scope of GEEMA is limited to the US patents, he said, and thus only applies to US cultivation and “ensuring regulatory authorisations are maintained and obtained in export markets.”

    “It is possible that the GEEMA could be a model for industry in other countries, but we intended to enable industry in other countries to determine the best path forward in their respective country,” he said.

    Both the GEEMA and the DUCA agreements are voluntary, but according to the Accord’s website, “they are binding contracts among signatories.” The agreements “promote continued innovation in the seed industry, preserve strong protection for intellectual property rights and potentially provide for new business opportunities,” it says.

    EU Commission: Rights and Obligations Independent of IPRs

    According to Frédéric Vincent, spokesperson for health and consumer policy at the European Commission, under the EU legislation, “GMOs may be placed on the EU market, either to be used as food or feed or to be cultivated, only if they are authorised for that specific use.” The risk assessment is usually performed by the European Food Safety Authority and member states, he told Intellectual Property Watch.

    “Decisions of authorisation of GMOs impose rights and obligations on the authorisation holder and on the users of the GMO,” he said, adding that these rights and obligations apply independently of the intellectual property rights on the genetic traits that could be held by the authorisation holder, which is usually an individual company.

    “When the company loses its patents on the GMO, other seed companies can start selling seeds,” which means that the authorisation holder may experience difficulties in ensuring that its obligations are fulfilled, he said.

    “Even if there is in principle no link between the GMO legislation and intellectual property rights, it is important that the decision of authorisation provides the conditions to allow the authorisation holder to fulfil its obligations,” according to Vincent.

    On the specific question of environment monitoring, Vincent said the European Commission “is currently reflecting on how to adapt the obligations imposed respectively on the users and on the authorisation holder in order to ensure that the latter is able to fulfil its monitoring obligations imposed on him/her by the decision of authorisation with the same level of performance after the intellectual property rights have expired.”

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

     

    Comments

    1. Report On Seed Giants’ Initiatives To Preserve Monopoly On Global Food | Intellectual Property Watch says:

      [...] The group also criticises the framework developed by leading seed companies to address the upcoming expiry of patents. Named “the Accord,” the framework includes two agreements: the Generic Event Marketability and Access Agreement (GEEMA), and the Data Use and Compensation Agreement (DUCA) (IPW, Patent/Design policy, 5 February 2013). [...]


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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.

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    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.

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