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    Inside Views
    Inside Views: Intellectual Property Is Driving Agricultural Innovation, Says CropLife

    Published on 21 September 2009 @ 7:21 pm

    Disclaimer: the views expressed in this column are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors.

    Intellectual Property Watch

    By Javier Fernandez

    Summary: With the global population set to exceed 9 billion by 2050 and limited natural resources, food production needs to double if we are to provide food security. Innovation in agriculture will be central to finding ways to help farmers grow more food on less land. Crop protection products already help farmers to increase their yields per hectare and innovation in this area promises to further increase their efficacy. However, plant science companies invest significant amounts in many years of research to develop these products and without intellectual property protection, the incentive to invest in such innovation is severely diminished. Protection of safety and efficacy data along with data confidentiality is a key tool to foster this innovation. Javier Fernandez of CropLife Latin America explains the importance of protection of regulatory data and its relevance to the bid for food security. CropLife International will also be hosting a discussion on these issues in public-private development partnerships at the WTO Public Forum in Geneva later this month.

    The value of innovation is hard to argue against, defined by the US Federal Trade Commission as delivering new and improved goods, services and processes that increase consumer standard of living and economic growth.1 Intellectual property operates as a driver for innovation, but remains to be fully understood and appreciated as such. Sound intellectual property regimes not only benefit particular right holders, but also society as a whole. In agriculture, they make it possible to develop innovative tools, such as crop protection products and improved plant traits, to help meet the critical challenge of feeding a growing world.

    There is a strong development case for intellectual property rights, too. “Today, IP underpins between 50 percent and 70 percent of a country’s private sector gross earnings, so it is often decisive for commercial success or failure,” a recent study concluded.2 In fact, a “significant correlation between protection of rights and economic growth”3 was found in a study comprising 115 economies representing 96 percent of the world’s gross domestic product. On average, top percentile countries that honour property rights, including intellectual property protection, enjoy almost 10 times higher GDP than the lowest percentile.4

    Intellectual property policy efforts have commonly focused on patents, trademarks and copyrights to spur innovation and creativity, particularly in industrialised and service-driven economies, and their acceptance and geographic scope has improved. However, developing country economies are supported by and large on agricultural or primary production and not industry and services. Far from reaching a mature stage, agriculture faces significant challenges: population growth, increasing demand for high quality and versatile food, a decreasing ratio of arable land per person and growing water scarcity, as well as a need for renewable energy sources. Innovative technologies in agriculture promise to be an important part of the solution to enable farmers to grow enough food, feed and fibre in a sustainable way.

    Patents and plant variety protection are intellectual property tools instrumental to shepherd public and private investment for agricultural innovation. However, one of the plant science industry’s most important contributions to agriculture derives from the research and development of novel agrochemical technologies. There is a specific and globally accepted intellectual property instrument to bolster ongoing research in agrochemical technologies: regulatory data protection.

    The significance of regulatory data protection for society is twofold: it is a paramount incentive that spurs innovation and technology transfer, translated into novel crop protection products that protect crops and improve farmers’ yields across geographies. Likewise, farmers, consumers and the environment are benefiting from safer, thoroughly-tested products that help farmers grow more food on less land.

    Protection of Safety and Efficacy Data

    Plant science products are among the most rigorously regulated products to ensure absence of unacceptable risks to farmers, consumers and the environment through stringent testing. Data generation necessary to demonstrate product safety and efficacy requires a plant science company to invest over 9 years in completing more than 120 studies costing approximately $200 million. In addition, these companies hold close scrutiny throughout the product lifecycle to uphold high standards in user, consumer and environmental safety.

    The system of regulatory data protection is two-pronged:

    1. Data protection – Data protection provides a temporary protection period that assures innovators that their proprietary data used to obtain a marketing approval will not suffer third party entrenchment in that given market. The rationale for exclusivity derives from dedication and significant investment required to perform costly, time-consuming and sophisticated studies.

    The preferred mechanism adopted worldwide to protect proprietary regulatory data from unfair commercial use is a product exclusivity period of 10 years. During the exclusivity period, third parties are precluded from relying on the originator’s proprietary test data to obtain their crop protection product marketing approvals. Nonetheless, third party suppliers can enjoy equitable market participation opportunities if they (a) devote time, effort and investment to develop and file their own data; or (b) obtain licensed access to use proprietor’s data.

    Conversely, deficient data exclusivity enforcement could have daunting effects. Improper reliance on originators’ proprietary data increases the possibility of substandard, copycat products reaching the marketplace that can pose unacceptable risks to health and the environment. Similarity of chemical, biological and toxicological properties between me-too and original products cannot be assumed. For instance, hazard and flammability ratings and warning symbols vary with choices of solvents; volatility is influenced by solvent choice and can impact crop safety; and a change in additives may have unforeseen health effects.

    2. Data confidentiality – Data confidentiality provides protection of confidential business information housed in the regulatory dossier against disclosure throughout its tenancy with regulatory authorities.

    The plant science industry commits itself to performing necessary testing and submitting results to regulatory authorities for due product assessment. However, authorities must guarantee adequate custody and traceability of regulatory data to prevent its disclosure during the temporary exclusivity period and after expiration thereof. Mismanagement of regulatory data after submission may irreversibly damage the innovator’s interest in a product supported by the scientific data. For example, retro-analysis of elements contained in a regulatory dataset can help copycat manufactures obtain innovators’ precise formulations. Thus, disclosure of information containing product blueprints would severely hinder the value of innovation.

    Recently, public desire to access government-held information has spiralled, placing pressure on data confidentiality. There could be a legitimate interest to review scientific data for non-commercial research, educational reasons, criticism, review or news reporting. However, access to information should not be interpreted as an uncontrolled, free exchange, disclosure capability. A careful balance must be struck between preserving data confidentiality and satisfying legitimate interests in understanding effects associated to plant science products.

    Robust, un-politicised and science-based regulatory and intellectual property regimes are policy instruments that benefit society as a whole. When an industry sector, such as crop protection, invests 7.5 percent of their sales to innovate optimal technology solutions for agriculture,5 an enabling business environment can only serve to improve sustainability and help to achieve the industry’s greater goal of feeding a growing population with dwindling natural resources. Protection of regulatory data is a tool that welcomes industry’s commitment to such social goals by providing the framework to enable and encourage innovation and investment, and countries should not refrain from its implementation.

    jf3
    The author is Javier Fernandez, Lawyer, CropLife Latin America

    1. Federal Trade Commission. To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy. October 2003. p. 1. [^]
    2. Ghafele, Roya; Hundertmark, Stephan; Reboul, Yves; Wurzer, Alexander. 2006.It’s Time to Rethink IP Education. Intellectual Asset Management. December/January 2007. p. 28. [^]
    3. Chandima Dedigama, Anne. International Property Rights Index. Property Rights Alliance. 2009. p. 13, 18. [^]
    4. Chandima Dedigama, Anne. International Property Rights Index. Property Rights Alliance. 2009. p. 29. [^]
    5. Phillips McDougall. Agrochemical industry Research and Development Expenditure. September 2005. p. 3. [^]

     

    Comments

    1. IP Osgoode » Protecting Regulatory Data in the Agricultural Industry says:

      [...] an article on Intellectual Property Watch, Javier Fernandez, a lawyer for CropLife Latin America, argues that better protection of regulatory [...]


    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.

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    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.

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    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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