George Nathanael is a JD candidate at Osgoode Hall Law School.
In an article on Intellectual Property Watch, Javier Fernandez, a lawyer for CropLife Latin America, argues that better protection of regulatory data is necessary in order to foster innovation in the agricultural industry. In consideration of projections of an exploding global population, a decreasing amount of natural resources, and the greater reliance of farmers (especially in developing countries) on efficient technologies to remain profitable so that they can continue to produce, proper stimulation of the agricultural industry may be vital. Intellectual property law has historically been used as a means of shaping a variety of industries, but the standard protection of the final invention is sometimes not enough of an economic incentive for companies to continue productive research. By protecting the large amounts of useful data that innovative companies have discovered while developing a new product, and which they must release to regulatory bodies to judge safety and efficacy, these companies are more likely to continue investing in such costly research.
Mr. Fernandez believes that there are two main ‘prongs’ of regulatory data protection, which he calls ‘data protection’ and ‘data confidentiality’. The first prong has to do with implementing an exclusivity period in which “third parties are precluded from relying on the originator’s proprietary test data to obtain their crop protection product marketing approvals”. The second prong requires regulatory bodies to maintain high standards with the information that they collect. Despite legitimate reasons for release to the public of this data (such as for public safety, non-commercial research, education, etc.) the release of this information should be strictly controlled, keeping in mind the interests of the company that originally produced it.
This additional layer of protection on top of standard patent protection can be said to be needed because the data must be released in order to get approval for the originator’s product from a regulatory agency and so it can be used by another company to get approval for a similar product that may not infringe on the originator’s patent. Article 39 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement provides that member states “shall protect [test and other] data against unfair commercial use … [and] against disclosure”. As an example of the rationale underlying such a provision, the Pest Management Regulatory Agency of Health Canada uses the following as one of its objectives in its policy dealing with the protection of proprietary interests in pesticide data:
A policy that provides fair protection of the proprietary interests in data to encourage the introduction of new and reduced-risk pest control products while providing a predictable, timely process for the introduction of competing generic pesticide products to the Canadian market.
A separate argument for greater protection of regulatory data that is made in the article is that “[i]mproper 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”. This seems quite sensible, but if safety is an actual concern, then it should follow that such an exclusivity period ought to be infinite, meaning that third parties should never be allowed to use another company’s regulatory data to get approval for a separate product. Understandably, this argument can be viewed outside of the sphere of intellectual property, but one of the ideas simultaneously brought up by Mr. Fernandez is that third parties can obtain licences to use the originator’s information, and this does not seem to mesh with the idea of maintaining high safety standards.
The substance of this topic is very applicable to other industries as well. This past summer, for example, there were many debates in the U.S. over legislation that touched on the exclusivity period for biologics companies. The economic bases that underlie these sorts of debates obviously vary by sector, and so research is always necessary to determine the likely market consequences that would follow with any amendment to the law. Within the agricultural industry specifically, given the wide social implications mentioned earlier, it is crucial that a correct balance is struck in order to benefit all interests at stake.
2 Responses
Mr. Nathanael’s post about data protection explained better the instruments than I did in my IP Watch piece.
To celebrate IP Day, I have another piece on IP, agriculture and innovation. This time, I drafted it in Spanish. Feel free to circulate at your convenience.
DIA MUNDIAL DE LA PROPIEDAD INTELECTUAL: INNOVACION EN LA AGRICULTURA.
Por: Javier Fernandez. Asesor Legal y Asuntos Regulatorios de CropLife Latin America.
El 26 de abril, la Organización Mundial de la Propiedad Intelectual (OMPI) y sus 184 Estados miembro celebran el décimo Día Mundial de la Propiedad Intelectual. Es un día para reflexionar sobre el papel que juegan las patentes, marcas, derechos de autor, protección de datos de prueba, diseños industriales y otros instrumentos similares en la vida cotidiana. La propiedad intelectual dejó de interesarle solo al mundo de los negocios ya que fomenta la creatividad e innovación que forja el mundo como lo conocemos. Síntoma de su importancia económica, la propiedad intelectual es un tema ampliamente debatido en la actualidad.
Recientemente John Dalli, Comisario a cargo de la Política de Salud y Consumidor de la Unión Europea, resaltó la importancia de la innovación para la agricultura. Según su visión, también hay amplios valores societarios que deben considerarse en la toma de decisiones y diseño de políticas de adopción de tecnología innovadora. No es un secreto que la población mundial casi se ha triplicado desde 1950 y que la agricultura todavía necesita casi duplicar la producción alimentaria antes de año 2050 para suplir a la población en constante crecimiento. El reto incluye lidiar con escasez de agua, cambios climáticos extremos y procurar el uso de energías renovables.
Para atender las necesidades comunes de alimento, semillas, fibra y combustible la humanidad debe abogar por el desarrollo agrícola sustentable. Cultivar debe ser ambiental y económicamente factible, así como socialmente responsable.
La Industria de la Ciencia de los Cultivos provee herramientas innovadoras que fomentan la agricultura sostenible. Agroquímicos innovadores requieren menores dosis de aplicación, ofrecen eficacia incrementada, tienen mayor amigabilidad con el ambiente, son menos riesgosos para el trabajador, y ofrecen alternativas a la resistencia de plagas. Como herramienta, colaboran a mejorar la tierra, la calidad del agua y a mitigar las emisiones de gases que causan el efecto invernadero. El agro-productor obtiene mayor productividad, y su legado es una mejor parcela de la que labró. Además agro-productores enfocados a las exportaciones pueden aplicar los más novedosos productos de calidad aceptada mundialmente para que su cosecha goce de mayor aceptación en mercados meta. Esto es posible con la ayuda de una industria comprometida en invertir continuamente en investigación y desarrollo de soluciones innovadoras para la producción agrícola.
Regimenes adecuados de propiedad intelectual son fundamentales para apoyar el necesario y constante aporte de la industria de la ciencia de los cultivos a la agricultura. Un claro ejemplo es la protección a los datos de prueba que demuestra la calidad, seguridad y eficacia de los agroquímicos. Detrás de un producto innovador hay $256 millones de dólares en investigación y desarrollo, invertidos durante un promedio de 9.8 años desde el descubrimiento hasta la comercialización efectiva del producto. Como resultado se consolidan aproximadamente 120 estudios útiles para demostrar la seguridad y eficacia del producto innovador en diferentes países. El esfuerzo se realiza sin garantia de éxito, pues solamente 1 entre 140,000 productos candidatos llegan al mercado. Por ende, la protección de datos de seguridad y eficacia es esencial para la innovación pues da confianza y estimula la investigación y desarrollo para cumplir con altos estándares de regulación.
El mecanismo preferido a nivel mundial para la protección de datos de seguridad y eficacia es un plazo de exclusividad de 10 años. Durante ese periodo, un producto copia no puede obtener una autorización de comercialización sustentada en los estudios del innovador. Transcurrido el plazo de protección el paquete de datos del producto innovador puede usarse como referencia para comparar la equivalencia de un producto copia. Si la copia comprueba ser de una calidad aceptable y no representar un riesgo para la salud y el ambiente, puede prevenirse la repetición de ciertos estudios y por ende se facilita su entrada al mercado.
De esta manera, productos innovadores y copias coexisten y ofrecen a las agro-productoras soluciones que mejor se ajustan sus necesidades. Mientras tanto, el limitado plazo de exclusividad permite al innovador recuperar su inversión para continuar con su tarea, e incluso patrocinar el entrenamiento de agricultores en buenas prácticas agricolas y la recolección de envases vacíos.
En el Día Mundial de la Propiedad Intelectual, celebremos la innovación al servicio de la agricultura y sus beneficios para la sociedad en general.
Javier Fernandez makes an interesting submission which triggers some more basic questions in my mind.
Given the Key principles behind the protection of regulatory data and the corresponding international agreements are:
Universal Declaration of Human Rights
Rights associated with property, including intellectual property, are protected in accordance with the Universal Declaration of Human Rights adopted by the General Assembly of the United Nations in 1948 and are set out in Articles 17 and 27 of the Declaration: –
1. ‘Article 17
(1) Everyone has the right to own property alone as well as in association with others.
(2) No one shall be arbitrarily deprived of his property.’
2. ‘Article 27
(1) Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.
(2) Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.’
International Covenant on Economic, Social and Cultural Rights
Rights concerning intellectual property were re-affirmed in the context of the International Covenant on Economic, Social and Cultural Rights adopted by the General Assembly of the United Nations in 1966 and which came into force on 3rd January 1976. Article 15 of the Covenant specifies: –
‘1. The States Parties to the present Covenant recognise the right of everyone:
(a) To take part in cultural life;
(b) To enjoy the benefits of scientific progress and its applications;
(c) To benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.
2. The steps to be taken by the States Parties to the present Covenant to achieve the full realisation of this right shall include those necessary for the conservation, the development and the diffusion of science and culture.
3 The States Parties to the present Covenant undertake to respect the freedom indispensable for scientific research and creative activity.
4. The States Parties to the present Covenant recognise the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields.’
Paris Convention for the Protection of Industrial Property
The Paris Convention requires the members to protect industrial property rights and to provide effective protection against unfair competition. Article 10bis specifies
(1) The countries of the Union are bound to assure to nationals of such countries effective protection against unfair competition.
(2) Any act of competition contrary to honest practices in industrial or commercial matters constitutes an act of unfair competition.
(3) The following in particular shall be prohibited:
(i) All acts of such a nature as to create confusion by any means whatever with the establishment, the goods, or the industrial or commercial activities, of a competitor;
(ii) False allegations in the course of trade of such a nature as to discredit the establishment, the goods, or the industrial or commercial activities, of a competitor;
(iii) Indications or allegations the use of which in the course of trade is liable to mislead the public as to the nature, the manufacturing process, the characteristics, the suitability for their purpose, or the quantity, of the goods.
Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Article IV (paragraph 5) of the 1994 International Agreement establishing the World Trade Organization (WTO) establishes inter alia a Council for Trade-Related Aspects of Intellectual Property Rights (Council for TRIPS), which ‘shall operate under the general guidance of the General Council. The Council for TRIPS shall oversee the functioning of the Agreement on Trade-Related Aspects of Intellectual Property Rights (hereinafter referred to as the “Agreement on TRIPS”). These Councils shall carry out the functions assigned to them by their respective agreements and by the General Council. They shall establish their respective rules of procedure subject to the approval of the General Council. Membership in these Councils shall be open to representatives of all Members. These Councils shall meet as necessary to carry out their functions.’
The provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) form Annex IC of the International Agreement establishing the World Trade Organisation (WTO). The objectives of the Agreement are both simple and clear and are set out in Article 7:
‘Article 7
The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.’
Article 39 of the TRIPS Agreement links the protection of undisclosed data and data submitted to regulatory agencies with unfair business competition and as such must be prevented under Article 10 bis of the Paris Convention.
The specific provisions of TRIPS concerning CBI and intellectual property rights to data are set out in Article 39 of the Agreement:
‘Article 39
1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.
2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information:
(a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;
(b) has commercial value because it is secret; and
(c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.
3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilise new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use.’
So given this background where does Copyright fit into the scheme of IP related law and does TRIPS actually take away the effect of Copyright on the studies submitted for Regulatory approval?
One could argue that this is a very important point for new and emerging technologies to decide if Copyright is an adequate protection, or should the TRIPS agreement be expanded to cover a new technology. As an example Biological Pharmaceuticals or Agricultural Biotechnology Products are not covered by Trips 39.3 so should industry press for their inclusion or is it better off to remain under Copyright..
In addition the increase demand for transparency combined with the ease of access to data by electronic means adds a further dimension to the treatment of Copyright. I mean does the simple act of submission to a Regulatory Authority remove your copyright and by what legal justification can they release the information without your permission. This is particularly relevant with the emergence of the Aarhus Convention on the right of public access to environmental information
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