Mexico: advances in biotechnology hampered by the patent system
Biotechnology is presently one of the fastest developing sciences in Mexico. For instance, there is an excellent marine biotechnology centre in the north-western region, while there have been important successes in pharmaceuticals in the central and northern regions.
Mexico has the necessary natural resources to generate and export biological technology. However, in the absence of suitable regulation, there was a risk of overexploitation of its rich biodiversity and, in order to face this issue, the Law on Biosafety of Genetically Modified Organisms, better known as the Monsanto Law, was passed.
The objective of this law was to “regulate the confined utilisation activities, experimental liberation, pilot scheme liberation, commercial liberation, trading, import and export of genetically modified organisms (GMOs) so as to prevent, avoid or reduce the possible harm that these activities could cause to human health or to the environment or the biological diversity or animal, vegetable and marine health” (Article 1). This means that special care has to be taken in the regulation of genetic materials so as to avoid contravening the object of the law, including the protection of the inventors of these products through the Industrial Property Law and the Federal Law on Vegetable Varieties.
On the other hand, Article 6, paragraph VII of this law states that excluded from the scope of application of this law, are “… IP on biotechnological products or processes subject to the Industrial Property Law, the Federal Law on Vegetable Varieties and the international agreements of which the Mexican United States are part.”
It is important to underline that this exclusion from these laws or agreements is purely about their scope, and is not intended to create exclusions since, as has already has been established, genetic inventions or creations, either of animal or vegetable origin, are respectively regulated by the Industrial Property Law and the Federal Law on Vegetable Varieties.
The moral clause
Mexican legislative practice includes a ‘moral clause’, which ensures that no patent, registration or authorisation is to be granted, nor can be published in the Gazette, to any figure or institution regulated by this law, when the content or form thereof is contrary to public order, morals and good manners or is against any legal provision. This moral clause was designed “to protect public order and morals, including the protection of human, animal and vegetable life and health, and to avoid serious damage to nature or the environment”.
It is apparent that these concepts are abstract and depend on special temporary social factors and on development itself which, arguably, is being generated within biotechnology. There is strong pressure within society for greater care to be taken and for limits to put on some scientific investigations.
It is important to point out that Mexico is one of the ten world leaders in the sowing of GM crops. Nevertheless, at present, only transgenic soya and cotton are being sown commercially; although the possibility of doing the same with other species of transgenic plants is being researched.
On the other side, biotechnological research in Mexico faces a serious problem because of the lack of impetus and this means that researchers, very often, decide to migrate abroad.
The Mexican Academy of Sciences and the Yucatan Centre for Scientific Research (CICY) have acquired a positive international reputation, but researchers consider that Mexico still has a great deal to do to connect their achievements to national industry, as the brain drain and a technological deficit become more and more acute.
Dr. Victor M. Loyola-Vargas, a member of the Academy, considers that: “As the research centres and the universities are treated as entities, they have no places available and, therefore, there are no jobs for postgraduates. How can we generate our own technology if we are not generating new knowledge?”
"biotechnological research in Mexico faces a serious problem because of the lack of impetus and this means that researchers, very often, decide to migrate abroad."
Dr. Lourival D. Possani, a researcher at the Biotechnology Institute of the National Autonomous University of Mexico (UNAM) adds: “A number of centres are involved in biotechnology but no new places have been created, or these are limited to state universities or National Science and Technology Council centres, and these are not generally the best places for the production of inputs with important aggregated value capable of producing products for public consumption.”
Herein lies Mexico’s true challenge: how to develop biotechnology, by means of IP, through patent protection.
Notwithstanding the existence of a great body of scientific research, as can be seen from the activities of the research centres, there is no culture of protection for these processes through patents.
Biotechnology, as a constituent part of biology, and its activities per se, imply creativity through biotechnology capable of generating new processes that have industrial applications and, because they stem from inventive activity, should clearly be protected, as are other inventions, by the Industrial Property Law, through patents.
Biotechnology depends on biodiversity for its future development so it has the tools necessary for its conservation and utilisation. IP protection will promote the growth of this technology.
In developing countries a link between IP rights and genetic resources has become essential before the patentability of living matter can be broadened; the legislature must modify the Mexican Industrial Property Law so as to include measures for regulating the registration of biotechnological patents so that the law in Mexico is in accord with the legislation in other countries that have already legislated positively in this matter.
Gabriela Fernández is a director at Fernandez Manzo Y Asociados. She can be contacted at: gabyf@fernandezmanzo.com.mx
