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Patents in the biotechnology sector in Colombia

Growth in the biotechnology sector has been accompanied by an increase in patent applications in the same field, where the research and development process, besides being intensive, often entails use of genetic resources considered State assets or property.

Patent applications filed in Colombia relating to products or procedures developed from genetic resources should meet a formal requirement concerning existence of an agreement to access such genetic resources duly entered between the corresponding national authority in representation of the State and the applicant during processing of such application. These access agreements are intended to establish the terms and conditions for accessing such genetic resources.

The above requirement is provided under the Andean regulations, Decision 391 of the Commission of the Cartagena Agreement, Common Regime on Access to Genetic Resources, which determine access conditions to such resources, conservation and sustainable utilization of the same. Likewise, the community regulation on Industrial Property, Decision 486 of 2000, provides that an invention patent must comprise among other formal requirements, the access agreement to such genetic resources when the product or procedure whose protection is sought has been obtained from such resources.

According to the current practice of the Patent Office in Colombia, formal examiners are required to verify upon filing of the application, the existence of a copy of the access agreement, its registration certificate or number, when the applicant asserts the existence of an access agreement to genetic resources. These agreements executed with the corresponding authority in Colombia may refer to other purposes, such as research and/or commercialization. Hence an access agreement for research purposes only will comply in principle with the formal requirement established by the Patent Office for further processing the application and even secure protection for the invention under a patent, yet it would hinder commercially exploitation of the genetic resource.

Obtaining an invention patent in connection with the biotechnology sector while fulfilling the formal requirement of having an access agreement to the genetic resources, both for research and commercial purposes, is only half of the proceeding. Our recommendation would be to start not only by trying to establish an access agreement from the very beginning of the development research process but also the commercial purpose it should contain, as the investment represented by this process should be reflected at the very same time of exploiting this right, whether by doing it directly or through third parties, thus securing the protection sought and advancing to the next major challenge, transforming the patented invention into a profitable asset.

Carmen Sánchez-Puelles