#01 Biodiversity
Jorge Cabrera Medaglia

Intellectual Property Rights Management, Benefit Sharing Policies and Practices of Costa Rica's INBio

The National Biodiversity Institute and the Bioprospecting Unit - General information on INBio

The National Biodiversity Institute (INBio) was created in 1989 as a non-governmental, non-profit association and has been declared to be of public interest. Its mission is to promote a new awareness of the value of biodiversity, thus promoting its conservation and use to improve the quality of life.

In 1991, INBio developed the concept and practice of "bioprospecting" as one solution to the need to use Costa Rican biodiversity in a sustainable way to benefit society. This concept continues to gain acceptance in government, scientific, academic and management circles. It refers to the systematic search for new sources of chemical compounds, genes, proteins, microorganisms and other products that have a current economic value or potential and can be found in our natural biological wealth. The use of the biodiversity presents opportunities and challenges for promoting and organising infrastructure investments and human resources that add value and contribute to its conservation.

INBio has a formal agreement with the Ministry for Environment, Energy and Telecommunication (MEET), which allows it to carry out specific activities on the national inventory and use of biodiversity in the government's protected areas. Each research initiative must, however, obtain a permit from the National Competent Authority before starting. INBio actively develops biodiversity prospecting in the protected wild areas of the country under that agreement with the participation of the national and international academic and private sectors.

INBio’s collaborative model

The agreements between INBio and its partners specify that 10% of the research budget (for commercial agreements) and 50% of future royalties are paid to MEET to be reinvested in conservation. Other benefits for the conservation areas are: possible equipment donations from partners, funding of publications and the dissemination of scientific literature of interest to the field, and training. The research budget supports the scientific infrastructure in the country, as well as activities of added value aimed to conservation and sustainable use of biodiversity.

The agreements must comply with the following criteria:

  • Limited access: in time and quantity
  • Equity and compensation: research budget, benefit sharing (royalties and milestones, etc.), technology transfer
  • Training, information sharing etc.
  • Non-destructive activities
  • Traceability
  • Up-front payment for conservation in cases of commercial research

To date a few royalties have been paid for products that have reached the market and more products are under development.

As a result of these agreements, many benefits have been generated, including the following:

  • Monetary benefits from direct payments
  • Payment for samples supplied
  • Research budgets covered
  • Transfer of important technology which has enabled the development of the infrastructure at the Institute (biotechnology lab, etc.), which can be used for the investigation and generation of their own products
  • Training of scientists and experts in state-of-the-art technology
  • Negotiating experience and knowledge of the market and the probabilities of searching for intellectual uses for biodiversity resources
  • Support of conservation through payments made to the Ministry of the Environment for strengthening of the National System of Conservation Areas
  • Transfer of equipment to other institutions, such as to the University of Costa Rica
  • Donation of equipment from partners
  • Funding of publications and for the dissemination of scientific literature
  • Future royalties and milestone payments to be shared 50:50 with the Ministry of the Environment
  • Establishment of national capabilities for assessing the value of biodiversity resources
  • Royalties received from 2 products: a phytomedicine generated from the collaboration with Lisan (national company) and an industrial enzyme (Cottonase) for textile processing of cotton (an environmental friendly alternative for chemical scouring in cotton preparation) arising from the Diversa (now Verinium) collaboration. The enzyme cleans better than chemical scouring agents and also greatly reduces the need for extensive waste, waste treatment and energy consumption. A fluorescent protein has also been developed (with Diversa), but no royalties have accrued yet to INBio.
  • Access to drugs developed from collaboration on non-commercial and more favourable basis

IP MANAGMENT

Each scenario is different, but in general the following subjects are taken into consideration when negotiating IPR in the contracts, according to the scenario:

  • Invention property
  • Collaboration and communication mechanisms between both parties
  • Applicable legal frame to determine who is the inventor
  • Obligation to state the country where the sample comes from (country of origin)
  • Whether or not IP depends upon the inventive contribution
  • Who faces the expenditure of requesting, maintaining and litigating a patent? If the user does, the patent is still registered under the name of the provider partner.
  • Whether there is a right to first refusal option.
  • Whether one party can assume the costs of applying for and maintaining the patent should the other part decline to do so.
  • Whether the other part gets a license, and if so, under what terms (free of charge, restricted to some countries, restricted to some uses, only for certain purposes, etc.)
  • Confidentiality/exceptions: Prospecting contracts are particularly confidential, especially about issues dealing with payment, royalties, samples, technologies and research results. This includes three aspects: confidentiality about the contractual terms, confidentiality of information provided by each party, confidentiality of research reports. In addition to confidentiality, there is a non-use clause on the information provided, except for the purposes of collaboration, valid for at least 5 and up to 10 years. Upon termination of the agreement, parties must return all materials and information only keeping one copy in the partner’s file.

Future Challenges

At present, the Institute does not have a clearly-defined institutional policy to cover the different intellectual creations that occur in the various units that comprise it. In the case of Bioprospecting, there are agreements with the employees, consultants and assistants that guarantee the confidentiality, non-use and intellectual property that must be afforded to INBio. Nevertheless, these provisions are in the process of revision in order to update them and, if necessary, amend them, taking into account the need to promote and stimulate internal processes of innovation.

Secondly, INBio has major experience in negotiating collaboration agreements, material transfer agreements and the respective IPD clauses, distribution of profits and others. Nevertheless, due to the development of different innovations, it has been necessary to develop similar skills for licensing them to third parties. Therefore, it is possible that agreements for licensing the use of information (Know-How) and others will increase in the future, including the respective IPD clauses.

Thirdly, recently a branch of INBio has been set up (Bioinnovar), aimed at promoting innovations related to biological resources (its own and those of third parties), due to which the main strength of INBio lies in its scientific capacity to generate information, not necessarily to market it. This recent approach requires in turn the development of a sound institutional policy with INBio employees and third parties (suppliers, contractors, etc.) in relation to IPD which will cover other forms or methods, such as trademarks, trade names, copyright and related matters, among others.

References

Cabrera Medaglia, Jorge: Legal framework and public policy (on access to genetic resources), Accessing Biodiversity and sharing the benefits: lessons for implementing the Convention on Biological Diversity, in: Santiago Carrizosa et al. (eds): IUCN Environmental Policy and Law Paper No. 54, 2004.

Cabrera Medaglia, Jorge: Contratos Internacionales de Uso de Diversidad Biológica. Una nueva forma de cooperación Norte-Sur, Revista de Relaciones Internacionales 56-57. Escuela de Relaciones Internacionales de la Universidad Nacional, Primer y Segundo Semestre de 1997, Heredia.

Cabrera Medaglia, Jorge: The Role of the National Biodiversity Institute in the Use of Biodiversity for Sustainable Development: forming bioprospecting partnerships, in: Genetic Resources, Traditional Knowledge and the Law, E. Kamau and G. Winter (eds), Earthscan, London, 2009.

Cabrera Medaglia, Jorge: Biodiversity for (Bio) technology. Biodiversity prospecting in practice, in: IP Strategy Today, No 11, Biodevelopments, New York, 2004.

Gámez, Rodrigo, y Sittenfeld, Ana: Biodiversity Prospecting in INBio, in: Biodiversity Prospecting, World Resources Institute, 1993.

Guevara, Lorena, Cabrera Medaglia, Jorge: Análisis de la viabilidad técnica, económica y legal de un sistema de trazabilidad de recursos genéticos: el caso de Costa Rica y el INBio.

Mateo, Nicolás: Wild Biodiversity. The last frontier? The case of Costa Rica, in: The Place of Agricultural Research, Bonte Sheridan, Christian et al. (ed), ISNAR, 1996.

Mateo, Nicolás: Bioprospecting and conservation in Costa Rica, Responding to Bioprospecting, Svarstad, Hanne et al. (ed), Oslo, 2000. Sittenfeld, Ana y Lovejoy, Anne:Biodiversity Prospecting frameworks. The INBio experience in Costa Rica, in: Protection of global biodiversity. Converging Strategies, L.D. Guruswamy and J.A. McNeely (ed), Duke Press University. Durham and London, 1998.

Sittenfeld, Ana, Cabrera, Jorge y Marielos, Mora: Bioprospecting frameworks. Policy issues for Island Countries in Insula Internacional Journal of Island Affairs, 2003, February, Year 12. No 1.

Tamayo, G.; Guevara, L.; Gámez, R.: Biodiversity Prospecting: The INBio Experience. In Microbial Diversity and Bioprospecting. 2004, Chapter 41, p. 445-449.

Ten, Kate and Laird, Sara: The commercial use of biodiversity. Access to genetic resources and benefit-sharing, Earthscan, London, 1999.