Genetic and other biological resources constitute unique subject matter for IP protection ever since IP systems began to protect innovation in the modern life sciences, as early as the mid1970s. They include, for example, microorganisms, plant varieties, animal breeds, genetic sequences, nucleotide and amino acid sequence information, traits, molecular events, plasmids, and vectors.
GRs and related life science innovation and information cut across a number of branches of intellectual property (IP) law and practice, including patents, trade secrets, copyright, technological protection measures as well as other branches of the law. The IP issues associated with GRs therefore need to be addressed in a customized, cross-cutting and practical manner.
In considering IP issues associated with GRs, WIPO’s work complements the frameworks for access and benefit-sharing provided by the Convention on Biological Diversity (CBD) and its Nagoya Protocol, the International Treaty on Plant Genetic Resources for Food and Agriculture of the United Nations Food and Agriculture Organization (FAO), the Pandemic Influenza Preparedness Framework (PIP) Framework of the World Health Organization and other specialized access and benefit-sharing framework.
Issues under discussion at WIPO
Negotiations on an international legal instrument on IP issues related to GRs are taking place in the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore.
Issues under discussion include:
Prevention of erroneously granted patents
It is generally considered that the granting of patents over inventions based on or developed using GRs (and associated traditional knowledge) which do not fulfill the existing requirements of novelty and inventiveness should be prevented.
To help patent examiners find relevant “prior art” and avoid the granting of erroneous patents, WIPO has improved its own search tools and patent classification systems, and it is proposed by some that databases and information systems related to GRs be created to address this issue.
Ensuring and tracking compliance with access and benefit-sharing frameworks
Disclosure requirements mean patent (and perhaps also other forms of IP) applicants should disclose several categories of information concerning GRs, such as the source or origin of GRs and evidence of prior informed consent and benefit-sharing, when these GRs are used in developing the innovation claimed in a patent application.
The relationship between IP and GRs could be addressed by contract: see the Database of relevant contractual practices and Guide to Intellectual Property Issues in Access and Benefit-sharing Agreements, which offer users and providers of genetic resources an accessible overview of IP issues in access and benefit-sharing agreements.