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09 September 2013
The different branches of IP law have common objectives, such as encouraging innovation and creativity by allowing their owners to receive (at least partially) the benefits that their creations produce for society. Some of these rights (eg, trademark rights, patent rights and copyright) date back many centuries; others have been acknowledged more recently (eg, plant breeders' rights, database rights and scientific data protection), closely related to the technological revolution that took place in the second half of the 20th century. New technological developments also affect existing branches of IP rights.
One of the fields in which science has experienced the most groundbreaking advances in the last few decades is biotechnology, and it is in biotechnological patents that one of the most significant challenges arises. Among these issues, one of the most controversial is whether genetic material is patent eligible.
The Agreement on Trade-Related Aspects of Intellectual Property Rights does not expressly exclude genes from patentability. In Argentina, Section 7(b) of the Patent Act (24.481) sets forth that the following shall not be patent eligible:
"All biological and genetic material existing in nature or a replica thereof in the biological processes involved in animal, plant and human reproduction, including the genetic processes related to material capable of conducting its own replication under normal and free conditions as in nature."
Therefore, genetic material is excluded from patentability in Argentina only when it is used in biological processes inherent in animal, plant or human reproduction.
In this regard, cases related to processes where technical human intervention is crucial to obtaining the desired result (eg, in genetic engineering) would not be excluded from patentability. In particular, genetic material is patent eligible as long as the patentability requirements are complied with (ie, novelty, inventive step and industrial application).
Even though the patentability guidelines issued by the Argentine Institute of Industrial Property (INPI) establish that the discovery of a nucleotide sequence encoding a given protein would not be eligible for protection, since it entails a discovery and is thus not considered an invention under the Patent Act, these guidelines accept the patentability of genetic sequences provided that its industrial application is specified.
Despite the restrictive patentability criteria adopted by the INPI, especially in cases of biotechnological innovations, it has granted patents related to genetic sequences with an industrial application.
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