Proposed regulations concerning the commercialization of gene-edited organism has ignited a discourse among the farmers and plant-focused companies in Europe, as it brought questions concerning its impact on IPs.
The new regulations in question are the EU Commission’s issued proposals for separate legislations concerning the commercialization of such patents. Specifically, it looks to regulate distinctions between crop varieties developed by different ’new genomic techniques’ (NGTs)—methods used to alter the genetic makeup of an organism.
The Commission’s proposal was unveiled last July and intended to improve and further develop the strength of EU food systems and farming. The most essential stipulation of the proposed regulations is that gene-edited crops that change the DNA of the organism and could be achieved with normal breeding methods will face much less strict regulations than genetically modified crops that contain genes that do not already exist in the organism.
Interestingly, the Commission specifically clarified in a press release that the new regulations does not deal intellectual property rights, as it regulates the commercial aspects such as the release and placing NGT plants, not patentability– leading to much confusion and speculation concerning issues of IP for plants developed through the aforementioned new methods.
Despite so, the European Patent Office (EPO) has declared that they will continue to examine patent applications for gene-edited and gene-modified organism according to current rules. In other words, the European Patent Office (EPO) will examine patent applications for NGTs under the same rules as genetically modified organisms (GMOs). “NGTs is not a term for us. What is relevant for us is whether there is a question of technical invention or not,” clarifies EPO director of patent law and procedures, Heli Pihlajamaa, in an interview with EURACTIV.
Gene Editing in Indonesia
Concerning gene-edited organisms from the perspective of Indonesia’s patent regime, Article 9 of Law No 13 Year 2016 on Patent stipulate as follows:
The Invention which cannot be given a Patent includes:
- The process or product announcements, usage, or practice contrary to regulations, religion, public order, or decency;
- Methods of examination, usage, treatment and/or surgery applied against human and/or animal;
- Theory and methods in science and mathematics;
- Living beings, except the remains miniscule; or
- Essential biological processes for producing plants or animals, except the non-biological process or purity process.
In regards to the patentability of modified organisms, essential biological processes for producing plants or animals are not patentable in Indonesia. Despite so, applicant can claim patents of gens from plants, non-biological processes, or microbiological processes of a plant or animal—with regards to the aforementioned restrictions.
Of course, more comprehensive regulations concerning gene-edited crops are under Indonesia’s plant variety protection regime. However, Laws No. 29 of 2000 on Plant Variety Protection does not differentiate between gene-edited crops that change the DNA of the organism and could be achieved with normal breeding methods and gene-edited crops that contain genes that do not already exist in the organism. It’s stipulations for crops that qualify for protection are in line with most PVP norms, namely “plants or species that are new, distinct, uniform and stable and given a denomination.” Only time will tell on whether the distinction between two aforementioned types of gene-edited crops will be relevant in Indonesia’s IP ecosystem. However, interested parties are well advised to monitor such developments.
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