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16 September 2019
New assessment criteria for plants without artificially modified genome
Key loopholes in Mexican law
The Mexican Institute of Industrial Property's (IMPI's) examination criteria was previously consistent enough to provide patent applicants with legal certainty about the eligibility of plant-related inventions. However, recent changes to the criteria for these kinds of invention have resulted in uncertainty which may affect even the validity of already granted patents.
Basic patent eligibility is established in Articles 16 and 19 of the Industrial Property Law, but provisions for plant eligibility are found only in Article 16. Under Article 16, all inventions are patentable if they are new, are the result of an inventive step and have industrial applicability, except for:
As there is a clear prohibition on granting patents for plant varieties and essentially biological processes for the production, reproduction and propagation of plants, there has always been a debate between patent practitioners and the IMPI regarding inventions which relate to plants in some way. The Industrial Property Law and case law offer no further guidance to clarify the scope of the restrictions on the patentability of plant-related inventions. The only guidance for patent practitioners and plant inventors on the patentability of plant-related inventions are patent prosecution cases.
The IMPI previously developed clear and simple criteria for evaluating the eligibility of plant-related inventions. It established that plant-related inventions obtained by any kind of artificial plant genome manipulation through genetic engineering techniques involving human intervention in a laboratory are patentable, as they clearly fall outside the scope of the first and second exceptions under Article 16 of the Industrial Property Law. With regard to the fifth exception on plant varieties, it was also generally accepted that genetic engineering techniques did not necessarily lead to the creation of a plant variety, in particular under the International Convention for the Protection of New Varieties of Plants and the Mexican Law on Plant Varieties, as opposed to plants generally considered as products obtained by such genetic engineering techniques.
The IMPI assessed plant-related inventions obtained by other techniques (eg, the selection of plant varieties through genetic markers or specific technical tests such as sugar content, the tensile strength of fibres and shells or the like) on a case-by-case basis. In general, the assessment aimed to identify an evident human intervention beyond what could be considered a traditional cross-breeding process. The IMPI granted many patents linked to these inventions and processes. The assessment included evaluating whether:
Changes to the EU's patent eligibility criteria in recent years have led the IMPI to change its assessment criteria and had the following results.
In 2016 examiners began to make the eligibility criteria for plant-related inventions more restrictive, particularly where the technical component did not include the genetic modification of a plant genome. This criteria has become even more restrictive in recent months.
In short, the IMPI now considers all plant selections to be 'essentially biological' regardless of the technical nature of the parameters used to make them and that they therefore fall within the scope of the exception under Article 16(I). Therefore, it does not matter if a selection is made by molecular markers or through a difficult laboratory technique that require the skilled intervention of scientists. The bottom line is that examiners consider any process used to create new plants to be essentially biological. This has led to an increase in patent objections and rejections in this field of technology.
IMPI examiners have failed to justify fully that these complex techniques for improving plants are 'essentially biological'. Thus far, the approval or rejection of patents due to the relevant processes used therein appears to relate to how important these techniques were for the applicants. Few applicants have challenged the IMPI's criteria and consequently there has been no further clarity on what 'essentially biological' should mean when assessing patent eligibility.
There is great uncertainty about the patent eligibility of plant products. The eligibility obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights allow countries to exclude plants from patentability provided that there is a sui generis right for their protection. However, Mexican law refers to plant varieties only and not to plants in general. This is why the IMPI and patent practitioners agree that plants which are products of a "non-essentially biological process" should be patentable. However, this is only an interpretation with no additional legal support and which could be changed by the patent office from one day to the next. It therefore needs support by the courts.
This uncertainty is heightened by the fact that the International Convention for the Protection of New Varieties of Plants refers in English to "harvested material", which in Spanish was translated as "product of the harvest", and could therefore result in new discussions on whether a plant is considered as a whole or whether its products and parts are different than the general definition of a 'plant'. In fact, Article 16(III) of the Industrial Property Law refers to human or animal body parts, but not to plants.
Further, by signing and ratifying the US-Mexico-Canada Agreement, the Mexican government has tacitly accepted that patents are already available for "non-biological processes" for obtaining plants and for "inventions that are derived from plants" (Article 20.36, Sections (3)(b) and (4)). This recognition seems inconsistent with the IMPI's existing interpretation of the Industrial Property Law's statutory provisions.
The IMPI's interpretation of the Industrial Property Law is fundamental to provide clarity to applicants in all areas of plant product development, especially considering that there is a global trend towards naturally obtained products.
Given the significant developments in cannabis regulation and the new industries based on plant products (eg, novel plants, sweeteners, functional food and pharmaceutical compounds), clarification of the patent eligibility of plant products is an urgent matter that will more than likely have to be pushed forward by challenging IMPI patent rejections.
For further information on this topic please contact Héctor Elias Chagoya at Becerril, Coca & Becerril SC by telephone (+52 55 5263 8730) or email (firstname.lastname@example.org). The Becerril, Coca & Becerril website can be accessed at www.bcb.com.mx.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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