Patent eligibility trends in Mexico on Plant Inventions23 de agosto 2019Por:
We invite you to read the following article written by our Partner Héctor Chagoya in which he talks about trends in Mexico on plant inventions.
For many years the examination criteria of the Mexican Institute of Industrial Property (IMPI) was steady enough to provide patent applicants legal certainty about the eligibility of plant-related inventions. However, recent changes in these criteria for this kind of inventions have triggered uncertainty regarding patent eligibility in this technology area that may affect the validity even of already granted patents.
The statutory provisions
Patent eligibility is established basically in Articles 16 and 19 of the Mexican Industrial Property Law (IPL). Particularly, provisions for plant eligibility are only found in Article 16. Under said statutory provisions, all inventions shall be patentable when they: are new; result from an inventive step; and are susceptible of industrial applicability, excepting:
I. Essentially biological processes for the production, reproduction and propagation of plants and animals.
II. The biologic and genetic material as found in nature.
III. Animal races.
IV. The human body and its living parts comprising it.
V. Plant Varieties.
Because there is an express prohibition to grant patents to plant varieties and also to essentially biological processes for producing, reproducing and propagating plants, there has always been a debate between patent practitioners and the IMPI regarding inventions that are, in some way, related to plants. No further guide in this regard appears in the regulations of the IPL nor in any court decisions, that could clarify the scope of the restrictions to patentability of plant-related inventions. All there is to guide patent practitioners and plant inventors regarding patentability of plant-related inventions is patent prosecution cases themselves.
The former practice.
Through the years, the IMPI had developed clear and simple criteria for evaluating the eligibility of plant-related inventions. On the one hand, it established that inventions of plants obtained by any kind of artificial plant genome manipulation through genetic engineering techniques that involved human intervention at laboratory level are patentable because they clearly avoid exceptions I and II of Article 16 of the law. Regarding exception V related to plant varieties, it was also generally accepted that genetic engineering techniques do not necessarily lead to obtaining a plant variety, particularly under the definitions of the UPOV Convention and of the Mexican Law on Plant Varieties, as opposed to a plant generally considered as a product obtained by such genetic engineering techniques.
As for plant inventions obtained by other techniques such as selection of varieties through genetic markers or specific technical tests such as sugar content, tensile strength of fibers and shells, or the like, the IMPI assessed these on a case-by-case basis. Generally, to identify an evident human intervention beyond what could be considered a cross-breeding “traditional” process was part of the objectives of the assessment. The IMPI granted many patents related to these inventions and processes. The assessment included evaluating if the process was not “essentially biological” to avoid falling into the exception of patentability contained in section I of Article 16, if the product was different from an “as found in nature” product to avoid the exception of section II of the same article or if it was a “plant variety” to avoid the section V exception.
The changes on eligibility criteria in Europe throughout the years led the IMPI to change the current assessment criteria, affecting the following kind of patents as it is described below.
Definition of the new assessment criteria for plants which genome has not been artificially modified.
As of year 2016 examiners started to make their criteria for eligibility more restrictive regarding plant-related inventions, particularly those where the “technical” component was not the modification of the plant genome by genetic engineering techniques. These restrictive criteria have been hardened in the last months by the IMPI examiners.
The shift consists essentially in that the IMPI is now considering that every selection of a plant regardless of the technical nature of the parameter used to make it, is now considered “essentially biological”, and therefore, falls into the exception of section I of Article 16. Therefore, it does not matter if a selection is made by molecular markers or through a very difficult laboratory technique requiring the skilled intervention of a scientist. Bottom line, the examiners are considering that any process for obtaining new plants is essentially biological. This has led to an increase in the objections and in the final patent rejections in this field of technology.
The key loopholes in the Mexican law.
In our experience, the IMPI examiners fail to fully justify that these very complex and technical techniques we are referring to for improving plants are “essentially biological”. So far the allowance or denial of patents on the processes are relating more on how important they are for the applicants. Very few applicants have challenged the IMPI criteria and consequently, there are not significant resolutions that could establish clearer criteria on what “essentially biological” should mean for assessing eligibility.
As for the eligibility of plant products, there is great uncertainty. The obligations of TRIPS regarding eligibility allow countries to exclude plants from patentability provided that there is a sui generis right for their protection. However, the Mexican law refers to “plant varieties” only and not to plants in general. This is why the IMPI and patent practitioners still agree that plants as a product of a “non-essentially biological process” should be patent eligible. However, this is only an interpretation criterion without any other legal support that could also be changed by the patent office from one day to the other and therefore, this criterion needs support by courts.
This uncertainty is enlarged if we consider that UPOV refers in English to “harvested material”, which in Spanish was translated as “product of the harvest”, and therefore could rise new discussions on whether a plant is considered as a whole or if its products and parts are different than the general definition of a plant. In fact, fraction III of Article 16 of the IPL refers to parts of the human or animal bodies, but not plant bodies.
Furthermore, the Mexican government, by signing and ratifying at the Mexican Senate the United States – Mexico - Canada Agreement (USMCA), under Article 20.36 sections (3)(b) and 4, tacitly accepted that patents are available already for “non-biological processes” for obtaining plants and for “inventions that are derived from plants”. This recognition does not seem to be consistent with the current interpretation of IMPI of the statutory provisions of the IPL.
The interpretation of these articles is fundamental to give certainty to applicants in all areas of plant products development, considering that there is a global trend towards naturally obtained products. In the verge of significant development of Cannabis regulation issues on the plant itself and its components, and with whole new industries the development of which is based on plant products, including novel plants, new sweeteners, functional food and pharmaceutical compounds, clarification on patent eligibility of plant products seems an urgent matter that probably will have to be pushed by challenging IMPI patent rejections.