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Plant Patents in Mexico: Courts Reverse Patentability Exclusion of Marker-Assisted Breeding Methods 

By: Paulina Aguilera, Eder Gutiérrez, Alberto Ávila

January 16, 2024

In recent months, the Federal Court of Administrative Justice (“TFJA” for its initials in Spanish) has reversed in a series of three consecutive rulings, the currently standing criteria adopted by the Mexican Patent Office (“IMPI” for its initials in Spanish) on the patentability of modern plant breeding techniques, including marker-assisted breeding methods, and plants obtained through such methods.

The TFJA has concluded in its rulings, that such methods do not correspond to essentially biological methods but to biotechnological methods, requiring a sufficient degree of specialized technical intervention, so that they are not excluded from patent protection according to the Industrial Property Law. 

Previously, the IMPI narrowly interpreted and applied that the exclusion in Article 16, fraction I, of the Mexican Industrial Property Law[1] (“LPI” for its initials in Spanish), should be enforced exclusively on applications directed to essentially biological methods for the production, reproduction, and propagation of plants; granting patents to applications directed to plants produced through methods comprising at least one technical step, either a molecular or genetic technique, such as molecular assisted selection (MAS)[2]

However, since 2017, the IMPI shifted from this historical criterion, adopting that applied by the European Patent Office (EPO) regarding the definition of “essentially biological processes”[3] and the extension of the patentability exclusion to products of essentially biological processes[4]. Notably, IMPI acted in the absence of a parallel discussion at the local Courts, a similar amendment of the respective rules, or a cut-off date for the application of the criterion, affecting all pending applications examined under the LPI. Thus, IMPI consistently rejected patent applications for non-genetically modified plants, obtained through a process comprising at least one technical step, such as marker-assisted techniques or other molecular techniques, but also comprising crossing, back-crossing and selection steps, alleging that such plants were obtained from essentially biological processes. The processes themselves were also rejected on the same basis.

Consequently, from this shift, such rejections have been challenged before the TFJA. 

Recently, three appeals filed before the TFJA challenging rejection decisions by the IMPI for applications directed toward plant breeding methods involving molecular or genetic techniques, as well as the plants expressing a desirable agronomical trait and produced by such methods; have been resolved by the Court in favor of the plaintiff. In this sense, the Court concluded that the sought inventions do not fall in the patentability exceptions defined in the former Mexican LPI and ordered to annul the rejection decision and to grant the respective patents. 

The Court based its decisions on the analysis of an expert witness’ opinion to resolve whether the claimed plant breeding methods described in the application could be defined as essentially biological. In the Experts’ opinions, the sought inventions cannot be produced spontaneously without human intervention, on the contrary, they comprise technical molecular biology steps which define the process, when considered as a whole, as a biotechnological one. Thus, the Court concluded that the IMPI incorrectly defined the sought inventions as essentially biological processes, excluded from patent protection by Article 16, fraction I, of the LPI. 

Further, the Court defined plant breeding methods involving steps such as the MAS or recombination by protoplast fusion, as biotechnological methods, requiring implementation in a laboratory, excluding the possibility of achieving the same results naturally by the mere sexual crossing of the parents. 

It is worth noting that in one of its rulings, the Court pronounced on the patentability exclusion put forward by Article 16, fraction I, of the Mexican Industrial Property Law; asserting that such exclusion could not be extended to the products (plants), as the fraction I of Article 16 is directed towards processes. 

Unlike the LPI, now abrogated, the new Federal Law for the Protection of Industrial Property (“LFPPI” for its initials in Spanish), in force since November 2020, does contemplate exclusion to both essentially biological processes and the products resulting from such processes. 

However, the LFPPI still does not demarcate the patentability criteria applicable to define a process as essentially biological. In this sense, these decisions by the TFJA establish a precedent to legally define “essentially biological processes” in Mexico under both LPI and LFPPI.  This means that the TFJA rulings could be used to support the patent-eligibility of processes for producing plants that involve biotechnological steps (as well as the resulting products).

For the time being, without such definition, and bearing in mind the current legal framework, Applicants interested in seeking the protection of applications related to plant inventions, should duly demonstrate that they are not derived from nor directed to essentially biological processes. To that end, even though the Court reasoning applied in these cases is not binding, it provides a more favorable outlook for this type of invention at the appeal stage.

[1] Article 16.- Inventions that are new, the result of an inventive step and industrially applicable under the terms of this Law shall be patentable with the exception of: I. essentially biological processes for obtaining, reproducing and propagating plants and animals.

[2] Padikasan, I. A., Chinnannan, K., Kumar, S. P., & Subramaniyan, G. (2018). Agricultural Biotechnology. In Omics Technologies and Bio-Engineering. https://doi.org/10.1016/b978-0-12-815870-8.00006-1.

[3] Decisions G 1/08 and G 2/07 of the EPO’s Enlarged Board of Appeal.

[4] Rule 28(2) EPC (as amended by decision of the Administrative Council CA/D 6/17 of 29.06.2017).

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