Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

Earlier this year, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent Cooperation Treaty (PCT) and is also rolling out a new Gene Editing (GE) Decree. Together, these changes reflect major updates to Uruguay’s intellectual property (IP) system broadly. The impact of this shift is compounded for inventions in the agbiotech space when combined with the regulatory updates regarding gene editing. Accession to the PCT serves to streamline and align Uruguayan patent filing options with the majority of the countries in the world. Further, the regulatory updates put Uruguay among the growing group of countries that are restructuring their regulations to favor and incentivize investment in gene editing and agbiotech. Thus, these updates have important impacts on protection and regulation of plants and they also align Uruguay with countries worldwide.

Plant regulation and IP are particularly important in Uruguay, and the country is often on the shortlist of top target destinations for IP filings in agriculture, as it has the capacity to grow food for its own population as well as much of the rest of the world. This gives Uruguay “a unique opportunity to address the enormous challenge of improving agriculture,” according to the InterAmerican Network of Academies of Sciences. This means growers and seed companies may increasingly turn to Uruguay to grow and produce gene edited crops to export worldwide, streamlining national IP entry, and GE plant regulation will become increasingly more important. Further, Uruguay is known for its particularly strong focus on grass- and forage-focused agriculture, so it may see particular increases in IP filings and regulatory developments for engineered grasses and forage crops.

Uruguay Accession to the PCT

On June 11, 2024, Uruguay announced that both chambers of its Parliament had unanimously approved the country’s accession to the Patent Cooperation Treaty (PCT) with a reservation to Chapter II of the Treaty (for “International Preliminary Examination”). The PCT is an international agreement to simplify patent prosecution in a variety of member states by using a single patent application. Joining the PCT means more streamlined international patent protection processes, making Uruguay a more attractive destination for innovation and investment, potentially fostering research, development, and growth opportunities.

However, it should be noted that the PCT guidelines specify that the International Searching Authority is not required to perform an international search for claims directed to “plant or animal varieties or essentially biological processes for the production of plants and animals, other than microbiological processes and the products of such processes.” Thus, while accession into the PCT may generally streamline IP processes, plant and seed developers may not be able to reap all of the benefits of the PCT international search. That being said, as discussed below, Uruguayan patent law is more restrictive than the U.S. law on what types of plant biotech inventions are patentable.

Gene Editing Decree

On March 18, 2024, Uruguay announced its Gene Editing Decree, calling for a new, multi-ministry effort to improve regulations of products or organisms that may be considered Genetically Modified Organisms (GMO). This marks a milestone in GMO regulation, particularly for the country’s seed sector.

The GE Decree sets forth a gene editing approval process. Rather than a specific authorization, the GE Decree establishes a Technical Working Group (TWG) of specialists and experts that use a science-based, transparent procedure to determine whether a product should be considered a GMO and therefore subject to GMO regulations.

The TWG represents a joint effort between the Ministry of the Environment and the Ministry of Livestock, Agriculture and Fisheries. The group also draws technical support from scientific institutions such as the University of the Republic, the Pasteur Montevideo Institute, the National Institute of Agricultural Research, the National Seed Institute, the Technological Laboratory of Uruguay, and the Clemente Estable Biological Research Institute.

This new regulatory framework is designed to promote agricultural innovation, provide greater product offerings, improve the country’s position in the international market, and align Uruguay with other systems worldwide.

Comparison with the U.S.

Given these recent updates to Uruguayan law, it is important to understand how it compares now with U.S. law regarding patentability and gene editing.

On the patentability side, engineered nucleic acids and peptide sequences, as well as methods of altering the characteristics of a plant, such as improving seed yield or increasing pest resistance, are not excluded from patentability in Uruguay, though seeds and/or plants are not directly patentable (plants are instead directly protectable in Uruguay only via Plant Breeders’ Rights (PBR) under the UPOV system).

Similarly, in the U.S., methods of altering a plant as well as engineered nucleic acids and peptide sequences are patentable. However, in the U.S., the seeds and/or plants produced by the modifying methods may be protected both under the patent system (via utility patents and/or plant patents) and by the U.S.’s PBR system.

On the GMO regulation side, the U.S., like Uruguay, has a multi-agency framework for regulation of plants produced through genetic engineering. The U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) work together under the Coordinated Framework for the Regulation of Biotechnology to regulate novel and engineered plants. For example, under this framework, the USDA Animal and Plant Health Inspection Service (APHIS) oversees biotechnology products that could pose a plant pest risk, the EPA regulates pesticidal substances and sets tolerance limits for residues of pesticides, and the FDA sets approval standards for all food and feed.

As Uruguay makes the legal adjustments to align with the PCT and puts its Gene Editing Decree into effect, it will be interesting to see whether the combination of patent and regulatory changes will result in increased innovation and investment in plant biotechnology in Uruguay.

Additional reading on patent/plant biotechnology updates can be found on our MoFo Life Sciences blog.

Marley Macarewich, a summer associate in Morrison Foerster’s San Francisco office, contributed significantly to this post.