Protecting transgenic plants: Patents and Cultivar Protection Certificates

Protecting transgenic plants: Patents and Cultivar Protection Certificates

Transgenic PlantsThe arrival of transgenic plants in Brazil

In recent years, biotechnological solutions have emerged in various fields of application, offering a range of innovative possibilities for modern society to explore.

The solutions facilitated the development of new inventions, including products, processes, and technological tools with a primarily biological nature. Out of the many biotech-related innovations launched in the past three decades, transgenic plants have undoubtedly had the most significant impact on humanity. Through genetic modification, new genes were added, and others were deleted to create varieties with unprecedented characteristics, such as greater resistance to drought, diseases and pests, better tolerance to herbicides, increased production of certain types of oils and nutrients, and faster growth, among others.

The introduction of new transgenic varieties in Brazil was inevitable given the country’s potential in the agricultural field.  Indeed, in 1998, Monsanto sought approval from the Brazilian government, specifically through the National Technical Biosafety Commission (CTNBIO), for the commercial release of the first transgenic plant variety in the country. This soybean variety was specifically designed to resist glyphosate herbicides.

The year 1998 witnessed a concomitant series of events with Monsanto’s request that ensured its transgenic variety found a profitable and secure sector for economic exploitation in Brazil.

The Industrial Property Law (LPI), promulgated in 1996, established Law N°9,279 that provides a comprehensive legal framework for the protection of inventions, including transgenic technologies. The Cultivar Protection Law (LPC), promulgated in 1997, established Law N°9,456 that created a distinct system for the protection of new plant varieties. Both laws were enacted after Brazil entered into the international Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in 1994.

Cultivar Protection Law (LPC)

The LPC provides protection for entire cultivars, including their reproduction or vegetative multiplication parts, through the issuance of a Cultivar Protection Certificate (CPC). The holder of the new variety is granted exclusive rights to its use and may prevent third parties from using it without authorization, similar to other forms of intellectual property rights. The LPC specifies this in more detail.

Article 9 of the Protection guarantees the holder the right to reproduce commercially within Brazilian territory. Third parties are prohibited from producing, offering for sale, or commercializing the propagation material of the cultivar for commercial purposes without your authorization during the term of protection.

The rights last for the duration of the valid certificate, which is 15 years from the date of CPC granting, except for vines and trees, whose term is extended to 18 years.

Anticipating potential abuses of these rights, the LPC outlines exceptional circumstances that do not violate the holder’s rights:

Art. 10. The document does not infringe upon the property rights of the protected cultivar for when:

  1. reserve and plant seeds for your personal use or for third-party establishments under your ownership;
  2. uses or sells the product derived from its plantation as food or raw material, except for reproductive purposes;
  3. the cultivar is utilized as a source of variation for genetic improvement and scientific research;
  4. as a small-scale rural producer, he propagates seeds for donation or exchange solely to fellow small rural producers. This support is provided through financing or support programs administered by public bodies or non-governmental organizations authorized by the government;
  5. multiplies, distributes, exchanges, or sells seeds and other propagative materials within the provisions of article 19 of Law No. 10,696, enacted on July 2, 2003, as a family farmer or family business that meets the criteria of Law No. 11,326, enacted on July 24, 2006.

From analyzing the exceptions listed by the LPC, it is evident that some of the principles that also inform the exceptions of use provided for industrial property, such as free use for scientific purposes and use in a private family environment, are similar. It is important to note that the LPC protection only applies to the sale of plants as an agricultural input and not their sale as food, whether for the human or animal market.

If a plant variety is deemed to have resulted from the use of another protected variety, “dependent patents” apply, a similarity with industrial property. Under the LPC, the holder of the first must seek consent for use from the holder of the second.

Article 10 §2 For the purposes of section III of the caput, whenever:

  1. If using the protected cultivar repeatedly is necessary for the commercial production of another cultivar or hybrid, the holder of the second cultivar must obtain authorization from the holder of the protection right for the first.
  2. If a cultivar is determined to be essentially derived from a protected cultivar, its commercial use will require authorization from the holder of the protection of the original cultivar.

While a CPC is a robust way to protect transgenic plant technologies, it only offers partial protection. As a result, inventors and holders typically rely on additional protection mechanisms supported by the Industrial Property Law (LPI) to create a more comprehensive protection strategy in conjunction with the LPC provisions.

Industrial Property Law (LPI)

The LPI specifically focuses on the protection of inventions and utility models, which will be the subject of this article. The LPC and LPI provide different scopes of protection. The LPI specifically focuses on the protection of inventions and utility models, which will be the subject of this article. This difference in subject matter indicates how the LPC and LPI complement each other. The absence of intersection between these objects is even clearer when we consider Article 10, item IX of the LPI:

Article 10 The following are not considered inventions or utility models:

IX – Natural living beings and biological materials, whether found in nature or isolated from it, are included within this term. This encompasses the genome or germplasm of any living being as well as biological processes occurring naturally.

According to the given excerpt, patenting any object that comprises a part or whole of living beings, such as transgenic plants and their seeds, is forbidden, except in the case of transgenic microorganisms, which are eligible for patenting (refer to the article).

How can a transgenic plant be protected through patents?

To create a transgenic plant, one needs various supporting technologies such as specific genetic constructs, processes for inserting them into the plant’s genome, and methods for utilizing the resulting plant. Patenting such technologies is crucial in indirectly safeguarding transgenic plants and seeds and ensuring exclusive rights over their economic exploitation.

This protection is indirect and based on the understanding that these plants are only obtained using specific technological devices and/or processes. Article 42 of the LPI provides further clarification:

Article 42 The patent holder has the right to prevent third parties from producing, using, offering for sale, selling, or importing without their consent.

  1. product subject to patent;
  2. process or product obtained directly through a patented process.

For a process patent, it is understood that the resulting product is also protected, as stated in the preceding text. Similarly to a patent for a device necessary in a process to produce a specific product, the scope of protection must encompass the resulting product as well.

Given the understanding of technologies associated with transgenic plants, genetic constructions and genetically modified microorganisms are classified as devices. These devices are used to insert or delete a specific gene, such as an invention of an Agrobacterium strain or virus plant. Additionally, genetic engineering methods for insertion or deletion of specific genes and variety selection methods are classified as processes. The aim of the variety selection methods is to identify and select only the most efficient plants.

Obviously, for technology to be eligible for patenting, it must meet the criteria outlined in the LPI (refer to the article).

As with the LPC, the LPI also lists exceptions to the patent holder’s exclusivity rights, primarily related to usage in private and research contexts:

article 43 The provisions of the precedent Article do not apply:

  1. to acts practiced by unauthorized third parties privately and without commercial ends, provided they do not result in prejudice to the economic interests of the patentee;
  2. to acts practiced by unauthorized third parties for experimental purposes, related to studies or to scientific or technological research;
  3. to the preparation of a medicine according to a medical prescription for individual cases, executed by a qualified professional, as well as to a medicine thus prepared;
  4. to a product manufactured in accordance with a process or product patent that has been placed on the internal market directly by the patentee or with his consent;
  5. to third parties who, in the case of patents related to living matter, use, without economic ends, the patented product as the initial source of variation or propagation for obtaining other products; and
  6. to third parties who, in the case of patents related to living matter, use, place in circulation or commercialize a patented product that has been introduced lawfully onto the market by the patentee or his licensee, provided that the patented product is not used for commercial multiplication or propagation of the living matter in question.

It is noteworthy that section VI of the cited article suspends the use of patents related to living matter from exceptions when used for commercial multiplication purposes, similar to the provisions of the LPC.

Final considerations

The safeguarding of Intellectual Property Rights for a genetically modified plant can be achieved by examining a wide range of available options, such as patent protection and CPC. A strategically fashioned defense not only positions the product (genetically modified plant) better in the market, but it also contributes to enhancing its value. This, in turn, facilitates successful negotiations for licensing, assignment, and technological co-development agreements that favor the rights owner.

Businesses in the agricultural sector must always be aware of current patents and registered cultivars to protect transgenic plants and anticipate possible obstacles to economic exploitation and infringements of intellectual property rights.