A. Overview of Patentable Subject Matter
A.1. Legal frame
After TRIPS, a new Patent Law (PL N° 24481) was enacted. The most important change introduced by the new law was the patentability of pharmaceutical products, which until then were protected only through process patents.
The new law also included specific provisions for the protection of living matter. However, the wording of these provisions is not very clear and admits several interpretations.
In 1996, an Executive Decree implementing the Patent Law was passed. Although it is a regulation of lower status, according to a general opinion, the decree set further limitations to patentability than those established by the law. For example, the law contains no provisions regarding patentability of genetically modified plants and animals while the decree provides for the exclusion of patent protection for any kind of plant or animal.
In 2002, the Secretary of Agriculture and the Patent Office created a working team in order to provide clear definitions and patentability criteria for biochemical inventions. These were the basis for drawing up the Guidelines for Patentability published by the Patent Office in December 2003.
These guidelines adopted an even narrower interpretation of both the law and the decree, thus leading to a gap of protection causing that several potentially valuable plant (or animal) creations actually lack protection for not being encompassed by any of the available systems.
A.2. Inventions and Patentability Criteria
Inventions in the field of biochemistry are subject to the same patentability requirements as inventions in other technical fields, provided they are not explicitly excluded from patent protection. The requirements of novelty, inventive step, industrial applicability, enablement and sufficiency apply to biochemical or genetic engineering inventions, in the same way as for all other inventions. The nature of this subject matter entails particular problems, for example, of sufficiency or ethical discussions.
In Argentina, the new Patent Law was mostly inspired in the European Patent Convention (EPC). However, unlike the EPC, it includes a definition of invention: "an invention is everything created by man which allows the transformation of matter or energy for exploitation by man".
Grounded on this definition of invention and on Arts. 6/7 of the PL (subject matters not considered as inventions and not patentable inventions), the following criteria were adopted:
(i) Discoveries are not considered inventions. The same applies to any kind of living matter and substances pre-existing in nature or identical to a natural element. Substances pre-existing in nature that have been isolated and purified are still considered discoveries and therefore, not inventions;
(ii) Among the living matter not considered an invention are animals, their parts or components that lead to a whole individual. The same applies to plants, their propagation material and plant parts or components that may lead to a whole individual;
(iii) Plant varieties are not patentable and can be protected by the Seeds Act and UPOV 78;
(iv) Micro-organisms are not considered patentable subject matter, either if they pre-exist in nature or if they are identical to a natural element. This exclusion applies even if the micro-organisms have been isolated from the environment and purified. On the other hand, modified micro-organisms can be protected through patents;
(v) Other classifications of living matter different from plants or animals, e.g. multi-cell fungi, pre-existing in nature or identical to a natural element, even isolated and purified, are not patentable, unless they have been modified;
(vi) As to cells, those that may lead to a whole plant or animal are not considered patentable, e.g. embryonic cells, callus cells. However, as cells are considered the smallest living matter, their parts may constitute patentable subject matter, in the same way as substances;
(vii) Substances modified as to their natural state and synthetic substances that are different from natural ones, are considered patentable. For example DNA sequences, genes, plasmids, proteins, enzymes, etc., which are not identical to a natural element;
(viii) Essentially biological processes are not patentable. These are defined as: "Series of steps that result in obtaining plants or animals and that are accomplished to a great extent by action of phenomena existing in nature". Claims directed to the natural reproduction of life, specially plants, fall into the "essentially biological" category, for example, a process for breeding a plant by crossing and selection;
(ix) Microbiological processes are eligible for patent protection, being these understood as: "Industrial processes that use, apply or result in a microorganism". A genetic engineering process for obtaining a plant or animal is generally considered microbiological and hence, patentable. In some cases, a process can include biological and microbiological stages. When this occurs, human intervention is relevant to determine patentability.
B. Plant Breeders' Rights
The need to protect IPR in plants is a priority in the market of species where the harvested grain is genetically identical to the planting seed and can propagate or transmit all its traits to the progeny, e.g. wheat and soybeans. The need of protecting IPR in hybrid seeds is lower or null, since hybrids have an extremely poor ability to transmit their traits to the next generation. Among hybrids, IPR are satisfactorily protected by the commercial secret of the hybrid formulae and the natural difficulty of recovering the genetic traits of the parent seeds in the harvested grain.
In Argentina, seeds have been protected through national laws for more that seventy years, being a "seed" understood as all the propagating material of a plant. The Seeds Act (N° 20247) was passed in 1973 and later modified in 1994.
On an international stand, since 1994 Argentina is a member of the International Union for the Protection of New Varieties of Plants, also known as UPOV. Argentina adheres to the UPOV 78 Act, which provides that: (i) Property of any plant variety can be registered by the breeder to obtain exclusive rights; (ii) Each country may protect a plant variety through Plant Breeders' Rights or through Patents, but not through both. As in Argentina all kinds of plant varieties may obtain protection through Plant Breeders' Rights (PBR), patent protection cannot be granted.
Plant Breeders' Rights give breeders the right to exclude third parties from producing or reproducing, propagating, selling, offering for sale, importing, exporting or stocking for these purposes. Protection lasts for up to 20 years.
For obtaining the PBR protection, a new variety shall be:
- Distinguishable from any other variety
- Sufficiently uniform among individuals
- Stable after repeated reproduction
The only varieties eligible for registration are those new or recently exploited. A new variety is one which has not been sold with the breeder's consent. A recently exploited variety is one which has been sold with the breeder's consent for up to 12 months in Argentina or, in the case of varieties sold abroad, this limit is extended to 4 years (except trees and vines, for which a 6-year time limit is permitted).
Plant Breeders' Rights (PBR) do not extend to the use or sale of a farmer's crop (that is, the grower does not have to pay a royalty on the harvested grains), nor does it extend to the use of the variety in plant breeding. Growers are allowed to retain planting seeds for production on the same area of their land (farmers' privilege) but not for delivering seeds to third parties for reproductive purposes.
Requirements for obtaining PBR are different from patentability criteria: PBR may be granted to any kind of plant variety, no matter whether its origin is natural or artificial. Besides, registration of PBR requires neither a disclosure nor reproducibility of the breeding method. In certain cases, the method of breeding a particular variety cannot be reproduced by others, since it is the result of the interaction between nature and the work of man, where the skills of the breeder play a fundamental role.
It should be noted that those plant creations which do not comply with the requirements established by either the Patent Law or the PBR system, fall within the non-protection arena. This scenario would not necessarily need a law reform in order to be reverted, but simply a modification of the present decree and guidelines, or even just a ruling by the Supreme Court of Justice setting a precedent as regards the unconstitutionality of the case, restoring the law pyramid to its normal position.
For more information on patent law and patent strategy in Argentina, please contact Alicia Alvarez Berkenwald, Partner [firstname.lastname@example.org], GOLD-BERKENWALD [www.goberal.com.ar]
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