The patenting of human genes has generated considerable controversy, both in the doctrinal field as well as in the legal and administrative fields, not only in the northern hemisphere (United States of America and Europe), but also in Latin America.
The World Intellectual Property Organization (WIPO) defines intellectual property as “creations of the mind: inventions; literary and artistic works; and symbols, names and images used in commerce”. Intellectual property rights protect an author’s work from being copied or duplicated by competitors. Latin America historically has had less developed intellectual property regulations compared to the United States and European countries. As detailed below, Latin American countries almost unanimously banned the patentability of genes and gene sequences in their respective legislations. Regardless of the difficulties of a particular discovery, Latin American countries oppose the patentability of human genes as a general rule due to the fact that the researcher or discoverer does not in fact modify the content of the genetic information but only makes it possible -recurring to particular methods and techniques- to attain knowledge of a natural object already in existence, just like a mountain, or a river.
The difference between invention and discovery is not just a legal or technical issue, but also has ethical and political implications. While discovery means the revelation of something pre-existed prior any public visibility of awareness, aninvention implies an act of human creation directed to solve a technical issue. The rationality of rejecting the patentability of genes originates in the consideration that they are strictly part of living beings in nature. Genes do not exist as isolated units, being only recognizable through scientific effort. The position of Latin American countries in prohibiting the patentability of genetic material is aligned to the past and current principles of patent law, allowing the free circulation of knowledge. The main fact that genes and the genetic information they contain are part of the human body is ignored by some industrialized countries, and therefore, they are subject to similar ethical limitations regarding appropriation and commercialization.
Argentina’s patent law 24441 in its article 6(g) that excluded from being regarded as an invention “any kind of living material and pre-existing substances of the nature”; while article 7(b) specifies as non- patentable “biological and genetic elements existing in nature or their replicas issued from biological processes that are implicit in vegetal, animal and human reproduction.” According to the patent examination guidelines from the INPI (Instituto Nacional de la Propiedad Industrial) “substances that pre-exist in nature, even when purified, isolated or characterized, are not patentable” (article 220.127.116.11). “An ethical focus indicates that patenting simple discoveries of genetic material in the first steps of research, before any process of invention has occurred and before a true patent portfolio could be established, is designed with the unique and exclusive goal of blocking competition and ensuring a monopoly access to entire areas of knowledge, implying the abusive and distorted exercise of an industrial property right against weightier, more important social interests. (Correa and Bergel 2013).”
In Brazil, article 10.11 of patent law 9279/96 determines that a living being, the human body, the human genome, human genetic material and natural processes are not inventions. Patent Law is very restrictive, as we can see in the Article 18 of the Law, which deals with biology matters. The Law 9279 prevents patenting parts of organisms (microorganism, plant or animal) and consider cells not patentable. Genes are also not patentable, unless essential for a patented process.
The sequences of genetic material are notpatentable because no inventive activity was involved in isolating the sequences or a gene (Freire de Sa and Oliveira Naves 2009). Unlike US patent law, which does not exclude therapeutic methods from patent protection, Brazil’s patent system follows a similar rationale to Europe’s: that “methods of treatment” are not patentable. The non- acceptance of therapeutic method claims in Brazil is grounded in the provisions of article 10(VIII) of Brazilian IP Law 9279/96, which establishes that therapeutic, surgical and diagnostic methods applied to the human or animal body are not considered to be inventions. Therefore, methods having at least one invasive/administration step and/or methods with the purpose of cure, prophylaxis or diagnosis are usually non-patentable in Brazil.
There is ambiguity as to whether the Brazilian Patent Law No. 9279 excludes genes from patentability. Article 18, item III, states that living beings, in whole or in part, are not considered patentable. Article 10, item IX, states that natural living beings, in whole or in part, and biological material encountered in nature or isolated including the genome or germplasm of any natural living being, are not considered as inventions. The law does allow for the patenting of chemical products, provided they fulfill patent criteria: if sequences of DNA are interpreted as chemical products, they may be patentable; but if Brazil were to conclude that DNA is not merely a large polymer, it could permit chemical product patents while blocking patents on genes.
Colombia currently lacks sufficient coverage for life sciences but has taken some big steps to improve its market for intellectual property. In 2017, it received 8.6% of total Latin American foreign direct investment, totaling US$13.9 billion. Such investment requires sufficient protection for foreign and domestic firms.
Colombia continues to make efforts to provide effective protection and enforcement of intellectual property rights and to implement its obligations under the U.S.-Colombian Trade Promotion Agreement. The Colombian IP system is ruled by an Andean Regime, and when an Andean Law rules on a subject matter, its provisions prevail over the correspondent domestic laws. The applicable IP law in Colombia is the Andean Decision 486 of 2000, which sets both substantive and procedural rules. The pharmaceutical sector has raised concerns about Colombia’s regulation of this sector.
The Colombian Patent Office granted a patent protecting revolutionary genetic therapy against cancer to Novartis AG and The Trustees of the University of Pennsylvania. The patent granted covered the recent granting of a patent directed to an isolated chimeric antigen receptor (CAR). This development is related to the drug recently approved by the FDA, Kymriah®, considered the first gene therapy against acute lymphoblastic leukemia (ALL) in children and young adults.
Chile’s national agency for intellectual property is the National Industrial Property Institute (INAPI) which coordinates with other government agencies. In Chile, article 37(f) of the patent law 19039 establishes that the following are not considered inventions and therefore remain excluded from the protection of patent law: “parts of human beings as found in nature, natural biologic processes, or biologic material existing in nature, or the one that can be isolated, including the genome and germplasms.” On October 2, 2018, a new draft law was sent to the Chilean Congress to update the Law No. 19,039 on Industrial Property, the Law No. 20,254, which establishes the National Institute of Industrial Property and the Criminal Procedure Code. The main changes introduced by the draft law regarding patents and industrial designs did not include a change in connection with this topic.
In Ecuador, article 26 of law 2006-013 establishes areas of activity which must not be subject to commercial exploitation in order to protect morality, namely, the human body and its genetic identity, which are therefore not patentable. The limits on patentability are: things that are not considered to be inventions according to Article 125 of the Intellectual Property Law. Patents shall be granted for any invention, being of products or procedures, in all fields of technology, providing that it is novel, non-obvious (inventive level) and has some industrial application.
The following items shall not beconsidered as inventions: (1) Discoveries, scientific theories, mathematical methods; (2) Materials already existing in nature, including any living form genome; (3) Literary and artistic works or any other aesthetic creation; (4) Plans, rules and methods for the exercise of intellectual activities, for games or economical and commercial activities, as well as computer programs or logical supports not being susceptible of industrial application; (5) Ways to show information. Expressly excluded from patentability are: (1) The inventions whose commercial exploitation must be necessarily prevented to protect public order or morality, including the protection of life or health of people, or animals, or to preserve vegetables or to avoid serious damage to the environment or ecosystem; (2) Diagnosis, therapeutic and surgical methods for people or animals; and, (3) The plant and animal breeds, as well as essentially biologic procedures to obtain plants or animals. New or second uses of patented products or processes are not patentable (Decision 486, Art. 21).”
Due to its extensive trade agreements, Mexico has had to keep up with modern intellectual property requirements. A progressive reform was entered into force in 2018. Patent applications are regulated by the Industrial Property Law (IP Law) and its regulations. Patentable inventions must (Article 16, IP Law): (1) Be novel; (2) Result from an inventive step; (3) Be industrially applicable. Products and processes can be the subject of patent protection under the IP Law. The IMPI Mexican Patent and Trademark Office (Instituto Mexicano de la Propiedad Industrial) (www.impi.gob.mx) grants patents protecting compounds, formulations, uses and manufacturing processes for medicines. Article 19 of the IP Law excludes medical procedures from being the subject matter of an invention. However, a patent can be obtained for a therapeutic method by drafting the claims in the Swiss-style format, that is, claiming the medical use of the compound for the treatment of a specified illness. Article 19 of industrial property law establishes that discoveries revealing something that pre-existed in nature are not considered inventions. Thus, patenting human genes is not allowed.