Considerations for filing and prosecuting gene patents in Mexico
Genetic material in the form of gene or partial DNA or RNA sequences plays an important role in medical research, for example, for the development of new drugs, tests and in diagnosis, monitoring and treatment of diseases as well as in agricultural and industrial fields.
In this regard, Article 16, Section II of the Industrial Property Law states:
“Inventions that are new, the result of an inventive step and susceptible of industrial application within the meaning of this Law shall be patentable, with the exception of: […] II. biological and genetic material as found in nature.”
Moreover, Article 19, Section II of the Industrial Property Law states: “The following shall not be considered inventions for the purposes of this Law:
[…] II. discoveries that consist in making known or revealing something that already existed in nature, even though it was previously unknown to man.”
The prohibitions are similar to the patentability criteria dictated by the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO)—genetic material that is a mere discovery of nature is not patentable.
Nevertheless, the Mexican Institute of Industrial Property (MIIP), as well as the EPO and USPTO, allow the protection of genetic material taken from humans, animals, plants, bacteria, viruses, yeast, etc., provided that it has been isolated or purified from its natural environment or synthesised, and it has been definitively characterised by a technical process. The technical application of the genetic material must also be described along with the specification of the application.
In this regard, genetic material that can be protected in Mexico is, for example, in the form of DNA copies known as complementary DNA (cDNA). This matter is regarded as patentable because the non-coding segments found in chromosomal DNA and the coding segment splicing are done at the RNA level in the natural environment, and consequently cDNA might not correspond to something found in nature.
Under Mexican practice, claims can be drafted so as to claim the isolated genetic material per se. Examples of genetic material that could be susceptible of patentability include:
