Patenting microorganisms in Mexico

In 2015, the Microorganism Collection of the National Center for Genetic Resources (CM-CNRG) of the National Institute of Forestry, Agricultural and Livestock Research (INIFAP) in Mexico acquired the status of an international depositary authority (IDA).

This was acquired under the World Intellectual Property Organization (WIPO)-administered Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.

The CM-CNRG was inaugurated in 2012 in response to national concern for protecting and accessing the genetic resources of Mexico, which is the fourth most diverse country worldwide, according to the National Commission for the Knowledge and Use of Biodiversity.

The Budapest Treaty, signed in 1977 and amended in 1980, facilitates the procedure for biotech patenting as it eliminates the need to deposit multiple samples of the same microorganism or other biological material, offering applicants an efficient means of meeting the disclosure requirements.

Based on this treaty, people seeking patent protection for biological materials are required to deposit only one sample of the material in a scientific institution capable of storing microorganisms—ie, an IDA. It is tested for purity and viability, and stored for up to 30 years.

The treaty therefore offers an efficient, streamlined and cost-effective means of meeting the disclosure requirements associated with patenting inventions involving microorganisms or the use of a microorganism.

However, for a member country (especially developing countries) the benefits of the treaty are less evident if IDA status is not established in the same, because time and costs inherent to the complex procedures related to depositing in a distant country could still be very high.

Types of material

The CM-CNRG holds approximately 1,856 deposits in its collection.

It accepts the following deposits of microorganisms and materials: microalgae, animal viruses, plant viruses, bacteria (non-pathogenic and pathogenic), bacteriophages, mammalian embryos and gametes, eukaryotic DNA, hybridomas, fungi (pathogenic and non-pathogenic), human cell cultures, yeasts (non-pathogenic), nematodes, viroids, animal cell cultures, plant cell cultures, mycoplasms, plasmids (in host and without host), protozoa (non-parasitic), DNA of microorganisms, RNA of microorganisms, genomic libraries, and microbial consortia.

The CM-CNRG has received only 70 Budapest Treaty deposits of patentable strains so far.

The impact of having IDA status in Mexico remains to be seen. However, it is expected that it will be very positive for Mexican and Latin American public and private research and development centres as it provides a direct benefit to the patent owner by simplifying deposit procedures.

In that way, local and national scientific innovation in biotech may be boosted.

A growing demand

The CM-CNRG and the Chilean Collection of Microbiotic Genetic Resources of the National Institute for Agrarian Research, recognised in March 2012 by WIPO, are the only two culture collections with IDA status located in Latin America.

The combination of biotechnology continuing to thrive, the growing demand for biotechnology-related patents and the fact that Latin America and the Caribbean is the region with the greatest biological diversity on the planet, makes it likely that the establishment of more IDAs in this area will take place in the coming years.

This is not a minor trend, in light of the fact that discussions related to access to genetic resources and traditional knowledge, including informed consent and benefit-sharing, are very active in Latin American countries.

Having a good local collection of microorganisms with well-identified and well-maintained sources of origin could help not only to properly address the enablement requirement of biotechnology-related inventions for patents, but also to address the concerns raised regarding access to genetic resources.

Accordingly, a discussion on the further role of microorganisms collections under the Budapest Treaty may be relevant in order to implement certain agreements in this area.

Regarding patentability of biological materials in Mexico, article 47 of the Mexican Industrial Property Law (IP Law) states that if the biological material or biotechnology-related invention cannot be fully described in and of itself in the specification, the patent application must be completed with a copy of the certificate of deposit of said material.

Attention must also be focused on article 16 of the Mexican IP Law, which states that only those inventions that are new, the product of an inventive activity and subject to an industrial application shall be patentable, except: essentially biological processes for the production, reproduction and propagation of animals and plants; biologic and genetic materials such as they are found in nature; animal breeds; parts of the human body; and plant varieties.

In Mexico, the way such provisions have been interpreted in practice is in the sense that naturally occurring biological or genetic material may be patented if it has been transformed by human intervention.

This includes isolation or purification from its natural state or production by artificial means of living organisms (with the exception of humans, animals and plant varieties).

Patentability

In order to determine whether some biological or genetic material is patentable under Mexican IP Law it is important to assess if it is in a different state from its state as found in nature.

In other words, it is necessary to determine if the biological or genetic material is in an artificially created state in order to consider it as patentable matter.

For example, in the case of an isolated natural gene for which a function has been identified, in order to determine its patentability, it must be decided whether the gene was identified and isolated by human intervention in order to use its function to solve a technical problem that otherwise would not have a solution.

If the answer points to the conclusion that the isolated gene is considered to be chemically, structurally and functionally different from the gene as found in nature, the gene would be defined as an invention.

In this sense, usually an isolated gene is chemically and structurally different from the same gene—as part of a DNA molecule—as found in nature. Also, even when its function is somehow known, when a gene is in its natural state it cannot be used to solve any technical problem if the gene is not isolated in a functional manner.

Thus, isolated genes are, most of the time, not identical to the corresponding sequences in nature and have new applications which do not apply to the sequences as found in nature, due to their very different functionality which implies a technical effect.

Another issue surrounding inventions directed to an isolated nucleic acid is that when proper experimental evidence is lacking, the Mexican Institute of Industrial Property often rejects these inventions on the grounds of lack of sufficiency of disclosure even if the pertinent deposit has been made.

For example, inventions related to DNA vaccines or combination vaccines including antibodies require a substantially well described experimental procedure in order to comply with the aforementioned article 47; otherwise even if the nucleic acid is different from the one present in nature, the rejection could be based on lack of a “proof of concept”.

It is important to note that although animal breeds and plant varieties are not patentable, genetically engineered plants and animals are potentially patentable, based on similar arguments to those explained above, considering there is no express provision to the contrary in Mexican IP law.

Additionally, plants that have not been produced by recombinant gene technology, but obtained by new breeding techniques, for example marker-assisted breeding, should also be considered patentable.

Biotechnology inventions filed in Mexico and made by Mexican inventors have considerably increased in the last decade, especially those related to genetic engineering, bioprocesses and microorganisms for agricultural applications.

Based on an analysis of patents over time, it is possible to see that the number of biotechnology patents filed from Mexicans in the last five years has doubled since the beginning of the 2000s.

Although the number of patent applications filed by Mexicans is still not very high (a total of 1,334 patent applications filed in 2017), the growth rate of filed biotechnology patents is above the average growth rate of filed patent applications in all areas of knowledge.

Conclusion

IDAs under the Budapest Treaty are increasingly relevant for the patent system as biotechnology keeps evolving and making the most out of microorganisms’ interactions for the benefit of humankind.

The existence of an IDA in Mexico is good news, although its relevance for the future and for discussions related to access to genetic resources are still to be seen.

However, this first step is a good starting point, not only for Mexico but for Latin America as a whole.

Mariana Gonzalez-Vargas is junior partner at Becerril, Coca & Becerril. She focuses her practice on substantive issues of patent litigation, technological competitive intelligence, health regulation and strategic knowledge management, as well as other activities related to technology transfer. She is responsible for all patent analysis and drafting patents. She can be contacted at:  mgonzalezv@bcb.com.mx