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GENETICS IN MEXICO


Under Mexican practice, claims can be draſted so as to claim the isolated genetic material per se. Examples of genetic material that could be susceptible of patentability include:


• Isolated or purified genes • DNA sequences that code for certain proteins


• Oligonucleotides of identical sequence to natural sequences


• Oligonucleotides of artificial sequence • Chimeric genes


• Isolated promoter sequences, artificial promoters, linkers, DNA or RNA probes


• DNA recombinant molecules • Recombinant polynucleotides • Recombinant expression vectors • Isolated cDNA • Antisense oligonucleotides, and


• Plasmids and transformation vectors containing a gene sequence.


Methods to prepare, isolate, modify or manipulate the genetic material in plants, seeds, animals as well as pharmaceutical uses, kits, human and animal cell lines, transformed host cells, and micro-organisms containing the recombinant genetic material may also be patented.


Inventions directed to genetic material within the biotechnology and genetic engineering areas oſten contain nucleic acid and/or amino acid sequences. A very important formal requirement defined by Articles 14 and 15 of the Rules for Filing Patent Applications must be complied with when an application of this type is filed in Mexico. Each nucleic acid and protein sequence included in the corresponding specification should be disclosed in a separate section defined as Sequence Listing. Each sequence must be assigned with a consecutive identification sequence number. Te disclosed sequences must be referred to in the specification text and/or claims by


their corresponding identification sequence number.


In order to obtain a patent for this subject matter, the invention must comply with the basic requisites demanded by law: it must be novel, it must involve an inventive step and it must be capable of industrial application.


Te assessment of novelty of gene sequences requires a determination of whether they have been disclosed in the prior art, using a photographic novelty approach. In this regard, a difference of only one nucleotide or amino acid within a DNA or amino acid sequence is sufficient to recognise the novelty for genetic material isolated for the first time. For instance,


economic activity, for the purposes disclosed in the application.


“ IN ORDER TO BE PATENTABLE UNDER THE MEXICAN INDUSTRIAL PROPERTY LAW, AN INVENTION CLAIMING GENETIC MATERIAL MUST ALSO INVOLVE AN INVENTIVE STEP. WHEN ASSESSING WHETHER THERE IS INVENTIVE STEP OR NOT, THE MIIP IDENTIFIES THE CLOSEST PRIOR ART AND ASSESSES THE TECHNICAL PROBLEM UNDERLYING THE CLAIMED INVENTION IN ORDER TO DETERMINE WHETHER THE SOLUTION PROVIDED BY THE ALLEGED INVENTION IS OBVIOUS OR NOT FOR A PERSON SKILLED IN THE ART.”


the whole or partial sequence of a gene is considered novel if the exact position of the nucleotide in the sequence claimed was not known in the state of the art.


In order to be patentable under the Mexican Industrial Property Law, an invention claiming genetic material must also involve an inventive step. When assessing whether there is inventive step or not, the MIIP identifies the closest prior art and assesses the technical problem underlying the claimed invention in order to determine whether the solution provided by the alleged invention is obvious or not for a person skilled in the art.


Another means of establishing inventive step is to demonstrate that


the claimed sequence


or the encoded polypeptide has unexpected advantageous properties with respect to the disclosed matter in the state of the art. Such unexpected advantageous properties should be disclosed in the specification of the application and must be demonstrated by filing technical data.


An assessment of industrial application requires that the genetic material has a practical utility or can be produced or used in any branch of


24 Life Sciences Intellectual Property Review 2011


Fernando A. Rincón is a biologist with a master’s degree in health sciences. He joined Becerril, Coca & Becerril, S.C. in September 2006. As department engineer, he handles technical aspects of patent filings and technical official letters on the merits of inventions issued by the Mexican Patent Office in the biotechnology and pharmaceutical areas.


In this sense, Article 47 of the Industrial Property Law has been recently modified as follows:


“Te patent application shall be accompanied by:


I. Te description of the invention, which shall be sufficiently clear and complete to be fully understood and where appropriate, to serve as a guide for a person with average skill in the art to make it; it shall also mention the best method known to the applicant for carrying out the invention when this is not clear from the description thereof, as well as information that exemplifies the industrial applicability of the invention.”


From the above, it could be concluded that patent applications should disclose the utility of the genetic material in the specification and, in addition, should contain experimental evidence about the function of the claimed sequence or the encoded polypeptide to demonstrate the industrial applicability of the invention.


It is extremely important to highlight that the filing of experimental evidence is fundamental for the conclusion of the cases. Te mere mention in the specification of practical utility will not be enough to evaluate and demonstrate the industrial applicability of the invention.


Fernando Rincón is a department engineer at Becerril, Coca & Becerril, S.C. He can be contacted at: frincon@bcb.com.mx


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