What about biotech patentable subject matter in Colombia?
By Andres Rincon
Posted: 7th August 2017 09:48The world is in constant change and biotechnological inventions have transformed its relevance from just classic fermentation processes, to genes, recombinant DNA, monoclonal antibodies, nucleic acids, recombinant proteins, vectors or microorganisms of most importance for mayor IP players around the globe, not only in the pharmaceutical industry, but also in agriculture, oil & gas, and even software, just to mention the most relevant fields of industrial applicability or utility. This importance in current economy also generates bigger concerns and uncertainties as to the ability to protect new developments in the field through the patent system in different jurisdictions around the world. This is due mainly because of the difficulties that arise from the conflict between science and civil rights around patent eligibility of living things.
There is perhaps unanimous understanding in the fact that the “laws of nature, physical phenomena, and abstract ideas have been held not patentable” to the extent “such discoveries are manifestations of nature, free to all men and reserved exclusively to none” (Diamond v. Chakravarty – 1980). However there is a lot of debate on whether isolated products of nature can provide patentable subject matter, such as isolated DNA or genes.
As far as the Andean Community is concerned (Andean Decision 486 2000 applicable to Bolivia, Colombia, Ecuador and Peru), aligned with TRIPS (Article 27), patents are to be granted in all fields of technology, including biotechnology, bearing in mind that discoveries, all or part of living things as found in nature, natural biological processes, biological material as existing in nature or even isolated material, including genome or germplasm is not patent eligible to the extend it cannot be considered as invention (Andean Decision 486 2000, articles 14 and 15).
Although this might sound like a big limitation towards living material being considered as patentable subject matter, the above is not far from reality in other, perhaps more sophisticated, jurisdictions such as the US, where the Supreme Court stated that, contrary to the USPTO prior practice of more than 20 years, isolated naturally occurring gene sequences were not patent eligible (Association for Molecular Pathology v. Myriad Genetic – 2012). This was also the case in Australia (D’Arcy v. Myriad Genetics Inc.- 2015) where again, human intervention and transformation was required aside from the natural phenomena. This, however, is not the case in Europe (Directive 98/44/EC), or Japan, where isolation processes and isolated products may be considers as patentable.
With the analysis of prosecution cases before the Colombian Patent Office it becomes clear that essentially biological processes or isolated material as such is not patent eligible. However, it is also possible to establish that non-biological and microbiological processes or altered biological material with human intervention in general might be considered in fact as patent eligible. According to that, nucleic acids, polypeptides or recombinant proteins, recombinant vectors, antibodies, modified microorganisms and processes for producing transformed cells are patentable subject matter. Here are some useful examples for daily drafting when referring to these types of biological material:
1. Claims referring to nucleic acids must be characterised by its nucleotide sequences and make reference to the recombinant or modified sequence. Something like Nucleic acid molecule codifying protein “X”, characterised by consisting of sequence ID “Y”.
2. Polypeptides or recombinant proteins must be defined by the amino acid sequence identified by its number (not by the nucleotide sequence due to the redundant nature of the genetic code). Anything like Recombinant protein “X” (function or property) of sequence ID “Y”.
3. A valid claim for a recombinant vector should specify the type of vector and the recombinant sequence that it contains. For example, Plasmid vector comprising the nucleotide sequence ID “X”.
4. Modified microorganisms would ideally have to be characterised with the specification of the type of microorganism, the sequence that was introduced or the mutation performed, along with the number of biological deposit thereof. For example, Modified yeast characterised by comprising nucleonic sequence ID “X”, with deposit number “Y”.
5. The characterisation of functional antibodies should be made defining its light and heave chains, mentioning the amino acid sequence of both and, if possible, determining the location within the sequences.
6. The process for producing a transformed cell must at least include (i) the cell line to be transformed, including the type of cell; (ii) the gene to be introduced or the recombinant vector; (iii) the host; (iv) the method for introducing that gene or recombinant vector within the host; and (v) the method for collecting or selecting the transformed cell.
It is also worth mentioning that characterisation by homology or identity of percentages in general is not allowed.
Believing that biotechnological inventions are not patentable or enforceable in jurisdictions like Colombia is a tremendous mistake. The Colombian Patent Office efficiently prosecutes patents in all fields of technology as any other developed jurisdiction, with reasonable, and perhaps controversial limitations in order to guaranty that laws of nature, physical phenomena, and abstract ideas remain “free to all men and reserved exclusively to none” under the premise that isolation is not an inventive act.
Partner - Head Innovation, Patents & Life Sciences Department
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With a law background and 16 years IP experience, ten focused on patents, Andres has successfully intervene in the most important validity, infringement and compulsory license cases, either before Colombian and Andean Courts. His main areas of practice are related to patent drafting, prosecution and litigation in patents and life sciences. He leads as Head Patents an in-house team of patent specialist in chemistry, pharmaceutical chemistry, industrial chemistry, biotechnology, microbiology, physics and mechanical engineering, and has been recognized by international rankings as a leading practitioner for Life Science affairs in Colombia. He is a WIPO patent expert for LATAM, and an active member of different patent committees in AIPLA, AIPPI, ACPI and ASIPI.