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Patenting Pharmaceutical Inventions in Colombia

26 Apr 2018
Patenting Pharmaceutical Inventions in Colombia

by Moeller IP Advisors

In the latest years, Colombia has become an attractive market for pharmaceutical companies.

According to a report from the consulting firm, Global Data, the value of the pharmaceutical market will rise from $5 billion in 2015 to $7.1 billion by 2020, with an astounding annual growth rate of 7.3%.

The growth is due to an increase in drug consumption and to several government-funded initiatives in the public healthcare sector. Moreover, Colombia is becoming popular for hosting clinical trials due to the low cost, the good quality of the medical infrastructure and a pool of highly specialized researchers.

Tecnoquimicas, Pfizer, Merck & Co., Roche, Bayer and Procaps are some of the major pharmaceutical groups present in the country. Pharmaceutical corporations from the USA, Germany, Switzerland, Sweden, United Kingdom, France and Spain have filed the greatest number of patent applications in Colombia in the last few years.

According to the clinical research organization Clinlogix, multinational corporations are also using Colombia as a platform to access to the surrounding regions of Argentina, Peru, Chile, and Ecuador.

How to Patent Pharmaceuticals in Colombia

The legal framework for the intellectual protection of pharmaceutical products needs to evolve at the same speed.

In Colombia, inventions can be patented as long as they meet the traditional requirements of novelty, inventive step and industrial applicability – article 16, 18 and 19 of  Andean Community Decision 486. Patent protection lasts for 20 years from the filing date of the application. On average, it takes from about 2 to about 3 years to obtain a patent.

In 2016, a new technology platform was implemented for filing and consulting patents online.

When it comes to pharmaceutical inventions, the situation becomes more complicated.

Decision 486 denies patentability to inventions of “biological material, as existing in nature, or able to be separated, including the genome or germplasm of any living thing.”

This seems to exclude a great number of biotechnological inventions from patentability; however, experience shows that the Superintendencia de Industria y Comercio (SIC), which acts as the Patent Office in Colombia, tends to interpret the exception quite narrowly. As long as the subject matter does not exist as such in nature, or isolated therefrom, it is generally patentable. So for example, cDNA, modified amino acid sequences, vectors containing isolates, and monoclonal antibodies are patentable.

However, the methodology and criteria used by the SIC to evaluate some pharma patents are somehow unclear: the Biotechnology Innovation Organization has been complaining that applicants from many of its member countries have been denied protection for certain chemical polymorphs and isolates that are normally patented in 37 other jurisdictions. Moreover, the Decision 486 also excludes the patenting of use claims.

In addition to that, Colombia has specific rules for patenting genetic resources, traditional knowledge from local and Afro-Colombian communities and genetic resources derived from traditional knowledge.

According to Decision 391 of 1996,  these resources can be patented, provided that some requirements are satisfied. In particular, in some cases, the applicant needs to obtain the prior informed consent from the State or from the local communities and is under the obligation of sharing the benefits of the patent with the State or the communities. Decision 391 has been strongly criticized by the Biotechnology Innovation Organization, as the requirements represent an excessive burden for the applicant, and in some cases “may result in the outright denial of patent protection for valuable inventions”.

 




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