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Critical evaluation of the introduction of the bolar exemption in Colombian Patent Law

With the entry into force of the Free Trade Agreement between Colombia and United States of America on May 15, 2012, and in compliance with the terms stated in said Agreement, the Colombian government has issued multiple regulations and amendments relevant to several sectors such as the protection of the industrial property.

One of said modifications was the introduction of the bolar exemption by means of the Decree 729 of 2012, which provides exceptions to the exclusive rights granted to a patent holder related to pharmaceutical and agrochemical products and procedures.

Thus, the bolar exemption is a legal reform allowing third parties to use and import a patent protected product for research and development, for the sole purpose of submission of information required for obtaining regulatory authorization.

According to the above, the bolar exemption provides third parties the legal tools to ensure that their products having similar characteristics to the patent protected product are ready with the necessary regulatory approval for market launch, immediately after the expiration of the patent term.

In the pharmaceutical and agrochemical industry, the bolar exemption allows generic manufacturers to use a patent protected compound or substance in the studies and trials that are required for obtaining a generic version of said compound/substance, for the purpose of marketing of said generic product after the patent term of innovator products expires.

The generic version comprises the same active ingredients and has an identical or acceptable bioequivalent range to the patent protected product with respect to kinetic and dynamic properties, with the difference that it is developed using reverse engineering, directed to reduce its manufacturing costs and allowing marketing at lower prices.

Nevertheless, patent owners may conduct monitoring and control of generic manufacturers as it was also issued the Decree 733 of 2012, which orders the national food and drug administration (INVIMA) to publish the information of all of the applications concerning pharmacologic evaluation and sanitary registration.

Thus, in case a patent owner considers there is patent infringement, legal actions can be conducted legal actions before the INVIMA application is granted.

Paola Rúa