Patents and Trademarks
Read more to find out about patents and trademarks in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
Colombia is an Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) standard jurisdiction with a pre-grant opposition, absolute novelty patent system where all technical fields are eventually patentable, including pharma. That means that any pharmaceutical product may be patent protected, provided that it is novel, inventive and industrially applicable. Non-patentable subject matter is limited to discoveries, living matter as found in nature, and methods of treatment.
There are no specific regulations for pharmaceutical trademarks. The basic requirements are distinctiveness of the sign and the lack of confusable registered trademarks or applications to identify competitive linked products or services.
2. What agencies or bodies regulate patents and trademarks?
The Superintendence of Industry and Commerce is the local Trademark and Patent Office (PTO). Filing and prosecution are handled before this authority. The Council of State handles nullity actions for IP matters. Finally, The Superintendence of Industry and Commerce and the district judges handle IP infringement matters.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
There is no specific limitation on patentability of substances or processes to obtain those substances both for chemical synthesis or biological products, to the extent those products come as a result of human intervention. Process claims are allowed as a chain of steps towards obtaining a product. Methods of treatment are not allowed.
All products and services listed in the Nice Classification (NCL) can be protected or covered under a trademark registration.
4. How can patents and trademarks be revoked?
Trademarks and patents can be revoked through Nullity Actions before the Council of State, which is a judicial authority with jurisdiction over validity. Patents and trademarks are presumed valid unless there is a judicial declaration stating to the contrary. Validity and infringement are two different paths and invalidity might not be raised as a defense against infringement allegations. Another way to revoke patent or trademark rights is by a direct consideration of the Patent and Trademark Office (PTO), provided that the right owner provides the PTO with explicit authorization to do so.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
The principle of territoriality applies for patents and trademarks under a first to file system. Therefore, foreign rights are not recognized unless they are registered in the country. Of course, priority under Paris Convention rules is available, and Patent Cooperation Treaty (PCT) patent applications are welcome within 31 months following such priority. Moreover, Colombia is the only Latin American Patent Office that is a member of the Patent Prosecution Highway (PPH) Global agreement, allowing accelerated patent prosecution with other Patent Offices around the world.
As for trademarks, Andean registrations (trademarks granted in Colombia, Peru, Ecuador or Bolivia) or trademarks protected in any country member of the Washington Convention can be used as grounds on opposition procedures.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Test Data Protection is available for new chemical or biological entities, understood as active principles not included under the Colombian Pharmacological Code. According to this protection, generics or biosimilars would have to provide their own safety and efficacy studies in order to obtain market approval for new chemical entities which protection was requested and granted by INVIMA. Test Data Protection is regulated under Decree 2085 2000.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
There are no restriction of medicines or devices that could be protected through patents or trademarks different than the ones already mentioned. moreover, trademarks cannot describe the product, or only consist in the active principle of the product.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
License agreements do not require a government approval; however, it is mandatory to record these contracts before the local Patent and Trademark Office and the National Customs & Tax Authority in order to regularize royalty payments.