Ways to Protect Innovative Pharmaceutical Products in Nicaragua

Published on Sep 6, 2024

Carlos Úbeda, associate in ARIAS Nicaragua and expert in Intellectual Property, shares the following article on different ways to protect pharmaceutical products in Nicaragua. 

 

The recognition of the legal protection of innovative pharmaceutical products is and has been a matter of great importance for the health sector and for the pharmaceutical industry. This is due to the relevance of the adequate legal protection of research and development activities to generate a growing incentive in the industry that allows the constant generation of products for the treatment, prevention and/or cure of diseases that affect human health. Like all Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Dominican Republic-Central America-United States Free Trade Agreement (CAFTA-DR) member countries, Nicaragua recognizes the importance of legal protection for innovative pharmaceutical products and through laws, regulations, and ministerial resolutions, establishes patent protection and regulatory exclusivity mechanisms. 

In Nicaragua, legal protection for pharmaceutical products can be obtained through patents. On the other hand, special protections applicable only to pharmaceutical products can be obtained through exclusivity mechanisms, such as test data protection and Patent linkage. 

Patent protection for the invention of pharmaceutical products 

In Nicaragua, Law No. 354 "Law on Patents, Utility Models and Industrial Designs” ("Law No. 354”) establishes in a general manner the legal requirements and procedures to be followed for the protection of inventions. Generally, as most of the World Trade Organization (WTO) and TRIPS member countries, Law No. 354 recognizes as an invention any product and/or procedure that provides a technical solution to a specific problem. For this purpose, said invention must meet the requirements of novelty, industrial application, and inventive level; that is, the product and/or procedure must not have been disclosed or be publicly available, it must not be obvious or evident to a person skilled in the industry in which the invention applies and, finally, said procedure and/or product must be useful and applied to a certain industry. 

Although Law No. 354 does not specifically define what an "innovative pharmaceutical product” is, through the general concepts established above, we can determine that in Nicaragua an innovative pharmaceutical product will be understood as a product applied to the pharmaceutical industry and whose creation is novel and not obvious to a person skilled in such industry2.  Well, any pharmaceutical product that complies with the requirements established in Law No. 354 may be protected by a patent and with this, the holder will enjoy the prerogatives established by law, specifically the right to prevent third parties without its consent: (i) to produce and manufacture the product; (ii) to offer for sale, sell or use the product; (iii) to import or store it for the above purposes; (iv) to use the process (in the case of processes); and (v) to offer for sale, sell or use the product obtained from the process. 

To determine the scope of protection of the innovative pharmaceutical product in Nicaragua, the literal wording of the claims must be considered; however, it may also be interpreted in conjunction with the description of the invention and the drawings, if any. Regarding the scope of protection, it is important to consider that the Nicaraguan Patent Office is rigorous with respect to the clarity of the claims, so that claims that do not specify the product and/or process and its technical solutions, nor are not based on the description of the invention, may be subject to official action in the substantive examination of the patent application, as well as those that are not clear due to multiple dependencies. Despite the above, in Nicaragua it is allowed to protect both the pharmaceutical product and the specific process for the manufacture of said product in the set of claims, or the product and the process may be protected separately. 

In relation to the type of claims allowed by the Nicaraguan Patent Office, it is important to mention that any type of claims is accepted if they are clear and refer to the technical characteristics of the invention and what is to be protected. Therefore, Markush and second use claims are allowed, if they are clearly worded and do not fall within the prohibition of protection of therapeutic methods. 

With respect to the protection of pharmaceutical products that include the use of biotechnology, in Nicaragua the patent protection will be extended to any biological material derived by multiplication or propagation of the patented material and having the same characteristics. 

The rights of the owner of a patent in Nicaragua lasts 20 years counted from the filing date of the application in Nicaragua, or from the international filing date in the case of a national phase of a PCT international application. However, this term may be extended due to delays by the Nicaraguan Patent Office in examining the application or granting the patent and, in the specific case of a pharmaceutical product patent, when the Ministry of Health ("MINSA”)-as regulatory authority-does not grant, in an unjustified manner, the required marketing approval within an established term. 

The grounds and specific times for extending the 20-year patent protection term for pharmaceutical products are established in Law No. 354 and are as follows: 

  1. When for causes attributable to the Intellectual Property Registry, it delays in granting the registration of a patent for more than five years counted from the filing date of the patent application. For this specific cause, the filing date before Nicaraguan Patent Office must be considered and the holder must request the extension within 60 days after obtaining the certificate of granting. The term to be extended will be of one day for each day of delay counted from the first day of the sixth year, but in no case the term can be longer than 550 days.  

  1. When for causes attributable to the Intellectual Property Registry, it delays in granting the registration of a patent, more than three years counted from the filing date of request for substantive examination. For this specific cause, the filing date before the Nicaraguan Patent Office must be considered and the holder must request the extension within 60 days after obtaining the certificate of grant of the patent. The term to be extended will be of one day for each day of delay counted from the first day of the fourth year, but in no case the term can be longer than 550 days. 

  1. When for causes attributable to the competent authority, for the granting of registrations for the commercialization of pharmaceutical products, it delays in granting the sanitary registration for more than five years counted from filing date of the application. The provisions of this paragraph shall only apply in case the pharmaceutical product is covered by a patent in force in Nicaragua. For this specific cause, the filing date of the application for sanitary registration of the pharmaceutical product before MINSA must be considered and the holder must request the extension within 60 days after obtaining the first marketing approval. The term to be extended will be of one day for each day of delay counted from the first day of the sixth year, but in no case the term can be longer than 550 days. 

 

Considering all the above grounds, the maximum period of validity that a pharmaceutical patent could have in Nicaragua would be 21 years and 6 months, provided that the unjustified delays established above occur and that the patent holder requests the extension within the established term. 

Test data protection and Patent Linkage  

Innovative pharmaceutical products may also be protected before the regulatory authorities and, in the specific case of Nicaragua, before MINSA, which is the authority in charge of granting marketing authorizations for pharmaceutical products. Protection before MINSA is intended to: (i) prohibit the entry into the Nicaraguan market of generic pharmaceutical products and (ii) discourage the entry of pharmaceutical products that infringe patent-protected innovative pharmaceutical products. 

The first protection before MINSA is better known as "test data protection”, which began to be regulated in Nicaragua with the adoption of CAFTA-DR and the consequent amendment of Regulation No. 88-2001, "Regulations of the Law on Patents, Utility Models and Industrial Designs” ("Amendments to the regulation of Law No. 380”) in 2006, which established that if, as a condition for approval of a new pharmaceutical product, it is required to submit undisclosed data on its safety and efficacy, the national authority must guarantee that third parties that do not have the consent of the person providing the information, use for commercial purposes, the information or the approval granted to the person who submitted the information, for a period of five years. 

The protection of this test data introduced in the Amendments to the regulations of Law No. 354 was subsequently adopted by MINSA in 2006 through Ministerial Resolutions No. 115-2006 and No. 119-2006, establishing the procedure for the protection of test data and ratifying the protection of such data for a period of 5 years, within which no other generic product may be approved for marketing. Likewise, it establishes that, once the 5-year protection period for test data has expired, if a third party wishes to obtain marketing approval based on such data, the following documentation must be submitted: 

  1. notarized affidavit that there is no valid patent in Nicaragua protecting the product previously approved to be marketed in Nicaragua or its protected use;  

  1. if there is a valid patent registered in Nicaragua, written authorization by the owner of a patent; and  

  1. a notarized affidavit attesting the existence of a patent, its expiration date and indicating that the applicant will not market the product before the expiration date of the patent; under these circumstances, the authority may grant the marketing authorization at the time the patent expires. 

 

On this last point, the Patent Linkage plays a vital role as a second protection purpose. This is a method by which a patent holder can notify a regulatory authority that a pharmaceutical product already approved for marketing is also protected by patent, and that, therefore, the marketing of another product that infringes the patent will not be approved.  

In Nicaragua, Patent Linkage works through a notification to MINSA indicating that a certain pharmaceutical product is protected by patent and is therefore included in a public list available on its website. However, this does not guarantee that MINSA, at the time of conducting an analysis for marketing approval of a new pharmaceutical product, may determine during the approval process that such product infringes a patent of another pharmaceutical product already approved for marketing. If MINSA does not determine infringement during the approval process of the new pharmaceutical product, administrative procedures are still available through which MINSA can be advised of the patent infringement and request the refusal of marketing approval of the new pharmaceutical product. 

This is logical since MINSA does not have the authority to conduct patent infringement analyses; however, such authority does function to discourage the entry of pharmaceutical products that infringe on innovative patent-protected pharmaceutical products. Thus, a competitor that is evaluating entering the Nicaraguan market can review the list and consider not entering the market due to the prior existence of a patent-protected pharmaceutical product. 

In conclusion, Nicaragua complies with the provisions of TRIPS and CAFTA-DR with respect to the protection of patents for pharmaceutical products, thus having a solid legal system that provides the necessary tools to protect innovative pharmaceutical products through patents and regulatory exclusivity by MINSA. 

Bibliographic references 

World Trade Organization (1994). Annex 1C - Marrakesh Agreement - Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Dominican Republic-Central America-United States Free Trade Agreement (CAFTA-DR) (2004).  

National Assembly (2022). Law No. 1097, Law of the Nicaraguan Legal Digest of Business, Industry and Commerce - Law No. 354 "Law of Patents of Invention, Utility Models and Industrial Designs”. 

National Assembly (2022). Law No. 1097, Law of the Nicaraguan Legal Digest of Business, Industry and Commerce - Decree no. 88-2001, "Regulations of the Law of Patents, Utility Models and Industrial Designs”. 88-2001, "Reglamento de la ley de patentes de invención, modelo de utilidad y diseños industriales”. 

Ministry of Health (2006). Ministerial Resolution No. 115-2006. March 22, 2006. 

Ministry of Health (2006). Ministerial Resolution No. 119-2006. March 29, 2006. 

 

The information provided by ARIAS® is presented for informational purposes only. This information is not legal advice and is not intended to create, and does not constitute, an attorney-client relationship. Readers should not act upon this information without seeking advice from professional advisers.