Protecting Innovative Pharma products

The recognition of the legal protection of innovative pharmaceutical products is and has been a matter of great importance for the health sector and the pharmaceutical industry, due to the relevance of 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 member countries that are signatories of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Free Trade Agreement between Central America, the United States of America and the Dominican Republic (CAFTA-DR), Nicaragua recognizes the importance of legal protection of innovative pharmaceutical products and, through laws, regulations and ministerial resolutions, establishes mechanisms for patent protection and regulatory exclusivity.

In Nicaragua, legal protection of 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 protection of test data and patent linkage.

Patent Protection for Pharmaceutical Products

In Nicaragua, Law No. 354, the “Law on Patents for Inventions, Utility Models, and Industrial Designs” (“Law No. 354”) generally establishes the legal requirements and procedures to be followed for the protection of inventions. Generally, like most member countries of the World Trade Organization (WTO) and TRIPS, Law No. 354 recognizes as an invention any product and/or procedure that provides a technical solution to a specific problem. To do so, said invention must meet the requirements of novelty, industrial application, and inventive level; that is, that the product and/or procedure has not been disclosed or is not publicly accessible, that it is not obvious or evident to a person trained in the industry in which the invention is applied, and lastly, that said procedure and/or product is useful and applicable 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 trained in said industry. 1 Any pharmaceutical product that meets the requirements established in Law No. 354 may be protected by means of a patent and thus the owner will enjoy the prerogatives established by law, specifically the right to prevent third parties without his consent from: (i) producing and manufacturing the product; (ii) offering for sale, selling or using the product; (iii) importing or storing it for the above purposes; (iv) using the procedure (in the case of procedures); and (v) offering for sale, selling or using the product obtained from the procedure.

To determine the scope of protection of the innovative pharmaceutical product in Nicaragua, the literal meaning of what is established in the claims must be taken into account; 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 regarding the clarity of the claims, so that claims that do not specify the product and/or procedure and its technical solutions, nor find their basis in 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 dependence on multiple dependencies. Despite the above, in Nicaragua it is permitted that in the set of claims both the pharmaceutical product and the specific procedure for the manufacture of said product are protected, or, one can choose to protect the product and the procedure separately.

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

Regarding the protection of pharmaceutical products that involve the use of biotechnology, in Nicaragua patent protection will extend to any biological material derived by multiplication or propagation of the patented material and that has the same characteristics.

The rights of a patent holder in Nicaragua are 20 years from the date of filing of the application in Nicaragua, or from the date of international filing in the case of the national phase of an international application under the Patent Cooperation Treaty (PCT). However, this period 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 patent for a pharmaceutical product, when the Ministry of Health (“MINSA ” ) – as the regulatory authority – does not grant, in an unjustified manner, the required marketing permit within a set period.

The specific causes and times to extend the 20-year protection period for a patent on pharmaceutical products are established in Law No. 354 and are the following:

I. When, for reasons attributable to the Intellectual Property Registry, it delays granting the registration of a patent for more than five years from the date of filing the application for patent registration. For this specific reason, the date of filing at the Nicaraguan patent office must be considered  and the owner must request the extension within 60 days of obtaining the certificate of granting the patent. The extension period will be one day for each day of delay counted from the first day of the sixth year, but in no case may the period be greater than 550 days.

II. When, for reasons attributable to the Intellectual Property Registry, the granting of a patent registration is delayed for more than three years from the date of filing of the application for substantive examination. For this specific reason, the date of filing at the Nicaraguan patent office must be considered and the holder must request the extension within 60 days of obtaining the certificate of granting the patent. The extension period will be one day for each day of delay counted from the first day of the fourth year, but in no case may the period be longer than 550 days.

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

Taking into account all the above causes, 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 period.

Protection of test data and patent linkage

Innovative pharmaceutical products may also be protected before regulatory authorities and, in the specific case for Nicaragua, before the MINSA, which is the authority in charge of granting marketing authorizations for pharmaceutical products. Protection before the MINSA has the purpose of (i) prohibiting the entry of generic pharmaceutical products into the Nicaraguan market and (ii) discouraging the entry of pharmaceutical products that infringe innovative pharmaceutical products protected by patents.

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

The protection of these test data introduced in the Reform to the regulations of Law No. 354 was later adopted by the MINSA in the same year through Ministerial Resolutions No. 115-2006 and No. 119-2006, establishing the procedure for the protection of test data and ratifying the protection of said 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 said data, it must submit the following documentation:

I. a notarized sworn statement that there is no valid patent in Nicaragua protecting the product previously approved for commercialization in Nicaragua or its protected use;
II. if there is a valid patent registered in Nicaragua, written authorization from the patent holder; and
III. a notarized sworn statement attesting to the existence of a patent, its expiration date and an indication that the applicant will not market the product before the patent expiration date, and that the authority may, under these circumstances, grant the marketing authorization at the time the patent expires.

This is where the so-called Patent Linkage plays a vital role as a second protection objective. 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 a patent, and that, therefore, the marketing of another product that infringes the patent should not be approved.

In Nicaragua, Patent Linkage works through a notification to the MINSA indicating that a certain pharmaceutical product is protected by a patent and that it is therefore included in a public list available on its website. However, this does not guarantee that the MINSA, when carrying out an analysis for approval of marketing of a new pharmaceutical product, can determine during the approval process that said product infringes a patent of another pharmaceutical product already approved for marketing. In the event that the MINSA does not determine the infringement during the approval process of the new pharmaceutical product, there are still administrative procedures through which the MINSA can be warned about the infringement of the patent and request the denial of approval of marketing of the new pharmaceutical product.

This is logical since the MINSA does not have the authority to carry out patent infringement analyses; however, said authority does function as a means to discourage the entry of pharmaceutical products that infringe innovative pharmaceutical products protected by patent. In this way, a competitor that is considering entering the Nicaraguan market can review the list and consider not entering the market due to the prior existence of a pharmaceutical product protected by a patent.

In conclusion, it can be considered that Nicaragua complies with the provisions of the TRIPS and CAFTA-DR regarding 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 the MINSA.

References

1. In Nicaragua, the concept of “innovative pharmaceutical product” should not be confused with that of “new pharmaceutical product”. The latter is defined by ministerial resolution No. 115-2006 issued by the Ministry of Health as “one that has a chemical entity that has not been previously approved in the country”. This point will be discussed further below.
   

The information provided by ARIAS® is presented for informational purposes only. This information is not legal advice and is not intended to create, nor does it constitute, an attorney-client relationship. Readers should not act upon this information without seeking the advice of legal professionals.