Challenges for patent owners in Costa Rica
For the past two decades patent regimes have undergone important changes. The purpose of these changes was to strengthen patent rights and to reinforce exclusive rights granted to patent holders, increasing their coverage and facilitating their enforcement.
In most Latin American countries, the enforcement of intellectual property (IP) rights was never a priority for the legal systems. In the specific case of patent protection in Costa Rica, there was a status quo and a well-defined protectionist culture with respect to patent registration and enforcement. The protection terms were the bare minimum and a patent registration culture was non-existent.
Nevertheless, as Costa Rica joined the World Trade Organization in 1995, several IP obligations were adopted by the country.
The TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) sets minimum standards for the protection, enforcement and dispute settlement of IP rights, modifying the country’s domestic procedures and remedies to comply with international standards.
As a consequence of Costa Rica’s compliance with the TRIPS Agreement, its patent legislation was amended in 2000. Key aspects of the regime were modified and minimum terms of protection under international standards were set, which represented an important first step in the strengthening of the patent protection regime.
CAFTA (the Free Trade Agreement between the Dominican Republic, Central America and the US) was later enforced, allowing Costa Rica to accede to obligations that resulted in the modification of its IP laws, and therefore, the legal system was again strengthened and modified to comply with international standards.
There is now a well-defined and harmonised patent regime with a broad understanding of the patent owner’s requirements. However, in practice the system has not completely developed and the administrative and judicial authorities have not fully embraced the patent regime’s potential. There are several main patent developments in Costa Rica to consider, as well as approaching challenges.
Patentability exclusions
Clarification has been given on the patentability of certain inventions in Costa Rica. Microorganisms, microbiological, and non-biological procedures for the production of plants and animals are patentable.
According to a section of the patent law (No. 6867), the following are excluded from patentability: (i) inventions that could negatively affect public order, morality, the health or life of people or animals, plants, or the environment; (ii) diagnostic, therapeutic and surgical methods for treatment of people or animals; (iii) plants and animals; and (iv) essentially biological procedures—which are neither non-biological nor microbiological—for the production of plants and animals.
The state of the art
An invention is new when it does not exist previously in the state of the art. Now, the disclosure resulting from a publication made by an industrial property office in the proceedings to grant a patent, shall be comprised in the state of the art, except for the applicant of the patent; or when the publication has been filed by a person not entitled to be granted the patent or the publication has been improperly made.
Term for patent oppositions
The patent term is extended to three months from the date of the third publication of the application in the Official Gazette. Additionally, a term of two months that is recorded from the filing date of the opposition is established for the submission of supporting evidence.
Marketing authorisation or patent linkage
Costa Rica’s patent law, specifically article 16, states that the Ministry of Health and other competent authorities must adopt measures within the marketing approval process to prevent any person other than the patent holder from commercialising a product while the patent is in force, unless the patent holder gives consent.
"The administrative and judicial authorities are not specialist and lack specialised knowledge."
Patent linkage is now applied through the submission of an affidavit before the health authorities. In this regard, an article of the Inscription, Control, Import and Publicity of Pharmaceuticals Regulation stipulates that if there are any product or procedure patents in force in Costa Rica, which cover the pharmaceutical product that is being registered, the health registration certificate may be issued as long as the application or its legal representative: (i) submits an affidavit indicating that the applicant is the holder of the patent; or (ii) submits an affidavit indicating that the applicant is authorised to use the patent.
Adjustment of the patent term for unreasonable delays
A patent law amendment spells out the conditions for extending a product patent’s term if the Costa Rican Patent Offi ce causes it to be unfoundedly delayed or, specifically, if the health authorities unfoundedly delay granting marketing approval for a pharmaceutical product.
In the first case, the adjustment of the term applies to delays of more than five years from the filing date of the patent, or three years from the date of the substantive examination request of the patent, whichever is later.
In the second case, the term adjustment applies to patents that cover a pharmaceutical product and when marketing approval takes more than three years. The term adjustment applies from the date of the marketing authorisation application and as long as the rest of the patent term does not exceed 12 years. In both scenarios, the restoration will not exceed 18 months.
Exclusive rights over test data
Two articles (15 and 16) of the Undisclosed Information Law grant exclusive rights over test data on safety and efficacy for a period of five years for pharmaceutical products and 10 years for agricultural chemical products.
Current challenges
Costa Rica has a perfectly harmonised legal framework and it is no longer in a state of implementation of standards and regulations. Ten years after the initial steps were taken to strengthen the regime, patent application numbers have risen and there is a stronger registration culture.
The most significant steps taken after the enforcement of CAFTA are highlighted by the recognition of unreasonable delays in patent granting and patent linkage. These steps have now surpassed international standards and have placed Costa Rica in an advantageous position over other countries in the area.
However, the protection of IP rights is not yet a key factor in the development of local policies. In this regard, the administrative and judicial authorities that are responsible for resolving patent disputes are not specialised and lack specialist knowledge.
Furthermore, the judicial authorities use no specialised judges to rule on patent-related litigation. Additionally, there is a gap in the development of doctrine and case law at a local level, and very few cases have reached the higher legal spheres.
A good example of this is a case that is currently pending. The court is yet to rule the first case of invalidation of a patent at the judicial level in Costa Rica. This is litigation that must be decided by the country’s Administrative Court, which resolves disputes in legal cases that are very different from IP law.
There are also huge steps that need to be taken in relation to the protection of Swiss claims, as there are restrictions on the patentability of a medicinal use of an already patented compound. Also, such claims are difficult to comprehend because their structures may not reproduce the underlying substance of the inventions.
Moreover, although the internal legislation does not prohibit the registration of polymorphs, whether they will be accepted is still uncertain, as there is no uniformity in the criteria for granting exclusive rights for them.
Despite the revisions and challenges facing the Costa Rican patent system, and regardless of the fact that patents are more difficult and costly to obtain, a patent can provide a competitive edge for many years. The strategic management of patent rights will allow a business effectively to protect and promote its innovations and technologies.
This, in turn, will enable right holders to enter or expand in the market, obtain a bigger market share and improve profitability. Inventions involve time, expense and considerable effort, and unless protected by a patent, the invention will be in the public domain and freely available to competitors.
María del Pilar López is a senior lawyer and director of the IP department at Zürcher Lawyers. She can be contacted at: plopez@zurcherip.com
Esteban Monge is a law clerk in the IP department at Zürcher Lawyers. He can be contacted at: info@zurcherip.com
