The team at Moeller IP’s Legal Department, working with very experienced local colleagues, reached a very important favorable decision for their client that we believe may be of interest to those facing similar situations.
Relevant Facts of the Case
On August 26, 2005, Bayer Healthcare LLC (hereinafter “BAYER”) filed a patent application with ONAPI related to a pharmaceutical composition and methods for its preparation.
After almost sixteen years, during which several technical analyses had been carried out and different administrative appeals filed during the prosecution process were resolved, ONAPI granted the patent on April 29, 2021, with a duration of 20 years from the date of filing, which was non-extendable according to the original letter of Article 27 of Law Number 20-00.
Subsequently, on June 29, 2021, BAYER filed with ONAPI a “request for compensation of the term of validity of the patent, for three more years,” which was denied on July 5, 2021. The main argument of ONAPI was that it was only possible to invoke the compensation of the term for applications with a national filing date as early as March 1, 2008, due to the entry into force of the Free Trade Agreement (DR-CAFTA) and the Principle of Non-Retroactivity of the Law stated in Article 110 of the Constitution.
On July 28, 2021, BAYER filed an administrative appeal with the Director of the Inventions Department of ONAPI, which was rejected on February 23, 2023, with the same arguments previously used by ONAPI. The decision stated that the term of validity of a patent is “twenty (20) non-extendable years from the date of filing of the application in the Dominican Republic.”
That decision was appealed by BAYER on July 5, 2023, leading to the decision discussed here, issued on March 26, 2024, by the First Chamber of the TSA.
The TSA’s Decision Analysis
The TSA first cited Article 52 of the Dominican Constitution, which recognizes and protects “the right of exclusive ownership of scientific, literary, artistic works, inventions, and innovations… for the time, in the form, and with the limitations established by law.” Thus, the exclusivity rights generated by a patent must be within the framework of respect for the law. Therefore, the State and its authorities must ensure an efficient allocation of exclusivity rights in accordance with the Principle of Legality to avoid a high negative impact on society.
The TSA then analyzed both Article 27 of Law No. 20-00, used by ONAPI to justify its decision to deny the request for compensation, and Article 2 of Law No. 424-06 dealing with the national implementation of DR-CAFTA.
Article 2 amended Article 27 of Law No. 20-00 by introducing the figure of compensation for unjustified delays not attributable to the applicant:
“Article 2. Article 27 of Law 20-00 on Industrial Property is amended to read as follows:
“Article 27.- Term of the patent. ” The patent has a non-extendable duration of twenty (20) years, counted from the date of filing of the application in the Dominican Republic, except as provided in the paragraphs of this article.
“Paragraph 1. Compensation of the term of validity of patents for inventions.
- At the request of the owner of an invention patent, the term of validity of the patent may be extended only once, extending it up to a maximum of three (3) years, after the evaluation carried out by the Directorate of Inventions in cases in which said Directorate has incurred an unreasonable delay, it being understood that “unreasonable delay” is that attributable to the Directorate of Inventions in the granting of! registration of a patent of more than fiveyears(5) years from the date of filing of the application or three (3) years from the date of the application for substantive examination of the patent, whichever is later. (…)” (continues)
Furthermore, the TSA mentioned Article 33 of this Law No. 424-06 which provided that the figure of compensation for unjustified delays introduced by the new Article 27 would enter into force one (1) year after the entry into force of the DR-CAFTA, which had occurred on March 1, 2007 and therefore the new Article 27 entered into force on March 1, 2008.
Next, the TSA analyzed Article 110 of the Constitution, which establishes the Principle of Non-Retroactivity of the Law, as well as the interpretation of it made by the Constitutional Court, concluding that this principle is the maximum exponent of legal certainty, so it should be set aside only in exceptional circumstances.
The TSA finally cited precedents issued by the Third Chamber of the Supreme Court of Justice that confirmed the criterion previously proposed by the TSA in analogous cases to reject the main argument of the ONAPI consisting of taking the date of national filing of the application as the main factor instead of the date of grant of the patent. Those precedents had considered the date of the granting as the constitutive act of the property right to which the regulations in force must be applied.
The holding of the decision and its application to the specific case
In paragraph number 33 of its decision, the TSA issued the holding of the case very clearly, so we believe it is appropriate to reproduce it:
“It is correct to maintain that the date of grant of the patent is the determining factor for the request for compensation of the term of validity, and this is based on a solid logic, because a term that has not yet been granted cannot be extended. Thus, the date of grant of the patent becomes the logical reference point for the request for compensation of! term of validity, since it is at this time when the right on which the request for extension is based materializes“
As a result of this decision, on July 4, 2024, the Director of the Department of Inventions of ONAPI issued Resolution No. 200-2024 by which the maximum compensation period allowed has been granted to BAYER’s patent No. P2005000169, which is 3 years, so it will continue in force until August 26, 2028.
Application of the holding company to other similar cases
The TSA’s confirmation of the relevance of the date of the grant instead of the one proposed by the ONAPI consisting of the date of filing of the application for a patent whose validity is to be extended because it has suffered unjustified delays during its processing not attributable to the applicant, allows us to conclude in an abstract way that the universe of possible cases in which such compensation could be requested would cover all the patents granted after March 1, 2008.
But in order for the extension of the validity to proceed, the rest of the requirements listed in the new article 27 of Law 20-00 must be complied with after being amended by article 2 of Law 424-06, which requires a thorough analysis of the circumstances of each patent prosecuted until its granting, for which we invite you to contact us with your inquiries in hello@moellerip.com.
