The term of validity of mailbox drug patents in Brazil is limited to twenty years from the filing date of the application in the National Institute of Industrial Property (INPI). Mailbox is the term used for pharmaceutical products filed between January 1, 1995, and May 14, 1997.
The Brazil Federal Court of Appeals for the Second Circuit held a hearing for the 1st Specialized Panel to rule on the Repetitive Demands Resolution Incident regarding the validity date for mailbox patents.
This was the thesis signed by the 1st Specialized Section of TRF2, which ruled on Thursday, June 27, a repeating demand resolution incident (IRDR) presented by Trinity College, a university-based in Dublin, Ireland. The institution sought to convince the judges to change the understanding that had already been adopted by the Court and which, however, has now been confirmed.
With the position defined in the IRDR, the collegiate concludes that it is not worth the argument of the laboratories, which defend the validity of the exclusivity of production and commercialization of these products for at least ten years, calculated from the date of granting the patent. In practice, because of INPI’s delay in examining patent applications, the change of understanding would benefit large pharmaceutical industries, making it possible to extend the term of protection beyond the twenty years outlined in the Industrial Property Law (LPI), Law 9279/96.
With the decision, TRF2 defines guidance that should be followed in all cases dealing with the same issue in the Federal Court of Rio de Janeiro and Espírito Santo. This was the first IRDR judged by the 1st Specialized Section. The instrument, which serves to unify understanding of identical demands in the second degree of jurisdiction, was established by the Code of Civil Procedure of 2015.
The case began with an action filed by the INPI requesting the declaration of nullity of patent PI9700768-4, which refers to a live vaccine to combat infection by streptococci (a genus of bacteria) in horses. The registration had been granted to Trinity College by the autarchy, which decided to administratively review the validity of hundreds of mailbox records. The 13th Federal Court of Rio de Janeiro granted an injunction (a type of injunction) to INPI. Against that measure, the Irish institution appealed to the Court, which upheld the first-degree decision. Because of this, Trinity College raised IRDR.
Understand the controversy
The old Brazilian industrial property code, Law No. 5,772, dated December 21, 1971, vetoed the patenting of medicines and agrochemicals. The rule changed in 1994, when Brazil adhered to the agreement TRIPs (Agreement on Aspects of Intellectual Property Rights Related to Trade), signed at a meeting held that year in Uruguay. At the time, the World Trade Organization (WTO) was created.
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In the negotiations, the signatory states undertook to maintain protection rules for these products, which was done in Brazil with Decree 1355 of 1994. Two years later, the new Industrial Property Law (LPI – Lei 9, 799/1996), which retroactively guaranteed the patentability of medicines filed in the INPI between the beginning of Decree 1355/1994 and that of the current LPI, that is, between January 1, 1995 and May 14, 1997, creating the mailbox category.
In legal proceedings, pharmaceutical companies usually base their arguments on the single paragraph of article 40 of the new law, which provides for a minimum period of ten years of validity of the patent, from the date of grant. However, in the unanimous opinion of the judges of the 1st Specialized Section, this count does not apply to mailbox drug patents, since article 229 of the LPI orders that the calculation of the term for these products be made from the “effective date of the filing of the application in Brazil or the priority, if any, ensuring protection from the date of granting of the patent, for the remaining term from the day of filing in Brazil, limited to the period set forth in the caput of Article 40 “. The caput of this article determines the validity of the patent for a term of twenty years.
Public interest
In his vote, IRDR’s rapporteur, federal judge Ivan Athié, stressed the need to establish a legal theory on the problem and stressed that the interpretation of the rule should “protect the public interest primarily to the detriment of the individual.” The magistrate rebutted the argument that the Federal Judiciary would be breaking the isonomy regarding the treatment given to the issue by the other WTO countries, since “patent offices of other member states, corresponding to INPI, also adopt criteria that establish the precedence of the collective interest “.
Besides, Ivan Athié, citing the opinion of the Federal Prosecutor’s Office, considered that INPI’s difficulty in quickly examining patent applications is not a justification for benefiting the pharmaceutical industry: “The burden of delay can not be transferred to society”, warned.
In conclusion, the rapporteur reminded that laboratories have protected their products since the filing date, regardless of whether there is a patent granted, since Article 44 of the LPI guarantees the right to compensation for improper exploitation of the product, “including in relation to between the date of publication of the application and that of the granting of the patent “.
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