Troubled times for pharma patents
November 10, 2017

Otto Licks Since 1999, patent applicants claiming pharmaceutical inventions (products and processes) in Brazil have faced an awkward provision in the Brazilian patent law, commonly known as Article 229-C. On March 25, 2012, joint ordinance 1,065 was issued, suggesting severe changes to the Brazilian government’s interpretation of the country’s patent statute (Law 9,279 of May 14, 1996) in light of Article 229-C. Without a legislative change, the country’s administration (president Dilma Rousseff) has signaled major changes to patentability requirements, patent-defeating statutory provisions and patent prosecution. Ordinance 1,065 was jointly issued by the Ministry of Health, the Ministry of Commerce and the country’s Attorney General, which suggests that the disputes between the Brazilian Patent Office (INPI) and the Brazilian food and drug agency (ANVISA) are over. Article 229-C, as amended on December 15, 1999, establishes that the grant of patents to pharmaceutical products and processes will depend on ANVISA’s prior approval, as an attempt to change the ministerial acts of technical examination, allowance and grant of a patent claiming pharmaceutical products or process into a discretionary one. It imposes an additional patentability requirement for pharmaceutical patent applicants and discriminates against a specific field of technology, infringing many sections of the World Trade Organization TRIPS Agreement. Nevertheless, Article 38 of the Brazilian patent law establishes that a patent will be granted after the application is allowed and, after proving payment of the corresponding fee, the respective letters-patent will be issued. Article 229-C is not a requirement for the allowance of the application, after the substantive examination, under Article 37, but a requirement for the grant of the letter-patent. Thus, Article 229-C is a requirement for the grant of a patent under Article 35. The problem with ordinance 1,065 is that it made public an inter-agency report, dated January 19, 2012, by the same parties, alongside ANVISA and the INPI, suggesting changes to the interpretation of Law 9,279. The report also covers the institutional relationship between the INPI and ANVISA. It is not clear if the report is self-implementing or if makes changes to the agencies’ regulations. The impact of the report is not yet fully understood. As of June 1, 2012, ANVISA officially announced that rule 45 of 2008 was enforceable, without any changes. On June 4, INPI said that the new workflow has been already implemented, without the need for it to make new rulings. [blockquote]"IF IT IS PROPERLY FILED AND DULY PUBLISHED, THE INPI WILL LOOK FOR CLAIMS FOR A PHARMACEUTICAL PRODUCT OR PROCESS AFTER EXAMINATION HAS BEEN REQUESTED."[/blockquote] The report suggests that an ANVISA substantive examination will be limited to Article 18.I of Law 9,279/96, following the decision of Brazilian courts in the Takeda case. Article 18.I is a limitation on patent subject matter for subject matter contrary to public health, and is almost never used. However, in June ANVISA issued decisions denying prior approval based on lack of patentability requirements, such as novelty and inventive step, which creates several doubts about the political leeway ANVISA will exercise in the prior approval procedure. The most important changes can be summarized as follows: • Ordinance 1,065 and the associated report change patent prosecution and the relationship between the two agencies. Apparently, the INPI will perform the preliminary formalities examination of the application or Patent Cooperation Treaty (PCT) national phase under Article 19 of Law 9,279/96 and AN 128/97. If it is properly filed and duly published, the INPI will look for claims for a pharmaceutical product or process after examination has been requested. The INPI will send the patent application to ANVISA if a claim for a pharmaceutical product or process is found. It is not clear whether the INPI will act only after the application is published and the examination has been requested, or whether it will publish the notice in its Gazette. • ANVISA will than do an analysis of the application. ANVISA’s IP commission (COPI) might grant prior approval, issue an office action for amendments or issue an opinion of preliminary rejection. • Only after prior approval is granted by ANVISA will the INPI start its substantive examination. According to the ordinance and the report, the INPI is required to reject the application if prior approval is not granted by ANVISA. This is another major change. Until ordinance 1,065 was issued, the INPI would place applications allowed but without prior approval from ANVISA in limbo, giving the applicant an opportunity to seek reversal of the denial. It is still too early to understand the full impact of these new changes, but ordinance 1,065 is being viewed as another anti-patent act by the current Brazilian administration that might jeopardize investments in the country.

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This article was originally published in “WIPR”, World Intellectual Property Review. For further information, please access the following website:

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