1 August 2012Jurisdiction reportsOtto Licks

Troubled times for pharma patents

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 signalled 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.

"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 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 summarised as follows:

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