Troubled times for pharma patents


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 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.

Pharmaceuticals, INPI, ANVISA