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.
To continue reading, you need a subscription to WIPR. Start a subscription to WIPR for £455.
In-house feature articles, the archive and expert comment require a paid subscription. Subscribe now.
Want to give it a try? We are offering a two week free trial to the WIPR website – register and select “Free Trial” to begin access to the full WIPR archive and read the latest news, features and expert comment. Begin your free trial here.
Is your 2 week free trial about to end? Upgrade to a 12 month subscription for £455 now.
If you have already subscribed please login.
If you have any technical issues please email tech support.
Pharmaceuticals, INPI, ANVISA