Two Important Decisions Addressing ANVISA’s Prior Approval of Pharmaceutical Patents in Brazil

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.  These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country. 

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:  novartisdecision genentechdecision).  Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin). 

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute.  In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI) is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products. 

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil.  Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.  Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).   The judge, the Honorable Iolete Oliveira, accepted  Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:  (1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health. 

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis.  The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis. 

Please continue to watch the BRIC Wall Blog for continuing updates on Brazil’s prior approval of pharmaceutical patent applications.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho, LLM candidate at Stanford University.

A New Beginning? The Brazilian Patent and Trademark Office has a New President.

Mr. Luiz Otávio Pimentel has been appointed as the new president of INPI (the Brazilian Patent and Trademark Office – BRPTO). The official notice for the nomination was published yesterday, July 28, 2015, in the Federal Register. On April 10, 2015, President Dilma published an official notice dismissing the former president, Otávio Brandelli, who had been in charge of the office for less than one and a half years. Since then, vice-president, Ademir Tardelli, acted as interim head of the BRPTO. There is strong speculation on the reasons for Mr. Brandellis’ departure. Mr. Brandelli had a strong background in Intellectual Property and, while in office, took a series of measures to expedite prosecution and to reduce the BRPTO’s backlog.

What do we know about Mr. Pimentel? He is a professor with expertise on International Law and Intellectual Property. He holds a Masters in Law from the Federal University of Santa Catarina (UFSC) and a Ph.D. in Legal Sciences from the National University of Asunción – Paraguay. He is also an arbitrator at the Ad Hoc Arbitration Court of Mercosur.

Mr. Pimentel faces numerous challenges in his new position as the BRPTO requires strong leadership by an intellectual property expert with the ability to take drastic measures to restore a high-quality management at the office. In addition to having the fortitude needed to fight the battle against the huge backlog, Mr. Pimentel will need to lead the BRPTO with transparency, allowing applicants to have advance knowledge of which guidelines and rules the examiners will adopt during prosecution.

Other important goals that need to be achieved are the acceleration of the examination process and signature of the main international agreements to simplify prosecution, such as the Patent Prosecution Highway.

The next few months will be crucial for the BRPTO’s future and for the development of Intellectual Property in Brazil.

This post was written by Lisa Mueller and Licks Attorneys law firm.