The National Sanitary Surveillance Agency (ANVISA) introduced significant changes to pharmaceutical patent examination through the publication of new Resolution RDC 21/2013. The resolution resulted in a new workflow for pharmaceutical patent applications. With the advent of the new workflow, pharmaceutical cases are sent directly to ANVISA for examination in order to deal with public health issues. ANVISA examiners determine whether an application poses risks to public health, which will result in either grant or denial of “prior consent” in respect of the pharmaceutical application. Patent cases which receive prior consent will be returned to the Brazil Patent and Trademark Office (BPTO) for further prosecution.
If the applicant receives an unfavourable opinion denying prior consent, it has 90 days from receipt of the opinion to submit a reply. If it fails to submit a reply, ANVISA will deny prior consent. All written opinions reporting the conclusion of ANVISA’s analysis regarding prior consent are published in the Brazilian Official Gazette. If prior consent of an application is denied by ANVISA, the applicant can file an administrative appeal to the ANIVISA Appeal Board within 60 days of receipt of the opinion. In the event that the appeal is held to be unfounded, the denial of prior consent will be ratified by ANVISA. After ratification of the denial, the application will be sent back to the BPTO. At this point, the BPTO will 'shelve' the application for an unknown period of time. At present, the BPTO has not shelved any patent applications for which prior consent has been denied.
The majority of Brazilian attorneys view the shelving of a patent application without substantive examination by the BPTO as unconstitutional. The rationale is that on paying an examination fee to the BPTO, an applicant is entitled to have its application examined by the BPTO (which is specifically authorised under the Brazilian constitution to review patent applications).
In the event that an application is shelved by the BPTO, the applicant can file an administrative appeal. Administrative appeals filed at the BPTO are analysed by a board of examiners. If the appeal is rejected, the only available recourse for the applicant is to file a lawsuit in Brazilian federal court against ANVISA’s intervention in the substantive examination of the pharmaceutical patent application and the BPTO’s refusal to examine the application.
Approximately 20 lawsuits have been filed against ANVISA in connection with its denial of prior consent under the previous workflow (where applications were first examined by the BPTO and then sent to ANVISA for examination based on public health issues). In the majority of these lawsuits, the courts have reversed ANVISA’s denial of prior consent, holding that ANVISA must limit its review of an applicant’s patent application solely to health issues – meaning that if the BPTO approved a patent application directed to a process for a pharmaceutical product, a patent should be granted.
Court decisions in favour of patentees have been issued in district courts in Brasília. Some courts issued preliminary injunctions ordering ANVISA to grant prior approval of patent applications on the grounds that ANVISA did not have the competence to conduct patentability examination.
A recent unexpected decision from the Rio de Janeiro Federal District Court denied a preliminary injunction and ruled that ANVISA is competent to examine a pharmaceutical patent application in terms of patentability requisites. This decision is likely to be used by ANVISA to assert its legitimacy to examine pharmaceutical patent applications, and patentees and Brazilian attorneys will have to be creative to overrule this decision.
At the close of 2015 the Brazilian government and the United States signed a memorandum of understanding for the Patent Prosecution Highway (PPH) in respect of patent applications filed for oil and gas technology. Since then, a pilot programme has been enacted under which an applicant that receives a positive ruling on a patent claim from either the Brazilian National Institute of Industrial Property or the US Patent and Trademark Office may request accelerated prosecution of corresponding claims in the other office. The PPH allows the applicant to obtain a patentability decision in the office of later examination (OLE) more quickly. Further, the PPH promotes patent application processing efficiency by allowing the examiner in the OLE to reuse the search and examination results from the office of earlier examination, thereby reducing workload and duplication of effort.
In May 2016 Brazilian President Dilma Roussef was stripped of her duties on account of an impeachment process. The process has not been entirely completed, but Roussef has been removed until a final decision is rendered by the Senate. It is likely that Roussef will not return to her duties. In the meantime, an interim government has stepped in. There are discussions to restructure the BPTO to become more efficient; this measure would mean increasing the number of examiners to reduce the backlog. It is not a simple task, but it is a necessity. There are interested parties in the private sector that are willing to invest in the restructuring of the BPTO. There are also discussions to expand the PPH tool to other technological areas and important jurisdictions such as Europe and Asia. Further, ahead of the Summer Olympics 2016 taking place in Rio de Janeiro, the BPTO took measures to expedite industrial design registrations, this favouring registration owners.
General practice and enforcement trends
The BPTO has recently filed a large number of court actions aimed at the cancellation of several pharmaceutical and agrochemical patents before the Rio de Janeiro Federal Court. All patents involved in such court actions are related to pharmaceutical and agrochemical products or processes that belong to the so-called 'mailbox' types – that is, they were filed between January 1 1995, when the Agreement on Trade-Related Aspects of IP Rights came into force, and May 14 1997, when the new IP Law came into force.
The day before filing the court actions, the BPTO published a legal opinion from the Public Office of Attorneys stating that mailbox patents must be granted with a 20-year term starting from the filing date (as provided by Article 40 of the IP Law), and not with a 10-year term counted from the grant. Therefore, considering that all patents involved in the court actions were granted with a 10-year term from grant rather than the 20-year term from the filing date, the BPTO argued that they were granted in contravention of the IP Law, and therefore should be cancelled by the Rio de Janeiro Federal Court. Alternatively, based on Article 229 of Law 9279, the BPTO requested that the Federal Court recognise that the patents should not have been granted with the 10-year term, and thus apply the 20-year term from the filing date.
The court ruled against the BPTO in six cases, maintaining the patents in force with a protection term of 10 years from grant. The BPTO appealed the first-instance decisions, and the Court of Appeals held that mailbox patents should have a term of 20 years from the filing date. Holders of mailbox patents may choose to appeal.
Moreover, Brazil has now enacted the new Civil Procedure Code (13.105/2015) which regulates the proceedings of most civil lawsuits, from family issues to contracts and IP rights enforcement. The new code, which came into force in March 2016 for all new and ongoing lawsuits, is intended to meet the difficulties and challenges of modern litigation. It is designed to be less bureaucratic and to provide fast and effective solutions to all kinds of legal dispute in Brazil, reducing appeals, optimising preparatory actions and encouraging settlement.
An earlier version of this article first appeared in the seventh edition of The International Comparative Legal Guide to Patents published by Global Legal Group Ltd, London (www.iclg.co.uk).
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