Overcoming the Backlog

Fast-track examination at the PTO: we make sure our clients take advantage of all the available options to obtain fast-track examination for their patent applications. Typically, after a request for fast-track examination is granted, the PTO examines the application within 14 months. Eligibility for taking the fast-track is fairly broad, and includes, amongst others:

  • Applications with at least one infringed claim;
  • Applications covering green technologies (envirotech);
  • Pharmaceutical applications related to the treatment of certain diseases (including cancer, AIDS, and neglected diseases);
  • Applications filed by senior persons or by persons suffering from certain health conditions;
  • Applications filed by small companies;
  • Applications that need to be granted as a condition for obtaining financial resources from local development institutions;
  • Applications eligible for the Patent Prosecution Highway Pilot Program (currently limited to applications related to oil & gas).

Judicially induced fast-track examination: the Federal Constitution establishes that all persons have the right to a reasonable duration of legal and administrative proceedings. It is not hard to establish that waiting several years until the PTO is able to examine patent, trademark and design applications is not reasonable. Instead of waiting in line, some applicants decided to start suing the Brazilian PTO in federal courts challenging unreasonable delays.

So far, over 40 lawsuits were already filed with the objective of overcoming the backlog at the PTO. In more than 80% of the cases, the applicants prevailed and the courts ordered the PTO to examine pending matters within 60 days or less. Some applicants were even able to obtain preliminary injunctive relief, achieving favorable outcomes in record time.

While we understand that initiating litigation might not be a viable option for every case, our experience shows this is the best way to avoid important applications and other matters from being stuck at the PTO and can give our clients an important advantage against competition.

Preventing ANVISA from stalling pharmaceutical applications: In Brazil, differently from all other jurisdictions, patent applications covering pharmaceutical products and processes must be examined not only by the PTO, but also by the Brazilian F&D Agency (ANVISA). Basically, ANVISA needs to give “prior approval” to a patent application before the application is examined and granted by the PTO.

This analysis made by ANVISA is completely distinct from the examination of a request for marketing approval for the products covered by the patent. While the request for marketing approval is examined in light of the Food & Drug Statute (safety and efficacy of a particular product), the analysis of a patent application by ANVISA should be done exclusively in view of the Brazilian IP Statute.

According to many court precedents, ANVISA does not have statutory authority to examine a pharmaceutical application in view of the patentability requirements established by the IP Statute (novelty, nonobviousness etc). ANVISA should only deny prior approval to a pharmaceutical application, preventing the issuance of the patent, in case ANVISA is able to show that the product/process covered by the application can create risks for public health.

In practice, despite the existence of many precedents on this matter, ANVISA insists on examining certain pharmaceutical application (the ones that are more relevant to the Brazilian Public Health Care System) in view of the patentability requirements, illegally denying prior approval to a many applications. When this is the case, filing a petition for writ of mandamus before a federal district court is the most-effective solution to make sure prior approval is granted.

A petition for writ of mandamus is a straightforward legal proceeding quickly decided by the courts. The litigation focuses on a single issue: ANVISA´s lack of statutory authority to examine patentability requirements. The objective is to force ANVISA to grant prior approval and send the application back to the Brazilian PTO for examination.

Statistics show that in the vast majority of cases, a request for preliminary ex parte injunctive relief is granted even before ANVISA is served with the summons. Our partners have a proven track record litigating this matter against ANVISA, and according to current case law, the chances of ultimately prevailing are outstanding.

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