All material subject to strictly enforced copyright laws. © 2022 Managing IP is part of the Euromoney Institutional Investor PLC group.

Brazil counsel embrace creative enforcement after SC ruling


Counsel at Daniel and a pharma firm said secondary patents and food and drug law have become more important as a result of the Direct Action 5,529 ruling

Counsel in Brazil are becoming more creative with their enforcement strategies after the Supreme Court ruled last month to remove the 10-year guarantee for successful patents and to make that judgment retroactive for pharmaceutical and medical device patents.

Lawyers at Daniel and a pharmaceutical company told delegates at the Managing IP Life Sciences Forum on Thursday, June 17, that secondary patents and exclusivities provided by food and drug law could become much more important as a result of the ruling.

They pointed out that companies might enforce these rights more actively if the Supreme Court judgment significantly reduces the terms of their main patents, particularly chemical compound patents, which are extremely valuable to pharma companies.

“Now that the Supreme Court has suddenly decided to adjust or reduce the term of protection for more than 5,000 patents, including some very important ones, we may see companies having to rely on other claims to protect their exclusivity,” said Ricardo Nunes, partner at Daniel in Rio de Janeiro.

Related stories

Managing IP broke the news in May that the Brazil high court had ruled nine to two in Direct Action 5,529 that the sole paragraph of Article 40 of Brazil's Industrial Property Law was unconstitutional.

The provision set out in the paragraph had guaranteed at least 10 years of patent term from grant date, to make up for long delays at Brazil's patent office.

Secondary priorities

Nunes pointed out at the forum that pharma and medical devices companies in Brazil didn't traditionally focus on secondary patents.

“Companies didn’t use to pay much attention to those patents that covered combinations, formulations, salts, polymorphic forms, second medical uses and processes, partly because it was difficult to enforce them. Often competitors would just design around them.

“But now that patent terms have been slashed by as much as six years, they’ve become more relevant,” he said. 

He added that in the past, it was relatively rare to see anyone trying to enforce formulation claims in Brazil, but that the scarcity of these cases might not persist as a result of the Direct Action 5,529 ruling.

Erick Stegun, the legal manager for intellectual property at a pharma company in Brazil, pointed out that these secondary patents are typically filed after the main patent.

“If you think about it, these secondary patents might help you retain two or three more years of exclusivity now than the main patent,” he added.  

Data exclusivities

Nunes at Daniel added that in view of this change in Brazil, companies might rely more heavily on food and drug law to enforce against copies that could be considered substandard.

“Some generic products are great, but some might not meet the safety and efficacy standards required by Brazilian law, or they might not be interchangeable with the reference drug, which is something that’s also needed.

“You may see more actions related to food and drug issues because companies might not always be able to rely on the patents,” he said. 

Stegun added that pharma companies are already in conversations with the relevant authorities to try to keep product reference studies secret as well.

He pointed out that to register a product at the Brazilian health agency, a company has to produce numerous studies. A competitor that wants to produce a generic product of this reference drug has to use the same studies.

If those studies were kept confidential, it would become harder for a generics company to launch a copy.

“No one was having this conversation in Brazil for a number of years,” Stegun said. “But now everyone wants to talk about it, especially the patent owners. They want that data exclusivity.”

The Brazil high court’s ruling may have been a big blow to intellectual property owners, particularly pharma companies, but it didn’t blow them out completely.

Counsel are simply doubling down on other forms of exclusivity, which will likely become more important in Brazil over the next few years.

More from across our site

In-house and private practice counsel discuss issues with pre-grant opposition in India, including the rise of non-speaking orders and straw man filings
The US Supreme Court rejected an appeal on American Axle, dashing hopes of a judicial fix to patent eligibility uncertainty
The Copyright Office refused to grant protection on the basis that the authorship couldn’t be distinguished from the final work produced by the program
COVID vaccines top Clarivate’s new brands list; Fed Circuit reverses Coca-Cola’s TTAB win; Skechers sues Brooks; USPTO to retire Public PAIR tool; CCB sees cricket complaint
Lawyers should pay attention to APJs’ questions and remember that PTAB proceedings aren’t jury trials, say former PTAB judges
The USPTO cancelled ‘Galavava’ and 'Surfstar Wake' and partly cancelled ‘Heika’ this month
We have published all the 2022 rankings of the leading firms for patent litigation and protection work
In-house and private practice counsel say UK judges have raised the bar for preliminary injunction requests
António Campinos will serve another five years as EPO president – perhaps he’ll calm unrest at the office in that time
LGBTQ IP lawyers say using rainbow colours and posting solidarity messages on social media must be followed by concrete action
We use cookies to provide a personalized site experience.
By continuing to use & browse the site you agree to our Privacy Policy.
I agree