January 3, 2023
A five-judge panel of the Supreme Federal Court of Brazil has overturned a preliminary decision that could have allowed the extension of patents by the judiciary where there have been unreasonable delays in granting.
The preliminary decision in November followed an earlier apex court ruling finding the unconstitutionality of a provision guaranteeing a 10-year term of exclusivity from the point of grant. As of 2019, the Brazilian Patent and Trademark Office (INPI) took longer than 10 years to grant in 65% of cases.
Supreme Court Justice Luiz Fux’s decision in favour of patent owners was reviewed by the First Panel of the Supreme Court and overturned by a vote of three to one on 16 December. Rob Rodrigues of Licks Attorneys tells IAM that Hon Dias Toffoli submitted a dissenting opinion that was followed by Hon Carmen Lucia and Hon Alexandre Moraes.
The panel decided that a patent term adjustment can only be established by Congress and not before courts. There is another similar case pending before another five-person panel that should be decided in 2023.
Despite some setbacks for life sciences patentees in the past two years in Brazil, there have been a number of less-noticed favourable developments for healthcare originators.
Looking past the landmark Supreme Court ruling that led to thousands of pharma and medical device patents having their terms shortened, there has been positive legislation and other actions supporting life sciences.
Outgoing President Jair Bolsonaro vetoed an aspect of the congressional approval in 2021 of a bill expanding the country’s compulsory licensing powers, specifically compulsory tech transfer provisions that would have required pharma companies to hand over valuable trade secrets, know-how and data or else have their Brazilian patents nullified.
In addition, a 2021 law was reformed so that Brazilian pharma sector patent applications no longer need to be approved by the country’s drug approval regulator, ANVISA.
Furthermore, Brazil has worked to reduce its lengthy patent application backlog. By the end of 2021, INPI’s efforts – which included using international search and examination results and employing artificial intelligence – reduced the patent application backlog by 77%. The country also adopted a new 10-year National Intellectual Property Strategy aimed at modernising the country’s patent system and developing its innovation ecosystem.
Brazil also has become known for having a relatively low bar for granting preliminary injunctions, and a series of decisions have demonstrated the courts’ willingness to grant injunctions against generic or biosimilar products.
Finally, legislation introduced in Congress sought to introduce new patent term adjustment rights to allow life sciences affected patent office delays to have the length of their exclusivities extended accordingly.
Brazil’s election of Luiz Inácio Lula da Silva as president in late 2022 represents a significant change in direction politically that could lead to changes in the country’s approach to patents. The largest economy by GDP in Latin America and typically among the top 12 worldwide, Brazil in recent years has further aligned with the global patent system.
Lula repeatedly said on the campaign trail that he would change the make-up of the administration, restoring several ministries that outgoing president Jair Bolsonaro abolished, and revoking some of Bolsonaro’s decrees. This could result in change to the administration and command of the Brazilian patent and trademark office, possibly affecting its self-governance and budget.
But Lula’s administration is expected to continue progress made under Bolsonaro’s 10-year National Intellectual Property Strategy (2021-2030), which was developed in consort with the World Intellectual Property Organisation. The strategy syncs Brazil’s patent and trademark processing with other leading national offices.
An area to watch is patents and pharmaceuticals and other medical products. During his last mandate in 2007, Lula promoted compulsory licensing of medicines when manufacturers do not practice a “fair price” for imported drugs, the opposite of Bolsonaro’s stance. Lula also has indicated support for the World Trade Organisation waiver on intellectual property rights on covid-19 vaccines.
Colombia made a mark on the global patent litigation map after a Bogotá court issued an injunction that prevented Apple from importing and selling 5G iPhones and iPads in the country. The ruling in favour of Ericsson stemmed from its action as part of the two companies’ now resolved global licensing dispute.
Ericsson chose Colombia for several reasons. It is a small market for Apple but the injunctions still have an impact. Ericsson was the leading patent filer in Colombia in 2021 and continued to build its portfolio there in 2022. There is very little full-scale patent litigation in Colombia as most disputes reach quick settlements.
There are several attractions to Colombia for patent holders. For instance, the patent office takes “very strong presumption” of validity of grants, and the country has a bifurcated system like Germany’s which can lead to quick preliminary injunctions.
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