A draft for what will be Brazil’s first comprehensive national strategy for IP policy has been published by the country’s government, with a view to ushering in a 10-year period of reform. The document highlights several important legal questions relating to pharma and biotech for review and potential adjustment. While these are a mixed bag from the rights holder point of view, the pro-innovation emphasis of the strategy suggests that life sciences patentees can expect favourable changes in a country where they have previously faced significant challenges.
The proposed National Strategy of Intellectual Property seeks to provide a roadmap for building an IP ecosystem better able to foster innovation, investment and growth in the Brazilian economy. Having received input from private stakeholders and the academic community, the government is now holding a broader public consultation (ending on 13th September) as the final step before the strategy is formalised by presidential decree.
As well as promising improvements to IP administrative bodies, greater predictability and further harmonisation with global IP systems, the draft identifies several legal and regulatory issues for review and potential reform in the coming years. Many of these relate to the pharma and biotech sectors, which currently experience notable idiosyncrasies in the Brazilian IP system.
Some of the questions highlighted for review augur well for innovative biopharma companies. There is, for example, a commitment to consider introducing regulatory data protection for drugs. “It is an interesting development that Brazil is starting to align itself with countries like the US and Europe as far as data is concerned,” comments Roberto Rodrigues of Licks Attorneys. “This is highly relevant for biologics and biosimilars, and it is good news that data protection for drugs is no longer a no-go topic. If we are willing to discuss it, we might see change in this area.”
The lack of such protection has been a problem for pharma companies for years, says his colleague Eduardo Hallak, especially “when you add in the significant backlogs that have existed at the patent office, which often takes 10-12 years to grant a patent”.
The draft also calls for the review of the current system whereby ANVISA (the equivalent of the FDA or EMA) has to give prior permission for the grant of any pharmaceuticals patent – a prerogative it has frequently used to block secondary patents. Some of ANVISA’s patent-related powers were trimmed by a joint Ordinance in 2017, but it would be a great relief to applicants if its role in the granting of rights were completely abolished, as this would be in keeping with international practice. “Currently, until ANVISA says something about an application, the PTO does not start examinations,” explains Hallak. “So, we have the ANVISA backlog and the PTO backlog.”
The national strategy draft also proposes exploring something akin to patent linkage – the inclusion of a patent evaluation at ANVISA prior to the approval of the first generic version of a drug. It suggests, too, that preparations be made to join the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. “Adhering to this treaty would speed up the process of granting patents for biological inventions by removing the need to deposit biological materials abroad,” stressed Roberto Ribeiro of Daniel Law.
More negative for pharma innovators is a commitment to review the sole paragraph of Article 40 of the patent code, which guarantees at least 10 years’ patent term from grant. This may reflect the influence of the country’s large generic pharma sector. But the legality of the provision is also being challenged at the Supreme Court, so this may be an attempt to reclaim this issue for the political sphere. Also ambiguous from the patentee perspective is the proposal to reconsider the rules regarding the patenting of second medical uses (currently permitted but difficult in the country).
However, the draft considered as a whole is good news for innovative biotech and pharma companies, representing an ongoing shift in Brazilian political attitudes towards life sciences. “We have seen in the last year or so, as well as in connection with this new strategy, Brazil taking some active steps to move forward and improve its IP system,” comments Casimir Jones’ Lisa Mueller, a US attorney who pays close attention to Brazilian patent law. The country has already taken steps to reduce the logjam at its patent office, she points out.
“This is another step in the right direction,” Mueller continues. “It is a sign that Brazil really wants to shore up its IP protection and give confidence to pharmaceutical and biologics companies.” Rodrigues agrees: “Brazil is becoming more friendly to pharma patents. A few years ago, discussing pharmaceutical rights was a no-go. But nowadays, the current government wants to make international deals and have growth, so need to strengthen IP.” However, he qualifies: “It is tit-for-tat, so they will probably give something for local generic companies too.”
The exact nature of IP reform in Brazil is still being determined, so those with an interest in the country may want to have their say in ongoing consultations and watch for further developments.
Published on IAM. Read it here.