A recent proposal by the Brazilian government to effectively privatize its patent office has alarmed patient advocates, who fear such a move would make it easier for the pharmaceutical industry to maintain monopolies on medicines and, consequently, higher prices in one of the world’s largest economies.
In its notice the Ministry of Economy suggested merging the National Institute of Industrial Property, or INPI, which oversees patent reviews, with another government agency to form a new public-private sector entity called the Brazilian Agency for Development and Industrial Property, or ABDPI. The goal is to create “greater efficiencies,” according to the ministry notice.
However, such a move would likely allow industry to have a greater say in how patents are examined because the new entity would have an autonomous administration even as it works to serve the public, according to academic= researchers tracking the development. For this reason, patient groups argue the government is essentially abdicating its role.
“The patent system is based on an exchange between private and public sectors. But if it is taken out of the public domain and effectively placed into the private domain, it would be like having the fox watch over the chickens. The private sector would decide for itself whether an invention is merited or not,” said Pedro Villardi, coordinator at the Brazilian Interdisciplinary AIDS Association.
“The patent examination is a crucial step in deciding whether a drug patent stays in private hands or is in the public domain. And if there is more room for the private sector to decide patents, it’s very worrisome, because the private sector can benefit from a fragile examination process and receive more patents to establish more monopolies that can be used to raise prices.”
Interfarma, the trade group for brand-name drug makers in Brazil, could not be reached for comment.
The issue arises amid ongoing scuffling among patient advocacy groups and the pharmaceutical industry over patents and access to medicines in different countries. Drug makers regularly argue that patents preserve the profits needed to invest in innovation, while patient advocates have pushed back that the pharmaceutical industry too often attempts to exploit patents at the expense of affordable health care.
The battle is playing out across the globe as the cost of medicines has prompted a growing number of people to skip or forgo treatment, or face financial strain. The proposal from the Brazilian ministry is just the latest example in which the problem has factored into a larger government debate over budgets and resources.
As a practical matter, the proposal by the Brazilian ministry could benefit industry — but not just the pharmaceutical industry — because the number of patent examiners may be reduced, given that the Ministry of Economy is looking to find a way to lower costs. This suggests that the workload confronting examiners in the newly formed entity would weaken the review system.
As of July, the Brazilian patent office had 318 reviewers and a backlog of more than 131,000 applications, or about 412 pending applications per examiner, according to Eduardo Mercadante, a PhD student in international development at the London School of Economics, who also works with the Institute of Economics at the Federal University of Rio de Janeiro.
If the move reduces the number of examiners and increases the time needed to examine patents, then more patents would be extended under Brazilian patent law, potentially benefiting drug makers. This also raises concern that lowerquality patents could be granted, according to Villardi.
If the number of examiners is cut but review time is not increased, “that almost certainly would mean the (office) is not examining the patents very carefully, so patents that shouldn’t be granted get granted,” said Ken Shadlen, a politica scientist at the London School of Economics who studies the global pharmaceutical industry and patent issues “If the government is serious about reducing the application backlog, then they need to pour more resources into INPI, not shrink it and examination capacities,” he continued. “This proposal has some of the examiners going to (the Brazilian Agency for Development and Industrial Property), so even if nothing else changed, this is, at best, a reduction in human resources allocated to examining patent applications.
“…There is also the point about ‘privatization,’ which isn’t just a legal thing, but about how pro-grant biases get built into the process of patent examination.”
Published by STAT