Luiz Otávio Pimentel is president of the National Institute of Industrial Property (INPI) of Brazil. In Geneva this week for the annual World Intellectual Property Organization General Assemblies he took time to sit down with Intellectual Property Watch’s William New. INPI is part of the Ministry of Industry, Foreign Trade and Services.

On a breaking issue, Pimentel, speaking through a translator, talked about the case in Brazil involving sofosbuvir, marketed as Sovaldi, Gilead’s effective medicine against hepatitis C that has been known for its exorbitant prices.

Sofosbuvir Hepatitis C Drug Case

Calling it “the most important case in recent years,” he stressed that the decision to grant a patent for the drug in Brazil over the outcries of health advocates was “a technical decision without interference.”

IP office was accused of letting it happen, said Pimentel. But that does not take into account that the patent decision was technically oriented, he said. The issue is one that has come up in Brazil’s presidential campaign which is two weeks away, and is well-discussed in the Brazilian press.

The patentability requirement is present, so it does not matter what the decision is, he said. “Regardless of the technology, if the technical requirements are met, we’re supposed to grant it,” said Pimentel.

On the sofosbuvir patent, the INPI received 13 letters of opposition, which required an assessment. Through the process, what was a “huge” application narrowed the scope of the patent to only one molecule, he said.

Initially, it was found that the application was missing inventive step, and the Brazilian Health Regulatory Agency (Anvisa) had used the Article 229C of the Brazilian Industrial Property Law to block it. The judge then decided that Anvisa should limit itself to health aspects of the patent, and that the patent should be granted.

The first administrative opinion that suggested the application did not fulfil the inventive step was contested, and Gilead narrowed and was granted the patent.

Under Brazilian law, the intention to grant is notified, so the patent is not yet issued, as there is a 90-day period.

And now this week a Brazilian federal court suspended the patent. The lawsuit was brought on behalf of the people of Brazil based on the Brazilian constitution, which includes a right to health for all citizens, he said. The judge granted an injunction.

INPI will respond to the judge, Pimentel explained, adding that his office is bound by the law to respect the decisions of the judicial branch.

The industrial property law does provide that if there is a market problem with price, the government can issue a compulsory licence, he said. This allows cheaper generic versions to be sold.

Health Advocates Weigh In

Médecins Sans Frontières (MSF, Doctors Without Borders), which is involved in the Brazilian case, issued a statement on the court’s decision this week.

“Given the impact this granted patent would have on public health and on the government’s budget, the court has suspended the patent and ordered the patent office to review its ruling, opening up the possibility for companies in Brazil to produce affordable generic versions of sofosbuvir,” MSF said. “Key patents on sofosbuvir have already been rejected in China, Egypt and Ukraine, and decisions are pending or being appealed in several other countries including Argentina, India, Thailand and Russia.”

MSF acknowledged that the latest Gilead product represents an improvement on earlier versions. “Sofosbuvir is an oral, direct-acting antiviral drug that is safer, more tolerable and more effective than older hepatitis C treatments,” it said.

But pricing of the patented version makes it inaccessible to many patients, making lower priced generic versions vital, it said. “Sofosbuvir forms the backbone of most hepatitis C treatment combinations, but sofosbuvir and its key companion drugs are priced out of reach for people who need them in many countries, including Brazil. About 700,000 Brazilians have the disease but no access to treatment due to its high price.”

Ana de Lemos, executive director, MSF-Brazil, in the statement called the court’s decision “extremely encouraging, because it shows that intellectual property issues cannot be disconnected from their impact on public health and people’s lives. The 700,000 people in Brazil who still don´t have access to the hepatitis C cure they need should not be let down.”

Brazil’s Rapid Reduction of Trademark and Patent Backlogs

Separately, Intellectual Property Watch asked the INPI president about Brazil’s recent notable reduction in the pendency for patents and trademarks.

Pimentel said the reduction was accomplished by restructuring of the management systems and the IT systems, as there were issues of financing and human resources. One main emphasis was on productivity, he said, addressing issues of the work environment. A big contributor was a telework program, allowing trademark and patent examiners to work from home. They also had a restructuring of the organizational chart.

The office reduced administration and increased examiners, for instance there was a team with expertise in raising awareness about intellectual property with the skills to examine who were moved over.

There was also a reduction in costs, for instance, the office previously was located in two nearby buildings and now is all in one, and as well it had 11 regional offices that now through agreements with regional governments are sharing public offices.

Asked why these improvements were happening now, Pimentel said that in the past there were “moments” where there was attention paid to improvements from the national level. Recently, there has been a change that gave a new focus to IP, making it a priority, as part of the focus on development to attract investment. “Now it is a priority,” he said.

The improvements in timing have not had a negative impact on patent quality, Pimentel insisted, because it largely came from modernization and automatization. For instance, now the patent application of a filer who has not paid the fee is automatically withdrawn. The improvement also is due to an increase in examiners so there is no impact on quality, he said.

It is still too early to see the impact on the economy of the changes, but there is increased legal certainty, he said, and the feedback they have is that as administrative problems decline, users are more positive about IP rights and “that improves the business environment,” he said.

One effort of note in Brazil is to accede to the Madrid Protocol on the international registration of marks. Pimentel said it has been recommended three times by the Ministry of Foreign Affair and the ministry his office is in, and this time it was recommended to Congress. It is in the House and then would go to the Senate, and if passed, will be an authorization to accede to Madrid – and would be presented to WIPO.

In parallel, he said, an issue of the time limit of applications has been adjusted to fit Madrid as well. Brazil’s pendency far exceeded the time limit for refusals.

For trademark applications it was taking some 64 months for an application, or 28 months without opposition, as of January 2017.

This year, they increased examiners by 50 percent, and as of August, pendency was 17 months, already under the 18-month time limit of Madrid. The end-of-year target is 14 months, and by the end of 2019 they hope to be down to 4 months, or 8 months with opposition.

They also have made changes to the IP system to allow for implementation of a multi-class system, where right now there is one class. The change would allow joint ownership, he said.

Some 200,000 trademark applications are expected in 2018, an increase of 11 percent, he added.

Image Credits: William New