BOGOTA, Colombia - Gilead Sciences Inc. is facing a somewhat complicated judicial challenge in Brazil to its patent for hepatitis C drug Sovaldi (sofosbuvir).

The case, which may have been politically motivated, is complicated by legal technicalities that have raised eyebrows within the country's legal communities, including the exclusion of the company from the legal challenge despite its ownership of the patent.

The challenge in Brazil was launched by former presidential candidate Marina Silva, in the midst of the first round of presidential elections during which she was disqualified.

On Sept. 23, a federal judge in capital city Brasilia found sufficient evidence to issue an injunction suspending Sovaldi's patent in the country.

"In this case, we are talking about a decision that actually anticipated the result of the merits of the case, but it is a provisional decision and it can be overturned," Breno Akherman, a partner at Daniel Legal & IP Strategy in Rio de Janeiro, told BioWorld.

"It can be preliminarily overturned, meaning that, as it was granted in a preliminary fashion, it could also be revoked in a preliminary fashion and not only when the judge actually decides that case on the merits. It can go both ways," Akherman explained.

The lawsuit proved to be a popular move by the Brazilian politician who was running (unsuccessfully) for president. The suit claims that Sovaldi was protected by a patent in which the National Institute of Industrial Property (INPI, for its acronym in Portuguese) did not take into account the social interest and economic situation of the country.

Gilead, based in Foster City, Calif., did not respond to BioWorld's request for comment but Gilead Sciences Farmacêutica do Brasil, a Gilead affiliate in Sao Paulo, Brazil, issued a press release stating the firm would not comment on the case outside of the courts. The release did point out that patents are conceived to protect innovation and that market realities should be left out of the discussion.

"We would like to emphasize that, for Gilead, the granting of patents is tantamount to recognition of the innovation of its medicines, which has nothing to do with abusive pricing or a market monopoly," the company said. "We strongly believe in the innovative character of our products and we trust that the patent applications meet all the technical and legal requirements necessary to grant it."

For his part, Akherman took issue with the judge's decision.

"The decision addresses that the Brazilian [Patent Office] indeed did not pay attention to social aspects, technological aspects and public interest involved in the granting of such patent, and ordered the invalidation of the patent," he said.

"This was the actual decision, which is very wrong, because the PTO already clarified that the patent wasn't even granted yet. It was allowed for grant by the Brazilian PTO and after a patent is allowed for grant, the patent holder must pay official fees and only then, the patent will be actually granted. Before that, there is no actual patent," he explained.

Akherman said people in the industry are concerned with the judge's decision.

Groups like Interfarma, from Sao Paulo, Brazil, a not-for-profit association of pharma industry research companies, released statements supporting the Brazilian PTO's independency when it comes to analyzing technical aspects of patents.

"So, on one hand, people are concerned about this decision, because it was never issued something like that before, but on the other hand, I think that there is an expectation that it will be overturned and it should not become an actual precedent for the future. That's my feeling," said Akherman.

Although the decision does not prevent Gilead from distributing Sovaldi in Brazil, it opens the door for generics to flood the Brazilian market.

"It is important to mention the partnership that has been built with the government since the launch of Sovaldi in Brazil, since Gilead has been applying progressive discounts (and above 90 percent in relation to the reference price of the drug)," Gilead said in its local press release.

The next step for Gilead is to attempt to become part of the case. The company was excluded from the case by the judge.

"The decision that granted the preliminary injunctive relief awkwardly also excluded Gilead from the lawsuit. According to this judge, although Gilead is the owner of the patent, it shouldn't be a defendant in the court action," Akherman said.

"Their first fight will be to get back on board in the lawsuit and after that they will have to fight to overturn the preliminary injunction that was granted," he added.

Gilead has faced legal issues with Sovaldi's patent in other countries, including Argentina, China, India and several European countries. (See BioWorld Today, June 24, 2015.)