Drug firms challenge Brazilian regulator's right to veto patents
This article was originally published in SRA
Companies are finally set to get legal clarity on one of the biggest causes of contention between the pharma industry and Brazilian authorities. The courts will eventually decide on the legality of the medicine regulator's role in vetoing patent applications after Interfarma, the Brazilian pharmaceutical industry association, filed a suit against regulatory agency ANVISA.
Lawsuits against ANVISA over prior consent are nothing new: it is currently facing around 30 suits, according to Interfarma. However, this case ups the stakes given that it has been filed by a body representing 55 companies responsible for 80% of originators and 33% of generics available on the market.
The prior consent mechanism gives ANVISA a say in rejecting or approving a patent application relating to a medicinal process or product on the grounds of public health. The mechanism was aimed at ensuring that generic medicines did not face any undue delays to entering the market. It dates back to 1999 when the 1996 patent law was amended to give ANVISA final approval of patent applications already okayed by the national patent authority, INPI.
However, prior consent has proved increasingly problematic and confusing for companies as ANVISA has become more involved in the patent approval process. What exactly ANVISA's role should be, and whether it should have a role at all, have been in dispute for some years and in 2013, the Attorney General's Office decided that it should be confined to deciding matters of public health, while INPI should look at patentability. But the problem, according to Interfarma, is that the law does not specify exactly how ANVISA should evaluate the molecule in question. The organization claims that ANVISA uses this "legal loophole" to use the same patentability tests that INPI uses. This can lead to gridlock as INPI does not recognize ANVISA's decisions, and often the courts become involved.
The situation as it stands means uncertainty for firms, which have no exclusivity for their molecules during the process. It can take up to ten years to obtain a patent, and up to 12 years if ANVISA is involved, says Benny Spiewak from the Brazilian law firm Zancaner Costa, Bastos and Spiewak. According to Mr Spiewak, this is one of the big reasons that companies do not come to Brazil to invest in R&D.
The lawsuit means that there will be no compromise between the government and the industry, as many people had expected, says Mr Spiewak. Some sort of new pricing control that would make prices more attractive to government had looked possible, he said. ANVISA will likely present its arguments within the next six months, but it could take up to two years for the court to reach a decision. A final ruling could be up to ten years down the line if either side decides to appeal.
While companies will be hoping for change that will help business, NGOs and civil society groups argue that the prior consent mechanism is necessary to protect the public interest. ABIA, an AIDS-focused non-profit organization, claims that the mechanism is important because it protects against dubious patents and the practice of "evergreening" condemned by the European Commission. It points to the case of AbbVie, which ABIA claims has tried unfairly to extend the monopoly of its HIV/AIDS drug Kaletra by filing 11 patent applications. After ANVISA rejected one such application, AbbVie took the regulator to court. ABIA says that the government could save some $26m a year by buying the cheapest Kaletra generic available on the international market. AbbVie declined to comment.
Médecins Sans Frontières also defends the mechanism, claiming it makes the process more rigorous. According to MSF, of 988 applications that won a green light from ANVISA, some 40% required work to reduce the scope of the claims or to enhance disclosure of the invention. It adds that ANVISA analyzed 1,346 applications between 2001 and 2009 and rejected 209 of them.
MSF believes that prior consent is perfectly legal under Brazilian law and allowed for under the TRIPS agreement (the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights) flexibilities for developing countries. The organization also points to a 2006 WHO report that advocates the involvement of public health authorities in pharmaceutical patent analyses to prevent frivolous patents. The organization is urging the Brazilian government to protect the flexibilities it has introduced, and to share its experiences with other developing countries seeking to provide affordable access to medicines.
Other countries may be paying attention to what happens in Brazil and to how well it can defend the mechanism. Colombia has already considered and rejected the introduction of a similar tool.