Good news as Brazil changes direction
The Brazilian administration signalled a change in policy on the enforcement of Article 39.3 of the World Trade Organization’s Trade-Related Aspects of IP Rights (WTO TRIPS) Agreement regarding data package exclusivity in the same month the Brazilian patent office (INPI) issued a draft new manual of patent examination procedures.
The Brazilian administration has always failed to comply with the country’s obligations under Article 39.3 of TRIPS, even after implementing ‘TRIPS-plus’ legislation making infringement of IP rights over data packages a criminal felony. However, on May 14, 2012, ANVISA’s (the Brazilian food and drugs administration) solicitor’s office disclosed a significant change in its policy on data package exclusivity for the pharmaceutical industry for human products.
The change was first noted in a brief submitted by ANVISA on litigation before Brazilian federal courts reviewing the issuance of marketing approvals for generics and branded non-interchangeable copies of drugs granted in violation of regulatory requirements.
In a document that will please all pharmaceutical companies investing in the development of efficacy and safety information for approval of new drugs, ANVISA stated that infringement of data package exclusivity rights places the economics of the system in jeopardy. ANVISA’s document goes further, disclosing that the agency sees the data produced by copies as also subject to data package exclusivity.
The statements created an immediate effect before the judge, who rendered a decision fully applying Article 39.3 of TRIPS, as implemented by the Decree 1.355/94, as well as Article 195, XIV, of the Brazilian Intellectual Property Law, in order to establish unfair competition protection for pharmaceutical data.
The decision is a major blow to the policy of the Brazilian administration, which has in recent years denied the implementation of the TRIPS Agreement as a defence to allegations of infringement of WTO TRIPS obligations above and beyond data package exclusivity.
"ANVISA declared that the IP of work done on pharmaceutical test data must be protected in order to ensure the economic development of the country."
The office of the Brazilian Attorney General (AGU) issued a press release on July 4, stating that AGU/ANVISA has a legal duty to protect undisclosed information received for marketing approvals, as set forth in Section 39.3 of the TRIPS Agreement and in Article 195, XIV of Law 9,279 of 1996. The press release reiterates that ANVISA declared that the IP of work done on pharmaceutical test data must be protected in order to ensure the economic development of the country.
Neither ANVISA nor the AGU commented on the term of protection, a much-debated issue in Brazil regarding data package exclusivity. Nothing has been said about any changes in the procedure for registration of generic and branded copies. Another salient point was access to data on freedom of information requests and citizen’s petitions.
ANVISA and the AGU’s statements, alongside the decision rendered by the federal court, might signify the start of a new era for the pharmaceutical industry seeking to enforce IP rights before ANVISA, which has always denied any possibility of a linkage system or compliance with the country’s IP laws, despite participating in the examination of patent applications under Article 229-C.
The patent system might show improvements too. In July INPI started a public consultation in order to change the guidelines for examination of patent applications. The guidelines are taken as a priority for the INPI in an action plan up to 2015. The changes might contribute to a substantial decrease in the patent backlog in Brazil—the delay to grant a patent by INPI is currently almost 80 months.
The new guidelines will implement important changes on the analysis of claims submitted by an applicant. INPI will also give priority to the examination of patent applications related to pharmaceutical products.
Nevertheless, the patentability of software is still a problem in Brazil. Despite its strong position in favour of granting software patents, INPI has been under pressure from other areas of the Brazilian government that have historically exercised severe control over the software industry. As expected, the new guidelines did not mention any possibility of obtaining a software patent.
