The Government of Brazil approaches the patent policy crossroads with two ministries wanting to move in opposite directions. In the last few months, both the Brazilian Patent Office (INPI) and the Brazilian Regulatory Authority (ANVISA) issued proposed rules concerning patents and are sifting through public comments to determine how they will deal with biotech patents.
A quirk in Brazilian law requires that the health regulatory authority (ANVISA) must provide “prior consent” on the grant of a pharmaceutical patent. Traditionally, ANVISA has interpreted this requirement as an obligation to review patentability criteria. However, the Brazilian Attorney General of the Union (AGU) determined that ANVISA’s review was contrary to Brazilian law and should be restricted to an analysis of the sanitary risks of the patented drug to health.
On October 16, 2012, ANVISA issued a proposed rule detailing their new approach, which may not be much different than its old approach. ANVISA determined that it would review pharmaceutical patent applications that “present a health risk” or do not meet patentability requirements of the Brazilian IP law. How does a patent “present a health risk”? Risks and benefits of a biopharmaceutical only become clear after years of clinical and toxicological testing of actual products, not patents. Is ANVISA referring solely to those products whose only application would be dangerous to the public health? Which patents are “of interest to the policies regulating the universal access to medicine and pharmaceutical assistance as provided for under SUS”? As the SUS (Universal Public Health System) reimburses approved drugs, does this only refer to patents on approved medicines on the SUS reimbursement list? Finally, the rules seem to re-implement previous ANVISA practice of reviewing patent applications for patentability requirements, a matter clearly outside its competence and directly contrary to the Attorney General’s opinion. BIO’s full comments address each of these points in more detail.
Meanwhile, INPI issued proposed rules to implement new Biotechnology Patent Examination Guidelines. Comments from the public were recently submitted, but the Guidelines seem to be a vast improvement over previous practice and signal a recognition of the value of IP. While still constrained by Brazilian legal restrictions on certain patentable subject matter and patent disclosure requirements, INPI’s new rules seem to move in a positive direction. BIO’s full comments provide further detail about potential pitfalls that remain in the Guidelines.
Brazil needs to boost innovation to tackle its competitiveness challenges, and transparency and predictability surrounding patents are essential to this task. Time, and the final rules of ANVISA and INPI, will tell if Brazil can proceed quickly down its next phase of development.