JURISDICTION REPORT: BRAZIL
WHO APPROVES BRAZILIAN PHARMA PATENTS?
Otto Licks and Anderson Nascimento Momsen, Leonardos & Cia
Te 1996 Brazilian Patent Statute was amended in 1999 to include Article 229-C, which established that pharmaceutical patent applications could only be granted by the Brazilian Patent and Trademark Office (INPI) aſter receiving approval from the Brazilian Food and Drugs Administration (ANVISA). Tis provision violates the TRIPS Agreement since it creates a fourth patentability requirement, to be decided by ANVISA, without a statutory basis.
ANVISA’s administrative decisions on patent applications claiming pharmaceutical inventions have always been political and discretionary, causing controversy since the beginning. ANVISA maintains that it should provide checks to the Brazilian patent system to protect the Brazilian people and the local interests of public and private pharmaceutical industries, collectively known as “public interest” in the agency’s statements.
During the last decade, INPI and ANVISA have been fighting over Article 229-C and the definition of ANVISA’s statutory powers. Finally, 11 years aſter the article came into being, ANVISA’s intervention in the Brazilian patent system has been analysed by the country’s judiciary.
Te Federal Appellate First Circuit Court decided a case in June 2010, in which it established that ANVISA should limit its “prior approval” to assessing possible risks to public health. Te unanimous decision of the panel became even more significant aſter the reporting judge, Honourable Maria Isabel Gallotti, was appointed to the Brazilian Superior Court of Justice one month aſter the decision. Judge Gallotti takes her views to a court with national jurisdiction and much-needed expertise in patent law.
According to Judge Gallotti, INPI’s statutory authority is to implement the rules regulating industrial property, while ANVISA’s is to foster the protection of the health of the population through imposing sanitary controls on the production and sale of products and services. Judge Gallotti also stated in the panel decision that the scope of ANVISA’s prior approval for the grant of pharmaceutical patents for products and processes is confined to the legal ban on patenting inventions harmful to public health, as provided by Brazilian patent law. Te opinion rules that ANVISA does not have jurisdiction to deny its approval by finding a lack of patentability requirements, when INPI has already declared the product patentable.
Judge Gallotti also warned of the dangers of an incorrect interpretation of Article 229-C: “…over the short term, it might seem that the absence of patent protection would favor consumers, insofar as this eliminates the remuneration paid to the inventor and steps up competition, but over the medium and long term, it hampers the entry onto the Brazilian market of discoveries that are crucial for progress and upgrading the living conditions of the population, especially in today’s globalized world”.
“ ACCORDING TO JUDGE GALLOTTI, INPI’S STATUTORY AUTHORITY IS TO IMPLEMENT THE RULES REGULATING INDUSTRIAL PROPERTY, WHILE ANVISA’S IS TO FOSTER THE PROTECTION OF THE HEALTH OF THE POPULATION THROUGH IMPOSING SANITARY CONTROLS ON THE PRODUCTION AND SALE OF PRODUCTS AND SERVICES.”
Te decision is a necessary limitation to the political and discretionary use of ANVISA’s statutory authority. ANVISA has frequently exceeded its statutory powers to re-examine pharmaceutical applications in light of the agency’s own patentability standards, which include bans on second use, among many others.
While some divergence remains, many cases in which INPI decides to grant pharmaceutical patents are hindered by ANVISA’s unfavourable opinions. Te opinions frequently exceed the agency’s responsibility.
Te situation is even more absurd in those cases where ANVISA has unduly analysed the patentability requirements of pipeline applications. Pipeline applications were conceived in Brazil as a transitory mechanism to grant patent protection for pharmaceutical drugs or processes that had already been granted in foreign countries. Tey were not meant to be subject to examination of patentability requirements, and could only be granted if the products had not been placed in any market and if no serious efforts had been carried out by third parties to exploit them in Brazil.
In light of these cases, companies can expect solid jurisprudence to emerge, which will rein in ANVISA and prevent breaches of constitutional and administrative provisions related to the granting of pharmaceutical patents.
Otto Licks is a partner at Momsen, Leonardos & Cia. He can be contacted at:
oblicks@leonardos.com.br
Anderson Nascimento is an associate at Momsen, Leonardos & Cia. He can be contacted at:
arnascimento@leonardos.com.br
76 World Intellectual Property Review September/October 2010
www.worldipreview.com
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