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BRAZIL


CHALLENGES IN BRAZIL Otto Licks Leonardos & Licks Advogados


Twenty eleven was a challenging year in Brazil for intellectual property (IP), with entrenched anti-IP local interests pitted against the establishment of a contemporary IP-based innovation society. Important decisions were rendered by national courts on various subjects. In 2011 the fi rst landmark decision recognising and enforcing data-package exclusivity protection for the pharmaceutical industry, limited to a 10-year term for new chemical entities, was made. Additionally, the discussion about ANVISA’s (the Brazilian Food and Drug Administration) statutory authority to review patentability requirements reached a new, pro-inventor position.


Patents Schering Corporation v Brazilian Patent and Trademark Offi ce


Schering Corporation fi led a lawsuit seeking to nullify the Brazilian Patent and Trademark Offi ce’s (BPTO’s) rejection of Schering’s pipeline patent application. T e BPTO affi rmed that a pipeline patent could not be granted when the invention had been previously claimed in a Patent Cooperation Treaty (PCT) application that nominated Brazil as one of the countries, but was not fi led in Brazil. Aſt er an unfavourable fi nal decision from the trial court, Schering fi led an appeal to the Court of Appeals for the Second Circuit.


T e court granted Schering’s appeal on the grounds that since the PCT application was not fi led in Brazil, there was no administrative procedure relevant to this case and, therefore, article 18 of the BPTO Normative Act is not applicable to Schering’s pipeline patent application.


Komlog v BPTO


Komlog, a Brazilian company, was under a threat of being sued by one of its competitors for patent infringement. T e patent in question had been subject to an administrative post-grant opposition before the BPTO, which had excluded several claims from the original patent granted, entirely re-writing the claim chart and narrowing its scope. However, the BPTO did not issue a new claim chart, even aſt er Komlog fi led an administrative request. Komlog


60 World Intellectual Property Review e-Digest 2012


fi led a writ of mandamus seeking an order to force the BPTO to publish the new claim chart, stating it was impossible to defend the patent without it.


In the fi nal decision rendered by the 31st Federal Court of Rio de Janeiro, His Honour Judge Marcio Solter construed that the BPTO violated both federal and constitutional provisions by not giving the due publicity to its acts. He also stated that Komlog could know if it was infringing its competitor’s patent only if the BPTO issued the claim chart as amended aſt er the post-grant opposition. Twenty days later, the BPTO presented the document in court.


Takeda Pharmaceutical Company Ltd v ANVISA


Takeda fi led a writ of mandamus against ANVISA’s decision not to grant prior approval to its patent application. On August 26, 2010, the trial court judge rendered a favourable fi nal decision for Takeda, ruling that ANVISA does not have statutory authority to analyse patentability requirements, and that the agency’s analysis should be restricted to public health and sanitary control aspects. ANVISA appealed.


Aſt er three months of not complying with the preliminary injunction, the agency issued a new technical opinion, claiming that every medicine could represent an intrinsic danger to public health, so the prior approval request should be denied. On January 2011, Takeda reiterated its request for ANVISA to comply with the court’s ruling, arguing that ANVISA’s new technical opinion was illegal, since the same active ingredient as the one used by Takeda’s medicine had previously received the agency’s marketing approval. On that basis, there were no grounds to maintain that it put public health at risk. Judge Da Silveira agreed with the arguments and called on ANVISA to grant prior approval within 72 hours, establishing a $100,000 fi ne for contempt and a daily fi ne for non-compliance. At last, ANVISA granted Takeda’s request for prior approval.


Germed v Merck and BPTO


Germed fi led a patent invalidity lawsuit against Merck and the BPTO in April 2010, based on the following arguments: (i) the expiration of a US patent for


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