BRAZIL
ACCORDING TO THE COURT, ANVISA IS NOT ALLOWED TO EXAMINE PATENTABILITY REQUIREMENTS NOR THE SAFETY AND EFFICACY OF THE PRODUCTS COVERED BY THE APPLICATION, BUT ONLY THE IMPACT ON PUBLIC HEALTH.
lack of annuity payments would cause the extinction of the corresponding pipeline patent in Brazil, and (ii) lack of novelty and inventive step in light of two pieces of prior art. Germed also requested a preliminary injunction to stay the eff ects of the patent, which was rejected by the trial court and also by the appellate court (aſt er the fi ling of an interlocutory appeal). Reporting Appellate Judge Mendes stated that any extension to, or reduction of, the term of protection of a foreign patent, if it occurred aſt er the fi lling of the correspondent pipeline patent application in Brazil, does not aff ect the term of protection of such pipeline patent, especially in the present case, since the end of the foreign patent was caused by the non-payment of the maintenance fees. Judge Mendes also affi rmed that pipeline patents are not subject to the novelty and non-obviousness technical requirements.
Aſt er its request for the production of technical evidence was granted, Merck fi led a motion for clarifi cation, in which it aimed at limiting the expert evidence’s scope. T is is very important in this case since the BPTO agrees with Merck that the pieces of prior art were covered by the grace period and, for this reason, should not be considered as part of the state of the art for the patent. T e motion was rejected and Merck fi led an interlocutory appeal seeking also the extension of the technical evidence to the case. T e Court of Appeals granted only this request.
www.worldipreview.com Merck Frost Canada Ltd v ANVISA
T is case covers ANVISA’s denial of prior approval for Merck’s patent application due to the alleged lack of novelty. In addition to challenging ANVISA’s jurisdiction, Merck stated that the patent application fulfi ls the legal requirements of patentability. T e judge rejected Merck’s preliminary injunction request, followed by an interlocutory appeal against such decision. T e appellate court issued a decision requiring ANVISA to analyse the patent application “according exclusively to its institutional attributions”. Merck presented a motion for clarifi cation to state that ANVISA should examine just the public health impact. T e court granted Merck’s request and ANVISA fi led a motion for clarifi cation, alleging that the relevant article of Brazilian Patent Law has not yet been applied in Brazil and the court should instruct the agency on how to examine the patent application in light of that provision.
ANVISA’s motion for clarifi cation was rejected by the court of appeals by unanimity. ANVISA will now have to reexamine the patent application in a very narrow fashion. According to the court, ANVISA is not allowed to examine patentability requirements nor the safety and effi cacy of the products covered by the application, but only the impact on public health. Although this is not a fi nal decision, it is a positive one. Aſt er ANVISA complies with the decision, the case should be sent to the BPTO for the immediate continuation.
World Intellectual Property Review e-Digest 2012 61
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