JURISDICTION REPORT: BRAZIL
GOVERNMENT CHANGE OF HEART IN DATA PACKAGE PROTECTION IN BRAZIL
Otto Licks and Eduardo Hallak Momsen, Leonardos & Cia
Te Brazilian courts are currently analysing a few lawsuits whereby research- based companies are seeking the enforcement of data package protection for new drugs against the Brazilian food and drug agency (ANVISA) and infringers.
However, ANVISA’s defence in these lawsuits has been that there is no such data package protection to drugs for human use in Brazil.
ANVISA makes this statement despite the fact that Brazil entered the TRIPS agreement on December 30, 1994, aſter the enactment of Decree 1.355/94, incorporating the Final Act of the General Agreement on Tariffs and Trade (GATT’s) Uruguay Round, and that the then newly-created World Trade Organisation (WTO’s) framework ensures a single undertaking approach to the TRIPS agreement, meaning that the membership in the WTO entails accepting all of its results without exception.
Te protection of undisclosed information, submitted before the ANVISA as a condition for obtaining marketing approval for drugs for human use, is set forth in Article 39.3 of the TRIPS agreement and its municipal implementation into the Brazilian legal system. Further, the Industrial Property Law (IPL) enacted on May 14, 1996, provides for the data package protection on Article 195, XIV, even going to the extent of considering its unauthorised use a statutory felony of unfair competition.
It is worth emphasising that, on August 31, 2001, the Brazilian government confirmed before the WTO, on the Review of Legislation IP/C/W/303, that the protection of undisclosed information required for approval of human drugs, especially against the reliance of third parties in such data, was set forth in Article 195, XIV, of the Brazilian Industrial Law, and that there was no defined term for such protection.
Now the same Brazilian government argues that the legal framework concerning data package changed with the enactment of Law 10.603/02 on December 17, 2002, which established a 10-year limiting term for the protection afforded by Article 195, XIV, for undisclosed information submitted for approval of agrichemicals and veterinary drugs. Te same Law 10.602/02 provided for a compulsory licence system for data packages, previously unforeseen in Brazilian legislation.
Te government’s argument is based on the fact that Law 10.603/02 did not establish a 10-year term for drugs for human use as well, meaning any existing protection for such drugs was extinguished on the day the referred law was enacted, because Law 10.603/02 was approved without any reference to drugs for human use.
However, Law 10.603/02 did not create the data package protection in Brazil. 68
“IT IS CLEAR THAT THE DATA PACKAGE PROTECTION IS FORESEEN IN THE BRAZILIAN LEGAL FRAMEWORK SINCE THE TRIPS AGREEMENT WAS INCORPORATED.”
It was enacted to limit the data package protection already foreseen for agrichemicals and veterinary drugs on the TRIPS agreement and the IPL.
In fact, Law 10.603/02 is the result of the Arbitral Decision VII rendered by the ad hoc arbitral court of the Mercosur, in a case brought by Argentina against Brazil. Argentina complained that Brazil forbade the reliance on the data package of approved agrichemicals in order to grant marketing approval to generic agrichemicals purchased from China and India and, therefore, Brazil was in breach of Mercosur’s resolutions nos. GMC48/96, 87/96, 149/96, 156/96 and 71/98.
Brazil lost before the Mercosur’s arbitral court (in fact, until now, Brazil was defeated in every single arbitral proceeding before the Mercosur) and then the executive and the legislative initiated the discussion of then-enacted Law 10.603/02. During the discussion in congress, the application of the same 10-year limitation for the undisclosed information regarding drugs for human use was also considered, but, in the end, it was excluded from the final draſt.
Of course, setting a 10-year term for the data package protection for drugs for human use would allow for the marketing approval of generic drugs without submitting them to its own safety and efficacy tests, solely relying on the information provided by the drugs already approved by the government.
But, at that time, the conclusions of the 2000 congressional investigation on substandard and counterfeit drugs were very vivid, as well as the health scandals with similar drugs such as Celobar, which should have led the congress not to limit data package protection for drugs for human use at that time, thus directing Law 10.603/02 solely to agrichemicals and veterinary drugs.
It is clear that the data package protection is foreseen in the Brazilian legal framework since the TRIPS agreement was incorporated and that such protection was then reinforced when the IPL was enacted. It is yet to be seen how courts will ultimately decide this matter.
Otto Licks is a partner at Momsen, Leonardos & Cia. He can be contacted at:
oblicks@leonardos.com.br
Eduardo Hallak is an associate at Momsen, Leonardos & Cia. He can be contacted at:
etphallak@leonardos.com.br
World Intellectual Property Review November/December 2011
www.worldipreview.com
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