When Mexico's Seventh Auxiliary Circuit Court issued a final decision in June upholding a ruling by the Federal Court of Tax and Administrative Affairs (the country's specialised IP court) in favour of data package exclusivity (DPE) protection, it marked a turning point for pharma inventions in Mexico. The appeals court agreed that Novartis has a right to block reliance by third parties on its clinical information, subject to the determination that the efforts incurred were considerable from a monetary investment and time perspective. It further ruled that the FCTAA must determine that Novartis's efforts were considerable, based on the number of patients and countries where clinical trials took place. In response to the ruling and lobbying efforts by R&D companies, Mexico's health authority COFEPRIS published guidelines in June recommending protection for DPE rights.
Alejandro Luna of Olivares & Cia, which represented Novartis, said he is concerned that the proposal offers no explicit protection for biologics and limits the protection of DPE rights to a maximum of five years. Additionally, it is unclear whether such internal guidance will stand up considering the lack of domestic statutory law recognising DPE.
This case was selected as one of Managing IP’s Cases of the Year for 2012.
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