IMAK's Tahir Amin has written an incisive piece on the hurdles being faced by Gilead in its quest to patent Tenofovir in Brazil and the possible spin-offs for Indian companies in the process.
However, even if the patent is granted by INPI, according to procedure as we understand it, the final decision for the granting of pharmaceutical patents rests with the regulatory body Agencia Nacional de Vigilancia Sanitaria (ANVISA). The controversial role of ANVISA in deciding on pharmaceutical patents was incoporated into Law No. 9279/96 under Article 229 - C and it is understood that the body has hired thirty or more personnel to specifically analyse patent applications. So even if Gilead succeeds in overcoming INPI's objections, it may face a tougher task overcoming ANVISA, given its role in public health matters and the declaration that TDF be in the public interest.
Readers must obviously be reminded of the Justice Bhat's use of the 'public-interest' factor in the the Roche-Cipla litigation to deny an injunction. 'Public interest' therefore is a pivotal factor in any patent litigation involving life saving pharmaceutical inventions.
Also interesting, is the creeping role of drug regulators, into the patenting system. The day may not be far when even India moves in this direction especially given the fact that Section 3(d) requires that the patentee prove an 'increase in efficacy' and 'efficacy' is clearly more of a drug regulatory subject than a subject of patent law. Hopefully we'll carry a more detailed post on this later (or instead hope that Mr. Tahir Amin does so!)