Following our previous post, the Brazilian Patent Office (INPI) has now issued a final refusal of Gilead’s patent application for the fumarate salt of Tenofovir Disoproxil (TDF). A full report by Pharmalot on this story can be found here.
In April, 2008 INPI had issued an initial refusal against Gilead’s application. Gilead then had 90 days to file a response to overcome the initial refusal, which appears to have failed. However, according to a statement by a Gilead spokeswoman in the Pharmalot story above, it is not clear if Gilead may still have the 90 day period to respond plus the additional 60 days within which to file an of appeal as permitted under Art 212 of Brazil’s Law No. 9279/96. According to our sources in Brazil, Gilead now has 60 days in which to file an appeal against the final decision.
As already mentioned in our previous post, the likelihood of Gilead successfully appealing INPI’s decision looks remote. This is particularly so given that Brazil’s Ministry of Health has declared TDF of national interest and more importantly the regulatory agency, ANVISA, has the final word on deciding whether to grant pharmaceutical patents. That said, it could be that the Brazilian Ministry of Health is using this situation as a way to negotiate a better price with Gilead on the drug and the patent may ultimately be granted.
What is particularly noteworthy is that INPI was not influenced by the recent confirmation by the USPTO of the validity of the TDF patent in the U.S (US Pat No. 5935946) following its re-examination. It now remains to be seen whether the Delhi Patent Office, which is due to be hearing the oppositions filed by patient groups and Cipla on the corresponding patent application for TDF in India (896/DEL/2002), will follow Brazil. It should be noted, however, that Gilead has a further patent application for the ester derivative of Tenofovir (Tenofovir Disoproxil) filed in India, which if granted could be enough to block generic production irrespective of whether the patent for TDF is refused.