According to the Business Standard and The Hindu, the Brazilian Interdisciplinary AIDS Association (ABIA) group has joined with the Indian non-governmental organisation, Centre for Residential Care & Rehabilitation (SAHARA), to challenge Gilead’s patent for tenofovir in India.
Following I-MAK’s pre-grant opposition against Abbott’s heat stable Kaletra patent application last year, this appears to be the second time an international organisation has filed an opposition in India.
This challenge is separate to the pre-grant oppositions we helped prepare for Indian patient groups in 2006. Notably, in the opposition we prepared, it was argued that under s8 Gilead was required to keep the Indian patent office informed of the status of the corresponding application for tenofovir disoproxil fumarate (TDF) in Brazil.
The strategy being adopted by the groups involved appears to be to exert additional pressure on the Indian patent office to refuse the patent(s) so as to support the Brazilian patent office’s preliminary refusal of the TDF patent there. Also, as mentioned in our pevious post, a number of generic companies are locked into voluntary licenses with Gilead that prevent them supplying API or the end product to Brazil. Ensuring the refusal of Gilead’s patents in India could allow Brazil to procure from indian companies that didn’t enter into a license agreement.
Relevant to the reason for the latest opposition must be the USPTO’s recent decision to uphold the validity of the ester derivative patents on tenofovir in the U.S and a decision on the TDF patent being imminent. There is concern the USPTO decisions will be used to influence the Indian patent office in its examination. This is despite the particular requirements of s3(d) in India and the emerging position in the patent offices that efficacy should equate to therapeutic efficacy.
It is not clear from reports whether the groups have filed oppositions against both of Gilead’s patent applications in India. If the objective is to also clear the path for generic production by Indian companies that did not take voluntary licenses, then both of Gilead’s patents would need to be challenged as done previously.This is because the ester derivative patent is the intermediate compound leading to the final formulated patent, TDF. It also remains unclear whether new evidence has been brought to light in addition to the previous oppositions filed, or whether this is simply a case of giving voice to the concerns of Brazilian patient groups to exert more pressure on the Indian patent office.