On 30 January, the Chennai Patent Office dismissed a pre-grant opposition representation that had been filed by two NGOs opposing the patent for Roche’s drug Valcyte.
Valcyte is the brand name of an antiviral drug that is used to treat cytomegalovirus retinitis infection in HIV/AIDS patients and in patients who contract this infection during organ transplants. It was developed in 1994 by US-based Syntex, now a subsidiary of Roche, and first patented in Switzerland in 1994.
The two opponent NGOs, the Indian Network for People Living with HIV/AIDS and the Tamil Nadu Networking People with HIV/AIDS, had originally filed the pre-grant opposition in 2006. The grounds raised by the opponents were: (i) The subject matter claimed was not patentable under the Patents Act and (ii) There was delay on the part of the applicants for filing information regarding corresponding foreign patent filings to the controller – a violation of section 8 of the Patents Act. However, the Chennai Patent Office dismissed the NGOs’ representation without informing them of its decision. A patent was subsequently granted to Roche and news of the approval was reported in the patent office’s official journal.
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The NGOs asked the patent office for clarification, without result. They subsequently filed a writ petition with Madras High Court under article 226 of the Indian constitution, hoping to obtain a writ of mandamus to quash the patent and direct the patent office to consider Roche’s application only after hearing the NGOs’ objections.
The chief justice of the high court allowed the writ petition, stating that granting the patent without hearing the NGOs’ representation was “in blatant violation of statutory procedure by the statutory authority, which is acting in a quasi-judicial capacity”. The chief justice also stated firmly that such a grant was “not legally sustainable”.
In December 2008, the high court ordered the patent application to be re-examined in light of the pre-grant opposition, giving the NGOs an opportunity to be heard.
The Chennai Patent Office heard the opponents and applicants at a hearing conducted in January 2009. Roche’s patent application ultimately survived the opposition, which was heard and dismissed, allowing Roche’s Valcyte patent to remain valid.
The judgment does not spell the end of litigations for Roche, which reportedly faces five post-grant oppositions as well, some of which have been launched by generic drug-producing companies that have already started marketing versions of Valcyte. In one example, Roche obtained a favourable interim order against Cipla’s generic equivalent, Valcept, in December 2008 for trademark infringement. The patent infringement suit against Valcept is pending before Bombay High Court.
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The legislative and regulatory update is compiled by Nishith Desai Associates, a Mumbai-based law firm. The authors can be contacted at nishith@nishithdesai.com. Readers should not act on the basis of this information without seeking professional legal advice.
