The Chennai Patent Office has dismissed the pre-grant opposition filed way back in 2006 by two activist groups against Roche's Indian patent application on antiviral drug Valcyte (valganciclovir hydrochloride).
The decision on the pre-grant opposition filed by the Tamil Nadu Networking People with HIV/AIDS and the Indian Network for People living with HIV/AIDS was issued by the patent office in the end of January 2009. The office has declared the arguments of the activist groups, that the company is not eligible for patent protection under section 25(1) (f) and section 25(1) (h) of the Patent Act, void.
With this, the Switzerland-based healthcare major, Roche has passed one of its hurdles to ensure patent protection for its key drug Valcyte in India. However, the company is also facing post grant opposition from generic majors like Cipla, Ranbaxy (now Daiichi Ranbaxy) and Matrix, who have launched their generic valganciclovir products in a cheaper price, before enjoying a long term market exclusivity, according to patent experts.
"The dismissal of pre-grant opposition has made the patent right of Valcyte in the country valid for the time being. However, the post-grant opposition by the generic companies will be considered by the controller on de novo (afresh) basis and the validity of patent will be checked on the grounds of their arguments," said Varun Chhonkar, CEO with the Mumbai-based intellectual property consultancy firm, IP Feathers.
Valcyte, a drug for treatment of cytomegalovirus (CMV) retinitis – an opportunistic infection that affects persons living with HIV – and to prevent CMV infection in patients who have received organ transplants, costs around Rs2.5 lakh and more for a full course of medication, informed sources.
Interestingly, the patent office was hearing the pre-grant opposition after issuing the patent in June 2007 following a directive from the Madras High Court. The High Court, of late, has ordered the patent office to consider and hear the opposition arguments as the activists filed a petition with the court against the patent office for taking without hearing the pre-grant opposition remarks under the Section 25 (1) of the Patents Act prior to issuance of Patent No 207232 for the drug.
The Switzerland-based healthcare giant Roche has challenged the High Court order in the Supreme Court where the judiciary has modified the order stating that the Assistant Controller of Patent & Designs should take the arguments of the opposition filed in the case and need not have to consider any other pre-grant objection.
Though the opposite party, the activist groups, has put forward a rejoinder with additional documents, the patent office refused to consider the fresh documents abiding the order of Supreme Court and references of previous judgments. However, the law does have other legal options left for the activist groups in the case, revealed a source from Lawyers Collective – the non governmental organisation working for legal aids for the public in India – who has appeared for the opposite party in the patent office.