Swiss pharmaceutical major Novartis AG on Monday virtually lost its long legal battle to get its anti-cancer drug Gleevec patented in India.
The Madras High Court in the southern Indian State of Tamil Nadu rejected a petition filed by Novartis challenging the Constitutional validity of Section 3 (D) of the Indian Patents (Amendment) Act 2005, a law on the basis of which the Indian Patent Office had earlier declined to entertain the pharmaceutical company's plea for patenting the beta crystalline form of Imatinib Mesylate (popularly Gleevec).
The impugned section prohibits patents for a new form of a known substance unless that new form has considerably better efficacy. Anyone applying for a new patent must prove that the properties of a derivative were significantly different from the original substance with regard to efficacy.
The company had argued that this Section was violative of the Constitution as it was vague and gave arbitrary powers to the patent authority.
Dismissing the contention, Justice R Balasubramanian and Justice Prabha Sridevan, who heard the plea, said 'Novartis is not a novice in pharmacological field and it cannot plead that it does not know what is meant by enhancement of known efficacy of a substance or that derivatives differ significantly in properties from the original substance.'
'This court holds that the impugned Section is not vague or ambiguous nor did it give arbitrary powers to a patent authority. The law has in-built materials which should guide the patent authorities in taking a decision on a patent application,' the judges observed.
Holding that the TRIPS agreement provided for a dispute settlement mechanism, the judges said, "this court has no jurisdiction to decide whether the amended section was violative of Section 27 of the TRIPS." There was no inequality under Article 14 of the Constitution of India since the company was not barred from carrying on its trade in the country.
This is the second major setback for the company in recent times in its attempt to patent the controversial Gleevec, which was an improvisation on an earlier molecule patented by it 1995. The Patent Controller of India had in January 2006 held that there was no marked difference in the efficacy of the Gleevec and therefore it need not be patented.
Earlier, on July 21, this year, the Intellectual Property Appellate Board, also in Chennai, the capital of Tamil Nadu, had refused to remove from its panel, a technical expert Chandrasekaran who as Controller General of the Indian Patent Office had rejected the company's original patent application.
The Board is currently hearing an appeal from Novartis challenging the Indian Patent Office decision not to grant patent for Gleevec. The decision of the Madras High Court is bound to bring relief to hundreds of activists who had been campaigning against patenting Gleevec. Several activists including those from the Medicins Sans Frontieres, an organisation based in Netherlands, had earlier appealed to Novartis to withdraw its case in the High Court.
They had argued that patenting the new derivative would make anti-cancer drugs beyond the reach of the ordinary man. 'Granting a patent to Novartis for Gleevec will eliminate generic drugs from the market. While generic drug for cancer costs around Rs 8,000 per month, Gleevec would cost Rs 1.20 lakh a month,' People's Health Movement joint convenor Amit Sengupta had warned a few months ago.
With India being one of the main suppliers of life saving drugs to developing countries, any attempt to patent new derivatives will affect millions.