In a major blow to Swiss pharma giant Novartis, the Supreme Court on Monday rejected its plea for a patent on cancer drug Glivec, a verdict that is expected to pave the way for Indian firms to provide affordable drugs to lakhs of cancer patients in the country.
Ending a seven-year legal battle by Novartis to have exclusive right for manufacturing Glivec and to restrain Indian firms from making generic medicines, the apex court, while dismissing its plea, held that there was no new invention and no new substance used in the drug prescribed for treating blood, skin and other types of cancer.
Indian pharmaceutical companies had opposed the claim of Novartis saying it was not entitled for the patent and alleged that it is indulging in “ever-greening” of patent by simply changing the composition of the ingredients of the drug.
A Bench comprising justices Aftab Alam and Ranjana Prakash Desai dismissed the claim of the Swiss firm seeking exclusive rights for manufacturing the cancer drug.
The Bench held that ‘imatinib mesylate’ used in Glivec is a known substance and Novartis can’t claim patent over the drug for using this chemical.
It is stated that a one-month dose of Glivec costs about `1.2 lakh, while generic drugs, manufactured by Indian companies, cost about `8,000 for the same quantum. Thus, the verdict is seen as a great boon for cancer patients in India.
Justice Aftab Alam, writing the judgment, noted that Novartis had filed an application on July 17, 1998, for grant of a patent for imatinib mesylate in beta crystalline form at the Chennai Patent Office. After the application was made and before it was taken up, several amendments were introduced in the Indian Patents Act, 1970, which brought about fundamental changes in the patent law of the country, the judge noted.
The Assistant Collector of Patents and Designs heard all the parties in December 2005, as provided under Patent Rules 2003, and rejected the application of Novartis for a patent.
After this, Novartis filed two petitions in the Madras HC seeking a declaration that Section 3(d) of the Patent Act is unconstitutional.