In response to the
Supreme Court dismissing Novartis AG's plea for a patent on its blood cancer drug, Glivec, the pharmaceutical major on Monday said the ruling could hamper innovation in India.
India has refused protection for Glivec on the grounds that it is not a new medicine but only an amended version of a known compound. A special clause in the Indian Patent law, Section 3 (d), is
the bone of contention in this case. The clause aims to ensure that pharma companies do not seek patents for amended versions of a known compound or for newer forms of an existing or known molecule.
In response, Novartis said: "Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India."
It further stated that the court's decision discourages innovative drug discovery essential to advancing medical science.
"Novartis has never been granted an original patent for Glivec in India. We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs," said Ranjit Shahani, Vice Chairman and Managing Director,
Novartis India Limited, in the press release.
"We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."
VIDEO: What the SC ruling means for the pharma sectorFurther, the statement says: "The Court denied an appeal challenging the rejection of a patent for Glivec, a life-saving medicine for certain forms of cancer, patented in nearly 40 countries including China, Russia, and Taiwan. Novartis filed a Special Leave Petition with the Indian Supreme Court in 2009 challenging the denial of the Glivec beta crystal form patent on two grounds, based on Sections 3(d) and 3(b) of the Indian patent law. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects of the patent law."
It, however, tried to dispel
any fear among patients by stating: "Novartis remains committed to patients and access to medicine. Through its full donation programs, Novartis provides Glivec free of charge to 95 per cent of patients prescribed the drug in India, currently more than 16,000 patients. The remaining 5 per cent of patients are either reimbursed, insured, or participate in a very generous co-pay program. Since Novartis began its first donation program in 2002, the company has provided more than 1.7 billion dollars' worth of Glivec to patients in India."
While Novartis maintains that it is helping a significant number of patients through its patient assistance programmes, not many Indian generic companies agree that all patients benefit.
ANALYSIS: Pharma's fuzzy future"If Novartis was providing the drug free or covering them under patient assistance then how is it that there is a Rs 60 crore market in India for the generic version of this drug in India," asks one pharma company head, who did not wish to be identified.
On the point that the ruling could impact future innovation and discourage new drug development in India, his argument is that the Supreme Court ruling clearly shows that there can be no room for "repetitive innovation."
The generic version of this drug has been available for a long time in India. For instance,
Natco Pharma, which is based out of Hyderabad, has for instance, had the generic version in the market since January 2003.
Reacting to the Supreme Court ruling, Rajeev Nannapaneni, Natco's Vice Chairman and CEO said: "It was along expected lines and it vindicates our stand that this was not a new innovation."
FROM THE MAGAZINE: India's confused search for cheap drugs "The judgment in the Novartis case is a victory for patients both in India and around the world. We are pleased with the judgment, which prevents the use of frivolous patents to deny patients access to medicines," said
Cipla's chairman Y.K. Hamied.
"India, being the pharmacy capital of the world can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgment will not only benefit patients in India, but patients around the world," he says.
Novartis India shares, which opened at Rs 599, were trading at around Rs 574, down 4.1 per cent, at around 2.50 pm on the Bombay Stock Exchange.
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