SC verdict discourages innovation: Novartis3 min read . Updated: 01 Apr 2013, 08:46 PM IST
The ruling is a setback for patients that will hinder medical progress, says Novartis India vice-chairman
Mumbai: The Supreme Court’s rejection of Novartis AG’s case challenging Indian patent law will discourage innovative drug discovery essential to advancing medical science for patients, Novartis India vice-chairman Ranjit Shahani said on Monday.
Novartis, following the Indian patent office’s decision to reject its patent application for a beta crystalline form of blood cancer drug imatinib mesylate in 2006, had filed a special leave petition at the apex court. It sought clarification of mainly two sections—Section 3(d) and Section 3(b) that define the kind of products that won’t get patent protection.
These sections, introduced at the time of the law’s amendment in 2004, mainly refer to modified forms such as salts, derivatives or polymorphs of known discovery products. They cannot be considered for grant of patent unless such modifications significantly enhance the efficacy of the product, in the case of a drug or a therapeutic system or device.
Novartis’ patent application for the crystalized form of imatinib mesylate was rejected in 2006 by the patent office in Chennai. Novartis had launched the modified form of the drug in India in 2003 under the brand name Glivec, priced at about ₹ 1.2 lakh for a month’s treatment.
The company’s appeals were defeated based on the terms of the existing legislation. The Chennai court, while dismissing Novartis’ appeal in 2007, also said the drug was too costly and that Indian patients wouldn’t be able to afford the drug if it was the only brand available.
“We brought this case because we strongly believe patents safeguard innovation and encourage medical progress," Shahani said on Monday at a press briefing in Mumbai. “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."
India’s generic drug industry, which opposed the Novartis patent application for Glivec at the patent office and in court, said the judgement would be good for cancer patients.
“We are pleased with the judgement which prevents the use of frivolous patents to deny access to medicines for patients," said Y.K. Hamied, chairman, Cipla Ltd, one of the key opponents to the Novartis claim in the case.
“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 judgement will not only benefit patients in India, but patients around the world," Hamied said in a statement.
The top local generic drug makers’ body, the Indian Pharmaceutical Alliance (IPA), welcomed the Supreme Court verdict.
“This is a landmark judgement that will serve to set at rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions," IPA secretary general Dilip G. Shah said in a release.
Imatinib is on the national list of essential medicines and is used in the treatment of certain blood and stomach cancers. The decision of the Supreme Court will mean several Indian companies, including Cipla, Ranbaxy and Natco, can continue selling imatinib at a fraction of the cost of the Novartis product, said Shah of IPA, which was an intervenor in the litigation before the Supreme Court.
“The Supreme Court decision in the Novartis case on Monday is a major victory for patients’ access to affordable medicines in developing countries," said the international medical humanitarian organization Médecins Sans Frontières (MSF) in a statement.
“This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF," said Unni Karunakara, international president, MSF.
“The Supreme Court’s decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law," he added
The court order had an impact on stocks. Novartis India Ltd lost 1.81% to close at ₹ 587.95 per share on BSE Ltd. Local drug makers such as Cipla Ltd, Natco Pharma Ltd, Ranbaxy Laboratories Ltd gained. Natco rose 5.44% to ₹ 452.40, Cipla Ltd gained 1.2% to ₹ 384.30 and Ranbaxy Laboratories Ltd gained 2.65% to ₹ 451.55. The benchmark Sensex gained 0.15% to close at 18,864.75 points.
“The (Novartis case) judgement is indeed a landmark one simply because it empowers the common man and serves what we consider a social and national priority," said Ramesh Swaminathan, chief financial officer of the country’s third largest generic drug maker Lupin Ltd.
“On India healthcare, the most important priority at the end of the day is that the man on the street to be able to have access to affordable life-saving medicines," he said in a statement.