Indian Supreme Court rejects Novartis’ Glivec patent application
Novartis says ruling is a ‘setback for patients’
In a landmark case, the Indian Supreme Court has rejected Swiss pharmaceutical manufacturer Novartis’ application to win patent protection for its cancer drug Gilvec (imatinib mesylate).
The international medical humanitarian organisation Medecins Sans Frontieres said the decision was a major victory for patients’ access to affordable medicines in developing countries.
‘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 Dr Unni Karunakara, MSF International President.
‘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.’
Leena Menghaney, India Manager for MSF’s Access Campaign, added: ‘Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected.’
However, Novartis India Vice Chairman and Managing Director Ranjit Shahani described the ruling as a ‘setback for patients that will hinder medical progress for diseases without effective treatment options’.
We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs
‘We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs,’ he said.
Shahani also pointed out that Novartis has never been granted an original patent for Glivec in India, in spite of being granted patents in nearly 40 countries, including China, Russia and Taiwan.
‘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.’
The Supreme Court gave its decision in a detailed 112-page report, in which the judges said the questions were debated ‘intensely and at great length’.
‘The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly at the minimum,’ the judges said.
Counter arguments were made to protect India’s status as the pharmacy of the world
‘Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world”.
‘The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India.’
Novartis said it would continue to provide Glivec free of change to 95% of patients prescribed the drug in India, currently numbering more than 16,000.
‘The remaining 5% of patients are either reimbursed, insured or participate in a very generous co-pay programme,’ Novartis said. ‘Since Novartis began its first donation programme in 2002, the company has provided more than US$1.7bn worth of Glivec to patients in India.’
