New Delhi : In a judgement with global healthcare ramifications, the Madras High Court Monday dismissed a controversial claim by Swiss pharmaceutical giant Novartis that it should be given the right to patent life-saving drugs and prevent their generic production in India.
The ruling was immediately hailed by civil society around the world as a victory for the rights of patients in poor countries to access affordable Indian-made medicines.
“This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India,” said Tido von Schoen-Angerer, director of the Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines.
Novartis had moved the court when the Assistant Controller of Patents, Chennai, rejected its application for a patent for the beta-crystalline version of its drug, imatinib mesylate, which is sold under the brand name Glivec and is used in the treatment of blood cancer.
Nationally, the judgement is a major victory for campaigners who say multi-national companies try to patent life-saving drugs by merely producing new forms of existing compounds, or by twisting the intellectual property law by a process dubbed “ever-greening” – indefinitely perpetuating patent protection by passing off variants and derivates as fresh inventions.
Globally, hundreds of millions of patients, particularly in the poorest regions of the world will breath a sigh of relief – for many of them Indian generic drugs often mean the difference between life and death.
“The Court’s decision now makes Indian patents on the medicines that we desperately need less likely. We call upon multinational drug companies and wealthy countries to leave the Indian Patents Act alone and stop pushing forever stricter patent regimes in developing countries,” von Schoen-Angerer said from Geneva in a statement.
Médecins Sans Frontières said that Indian ruling protects India’s status as the ‘Pharmacy of the Developing World’.
In their judgement, Justices R. Balasubramanian and Prabha Sridevan summarily rejected Novartis’ challenge against the constitutional validity of Section 3 (d) of the Indian Patents Act, saying the right of Indian citizens to have easy access to life-saving drugs could not be denied.
The division bench also declined the multinational company’s plea to declare the statute as non-compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPS), the global intellectual property treaty.
The bench noted that TRIPS itself provided for a Dispute Settlement Board to adjudicate all issues relating to the treaty. “As the participating nations themselves had created a dispute settlement mechanism, we see no reason at all why we must disregard it,” the court said.
In January 2006, the assistant controller had invoked Section 3(d) of the Indian Patents Act to deny the company’s claims of discovery of a new form of a known substance because it had not resulted in “enhancement of its known efficacy”.
Novartis challenged the controller’s decision and questioned the validity of the relevant section, which was introduced in the Patents Act, 1970, through an amendment in 2005. Novartis lawyers argued that the section was vague, arbitrary and ambiguous and gave unbridled power to the authority to use or misuse it.
The bench upheld the contention of the central government, the Cancer Patients’ Aid Association of India, Mumbai, and several other rival pharmaceutical companies, who stressed that the section was neither vague nor arbitrary.
Also welcoming the ruling, Y. K. Sapru, founder and Chairman of the Cancer Patients Aid Association (CPAA) said: “”This landmark victory will help avoid many deaths from life-threatening diseases in India and other countries.”
Loon Gangte of Delhi Network of Positive People (DNP+) was jubilant: “This is really exciting news for activists in India and across the world – this decision gives me and many others fresh hope for life.”
Developing countries and international agencies like Unicef and the Clinton Foundation rely heavily on affordable life-saving drugs from India, which they supply to poor patients across with the world.
Over 420,000 people worldwide, including Indian Health Minister A.Ramadoss, Archbishop Desmond Tutu of South Africa, former Swiss President Ruth Dreifuss and former UN special envoy for AIDS in Africa Stephen Lewis, had signed a petition urging Novartis to drop the case.