New Delhi: In a landmark verdict with far reaching consequences, the Supreme Court on Monday rejected a plea by Swiss pharma giant Novartis AG for getting its blood cancer drug Glivec patented in India, thereby paving way for the continued production of the drug’s generic version by Indian companies.
Glivec, used in treating chronic myeloid leukemia and some other cancers, costs a patient about Rs 1.2 lakh/month, much higher than Rs 8,000 which is the price of the generic drug.
Delivering the verdict, the bench of justices Aftab Alam and Ranjana Prakash Desai said that the Novartis’ claim for patent is being rejected as the new drug does not meet any standard for novelty or inventiveness. It was an old molecule; hence the drug can’t get repeated patent protection in India.
The verdict is of immense significance for all big pharma companies and future of pharmaceutical industries worldwide. As per their view, patent protection was important to ensure effective protection for innovation and for protection of investment.
The international drug majors had argued that if the rights of investors are not upheld then it will hit research and development of new drugs. The verdict surely comes as a setback for big pharma companies as they have been pushing for stronger patent protection in India to regulate the country’s USD 26 billion generic drug industry, which they say often flouts intellectual property rights.
However, as people across the world rely on India for supplies of affordable versions of expensive patented medicines, the SC verdict is welcome news for health aid groups that support the production of generic version of lifesaving drugs.
Groups such as Doctors Without Borders say that India is the ‘pharmacy of the world’ as cheaply made Indian generics are a lifesaver for millions of patients in poor countries who cannot afford to pay Western prices to treat diseases such as cancer, malaria and HIV.
The case goes back to 2006 when Novartis’ application for a fresh patent in India for its cancer drug imatinib mesylate was rejected by the Indian patent office.
Novartis approached the apex court challenging the order of Chennai-based Intellectual Property Appellate Board (IPAB), which rejected its appeal against patent department’s decision on Glivec.
The Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law.
Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy while Section 3(b) bars patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products.
Some Indian pharmaceutical companies and social organisations had also approached the apex court against Novartis claiming that the multinational company is making an attempt to “evergreen” its patent right.
Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire.