New Delhi: The Supreme Court on Monday is likely to pronounce its verdict in the much awaited patent case involving Glivec - the anti-cancer drug manufactured by Swiss pharma-giant Novartis - priced at a whopping Rs 1.2 lakhs for a monthly dosage. The case dates back to India's denial of a patent in 2006 on the grounds that it wasn't considered a new molecule, but an altered version of one that had been around for 15 years.
If Novartis doesn't win this case, then the entire branded-drug business faces further erosion of its intellectual property in India. Activists believe that Novartis' appeal rejection might hurt India's reputation but it will be a huge moral victory for those in favour of accessible and affordable life-saving drugs.
A bench of justices Aftab Alam and Ranjana Prakash Desai had reserved the verdict on December 4 after marathon arguments spanning over two and half months. 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.
If Novartis doesn't win this case, then the entire branded-drug business faces further erosion of its intellectual property in India.
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.
A patent on the new form could give Novartis a 20-year monopoly on the drug. During the hearing, the apex court had questioned the pharma company on the high price of the cancer drug. A month's dose is around Rs 1.2 lakh, much higher than Rs 8,000 which is the price of the generic drug.
The firm had tried to dispel the impression that its drug would be beyond the reach of poor cancer patients. "The purpose is not to make money from the poor. This is not the purpose, but am I not entitled for patent for our drug? We are fighting the case on principle," senior advocate Gopal Subramanium, appearing for the company, had said. He had submitted that there should be no cause of concern that the poor would not get treatment and submitted that 85 per cent of the patients are treated free under its scheme.
(With Additional Inputs From PTI)