New Delhi: The drug industry is waiting to see which way the Supreme Court rules in a landmark patent case on Monday after a series of recent setbacks for multinational drug makers on intellectual property rights issues in India.
The case over Glivec—a blockbuster anti-cancer drug made by Swiss drug maker Novartis AG—dates back to India’s denial of a patent for it in 2006 as the drug wasn’t considered a new molecule, but an altered version of one that had already been on the market for around 15 years.
Paul Herrling, head of tropical disease research at Novartis, says they are prepared for a “negative” response.
The verdict could also settle the debate over the so-called evergreening of drugs by providing clarity on the extent of innovation required to retain patents in India, they said.
Evergreening is a tactic that drug companies are accused of engaging in to extend the patent by slightly modifying the formulation, which may or may not have any therapeutic difference—an issue addressed in a section of the Indian Patents Act.
“The ruling by the court is an important step in understanding how India will implement IP for innovative medicines. This is about safeguarding incentives for better medicines so that patients’ needs will be met in future,” Ranjit Shahani, country head and managing director for Novartis in India, said in an email. “It is important to note that the outcome of this case will not hinder the supply of essential medicines because international trade agreements include safeguards to ensure access and our legal case does not challenge these provisions.”
Until 1994, when India signed the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, the country did not recognize patent laws. India introduced patented drugs under TRIPS in 2005, guaranteeing 20-year patent protection to companies for new drugs.
“For decades, intellectual property rights were non-existent in India. So cases like this one will refine the laws in terms of incremental innovation, etc.,” said Muralidharan Nair, partner (healthcare and life sciences) at consulting firm Ernst and Young India. “Since the matter is sub judice I would not like to comment on Glivec in particular, but there have been lots of cases where patents were granted when they did not deserve it. So this matter is of utmost relevance to our country where regulations like IPR are crystallizing through debates and litigations and interpretations of the law are being refined.”
Activists said defeat for Novartis would be a boost for the cause of affordable drugs.
“If the case goes against Novartis, it will be a huge moral victory for those in favour of accessible and affordable life-saving drugs,” said Chinu Srinivasan, founder of Locost (Low Cost Standard Therapeutics), a non-profit, small-scale drug maker. “While no one is against private companies making a profit, charging exorbitant amounts for life-saving drugs is wrong. Companies cannot be singularly worried about profit and loss when dealing with human lives.”
To be sure, decisions related to patents have gone in the favour of local, generics companies.
The patent office allowed Natco Pharma Ltd last year to sell a generic version of Bayer AG’s cancer drug Nexavar through a compulsory licence, overruling the German company’s objections.
The TRIPS agreement allows countries to bypass patent protection by issuing compulsory licences for drugs that are deemed unaffordable to large sections of their population.
Earlier this year, the health ministry approached the department of industrial policy and promotion to issue compulsory licences for three anti-cancer drugs.
India granted marketing approval for Glivec, the chemical name of which is imatinib mesylate, in 2001, but it was not until 2005 that the country established the Indian Patents Amendment Act and became TRIPS compliant. The Indian Patent Office rejected the patent request in 2006.
The company had challenged section 3(d) and the case eventually was transferred to the Patent Appellate Board. In 2009, the Patent Appellate Board acknowledged that international patentability standards were met, but refused to grant a patent for Glivec based on an additional requirement introduced in 2005 in the Indian law.
In 2009, Novartis moved the Supreme Court, this time challenging the interpretation of section 3 (d). In 2011, the Supreme Court agreed to hear the case, and after many delays, the hearing began on 11 September 2012. The hearing ended on 4 December last year and the verdict is expected on 1 April.