Indian court ruling hailed as victory of ‘rights of patients over patents’
* Madras High Court strikes down Novartis petition for intellectual property rights over drugs, gives Indian firms go-ahead to make affordable generic versions
By Iftikhar Gilani
NEW DELHI: In a major ruling on intellectual property rights over drugs, the Madras High Court on Monday struck down the petition of Swiss drug company Novartis, giving Indian firms the go-ahead to continue making affordable generic drugs.
Medical aid organisations the world over declared the ruling a victory for the “rights of patients over patents”.
Novaratis warned that it would “discourage investments in innovation” and undermine drug companies’ attempts to improve their products.
The details of the case are complex—extending into the precise analysis of chemical formulations of popular drugs while simultaneously posing a constitutional challenge—but the issues at the heart of the case are simple.
Novartis wanted to secure the product patent for its blockbuster anti-cancer drug Glivec. The Madras High Court, however, has directed Novartis to take up the patenting issue with the Geneva-based dispute settlement body. A report from Novartis headquarters, though, said it would not pursue the case further.
Had Novartis won, Indian companies would have been prevented from manufacturing generic versions of Glivec, which they sell both domestically and internationally for around a tenth of the cost of treatment charged by Novartis (Rs 12,000 per month). This would have left a large number of patients without access to cancer treatment, and the precedent created would have prevented the manufacture of a wide range of other drugs which Indian companies produce at a fraction of the cost of the originals.
Aid agencies stress that the ability of Indian companies to continue making cheap drugs has been secured as a result of the decision. Companies making the original drugs contend that the ruling has weakened patent protection internationally.
Both the international pharmaceutical industry and global relief organisations have been scrutinising the progress of this long-running case in Chennai, aware that the judgment would have profound implications for their work.
“This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicine from India,” Tido von Schoen-Angerer, director of the Médecins Sans Frontiéres (MSF) campaign for access to essential medicine, said in a statement released by the organisation.
The head of research at Novartis, Paul Herrling, on the other hand, reacted sharply: “It is clear there are inadequacies in Indian patent law that will have negative consequences for patients and public health in India.”
“Medical progress occurs through incremental innovation. If Indian patent law does not recognise these important advances, patients will be denied new and better medicines,” he said.
Novartis mounted a test case last year, asking the Madras High Court to clarify a key element of a 2005 Indian patent law, to determine whether an Indian court had been right not to grant the company a patent on a freshly modified form of its leukemia drug Glivec. The application was rejected last year on the grounds that the new drug was insufficiently innovative.
At issue was the question of granting patents for incremental developments. Indian law does not allow “evergreening,” the practice of issuing patents for already-known drugs that have undergone modification.
Novartis argued that the section of the legislation which states that patents must not be granted to products that are “incremental innovations” contravened the World Trade Organisation’s agreement on trade-related aspects of intellectual property rights.
The High Court, however, rejected the challenge, arguing that the court had no jurisdiction to rule on whether Indian patent laws complied with the World Trade Organisation’s guidelines on intellectual property law.
If the court had ruled the other way, the decision could have set an important precedent which may have allowed other international companies to receive patents for newly modified versions of already known medicine, thereby extending the timeframe of their exclusive right to produce the drug.
Such drugs account for the vast majority of about 9,000 patent applications waiting for approval in India, according to MSF, which warned that such a ruling would have resulted in a “shut-down of the pharmacy for the developing world”.
Indian companies provide 84 percent of the drugs to fight AIDS that MSF supplies to patients worldwide. They also provide more than 25 percent of other essential drugs used by the organisation.