Pro-health groups are cheering the Supreme Court’s dismissal of Novartis plea seeking patent protection on its blood cancer drug Imatinib mesylate, sold under the Glivec brandname.
It is a major victory for affordable access to medicines in developing countries, said international humanitarian organisation Doctors Without Borders / Médecins Sans Frontières (MSF).
“The Supreme Court's decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian Patent Law,” said Unni Karunakara, MSF International President.
India began granting patents on medicines to comply with international trade rules, but designed its law with safeguards – including a clause known as Section 3(d) - that prevented companies from abusing the patent system, they said. Section 3(d) prevents companies from gaining patents on modifications to existing drugs, in order to ever extend monopolies.
Leena Menghaney, India Manager for MSF’s Access Campaign, added that patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected.
Financing innovation
Raising the concern on financing medical innovation, Karunakara said, “Instead of seeking to abuse the patent system by bending the rules and claiming ever longer patent protection on older medicines, the pharmaceutical industry should focus on innovation, and governments should develop a framework that allows for medicines to be developed in a way that also allows for affordable access. This is a dialogue that needs to happen. We invite Novartis to be a part of the solution, instead of being part of the problem.”
Domestic jubilation
The high-profile judgment has also been welcomed by the domestic pharma industry.
The judgment will serve to put to rest the controversy raised regarding the scope of Section 3(d) in the Patents Act, said the Indian Pharmaceutical Alliance, a platform for large domestic drug companies.
“Imatinib is on the National List of Essential Medicines and is an important drug in the treatment of several cancers. The decision of the Supreme Court will come as a relief to patients suffering from diseases as several Indian companies including Cipla, Ranbaxy and Natco can continue marketing imatinib at a fraction of the cost of the Novartis product,” it said.
A significant player in contesting Novartis’ patent, Natco Pharma’s Chief Financial Officer, P. Bhaskara Narayana , welcomed the judgment “as the court had said genuine innovation was a must for grant of patents’’. The judgment would have no adverse impact on investments in the country, he added, as “it is too big a market to be ignored by the multinational pharma companies.”
Natco sells its version of the drug at a fraction of the cost Glivec sells. “Though there is no direct impact, we now continue to sell in more risk-free environment,’’ Narayana added.
Cipla’s Y.K. Hamied said the judgement was a victory for patients both in India and around the world. “We are pleased with the judgment which prevents the use of frivolous patents to deny access to medicines,” he said.
“India, being the Pharmacy Capital of the World can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines,” he added. Cipla is also a respondent in the Glivec case.