Novartis to proceed with case against Indian patent law

Despite growing pressure from non-governmental organisations and public health groups across the world, Swiss multinational Novartis AG has decided to go ahead with its legal challenge against the provisions of the Indian patent law specifically meant to restrict the scope of patentability on drugs.

The Novartis petition, which will come up for hearing before a Division Bench at the Chennai High Court on January 29, has garnered global attention.

The protesters, who urge Novartis to drop the case, fear that any favourable verdict for the company could undermine India's capability to supply affordable medicines to the developing and least developed countries.

The protests from public interest groups gathered momentum after a government appointed committee on patent laws, headed by former chief of the Council for Scientific and Industrial Research RA Mashelkar, favoured the grant of patents to all incremental innovations made to a drug molecule.

The committee also opined that the restriction of patents to new chemical entities (new drugs in the strictest sense) is not in tune with India's Trade and Intellectual Property Rights obligations before the World Trade Organisation.

In the petition, Novartis challenges the constitutional validity of the specific provision in the Indian Patent Act, Section 3 (D), which restricts grant of patents to existing drugs with proven therapeutic advantages.

It is also challenging a decision of the Indian patent office to refuse patent to its blockbuster blood cancer drug Glivec (Imatinib Mesylate).

As the company finds itself in a stronger position to argue its case after the favourable comments from the Mashelkar panel, global NGOs have stepped up their protests against Novartis' position.

The NGOs even succeeded in persuading some members of the European Parliament to call for a hearing this week to discuss the seriousness of the issue. The NGOs led by Medicines Sans Frontiers, had wanted political intervention to persuade Novartis to drop the case.

Interfaith Center on Corporate Responsibility, a corporate responsibility NGO whose members have a combined portfolio value of $110 billion is another organisation that wanted Novartis to withdraw from the case which, according to them "could have an adverse impact on the availability of affordable medicines to millions in the developing world".

For Medicines Sans Frontiers, the NGO that has been in the forefront of the fight for affordable medicines, India is a crucial source of affordable generic medicines.

About 84 per cent of the drugs for acquired immunodeficiency syndrome (AIDS) Medicines Sans Frontiers uses to treat over 60,000 patients in more than 30 countries are sourced from India.

However, Novartis, on January 17 reiterated its stance and stated that it wanted the Indian government to grant patent to its anti-cancer drug Glivec and ensure that Indian laws reflect international standards of patentability.