EU, US oppose Novartis' Glivec move

International health organisations protesting the Swiss pharmaceutical major Novartis AG's legal challenge against the provisions of Indian Patent Act, which supports generic drug production, have found high-profile supporters from the US and the European Union for their cause.

Henry Waxman, chairman of the Government Reform Committee of the US Congress, and five members of the European Parliament have expressed solidarity with the protestors and raised concern over the public health impact of the Novartis move.

The Madras High Court will take up the Novartis petition for the final hearing tomorrow.

The petition challenges the constitutional validity of the specific provision in the Indian Patent Act, i.e. Section 3(D), which restricts grant of patents to existing drugs with significant improvements and proven therapeutic advantages.

It is also challenging a decision of the Indian Patent Office to reject patent to its blockbuster blood cancer drug called "Glivec (Imatinib Mesylate)".

Waxman, in a letter to Novartis Chairman Daniel Vasella, said that while he did not dispute Novartis's right to apply for a patent or appeal against patent denial, he was concerned about the company's attempt to influence a domestic Indian law that could have a severe impact on world-wide access to medicines.

"India's robust generics market supplies affordable, essential drugs to its citizens as well as to poor nations around the world. Its law contains safeguards designed to preserve a balance between protecting innovation and promoting public health.

"If India is pressured to make its patent laws more stringent than its obligations under the International Trade Law, this crucial supply of medicines could be threatened," he said.

Waxman is the co-sponsor of the Drug Price Competition and Patent Term Restoration Act, (informally known as the Hatch-Waxman Act), a landmark legislation that allowed more space for generic drug supplies in the US.

The EU parliamentarians said that "as representatives of European citizens" they have grave concerns regarding Novartis's action "against a government that chooses, in compliance with the Doha Declaration on TRIPS and Public Health, to interpret and implement the TRIPS Agreement in a manner supportive of (its) right to protect public health and, in particular, to promote access to medicines for all."

Meanwhile, Novartis has reiterated that the company was denied a patent on its anti-cancer drug Glivec in India because its laws do not comply with the intellectual property rights standards drafted by the World Trade Organisation.

In a statement, the company said the ongoing hearing on the issue at Madras High Court is to 'gain clarity on the status of the country's laws regarding the protection of intellectual property and the granting of patents, which are critical to helping patients by creating incentives for long-term research and development investments into new and better medicines.'