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Novartis changes tack in patent law challenge

Swiss pharma major Novartis has decided to continue with the case it has filed in the Madras High Court challenging the Indian Patent Act.

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MUMBAI: Despite increasing global pressure, Swiss pharma major Novartis has decided to continue with the case it has filed in the Madras High Court challenging the Indian Patent Act.

On Monday, Novartis started its arguments against section 3(d) of the Indian Patent Act. People closely following the case said the pharma major is now trying to change its stand. Soli Sorabji, who appeared for Novartis, argued that the company was not against the whole section, but against its explanation. Earlier the company had said it was opposed to the entire section.

Arguing there is a lack of guidelines in section 3(d) and approval is dependent on the patent controller, he argued, “Absence of guidelines in section 3(d) may lead to arbitrary exercise of power by the controller.”

Further, Shanti Bhushan, appearing for Novartis, argued that the term efficacy in section 3(d) is a regulatory requirement and may bring additional burden on the patent act. The arguments will continue on Tuesday.

Section 3(d) of Indian Patent Law clearly says that without having any significant efficacy, any new use or a new variant of an old substance cannot be patented. On its basis, the Chennai Patent Office had rejected Novartis’ patent application of leukemia drug, Glivec.

Novartis approached the Madras High Court against the verdict arguing that section 3 (d) of Indian Patent Act is not compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement that India had signed in 2005.

Meanwhile, global religious leaders have joined worldwide demands that the company withdraw the case in India. These include Nobel prize winner, Desmond Tutu, Bishop Yvon Ambroise of the Commission for Justice and Peace of the Catholic Bishop’s Conference of India, Prawate Khidharn, General Secretary of the Christian Conference of Asia, Bishop Mark Hanson, presiding bishop of the Evangelical Lutheran Church in America.

“People, not profits, must be at the centre of patent law for medicines,” said Archbishop Desmond. Charitable associations see Novartis’ challenge as one against the right of worldwide poor patients for affordable drugs.

They point to the likely impact if Novartis’ were to the win the case. Glivec is priced at Rs 1,20,000 per month by Novartis when generic versions manufactured by Indian companies  are available for Rs 8,000.

If Novartis wins it could also lead to the ever greening of molecules, which will prevent manufacture of generic versions. Ever greening allows companies to make slight changes in off patent molecules and patent them again arguing it has improved efficiency.

Usually, pharmaceutically active organic bases are converted to salt forms as higher solubility leads to improved efficacy. Section 3(d) specifically excludes salt forms from patenting.

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