Madras HC dismisses Novartis' petition

By Savvy Soumya Misra
Published: Friday 31 August 2007

Health insurance has several m the verdict is heavy on symbolism. The Madras High Court dismissed a petition by pharmaceutical giant Novartis challenging section 3d of the Indian Patent (Amendments) Act 2005. Human rights groups said it will help ensure access of drugs to the poor. The company said the ruling will adversely affect innovations in drug research.
Fallout of refusal Novartis moved the court after the Chennai patent office rejected a patent request for its cancer drug Gleevec in January 2006 (see 'Patent puzzle', Down to Earth, February 28, 2007). The office said the drug was not a completely new product (innovation). The request was rejected under section 3d of the patent act. Challenging the clause, the Swiss multinational said it was not in compliance with the trade-related trips and the constitution of India. Novartis holds the patent on Gleevec in 40-odd countries.

Dismissing the petition on August 6, 2007, the court said, "the act wanted to achieve provide easy access to the citizens of this country to life saving drugs and to discharge their constitutional obligation of providing good healthcare to its citizens". Novartis said it would not appeal the judgement in the Supreme Court. "We are waiting for the full judgement to better understand the court's position," said Ranjit Shahani, vice-chairperson of Novartis India Limited.

Activists have welcomed the court ruling. "Even blood cancer patients can now afford to buy medicines at a cheaper rate. Novartis's drug costs nearly Rs 1,20,000 per month while its generic version costs Rs 8,000," said Y K Sapru, chairperson of the Cancer Patients Aid Association (cpaa), Mumbai. The association had filed a pre-grant opposition against patenting Gleevec. Last year, five Indian generic drug companies--Cipla, Ranbaxy, Hetero, Sun and Natco--had moved court opposing Gleevec's patent.

Indian drug industry is worth us $5 billion and 65 per cent of its production is exported to poor countries. "Over half the anti- aids medicines in developing countries come from India," says Leena Menghaney of the Medicines Sans Frontiers. "Many of us need expensive hiv drugs. We can afford them only if competition brings down drug prices," said Loon Gangte of the Delhi Network for Positive People, an organisation for hiv-positive people.

Currently, nearly 7,000 patent-related petitions are lying at the four patent courts in India (see box Generically speaking). Activists say that the Madras High Court ruling will bear its stamp on the results of these petitions.

After the verdict Novartis's appeal against the decision of the Chennai patent office will be taken up by the Intellectual Property Appellate Board (ipab) set up by the Union government to settle patent disputes. Novartis has been demanding the removal of a member from the board saying he was part of the panel which denied patent to Gleevec. It had sought the high court's intervention into this.

Novartis is left with few options post verdict. "A company can't move to wto without another country's backing. The European parliament had asked it to withdraw the case. It will also not get the support of the Swiss government," says Chan Park, policy advisor of Lawyer's Collective's hiv/aids unit.

Novartis says the ruling will affect innovations. "There are inadequacies in Indian patent laws that will affect public health in India," said Paul Herrling, head of corporate research at Novartis. But activists disapprove it."Though patent protection has increased worldwide in the last two decades, innovation in drugs has declined. Novartis should contribute to efforts on alternative incentive systems for health needs driven by research that ensure affordability of new drugs," said Menghaney.

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