The Telegraph
Since 1st March, 1999
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Patent win keeps India pharmacy of the poor
- A giant tiptoes in, another trips

New Delhi, Aug. 6: A woman — a mother of three — from Jaipur fighting a type of blood cancer, a 40-year-old HIV infected man in Delhi, and thousands of patients like them in India and elsewhere may have received a lifeline from a Chennai court.

Madras High Court today dismissed a petition by international pharmaceutical giant Novartis, challenging a section of the Indian patent law. Doctors and health activists have welcomed the judgment, saying it will protect India’s role as the pharmacy of the developing world.

Novartis had challenged Section 3(d) of the Indian Patents Act, which patients’ groups and health organisations regard as a safeguard to prevent patents on questionable innovation such as new uses, new forms and new combinations of known drugs or molecules. It had argued that Section 3(d) was vague and contrary to India’s obligations under an international trade pact.

Madras High Court today held that 3(d) was not vague and ruled that the court was not the proper forum to decide whether Indian patent law was compliant with the international trade agreement.

The ruling has evoked jubilant responses from patients’ groups, health activists and doctors. “This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India,” said Tido von Schoen-Angerer, director of the Medicins Sans Frontieres (MSF) Campaign for Access to Essential Medicines.

“I’m very happy and excited,” said Loon Gangte, president of the Delhi Network of Positive People. “HIV-positive people in India and abroad will be able to live longer,” he told The Telegraph .

Many international organisations rely on Indian generic drugs. Nearly 84 per cent of drugs that MSF provides to prolong the lives of some 100,000 HIV-infected patients in developing countries come from Indian generic companies.

Health activists had feared that the removal of 3(d) would have facilitated patents on minor innovations — new forms, new combinations and new uses of known drugs — and hindered manufacture of inexpensive generic versions of such compounds.

The case was centred on Novartis’s product Glivec, used to treat chronic myeloid leukemia (CML), a type of blood cancer. India’s patent office had rejected a patent application on Glivec on the ground that it was a new form of a known molecule.

Novartis India has said the court ruling will have “long-term negative consequences” for research and development in better medicines for patients in India and abroad. The company’s appeal on Glivec remains pending with an intellectual property appellate board still reviewing the issue.

“We disagree with this ruling, however, we likely will not appeal to the Supreme Court,” said Ranjit Shahani, Novartis India managing director. “Our actions advanced this essential debate ... now local and international leaders, both in industry and academia, recognise the inadequacies of Section 3(d),” he said.

But many physicians believe 3(d) will help patients.

“This judgment is undoubtedly a relief,” said Purvish Parikh, a senior doctor at the Tata Memorial Hospital in Mumbai, who is treating the woman with CML from Jaipur. She spends about Rs 8,000 a month on a generic form of Glivec. The patented version costs Rs 120,000 a month.

Like hundreds of other patients under Parikh’s care, she is unlikely to have survived long without the generic form. “She’s now looking forward to seeing her eldest daughter get married,” Parikh said.

Doctors estimate that some 20,000 new patients are diagnosed with CML in India each year. Novartis has said it is providing Glivec free of charge to more than 7,500 patients under a special programme to help people who cannot afford the drug.

“This victory will help prolong the lives of tens of thousands of people living with HIV around the world,” said Leena Menghaney, a lawyer now working with MSF India’s Campaign for Access to Essential Medicines.

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