Indian court to hear crucial Novartis patent case on cut-price generic drugs

Campaigners say granting Indian patent for cancer drug Glivec would be 'death sentence' for ill people in developing world

India's highest court is due to hear a case that could decide whether cut-price generic drugs for cancer and other serious conditions will continue to be available in much of the developing world.

The long-running case, which resumes in Delhi on Wednesday, has been brought by the Swiss pharmaceutical company Novartis. It wants an Indian patent for its leukaemia drug imatinib mesylate, which has been patented as Glivec in nearly 40 countries including China, Russia, Mexico, Taiwan, Germany and the UK, and Gleevec in the US.

Novartis says the legal move is "about protecting intellectual property to advance the practice of medicine, not about changing access to medicines", according to Ranjit Shahani, the vice-chairman and managing director of Novartis India. But campaigners argue that a victory for Novartis could result in the deaths of thousands of people who will no longer be able to afford the drugs they need.

"It would quite simply be a death sentence for us," said Vikas Ahuja, who was diagnosed with HIV in 1993 and is now the president of the Delhi Network of Positive People. "I am quite sure that if Novartis wins, other multinationals will follow suit and other drugs will become prohibitively expensive."

Médecins Sans Frontières (MSF) believes the ramifications of a Novartis win would be felt beyond India's borders. "If Novartis won the case, patents would be granted in India as broadly as they are in wealthy countries and on new formulations of known medicines already in use," MSF says in a Q&A on its website.

"India would no longer be able to supply much of the developing world with quality affordable medicines … More and more treatments will remain priced out of reach for the duration of the patent term – 20 years or more – including those that are merely new forms of existing medicine and didn't deserve a patent in the first place."

Indian generic medicines are among the cheapest in the world, largely because India did not issue patents on drugs until 2005 after coming under pressure from the World Trade Organisation. Its size also means it has the production capacity to manufacture reliable and safe copies of branded medicines.

As a result, India now makes one-fifth of the world's generics, such as antiretroviral medicines used to treat HIV and Aids. About half are sent abroad, mostly to other developing countries.

Even if Novartis wins, generic versions of Glivec will still be available in India because it came on the market before 2005 and is protected under a so-called "grandfather clause" in Indian patent law, said Shahani.

This week's supreme court case is the final chapter in a legal spat that has rumbled on since 2006, when Novartis first tried and failed to patent Glivec. At that time, the drug was sold at £1,650 per patient per month in countries where Novartis had obtained a patent. In India, generic versions of Glivec were available for less than £127 per patient per month in 2006.

The patent office in Chennai rejected the claim on the grounds that the drug was not sufficiently new, but a slightly modified update of an older medicine. When India finally introduced a patent law seven years ago, it included a clause which decreed that "patentability" shall be granted only if pharmaceutical companies can prove "enhanced efficacy".

This legal provision aims to stop firms from seeking patents or extensions based on minor changes to existing treatments – a practice known as "evergreening" that is common in Europe and the US. The clause has allowed India to reject patents for a range of older drugs for cancer, Aids, tuberculosis, malaria and other illnesses that are made by India's generics industry.

Given India's own poverty – 30% of the population earn less than 32p a day – many argue the limits still make sense domestically, particularly as Indian patients bear at least 80% of their own medical costs. Branded and patented drugs are often 10 to 40 times more expensive than generics.

Shahani said Novartis had brought the case to clarify India's investment environment. "Knowing we can rely on patents in India benefits government, industry and patients because research-based organisations will know if investing in the development of better medicines for India is a viable long-term option," he said in an email on Tuesday.

"As one of the largest manufacturers of generic medicines in the world, Novartis understands the role played by legitimate generics and recognises that access to medicines is a far more complicated issue involving lack of diagnosis, infrastructure and distribution and goes beyond just making generic drugs available," Shahani argued.

"Without patents there will be no new drugs and without new drugs there will be no new generics. Governments, NGOs and companies need to work together to find innovative solutions to these issues."

But those whose lives depend on affordable drugs are not reassured. "Why do pharmaceutical companies spend so much on research that they can only make drugs rich people can afford?" said Ahuja, whose organisation is party to the supreme court case, along with the Indian government and the Cancer Patients Aid Association.

"If they are only going to serve a certain class of people, they should say so in their advertising, rather than pretending to be so altruistic."


Helen Pidd in Delhi

The GuardianTramp

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