Generic medicines walk the plank

The controversial legal challenge by Swiss pharmaceutical company Novartis to India's patent laws ended on Monday, casting a shadow over the future of the country's generic drugs industry.

A verdict in the case is expected in about a month. The company hopes for stricter patent protection of its drugs, some of which are manufactured and sold as generics in India. But for the millions of patients who depend on cheaper copies of their medicine, setting such a legal precedent could simply make life-saving drugs unaffordable.

Novartis wants patent protection for its leukaemia drug, Gleevec. Indian authorities rejected the request in January 2006, on the grounds that Gleevec was not a new drug, but simply a new formulation of an old product.

India's laws restrict patent rights to innovations only. The process of simply reformulating new drugs so that patent protection can be extended is called 'Evergreening'. As a result, Gleevec could not be patented under Indian law, but the claim Novartis filed in the Chennai High Court in January 2007 challenges this provision.

Chan Park, of the New Delhi Lawyers' Collective, which provides free legal representation to an association for cancer patients, contested Novartis's claim. He said the outcome of the case would affect all patients dependent on generic drugs, particularly people living with HIV.

"This is highly significant, as it is the first patent trial. Novartis is challenging the legal validity of all patent rejections, not just Gleevec. In effect, if Novartis were to succeed, it would induce a higher price not only for Gleevec, but for many more medicines," Park said.

Sanjay (not his real name), a New Delhi resident in his mid-forties and a father of two, was diagnosed with HIV in 1997. His generic antiretroviral (ARV) treatment is a burden on the family's budget. "Medicine used to be exorbitant, but now, with generic ARVs, treatment costs anything from 1,000 to 1,500 rupees (US$35) a month," he told IRIN/PlusNews. This is a substantial sum, as 80 percent of India's population live on less than US$2 a day.

"Later on, when your viral load increases, you need to get one or two protease inhibitors a month ... it amounts to at least 5,000 Rupees (US$ 115) a month, as they are not generics and the government never provides those - you have to get them from the market," Sanjay said.

The HI-virus needs protease, an enzyme, to make copies of itself. Protease inhibitors (PIs) block the protease enzyme, forcing the HI-virus to make copies that can't infect new cells.

All generics could become unaffordable

If 'evergreened' drugs are granted patent protection, manufacturers of generic medicine will have to pay substantial amounts to pharmaceutical firms for their intellectual property rights, which would increase the price of the drugs to such an extent that it could make them unaffordable to patients in developing countries.

Loon Gangte, president of the Delhi Network of Positive People, gives staggering figures: "Today, the generic ARVs I am taking cost me 1,000 Rupees (US$ 23) per month. But tomorrow, if I have to buy the branded drugs, it could cost as much as 15,000 Rupees (US$340) a month. I cannot afford that, and my government can't either."

The Communist Party of India, a member of the coalition government, calculates that the monthly cost incurred by people living with the virus would soar if India granted patent protection to drugs now manufactured generically. "This will result in the price of AIDS medicines becoming 20 to 50 times their current value as more and more patients shift to second-line AIDS drugs. As India is the major source of AIDS medicines today, this would have a worldwide impact," the party said in a statement.

Shutting down the pharmacy of the developing world

Gangte thinks the threat to generic ARVs is real, as many pharmaceutical companies have filed claims similar to Novartis'. "If Novartis wins the case, the generic ARV supply will dry up immediately, not only in India, but in the rest of the world as well," he warned.

Nongovernmental organisations (NGOs) and people living with HIV/AIDS have launched a global protest campaign: international relief group Medicine Sans Frontieres (MSF) and humanitarian agency Oxfam have circulated a petition signed by 300,000 people in 150 countries, asking Novartis to drop the case.

Dr Unni Karunakara, medical director of MSF's Campaign for Access to Essential Medicines, says Novartis is "trying to shut down the pharmacy of the developing world". More expensive generic medicines would especially affect HIV-positive people who depend on ARVs, most of which are produced in India.

According to Karunakara of MSF, "Indian drugs account for at least a quarter of all medicines we buy and form the backbone of our AIDS programmes, in which 80,000 people in over 30 countries receive treatment: over 80 percent of the medicines we use to treat people living with HIV/AIDS come from India."

The Network for People with HIV/AIDS, the People's Health Movement, and the Centre for Trade and Development in India have also petitioned the authorities. "We filed a 'pre-grant opposition' before the trial, asking the government to turn down Novartis's claim," said Gangte.

"We also had several street protests in Delhi, wrote letters to the pharmaceutical labs, to the government, and to foundations, but it is now in the court's hands."

World Trade Organisation commitments

Indian law recognised few patent restraints before the country joined the World Trade Organisation (WTO) in 2005, allowing it to develop one of the world's largest generic drug manufacturing industries. Indian generic drugs are often half or two-thirds cheaper than patented drugs.

But India is now bound by the WTO's Trade Related Aspects of Intellectual Property Rights (TRIPS), which strengthens the intellectual property rights of pharmaceutical firms, and it has had to revise its patent laws to align them with WTO standards.

However, the TRIPS agreement is attenuated by public health safeguards included in the treaty. India's Patent Act thus forbids the patenting of derivative forms of known drugs, unless the new version is proven to have a higher "efficacy". This provision could prevent the practice of 'evergreening'.

Proceedings in the Novartis were suspended after counsel for the Union of India asked the court to adjourn the hearing because they were expecting a report on intellectual property rights, published recently by the government's Technical Expert Group on Patent Law Issues.

Its conclusions seemed to favour Novartis's position in stating that "limiting grant of patents to pharmaceutical substances to new chemical entities only ... is not consistent with the TRIPS agreement."

The report, signed by Dr Mashelkar, director of India's Council of Scientific and Industrial Research, who led a committee that investigated the issue, has since been withdrawn, after it appeared that some of its recommendations had been plagiarised from research papers funded by Novartis and other companies. "Some conclusions were lifted, verbatim, from pharmaceutical firms' recommendations," noted Park of the New Delhi Lawyers' Collective.

The government has distanced itself from the report, but remains vague about its position on the stricter patent protection Novartis is requesting.

Novartis responds

Novartis says patent protection is essential to the research and development of new drugs: pharmaceutical innovation requires investments of billions of dollars, and patents are essential to the firm's revenues.

The firm claimed in a statement that granting patents protection to 'evergreened' drugs, such as Gleevec, was a binding legal obligation under the WTO treaty, and denied that it was threatening poor patients' access to its medicines because its Access-to-Medicines programme, on which it spent US$755 million in 2006, reached 33.6 million vulnerable patients worldwide.

But Gangte called on the government to step in, saying, "the elected members of the Indian Parliament have a moral obligation to protect the nation's health", and alleging that "the Indian government's response is already insufficient to cover the needs of 5.7 million Indians living with HIV. The 115 government-run centres throughout the country provide ARVs for about 30,000 people."

ha/kn/he