Drug verdict relief for poor patients

NGOs that advocate poor countries’ access to affordable medicines applauded an Indian court’s dismissal of a challenge brought by Swiss-based drug-maker Novartis. The ruling handed down on Monday by the High Court of Chennai, is a basic condition for achieving access to drugs, not only in India, but also in other developing countries, Julien Reinhard, director of the health campaign at the Swiss NGO Berne Declaration, said.

Tido von Schoen-Angerer, head of Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines, said the decision “is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India.” Novartis, which is based in the northern Swiss city of Basel, said in a statement on Monday that the ruling would “have long-term negative consequences for research and development into better medicines for patients in India and abroad”.

“Medical progress occurs through incremental innovation. If Indian patent law does not recognise these important advances, patients will be denied new and better medicines,” said Paul Herrling, head of research at Novartis. The court decision, which was anxiously awaited by activists concerned about the issue of drug patents and patients’ rights, rejected the challenge by Novartis that questioned the constitutionality of Section 3d of the Indian Patent Act of 2005. Section 3d basically permits the manufacture of low-cost life-saving generic drugs for the world’s poor, by only allowing drug patents on completely new compounds invented after 1995.

When Novartis filed for a patent on its leukaemia drug Glivec, India’s patent office ruled the drug was simply a new form of an existing treatment that was developed before 1995. It was India’s first-ever drug patent rejection. The company then decided to challenge Section 3d as unconstitutional. The stakes in the case were high. When the Swiss drug giant brought the case in January, the MSF’s von Schoen-Angerer said “If Novartis wins it could mean the end of India’s generic drug industry.” More than half of all the developing world’s HIV/AIDS patients rely on low-cost generic drugs from India.

Reinhard said on Monday that the Berne Declaration, one of Switzerland’s oldest NGOs, has urged Novartis to respect the ruling. He said he was worried that Switzerland or some other country could bring a complaint against India in the WTO’s dispute settlement mechanism, under pressure from Novartis, based on the argument that Section 3d is not compatible with TRIPS (the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights). Novartis said the Indian court “deferred to the WTO forum to resolve the TRIPS compliance question.”

In a Moday communiqué, the MSF observed that “A ruling in favour of the company would have drastically restricted the production of affordable medicines in India that are crucial for the treatment of diseases throughout the developing world. “Developing country governments and international agencies like UNICEF and the Clinton Foundation rely heavily on importing affordable drugs from India, and 84% of the antiretrovirals (anti-AIDS drugs) that MSF prescribes to its patients worldwide come from Indian generic companies. India must be allowed to remain the ‘pharmacy of the developing world.’” — IPS