Indian court refuses to grant patent to drugs manufacturer in landmark case that could keep life-saving medicine affordable

Health activists have welcomed a decision by India’s highest court not to grant a patent to a drugs manufacturer in a case campaigners say will help safeguard the ability of people around the world to afford life-saving medicine.

In what has been described a landmark case, the supreme court rejected a patent application by Novartis AG for a drug it claims was an updated anti-leukaemia treatment. Activists said the judgement would protect India’s £17bn generic drug industry, which makes cheaper, generic version of life-saving medicine.

“This is a ruling in favour of patients,” Leena Menghaney of Doctors Without Borders, told The Independent. “It will save the generic drugs industry. The impact will be felt in the decades to come.”

The dispute involving Novartis, a Swiss-based multi-national pharmaceutical company, dated back seven years and centred on its attempt to seek a patent for its anti-cancer drug Glivec. Glivec, which has been celebrated as a breakthrough in treating forms of blood cancer, costs £2,600 a month in its branded form while the generic version is available in India for just £48.

The company claimed the drug was a new product while activists said it was merely a slightly modified version of an earlier product whose patent had expired.

Activists said today’s ruling means other drug companies will also be prevented from obtaining patents on updated version of exiting drugs, a practise known as “ever-greening”. They said the impact will be felt around the world.

Pratibha Singh, a lawyer for Indian generics drug producer Cipla, part of an industry that is expected to be worth £46bn by 2010, told the AFP that the “ruling will have implications not just for India but also for other Asian, African and Latin American countries”.

She added: “The ruling also makes it clear you cannot patent a drug by just making some minor modifications — the key Section 3d of the patent law has been upheld by the court.”

India's generic drugs industry supplies around one-fifth of the world’s imitation drugs. It assumed this position because until 2005 it did not issue patents on drugs. It only did so to comply with rules laid down by the World Trade Organisation.

Novartis and other drug manufacturers argued that the patents are required to protect products that have required large sums in development research and testing.

Novartis said the ruling would “hinder medical progress”. It earlier told the Financial Times that it might halt supplies of the new medicine to India if the judgement went against the company.

“We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs,” said Ranjit Shahani, of Novartis India Limited. “We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.”

Novartis’ application for a fresh patent in India was turned down by the country’s patent office in 2005. It then filed an appeal, saying that the new product could be more easily absorbed and therefore qualified as a new product. That appeal was in turn rejected so the company turned to the supreme court.

Kiran Hukku of the Cancer Patients Aid Association, an Indian NGO that helps people with cancer, said over the last three years it had helped provide generic drugs to around 5,000 cancer patients who were still alive as a result of the medicine.

“So many lives will be saved as a result [of today’s ruling],” she said. “The medicine must come first.”