‘Victory for poor’ as call for cancer drug patent thrown out

Novartis had argued that it needed a patent to protect its investment in a new form of the cancer drug Glivec, while opponents said the drug did not merit intellectual property protection in India because it was not a new medicine. In response to the ruling, Novartis said it would not invest in drug research in India.

The court’s decision has global significance since India’s generic drug industry, which supplies much of the cheap medicine used in the developing world, could be stunted if Indian law allowed global drug companies to extend the lifespan of patents by making minor changes to medicines.

Once a drug’s patent expires, generic manufacturers can legally produce it. They are able to make drugs at a fraction of the original manufacturer’s cost because they do not carry out the expensive research and development.

Pratibha Singh, a lawyer for the Indian firm Cipla, which makes a version of Glivec for less than a tenth of the original’s price, said the court ruled that a patent could only be given to a new drug, and not to those which are only slightly different from the original.

Novartis called the ruling a “setback for patients,” and said patent protection is crucial to fostering investment in research to develop new and better drugs. Ranjit Shahani, the vice chairman and managing director of Novartis India, said the ruling “will hinder medical progress for diseases without effective treatment options.”

He said the court’s decision made India an even less attractive country for major investments by international pharmaceutical companies. “Novartis will not invest in drug research in India. Not only Novartis, I don’t think any global company is planning to research in India,” he said.

The Swiss pharmaceutical giant has fought a legal battle in India since 2006 to patent a new version of Glivec, which is mainly used to treat leukaemia and is known as Gleevec outside India and Europe. The earlier version of Glivec did not have an Indian patent because its development far predated the country’s 2005 patent law. Novartis said Glivec is patented in nearly 40 other countries.

India’s patent office rejected the company’s patent application, arguing the drug was not a new medicine but an amended version of its earlier product. The patent authority cited a provision in the 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines.

Novartis appealed, arguing the drug was a more easily absorbed version of Glivec and that it qualified for a patent.

Anand Grover, a lawyer for the Cancer Patients Aid Association, which led the legal fight against Novartis, said the ruling prevented the watering down of India’s patent laws. “This is a very good day for cancer patients. It’s the news we have been waiting for for seven long years,” he said.

Aid groups, including Medicins Sans Frontieres, have opposed Novartis’ case, fearing that a victory for it would limit access to important medicines for millions of poor around the world. Glivec, used in treating chronic myeloid leukaemia and some other cancers, costs about £1,700 a month. Its generic version was available in India for around £115 per month.

“The difference in price was huge. The generic version makes it affordable to so many more poor people, not just in India, but across the world,” said Y.K. Sapru, of the Mumbai-based cancer patients association.

“For cancer sufferers, this ruling will mean the difference between life and death. Because the price at which it was available, and considering it’s the only lifesaving drug for chronic myeloid cancer patients, this decision will make a huge difference,” he said.