Posted April 2, 2013 by Jessica Wright in Business

Novartis refused grant of patent on cancer drug in India

Novartis refused grant of patent on cancer drug in India
Novartis refused grant of patent on cancer drug in India

In what is being perceived as a blow to western pharmaceutical firms that look to gain market space in India, the apex court of the country, on Monday, refused to grant a patent to Novartis AG for Glivec, a cancer fighting drug that is used in the treatment of leukaemia and some forms of gastrointestinal cancer.

The decision comes as a relief to local companies like Cipla and Natco, which were selling generic versions of Glivec at very cheap rates as compared to what Novartis has to offer: had Novartis been granted a patent on the amended form of the drug, generic version would no longer be legal in the country. This case also indicates what other foreign firms like Pfizer Inc. and Roche Holding AG, which are involved in similar disputes can expect.

Experts say that this judgement means foreign firms will have to look for new strategies if they are to tap into India’s rapidly growing, $13 billion a year drug market. This might involve entering into licensing agreements with Indian companies to somehow make drugs available at lower prices in India.

Novartis, obviously, is disappointed with the judgement, which it says “discourages future innovation.” The Managing Director of Novartis’s Indian branch said that this decision will make the company cautious about launching new drugs in India. This means the company will look to have its drugs patented before it makes them available to the public in India.

Patents protect new products or processes for 20 years from the time they are granted. Once this time period expires, other companies can, according to the laws of the country, begin to manufacture generic versions of the product. However, the patent holders often make small changes to their products, looking to get a new patent for such updates. This creates the risk of a monopoly, and is called ‘evergreening of patents.’

Though the updated version of Glivec was granted a patent in a number of countries around the world, such as Russia, China and the Unites States of America, the Indian judiciary said the updated compound is not a new medicine and so, not patentable under Indian law. The Trade Minister for India, Anand Sharma, said this is a “historical judgement” which reaffirms the legal standards for patents in India: substantial innovation is a must if patents are to be granted on drugs or any other subject matter.

The judgement will serve as a landmark when it comes to intellectual property rights in India. Much of India’s 1.2 billion population cannot afford to buy expensive patented drugs, which is why many organizations in India were calling for a refusal of patent grant to Novartis and have hailed the judgement as proper. The aid agency Medicine Sans Frontieres welcomed the judgement, saying “The ruling will save a lot of lives across the developing world.”

Novartis representatives stated that they were making Glivec available to a large number of patients in India, free of charge. However, statistics show that some 16,000 patients of cancer use Glivec in India, as compared to 300,000 who rely on the generic versions of the drug, instead.

After the judgement, shares of Novartis India fell by almost 5 percent on the Bombay Stock Exchange. Natco stock ended 5.4 percent higher and Cipla gained 1.3 percent.

Jessica Wright

Jessica Wright graduate of Northwestern University getting both Bachelor’s and Master’s Degrees in Broadcast Journalism. Jessica has been Senior Correspondent focusing on the impact of political decisions and office holders. Jessica is our seasoned investigative, political and community-oriented reporter and columnist whose work has won awards locally, statewide and nationally. Her awards have come from the National Federation of Professional Writers, the Ohio Newspaper Association, the Cleveland Press Club.