If Novartis wins, cancer patients lose

It’s a battle, cancer patients across India are watching with bated breath. Losing this case in Supreme Court will make a potent anti-cancer drug Glivec® almost inaccessible to poor patients of blood cancer. A Division Bench of the Supreme Court, comprising Mr. Justice Dalveer Bhandari and Justice Mr. Deepak Verma on September 6, 2011 transferred this case to another bench of the court. This is the latest happening in the case which has held the nerve of cancer patients and activists alike since 1999.

So, why is Glivec®- an anti-cancer drug whose patent is with Swiss pharmaceutical giant Norvartis, so important? And what will be the ramification of SC’s judgment? Let’s first understand what this wonder drug is– Imatinib mesylate is a new crystalline form of anti-cancer drug which Novartis sells under the brand name Glivec®. The original molecule of this drug is patented out of India. Companies like Natco, Ranbaxy and Cipla produced and sell Glivec (Imatinib mesylate) to myeloid leukemia patients for about Rs.8,000 per month, affordable, to some extent. But this was stopped in 2004 when Madras High Court stayed local firms from selling Glivec® copies. Novartis sells the same drug for about Rs.1.2 lakh per month.

Novartis claims that it should have an exclusive right on production and sale of this drug as it holds the original patent in the United States. The company in 1999 filed for the patient of this wonder drug at Chennai regional patent office. Further in 2004 Madras HC stayed in local companies from selling this drug.

The turning point in the whole episode came in 2005 when India amended its product patent law to comply with its obligations under the TRIPS Agreement and consequently, Chennai patent office rejected Novartis’s claim of exclusive patent in 2006.

While refusing the patent, the Controller General of Patent office sighted Section 3(d) of India’s new patent law that doesn’t permit any modified form of an invention that was known prior to 1995. Patent right can only be given if the claimed modification results in increased “efficacy.” The same year Novartis challenged Section 3(d) of the Indian Patent law in the Chennai High Court which was dismissed in 2007.

Between 2007 and 2009, the case was hanging with the Intellectual Property Appellate Board (IPAB) and finally landed in the Supreme Court. Having lost its case in the lower court, Novartis is now asking the Supreme Court to interpret “efficacy” clause in Section 3(d) of Indian patent law in a way that will allow it exclusive patent.

Interestingly, the one reason cited by Intellectual Property Appellate Board (IPAB) in not giving the exclusive patent to Novartis was “excessive pricing” of the drug. The IPAB felt that the high price of life-saving drug Glivec® will make it almost unaffordable to ordinary cancer patients. It was perhaps for the first time that the tribunal used the price of a drug as a reason to reject a patent appeal.

There are approximately 2 lakh chronic Myelogenous leukemia or blood cancer patients across the country with 40,000-50,000 people getting affected each year. A patent on the new form could give Novartis a 20-year monopoly on the drug, thus “ever-greening” the patent. This could be dangerous.

A report published in Mint on July 5, 2009 quoted Novartis’ view point on the issue. Defending the company’s claim it said, “Novartis has provided Glivec at no cost to more than 37,000 patients in 80 countries.

In India, more than 11,000 patients currently receive their medicine through this program.” But this cannot be an excuse for high price of this life prolonging drug. Even if the apex court rules against Novartis, the company has the option to move to the international judicial bodies. Until then, fingers are crossed. Hope, patient will prevail upon the patent.