MUMBAI, India - January 24 - Drug company Novartis has taken an unprecedented step in India, challenging the rejection of a patent for its cancer drug Gleevec, and claiming that an entire section of India’s patent law, known as Section 3(d), is unconstitutional. For its Gleevec litigation, Novartis has been nominated for the Public Eye Award, granted each year to a corporation known for social irresponsibility. This years’ ceremony will take place on January 24, 2007, in Davos, Switzerland, to correspond to the World Economic Forum.

Novartis originally filed the two challenges in May 2006 as a response to a ruling from India’s Patent Controller that denied the company a patent for Gleevec. Should Novartis succeed in overturning the denial, Gleevec could no longer be produced by generic manufacturers, making the life-saving drug too expensive for thousands of sick patients.

“If Novartis obtains exclusive marketing rights for Gleevec, the drug will go back to its pre-generic rates, which were approximately 1.2 lakh for one month’s supply, or $2,500 USD,” said Y.K. Sapru, the founder and chairman of the Cancer Patient Aid Association (CPAA), a patients’ rights group based in Mumbai, India. “For a year’s supply, the drug would cost more than $30,000 USD, placing the drug out of reach for many of India’s cancer patients.”

In 2003, Novartis received exclusive marketing rights for Gleevec, effective until the patent application could be reviewed under the then-pending Indian Patent Act, which was passed in March 2005. The act includes two clauses to safeguard against frivolous patenting: Section 25, which allows anybody in India to file a pre-grant opposition to a patent application, and Section 3(d), which prevents the patent of minor changes to drug compounds, unless those changes result in superior therapeutic effects. The CPAA, under Section 25, contested the Gleevec application, arguing that Novartis did not make any patentable changes as required by Section 3(d). In January 2006, the Gleevec patent application was rejected, allowing generic versions of the drug to be produced for tens of thousands of Indian cancer patients. In response, Novartis filed its two challenges in the Chennai High Court, which is scheduled to hear the case on January 29, 2007.

If successful, Novartis' actions could make it easier for large pharmaceutical companies to patent trivial developments made to drugs, which could prevent generic manufacturers from making life-saving drugs. India is currently the largest supplier of generic drugs to more than 80 developing and under-developed countries, meaning that these trivial patents could result in millions around the globe being unable to access affordable life-saving medicine.

“The majority of patients that need access to Gleevec cannot afford $30,000 USD per year for medication, and rely on generic medicines,” said Sapru. “Should section 3(d) be overturned, big pharmaceutical companies may make it harder for generic manufacturers to reproduce life-saving medication, which could impact access to medication for patients of HIV/AIDS, Tuberculosis, and other types of cancer.”

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