A closely watched case began in India today where the Supreme Court is hearing arguments over whether the government had the right to deny a patent to Novartis for its Gleevec cancer medication. The drugmaker has spent five years waging a legal battle in hopes of securing a patent on a new form of Gleevec, which is used to treat chronic myeloid leukemia.

Since the patent in India expired on the original molecule, generic drugmakers have been marketing rival versions at a fraction of the cost. And so should Novartis win a patent on the new crystalline salt form, the drugmaker would walk away with a 20-year monopoly, an outcome that has patient advocates concerned that a needed cancer drug would be out of reach for many people.

“Novartis is trying to straightjacket Indian patent offices. It wants to stop them from being able to reject patents on new forms of old medicines that show little improved therapeutic efficacy,” Leena Menghaney of the Medicines Sans Frontieres Access Campaign says in a statement. “The system we have now is not perfect, but it does prevent drug companies from getting unjustified 20 year monopolies every time they come up with a new use or a new form of a known medicine. Novartis wants to make this safeguard meaningless, whatever the consequences it may have on public health.”

The case revolves around a legal provision of Indian patent law that is aimed at preventing drugmakers from seeking patents or extensions based on minor changes to their existing medicines, which is known as evergreening. This provision, known as Section 3(d), prompted India to reject patents for many older meds, such as cancer and AIDS drugs, that are churned out by generic drugmakers in India.

In 2006, the Indian patent office ruled the new salt form did not deserve a new patent, because it did not meet a provision referring to “increased efficacy.” Novartis argued the new form would be more easily absorbed by patients, but the Madras High Court clarified that “efficacy” means “therapeutic efficacy in healing a disease,” The Hindu notes. So Novartis is asking the Supreme Court to interpret “efficacy” in a way that would allow a patent to be granted.

In fact, the drugmaker insists that the new form actually represents a breakthrough, as opposed to a slight modification, and maintains that Indian patent law “intended as a hurdle for ‘evergreening’ is not applicable at all,” the drugmaker tells the Associated Press. “We believe there are important issues to be addressed that are essential to the future of intellectual property law in India and the viability of the innovative pharmaceutical business in this country.”

Earlier this year, Novartis insisted its effort will not prevent access to needed meds nor is it challenging provisions under existing trade agreements - known as TRIPS and the Doha Declaration. Novartis also added that a patient access program was created and remains is open to anyone whose doctor determines need. And Novartis noted that as a big generic drugmaker - its Sandoz unit is the world’s second-largest - the economics of generics are fully understood (back story).

“If Novartis succeeds in weakening the interpretation of Section 3(d) for the purpose of obtaining a patent on a specific salt, it would force India to grant far more patents than it currently does or is required to under international trade rules,” Amit Sengupta of People’s Health Movement says in a statement. “This could lead to generic competition on many essential drugs ending entirely and prices for these in both India and developing countries remaining very high.”

And this came from Mohga M Kamal-Yanni, a senior health & HIV policy advisor to Oxfam: “We are profoundly disappointed that Novartis has continued to pursue legal action against the Indian Government. Five years ago, hundreds of thousands of people called upon Novartis to drop its legal challenge against the Indian. Today, over 2 billion people still lack regular access to affordable medicines, and yet Novartis has persisted. Oxfam is seriously concerned that if Novartis succeeds, it will lead to long term and profound changes in India’s patent system that will undermine generic competition and access to affordable, low-cost medicines.”

Meanwhile, patient advocates are demanding that one Supreme Court justice, Dalveer Bhandari, recuse himself. Two years ago, he took this step after Novartis filed an appeal. Although he did not provide an explanation, reports suggest the reason was an article in a legal journal in which he wrote that “many of the medical drugs available in the market are too costly for the poor people in India” and that “ways and means should therefore be thought out for making these drugs available to the masses at affordable prices,” according to The Times of India.

Now, patient groups notes that he participated in at least two international conferences for judges organized by the Intellectual Property Owners Association, a US organization whose members include Novartis, among other drugmakers and information technology providers (read here). Advocates wrote the court that “several statements in the paper could be held to be in conflict with the intent and letter of the Indian Patent Act.” The conferences, they argue, were “disguised as educational events,” and so “it is highly likely that judges attending these meetings are unaware that these are not neutral venues offering balanced views and discussions on IP.”