Gleevec

This just might be a court decision that had no right answer.

In a decision that both sides agree will have significant consequences, the Supreme Court of India ruled against a major Swiss drug manufacturer yesterday.

The judges denied Novartis AG’s request for patent protection for its Gleevec cancer treatment, allowing the nation’s generic-drug makers to continue to sell copies of the drug at a lower price.

In a decision watched by non-profit groups seeking to expand access to medicines and drug makers concerned about India’s position on intellectual property, the court  upheld regulatory rulings dating to 2006 that the drug wasn’t sufficiently innovative to merit a patent. 

Novartis argued that the molecule imatinib, on which Gleevec is based, required years of research and modification to make it an effective, safe leukemia treatment. They had requested a patent on a formula modification that Novartis claimed made the drug easier to take.

Back in 2006, the Indian Patent Office denied a patent to Novartis, a decision upheld by the Indian Intellectual Property Appellate Board. The board cited a provision of Indian law that aims to prevent “evergreening,” in which companies make an incremental change to a drug’s chemical makeup, without any real medical benefit, to extend its patent life and prevent the introduction of low-cost generic copies.

Monday’s ruling is seen as a huge win for consumer groups concerned with the high price of life saving drugs, but there is a down side they are trying to ignore.  By limiting the ability to receive (and hold on to) patents, the Court has reduced the incentive for major manufacturers to spend the millions of dollars necessary to bring a new drug to market.  

“In decisions like the Gleevec ruling, India is weighing the cost of treating patients today against hampering innovation at a later point,” Darius Lakdawalla, a health economist at the University of Southern California, said in an interview.

“Today, India is allowing a robust generics industry and not protecting patents and the cost for that is low,” Lakdawalla said. “But what is going to happen five to 10 years in the future?”