Novartis fears it may lose Glivec case in Supreme Court

MUMBAI: The spate of patent defeats and an aggressive generic industry has made Big Pharma jittery. Ahead of a crucial court ruling on April 1, Swiss major Novartis said on Wednesday that going by the recent decisions in cases of protecting intellectual property rights, the “most likely” scenario is that the company may lose patent protection on its blockbuster cancer medicine Glivec.

In one of the most-watched patent cases, the Supreme Court is slated to announce a verdict in the case filed by Novartis in 2006 against the Indian government, challenging a key public health provision in patent law.

Novartis was refused patent on Glivec on the grounds that it is not a new medicine but an amended version of a known compound — a decision consistent with the patent law which sets tight restrictions on multiple patents for a drug.

The case will have far reaching ramifications on MNCs’ ability to sell lucrative blockbuster medicines in the country, and pitches the argument between public health and affordability against research and innovation.

Paul Herrling, head, corporate research, Novartis, said that the recent spate of rulings over the past year curbing drug patents in the country, and the compulsory licence issued to generic company , were a concern for research-based companies, and worrying for the Glivec case.

“Looking at recent cases, the mood in India makes it more likely that we would have a more negative response ,” he said in a telecon on Wednesday.

Anti-leukaemia drug Glivec is one of the blockbuster drugs for the Swiss company, mopping up global sales of nearly $4 billion and its treatment costs around $36,000 per patient per year. Glivec already has certain more affordable generics in the Indian market. When contacted, Ranjit Shahani , VC and MD, Novartis India , said, “Whatever be the outcome, the access programme for Glivec will continue in India.”