New Delhi: Novartis AG received a setback in one of two ongoing and high-stakes legal battles that its Indian unit has mounted over the cancer drug Glivec.
A government entity, the Intellectual Property Appellate Board, has dismissed a petition by the drug giant objecting to the presence of a former government patent official, S. Chandrasekharan, on the board’s technical panel that will hear the firm’s appeal. Chandrasekharan is one of the two members who were to hear Novartis’ patent appeal.
Novartis has challenged a Chennai patent office’s early-2006 decision to reject the drug company’s patent application for Glivec on the grounds that the drug didn’t qualify for protection under a new Indian patents law.
Novartis was objecting to Chandrasekharan’s presence since he was the former controller general of the Indian Patent Office, which had turned down the patent application in the first place.
A spokeswoman for Novartis India said: “We disagree with the decision and are considering our options.” She also said that Friday’s decision was “a summary judgment and we’ll not know the panel’s reasoning until a full written judgment is issued.” Novartis could potentially choose to challenge the board’s order by filing a writ petition in the Madras high court.
Rival Indian drug companies, such as Cipla Ltd, which are also party to the case, argued for retaining Chandrasekharan noting that he was not personally involved in the Chennai patent office’s rejection of Glivec.
In a previous interview with Mint, Chandrashekharan denied that he had any possible conflict of interest in hearing the Novartis case, noting that the patent was rejected by the Chennai patent office by the assistant controller of patents and designs there. “In effect, the case has never been heard before me,” Chandrashekharan said. “I’ll follow the provisions of the law.”
The drug maker was originally denied the patent on Glivec in January 2006, as it was not found to be innovative enough under Section 3(d) of the Indian Patents Act, 1970, which denies patents to modified versions of existing drugs. Novartis, in response, appealed not only against the patent controller’s order but also challenged the crucial provision in Madras high court. That appeal is still pending.
The case is being closely watched by the global pharmaceutical industry as a key battle between patents and generic versions. If the court’s decision goes in Novartis’ favour, public health and drug access activists claim that cheap, non-patented drug makers will be kept at bay, in turn making drugs unavailable for millions of patients in India and in all those countries that import from India.
Novartis says the issue is primarily a matter of protecting its intellectual property, noting that the drug has been granted a patent in nearly 40 countries. In 2006, sales of the cancer drug—sold as Gleevec globally—exceeded $2.5 billion (Rs10,075 crore) worldwide.