New Delhi: This week, Swiss drug maker Novartis AG is bracing for two crucial legal decisions in its Glivec patent battle in India.
The newly appointed patent cell at the Intellectual Property Appellate Board (IPAB) will on Monday hear its first ever patent appeal—in which Novartis has challenged a Chennai patent office’s early-2006 decision to reject its patent application for the cancer drug on the grounds that Glivec didn’t qualify for protection under what was then a newly-minted patents law.
The rules allow for product patents, but give the patent office powers to exclude combinations of existing compounds or ‘derivatives’, which are tweaked versions of drugs already in the market.
Then, the Madras high court is expected to deliver its judgement early in the week, in a case that has Novartis challenging the compliance of the Indian Patents Act, 2005, with global fair-trade laws. The Basel, Switzerland-based firm has questioned the validity of Section 3(d) of the law, which disallows patenting “incremental innovations”, which is the rule under which the Chennai patent office struck down its patent application.
The case, closely watched by the global pharmaceutical industry, is seen as a key ruling that will have the judiciary balancing between protecting the fruits of research of a drug ma-ker and making access to a life-saving drug cheaper. If the court’s decision goes in Nova-rtis’ favour, public health and drug access activists believe, 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.
The ruling will come at a time when governments from Brazil to Thailand have withdrawn patents on key HIV/AIDS and cardiac drugs to reduce costs of health care among their populations. In April, India’s health minister Anbumani Ramadoss had asked Novartis to withdraw the patent litigation and warned that the country should not be forced to “issue a compulsory licence” even though it had never issued one in the past.
According to legal experts, Novartis has the opportunity to raise an objection to the constitution of the patent cell bench at the IPAB deciding on the case. That’s because S. Chandrashekharan, one of the two members hearing the patent appeal—M.H.S. Ansari is the other—was also former controller general of the Indian Patent Office, under whose tenure the Novartis patent filing was rejected.
Novartis India’s chairman Ranjit Shahani refused to comment on such a possibility, saying “the decision will be taken by the global top management”. He reiterated that the firm strongly believed it deserved a patent for a drug that had similar protection in 40 other nations and would continue to fight for it. In 2006, sales of the cancer drug—sold as Gleevac globally—exceeded $2.5 billion (Rs10,250 crore) worldwide.
The firm has previously rais-ed the potential conflict of interest on IPAB’s patent cell. A Novartis press statement in April pointed out that “we are concerned that this new development may further delay review of the Glivec patent matter. The newly-appointed technical member of the appellate board is the former Controller General of the Indian Patent Office, who was responsible for the original decision on the Glivec patent in 2006 and is a party to the current case. We have confidence in the Indian court system, and we hope we can have the same confidence in the appellate board.”
But 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 told Mint. “I’ll follow provisions of the law. If there is an opposition on Monday, we will hear out all the parties.” Added A. Ramesh Kumar, legal counsel for Cipla Ltd, one of the companies that filed a patent opposition to Glivec: “The decision taken by an individual in an administrative capacity should not interfere with his work in the judicial capacity. However, Novartis can raise an objection on Monday and tell the board about its apprehensions.”
The other parties in the case against the grant of patent protection to Glivec are Cipla, Hetero Drugs Ltd, Ranbaxy Laboratories Ltd and Natco Pharmaceuticals Ltd, and public health activist Cancer Patients Aid Association.
C.H. Unnikrishnan in Mumbai contributed to this story.