The ongoing legal battle in the patent case of anti-cancer drug Glivec has taken a serious turn. Gopal Subramaniam, former solicitor general of India who represented Government of India in the case, is now representing pharmaceutical company Novartis. What's more, Rohinton Nariman who recently took over as solicitor general from Subramaniam was earlier representing Novartis in the same case. Calling it a serious case of conflict of interest, public health experts under All India Drug Action Network (AIDAN) have shot off a letter to Salman Khurshid, Union minister of Law and Justice on October 10 demanding immediate action.
Novartis had filed a patent application for Glivec in the Indian Patent Office, Chennai in 2006. Glivec is a beta-crystalline form of an already known substance, imatinib, used for blood cancer treatment. But the patent office rejected it referring to section 3(d) of Indian Patent Act of 1970 which prevents patenting of new forms of known substances, unless the new form exhibits a significant enhancement in efficacy.
Adamant to get Glivec patented, Novartis challenged the validity of section 3 (d) in the Madras High Court but the court upheld it in August 2007. Undeterred, it approached Chennai-based Intellectual Property Appellate Board (IPAB), challenging the rejection of its patent in late 2008. But IPAB turned it down as well. Now the case is in Supreme Court where Novartis has challenged the decision of IPAB. The next hearing of the case is on October 17.
The activists fear if the issue of conflict of interest is not looked into, the outcome of the case will not only affect the patenting of Glivec but also determine the position of India on patenting of new forms of already known drugs.
Rohinton took over from Subramaniam after the latter resigned from the post of solicitor general of India in July 2011. Subramaiam took up Novartis case in August.
“We are concerned about Nariman’s objectivity in arguing for the government since he has been fighting for Novartis. Subramaniam too has been privy to the government's thinking and arguments in the Novartis matter,” says Mira Shiva, member of AIDAN. The activists want Nariman and Subramaniam to recuse themselves immediately from the case.
The activists also demand a long-term policy that prohibits government officers from taking private sector assignments for five years after retirement or resignation. “There should be a mandatory requirement of declaration of conflict of interest by all government authorities and ministers involved in policy and decision making,” says S Srinivasan, managing trustee of LOCOST, a generic drug manufacturing company-based in Vadodara.