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Novartis takes patent row back to Indian High Court

Peter Ollier, Hong Kong

In another twist to its increasingly complicated legal dispute in India, Novartis yesterday filed an appeal at the Chennai High Court over the composition of the board considering the rejection of a patent for its cancer drug Glivec

In June Novartis objected to the inclusion of S Chandrasekaran on the Intellectual Property Appellate Board, which had been set up in April to hear its appeal.

Chandrasekaran was head of the patent office when Novartis’s application for a patent for Glivec was rejected. He also submitted documents when the case was being heard at the Chennai High Court. Because of this, the Swiss drug company argues that he is unable to act as an impartial member of the Appellate Board.

The Intellectual Property Appellate Board (IPAB) rejected the objection on July 21. It based its reason on the doctrine of necessity, arguing that no replacement to Mr Chandrasekaran was available.

"Novartis is in favour of India having an IPAB. We firmly believe this is a step forward in creating a fully functioning patent system...but surely in a country of over one billion people IPAB can find an alternative to Mr Chandrasekaran," Ranjit Shahani, vice-chairman and managing director of Novartis India told MIP Week.

Novartis claims that this case is similar to one argued in the Delhi High Court in May this year by Magotteaux, a Belgian castings manufacturer. The company argued that Chandrasekaran should not be part of the IPAB panel hearing its appeal against a patent rejection because he was head of the patent office when the application was rejected. The Delhi High Court agreed.

Novartis is challenging the rejection of its application for a patent over Glivec and is also claiming that section 3(d) of India’s Patent Act, which defines what is not patentable, is not compatible with the TRIPs Agreement.

The Chennai High Court began hearing the case in September 2006, and in April 2007 decided to split the case. IPAB was asked to consider the patent for Glivec, while the court decided to continue hearing the case into the compatibility of India's patent law with TRIPs.

Shahani told MIP Week that a verdict in the compatibility case "should have happened a while ago. We understand it is a complex judgment but it should be resolved one way or the other".

Novartis has come under pressure to drop the case from organizations such as Médecins Sans Frontières, which campaigns for more access to drugs in developing countries. It launched an international campaign and petition on December 20 claiming that a Novartis victory could lead to companies in India "restricting generic production and keeping prices for newer medicines high".