Novartis objects to IPAB appointment

Swiss drug-maker Novartis today objected to the appointment of S Chandrasekhar, the former Controller General of Patents, as a technical member of the Intellectual Property Appellate Board (IPAB), which is hearing its appeal against the Indian patent office's decision to not allow patent protection for its anti-cancer drug Gleevec in India. The IPAB considered Novartis' appeal and is now scheduled to hear the matter on July 2.

Except for the counsels of Natco Pharma, none of the respondents in the case, including the counsels for Ranbaxy Laboratories, Cipla, Hetero Drugs and the Cancer Patients Association (CPA), objected to Novartis's contention, sources said.

Experts said that even if the IPAB pronounces a judgement, the case could be further pursued in the High Court and the Supreme Court, paving way for a long legal battle between the government and advocacy groups on the one side and Novartis on the other.

The case came up before the IPAB, following a decision of the Madras High Court to transfer a part of the case - on the decision of the Chennai patent office to reject the patent on Gleevec - to the IPAB. The Madras High Court is expected give its judgement on Novartis's challenge on the TRIPS compatibility and the constitutionality of Section 3(d) of the Indian Patent Act, this week.

The IPAB, under the commerce ministry, was formed in 2003 to hear appeals against the decisions of intellectual property rights infringement in the country. So far, the agency was mainly considering trade mark-related cases and the Gleevec case is the first major patent case coming up before the IPAB.

S Chandrasekhar, the former Controller General of Patents, joined the IPAB as a technical member a few months ago, following his retirement from the IP office.

Novartis contended that the newly-appointed technical member of the appellate board is the former Controller General of the Indian Patent Office, who was also responsible for the original decision on the Glivec patent in August 2006 and was acting as a party in the recent court case reviewing the decision of the Indian Patent Office to reject its Gleevec patent filing.

"Gleevec, a life-saving breakthrough drug for cancer, has been granted a patent in nearly 40 countries, including China, Russia, Taiwan, and we firmly believe the same should be the case in India," said Novartis.

The much-publicised case had its origin in 1998 when Novartis filed a patent application for Gleevec (imatinib mesylate) in the Chennai Patent Office. The Chennai Patent Office had granted exclusive marketing rights for the drug in 2003, until the patent was granted as per the provisions in the Patent Act. Based on the pre-grant oppositions filed by patient groups, the patent office refused the application of Novartis in January 2006 on the grounds that the product was not new and did not involve an inventive step to grant a patent.

In May 2006, Novartis approached the Madras High Court, challenging the order of the Chennai patent controller and also the validity of Section 3(d) of the Indian Patent Act (from 1970 but amended in 2005) as not compliant with the TRIPS agreement.

In April, this year, the Madras High Court transferred a part of the case, on the decision of the Chennai patent office to reject the patent on Gleevec, to the IPAB. The Chennai High Court is likely to soon give its judgement on another major aspect of the case "" Novartis's challenge on the TRIPS compatibility and the constitutionality of Section 3(d) of the Indian Patent Act.