Hearing in controversial Glivec case between Novartis & Union of India enters crucial stage

Saturday, November 17, 2012

Hearing in the controversial imatinib mesylate (Glivec) case between the Swiss pharma major Novartis AG and the Union of India & Others is continuing in the Supreme Court of India which is expected to conclude by the end of this month.

After several adjournments during the last more than couple of years, the final argument in the case was commenced on September 11, 2012, with representatives for Novartis being the first to present their arguments before the apex court. The court then also heard the arguments from generic companies like Cipla, Natco, Ranbaxy and Hetero, Indian government and Cancer Patients Aid Association.

According to sources, the court will now hear the responses and rebuttals from the representatives from both sides on the case. The hearing is expected to be concluded by the end of November. The two judges hearing the case may then reserve their decision, with the verdict to be announced sometime thereafter, sources said.

The Supreme Court case, between Novartis and the government of India, is the final act in a legal battle that stretches back to seven years over India’s future capacity to produce low-cost generic medicines for its people, and for patients in other developing countries. In this long pending case, Novartis is challenging Section 3(d) of India’s Patents Act which prohibits ‘evergreening’ – the practice of multinational pharma companies to extend their patent terms by making small and trivial changes to existing molecules and thereby preventing manufacture of generic drugs.

Novartis patented the molecule imatinib in 1993. After the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office in Chennai. In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d), an important health safeguard that does not allow companies to get patents on new forms of old medicines.

With the Chennai Patent Office’s rejection of patent after 2005, Novartis approached the Madras High Court challenging the decision of Patent Office along with questioning the relevance of section 3(d) of Indian Patent Act.

In 2007, the Madras High Court rejected Novartis’ challenge to section 3(d) and held that it had no jurisdiction to determine the issue of TRIPS compatibility. In determining the issue of constitutional validity, the court held that the word “efficacy” used in section 3(d) had a definite meaning in the pharmaceutical field. The case was then transferred from the Madras High Court to the Intellectual Property Appellate Board (IPAB), which in turn rejected the application.

Novartis appealed again, this time to the Indian Supreme Court in 2009 after the IPAB rejected its appeal for a patent on the beta-crystalline form of imatinib mesylate, an anti-cancer drug.

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