Timeline: How Novartis lost a seven-year long battle over Glivec

The Supreme Court’s decision to strike down Swiss pharmaceutical giant Novartis’ appeal over the denial of a new patent for its cancer drug Glivec marked the end of a seven-year-long battle.

The battle hinged on the interpretation of Section 3 (d) of the Indian Patents Act, which Indian regulators believed did not entitle Novartis to be granted a new patent.

Here’s a brief timeline of the legal battle that has finally ended today:

1997: Novartis seeks patent

Novartis files a patent application with the Chennai Patent Controller’s office for Glivec. However, the application was not opened till 2005 when India, which did not provide patent protection at the time, began providing patents for pharmaceutical and agrochemical products.

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However, before the patent was approved by Indian authorities, Novartis reportedly prevented some generic drug manufacturers from selling their versions of the drug in India, says NGO Lawyers Collective.

[caption id=“attachment_680738” align=“alignleft” width=“380”]  Glivec has been the centre of a seven year long legal battle between Novartis and the Indian state. Image courtesy: Novartis[/caption]

2005: Opposition to patent to Novartis

After the patent law came into force, NGO Cancer Patients Aid Association and generic drug manufacturers filed oppositions to the grant of a patent to Novartis on the grounds that the drug lacked the novelty that the pharmceutical company claimed.

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2006: Patent controller declines to give Novartis a patent for the drug

In January 2006 , The Patent Controller in Chennai declined to grant Novartis a patent, setting the stage for a prolonged legal battle.

A result of the patent not being granted also meant that the exclusive marketing rights for the drug were lost by Novartis.

2006: Novartis goes to court

Novartis filed a series of writ petitions against the Government of India, CPAA, and four Indian generic manufacturers (Natco, Cipla, Hetero and Ranbaxy), before the Madras High Court. The pharmaceutical giant challenged the decision not to grant it a patent and the section of the Indian Patents Act that had prevented it from being granted.

2007: Government tells Intellectual Property Appellate Board to hear appeal

After the petitions by Novartis were converted into statutory appeals, the government notified the Intellectual Property Appellate Board to hear appeals.

2007: Madras High Court rejects Novartis pleas

The Madras High court rejected the writ petitions filed by Novartis in August 2007. Novartis did not challenge the high court decision.

2009: Intellectual Property Appellate Board rejects Novartis’ appeal

The IPAB in June 2009 rejected the appeal for a patent for the new version of Glivec.

The IPAB held that there was a new inventive step involved in the creation of the new version of the drug and therefore overturned the Patent Controller’s findings. However, it rejected the claim that the drug had significantly higher efficacy over the original version of the molecule. It was this finding that resulted in the IPAB rejecting the patent for Glivec.

2009: Novartis goes to the Supreme Court

On 10 August, 2009, Novartis filed a petition with the Supreme Court seeking to quash the decision of the IPAB rejecting the appeal of Novartis.

2011: Supreme Court begins hearing petition

On 4 February, 2011, the Supreme Court began hearing the petition.

2013: Supreme Court upholds IPAB order refusing to grant Novartis a patent for Glivec

The Supreme Court today upheld the IPAB order not granting a new permit for cancer drug Glivec.