Regulatory Focus™ > News Articles > Indian Court Sides with Gilead in Patent Dispute

Indian Court Sides with Gilead in Patent Dispute

Posted 02 February 2015 | By Michael Mezher 

Indian Court Sides with Gilead in Patent Dispute

The Delhi High Court has ruled that India’s patent office failed to follow proper procedures in evaluating Gilead’s patent application, LiveMint reports. The ruling invalidates the Patent Office’s recent decision to reject Gilead’s patent application for one of the active metabolites of its hepatitis C drug Sovaldi.


On 13 January 2015, India’s Patent Office rejected a patent application for a compound produced by the body as it metabolizes Sovaldi. Gilead said the patent rejection would not change its plans to sell the drug in India, and that the company would appeal the Patent Office’s decision.

In its decision to reject Gilead’s patent application (6087/DELNP/2005), the Patent Office observed that though changes described in the application make Sovaldi “novel and inventive,” the application filed by Gilead does not prove its enhanced “therapeutic efficacy” compared to its “closest prior art,” compound D1 (patent WO2001/92282).

The decision continues: “In other words we can say that a molecule with minor changes in addition to the novelty must show significantly enhanced therapeutic efficacy as compared to the nearest prior art molecule which is structurally and functionally close.” Additionally, the decision states that there was insufficient data in the application to demonstrate “improvement in therapeutic efficacy.”

The Court Ruling

The High Court's ruling, issued 30 January 2015, did not address the content of the Patent Office’s decision, but rather issues in the procedure the office used.

Gilead’s lawyers argued that the Patent Office decision relied too heavily on the pre-grant opposition filed by Natco Pharma Ltd.

Justice Rajiv Shakdher sided with Gilead, finding the procedure the Patent Office followed was not in line with law.

The Indian Patent Office will now need to reevaluate Gilead’s patent application. The High Court of Delhi website has not published a written decision at this time. When reached for comment by Regulatory Focus, Gilead said it will wait for the official order before commenting.

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