Hyderabad: After hearing pre-grant oppositions filed by Indian drug companies for more than a year, the patent office in New Delhi has rejected pharmaceutical giant AstraZeneca’s patent application for its lung cancer drug Iressa.
The patent office rejected the application citing “known prior use” of the drug, which prevents grant of a patent in India under the country’s 2005 amended patent laws.
Iressa is the third non-Indian drug brand to be turned down under relatively new Indian patent laws. Novartis AG’s Glivec and Eli Lilly and Co.’s Forteo have suffered similar rejections in different Indian patent offices.
Astra’s Indian generic rivals, Natco Pharma Ltd and J M Pharmaceuticals Ltd, had opposed the patent application citing that the drug has been in the public domain before the company filed its patent in India. Iressa is a branded formulation of the drug, known in generic terms as Gifitinib.
“We understand that India has different interpretations to patent applications, though Iressa is a patented product for Astra elsewhere in the world,” noted Staffan Ternby, a spokesman for AstraZeneca. He declined to say if the company would challenge the Indian patent office’s decision.
Astra filed its application for patenting Iressa in India in 1996. The drug, when launched here, first attracted the ire of domestic rivals after Astra applied for an exclusive marketing right three years ago. Though the right was not granted, Astra had bet on obtaining a product patent to protect its marketing rights.
Natco’s company secretary Adi Narayana said his company filed a pre-grant opposition against Astra’s application since the drug was not a new drug, under Indian law. “The scientific data regarding the efficacy and therapeutic functions of the chemical entity, Gefitinib, had been in the public domain before AstraZeneca filed its patent application in India,” he said. Natco, he said, also opposed the patent because of a “lack of inventive steps.”
Astra’s patent rejection follows two similar moves in India in the last two years.
The patent office of Chennai refused Novartis’ Glivec in 2006, while the Kolkata patent office rejected Eli Lilly’s osteoporosis drug, Forteo, in September. Novartis challenged the decision in the Madras high court and a related patent appeal is pending with the Intellectual Property Appellate Board. Natco was one of five drug makers that had opposed Glivec as well. Ely Lilly hasn’t said what it plans to do about the patent rejection.