In a setback to multinational drug major AstraZeneca, the Intellectual Property Appellate Board (IPAB) has dismissed its appeal against an earlier ruling that refused it a patent on lung cancer drug Gefitinib.
The London-headquartered pharmaceutical and biologics company's attempt to seek patent for Gefitinib was first turned down by the the Indian Patent Office in 2007 on the grounds of known prior use, while accepting the pre-grant opposition by Hyderabad-based Natco Pharma Limited, among others.
The company filed two review petitions, dismissed by the Patent Controller in May 2011. It then approached the IPAB against their dismissal.
"While observing this board had taken a view that no appeal shall lie against the controller's order passed in a review petition, even on merits, the appeal against the review petition fails," IPAB chairman Prabha Sridevan said in an order on Monday. In its appeal, the drug maker had argued the controller had erred on various aspects of patent determination and also in concluding that the comparison test did not establish increased efficacy of the drug.
"In the impugned order (related to review petition), the controller had accepted the contention of the respondent that any error which requires long-drawn process of reasoning cannot be rectified in review... Therefore, even if we entertain the appeal against the review, we do not find any error above in the review petition," IPAB said.
AstraZeneca sells the drug at around Rs 1 lakh for 30 tablets (250 mg), while Natco Pharma, which is considered to be the market leader in terms of overall sales of the drug, sells the same at around Rs 10,000. Some 13 companies, including Cipla, Dr. Reddy's, Glenmark and Cadila manufacture and market this generic drug in India.
The annual sales of Gefitinib this year is expected to be in the range of Rs 60 crore to Rs 70 crore, according to industry estimates.