AstraZeneca has once again failed in its attempt to get patent protection in India on its lung cancer drug Iressa.
The country’s Intellectual Property Appellate Board has dismissed an appeal filed by AstraZeneca challenging earlier rulings in August 2007 and May 2011 concerning the patent on Iressa (gefitinib). The board, for the third time, said it did not find merit in the appeal, claiming the invention was obvious.
Natco Pharma (later joined by another domestic drugmaker, GM Pharma), had opposed the initial patent application and the courts have backed their objections.
AstraZeneca told PharmaTimes World News that “regarding the Indian patent deal on Iressa, we are disappointed by the IPAB’s decision. We are confident in the validity of the claims in this patent application and are now evaluating our next steps”. That could see the Anglo-Swedish drugmaker take its case to India’s Supreme Court.
The case is the latest stand-off between India and pharma. Last month, Pfizer said it would appeal after the patent on its kidney and liver cancer drug Sutent (sunitinib) was revoked, while Bayer is currently trying to overturn a compulsory licence order imposed by the Indian Patent Court in March, forcing the company to give Natco exclusive rights to manufacture a generic version of its liver and kidney cancer Nexavar (sorafenib) for the Indian marketplace.
In September, the High Court in Delhi dismissed a patent infringement case filed by Roche over Cipla’s version of its cancer drug Tarceva (erlotinib). The most high-profile case is Novartis’ legal challenge against India’s patent laws following rejection in 2006 of the company’s patent application for its leukaemia treatment Glivec (imatinib).
Patent war ‘reaching a head’
Commenting on the situation, Nicholas Jones, partner and patent attorney at Withers & Rogers, said “there is a sense that the patent war between big pharma and the Indian Government…is reaching a head”. He added that “the sheer volume of these types of appeals coming through indicates that the Indian Government and courts are taking a hard line on patent matters – a position which is likely to be heavily influenced by the country’s commercial interest as a leading generics producer”.
Dr Jones went on to claim that the Indian authorities’ “specific use of exclusions to block patent applications on the grounds of failing to demonstrate enhanced efficacy and leaving this open to interpretation, seems out of step with patent legislation in other parts of the world. Similarly, the use of compulsory licence orders appears to be anti-patentee”.
He concluded by saying it is “vital that big pharma companies retain the right to protect their innovations. By bringing this in to question, the Indian Government could jeopardise the future of new drug research and development and the benefits it can bring globally”.
