The Intellectual Property Appellate Board has dismissed an appeal by British drug-maker Astra Zeneca on its cancer drug Gefitinib.
The multinational drug-maker had approached the Intellectual Property Appellate Board (IPAB), challenging the rulings of the Patent Controller on the patent application covering quinazoline derivatives - that includes Gefitinib.
Outlining the contours of the case, the IPAB order said: “In these circumstances, while observing that this Board had already 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. The appeal is dismissed.”
Astra Zeneca markets the drug under brand-name Iressa, and it is used to treat advanced or malignant non-small cell lung cancer in patients that failed traditional treatment.
Disappointed with the IPAB decision, Astra Zeneca said: “We are confident in the validity of the claims in this patent application and are now evaluating our next steps.”
Multinational drug-makers and local drug companies have been locked in several patent-related battles in the country.
Their outcomes are significant, as it would impact the availability of critical medicine at affordable costs.
Patent opposition
Astra Zeneca’s patent application was opposed by Natco and GM Pharma at the pre-grant stage (before a patent is granted) for lacking novelty, being obvious and lacking an inventive step.
The opposition also included section 3(d), which is a provision to prevent ever-greening, especially in a developing country like India where access to life-saving drugs such as Gefitnib at affordable prices is a necessity, explained a lawyer with S. Majumdar & Co, the law-firm that represented Natco Pharma and GM Pharma, at the pre-grant opposition and review stage.
The Indian Patent Act’s Section 3 (d) seeks to prevent drug-companies from tweaking existing patents and seeking a fresh period of protection and monopoly. The law requires the drug to establish greater efficacy than existing products in the market to be eligible for a fresh patent.
The Patent Office refused Astra Zeneca a patent on the drug in 2007.
Subsequently, AstraZeneca UK Ltd filed a review petition before the Patent Office regarding the August 2007 order.
In its order on May 2011, this petition too was dismissed for being like an appeal rather than a review petition.
Further it said, the review petition failed to point out any error apparent on the face of the order dated August 2007 and thus held the review petition as being not admissible, a lawyer explained.