The patent application which was opposed by Pharma firms including Ranbaxy Labs and Natco Pharma has now been granted to Pfizer. The opposition was filed by four parties, including Ranaxy Labs Ltd, Natco Pharma Ltd, GM Pharma Ltd, and an individual named Reena Manoharan.
This anti-fungal drug Voriconazole, is sold in US under the brand name Vfend.
Analysing various objections raised by the generic firms against approving the application, the Deputy Drug Contoller of Patents and Designs, Patent Office New Delhi, said that as per the discussions “there appears to be no ground to dissolve the patent on this application, hence the patent is granted and oppositions are dismissed.”
The application titled “Pharmaceutical formulations containing Voriconazole”, which is for a pharmaceutical formulation consisting of anti-fungal agent voriconazole, has been lyophilised to improve its stability in water.
In its opposition, Ranbaxy said that the subject matter of the application is not novel, the matter lacks innovation, its utility is not substantive, its claims are indefinite and that no patent can be granted for a combination of known substances. Natco said that the matter lacks innovation and novelty, and that the invention is present in the prior disclosure.
Pfizer rejected each and every objection with its arguments, stating that its application is eligible for approval in terms of novelty, inventive step, and that the Section 3(d) does not apply in the present matter. It has also submitted response to the objections raised in the First Examination Report (FER) with relation to a few US and other patents.