)
Pharmaceutical major Pfizer Inc has received a patent for its anti-fungal drug Voriconazole, which it is selling in US under the brand name Vfend, overcoming opposition from Ranbaxy Labs Ltd and Natco Pharma.
The composition is industrially useful in the preparation of medicaments for the treatment of fatal fungal infection and the opposition arguments on non-patentability of the innovation and prior claiming of the invention are not sustainable, said the Deputy Controller of Patents and Designs.
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.
The opposition was filed by four parties, including Ranaxy Labs Ltd, Natco Pharma Ltd, GM Pharma Ltd, and an individual named Reena Manoharan.
Pfizer rejected each and every objections 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.
The Deputy Controller, in his decision, said that the revised claims have full support in the specification and have been allowed. The official also acknowledged the inventive step of the patent, after finding that the patent was granted in United States Patent and Trademark Office and the European patent office on the same claims acknowledging novelty and inventive step.
