IPAB sets aside order against Cima Labs' painkiller for cancer

The Assistant Controller shall consider the matter afresh

The Intellectual Property Appellate Board (IPAB) has set aside an order of the Patent office, issued against a patent application of US-based Cima Labs related to an oral fentanyl pharmaceutical combination. Cima Labs has its fentanyl buccal tablet under the brand Fentora, mainly used as a cancer painkiller drug for breakthrough pain management.

The IPAB issued the order after considering the argument of Cima Labs that the Assistant Controller of Patents and Designs has not followed up the objections raised in the First Examination Report, by the examiner, in the later proceedings, among other contentions.

IPAB Chairman Justice K N Basha and technical member (Patent) D P S Parmar said that the Board is of the considered view that the impugned order was in flagrant violation of natural justice. The Board is constrained to set aside the order "and the controller shall consider the matter afresh by furnishing the objections on the date of hearing itself thereby enabling the company to give explanations for those objections," added Justice K N Basha.

In the order dated May 22, 2012, the Assistant Controller has observed that the composition of Fentanyl in the claims for the treatment of breakthrough pain of the cancer patient while administered through oral mucosa of a patient lacks inventive step. The controller added that the composition of Fentanyl and the method of preparing are not novel. It added an almost similar type of invention in a parallel invention application filed by the same company has been refused by the Assistant Controller of Patents and Designs, Kolkata, under concurrent jurisdiction.

In 2004, the oral disintegrated tablet and oral transmucosal technologies of Cima, which specialises in orally disintegrated tablet, oral transmucosal and oral powder drug delivery technologies, was acquired by Cephalon, Inc. In 2007 all Cephalon's drug delivery technologies are consolidated under Cima, according to the company.

Fentora is produced through and oral transmucosal delivery system, while it has also developed Actiq, a brand under the Oral Transmucosal drug delivery system utilising a "lozenge on a stick", with active drug fentanyl citrate.