Pfizer gets breather as IPAB quashes order rejecting patent for arthritis drug

Written by Sajan C Kumar | Chennai | Updated: Nov 1 2014, 06:23am hrs
In what could be seen as a breather for Big Pharma firms in the country, the Intellectual Property Appellate Board (IPAB) on Friday set aside an order rejecting patent to US major Pfizers rheumatoid arthritis treatment drug, Tofacitinib, in India.

The IPAB bench of Justice KN Basha, chairman, and DPS Parmar, technical member- patents, on an appeal by Pfizer, ruled that the assistant controller of patents & design had erred in rejecting the patent and there exists flagrant violation of principles of natural justice.

The IPAB bench ordered that the matter be reconsidered by an assistant controller other than the one who authored the impugned rejection order, within the next three months, providing sufficient opportunity to Pfizer to argue their case.

Coming down heavily on the assistant controller for not communicating the objections in advance, the IPAB bench observed that the objections raised under Section 3 (d) of the Indian Patent Act, were neither contained in the First Examination Report nor in the subsequent hearing notice, but was only communicated during the hearing.

In view of these serious lapses on the part of assistant controller, we are of the view that the impugned order had been vitiated on the ground of flagrance violation of principles of natural justice, the bench said. The bench further said that reasonable opportunity should be given to Pfizer to submit response to the objections under section 3 (d) which deals with the enhancement factor of the known efficacy of the said discovery that will enable the company to put forward submissions to prove novelty of the invention.

The Patent Office had dismissed Pfizers application for the patent, titled Chiral Salt Resolutionthe pharma formulation for Tofacitinib drug, citing that the claim was not patentable under section 3 (d) of the Patent Act, as it lacks novelty.

Archana Shanker, senior partner, Anand and Anand, who appeared for Pfizer Products, argued that the assistant controller had rejected the patent application without giving the objections to them in advance, thereby, deprieving opportunity for counter argument as well as erred in many aspects. She submitted that it is classic case of flagrant violation of principles of natural justice and pleaded that the impugned order be set aside and the patent application be moved for patent registration.