Not Again! Pfizer fails to establish enhanced efficacy

Pfizer Products Inc., US drug manufacturing company, cannot seem to catch a break.

One year after the patent office, Mumbai, rejected a review petition pertaining toa patent application for Pfizer’s rheumatoid arthritis treatment drug Tofacitinib, the reconsideration of the matter as directed by Intellectual Property Appellate Board (IPAB), has once again yielded the same result.

In 2003, Pfizer had filed a patent application titled “Chiral Salt Resolution” for its rheumatoid arthritis treatment drug Tofacitinib, sold under the brand names Xeljanz and Jakvinus, which was rejected by the patent office in 2011. A review petition was filed against this decision which was again rejected by the patent office in March 2014. Thereafter, the company approached the IPAB with an appeal. After allowing a condonation of delay petition filed by Pfizer,IPAB Bench had set aside the rejection order of the patent office. According to the Bench,since the learned Controller had not raised the objections under section 3 (d) of the Patents Act in the first examination report or the hearing notice, raising of the objections for the first time during the date of hearing and as such the non-communication of the said objections caused grave prejudice, as the appellant was not given the opportunity to respond to the objections. Thus there was flagrant violation of principles of natural justice. Moreover, even in the review order, learned Controller failed to consider such lapse which certainly amounted to error apparent on the face of the record; thereby necessitating reconsideration by another Assistant Controller and allowing Pfizer to argue their case.

However IPAB’s direction for reconsideration did not aid Pfizer one bit. Assistant Controller of Patents & Designs stated that Pfizer had once again failed to prove that the ‘invention’ was an invention under the provisions of the Act, as the company did not establish that the claimed compound had enhanced efficacy over the base compound, and hence was not patentable under Section 3(d) of Patents Act.According to section 3 (d) of Patents Act, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances are considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Pfizer is not the only company which has faced such disappointments. In the past few years, since Section 3 (d) was introduced by way of Patent (Amendment) Act 2005, pharmaceutical companies like Bayer Healthcare AG have also been denied grant of patents. Though criticism pertaining to Section 3 (d) continues, it is also felt that introduction of the said clause was necessary for prevention of ever-greening of patents, and that the removal of Section 3 (d) would delay introduction of generics in the market, thereby negatively affecting the public health.[1]