ARTICLE
23 November 2015

Indian Patent Office' Consecutive Decision On Rejecting Tofacitinib Patent Application

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Pfizer Products, Inc. (Pfizer) filed Indian patent application 991/MUMNP/2003 entitled "Chiral Salt Resolution" in the Indian Patent Office (IPO) on October 27, 2003.
India Intellectual Property

Pfizer Products, Inc. (Pfizer) filed Indian patent application 991/MUMNP/2003 entitled "Chiral Salt Resolution" in the Indian Patent Office (IPO) on October 27, 2003. The '991 application describes methods for effecting chiral salt resolution from racemic mixtures of enantiomers, particularly precursor enantiomers, for use in making pyrrolo[2,3-d]pyrimidine compounds. The said application is a national phase application of WO 02/096909 (PCT/IB02/01905) filed on May 29, 2002. The First Examination Report for the present invention was issued on 13th March, 2008 in which the Examiner rejected claims due to lack of novelty based on the prior art (WO 0142246) as well on the basis of Section 3(d). The applicant filed a response on 27th January, 2009 with amended claims. Since there were outstanding objections related to Novelty, Section 3(d) and Section 8, the applicants were called for a hearing on January 22, 2015. During the hearing, the Examiner raised a new objection for the first time that the claims were unpatentable under Section 3(d) of the India Patents Act 1970, as amended (Patent Act) and hence the application was rejected. Pfizer appealed and on October 31, 2014, the Intellectual Property Appellate Board (IPAB) contended that the patent office had violated the principles of natural justice thereby set aside the order and directed the IPO to reconsider the application. Upon reconsideration, the Indian Patent Office on September 3rd, 2015 denied Pfizer (Applicant) Inc a patent on its rheumatoid arthritis drug Tofacitinib for the second time. The IPO rejected the Patent Application on the grounds of anticipation by prior claiming as well as on basis of Section 3(d) of the Patents Act (Act).

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