IPAB has allowed an appeal and granted patent to Pfizer for Tofacitinib and its salts

                                                   

In a decision dated 21st August 2020 IPAB vide its Order has allowed an appeal and granted Patent to Appellant M/s.PFIZER PRODUCTS INC., USA for Tofacitinib and its salts. The appeal is against the  order dated 3rd September 2015 passed by the Controller of Patents under Section 15 of the Indian Patents Act, whereby the Appellant’s Indian patent application no. 00991/MUMNP/2003 was rejected on the ground that it is hit by section 13(1)(b) and being non-patentable under section 3(d). The Appellant requested for an urgent hearing of the matter and IPAB considered the request for urgent hearing and passed the present order. 

This Patent application claimed the compound 3-{(3R,4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile and pharmaceutically acceptable salts thereof (Tofacitinib and its salts) and was refused by the patent office on various grounds, including anticipation by prior claiming and section 3(d). The main document cited by the controller for novelty claimed and disclosed the compound 3-(4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl)-3-oxo- propionitrile.  The appeal was filed on various grounds including that the order was against principles of natural justice as the objection of anticipation by prior claiming was never raised during hearing, and “known substance” was not identified for section 3(d) and on various substantive grounds like non-applicability of such grounds. 

IPAB in its order at paragraph 56 stated that the Controller of Patents held that the prior document D1 anticipated the present impugned application as it gives an enabling disclosure of the claimed compound. The finding of the Controller of Patents is incorrect as only the claims of a prior art need to be considered when assessing the objection of anticipation by prior claiming. The disclosure is not to be considered. In D1 there is no direct, clear and unambiguous disclosure of any stereo chemistry associated with the compound 3R, 4R- isomer of any of the compounds of the examples of D1, let alone a specific disclosure of the 3R, 4R-isomer of the compound of Example 14 of D1.There is no direct and unambiguous disclosure in D1 of 3R,4R-stereochemistry.

IPAB has dealt the issue of Section 3(d) from paragraph  36 to 49 and held that Section 3(d) is not applicable to the case as there is no “Known compound”. D1 was not publically available at the priority date of the application. Further, even if Section 3(d) is applied without prejudice, the applicant by evidence has established the superiority of claimed form over 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)amino]- piperidin-1-yl}-3-oxopropionitrile, and other enantiopure forms of compound of D1 and hence the said objection is set aside. 

IPAB also discussed on delay in granting protection of valid Inventions and ground realities at paragraph 60 and enumerated various loop holes in the law that have been narrated from paragraph 60 (a) to Paragraph 60 (t) and warned against misusing the same. 

Indian IP Regime is being strengthened with these kinds of decisions and uploading the Patent Law in India.