IMPORTANT POINT
Enhanced bioavailability must be substantiated with data demonstrating enhanced therapeutic efficacy to meet patentability criteria under Section 3(d) of the Patents Act.

JUDGMENT :

(Senthilkumar Ramamoorthy, J.) :

(Prayer: This Civil Miscellaneous Appeal is filed under Section 117- A of the Patents Act, 1970, to pass an order setting aside the orders dated 30 March 2023 passed by the 1st respondent in Indian Patent Application No.5948/CHENP/2014 and pass any other order and/or direction that this Hon'ble Court deems fit and proper in the facts and circumstances of the case.)

Background

The appellant assails an order dated 30 March 2023 by which Patent Application No.5948/CHENP/2014 was rejected by the Indian Patent Office. The said application was the national phase application derived from PCT Application No. PCT/US2013/027648. The claimed invention is titled “N (5S 6S 9R) 5 AMINO 6 (2 3 DIFLUOROPHENYL) 6 7 8 9 TETRAHYDRO 5H CYCLOHEPTA [B] PYRIDIN 9 YL 4 (2 OXO 2 3 DIHYDRO 1H IMIDAZO [4 5 B] PYRIDIN 1 YL) PIPERIDINE 1 CARBOXYLATE HEMISULPHATE SALT”. The base compound is referred to throughout this order as Compound (I) and the claimed invention as the hemisulphate salt of Compound (I). Upon such application being presented before the Indian Patent Office (the IPO) on 04 August 2014 claiming priority from US Application Serial No. 61/603, 598 dated 27 February 2012, the First Examination Report (FER) was issued on 17 July 2018. The appellant responded to the FER on 16 January 2019. A hearing was held on 13 November 2019 and the appellant filed written submissions on 27 November 2019.

2. Upon the appellant requesting for an update in 2020, the appellant was notified of the pre-grant opposition of the second respondent on 17 December 2020. The opposition was filed on the grounds that: claims 1-6 lack novelty in view of anticipation in prior art D1; claims 1-6 lack inventive step over prior art documents D1- D4; claims 1-5 are excluded from patent protection under Section 3(d) of the Patents Act, 1970 (the Patents Act); claim 6 is excluded from patent protection under Section 3(e) of the Patents Act; and that there was non-compliance with the requirements of Section 8 of the Patents Act. The appellant filed a reply thereto on 15 March 2021 and a hearing was fixed on 4 January 2023. After the hearing, the appellant filed written submissions on 18 February 2023 and revised submissions on 20 February 2023. The impugned order was issued on 30 March 2023, and the present appeal arises in the said facts and circumstances.

Counsel and their contentions

3. Oral arguments on behalf of the appellant were addressed by Ms.Archana Shanker, learned counsel, assisted by Mr.Prem Chander and Mr.Vishal, learned counsel; on behalf of the first respondent by Mr.A.R.Sakthivel, learned SPC. The second respondent remained unrepresented in spite of private notice being served on 21 July 2023 as specified in affidavit of service dated 3 August 2023. The appellant and the first respondent also filed written submissions.

4. Learned counsel for the appellant opened her submissions by pointing out that the monopoly claims are in respect of a hemisulphate salt of Compound (I) and that the international non-proprietary name (INN) given to the substance by the WHO is Rimegepant. With reference to the impugned order, learned counsel pointed out that the objections with regard to both novelty and inventive step were rejected by the first respondent. On account of claim 6 being deleted, she further submitted that the objection with reference to section 3 (e) was rendered moot. In effect, learned counsel submitted that the application was rejected solely by relying on section 3 (d). As regards such rejection, learned counsel submitted that the first respondent failed to appreciate the data provided to support the claim that the invention disclosed enhanced bioavailability resulting in enhanced therapeutic efficacy. She submitted that calcitonin gene-related peptides (CGRP), which are naturally occurring amino-acid peptides, bind to receptors and are known to trigger pathophysiologic conditions, such as neurogenic vasodilation, neuroge