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SENTHILKUMAR RAMAMOORTHY
Bristol Myers Squibb Company, represented by its constituted attorney/authorised signatory, Vivek Ratudi – Appellant
Versus
Deputy Controller of Patents, Patent Office, Intellectual Property Building, G. S. T. Road, Guindy, Chennai – 600032 – Respondent
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
Enhanced bioavailability must be substantiated with data demonstrating enhanced therapeutic efficacy to meet patentability criteria under Section 3(d) of the Patents Act.
An interlocutory injunction can be granted if infringement is established, and no credible challenge to patent validity is presented, even when prior publications and claims are involved.
Point of Law : Intellectual Property Law - Revocation of patents - Appropriateness of Bioavailability and Bioequivalency as Pre- Market Clearance Considerations” by Jane Moffitt, which opined that “a....
A new form of a known substance can only be considered patentable provided the same demonstrates enhanced efficacy.
The main legal point established in the judgment is that an amended patent claim must not broaden the scope beyond the originally filed claims and must demonstrate significant enhancement of therapeu....
A claimed patent must demonstrate novelty and an inventive step, which cannot be established by mere derivations that lack enhanced efficacy.
The Controller must provide a reasoned decision on pre-grant opposition addressing all raised grounds, particularly under Sections 3(d) and 3(e), to ensure compliance with natural justice standards.
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