06 October 2022

Bar of patentability under Section 3(d) – Non-identification of ‘known substance’ is fatal

The Delhi High Court has held that for an objection of non-patentability under Section 3(d) of the Patents Act, 1970 to be raised, the basic pre-condition would be the identification of the ‘a known substance’. Section 3(d) bars patentability of a ‘new form’ of ‘a known substance’, without establishing enhanced therapeutic efficacy.

The High Court was of the view that it cannot be left to the Applicant to deduce as to what is the known substance and thereafter give efficacy data qua that known substance, based on the said deduction.

Observing that the compound which constituted the ‘known substance’ was not identified in the hearing notice, the Court stated that one specific known substance is to be identified and the manner in which the claimed compounds are ‘new forms’ ought to be mentioned by the Patent Office, even if not in detail but at least in a brief manner.

Holding the impugned order, rejecting the patent application, as not sustainable, the Court observed that Appellant did not have adequate opportunity to deal with the objection under Section 3(d) in as much as apart from merely specifying the said objection for the first time in the hearing notice, the manner in which the said objection was attracted was completely absent.

The Court in DS Biopharma Limited v. Controller of Patents and Designs [Decision dated 30 August 2022] noted that the objection was crystalized only in the impugned order.

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