S. 3(d): Examiner must identify ‘known substance’, explain how claimed compounds constitute new form
In a welcome decision passed recently by the High Court in the matter of DS Biopharma Limited vs The Controller Of Patents And Designs And Anr. , the High Court clarified that an objection raised under Section 3 (d) of the Patents Act is not maintainable unless the alleged ‘known substance’ is first identified by the Patent Office. The High Court went on to clarify the preconditions for an objection under Section 3(d) of the Patents Act to be made out.
The High Court considered this issue in an appeal instituted by the patent applicant, DS Biopharma Limited (hereinafter the “Appellant”), against an order of refusal of the Patent Office under Section 3(d) of the Indian Patents Act.
The present appeal was instituted by the Appellant challenging the order by the Assistant Controller of Patents and Designs rejecting its patent application 201717040270 for its invention titled ‘Compositions comprising 15 oxo epa Or 15 oxo dgla and methods of making and using same’. The application was originally filed with Claims 1-26, vide the First Examination Report (FER) dated March 05, 2020, the Patent Office raised objections with respect to lack of inventive step, non-patentability under Section 3(i) and lack of clarity and conciseness under Section 10(5) and Section 10(4)(c) of the Act.
In reply to the Examination report, the Appellant cancelled claims 7-26 and restricted claims to an amended claim set comprising claims 1-6. After a response to the FER was filed, the Patent Office issued a hearing notice with an objection under Section 3 (d) of the Patents Act stating that: “Subject matter claimed in claim 1, 4 is not Patentable u/s/ 3 (d) of Patents Act;”. The Appellant attended the hearing and in reply filed its written submissions and also amended it claims to further restrict them to 1-4. However, the Patent Office rejected the patent application vide its order dated January 13, 2021, giving rise of the present appeal proceedings.
The Appellant challenged the order on the ground that the objection raised in the hearing notice did not specify proper reasons for raising an objection under Section 3 (d) of the Patents Act. Placing reliance on the IPAB judgement of Fresenius Kabi Oncology Limited v. Glaxo Group Limited & Anr., it was contended by the Appellant that for an objection under Section 3(d) to be raised it was obligatory for the Patent Office to (i) identify the ` known substance’; (ii) provide reasons to show HOW and WHY the claimed substance is a ‘derivative’ or a ‘new form’ vis-a-vis the ‘known substance’ and (iii) provide a valid basis for asserting that the alleged ‘known’ substance and the claimed molecule or substance have the same ‘known’ efficacy?
As per the Appellant, the hearing notice has failed to identify any of the above three factors. The Appellant argued that the compound which constitutes the `known substance’ was not identified in the hearing notice. It was the grievance of the Appellant that in the absence of identification of the 'known' compound in the hearing notice, the Appellant did not get a reasonable opportunity to defend its patent application, thus violating the principles of natural justice.
Additionally, it was contended by the Appellant that all the initial objections which were raised in the FER were satisfied and the only new objection which was raised in the hearing notice was in respect of Section 3(d) of the Act. However, apart from Section 3(d), the refusal order again reintroduced the grounds of lack of inventive step under Section 2(1) (ja) and lack of clarity under Section 10(4)(c) of the Indian Patents Act, which further violates the principles of natural justice.
In reply, it was argued by the Patent Office that the Appellant failed to provide efficacy data even though it was in possession of all the prior arts D1 to D6 and accordingly, the patent has been rightly rejected.
Findings of the Court
The Court, while placing reliance on the impugned order of Fresenius Kabi supra. observed that “Section 3(d) bars patentability of a `new form’ of `a known substance’, without establishing enhanced therapeutic efficacy. For the said objection to be raised, the basic pre-condition would be the identification of the `a known substance’. The said `known substance’ could be one substance or a compound/s derived from a Markush formula. However, it has to be identified. 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.”
The Court held that the decision was liable to be set aside since the Patent Office had failed to identify the compound which constitutes the `known substance’, while issuing the hearing notice. The Court clarified that for the purposes of a Section 3(d) objection, the specific ‘known substance’ is to be identified and the manner in which the claimed compounds constitute ‘new forms’ ought to be mentioned by the Patent Office, even if not in detail but at least in a brief manner.
The Court noted that the rejection order of the impugned application does identify the known substances present in the prior arts. However, the Court held that this identification should have been made in the hearing notice, to provide the Appellant to properly respond to the objection so as to satisfy the preconditions under Section 3(d). Therefore, the Delhi High Court allowed the appeal since it was of the view that the Appellant was not provided with a proper opportunity to respond to the objection under Section 3(d).
The decision of the High Court is welcomed by patent practitioners across the IP fraternity since this decision provided much needed clarity on the manner in which an objection under Section 3 (d) should be raised by the Patent Office. This decision is expected to bring about a significant change in practice about Section 3 (d) of the Patents Act since the judgment lays down specific guidelines for raising such objections, which includes the requirement for the Patent Office to identify the specific compound(s) in the prior art against which a claimed compound has been considered a ‘new form of a known substance’.