The Delhi High Court recently emphasized a key procedural requirement under India’s patent law. The court ruled that when rejecting a patent based on Section 3(d) of the Patents Act, 1970, the Controller of Patents must explicitly name the "known substance" in the hearing notice against which the claimed invention is being assessed.
Section 3(d) prevents the patenting of a “new form” of a known substance unless it shows improved therapeutic effectiveness. Justice Amit Bansal clarified that this legal standard must be strictly followed, and any objection raised under this section must be backed by specific and objective details.
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The Court laid down three essential elements the Controller must mention in the hearing notice:
- The identity of the known substance with established therapeutic benefits.
- A clear explanation showing how the claimed invention is either a derivative or another form of that known substance.
- A direct and measurable comparison between the therapeutic efficacy of the claimed invention and the known substance.
“The focus of Section 3(d) is on the 'new form of a known substance'... These aspects must be stated in the hearing notice to give the applicant a fair chance to respond,” said the Court.
The ruling came during the review of a rejected patent application by a Japanese pharmaceutical company. The rejection was based on the claims allegedly lacking inventive step (under Section 2(1)(ja)) and being non-patentable under Section 3(d). However, the Court observed a significant procedural lapse. The hearing notice merely mentioned a prior art document (D1) but failed to identify a specific known substance from it.
This failure, according to the Court, deprived the applicant of a fair chance to respond and present data comparing the new invention’s efficacy with the correct known substance.
“The appellant cannot be expected to infer a known substance and provide efficacy data based on that assumption. Without a clear reference in the hearing notice, the rejection under Section 3(d) cannot stand,” the Court highlighted.
The Court also addressed the inventive step objection under Section 2(1)(ja). It found that this too was affected by the lack of clarity regarding the known substance. Since the reasoning behind both objections was closely linked, the Court concluded that the inventive step claim also required reconsideration.
“Since the reasoning under Section 2(1)(ja) is closely intertwined with the assessment under Section 3(d)... this too must be reviewed after proper identification of the known substance and comparison of enhanced efficacy data,” the judgment said.
In conclusion, the Court set aside the rejection and sent the matter back for fresh consideration, instructing the Patent Office to issue a proper hearing notice with all necessary details.
Appearance: Mr. Ankush Verma, Mr. Debashish Banerjee, Ms. Vaishali Joshi, Mr.Vineet Rohilla, Mr. Pankaj Soni, Mr.Rohit Rangi, Mr. Tanveer Malhotra & Ms. Gurmeet Kaur, Advocates for Appellant; Mr. Premtosh K. Mishra, CGSC with Mr. Manish Vashisht, Ms. Sanya Kalsi and Mr. Prakhar Singh, Advocates for Respondent
Case title: Taiho Pharmaceutical Co. Ltd v. The Controller Of Patents
Case no.: C.A. (COMM.IPD-PAT) 6/2022
