Additional evidence proving enhanced therapeutic efficacy under Section 3(d) is admissible on appeal in exceptional circumstances.

The Appellants filed a National Phase Application (No. 201817048074) on December 19, 2018, for a "Method of Producing Diphenylmethane Derivative," an SGLT inhibitor

The Controller issued a First Examination Report (FER) raising objections under Section 2(1)(ja) (inventive step) and Section 3(d) (non-patentability of derivatives)

While the Controller eventually accepted that the invention possessed an inventive step under Section 2(1)(ja), the application was rejected on January 4, 2022, under Section 15

The rejection was based on the Appellant's failure to provide "conclusive evidence" of enhanced therapeutic efficacy as required by Section 3(d), characterizing the submitted stability and solubility data as mere "pharmacokinetic data/physical properties"

During the appeal, the Appellants sought to introduce additional data via an affidavit, citing the COVID-19 pandemic as the reason for the delay in procurement

1. Whether the subject application’s crystalline form c28 met the requirement of "enhanced therapeutic efficacy" under Section 3(d) of the Patents Act

2. Whether additional data/evidence not presented before the Controller can be admitted at the appellate stage and remanded for reconsideration

Section 3(d) of the Patents Act, 1970, which precludes the patenting of a new form of a known substance unless it shows significantly enhanced therapeutic efficacy

Section 2(1)(ja) regarding inventive steps

Order XLI Rule 27 of the Code of Civil Procedure (CPC) to permit the production of additional evidence in an appellate court

Principle from University of Miami v. The Controller of Patent, which allows the submission of additional documents and data to overcome objections raised by the Patent Office

The court observed that the Controller’s rejection was solely predicated on the Appellant's failure to meet the evidential threshold for Section 3(d) at the time of the hearing

The court found the Appellant's explanation for the missing data—constraints imposed by the COVID-19 pandemic—to be reasonable and sufficient

Since the Court had already exercised its powers under Order XLI Rule 27 CPC to take the new data on record, it reasoned that the Controller must be the first instance authority to evaluate this evidence to determine efficacy

The court noted that because the objection regarding inventive step under Section 2(1)(ja) had already been resolved in favor of the Appellant, the only remaining barrier was the assessment of the newly provided efficacy data

The court held that while the Controller was correct to reject the application based on the record then available, the interests of justice required the consideration of the new data

The Controller was directed to decide the matter independently within four months, and the status of the application was ordered to be updated from "refused" to "pending"