Additional evidence proving enhanced therapeutic efficacy under Section 3(d) is admissible at the appellate stage.

The Appellants filed a National Phase Application (No. 201817048074) for an invention titled "Method of Producing Diphenylmethane Derivative," an SGLT inhibitor

Following a First Examination Report (FER) raising objections under Sections 2(1)(ja) and 3(d) of the Patents Act, 1970, the Appellants filed amendments and divisional applications

While the learned Controller found the invention met the "inventive step" criteria under Section 2(1)(ja), the application was rejected on January 4, 2022, solely under Section 3(d)

The Controller held that the Appellants failed to provide conclusive evidence of "enhanced therapeutic efficacy," classifying the submitted data on stability and solubility as mere "pharmacokinetic/physical properties"

During the pendency of this appeal, the Court permitted the Appellants to file an affidavit containing additional data under Order XLI Rule 27 of the CPC, which was previously unavailable due to the COVID-19 pandemic

1. Whether the subject application’s failure to meet the evidential threshold of Section 3(d) at the time of the Controller's hearing justifies refusal when additional efficacy data is subsequently provided during the appellate stage.

2. Whether additional data/evidence can be submitted and considered by the Controller to overcome objections during the patent prosecution process.

The Court applied Section 3(d) of the Patents Act, 1970, which prohibits the patenting of new forms of known substances unless they show significantly enhanced therapeutic efficacy

It also relied on Section 2(1)(ja) regarding the "inventive step"

Procedurally, the Court exercised its appellate powers under Section 117A of the Act and Order XLI Rules 27, 28, and 29 of the Code of Civil Procedure (CPC), which allow for the admission and consideration of additional evidence at the appellate stage

The Court further cited the principle from University of Miami v. The Controller of Patent, establishing that the submission of additional data to overcome specific patentability objections is permissible under Indian Patent Law

The Court observed that the Controller's rejection was predicated on a lack of "evidential threshold" regarding therapeutic efficacy

It noted that the Appellants were hindered from providing this data during the initial proceedings due to the "exceptional circumstances" of the COVID-19 pandemic

By invoking Order XLI Rule 27 of the CPC, the Court formally took the new data on record, noting that while an appellate court can evaluate evidence, the specialized nature of patent efficacy requires the Controller's technical expertise

Since the objection under Section 2(1)(ja) (inventive step) was already resolved in the Appellant’s favor by the Controller, the only remaining barrier was Section 3(d)

The Court reasoned that in the interest of justice, the Controller must reconsider the application de novo specifically regarding the new efficacy data provided in the supplementary affidavit

The Court held that additional data submitted to overcome patent objections is permissible and directed the Controller to evaluate the new affidavit dated April 1, 2022, after affording the Appellant a fresh hearing

The Controller is ordered to decide the application independently within four months, and the status of the application is to be updated from "refused" to "pending" on the patent register