In President and Fellows of Harvard College vs Controller General of Patents, Designs and Trademarks [C.A.(COMM.IPD-PAT) 493/2022], the Delhi High Court addressed a recurring procedural infirmity in patent prosecution: the failure of the Controller to consider amended claims prior to refusing an application.

The Court set aside the impugned order on the ground that it was rendered without considering the amended claim set that materially altered the nature of the invention.

The appeal concerned the refusal of patent application number 201617000758, entitled “SC‑β Cells and Compositions and Methods for Generating the Same”, relating to non‑native pancreatic beta (β) cells derived from stem cells, intended for therapeutic use in treatment of diabetes. The application, as originally examined, contained claims directed to a composition comprising non-native pancreatic β cells along with pharmaceutically acceptable carriers.

In the First Examination Report, the Controller raised objections under Sections 3(j) and 3(e) (non‑patentable subject matter) as well as under Sections 10(4) and 10(5) of the Patents Act (lack of clarity, and insufficiency of disclosure).

Following the hearing under Section 14, the Appellant filed post-hearing written submissions along with an amended set of claims, amending the claims from compositions to non‑native pancreatic β cells per se.

The Controller proceeded to refuse the application on the basis of the original claim framework on the grounds of Sections 3(j), 3(e), 10(4) and 10(5).

While the Court did not express any opinion on the merits of the objections under Sections 3(j), 3(e), and 10, it found that despite the amendment, the Controller relied on the objections identified in the composition claims, such as absence of technical disclosure of the claimed composition, absence of disclosure all the components or their amounts or synergy data.

The Court found that the impugned order merely recorded the existence of the amended claims as an “alternative set of claims” without undertaking any examination thereof. It observed that once the amended claims were placed on record, particularly where they altered the nature of the invention from a composition to a product (cell) claim, it became necessary for the Controller to examine their impact on the objections raised. The Court expressly observed that the “entire basis” of the refusal may undergo change upon consideration of the amended claims.

Reiterating its earlier decisions in Jitendra Kohli vs Controller of Patents and Akebia Therapeutics Inc. vs Controller of Patents, the Court held that failure to consider amended claims constitutes a “glaring error”.

On this limited ground of procedural infirmity, the Court set aside the impugned order and remanded the matter to the Patent Office for fresh consideration of the application in light of the amended claims. The Court clarified that it had not expressed any opinion on the merits of the objections under Sections 3(j), 3(e), or 10, which remain open for determination.