* IN THE HIGH COURT OF DELHI AT NEW DELHI % Judgment delivered on: 28.03.2026 + C.A.(COMM.IPD-PAT) 493/2022 PRESIDENT AND FELLOWS OF HARVARD COLLEGE .....Appellant versus CONTROLLER GENERAL OF PATENTS DESIGNS AND TRADEMARKS .....Respondent Advocates who appeared in this case For the Appellant : Dr. Satyapal Arora, Mr. Ashish Sharma, Mr.

Kuldeep Kumar Singh & Mr. Nitin Sharma, Advocates.

For the Respondent : Mr. Balendu Shekhar, CGSC with Mr.

Krishna Chaitanya, Mr. Rajkumar Maurya, Mr. Divyansh Singh Dev and Ms. Tanisha Samanta, Advocates.

Dr. Bhanumathi R, Assistant Controller of Patents & Designs (through VC).

CORAM:

HON'BLE MR. JUSTICE TEJAS KARIA

JUDGMENT

TEJAS KARIA, J INTRODUCTION

1. This is an Appeal under Section 117 of the Patents Act, 1970 (“Act”) read with Section 151 of the Code of Civil Procedure, 1908 filed against the order dated 25.08.2022 (“Impugned Order”) passed by the Controller General of Patents, Designs and Trademarks (“Respondent / Controller”) whereby the learned Controller refused the grant of patent vide Patent Application No. 201617000758 titled as “SC-β CELLS AND COMPOSITIONS AND METHODS FOR GENERATING THE SAME” dated

08.01.2016 (“Subject Application”).

FACTUALMATRIX

2. On 11.06.2013, the Appellant filed the First Priority Application corresponding to the Subject Application vide Application No. US 61/833,898. On 28.03.2014, the Appellant filed the Second Priority Application corresponding to the Subject Application vide Application No. US 61/972,272. On 11.06.2014, the Appellant filed the Patent Cooperation Treaty Application corresponding to the Subject Application vide Application No. PCT/US2014/041992 (“PCT Application”). On

08.01.2026, theAppellant filed the SubjectApplication.

3. On 08.01.2016, the Appellant filed Form No. 13 for amendments in the claims as PCT Application had 1 claim, while the Subject Application is filed with 29 claims. On 01.06.2017, the Appellant filed a request for examination and voluntarily amended the claims. Thereafter, the Respondent issued the First Examination Report dated 28.02.2020 (“FER”). The Appellant filed the response to the FER along with the amended claims and Form No. 13 for voluntary amendment in claims with respect to the PCT Application on 28.08.2020 (“Reply”).

4. The Respondent issued a hearing notice dated 24.11.2020 scheduling the hearing for 08.01.2021.A request for adjournment under Rule 129 of the Patent Rules, 2003 was filed for the hearing scheduled on 08.01.2021. An extended hearing notice was issued on 09.06.2021 for a hearing scheduled for 08.07.2021. Subsequently, an extended hearing notice was issued on 25.06.2021 (“Hearing Notice”) for a hearing scheduled for 06.08.2021 (“Hearing”). On 21.08.2021, written submissions were filed on the basis of the oral arguments submitted in the Hearing by the Appellant along with the amended claims (“Written Submissions”).

5. Vide the Impugned Order, the Respondent refused the Subject Application under Section 15 of the Act stating that the Subject Application does not meet the requirement under Sections 3(j), 3(e), 10(4) and 10(5) of theAct.

SUBMISSIONSONBEHALFOFTHEAPPELLANT

6. The learned Counsel for the Appellant made the following submissions:

6.1. The Respondent has refused the Subject Application on the following grounds for the objections raised in the Hearing Notice: (i) definitiveness under Section 10(4) and Section 10(5) of theAct; (ii) non-patentability under Sections 3(j) and 3(e) of the Act; and (iii) sufficiency of disclosure under Section 10 (4) of theAct.

6.2. The Respondent acknowledges that claim no. 1 recites a composition comprising a non-native pancreatic beta (“β”) cell and one or more pharmaceutically acceptable carriers, additives, and / or diluents. The Respondent has refused the SubjectApplication on the ground that the cells allegedly are defined by a broad generic gene expression profile and that the phrase ‘non-native’, ‘native’, and ‘gene expression profile’ are unclear. Thus, the claims a