President and Fellows of Harvard College Vs Controller General of Patents Designs and Trademarks

Head Note of the Case

Delhi High Court, in an appeal under Section 117 of the Patents Act, 1970, set aside the Controller’s order dated 25.08.2022 refusing Patent Application No. 201617000758 titled “SC-β CELLS AND COMPOSITIONS AND METHODS FOR GENERATING THE SAME”. The Court held that the impugned order was vitiated because the Controller failed to consider the amended claims filed by the appellant along with post-hearing written submissions. These amendments materially altered the nature of the claims — from a “composition” claim (non-native pancreatic β cell + pharmaceutically acceptable carriers) to a claim on the “non-native pancreatic β cell” per se. The Court clarified that when post-hearing amendments change the scope or character of the claims, the Controller is duty-bound to examine them afresh on all grounds (including Sections 3(j), 3(e), 10(4) and 10(5)) before refusing the application. The matter was remanded for fresh adjudication within six months after granting a hearing, without prejudice to the merits of patentability of stem-cell-derived non-native pancreatic β cells.

Introduction

This is a significant patent appeal concerning the patentability of human stem-cell-derived pancreatic beta (SC-β) cells developed for potential cell-replacement therapy in diabetes. The appellant, President and Fellows of Harvard College, sought protection for a novel in-vitro generated “non-native” pancreatic β cell population that functionally mimics mature human beta cells but exhibits distinct gene-expression profiles, improved glucose-stimulated insulin secretion (GSIS), and mono-hormonal characteristics not found in nature. The Controller refused the application primarily on the grounds that the claimed subject-matter fell within the non-patentable exclusions under Section 3(j) (plants and animals in whole or any part thereof) and Section 3(e) (mere admixture), coupled with objections on clarity and sufficiency of disclosure under Sections 10(4) and 10(5). Instead of deciding the substantive patentability issues, the Delhi High Court focused on a procedural imperative: the mandatory duty of the Controller to consider post-hearing amendments that materially alter the claim set. The judgment, delivered on 28 March 2026 by Justice Tejas Karia, reinforces procedural fairness in patent examination and remands the application for fresh consideration.

Factual Background

The invention relates to methods, compositions, kits and agents for generating stem-cell-derived beta (SC-β) cells from human pluripotent stem cells. These SC-β cells are “non-native” — i.e., they share many features of endogenous mature pancreatic β cells (insulin production, glucose responsiveness) but differ in gene-expression profiles and certain functional aspects, making them structurally and functionally distinct from naturally occurring β cells. The technology solves a long-standing problem in regenerative medicine: earlier protocols produced only immature or abnormally functioning insulin-expressing cells that failed to secrete insulin appropriately in response to glucose levels.

Key priority dates:

First US provisional: 11.06.2013 (US 61/833,898)

Second US provisional: 28.03.2014 (US 61/972,272)

PCT application: 11.06.2014 (PCT/US2014/041992)

National phase Indian application: 08.01.2016 (No. 201617000758) filed with 29 claims.

On 08.01.2016, the appellant also filed Form-13 amending the claims. Request for examination was filed on 01.06.2017 with voluntary amendments. First Examination Report (FER) was issued on 28.02.2020. The appellant replied on 28.08.2020 with further amendments. Multiple hearing notices were issued; the final hearing occurred on 06.08.2021. Post-hearing written submissions dated 21.08.2021 included yet another set of amended claims. The Controller passed the impugned refusal order on 25.08.2022 under Section 15 of the Patents Act, holding the claims non-compliant with Sections 3(j), 3(e), 10(4) and 10(5).

Procedural Background

The appeal was filed under Section 117 of the Patents Act, 1970 read with Section 151 CPC before the Intellectual Property Division of the Delhi High Court as C.A.(COMM.IPD-PAT) 493/2022. The matter was heard by Hon’ble Mr. Justice Tejas Karia. The Controller appeared through the Central Government Standing Counsel and the Assistant Controller (through VC). The appellant was represented by a team led by Dr. Satyapal Arora.

Dispute in Question

The core dispute before the High Court was whether the Controller’s refusal order was sustainable when it had (i) considered only the pre-hearing (original) set of claims, and (ii) failed to examine the materially amended claims filed along with post-hearing written submissions. Substantive questions — whether SC-β cells are excluded under Section 3(j) as “animals in whole or any part thereof”, whether the claims lack clarity/sufficiency, and whether they constitute a mere admixture under Section 3(e) — were not decided on merits. The procedural question was: does a Controller have a mandatory duty to consider post-hearing amendments that change the nature/scope of claims before finally refusing an application?

Arguments of Parties

Appellant’s Arguments (Harvard College):

The amended claims filed post-hearing shifted the primary claim from a “composition” (cell + carriers) to the “non-native pancreatic β cell” per se. The Controller ignored this change and decided the matter on the original claims alone.

The SC-β cells are man-made, non-naturally occurring constructs produced through a multi-step laboratory differentiation protocol involving technical human intervention. They do not occur in nature, are structurally and functionally distinct (different gene-expression profile, enhanced GSIS, mono-hormonal), and therefore fall outside Section 3(j).

Detailed definitions of “non-native” and supporting data on gene expression, crystalline insulin granules, and functional superiority are provided in the specification.

Precedents such as Imclone LLC (2024 SCC OnLine Mad 8397), BTS Research International (2025 SCC OnLine Cal 2943), and US Supreme Court decisions (Chakrabarty, Myriad) were cited to argue that genetically engineered or laboratory-created cellular products are patentable.

Corresponding patents have been granted in USA, UK, Australia, Germany, Japan, etc.

In any event, the Controller’s failure to consider the amended claims is a glaring procedural error warranting remand.

Respondent’s (Controller’s) Arguments:

SC-β cells, even if generated in vitro, are biological derivatives of human/animal material and fall squarely within the Section 3(j) exclusion (“animals in whole or any part thereof”).

The terms “non-native”, “native”, and “gene expression profile” are vague and lack a clear standard, rendering the claims indefinite under Sections 10(4) and 10(5).

No synergy data or specific component ratios were disclosed for the claimed composition.

Foreign grants are not binding; Indian law applies a stricter construction of Section 3(j), especially for human/animal-derived material.

The amended claims were mentioned as “alternative set” but did not require fresh adjudication because the core objections (Section 3(j) and sufficiency) persisted.

Reasoning of the Judge (including different provisions of law and their context)

Justice Tejas Karia began by reproducing the complete set of original and amended claims side-by-side (para 14). He observed that the amendment fundamentally altered the claim structure: the principal claim no longer required “pharmaceutically acceptable carriers” but claimed the isolated non-native pancreatic β cell itself (with functional and structural limitations).

Key Legal Provisions and Concepts Explained:

Section 15 of the Patents Act, 1970

Empowers the Controller to refuse or require amendment of an application after examination and hearing. The provision must be read with the principles of natural justice and the duty to consider all material placed on record.

Sections 10(4) and 10(5)

10(4): Requires the specification to fully and particularly describe the invention, enable a person skilled in the art to perform it, and disclose the best method.

10(5): Claims must be clear, succinct, and fairly based on the matter disclosed.

The Court noted that the Controller’s objections on clarity and sufficiency were framed entirely on the original “composition” claims.

Section 3(j)

Excludes “plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production and propagation of plants and animals.”

The Court did not decide whether SC-β cells fall within this exclusion but held that any such determination must be made only after examining the final set of claims.

Post-hearing amendments

The Patents Act and Rules permit voluntary amendments at any stage before grant (Section 57 read with Rule 81). When amendments are filed with written submissions after hearing and materially alter the claim scope/nature, the Controller cannot ignore them and decide on the pre-amendment claims.

Judgements relied upon by the Judge and their context

Jitendra Kohli v. The Controller of Patents, 2022:DHC:1904

The Delhi High Court held that failure to consider amended claims filed during proceedings is a “glaring error”. The order was set aside and the matter remanded for fresh adjudication after considering the amended claims on all grounds (novelty, inventive step, patentability).

Akebia Therapeutics INC v. The Controller of Patents and Designs, CMA(PT)/64/2024 dated 20.03.2025

When amendments change the nature of claims (e.g., from method to composition), the Controller must address the new set of claims. Rejection solely or substantially on the ground that claims were amended is not tenable. The matter was remanded with directions for a fresh hearing by a different officer.

The Judge applied these precedents verbatim, holding that the present case involved an identical procedural lapse: the impugned order was passed without considering the post-hearing amended claims that changed the claim from “composition” to the “cell” per se.

Final Decision

The appeal was allowed. The impugned order dated 25.08.2022 was set aside. The matter was remanded to the Controller (preferably a different officer) for fresh consideration of the Subject Application in light of the amended claims filed with post-hearing written submissions. The Controller was directed to pass a reasoned order within six months after affording a hearing to the appellant. No observations were made on the merits of patentability (Sections 3(j), 3(e), sufficiency, etc.). A copy of the judgment was directed to be sent to the Controller General at llc-ipo@gov.in.

Concluding Note

The judgment is a procedural landmark in Indian patent law. It underscores that the Controller’s quasi-judicial function cannot be exercised mechanically or on an incomplete record. When an applicant files amended claims that materially alter the invention’s scope after the hearing, those amendments must be examined on their own merits. The decision protects applicants from arbitrary refusal while reiterating that substantive questions of patentability of advanced biotechnological inventions (such as stem-cell-derived β cells) require careful, claim-specific analysis under Section 3(j) and other provisions. It also signals to the Patent Office that post-hearing amendments are not cosmetic but can fundamentally reshape the examination.

Legal Point Settled in this Case (with clear explanation of legal concepts)

The judgment settles the following important propositions:

Mandatory duty to consider post-hearing amendments

When an applicant files amended claims along with written submissions after the hearing under Section 15, and those amendments change the nature or scope of the claims (e.g., from composition to product per se), the Controller is legally bound to examine the amended claims afresh on all statutory grounds before refusing the application. Ignoring them constitutes a “glaring error” and vitiates the order.

Nature of amendment vs. scope

Even if the overall inventive concept remains the same, a change in claim category (method → composition → product per se) is material and triggers fresh adjudication. This prevents the Controller from deciding on an obsolete claim set.

Remand as the appropriate remedy

When the order is vitiated by non-consideration of material amendments, the correct course is remand for de novo consideration rather than deciding the merits in appeal. No observations on patentability (especially complex Section 3(j) issues) should be made so that the Controller exercises independent discretion.

Interplay between Section 57 (amendment) and Section 15 (refusal)

Amendments are a statutory right. The Controller’s power to refuse cannot be exercised without first addressing the final set of claims placed on record.

These principles provide clear guidance to patent examiners, applicants, and the bar that procedural fairness in the grant/refusal process is non-negotiable, especially in cutting-edge fields like regenerative medicine and stem-cell technology.

Case Detail

Title: President and Fellows of Harvard College Vs Controller General of Patents Designs and Trademarks

Date of Order: 28 March 2026

Case Number: C.A.(COMM.IPD-PAT) 493/2022

Neutral Citation: Not assigned in the judgment (as on date of delivery)

Name of Court: High Court of Delhi at New Delhi

Name of Hon’ble Judge: Hon’ble Mr. Justice Tejas Karia

Suggested Suitable Titles for YouTube Explainer Video

“Delhi HC Remands Harvard’s SC-β Cell Patent – Why Controller’s Refusal Was Set Aside | Section 3(j) Explained”

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