Delhi High Court Sets Aside Patent Refusal for Harvard’s Stem-Cell-Derived Insulin-Producing Pancreatic β Cells

Delhi High Court Sets Aside Patent Refusal for Harvard’s Stem-Cell-Derived Insulin-Producing Pancreatic β Cells

Introduction

The Delhi High Court set aside the Patent Office’s refusal of Harvard College’s patent application relating to stem-cell-derived insulin-producing pancreatic β cells intended for diabetes treatment. The Court held that the Controller committed a material error by failing to independently examine Harvard’s amended claims, which substantially changed the scope and nature of the invention.

Factual Background

Harvard College had filed a patent application concerning stem-cell-derived insulin-producing pancreatic β cells (SC-β cells) designed for therapeutic use in diabetes treatment. According to Harvard, these cells are non-native, man-made cellular constructs created through deliberate technical intervention and are structurally, genetically, and functionally distinct from naturally occurring pancreatic β cells.

The Patent Office, however, refused the application on the ground that the claimed subject matter fell within the statutory exclusions under Section 3(j) of the Patents Act, treating the cells as natural biological derivatives and also questioning sufficiency of disclosure.

Procedural Background

Aggrieved by the refusal order dated 25 August 2022, Harvard filed an appeal before the Delhi High Court under Section 117A of the Patents Act. The refusal order had primarily assessed the original claims and concluded that the claimed cells were barred from patentability as natural biological material. Before the High Court, Harvard challenged the refusal on the ground that the Controller had failed to consider a separate set of amended claims filed along with post-hearing submissions.

Issues

1. Whether the Patent Office erred in refusing the patent without examining the amended claims.

2. Whether the claimed stem-cell-derived pancreatic β cells were excluded from patentability under Section 3(j).

3. Whether the refusal order suffered from non-application of mind to the modified scope of the claims.

Contentions of Parties

Harvard argued that the amended claims materially transformed the application from a broad composition claim into a specific non-native pancreatic β cell claim, thereby changing the very basis of patentability analysis. It was submitted that these SC-β cells are novel, inventive, and do not occur in nature, as they require deliberate human intervention and possess distinct structural and functional characteristics.

The Controller, on the other hand, maintained that even if cultured in a laboratory, the cells remained derivatives of natural biological material and therefore fell squarely within the exclusion under Section 3(j), which bars patents over plants and animals or any parts thereof.

Reasoning and Analysis

The High Court found merit in Harvard’s challenge. Justice Tejas Karia noted that the refusal order was overwhelmingly based on the original claims, with little or no meaningful engagement with the amended claims filed after the hearing. The Court emphasized that the amended claims had significantly altered the invention by shifting from a general composition claim to a specific claim over non-native pancreatic β cells, which required an independent legal and technical assessment.

The Court observed that such a transition could fundamentally alter the patentability analysis, especially on issues of statutory exclusions and inventive contribution. By failing to independently consider the amended claims, the Controller had effectively denied Harvard a fair adjudication on the actual claims it sought to pursue.

The Court therefore held that the Patent Office must reassess the amended claims without being influenced by prior conclusions drawn on the original claim set.

Decision

The Delhi High Court set aside the refusal order dated 25 August 2022 and remanded the matter to the Patent Office for fresh consideration of the amended claims. The Controller was directed to grant Harvard a fresh hearing and pass a reasoned order within six months.

In this case the plaintiff was represented by Advocates Satyapal Arora, Ashish Sharma, Kuldeep Kumar Singh & Nitin Sharma.