Engineered Non-Native Cells Distinct From Natural Parts: Delhi High Court Directs Fresh Consideration Of Harvard's Patent Application
Bench held that where an invention represents a non-naturally occurring "man-made construct" rather than a mere product of nature, it must be evaluated on its own merits.
Justice Tejas Karia, Delhi High Court
The Delhi High Court has set aside the refusal of Harvard College’s patent application for SC-β cells, holding that "man-made" cellular constructs with distinct functional profiles warrant independent assessment from natural biological exclusions. The Bench remanded the matter back to the Controller for fresh consideration in view of the amended claims submitted along with post-hearing written submissions
The Court held that cellular products resulting from extensive human technical intervention, which exhibit structural and functional traits absent in nature, cannot be summarily dismissed under the Section 3(j) bar against "animal parts". It observed that where an invention represents a non-naturally occurring "man-made construct" rather than a mere product of nature, it must be evaluated on its own merits.
Justice Tejas Karia observed, “Consequently, amended claims that significantly alter the original claims transitioning from a composition to a non-native pancreatic β cell must be duly considered by the learned Controller independently without being influenced from prior conclusions regarding the original claims in the Impugned Order”.
Advocate Dr. Satyapal Arora appeared for the appellant and Balendu Shekhar, CGSC appeared for the respondent.
The dispute centered on a patent application filed by the President and Fellows of Harvard College for "SC-β Cells and Compositions and Methods for Generating the Same". These "non-native" pancreatic beta cells, engineered from human pluripotent stem cells, were designed to overcome the failure of existing stem cell-derived cells to secrete insulin appropriately.
The Appellant contended these cells are distinct from native biological entities due to stable gene expression patterns (INS, PDX1, NKX6-1, and ZNT8) and consistent mono-hormonal features.
Procedurally, the Controller General of Patents refused the application on August 25, 2022, citing Sections 3(j), 3(e), 10(4), and 10(5) of the Patents Act, 1970. The Respondent argued that the cells were "natural derivatives" and that laboratory handling should not allow biological material to be rebranded as "synthetic". The Appellant challenged this refusal, arguing that the engineered cells involve technical human intervention analogous to "cDNA," which is globally recognized as patentable.
In its reasoning, the Court noted that the Appellant’s SC-β cells exhibit "special features" not found in nature, including the presence of crystalline insulin granules and specific in vitro glucose stimulated insulin secretion (GSIS) responses.
The Bench, thus noted, “As regards the objections under Sections 3(j) and 3(e) of the Act, the Impugned Order again considers the original claims and it is concluded that the Complete Specification neither discloses a composition per se, nor does it disclose all the components or their amounts or synergy data. However, if the amended claims are considered, they claim a non-native pancreatic β cell instead of the composition in the original claims. Therefore, the entire basis of the Impugned Order may undergo change if the amended claims are considered by the learned Controller”.
The Court found that the amended claims, which transitioned the focus from a general composition to a specific "non-native pancreatic β cell," significantly altered the scope of the original application. Consequently, the prior conclusions regarding the original claims should not have prejudiced the assessment of the amended claims.
“The Respondent’s attempt to characterize non-native SC-β cells as ‘natural parts of animals’ is legally and scientifically untenable. The claimed SC-β cells consistently show stable and distinct gene expression patterns, superior insulin secretion, and glucose responsiveness, distinguishing them from any naturally occurring β cells. These reproducible differences demonstrate that the SC-β cells are not mere natural variants, but a new and distinct cellular construct created through human technical intervention. The present invention represents a man-made construct (non-native), not an essentially biological process or natural material. Thus, the claims fall outside Section 3(j) of the Act and are patent-eligible”, it noted.
“Accordingly, the Impugned Order is hereby set aside, and the matter is remanded back to the learned Controller for fresh consideration of the Subject Application in view of the amended claims submitted along with post-hearing Written Submissions. This learned Controller shall pass a detailed order on the Subject Application after considering the amended Claims within six months from the date of communication of this Judgment after giving opportunity of hearing to the Appellant”, the Bench directed.
Cause Title: President And Fellows Of Harvard College v. Controller General Of Patents Designs And Trademarks [Neutral Citation: 2026:DHC:2597]
Appearances:
Appellant: Dr. Satyapal Arora, Ashish Sharma, Kuldeep Kumar Singh & Nitin Sharma, Advocates.
Respondent: Balendu Shekhar, CGSC with Krishna Chaitanya, Rajkumar Maurya, Divyansh Singh Dev and Tanisha Samanta, Advocates. Dr. Bhanumathi R, Assistant Controller of Patents & Designs (through VC).