Geron Corporation Vs. The Assistant Controller of Patents and Designs

Introduction

The decision of the High Court of Delhi in Geron Corporation Vs. The Assistant Controller of Patents and Designs marks a significant doctrinal development in the interpretation of Section 3(i) of the Patents Act, 1970, particularly in the context of diagnostic methods and their interface with modern biotechnology inventions. The case addresses a recurring tension in patent jurisprudence: the boundary between patentable technical innovations and non-patentable methods of medical treatment. In an era where personalized medicine and biomarker-driven therapies are gaining prominence, the Court’s ruling assumes critical importance in clarifying whether screening and selection methods for treatment fall within the statutory exclusion of “diagnostic” processes. The judgment, authored by Justice Manmeet Pritam Singh Arora, provides a deeply reasoned analysis of statutory interpretation, international obligations under TRIPS, and evolving judicial precedents in India.

Factual Background

The appellant, Geron Corporation, a biopharmaceutical entity engaged in developing telomerase inhibitors, filed an Indian national phase patent application titled “Diagnostic Markers for Treating Cell Proliferative Disorders with Telomerase Inhibitors.” The invention related to an in vitro method for identifying cancer patients who would benefit from treatment with telomerase inhibitors based on the relative length of telomeres in cancer cells.

The patent application claimed a method involving the analysis of telomeric nucleic acids from biological samples of individuals diagnosed with or suspected of having cancer. Based on whether the telomere length fell within a specified percentile threshold, the method enabled selection of patients likely to benefit from specific therapeutic intervention. The invention thus operated at the intersection of biomarker detection and therapeutic decision-making.

The Patent Office, however, objected to the application on multiple grounds, including lack of novelty, inventive step, and most significantly, non-patentability under Section 3(i) of the Patents Act. The core objection was that the claimed invention constituted a diagnostic method and was therefore excluded from patentability.

Procedural Background

Following the filing of the application and issuance of the First Examination Report, the appellant submitted responses and amended claims to address objections raised by the Controller. A hearing was conducted, and further written submissions along with amended claims were filed by the appellant.

Despite these efforts, the Controller refused the application by order dated 31.12.2021, holding that the claims fell squarely within the ambit of Section 3(i) as a diagnostic method related to treatment of cancer. Aggrieved, the appellant preferred an appeal under Section 117-A of the Patents Act before the High Court of Delhi.

Reasoning

The Court undertook an exhaustive examination of the statutory framework, particularly Section 3(i), which excludes from patentability any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatment of human beings. The central question before the Court was whether the claimed “in vitro screening method” constituted a diagnostic method for treatment.

The Court rejected the appellant’s attempt to distinguish “screening” from “diagnosis” by holding that nomenclature is not determinative. What is crucial is the functional role of the claimed process. If a method contributes to or forms the basis of a treatment decision, it may fall within the scope of “diagnostic” under Section 3(i).

In interpreting the scope of “diagnostic,” the Court relied heavily on prior judicial precedents and Patent Office Guidelines. It emphasized that diagnosis need not be definitive; even a process that aids or influences treatment decisions qualifies as diagnostic. The Court also clarified that the statutory exclusion does not distinguish between in vivo and in vitro methods, thereby rejecting the appellant’s contention that laboratory-based techniques should be patentable.

A key aspect of the reasoning was the application of the “treatment nexus” test. The Court examined whether the claimed method inherently enabled a medical practitioner to make a treatment decision. It found that the method, by determining telomere length and applying a threshold, directly guided the selection of patients for telomerase inhibitor therapy. This, in substance, constituted a diagnostic process integral to treatment.

The Court further observed that granting patent protection to such methods would result in monopolisation of clinical decision-making processes, which is precisely what Section 3(i) seeks to prevent. The legislative intent behind the provision, reinforced by TRIPS, is to ensure that medical practitioners are not constrained by patent rights in performing diagnostic and therapeutic functions.

Judgments with Complete Citations Discussed

The Court engaged in a detailed analysis of prior judicial decisions to articulate the scope of Section 3(i). It relied extensively on Chinese University of Hong Kong v. Assistant Controller of Patents & Designs, 2023 SCC OnLine Mad 6372, wherein the Madras High Court held that diagnostic processes must be understood in the context of treatment and include processes capable of identifying pathology for therapeutic purposes.

Further reliance was placed on Chinese University of Hong Kong v. Controller of Patents & Designs, 2023 SCC OnLine Mad 8616, which clarified that diagnostic methods are not confined to in vivo procedures and must be interpreted in light of their role in treatment.

The Court also referred to Natera Inc. & Anr. v. Assistant Controller of Patents and Designs, 2025:DHC:8937, where it was held that processes employed by medical practitioners for diagnosis are excluded from patentability, irrespective of whether they are performed in vivo or in vitro.

Additionally, Sequenom Inc. & Anr. v. The Controller of Patents, 2025:DHC:8926, was cited to reinforce the principle that even non-definitive diagnostic processes, which influence treatment decisions, fall within the exclusion under Section 3(i).

Collectively, these precedents were harmonised to establish that any process contributing to diagnosis for treatment—whether labelled as screening, monitoring, or otherwise—is not patentable.

Decision of the Court

The Court upheld the order of the Controller and dismissed the appeal. It held that the claimed invention, though framed as an in vitro screening method, was in substance a diagnostic method forming the basis of treatment decisions for cancer patients. Consequently, it fell squarely within the exclusion under Section 3(i) of the Patents Act.

The Court further rejected the argument that grant of patents in foreign jurisdictions such as the United States or Europe should influence the Indian position, reiterating that patentability must be assessed strictly in accordance with Indian law.

Point of Law Settled

The judgment conclusively establishes that any method—whether termed as screening, monitoring, or selection—that contributes to or enables a medical practitioner to make a treatment decision qualifies as a “diagnostic method” under Section 3(i) and is therefore not patentable. It further settles that the exclusion applies equally to in vitro processes and that the determinative test is the functional role of the claimed invention in the treatment pathway, not its form or drafting.

Case Details

Title: Geron Corporation v. The Assistant Controller of Patents and Designs

Date of Order: 17 March 2026

Case Number: C.A.(COMM.IPD-PAT) 244/2022

Neutral Citation: Not specifically mentioned (Delhi High Court, 2026)

Court: High Court of Delhi

Judge: Justice Manmeet Pritam Singh Arora

Suggested Titles

“Screening or Diagnosis? Delhi High Court Clarifies the Scope of Section 3(i) in Biotechnology Patents”

“Patentability of Diagnostic Methods in India: A Critical Analysis of Geron Corporation Case”

“Biomarkers and the Law: Limits of Patent Protection under Section 3(i) of the Patents Act”

Suggested Tags

Patent Law India, Section 3(i) Patents Act, Diagnostic Methods, Biotechnology Patents, Delhi High Court, Geron Corporation Case, Patent Eligibility, Medical Treatment Exclusion, TRIPS Compliance, Intellectual Property Law

Headnote

The Delhi High Court in Geron Corporation v. Assistant Controller of Patents held that an in vitro screening method for selecting cancer patients based on telomere length for administering telomerase inhibitor therapy constitutes a diagnostic method under Section 3(i) of the Patents Act, 1970. The Court ruled that the functional role of the process in influencing treatment decisions is determinative, and not the manner of drafting or labeling of claims. It further clarified that diagnostic methods include both in vivo and in vitro processes and extend to non-definitive tests that guide therapeutic intervention. Consequently, such methods are excluded from patentability