Summary
The Delhi High Court upheld the Indian Patent Office’s refusal of Geron Corporation’s patent application No. 4506/DELNP/2015, relating to an in vitro screening method for selecting cancer patients for telomerase inhibitor therapy. The Court held that, despite being framed as a “screening method,” the invention is essentially a diagnostic process guiding treatment decisions and is therefore excluded from patentability under Section 3(i) of the Patents Act.
Background
Geron Corporation (“Geron”) filed a PCT application titled “Diagnostic Markers for Treating Cell Proliferative Disorders with Telomerase Inhibitors”, which entered the national phase in India in 2015. The application claimed methods to identify individuals with a cell proliferative disorder who would benefit from telomerase inhibitor therapy, based on the relative telomere length in cancer cells.
In the First Examination Report (FER) and the subsequent hearing notice, the Controller raised objections regarding lack of novelty and inventive step under Sections 2(1)(j) and (ja) , non-patentability under Sections 3(d), 3(i), and 3(j), and insufficiency under Section 10 of the Patents Act. In response, Geron submitted written arguments along with 14 amended claims, asserting that the invention was an in vitro screening method rather than a diagnostic process. The amended Claim 1 involved determining relative telomere length in cancer cells and selecting individuals with telomere lengths below the 50th percentile of a standard range for telomerase inhibitor therapy.
Despite these amendments, the Controller refused the application, holding that the method constituted a diagnostic process under Section 3(i).
Arguments of the Parties
Geron argued that the method merely screens individuals already diagnosed with, or suspected of having, cancer, without diagnosing the disease itself. They contended that telomere length cannot be considered a diagnostic marker and therefore the invention does not fall within the scope of Section 3(i). They also challenged the Controller’s reliance on the Guidelines for Examination of Biotechnology Applications, noting that guidelines are advisory and not legally binding.
Geron further argued that patentability must be assessed based on the claims filed in India, and that the term “diagnosis” should be interpreted according to its plain and ordinary meaning. The company also cited foreign patent grants to support its case. Geron challenged the Controller’s objections concerning cost and healthcare access, highlighting the claimed method only identifies patients likely to benefit from therapy.
The Controller maintained that the method is inherently diagnostic, as it tests biological samples to guide therapy, and reiterated that allowing such patents would monopolize medical decision-making, contrary to Section 3(i) and TRIPS obligations.
Key Issue
Whether an in vitro screening method for selecting cancer patients for telomerase inhibitor therapy constitutes a diagnostic process excluded from patentability under Section 3(i) of the Patents Act.
Court’s Observations and Analysis
Relying on the Patents Act, the Manual of Patent Office Practice, the Guidelines for Examination of Biotechnology Applications, and judicial precedents including Chinese University of Hong Kong v. Assistant Controller of Patents, Sequenom Inc. v. The Controller of Patents, and Natera Inc. & Anr. v. Assistant Controller of Patents and Designs, the Court outlined the following key principles:
- The term “diagnostic” in Section 3(i) refers to diagnosis for treatment of human beings, and does not encompass every test relevant to medicine.
- A diagnostic method may or may not reveal a medical condition; the key factor is whether it contributes to a medical practitioner’s treatment decision.
- Section 3(i) does not distinguish between in vivo and in vitro processes; in vitro diagnostics may also be excluded.
- Patentability must be assessed in the context of the complete specification, rather than isolated phrases or labels.
- A process need not provide a definitive diagnosis to fall under Section 3(i); methods that support treatment decisions also fall within Section 3(i).
- The distinction between “screening” and “diagnosis” is not determinative; screening tests that identify a disease or condition for treatment may qualify as diagnostic.
- Section 3(i) targets methods used by medical practitioners or paramedical staff to preventing monopolization of treatment.
- The “manner or process of diagnosis” such as measuring blood pressure, performing swab tests, or checking glucose levels, is not patentable.
- Diagnostic tools, devices, or products may be patentable if they meet standard patentability criteria.
- Biomarker-based monitoring of drug response is considered diagnostic and falls within the scope of Section 3(i).
- European Patent Office practice identifies four stages of a diagnostic method: examination, comparison with standards, detection of deviations, and a decision phase.
Applying these principles, the Court observed that the claimed method involved: (i) collection of biological samples, (ii) measurement of telomere length, (iii) comparison with a standard range, and (iv) selection of individuals for therapy. It underlined that the mere label of “screening” does not alter the substance of the method. Although the method did not directly diagnose cancer, its outcome guided the administration of telomerase inhibitor therapy, thereby contributing to a treatment decision and qualifying it as a diagnostic process under Section 3(i).
The Court further noted that granting such a patent would monopolize medical decision-making, contrary to the legislative intent of Section 3(i). It clarified that the reliance on foreign patent grants is immaterial, as patentability in India must be determined strictly in accordance with the Patents Act.
Conclusion
The Court concluded that, despite being framed as an in vitro screening method, the invention is in substance a diagnostic process essential to treatment decisions. Accordingly, the Delhi High Court upheld the Controller’s decision, confirming that Geron Corporation’s patent application was rightly refused under Section 3(i) of the Patents Act.
Citation: Geron Corporation vs The Assistant Controller Of Patents And Designs, 17 March, 2026. Available at https://indiankanoon.org/doc/32951888/
Article Review: Dr. Rukaya Amin Chowdery