Geron Corporation (\u201cGeron\u201d) filed a PCT application titled\u00a0\u201cDiagnostic Markers for Treating Cell Proliferative Disorders with Telomerase Inhibitors\u201d<\/em>, 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.<\/p>\n In the First Examination Report (FER) and the subsequent hearing notice, the Controller raised objections regarding lack of novelty and inventive step under\u00a0Sections 2(1)(j)\u00a0and (ja)\u00a0, 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<\/em> 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<\/sup> percentile of a standard range for telomerase inhibitor therapy.<\/p>\n Despite these amendments, the Controller refused the application, holding that the method constituted a diagnostic process under Section 3(i).<\/p>\n 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\u2019s reliance on the Guidelines for Examination of Biotechnology Applications, noting that guidelines are advisory and not legally binding.<\/p>\n Geron further argued that patentability must be assessed based on the claims filed in India, and that the term \u201cdiagnosis\u201d 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\u2019s objections concerning cost and healthcare access, highlighting the claimed method only identifies patients likely to benefit from therapy.<\/p>\n 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.<\/p>\n Whether an in vitro<\/em> 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.<\/p>\n Relying on the Patents Act, the Manual of Patent Office Practice, the Guidelines for Examination of Biotechnology Applications, and judicial precedents including\u00a0Chinese 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\u00a0Designs, the Court outlined the following key principles:<\/p>\n 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\u00a0that the mere label of \u201cscreening\u201d does not alter the substance of the method.\u00a0Although 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).<\/p>\n 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.<\/p>\n The Court concluded\u00a0that, despite being framed as an in vitro<\/em> screening method, the invention is in substance a diagnostic process essential to treatment decisions.\u00a0Accordingly, the Delhi High Court upheld the Controller\u2019s decision, confirming that Geron Corporation\u2019s patent application was rightly refused under Section 3(i) of the Patents Act.<\/p>\nArguments of the Parties<\/h4>\n
Key Issue<\/h4>\n
Court\u2019s Observations and Analysis<\/h4>\n
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Conclusion<\/h4>\n