Delhi High Court Denies Patent on Cancer Screening Method, Holds Treatment-Guiding Tests as Non-Patentable Diagnostics
Introduction
The Delhi High Court upheld the rejection of a patent application filed by Geron Corporation for a cancer-related screening method, holding that the claimed invention constitutes a non-patentable diagnostic process under Section 3(i) of the Patents Act, 1970. The Court emphasized that substance prevails over form in determining patentability.
Factual Background
Geron Corporation filed a patent application for an “in vitro screening method” aimed at identifying cancer patients who would benefit from treatment using telomerase inhibitors. The method involved determining telomere length and applying a threshold to assess patient suitability for therapy. The company contended that the invention did not diagnose cancer but merely assisted in selecting appropriate treatment for already diagnosed or suspected patients. It also relied on the fact that similar patents had been granted in foreign jurisdictions such as the United States and Europe.
Procedural Background
The Assistant Controller of Patents and Designs rejected the patent application on the ground that the claimed invention fell within the exclusion under Section 3(i) of the Patents Act, which bars diagnostic methods from patentability. Aggrieved by this decision, Geron Corporation filed an appeal before the Delhi High Court challenging the rejection.
Issues
1. Whether the claimed “in vitro screening method” constitutes a diagnostic process under Section 3(i) of the Patents Act.
2. Whether such a method is excluded from patentability despite being conducted outside the human body.
Contentions of Parties
Geron Corporation argued that the invention was merely a screening tool used to determine treatment response and did not amount to diagnosis of disease. It submitted that the Controller had misapplied the definition of diagnostic methods and failed to follow established guidelines. The company further contended that international patent practices recognize such in vitro methods as patentable and that the invention did not identify the disease itself.
On the other hand, the Assistant Controller contended that the method directly informs treatment decisions by identifying whether a patient should receive telomerase inhibitor therapy. It was argued that Section 3(i) does not distinguish between in vivo and in vitro processes and that any method that aids in diagnosis for treatment falls within the statutory exclusion.
Reasoning and Analysis
The bench of Justice Manmeet Pritam Singh Arora held that the determination of whether a process is diagnostic depends on its substance rather than the terminology used in the claims. It observed that the method, though described as a screening technique, inherently enables a medical practitioner to decide a course of treatment based on the analysis of telomere length. The Court clarified that diagnostic processes are not limited to identifying diseases but also include methods that guide treatment decisions.
It further held that Section 3(i) does not differentiate between tests conducted inside or outside the human body, and in vitro methods can equally fall within the exclusion if they serve a diagnostic purpose. The Court emphasized that allowing such patents would restrict medical practitioners from using standard methods for selecting appropriate therapies, thereby affecting public access to healthcare. It also noted that foreign patent regimes cannot override the specific statutory exclusions under Indian law.
Decision
The Delhi High Court dismissed the appeal and upheld the rejection of the patent application, holding that the claimed method constitutes a diagnostic process and is therefore not patentable under Section 3(i) of the Patents Act.
In this case the plaintiff was represented by Advocates Sanjeev Kumar Tiwari & Shatadal Ghosh. Meanwhile the defendant was represented by CGSC Pratima N Lakra with Advocates Kanchan Shakya, Shailendra Kumar Mishra, Priyam Sharma & Chanakya Kene.