Case Title: Sequenom Inc and Anr. Vs Controller of Patents
Order Date: 9th October 2025
Case Number: C.A.COMM.IPD-PAT 132022 and C.A.COMM.IPD-PAT 4482022
Neutral Citation: 2025:DHC:132022
Court: High Court of Delhi at New Delhi
Hon'ble Judge: Justice Prathiba M. Singh
Fact:
Sequenom Inc., a company registered in the United States, along with its affiliate Sequenom Center for Molecular Medicine, filed two Indian patent applications related to non-invasive prenatal testing (NIPT) methods. These methods involve analyzing fetal nucleic acids present in maternal blood samples to detect fetal abnormalities such as aneuploidy (chromosomal abnormalities), sex determination, and other genetic traits without invasive procedures like amniocentesis. The applications claim methods of methylation-based enrichment of fetal DNA to isolate and analyze specific genetic markers through DNA sequencing and amplification techniques. The applications originated as early as 2011 and 2012 with U.S. priority claims and underwent multiple rounds of claim amendments during prosecution to address objections.
Procedural Detail:
The Indian Patent Office issued First Examination Reports raising objections on multiple grounds, including lack of inventive step, and specifically non-patentability under Sections 3(b), 3(d), 3(i), and 3(j) of the Patents Act, 1970. The rejections were upheld in orders dated 12th December 2019 and 20th January 2020, primarily on the basis that the claimed inventions fall under the exclusion of patentability under Section 3(i), which excludes diagnostic methods from patent protection. The applicants appealed these refusals under Section 117A of the Patents Act to the Delhi High Court. Given the common issue of interpretation of Section 3(i), these appeals were heard in a batch along with other landmark cases including EMD Millipore Corporation. The proceedings included extensive submissions, including those from an appointed Amicus Curiae, and the judgment was reserved on 21st December 2024 and pronounced on 9th October 2025.
Dispute:
The central dispute revolved around the scope and application of Section 3(i) of the Indian Patents Act, 1970, relating to the exclusion from patentability of diagnostic methods. The appellants contended that their invention relates to a non-invasive screening test (NIPT) rather than a diagnostic method practiced on the human body and therefore should not fall under Section 3(i). They emphasized that the methods merely provide preliminary data and risk assessments without constituting definitive medical diagnosis or treatment. On the other hand, the Patent Office represented by the CGSC argued that the test claims to detect fetal abnormalities with high accuracy and results in clinical decisions, thus qualifying as diagnostic methods excluded from patentability. They contended that Section 3(i) does not distinguish between in vivo and in vitro methods and captures any method intended for diagnosis or treatment performed on humans or animals. The scope of exclusion includes methods practiced in laboratories on human samples having diagnostic purposes. The issue of inventive step was also raised but not primarily decided.
Detailed Reasoning:
The court undertook a detailed examination of the language of Section 3(i), which excludes from patentability "any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals." It reviewed precedents and legislative history including the amendments introduced post-TRIPS, the underlying public policy to safeguard freedom of medical practitioners from patent restrictions, and the need to balance this against incentivizing innovation.
Comparative analysis with foreign laws was undertaken with detailed references to Section 4A of the UK Patents Act 1977 and Article 53(c) of the European Patent Convention (EPC) 2000, both of which exclude methods of treatment or diagnosis practiced on the human or animal body but expressly allow patents for substances or compositions for use in such methods. The Enlarged Board of Appeal decisions of the EPO in Cases G 000104 and G 000107 were a key focus, elucidating that diagnostic methods are multi-step processes involving collecting and comparing data, followed by identifying deviations and making deductive medical evaluations. Such multi-step diagnostic methods practiced on the human or animal body require professional medical judgment and carry health risks, which justifies their exclusion.
The court clarified that the exclusions apply narrowly to processes that are core medical activities involving intellectual diagnostic decision-making performed on living bodies. Ancillary or supporting processes, especially in vitro laboratory techniques without final diagnosis or treatment steps, fall outside the exclusion and qualify for patent protection. Further, diagnostic tools, instruments, machines, and products remain patentable if they fulfill patentability criteria.
The court delved into the specifications and claims of the patent applications, noting that the inventions relate to in vitro non-invasive procedures analyzing fetal DNA from maternal blood without direct interaction with the body and without final diagnostic conclusions. The inventions primarily relate to identifying probabilities and risks, distinguishing them from definitive diagnostic processes. The court highlighted the distinction between screening tests and diagnostic tests, based on medical literature and case law, including the recent decision of the Madras High Court in Chinese University of Hong Kong v. Assistant Controller of Patents. Screening tests identify a need for further confirmatory diagnosis, whereas diagnostic tests confirm presence or absence of disease requiring clinical decision and possible treatment.
The court rejected the patent office's argument that all screening tests fall under Section 3(i) if they relate to diagnosis in a broad sense, stating that statutory interpretation demands a narrower reading. It was found that in vitro laboratory tests designed merely for data gathering or analysis supporting subsequent diagnosis by medical professionals do not constitute excluded diagnostic methods.
The court also considered the legislative history, observing that Section 3(i) was introduced with intent to harmonize Indian law with global standards while preserving medical practitioners' autonomy. It pointed out that unlike EPC and UK law that specify that the exclusion applies to diagnostic methods "practiced on the human or animal body," Indian law’s text does not contain this phrase, making in vitro diagnostic methods potentially subject to exclusion. However, the court adopted a purposive interpretation to avoid stifling innovation in biotechnological and medical research fields and not unduly broadening exclusions.
On the amendments and claims, the court noted the applications had undergone significant prosecution and claims restriction to comply with patentability standards. It emphasized that inventions providing novel technical methods of analyzing biological samples while not constituting direct diagnostic processes are patentable.
Decision:
The court allowed the appeals primarily holding that the claimed inventions in both patent applications do not fall under the exclusion of Section 3(i) of the Patents Act. The inventions constitute non-invasive prenatal screening tests, involving in vitro analysis outside the human body, and do not amount to diagnostic methods involving direct diagnosis or treatment by medical professionals. Consequently, the inventions are patentable subject matter. The court directed the patent office to grant the patents after completing formalities. The court clarified that patent exclusions should be narrowly construed to protect medical practice autonomy without hindering technological innovation. The judgments provide authoritative guidance on interpreting Section 3(i), balancing between innovation incentives and public health policy.
Legal Provisions Discussed:
Section 3(i) of the Patents Act, 1970 – Exclusion of medicinal, surgical, diagnostic, therapeutic processes
Sections 21(j) and 21(ja) – Novelty and Inventive Step
Section 59 – Amendments to Patent Applications
Section 117A – Appeals to High Court against Controller decisions
Article 27.3 of TRIPS Agreement – Flexibility to exclude certain inventions from patentability
Section 4A of UK Patents Act, 1977 – Methods of treatment or diagnosis exclusion
Article 53(c) EPC 2000 – Exceptions to patentability for diagnostic methods practiced on the human or animal body
Enlarged Board of Appeal Decisions G 000104 and G 000107 – Interpretation of diagnostic and surgical methods
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Suggested Titles for Legal Research Paper:
"Interpreting Section 3(i) of the Indian Patents Act: A Comprehensive Analysis of Sequenom Inc. Case"
"Diagnostic Methods and Patent Exclusions: Lessons from the Delhi High Court on Non-Invasive Prenatal Testing"
"Balancing Innovation and Medical Practice Autonomy under Indian Patent Law: The Sequenom Decision"
"Narrow Construction of Patent Exclusions for Diagnostic Processes: A Judicial Perspective from Delhi"
"Scope of Patentability in Medical Biotechnologies: Analytical Review of Sequenom vs Controller"
