Navigating Section 3(i): Making Space for Health-Tech Innovation in India
When we think about patent law, we often imagine pharmaceutical companies protecting new drug molecules or technology companies defending innovative inventions. But in India, patent law also raises a fundamental question about healthcare: how far should intellectual property protection extend when human health is involved?
At the centre of this debate is Section 3(i) of the Indian Patents Act, 1970. For patients and healthcare professionals, the provision can serve as an important safeguard against monopolisation of medical treatment. For health-tech startups and innovators, however, it can create significant challenges, particularly when an invention involves diagnostic methods, artificial intelligence, software, or data-driven healthcare. Section 3(i), therefore, represents a difficult policy balance: protecting public access to healthcare while encouraging the innovation needed to improve it.
What Is Section 3(i)?
In simple terms, Section 3(i) excludes certain medical treatment and diagnostic processes from patentability in India. The provision covers processes relating to the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatment of human beings, as well as similar treatment of animals. The important distinction is between a product and a process. A new medical device, drug molecule, testing apparatus, or other patent-eligible product may potentially receive patent protection. However, the method by which a doctor treats a patient or the process by which a disease is diagnosed or treated may fall within the exclusion. This distinction becomes increasingly complicated as healthcare moves towards AI-powered diagnostics and digital health.
Why Section 3(i) Matters for Public Health
The strongest argument in favour of Section 3(i) is that medical treatment should remain accessible to those who need it.
Keeping Healthcare Affordable
If companies could obtain exclusive rights over particular treatment protocols or diagnostic processes, they could potentially control their use and charge licensing fees. Excluding medical treatment methods from patentability helps prevent such monopolisation and supports broader access to healthcare.
Protecting Medical Autonomy
Doctors need to be able to make clinical decisions based on individual patients’ circumstances. Section 3(i) helps ensure that healthcare professionals can perform treatment without worrying that ordinary clinical techniques will expose them to patent infringement claims. This is particularly important in emergency situations, where patient welfare must come first.
Preventing Evergreening
Section 3(i) can also help prevent attempts to extend commercial exclusivity around existing medical knowledge through minor modifications. Keeping treatment methods outside patent protection helps ensure that established clinical knowledge remains available for use.
The Innovation Problem
While Section 3(i) serves an important public interest, its application can create challenges for innovators. Healthcare is no longer limited to conventional medicines and surgical procedures. Modern health-tech companies develop AI systems, diagnostic platforms, software, testing workflows, and sophisticated data-analysis technologies. For these businesses, distinguishing between a patentable technical invention and a non-patentable diagnostic process can be difficult.
The AI and Digital Health Challenge
Consider an AI platform capable of analysing medical images and identifying indicators associated with a disease. The system may involve significant research, specialised algorithms, data processing, and engineering. Yet if the claimed invention ultimately amounts to a process for diagnosing a medical condition, Section 3(i) may become a major obstacle to patent protection. This creates a critical question for health-tech entrepreneurs: How can an innovator protect the technology without attempting to monopolise the medical diagnosis itself? For startups, this issue can be particularly important because intellectual property may influence investment, valuation, and competitive advantage.
What Have Indian Courts Said?
Recent Indian court decisions have helped clarify some of the boundaries surrounding Section 3(i). One important issue is the distinction between screening and diagnosis. In Chinese University of Hong Kong v. Assistant Controller of Patents and Designs (Madras High Court) and Hirotsu Bio Science v. Assistant Controller of Patents and Designs (Delhi High Court), arguments that an invention was merely a screening or detection tool rather than a diagnostic method were subjected to close judicial scrutiny. The Courts emphasised that merely describing a process as “screening” or “detection” does not, by itself, avoid the exclusion under Section 3(i). The key question is whether the process is itself capable of identifying a disease or pathology, or if the process yields an intermediate indicator but requires further testing to identify a pathological condition. In Natera Inc. v. Assistant Controller of Patents, the Delhi High Court reinforced the importance of this distinction. A device performing a particular technical function may be patentable, whereas a claim directed towards using that device to analyse a patient’s health, to identify or rule out a disease may constitute a diagnostic method and therefore fall within the exclusion under Section 3(i). Section 3(i) also does not distinguish between in vitro and in vivo diagnostic methods, and excludes any manner or method of performing a diagnosis.
The courts have also recognised that not every process associated with healthcare is automatically excluded. In Sequenom Inc. v. Controller of Patents, the Delhi High Court distinguished between a step that only generates or measures information and a process that uses that information to actually diagnose a disease. Thus, merely detecting a genetic characteristic may not be excluded under Section 3(i). However, if the claimed process uses the detected information to confirm, identify, or rule out a medical condition, the process performs a diagnostic function and may be excluded as a diagnostic method. In this case a method or process of methylation of samples derived from the pregnant woman, albeit in a laboratory set up, which provides a result which would be sufficient to eliminate the pregnant woman from further tests, was held to be hit by Section 3(i) of the Act. These decisions also demonstrate that the substance and precise wording of a patent claim matter enormously.
What Should Health-Tech Startups Do?
Health-tech innovators in India should consider Section 3(i) at the earliest stage of their intellectual-property strategy. First, where appropriate, startups should focus patent claims on the technical system, device, or method of operation, rather than the ultimate medical diagnosis or treatment outcome. Second, innovators should identify the technical contribution of their invention. For software-driven technologies, this may involve emphasising the technical data processing, system architecture or technical implementation rather than simply claiming a method for diagnosing a disease. Finally, where patent protection is restricted by Section 3(i), companies may consider alternative protection, including copyright and trade-secret protection for proprietary algorithms, models, code, and technical know-how.
Finding the Right Balance
Section 3(i) represents a difficult policy trade-off. On one side is the public interest in ensuring that doctors can freely treat patients and that medical knowledge does not become excessively monopolised. On the other hand, it must not unnecessarily restrict researchers and businesses investing in new healthcare technologies. As AI, digital health, personalised medicine, and data-driven diagnostics continue to transform healthcare, this balance becomes increasingly important.
Section 3(i) remains an important public-health safeguard. At the same time, its application to emerging technologies requires careful interpretation so that legitimate technical innovation is not unnecessarily restricted. Ultimately, India’s challenge is to ensure that healthcare remains accessible while genuine technological innovation has room to grow.
Written by
Manju Pothen Manathara
