The boundary between an analytical research tool and a patentable-versus-excluded diagnostic method has long been contested in Indian patent law. When the Patents Act bars \u201cdiagnostic methods\u201d from patentability under Section 3(i), the question of precisely which methods clear that threshold has significant consequences for biotech and medical-device innovators seeking protection in India.<\/p>\n
Natalja Eikje (\u201cEikje\u201d), a Norwegian scientist whose research career spans dermatology, clinical physics, radiology, and physiological biophysics, developed a method for understanding how skin cancer progresses at the molecular level. Her invention involved an in vitro method of comparative spectral pattern analysis, using Fourier Transform Infrared (\u201cFTIR\u201d) microspectroscopy, to observe and characterize the intra-molecular and inter-molecular interactions of nucleic acids and proteins expressed in skin tissue samples across benign, premalignant, and malignant stages. A United States priority application was filed in February 2012, followed by a PCT international application in February 2013. The Indian national phase application, no. 7173\/DELNP\/2014, was filed in August 2014 and covered a total of sixteen claims spanning the spectral analysis method (claims 1\u20136), an FTIR microspectrometer apparatus (claims 7\u201310), and a combination group of nucleic acids and proteins with characteristic spectral parameters (claims 11\u201316).<\/p>\n
The First Examination Report, issued in February 2021, raised objections under Sections 2(1)(ja), 3(d), 3(i), and 3(k) of the Patents Act, but only against claims 1\u20136. Eikje filed a substantive reply in August 2021, accompanied by amended claims, and completed post-hearing written submissions in October 2023. Notwithstanding these responses, the Joint Controller of Patents and Designs (\u201cController\u201d) refused the entire application by order dated 15 April 2024, rejecting all sixteen claims solely on the ground that claims 1\u20136 were not patentable under the Section 3(i) diagnostic methods bar. Eikje challenged that refusal before the Delhi High Court under Section 117A of the Patents Act.<\/p>\n
The court observed that the undisputed factual position was that when the First Examination Report was issued, claims 7\u201316 attracted no objection under Section 3(i) of the Patents Act. The Controller nevertheless rejected all sixteen claims on the basis of Section 3(i) alone, providing no independent basis for refusing claims 7\u201316. The court noted that this was a blatant error in the impugned order that could not be countenanced in law. Whatever the outcome of the Section 3(i) diagnostic methods analysis with respect to claims 1\u20136, the Controller was required to assess claims 7\u201316 independently and pass appropriate orders. The blanket refusal of the entire application, including claims that had never been challenged under any provision, was itself sufficient to vitiate the order.<\/p>\n
On the substantive Section 3(i) question, the court found that the Controller had committed a fundamental error in technically comprehending the claimed invention. The court observed that the term \u201cin vitro\u201d carries a precise scientific meaning: it refers to studies, experiments, or tests performed outside a living organism, in a controlled laboratory environment, using isolated components of an organism, whether cells, tissues, or molecules, separated from their normal biological surroundings and placed in test tubes, petri dishes, or similar apparatus. Claims 1\u20136 expressly confined themselves to such an in vitro method.<\/p>\n
The court further observed that the Controller\u2019s reasoning was premised on the erroneous assumption that the claimed method was a diagnostic process performed on patients. The court noted that this assumption directly contradicted the express scope of the claims and was unsupported by the scientific literature or the text of the application. Eikje had specifically raised before the Controller that the claimed method produced intermediate analytical findings relating to the spectral characterization of nucleic acids and proteins expressed in biopsied tissue, and that these findings did not, by themselves, identify a disease or condition for treatment. None of these submissions had been engaged with in the impugned order.<\/p>\n
The court stated that a test qualifying as a \u201cdiagnostic method\u201d under the Section 3(i) diagnostic methods exclusion should inherently identify a disease or condition for potential treatment. The FTIR spectral method, by contrast, provided data about intra-molecular and inter-molecular interactions in nucleic acids and proteins across stages of carcinogenesis, intended to advance the scientific understanding of how skin cancer progresses at the molecular level. The court held that the Controller\u2019s failure to engage with the in vitro nature of the claims, and its conflation of an analytical characterization method with a diagnostic process, rendered the impugned order legally untenable. Rather than decide the Section 3(i) question on its merits, the court chose to remand the matter to give the Controller the opportunity to apply the correct legal and technical framework to the claims.<\/p>\n
In view of the observations and the arguments presented by both the parties, the Delhi High Court held that:<\/p>\n