Summary
The Delhi High Court delivered a significant ruling in the appeal filed by EMD Millipore Corporation, challenging the rejection of its patent application titled “Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules” by the Assistant Controller of Patents & Designs. The Court held that a method for detecting biomolecules using infrared light does not fall within the exclusion of Section 3(i) of the Patents Act, 1970. In addition, the Court allowed the applicant to revert to an earlier set of claims during the appeal proceedings.
EMD Millipore Corporation (Appellant), filed Indian Patent Application No. 1026/DEL/2012, titled “Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules” on 3rd April 2012 before the Indian Patent Office. The invention related to an infrared spectroscopic method and a corresponding device designed to quantify biomolecules such as proteins, lipids, carbohydrates, and nucleic acids in a wide range of samples including human plasma, food, cosmetics, water, sewage, and fuels.
During examination, the Assistant Controller (Respondent) raised an objection under Section 3(i) of the Patents Act, 1970, which excludes from patentability “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals.” By an order dated 18 February 2021, the Respondent refused the application on the ground that the claimed invention was a diagnostic method, thereby falling under the exclusion of Section 3(i).
Challenging the refusal order, the Appellant filed an appeal before the Honourable Delhi High Court. During the proceedings, the Court appointed an Mr. Adarsh Ramanujan as Amicus Curiae to assist in examining the interpretation and scope of diagnostic methods under Section 3(i).
Arguments by Parties
The Appellant contended that the claimed method, which employs a sample holder using an infrared absorption mechanism, had already been examined and found novel and inventive by the Respondent. Further, such a method was not confined to medical or diagnostic use, but could can be applied to a wide range of samples, including blood, water, soil, cosmetics, pharmaceuticals, sewage, and other liquid products. The Appellant emphasized that this broad applicability demonstrates that the invention was not restricted to diagnostic purposes within the meaning of Section 3(i) of the Patents Act.
The Respondent’s counsel argued that diagnostic methods are expressly excluded under Section 3(i) of the Patents Act, as they inherently include all interlinked steps from screening to analysis. They further contended that Section 3(i) makes no distinction between in vivo and in vitro methods, and granting a patent for such broadly applicable processes would effectively monopolize diagnostic techniques.
The Amicus Curiae, Mr. Adarsh Ramanujan, analyzed Section 3(i) of the Patents Act with reference to the Chinese University of Hong Kong v. Assistant Controller of Patents & Designs and the 2002 Amendment history. He noted possible drafting gaps and argued that only diagnostic methods leading directly to a curative decision should be excluded from patentability, while screening or analytical methods should remain eligible.
Court’s analysis
The Court first analysed the legal positions in other jurisdictions, including similar exclusions under the UK Patent Act, 1977, and Article 53(c) of the European Patent Convention (EPC). Specifically, the Court referred to the jurisprudence of the Enlarged Board of Appeal of the European Patent Office (EPO) in Case G 0001/04, which defined the essential steps of a diagnostic method. The Court noted that, as per the EPO, a diagnosis for curative purposes typically involves the following four steps: (i) the examination phase involving the collection of data, (ii) the comparison of these data with standard values, (iii) the finding of any significant deviation, i.e., a symptom, during the comparison, and (iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase. The Court observed that only methods comprising all four steps culminating in a clinical judgment amount to a diagnostic method “for curative purposes” and are thus excluded from patentability under Article 53(c) EPC.
The Court clarified that under Indian patent law, both products and processes are patentable if they satisfy the requirements of novelty, inventive step, and industrial applicability. The exclusion under Section 3(i) must therefore be interpreted in conjunction with the definitions of “invention” and “inventive step” under Sections 2(1)(j) and 2(1)(ja). The Court observed that the purpose of Section 3(i) was to protect the autonomy of medical professionals and prevent monopolies over core clinical activities that form part of their everyday medical practice. The Court further observed that Section 3(i) should be interpreted narrowly, protecting the freedom of medical practitioners while still enabling innovation. Each case, however, must be examined individually to determine whether it falls within the exclusion or qualifies as a patentable invention.
With respect to the present invention, the Court observed that the same pertains to the quantitative analysis of biomolecules using infrared spectroscopy, wherein the invention reduces the time required for generating a calibration curve and to eliminate the need for its repeated regeneration. The Court noted that the invention has broad applicability across diverse fields medical, environmental, cosmetic, and industrial and was not confined to any particular medical condition. Merely because the method could be used for analysing biological samples does not render it a diagnostic method within the meaning of Section 3(i) of the Act. Observing that a corresponding patent had already been granted in Europe under Article 53(c) of the EPC, the Court held that the Controller’s conclusion that the invention was hit by Section 3(i) was unsustainable and accordingly set aside the objection.
With respect to the objection raised under Section 59 of the Act, the Court compared the originally filed and amended claims and found that the amendments merely consolidated the invention into a single independent method claim with dependent claims detailing structural and procedural features. The added limitation regarding the infrared beam diameter was already disclosed as a preferred embodiment in the specification and did not introduce new matter or expand the scope. The Court further noted that reverting to originally filed or narrowed claims was permissible, even at the appellate stage, provided the amendments comply with Section 59. Accordingly, the Court held that the amendments were explanatory in nature, maintained within the original scope, and the Controller’s objection under Section 59 was unsustainable.
Conclusion
In conclusion, the Court found that the claimed invention did not fall within the exclusion of Section 3(i) of the Patents Act, 1970. It further found that the amendments complied with Section 59, being clarificatory in nature and within the original scope. Accordingly, the objections under Sections 3(i) and 59 were set aside, and the appeal was allowed.
Citation: Emd Millipore Corporation vs Assistant Controller Of Patents (C.A.(COMM.IPD-PAT) 7/2021) (H.C. Delhi October 9, 2025). Available at: https://indiankanoon.org/doc/81278453/
Authored: Dr. Vasundhara Paliwal
Accessibility Review: Rakesh Krishnan