EMD Millipore Corporation v Assistant Controller of Patents and Designs (2025)

Summary

“The present appeal involves an interpretation of the exclusion from patentability in respect of diagnostic processes/methods under Section 3(i) of the Patents Act, 1970 (hereinafter ’the Act’).” (para 2) “Vide the impugned order the Respondent has refused the Patent Application bearing No.1026/DEL/2012 titled ‘Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules’” (para 4), which “relates to an improved method for the quantitative analysis of biomolecules using infra-red (IR) spectroscopy” (para 67). The impugned order held that “it is evident that the claimed method is a diagnostic process which brings it into direct confrontation with Section 3(i) of the Act.” (para 7) The Respondent’s report recorded that “the subject-matter of final claims 1-14 is novel and involves an inventive step within the meaning of Section 2(1)(j)” (para 12), and “the Court appointed Mr. Adarsh Ramanujan, Advocate as an Amicus Curiae to assist the Court in this matter.” (para 13)

The Court held that “this exclusion was only intended to safeguard the autonomy and efficacy of the medical profession in delivering essential care, not to create a blanket bar on patent protection for all innovations relating to diagnosis or treatment” (para 59), that “the intention is to exclude process claims and not product claims” (para 61), and that “Section 3(i) does not make any distinction between in vivo or in vitro processes.” (para 65) Of the subject invention it held that “the invention does not claim any process for diagnosing a disease or interpreting medical conditions” (para 67) and that “such an in-vitro analytical method, claimed in the present invention cannot be excluded from patentability under Section 3(i) of the Act.” (para 70) Of the amended claims it held that “the requirements of Section 59 of the Act stand duly satisfied” (para 81), and that “the subject patent application deserves to now proceed for grant of patent.” (para 82) “The appeal is allowed and disposed of in the above terms.” (para 84)

What the court decided

1. The scope of section 3(i). The Court held that “this exclusion was only intended to safeguard the autonomy and efficacy of the medical profession in delivering essential care, not to create a blanket bar on patent protection for all innovations relating to diagnosis or treatment” (para 59), that “exclusions from patentability are to be applied narrowly and purposively” (para 60), that “the intention is to exclude process claims and not product claims” (para 61), and that “Section 3(i) does not make any distinction between in vivo or in vitro processes” (paras 59–61, 65)
2. The nature of the claimed process. “The subject patent application relates to an improved method for the quantitative analysis of biomolecules using infra-red (IR) spectroscopy.” “The process is applicable to a wide range of samples including human plasma, food, cosmetics, water, sewage, and fuels. Notably, the invention does not claim any process for diagnosing a disease or interpreting medical conditions, but rather seeks protection for a technical method that enhances the efficiency of IR spectroscopic analysis performed in vitro on a removed sample.” (para 67) “For determining whether the subject patent is excluded from patentability under Section 3(i) of the Act, this Court would first examine the nature of the claimed process, its technical character, and the context of its application.” (paras 67–68)
3. Use on humans or animals. “The subject invention, thus, has application across different medical conditions and is not restricted to any specific medical condition. ... Merely because of the fact that it is capable of being used for infra-red spectroscopy to be conducted on humans or animals would not exclude the said process or method from patentability as the manner in which the results of the spectroscopy are to be analysed is not being patented. The manner in which the curve is to be read is also not to be patented. It is the method of conducting the quantization of bio molecules in a new form of infra-red spectroscopy that is sought to be patented. The products based on this form of spectroscopy could also have varying implementation and applications across industries and such a method would not attract exclusion under Section 3(i) of the Act.” (para 69)
4. An in vitro analytical method. “The core of the subject patent application lies in improving the efficiency and reliability of quantitative analysis using infra-red spectroscopy, by reducing calibration time and avoiding repeated generation of calibration curves. The process is conducted entirely outside the human or animal body and does not involve any step that can be characterised as diagnostic in nature when practiced on the body. Further, the invention does not require or entail any clinical decision-making or medical judgment based on patient-specific data. Consequently, the process is clearly a technical innovation, which is distinct from a diagnostic method per se. Accordingly, such an in-vitro analytical method, claimed in the present invention cannot be excluded from patentability under Section 3(i) of the Act.” (para 70)
5. The Controller’s objection. “It is to be noted that the patent has already been granted in Europe where similar exclusions exist under Article 53(c) of the EPC, 2000. The Respondent’s decision, holding that the subject patent is hit by exclusions under Section 3(i) of the Act, is therefore, not sustainable. The said objection as raised by the Controller is, accordingly, set aside.” (para 71)
6. Novelty and inventive step. “During the pendency of this appeal, the Court had called a report from the Patent Office on a question as to whether the subject patent application satisfied the conditions of patentability under Section 2(1)(j) and 2(1)(ja) of the Act.” (para 72) “Thus, the subject invention satisfies the requirements of Sections 2(1)(j) and 2(1)(ja) of the Act and is eligible for grant of patent. However, the Court also has to consider the objection raised under Section 59 of the Act as to whether the amendments in the claims were permissible or not.” (paras 72–73)
7. The scope of Section 59. “A perusal of the above provision would reveal that no amendment of a patent application is permitted if the effect of such amendment is that the specification as amended would claim or describe matter not in substance disclosed in the specification before the amendment, or that the amended specification would claim any matter not falling within the scope of the claims of the specification before the amendment. Further, the provision permits amendments only by way of disclaimer, correction, or explanation. Any amendment that introduces new matter or results in a broadening of the scope of the claims beyond what was originally disclosed in the Complete Specification is expressly prohibited.” (para 75) “The above principles under Section 59 of the Act have also been analysed and highlighted by this Court in Open TV Inc. vs. The Controller of Patents and Designs and Anr., (2023:DHC:3305).” From OpenTV v Controller of Patents and Designs (2023) the Court reproduced that “The fundamental principle governing amendment of Claims is therefore, that amendments are permissible in the Claims so long as the said amendments are within the scope of the originally filed Claims as filed and do not expand the said Claims. Thus, reduction or narrowing down a Claim is permissible, but broadening, widening or expansion of Claims is not permissible.” and that “Thus, amendments having been held to be permissible at the appellate stage, this Court is of the opinion that irrespective of whether the amendment is directed by the Court or is at the instance of Patent Applicant, so long as the requirements as laid down under Section 59 of the Act are fulfilled such that the amended claims are within the scope of original claims, is not breached, the amendment is permissible.” (paras 75–76)
8. The amended claims. “In light of the legal position outlined above and for the purposes of examining the validity of the objection raised under Section 59 of the Act, both the sets of Claims of the subject patent application filed before the Patent Office shall be set out. The purpose of doing so is to assess, based on the disclosure and scope of the invention, whether the amendments made by the Appellant are in the nature of disclaimer, correction, or explanation, and whether they remain within the scope of the originally filed claims.” (para 77) “The final Claim further introduces a limitation requiring that the infrared beam used in the analysis must have a diameter equal to or larger than the diameter of the hydrophilic region. This Court is conscious of the fact that this specific limiting feature was not present in the originally filed independent claims. However, the said embodiment is disclosed in the Complete Specification ... as a preferred embodiment. This amendment, therefore, does not introduce any new matter but merely incorporates a preferred embodiment into the Claim. The inclusion of this limitation narrows the scope of the claim and enhances its precision, and is accordingly, permissible under Section 59 of the Act.” (paras 77, 79) “In the amended claims, the subject patent is consolidated into a single independent method claim, Claim 1. This results in a more streamlined and technically narrowed claim structure. ... Accordingly, in the opinion of this Court, this amendment does not introduce new matter or increase the scope. Rather, it incorporates a preferred embodiment into the claims, providing greater technical precision. Since it narrows the scope of the invention, it qualifies as an explanatory amendment, incorporating an actual fact, without adding any subject matter or changing the scope of the Claims, the same is permissible under Section 59 of the Act.” (para 80) “Accordingly, it is clear that the amended Independent Claim does not seek to expand the protection beyond the originally claimed subject matter. Rather, it reflects a refinement of the claimed invention, with greater structural clarity and functional specificity. Therefore, the amendments are in the nature of explanation and clarification and do not introduce any new technical feature that was not already disclosed. Accordingly, the amended claim falls within the scope of what was originally disclosed and claimed, and the requirements of Section 59 of the Act stand duly satisfied.” (paras 77, 79–81)
9. Disposition. “In view of the above, since the exclusion under Section 3(i) of the Act would not be applicable in the present case and the application satisfies the test of novelty and patentability, the subject patent application deserves to now proceed for grant of patent.” (para 82) “The appeal is allowed and disposed of in the above terms. Pending application(s), if any, is also disposed of.” (para 84) “List before the Patent Office on 31st October, 2025 for completion of necessary formalities and for grant of patent to the Appellant.” (paras 82, 84–85) “The Registry is directed to supply a copy of the present order to the office of the Controller General of Patents, Designs & Trademarks of India ... for compliance of this order.” (paras 82, 84–86)

What the court did not decide

Of product claims the Court said that “each product claim would have to be analysed on a case to case basis since, laying down an objective test could be quite challenging as a close scrutiny would be required to decipher as to what is patentable and what is not.” (para 61) Of the provision it said: “There may be a need for taking a re-look at the wording of this provision in order to remove ambiguity and vagueness and provide further clarity, consistency and predictability in patenting. This would, however, be in the realm of policy and the Legislature.” (para 66)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 10 October 2026.