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2025 Supreme(Online)(Del) 7677
IN THE HIGH COURT OF DELHI AT NEW DELHI
Prathiba M. Singh, J
EMD MILLIPORE CORPORATION – Appellant
Versus
ASSISTANT CONTROLLER OF PATENTS AND DESIGNS – Respondent
C.A.(COMM.IPD-PAT) 7/2021
For the Appellants/Petitioners: Mr. Vineet Rohilla, Mr. Debashish Banerjee, Ms. Vaishali Joshi, Mr. Ankush Verma
For the Respondents: Mr. Adarsh Ramanujan, Mr. Parth Singh, Mr. Harish V. Shankar, Mr. Srish Kumar Mishra, Mr. Alexander Mathai Paikaday, Mr. Sagar Mehlawat
The interpretation of Section 3(i) of the Patents Act excludes only diagnostic methods involving clinical judgment; novel in vitro methods enhancing diagnostic processes are patentable.
Headnote:(A) Patents Act, 1970 - Section 3(i) - Exclusion from patentability of diagnostic processes - Appeal challenging refusal of patent for 'Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules' due to claimed methods being diagnostic - Claims were deemed not patentable under Section 3(i) as they pertained to diagnostic processes with no definitive findings indicative of disease. (Paras 68, 70, 72)
(B) Exclusion analysis - Court reviewed distinction between in vitro methods and diagnostic methods pertaining to treatment, emphasizing narrow interpretation of Section 3(i) to avoid hindrance to innovation in medical technology while preserving professional autonomy. (Paras 59, 60, 66)
Facts of the case:
The Appellant, a U.S. corporation, filed for a patent on a method improving quantitation of biomolecules via IR spectroscopy. The Assistant Controller rejected the application, asserting it claimed a non-patentable diagnostic method as per Section 3(i) of the Act. (Paras 5, 4)
Findings of Court:
The Appellant's method does not directly involve diagnosing a medical condition and thus, remains patentable as it provides a novel technical improvement. (Paras 70, 82)
Issues: Whether the claimed method falls under the exclusion of patentability under Section 3(i) of the Act? (Para 38)
Ratio Decidendi: The Court concluded that only those diagnostic methods necessitating clinical judgement are excluded from patentability; in vitro analytical methods which enhance diagnostic efficiency may be patentable. (Paras 68, 82)
Result: The appeal was allowed, and the refusal of the patent application was set aside.
1. This hearing has been done through hybrid mode.
2. 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”).
3. The appeal has been filed under Section 117A of the Act, challenging an impugned order dated 18th February, 2021 passed by the Respondent - Assistant Controller of Patents and Designs.
4. 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” (hereinafter “the subject patent application”) under Section 15 of the Act. The impugned order refusing the application for grant of the patent held that the Claims of the subject patent application are not patentable in view of Section 3 (i) of the Act.
I. Factual Background
5. The Appellant is a U.S. Corporation which filed the subject patent application as a Convention application on 3rd April, 2012 before the Indian Patent Office. The Appellant claims priority from a U.S. Patent Application No. 61/457,434 dated 14th April, 2011. The application was originally filed with 24 Claims. However, during the prosecution of the application, the Claims have been amended and the final set of Claims before this Court has 14 Claims.
6. The Appellant had filed the Request for Examination of the subject patent application on 11th June, 2012. Thereafter, the First Examination Report (hereinafter “FER”) in respect of the subject patent application was issued on 31st October, 2017 by the Controller. The primary objection raised by the Controller was that the Claims of the subject patent were not patentable under Section 3 (i) of the Act. The Appellant filed its response to the FER on 27th April, 2018 along with supporting documents and amended the Claims of the subject patent application attempting to overcome the objections raised in the FER by the Controller. However, the Controller was still not convinced with the reply of the Appellant and thereafter, the Appellant was also issued hearing notices dated 26th October, 2020 and 1st December, 2020 by the Respondent. The hearing in respect of the subject patent application was held on 21st December, 2020 which was duly attended by the concerned Agent of the Appellant. Subsequent to the hearing, the Appellant submitted its written submissions dated 5th January, 2021 in support of patentability of the subject invention along with amended claims and supporting documents.
7. However, the subject patent application was refused by the Respondent vide the impugned order dated 18th February, 2021 on the ground that the Claims in the subject patent were not patentable under Section 3 (i) of the Act. The operative portion of the impugned order is set out below:
“6. Essentially, what is being claimed in claim 1 is a method for detection of biomolecules in a sample. Claim 2 recites that the biomolecule is selected from the group consisting of nucleic acids, proteins, lipids, polysaccharides and lipopolvsaccharides, optionally an endotoxin. Claim 7 recites that the sample comprises a biological fluid and, optionally, the biological fluid is selected from the group consisting of blood, plasma. serum and urine. Therefore, it is evident that the claimed method is a diagnostic process which brings it into direct confrontation with Section 3 (i) of the Act.”
Conclusion
7. To conclude, the instant application claims subject-matter (claims 1-11) which is not an invention within the meaning of Section 3 (i) of the Act. Therefore, I hereby order the instant application refused.”
8. Accordingly, the present appeal has been preferred by the Appellant.
II. Proceedings in the Appeal
9. The present appeal was first heard on 6th October, 2021 on which date notice was issued to the Respondent.
10. On 21st March, 2022 submissions in part, were heard by this Court and after hearing the parties, the
