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2025 Supreme(Online)(Del) 7678
IN THE HIGH COURT OF DELHI AT NEW DELHI
Prathiba M. Singh, J
NATERA INC – Appellant
Versus
THE ASSISTANT CONTROLLER OF PATENTS AND DESIGNS – Respondent
C.A.(COMM.IPD-PAT) 16/2023
For the Appellants/Petitioners: Ms. Vindhya S. Mani, Ms. Surbhi Nautiyal, Ms. Naina Gupta, Ms. Harshita Agarwal, Ms. Vedika Singhvi, Mr. Ritwik Sharma, Mr. Bhuvan Malhotra, Mr. Devesh Aswal
For the Respondents: Ms. Arunima Dwivedi, CGSC, Ms. Swati Jhunjhunwala, Ms. Pinky Pawar, Mr. Aakash Pathak, Mr. Prasad, Deputy Controller, Mr. Adarsh Ramanujan, Amicus Curiae
The patent application for a method of lung cancer detection was rejected as it was classified as a non-patentable diagnostic method under Section 3(i) of the Patents Act, 1970.
Headnote:(A) Patents Act, 1970 - Section 3(i) - The appeal challenges the refusal of Patent Application No. 201817033216 concerning a method for lung cancer detection. The Respondent held that the claims are not patentable under Section 3(i) as they relate to diagnostic methods. Claims 5 to 8 additionally were rejected citing Section 59 of the Act. (Paras 2, 11, 12, 90)
(B) Patentability - Diagnostic methods - The court found that the method in question, aimed at detecting lung cancer mutations, qualifies as a diagnostic method, thus falling within the exclusion in Section 3(i), negating the claim of non-diagnostic nature presented by the appellants. (Paras 93, 96)
(C) Findings from foreign jurisprudence indicate no distinction in patentability based on the method being invasive or non-invasive. The inclusion of diagnostic methods in the patent law is a public policy exclusion to safeguard medical practitioners. (Paras 56, 64, 74)
Facts of the case:
The appellants filed a patent application for a method to detect lung cancer through a blood sample using multiplex PCR. The Respondent rejected the application on grounds of it being unpatentable as a diagnostic method.
Findings of Court:
The Court concluded that the subject invention is indeed a diagnostic method, excluded under Section 3(i) of the Act.
Issues: The court addressed the questions of whether the subject invention qualifies for exclusion under Section 3(i) and the applicability of Section 59 concerning the amendment of claims.
Ratio Decidendi: The reasoning is based on the interpretation of diagnostic methods and the intent behind Section 3(i), aimed at maintaining the freedom of medical practice while fostering innovations.
Result: Appeal dismissed; the subject patent is held unpatentable under the current provisions of law.
| Table of Content |
|---|
| 1. interpretation of patentability exclusions. (Para 2 , 3 , 4) |
| 2. arguments on patent application rejection. (Para 14 , 15 , 32 , 33) |
| 3. boundaries of diagnosing methods under patent law. (Para 60 , 72 , 74 , 96) |
| 4. final judgment on the subject patent application. (Para 100 , 103) |
1. This hearing has been done through hybrid mode.
2. The present appeal involves an interpretation of the exclusions from patentability in respect of diagnostic 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 the impugned order dated 20th March, 2023 passed by the Respondent – Assistant Controller of Patents and Designs.
4. Vide the impugned order the Respondent has refused the Patent Application bearing No. 201817033216 (hereinafter “the subject patent application”) for the invention titled “Methods for Lung Cancer Detection” (hereinafter “the subject invention”). The impugned order has refused the grant of subject patent application while holding that Claims 1 to 4 thereto are not patentable under Section 3 (i) of the Act. Further, Claims 5 to 8 of the subject patent application have been rejected in view of Section 59 of the Act.
I. Factual Background
5. Appellant No.1 – Natera Inc., is a company registered in California, United Stated of America and is stated to be a leader in the field of clinical genetic, specializing in cell-free DNA testing technology. Appellant No. 2 – UCL Business Ltd., is a wholly owned subsidiary of University College London, having its registered office in London, United Kingdom and is stated to perform functions of knowledge transfer.
6. The subject patent application consisting of Claims 1 to 54 was filed before the Indian Patent Office on 5th September, 2019 and the Appellants claimed priority from US Application 62/323,589 dated 15th April, 2016. The request for examination was filed on 9th April, 2020. It is stated that vide communications dated 9th April, 2020 and 28th October, 2020 the Appellants had amended the Claims, whereby, inter alia, Claims 18 to 54 were deleted. The Claims were again amended by the Appellants vide communication dated 28th October, 2020.
7. The First Examination Report dated 31st August, 2021 (hereinafter “FER”) was issued by the Patent Office raising various objections, including the following:
(i) Claims 1 to 15 lack novelty under Section 2 (1)(j) of the Act;
(ii) Claims 1 to 15 lack inventive step under Section 2 (1)(ja) of the Act;
(iii) Claims 1 to 15 are non-patentable under Section 3 (d) and Section 3 (i) of the Act;
(iv) Claims 1 to 15 do not satisfy the requirements of Section 10(4)(c) of the Act.
8. Accordingly, the Appellants had filed their response to the FER on 25th February, 2022 along with the amended Claims 1 to 15. The Appellants were thereafter provided an opportunity of hearing on 9th December, 2022 which was adjourned at the request of the Appellants. A further opportunity for hearing was granted to the Petitioner on 9th January, 2023 vide hearing notice dated 12th December, 2022, (hereinafter “the hearing notice”). In the hearing notice, the following objections were raised:
(i) Claims 1 to 15 lack inventive step under Section 2 (1)(ja) of the Act;
(ii) Claims 1 to 15 are non-patentable under Section 3 (i) of the Act;
(iii) Claims 1 to 15 attract Section 10(4)(c) and Section 10(5) of the Act;
(iv) The subject matter of Claim 15 is broader than the complete specification which is not satisfying the requirement of Section 10(4)(a) of the Act.
(v) Non-submission of details of applications for patents filed outside India in respect of same or substantially same invention in terms of Section 8(1)(b) read with Rule 12(1) the Patent Rules, 2003 (hereinafter “the Patent Rules”).
(vi) Non-submission of details of the search/ examination report in respect of same or substantially same invention in terms of Rule 12(3) of the Patent Rules.
9. It is stat
