IN THE HIGH COURT OF JUDICATURE AT MADRAS
Senthilkumar Ramamoorthy, J.
Immunas Pharma, Inc. Kanagawa Science Park Japan and Another – Appellants
Versus
Assistant Controller of Patents and Designs – Respondent
(T) CMA (PT) No. 118 of 2023
Decided On : 06-03-2024
Patents Act - Antibody Capable of Binding Specifically to A-beta Oligomer - Section 3(c) - Summary
Fact of the Case:
The appellant filed a patent application for an invention titled 'Antibody Capable of Binding Specifically to A-beta Oligomer'. The respondent rejected the application citing lack of patent eligibility under Section 3(c) of the Patents Act, 1970.
Finding of the Court:
The court analyzed the scientific principles and legal provisions related to the patent eligibility of the claimed invention. It concluded that the claimed invention was not excluded from patent protection under Section 3(c) and directed the claimed invention to proceed to grant based on the current claims submitted during the hearings.
Issues: The issues involved interpretation of Section 3(c) of the Patents Act, determination of patent eligibility for a synthesized antibody, and examination of the sequence listing and engineering process of the claimed invention.
Ratio Decidendi: The court's decision was based on the interpretation of Section 3(c) and the conclusion that the claimed invention was not a mere discovery of a non-living substance occurring in nature, but was engineered through a specific process.
Final Decision: (T)CMA(PT)No.118 of 2023 is allowed on the above terms without any order as to costs.
JUDGMENT :
(Prayer : This Civil Miscellaneous Appeal is filed under Section 117-A of the Patents Act, 1970, praying to set aside the order dated 31 January 2018 and issued by the Respondent in Indian Patent Application No.6334/CHENP/2009 for patent be allowed to proceed to grant.)
1. The appellant assails an order dated 29 December 2017 by which Indian Patent Application No.5542/CHENP/2010, which is the national phase application derived from PCT Application No. PCT/JP09/052039 dated 06 February 2009, was rejected.
2. The appellant filed the above mentioned application dated 03 September 2010 for grant of patent in respect of an invention titled “Antibody Capable of Binding Specifically to A-beta Oligomer and Use Thereof” by claiming its priority date from JP Application No.2008-028386 dated 08 February 2008, JP 2008-201058 dated 04 August 2008 and US Application No.61/085, 545 dated 01 August 2008. Upon a request being made, the respondent issued the first examination report (FER) on 22 September 2014. In the FER, objections were raised inter alia on the grounds of lack of unity; lack of inventive step in view of prior art documents D1-D4; claims 1-8 not being patent-eligible under Section 3 (c) of the Patents Act, 1970 (the Patents Act); claims 9-17 not being patenteligible under Section 3(e) of the Patents Act; and claims 18-22 not being patent-eligible under Section 3(i) of the Patents Act. On 27 October 2014, the appellant filed a response to the FER. By such response, the claims were amended and the claim was restricted to a single antibody labelled as 6E4.
3. A further examination report was issued on 10 August 2015 raising objections inter alia that: the claimed invention lacks an inventive step in view of prior arts D1-D4; claims 1-8 are not patent eligible under Section 3(c); claims 9-17 are not patent eligible under Section 3(e); claims 18-22 are not patent eligible under Section 3(i); and claims 23-24 do not comply with Section 10(4)(c). A response was filed thereto on 22 September 2015 along with amended claims 1-4. It was stated that the claimed invention was not obvious from cited prior art documents because it is specific to A-beta oligomers. The objection under Section 3(c) was refuted by contending that the 6E4 antibody is not naturally occurring and that even the antigen is not found in nature. Claims 9-22 were deleted in response to the objections under Sections 3(e) and (i). Claims 23-24 were also deleted to meet the objection under Section 10(4)(c). By hearing notice dated 29 March 2017, objections were raised in respect of unity of invention; under Section 3(c) in respect of amended claims 1-3 and under both Section 10(4)(c) and 3(e) in respect of amended claim 4. In the written submissions filed after the hearing on 13 July 2017, claim 4 was deleted. Claims 1-2 were amended and limited to a single antibody 6E4 to meet the unity of invention objection, and the objection under Section 3(c) was dealt with by pointing out that the sequence under numerical identifier [400] should be the determining factor and not the organism from which the sequence is derived, i.e. sequence identifier [213].
4. By impugned order dated 29 December 2017, the respondent confirmed the Section 3(c) objection by holding that the claimed antibody with specific amino acid H or L sequence is an inherent feature and does not distinguish it from those that occur in nature. It was further held that the antibody 6E4, which is the subject of the patent claim, was discovered and, hence, not patent-eligible. The present appeal arises in the above facts and circumstances.
Counsel and their contentions
5. Oral arguments on behalf of the appellant were advanced by Mr.P.V.Balsubramaniam, learned senior counsel, assisted by Mr. Vijay Anand of De Penning and De Penning. The respondent was represented by Mr.N.Vijayaraman.
6. Learned senior counsel for the appellant contended that A-beta oligomers occur naturally in the human body and that, consequently,
The main legal point established in the judgment is the interpretation of Section 3(c) of the Patents Act and its application to the patent eligibility of a synthesized antibody.
The main legal point established is that patent eligibility under Section 3(c) of the Patents Act requires a thorough analysis of the nature and origin of the claimed invention, emphasizing the need ....
The main legal point established in the judgment is the interpretation of Section 3(c) of the Patents Act, 1970, and its application to the claimed invention. The court's decision clarified the scope....
The court allowed the amendment of claims at the appellate stage and found that the invention satisfied the criteria of inventive step.
The court established that inventions based on traditional knowledge are not patentable if they do not demonstrate a significant inventive step beyond known properties.
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