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Meeting the Objection under Section 3(c) of the Patent Act, 1970: Antibody Capable of Binding Specifically to A-beta Oligomer and Use case

A legal case concerning the rejection of a patent application under Section 3(c) of the Patent Act, 1970 has been discussed herein. The case revolves around Indian Patent Application No.5542/CHENP/2010, which sought protection for an invention titled "Antibody Capable of Binding Specifically to A-beta Oligomer and Use Thereof."

The rejection was based on the argument that the claimed antibody, with specific amino acid sequences, was inherent and naturally occurring. However, the appellate authority overturned the decision, emphasizing the engineered nature of the antibody. This article examines the legal and technical intricacies of the case, highlighting the interpretation and application of Section 3(c) in patent law.

Section 3(c) of the Patent Act, 1970, serves as a crucial provision governing the patentability of inventions. It stipulates that inventions that are mere discoveries of a scientific principle or naturally occurring substances are not patentable. This provision aims to prevent the monopolization of naturally occurring phenomena and encourage genuine innovation. However, its interpretation and application in specific cases often present challenges, as demonstrated in the case under review.

Legal Framework:
Under Section 3(c) of the Patent Act, inventions concerning substances occurring naturally are not patentable unless they are produced by means of a technical process involving human intervention, resulting in a substance not naturally occurring. This provision aims to strike a balance between promoting innovation and preventing the patenting of discoveries that merely reflect natural phenomena.

Case Analysis:
The case at hand involves a patent application for an antibody capable of binding specifically to A-beta oligomers. The application was rejected on the grounds that the claimed antibody, with specific amino acid sequences, was considered inherent and naturally occurring, falling under the ambit of Section 3(c). However, the appellant contested this decision, arguing that the antibody was engineered through a sophisticated process involving human intervention.

Technical Analysis:
From a technical standpoint, the appellant's argument holds weight. The antibody in question was not merely isolated from a natural source but was engineered using a series of deliberate steps. The process involved injecting an engineered antigen into mice, followed by the fusion of lymph material extracted from the mice with myeloma cells through the hybridoma process.

This resulted in the production of the antibody claimed in the patent application. The deliberate manipulation of biological materials through human intervention distinguishes the claimed invention from naturally occurring substances, aligning it with the requirements of patentability.

The appellate authority's decision to overturn the rejection of the patent application under Section 3(c) underscores the importance of human intervention in the patentability of biological inventions. While Section 3(c) aims to prevent the patenting of naturally occurring substances, it does not preclude inventions that involve significant human intervention and technical processes.

Case Title: Immunas Pharma, Inc. Vs Assistant Controller of Patent
Order Date: 06.03.2024
Case No. (OA/22/2018/PT/CHN)
Neutral Citation:2024.MHC.1144
Name of Court: High Court of Madras
Name of Hon'ble Judge: Senthilkumar Ramamoorthy, H.J.

This article is meant for informational purposes only and should not be construed as substitute for legal advice as Ideas, thoughts, views, information, discussions and interpretation perceived and expressed herein are are subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the fact and issue of law involved herein.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539

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