Erroneous assessment of inventions under Section 3(c).

The Honorable High Court of Madras, in an appeal (T) CMA (PT) No.126 of 2023 filed by Imclone LLC (the appellant) to overturn a decision made by the Assistant Controller of Patents and Designs (the respondent), denying the grant of the appellant's patent application under Section 3(c) of the Patents Act, 1970.

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Patent/Application in suit:                     5808/CHENP/2007 (Now Patent Number :539070)

Filing Date:                                           19/06/2006 (PCT)

Corresponding PCT:                              PCT/US06/23856

Publication Date:                                   13/06/2008

Request for Examination:                      17/06/2009

First Examination Report Date:              10/03/2014

 

Judgment Pronounced on: Mar 6, 2024

Conclusive Remark: 

The Court observed that the antibody in question was produced by introducing an engineered antigen into mice. Subsequently, material obtained from the inguinal lymph nodes of the mice was combined with myeloma cells using the hybridoma technique. This process led to the creation of the antibody that is the subject of the patent application. Consequently, the Court determined that the invention as claimed is not excluded from patent protection under Section 3 of the Act.

Interesting fact & remark of MHC :

·         The Court provided an interpretation of the language used in Section 3 of the Act. Firstly, the Court explained that the term "mere" preceding "discovery" indicates that only discoveries beyond scientific principles are eligible for patents.

·         The use of "mere" is restricted to qualifying the discovery of a scientific principle and does not extend to discoveries of living organisms or naturally occurring substances.

·         Secondly, the Court clarified that the phrase "occurring in nature" excludes living organisms to avoid redundancy in interpretation. Therefore, the Court concluded that "occurring in nature" in Section 3(c) refers specifically to non-living substances.

·         Additionally, the Court referenced decisions from the US Supreme Court to support its interpretation. Notably, the case of Sidney A. Diamond v. Ananda M. Chakrabarty, 1980 SCC OnLine US SC 128, where a man-made bacterium was deemed patent-eligible.

·         The Court also discussed the case of Association for Molecular Pathology et al v. Myriad Genetics et al, 133 S.Ct. 2107 (2013), highlighting that while a claimed invention related to the discovery of human genes was ineligible for patents, the creation of synthetic cDNA was considered patent-eligible.

Background:

The appellant (Imclone LLC) filed a Patent Application (5808/CHENP/2007) to secure patent rights for their innovation titled "Antibody Capable of Binding Specifically to A-beta Oligomer and Use Thereof". Upon review, the respondent raised objections in the First Examination Report (FER) under Section 3 of the Act, contending that the application did not qualify for patent protection.

In response, the appellant argued that the antibody in question was not naturally occurring and did not exist in nature, countering the objections raised in the FER. However, the respondent maintained their objection under Section 3(c), asserting that the antibody's specific chemical sequence was an inherent characteristic and did not differentiate it from naturally occurring antibodies. Moreover, they argued that since the antibody was discovered, it was not eligible for patent protection. Consequently, the claimed invention was denied patent protection under Section 3(c) of the Act.

Series of events:

·         The Appellant submitted a ordinary patent application under the title "Receptor Antagonists for treatment of Metastatic Bone Cancer," with application number 5808/CHENP/2007 ('Application'). The initial claims focused on recombinant antibodies or antibody fragments that specifically target human PDGFRα (Platelet-derived growth factor receptor alpha).

·         In the First Examination Report (FER), the Respondent raised objections under different sections of the Act, which included an objection to non-patentability under Section 3(c) of the Act. Additionally, there were further objections related to non-patentability under Sections 3(i) and 3(j) of the Act. Responded on 13/02/2015.

·         On 31/01/2018 The Respondent ultimately declined to approve the Application citing non-patentability under Section 3(c) of the Act. Dissatisfied with the Respondent's decision, the Appellant lodged an appeal.

·         The Appellant's representative started by providing a brief overview of the role of PDGFRα in bone cancer, particularly metastatic cancer. This was followed by a detailed explanation of the process involved in creating the recombinant antibody (IMC-3G) designed to target a specific epitope and inhibit ligand binding at the receptor site. By referencing specific sections of the complete specification, the Appellant's representative argued that the human anti-PGDFRα antibodies in question were not naturally derived but were instead produced using conventional hybridoma technology.

·         Moreover, it was stressed that the human body does not naturally generate antibodies to PGDFRα due to its crucial role in human embryonic development; any naturally occurring antibodies would have interfered with embryonic development. In discussing the interpretation of Section 3(c) of the Act, the Appellant's representative cited relevant judgments from the former Intellectual Property Appellate Board.

 

·         Therefore, the Appellant's representative concluded that the refusal of the application under Section 3(c) of the Act contradicts the principle of equality, given that patents for monoclonal antibodies have been previously issued by the Patent Office.

Discussion and decision

·         The High Court commenced by providing an overview of the scientific terms, concepts, and principles relevant for comprehending the dispute. Within this context, the High Court outlined the development of Section 3(c) of the Act. The Ayyangar Committee Report from 1959 played a pivotal role in shaping the Patents Act of 1970. In paragraph 328 of this report, the Committee asserted that

discoveries are generally not eligible for patents. It was argued that while an invention involves creating something new that did not previously exist, a discovery involves finding something already in existence.

·         Prior to the 2002 amendment, Section 3(c) of the Act consisted of two parts that prohibited the patenting of 'the mere discovery of a scientific principle or the formulation of an abstract theory.' The first part pertained to discovery while the second focused on the intellectual process of formulating an abstract theory. The inclusion of the term 'mere' before 'discovery' in the first part implied that something beyond a mere discovery of a scientific principle could potentially be patentable. Notably, this qualifier was absent in the second part concerning the formulation of an abstract theory.

·         The High Court then focused on the phrase ‘occurring in nature’ mentioned in the third aspect of Section 3(c) of the Act. Through an analysis of standard rules of language structure, the High Court suggested that if the phrase ‘occurring in nature’ were intended to apply to ‘living thing,’ the wording of the provision would have been 'the discovery of any living or non-living thing occurring in nature,' which is not the construction used. Additionally, extending ‘occurring in nature’ to 'living thing' would lead to redundancy given the current level of scientific understanding.

·         Consequently, the High Court determined that the term ‘occurring in nature’ in the third part of Section 3(c) of the Act only modifies the most immediate and logical reference, namely, ‘non-living substance.’

·         The High Court reviewed and considered the arguments put forth by both the Appellant and the Respondent's legal representatives. After interpreting Section 3(c) of the Act, the Court ruled that the argument suggesting the antibody in question is naturally occurring solely because the sequence listing identifies the organism as Homo Sapiens lacks merit. This reasoning would only hold if the Appellant had come across a previously unknown antibody in nature and isolated it.

      Furthermore, the High Court clarified that the antibody in question was not obtained from a human donor but was created through a specific engineering process detailed in the application. To elaborate, transgenic mice were developed by replacing murine genetic material with human genetic material. These mice were then exposed to an engineered antigen. Subsequently, material extracted from the mice's spleen was fused with myeloma cells using the hybridoma technique, resulting in the creation of the claimed antibody. Based on these details, the High Court determined that the claimed invention did not violate Section 3(c) of the Act. Consequently, the court overturned the challenged decision and instructed the approval of the application.