Introduction
Madras High Court’s recent decision in Genmab A/S v. Assistant Controller of Patents and Designs clarifies the interpretation of Section 3(c) of the Indian Patent Act for synthesized non-living substances, especially monoclonal antibodies.
This judgment provides a detailed explanation of why establishing the novelty or the technical advancement of an invention is a must for patentability for such inventions and not patent eligibility. This decision also sets a precedent for future cases involving synthesized substances. Furthermore, it establishes a framework for evaluating patent eligibility and encourages a thorough examination of scientific advancements in the field.
Background of the Case
Genmab filed an Indian patent application No. 4718/CHENP/2007, titled “Antibodies against CD38 for Treatment of Multiple Myeloma” on October 23, 2007, with 84 claims. A First Examination Report (FER) was issued with several objections such as obviousness in view of seven cited prior arts, non-patentability under Section 3(j), (e), (i), and (c), and non-compliance with Section 10(4) of the Act. Subsequently, the applicant filed a response to the FER, along with an amended set of claims.
The Controller of Patents then issued a hearing notice maintaining most of the objections of FER. The Applicant filed the written submissions along with further amended claims. However, the application was rejected for lacking inventive step, non-compliance with Section 10(4)(c), and ineligibility under Section 3(c) of the Act. Specifically, the Controller held that the claimed monoclonal antibody is nonpatentable under Section 3(c) of the Act and is a mere discovery of a naturally existing substance as the sequences defining the antibodies are human antibodies.
In response, Genmab filed an appeal at the Delhi High Court contending all three grounds of refusal, especially Section 3(c).
The Refused Independent Claims
[Claim 1]: “An antibody binding to human CD38 comprising human light chain and human heavy chain variable regions, wherein the light chain variable region comprises a VL CDR1 having the sequence as set forth in SEQ ID No:13, a VL CDR2 having the sequence as set forth in SEQ ID No:14 and a VL CDR3 having the sequence as set forth in SEQ ID No:15, and the heavy chain variable region comprises a VHCDR1 having the sequence as set forth in SEQ ID No:18, a VH CDR2having the sequence as set forth in SEQ ID No:19 and a VH CDR3 having the sequence as set forth in SEQ ID No:20, and wherein said antibody is encoded by (i) human light chain and human heavy chain nucleic acids comprising nucleotide sequences in their variable regions as set forth in SEQ ID No:11 and SEQ ID No:16, respectively.”
[Claim 2]: “An antibody binding to human CD38 comprising human light chain and human heavy variable regions, wherein the light chain variable region comprises a VL CDR1 having the sequence as set forth in SEQ ID No:13, a VL CDR2 having the sequence as set forth in SEQ ID No:14 and a VL CDR3 having the sequence as set forth in SEQ ID No:15, and the heavy chain variable region comprises a VH CDR1 having the sequence as set forth in SEQ ID No:18, a VH CDR2 having the sequence as set forth in SEQ ID No:19 and a VH CDR3 having the sequence as set forth in SEQ ID No:20.”
Appellant’s Contentions
The Appellant first contended that numerous patents were granted by the Indian Patent Office for monoclonal antibodies.
They further argued that the claimed monoclonal antibodies binding to human CD38 are defined by three light chain variable regions and three heavy chain variable regions, which are defined in the form of nucleic acid sequences. The antibody was produced by the hybridoma process, i.e., by fusing the extract from transgenic mice with an immortal myeloma cell wherein transgenic mice were immunized with two immunogens artificially produced by modifying the human CD38 antigen.
The transgenic mouse enzymes play a role in determining the final composition of the antibody by the introduction of somatic hypermutations. Therefore, the claimed antibodies are produced by substantial human intervention and not isolated from the human population, and isolating this class of antibodies from the human population is impossible.
Additionally, the Appellant contended that most naturally occurring antibodies are polyclonal, typically having different specificity and showing polyvalent affinity, i.e., they bind to different epitopes of the same antigen. In contrast, monoclonal antibodies have monovalent affinity, i.e., they bind to the same epitope of the antigen. The inventiveness claim centers around the sequences relating to the Complementarity Determining Regions (CDRs) of monoclonal antibodies, and the CDR sequence of the claimed antibody is different.
It was also contended that the annotation ‘homo sapiens’ was specified in numerical identifier [213] as the most similar or homologous because the antibody was developed from the transgenic HuMab Mouse platform based on human germline sequence. However, this does not establish that the monopoly claim is over a naturally occurring antibody.
Issue
Whether the final claims fall within the scope of Section 3(c) of the Act and what should be the correct interpretation of Section 3(c) for the patent applications related to recombinant DNA technology and genetic engineering.
Observation and Decision of the Court
The court divided Section 3(c) into three limbs: (i) the mere discovery of a scientific principle, (ii) the formulation of an abstract theory, and (iii) the discovery of any living thing or non-living substance occurring in nature is not a patentable invention.
Before its amendment in 2002, Section 3(c) read: “The mere discovery of a scientific principle or the formulation of an abstract theory [is not patentable].” The Court opined that the qualifier “mere” before the noun “discovery” in the first limb underscored that something more than a discovery of a scientific principle, such as the production of a novel device that operates on such scientific principle, might fall outside the scope of patent exclusion.
The court concluded that the adjective “mere” did not extend to the second and third limbs and that the phrase “occurring in nature” in the third limb of Section 3(c) only qualifies the nearest reasonable referent, i.e., “non-living substance.”
Ultimately, the Court ruled that the claimed invention met the eligibility criteria under Section 3(c) of the Patents Act. It concluded that isolating this specific class of antibodies from the human population was unfeasible and that the appellant had appropriately annotated ‘Homo sapiens’ in the numerical identifier [213] of the sequence listing, aligning with Standard 25 of WIPO.
Our Analysis
The Court’s explanation of Section 3(c) by dividing it into three limbs provides a clear interpretation that the real challenge concerning a patent application for a synthesized non-living substance, especially a monoclonal antibody, is establishing novelty or technical advancement, not patent eligibility.
One of the key takeaways from this decision is the importance of providing detailed documentation of the technical processes involved in creating the synthesized substance. Applicants must meticulously document every step of the synthesis process to demonstrate substantial human intervention. This documentation should include detailed descriptions of the techniques used, such as the hybridoma process in the Genmab case, where the antibody was produced by fusing an extract from transgenic mice with an immortal myeloma cell. This level of detail not only supports the argument that the substance is not a mere natural discovery but also helps establish the novelty and inventive step of the invention.
Highlighting the novelty and technical advancement of the invention over prior art is crucial. In the context of recombinant DNA technology and genetic engineering, practitioners should focus on the unique characteristics and functionalities introduced by human intervention. For instance, in the Genmab case, the claimed monoclonal antibodies had specific sequences in their light and heavy chain variable regions, which were not found in naturally occurring antibodies. Emphasizing such distinctive features can help overcome objections related to both patent eligibility and patentability.
When addressing objections under Section 3(c) of the Indian Patent Act, it is essential to underscore the artificial nature of the synthesized substance. This involves arguing that the invention is not a mere discovery of a natural substance but a product of deliberate and substantial human intervention. The appellant in the Genmab case successfully argued that the claimed antibodies were produced through a complex process involving immunization of transgenic mice with artificially produced immunogens, thus differentiating them from naturally occurring substances.
Comparative Analysis with the U.S.
In the United States, Chakrabarty set the precedent that a living organism, specifically a genetically modified bacterium, could be patented because it was not naturally occurring and had markedly different characteristics from any found in nature due to human intervention. In Myriad, the Supreme Court held that naturally occurring DNA sequences are not patentable merely because they have been isolated from their natural environment. However, it differentiated cDNA (complementary DNA), which is synthesized in the lab and does not occur naturally, as patentable because it results from human ingenuity.
Comparing this to the present decision of the Madras High Court in Genmab, we observe both similarities and key differences in the approach to patent eligibility and patentability. The court emphasized the necessity of demonstrating substantial human intervention and technical advancement for synthesized non-living substances, similar to the US standards. However, the court’s ruling appears to merge the concepts of patent eligibility and patentability more closely than the US does.
In the US, patent eligibility and patentability are distinct steps in the patent examination process. Patent eligibility is determined first, focusing on whether the subject matter fits within the statutory categories (i.e., process, machine, manufacture, or composition of matter) and is not a natural law, natural phenomenon, or abstract idea. Only after passing this threshold is the invention evaluated for patentability, which includes criteria like novelty, non-obviousness, and utility.
The Madras High Court’s decision appears to integrate these criteria, suggesting that establishing novelty or technical advancement directly impacts patent eligibility. This integrated approach could imply that the Indian framework does not distinctly separate the two concepts as the US system does.
Conclusion
To conclude, in Genmab A/S v. Assistant Controller of Patents and Designs, the court held that while non-living substances occurring in nature or isolated from nature are ineligible for patents, a synthetic version of a rarely occurring substance may not be excluded from patent eligibility, subject to meeting the non-obviousness and other patentability criteria.