This article discusses challenges faced by patent applicants for inventions in the field of Immunology, especially those relating to gene sequences, peptides, antibodies, and method of treatment; relevant provisions of the Indian Patents laws and strategies one may employ to improve the chances of overcoming the objections.
As our understanding of the internal and external communications and responses of the immune system is increasing, the list of potential therapeutic targets and technologies are expanding. Today, immunologists are addressing major medical and scientific challenges such as the global rise in inflammatory disease, autoimmunity, and broad range of cancers; the complex interaction between genes and environment; and the need for individualized and effective immunotherapies. Antibodies have been used in a wide range of technologies, particularly in diagnostics and other biochemical analyses. New immunology-based inventions, specifically vaccine compositions comprising proteins, polynucleotides, aptamers, hybridoma technologies and therapeutic antibodies are of great interest as they offer many applications and innovative products in the fields of immunotherapy and diagnostics. With the progress in the R&D and increasing number of patent application in this area, understanding of criteria for patentability of in field of immunology related inventions is becoming crucial.
PATENTABILITY OF IMMUNOLOGY BASED INVENTIONS IN INDIA
Patenting of immunological related inventions, such as nucleic acid sequences, peptides hybridomas, and monoclonal antibodies remain challenging. In addition to issues relating to meeting requirements of novelty, obviousness, industrial applicability, sufficiency of disclosure, enablement, and clarity in claims, patent eligibility of such inventions remain a serious concern to the applicants as well as the Patent Office.
Invention as per the Indian Patents Act is defined as “a new product or process involving an inventive step and capable of industrial application”. This definition is applied in a strict sense and hence any invention claiming use per se is considered ‘not an invention’ as per the Indian patent law and hence, not a patentable subject matter. Consequently, any claims directed to first or second medical use, such as use of any molecule in suppressing immune response, or treatment of immune disorder; or other application-based claims such as use of any peptides, antigens, etc. in preparing drug or medicine; use of immuno reactive fragments, peptide tags in diagnosis; or use of vaccines are not an invention within the meaning of Indian Patents Act.
- Section 3(c) excludes subject matter which is considered as mere discovery of any living substance occurring in nature. Many inventions claiming nucleic acid sequences, fragments, peptides, polypeptides, and other entities that are isolated, or without any modification, are objected under this Section contending that such molecules occur in nature and are therefore a mere discovery and not an invention.
- Section 3(d) bars those inventions which are construed as mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Though primarily this exclusion is meant for chemical entities like salts, esters, polymorphs, metabolites, isomers, etc of known compounds, this exclusion is often applied to biological inventions as well. Inventions claiming polypeptide eliciting immune response with the help of known biological molecules, fusion proteins, antibodies against novel receptors, compositions comprising known antigens, are regularly held to be not patentable as per this section. Inventions relating to second medical use are objected under section 3(d) and section 2(1)(j) in India.
- Section 3(e) is a criterion for determining patentability of compositions. Compositions which can be considered as mere admixture resulting only in the aggregation of the properties of the known component are found to be non-patentable. Vaccine compositions, compositions comprising genes/ nucleic acid molecules encoding immunogen, targeted delivery complexes, and fusion proteins are considered as mere admixtures if they result only in sum additive effect due to individual components.
- Section 3(i) is cited against method of treatment related claims. Any claims citing method such as medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products are not patentable in India as per Section 3(i). Method of invoking / regulating immune response, using biological molecules like proteins, antibodies, etc. is not patentable as per section 3(i). Claims relating to immunogenic compositions referring to route of administration are also construed to fall within the ambit of section 3(i). Any method of diagnosis of diseases for example those using peptide tags, diagnosis of immune response, method for monitoring the response of the subject to the immunogenic composition, are all examples of subject matters for which no patent protection can be obtained in India.
- Section 3(j) forbids patenting of plants and animals in whole or any part thereof other than microorganisms (provided they are modified), and essentially biological processes for production or propagation of plants and animals. Inventions claiming biological entities like antigens / antigen binding fragments without any modifications, isolated antibody, host cells, cell lines comprising novel nucleic acids, virus like particles, etc. are considered to fall within the scope of section 3(j) and hence, not patent eligible subject matters.
- Section 3(k), an exclusion criterion often used for refusal of computer program related inventions, is also applied in some immunology-related inventions and in-silico inventions. Any claim including a computer program product for monitoring the response of a subject who has received an immunogenic composition, for prognosis or diagnostic purposes is considered non-patent eligible subject matter under this Section.
In addition to above criteria for patentable subject matter, sufficiency of disclosure and clarity, definitiveness, conciseness, are some additional aspects which are faced by the Applicants during the prosecution.
Following are specific examples of objections raised during prosecution to show complexities and implications for invention relating to immunology:
- For invention relating to humanized antibodies against specific receptor, claims were objected u/s 3(i) of the Patents Act which were directed towards the method of treatment of human being or an animal. Additionally, the claims were found to fall within the scope of section 3(d) and 3(e) of the Act as the said claims were held to be mere use of a known method of the treatment of psoriasis and other immune-mediated diseases with the use of humanized antibodies, already known in the prior art and a mere admixture resulting only in the aggregation of the properties of the component. Furthermore, technical effect/efficacy in comparison to the prior art documents cited was considered to be not clear. The claims related to a host cell transformed with a vector, wherein the said cell was a CHO cell, was held to be directed towards the animal in whole or any part thereof, therefore, not allowable u/s 3(j) of the Patents Act. The application however was not prosecuted further and was abandoned.
- In case of one of abandoned patent application for polysaccharide protein conjugate vaccine composition, claims directed to the method of inducing an immune response to a Streptococcus pneumoniae capsular polysaccharide, comprising administering to a human an immunologically effective amount of the immunogenic composition was found to be a process for the medicinal, diagnostic or other treatment of human beings, and hence not patentable u/s 3 (i) and the composition was also objected u/s 3(e) in the absence of synergy.
- Similarly, patent application “Immunogenic compositions in particulate form and methods for producing the same” was abandoned by the applicant. The claims were objected for nonpatentability u/s 3(e) as they were directed to a composition comprising the non-viable bacterium like particle in combination with oligomers of a recombinantly produced polypeptide. The claims were held to be inadequate in defining the technical aspects of the said composition which could hence be presumed to be a mere admixture and in absence of further adequate elaboration on experimental data, it was construed to be unclear whether any synergistic effect was produced or not. Also, it was objected u/s 3(c) as the claimed polypeptide and nucleic acid sequence were isolated and occurring in nature and the claimed host cell was objected under section 3(j).
- In another abandoned patent application for “antibodies to the specific fragment of complement component 3”, the subject matter of claim was objected by the examiner u/s 3(i) of the Patents Act, as claims were found to refer to the method of treatment or administration method of animal to render them free of disease, that constitutes a method step for medical treatment exercised on the animal body. Further, claims directed towards hybridoma cell was objected u/s 3(j), as it clearly did not disclose the type of hybridoma cell, hence construed to be the animals in whole or any part thereof and not patentable. Also, the subject matter of claims was found not patentable u/s 3 (c) as it did not define the recombination with the structural features, therefore was considered to claim naturally occurring or isolated form of the antibody.
- Similarly, a patent application for vaccine composition was objected and abandoned for not complying with section 3(d), 3(e), 3(c) and 3(i). The claims directed to the fusion protein were held to be a mere modification of those which were well known in view of the cited prior art documents. The claims were found to be inadequate in defining the technical aspects of the composition hence presumed to be a mere admixture and in absence of further adequate experimental data, and non-clarity on synergistic effect and claims were also objected for relating to a method of treatment.
- In patent application relating to antibodies to specific receptor, the Controller rejected the argument that the claimed isolated human monoclonal antibody was not naturally occurring as it was produced by human intervention by recombinant DNA technology and the patent application was refused u/s 15.
STRATEGIES TO AVOID OR OVERCOME OBJECTIONS
The above illustrations may seem very challenging for applicants of immunology related inventions. However, some caution during the drafting of patent application and claims, and proper planning of experimental research targeted to generate and provide biological activity and efficacy data can help applicants and their agents to overcome objections and secure adequate patent protection. They are:
- Show structural and functional difference: Inventions directed to products of immunology research, for example bio-molecule or sequences, must be shown as structurally and functionally different from that occurring in nature to escape or successfully traverse objection under section 3(c). Preferably, human synthesis of such products (synthetic production) examples should be provided.
- Extensive disclosure: For inventions relating to biological entities / molecules, at the time of drafting of application inclusion of as much disclosure and examples to elucidate biological activity even invitro experimentation, and later supplementation of enhanced efficacy data can help avoid or overcome objections under section 3(d).
- Mention about experimental data: Inventions relating to composition can be successfully prosecuted with the help of experimental data proving synergistic efficacy of the composition in comparison with the individual components to overcome objection under section 3(e).
- Avoiding or including certain words or features: While drafting claims relating to composition, dosage forms or some processes, the word ‘administration’ should be avoided as claims may be misconstrued to relate to method of treatment and consequently objected under section 3(i). As far as possible, one may consider embodying the invention relating to diagnosis in the form of some device or well-defined kit in terms of active components to avoid section 3(i) objection. However, once such objection is raised, while it may be possible to overcome objections under other sections viz. 3(d), and 3(e), the objection under section 3(i) does not leave applicants with any other option but to delete such claims. Provisions relating to amendments as per the Indian Patents Act, does not allow applicants to change the scope of claims, hence claims originally directed to method of treatment cannot be changed to any other form like product or composition. The most problematic situation arises when all claims are method of treatment claims and none are directed to composition or product per se, leading to abandonment of patent application. Even if there may be a possibility of claiming the composition or any form of product in view of disclosure for the same and some aspect for example, a specific dose that can help establish novelty, inventive step and overcome objections under other exclusions like 3(d) and/or 3(e), absence of any other type of claim but method of treatment claim in the claim set, deprives the applicant any possibility of obtaining patent protection. Hence, when drafting a patent application, a preferable strategy would be to include at least one product claim viz. in the form of a complex, composition, kit, fusion product, etc.
The discussed strategies can be devised and adopted by the applicants with the help of a competent agent to ease prosecution and overcome objections faced during prosecution of patent applications in the field of immunology, biotechnology or life sciences.
To summarise, it can be concluded that the therapeutic and diagnostic methods that are performed on the body or result in the identification of a medical condition are specifically excluded from patentability in India. One can, however, patent the products of immunology research if they fulfil the patentability requirement and do not fall or can be proved during prosecution to not fall under any of the exceptions laid down in the Patents Act, 1970. Thus, the claimed bio-molecule or sequences, like any other invention to be patented must be novel, inventive and useful. The claimed products of immunology research must be shown to be structurally and functionally different from that occurring in nature. Any structural difference with respect to the naturally occurring bio-molecules that confer some unexpected advantage or surprising effect on the claimed products of immunology research must be captured and highlighted during drafting and prosecution to procure fruitful and meaningful protection to their invaluable intellectual property.
Author: Mita Sheikh, Associate Director, Devanjan Chakravarty, Intern and Dias Michelle, Intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at firstname.lastname@example.org