Computational Biology In India: Overcoming Patent Hurdles

Computational biology may be defined as a scientific field that lies at the boundaries of life sciences, computer science, and applied mathematics for biological information extraction and understanding. In the last decades, however, the significance of this discipline has increased drastically, and it is of great importance in genomics, proteomics, systems biology, and drug development. The emergence of high throughput techniques and the vast amounts of biological information produced have made computational methods critical to the storage, management, evaluation, and interpretation of data. The influence of computational biology in the advancement of medicine, biotechnology, and agriculture continues to grow with the help of computational methods and software. In this context, modelling biological systems, predicting how molecules interact, and devising novel treatments has become one of the principal aspects of scientific research today.

However, such growth in the field brings about the more important issues of a legal and ethical nature, especially for a country like India where the regimes of intellectual property rights related to computational biology are still developing. As the pace of discovery in this area increases, it also becomes imperative for researchers, institutions, and policymakers to appreciate the legal aspects relating to data ownership, patentability, and research conduct. The attempts are highlighted below to provide a deeper insight into the mainly rolled out into the open challenges which are related to the legal aspects.

CHALLENGES IN INDIAN JURISDICTION:

India’s intellectual property laws, especially the Indian Patent Act, present several demanding situations with regard to the patentability of improvements in the discipline of computational biology. Specific sections of the Act, in particular Section 3, define criteria that may restrict the scope of patent protection for biological discoveries and computational tools. Below are a few of the important things demanding situations that get up beneath one-of-a-kind provisions of the Act:

1. Section 3(c):

• What It States: This section states that the discovery of a scientific principle, an abstract theory, or any naturally occurring substance is not patentable.
• Challenge: Many innovations in computational biology involve the discovery of novel sequences, pathways, or biological processes using computational tools. The interpretation of these inventions can only be seen as already existing in nature, and not as creating something new or inventive, making them ineligible for patent protection.
• Example: If the computational method identifies additional genes associated with the disease but does not alter or otherwise use the sequence, it may not meet the requirements of a patent under this section.

2. Section 3(d):

• What It States: This section excludes the patentability of new forms of known substances unless they show a significant improvement in their effectiveness or involve a new and inventive use.
• Challenge: Many innovations in computational biotechnology involve the discovery of novel applications or methods for the synthesis of existing biological materials, such as proteins or genes. However, unless these inventions result in a substantial improvement or a new way of working, they do not satisfy the requirements for a permit pursuant to Section 3(d).
• Example: A technological tool that identifies a novel use for an existing protein but does not improve its efficacy or utilize an alternative method, shall not be eligible for patent protection under this section.

3. Section 3(I):

• What It States: This section excludes any process for medical, surgical, or therapeutic treatment from being patented.
• Challenge: Computational biology also plays a crucial role in the development of diagnostic gear and therapeutic treatments. However, considering that Section 3(i) excludes patents for scientific or healing tactics, even critical improvements in these areas might not be patentable if they are labelled as clinical techniques.
• Example: Computer algorithms that predict the likelihood of a disease based on genetic data may be considered ineligible for a patent under this section because they involve a method of diagnosis rather than treatment.

4. Section 3(j):

• What It States: This section excludes patents on plants, animals, and biological processes for their production or propagation.
• Challenge: Computational biology is generally the study of plant and animal genetics, using computational techniques for genetic analysis or breeding. However, Section 3(j) does not exclude the patentability of natural methods of producing or breeding plants and animals, creating challenges in other areas related to genetic engineering or computer-based breeding methods on the issuance of a license for research.
• Example: A computational approach that facilitates identifying specific traits for plant breeding might not qualify for patent protection if it entails in basic terms biological technique, although the device itself is revolutionary.

5. Section 3(k):

• What It States: This section excludes mathematical methods, business methods, and computer programs from being patented.
• Challenge: Many innovations in computational biology depend on algorithms and software equipment to research organic records. However, under Section 2(k), those strategies aren't patentable except if they produce a technical effect or are tied to specific hardware. This provision creates great hurdles for computational biology patents, as it calls for demonstrating that the discovery does more than carry out an insignificant calculation or set of rules.
• Example: Software applications that simulate biological phenomena may be rejected for patent protection under this section unless it can be shown that the software provides a technical solution to a specific biological problem, rather than an electronic one doing a job.

Mitigating the Challenges: To overcome the above challenges related to Section 3, the Applicants can use the following strategies:

• Demonstrating a Concrete Technical Effect: It is a must to clearly set up the computational approach that produces tangible, technical final results. It should resolve a particular technical problem or offer a realistic answer, as opposed to merely performing abstract mathematical operations. This will help to differentiate the invention from a trifling set of rules and showcase its real-world applicability.
• Integrating with Hardware or Technological Systems: The computational technique should be linked to unique hardware components or embedded inside a broader technological framework. This method allows to deal with exclusions under Section 3(k), ensuring that the approach isn't always seen as only a software-based totally invention, but instead a fundamental part of an operating device or tool.
• Highlighting Novelty and Inventive Step: The invention should focus on showcasing how the discovery introduces new techniques, methods, or packages that offer giant improvements over existing techniques. By emphasizing the newness and innovative step, the inventor may reveal that the invention is not certainly a discovery or abstract concept, but a realistic and innovative development within the discipline.
• Strategic Drafting of Claims: When drafting the patent claims, recognition of the technical capabilities and practical programs of the discovery. Carefully phrase the claims to emphasize how the invention addresses a selected technical problem or improves current problems, thereby warding off pitfalls underneath Section 3 associated with non-patentable problems counted consisting of abstract ideas or discoveries.

Case Study: Bharat Biotech International Ltd. v. Optival Health Solutions Pvt. Ltd. (2023)

Court: Delhi High Court

Issue: Patentability underneath Sections 3(d) and 3(k) of the Indian Patents Act

Facts: In this landmark case, Bharat Biotech International Ltd. sought to patent a singular approach for vaccine development through the usage of a computational biology platform. The technique integrated advanced algorithms to predict vaccine efficacy and optimize antigen designs. However, the patent software faced challenges, particularly underneath Sections 3(d) and 3(k) of the Indian Patents Act. Section 3(d) excludes patent claims that contain the mere discovery of a new shape of a regarded substance, even as Section 3(k) excludes mathematical strategies, algorithms, or business methods from patentability.

The important dispute arose around the declaration that the invention became merely a set of rules and lacked an ingenious step, raising concerns that it might be labelled as a summary concept without tangible, technical utility.

Judgment:

The Delhi High Court ruled in favour of Bharat Biotech, recognizing the imaginative step within the technique. The court decided that the computational biology technique turned into not only a mathematical algorithm but a unique application of computational techniques that supplied a realistic method to a particular technical hassle in vaccine improvement. The invention’s potential to optimize vaccine formulations and expect efficacy based totally on computational fashions was deemed to be a big technological advancement, addressing actual international demanding situations within the field of immunology.

Case Insights

This case emphasizes the importance of disclosing the practical and technical uses of computer inventions to ensure patentability. It means that, even in areas with algorithms or computational methods, products should be theoretically structured as solving specific problems rather than just abstract ideas. Building new computational processes to use to address an important technical problem in this case, improve vaccine production that is identified as a patent-worthy innovation.

This case serves as an important precedent for those seeking to patent mathematical methods or physics. It emphasizes the importance of clearly establishing the technological impact and real-world applications of those inventions in order to eliminate patent exemptions under Sections 3(d) and 3(k). By describing technical challenges as innovative computational ecosystem solutions, the Applicants can demonstrate their inventive steps and increase their chances of patent approval.

Opinion: From our perspective, the intersection of computational biology and the Indian legal system presents both challenges and opportunities. Ambiguities in the Indian Patent Act, particularly under Sections 3(d) and 3(k), create hurdles for inventors, as these provisions, intended to block patents for abstract ideas, may inadvertently hinder technological progress. Further, reinforcing regulatory frameworks around data privacy is crucial to ensuring innovation aligns with public safety. As computational biology transforms industries like healthcare and agriculture, robust data protection and transparent oversight are essential to ensure these innovations benefit society while maintaining ethical standards. With the right legal and regulatory framework, India has the potential to become a global leader in computational biology, fostering innovation while protecting public trust.

Article By:- KASHISH BAJAJ (Patent Associate) & Nishant Veer Vikram Singh (Patent Analyst)