In the realm of Patent law, once the novelty of an invention is established, the next hurdle in the patenting process is assessing whether there is an inventive step, also known as non-obviousness. The assessment of inventive step involves determining whether the invention, when compared to the prior arts, would not have been obvious to a person skilled in the relevant field at the time the invention was made. In essence, it’s about gauging whether the invention represents a significant advancement or innovation over what was already known. The assessment of inventive step is subjective and varies from case-to-case. The overarching objective is to ensure that patents are exclusively granted for inventions that genuinely represent significant advances in their respective fields.

In one such recent case, Alimentary Health Limited vs Controller of Patents and Design [C.A.(COMM.IPD-PAT) 458/2022], brought before the Delhi High Court, the Appellant sought to set aside the Order passed by the Controller of Patents that refused the Appellant’s application number 3989/DELNP/2012 for lacking inventive step under Section 2(1)(ja) of the Patents Act, 1970.

The Appellant had applied for securing patent protection for the invention titled “Probiotic Bifidobacterium Strain” that claimed a formulation of a probiotic bacterium, specifically the strain of Bifidobacterium longum designated as NCIMB 41676 (AH1714). The impugned order was challenged mainly on the following grounds:

• The subject invention possessed inventiveness: The claimed formulation was neither present in the cited prior arts nor there was sufficient teaching in any cited prior art to arrive at the claimed formulation which works synergistically.
• The impugned order lacked reasoning for refusing the application under Section 2(1)(ja): The Respondent merely quoted paragraphs related to different strains of Bifidobacterium from cited prior art without substantial analysis.
• The Respondent failed to appreciate relevant facts: The experimental data in the specification that established the technical advancement over other strains was ignored. The Respondent also disregarded the grant of corresponding applications in other jurisdictions despite similar prior art citations.

The Court systematically analysed the cited prior art and applied the objective assessment of obviousness and inventive step laid down in F.Hoffmann-La Roche Ltd & Anr. v Cipla Ltd. [2015: DHC:9674-DB]to evaluate the inventive step in the subject invention and held the claimed strain-based composition to be non-obvious. In its evaluation, the Court highlighted that:

• A broad similarity of a species’ general properties does not justify a generalization of effects across all strains.  Significant diversity of strains exists within species that have vast potential or variations in influencing immune responses, and, thus, while evaluating inventive step, strain-specific behaviours and characteristics should be assessed to see whether these represent mere variations of known strains or constitute innovative therapeutic advancements.
• In assessing inventive step, it’s crucial to steer clear of hindsight bias and instead conduct an objective analysis. This approach helps to foster genuine innovation and discourage the monopolization of “workshop improvements”.
• The mere inclusion of individual elements of an invention in prior art documents does not automatically establish obviousness. To determine obviousness, there must exist a clear and straightforward path from the prior art to the invention, indicating a foreseeable development in technology.
• An inventive step involves a “non-obvious conceptual leap” that would not be readily deduced by someone with ordinary skills in the field without the benefit of hindsight.

The Court alluded the Controller’s failure to analyse the distinct characteristics of the claimed formulation and provide any rationale in the impugned order explaining how the claimed composition lacks inventive step when compared with the cited prior arts. The Court also remarked that the grant of Appellant’s corresponding patent applications in other jurisdictions ought to have been considered.

In the light of the forgoing, the Court set aside the impugned order. The matter was, however, remanded to the Respondent for a limited re-evaluation of novelty of the claimed formulation as the fact that the Appellant had initially claimed the strain itself and had later narrowed the claims to a strain-based formulation was not examined by the Respondent, specifically how the formulation relates to the original strain. The Court directed the Respondent to ascertain whether the claimed formulation pertains to a specific dosage or method of administration for using the strain which in turn is the reason for the technical advancement; and whether the claims are directed towards the second medical use of the strain.