'Significant and Non-Obvious Leap in Probiotic Science: Delhi High Court Orders Revaluation of Alimentary Health's Patent Application

The High Court of Delhi has remanded Alimentary Health Limited's patent application back to the Controller of Patents for a fresh examination, highlighting the need for detailed analysis and a fair reassessment of the application's inventive step and novelty.

The Delhi High Court has ruled in favor of Alimentary Health Limited, remanding their patent application for a probiotic bacterium formulation back to the Controller of Patents for fresh consideration. The judgment, delivered by Justice Sanjeev Narula, emphasizes the necessity for a comprehensive analysis of the inventive step and novelty of the formulation, challenging the prior decision that dismissed the application on grounds of obviousness and lack of technical advancement.

Alimentary Health Limited filed a patent application for a formulation involving the probiotic bacterium strain Bifidobacterium longum NCIMB 41676 (AH1714). The application, initially a national phase entry of a PCT application, was refused by the Assistant Controller of Patents and Designs under Section 15 of the Patents Act, 1970. The refusal was based on the grounds that the claims lacked an inventive step and were non-patentable under Sections 3(c), 3(d), and 3(i) of the Act.

The court highlighted that the Controller's decision lacked a substantive examination of the specific strain's uniqueness and its inventive step. Justice Narula noted, "The decision superficially notes that prior art discloses the health benefits of probiotic strains such as Bifidobacterium and Lactobacillus, without a detailed analysis of how the specific Bifidobacterium longum NCIMB 41676 strain presented in the patent application is obvious or lacks an inventive step"​​.

The court underscored the need for a detailed comparative analysis when assessing inventive steps. It emphasized that the mere presence of individual elements in prior art does not conclusively establish obviousness. The Controller must consider whether the invention represents "a significant, non-obvious advancement that could not be easily deduced by a skilled practitioner at the time of the invention"​​.

Justice Narula pointed out the strain's unique immunomodulatory effects, which were distinct from those disclosed in prior art. The judgment stated that the "significant differentiation in immune response capabilities between strains, highlighted by the reduction in cytokine levels as demonstrated by strain 1714, supports Appellant’s contention that the subject invention 'lies so much out of the track of what was known before'"​​.

The court referenced key precedents, including Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd. and Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd., to outline the necessary inquiries for assessing inventive steps. These steps include identifying the ordinary person skilled in the relevant art, determining the inventive concept, and assessing whether the differences between the prior art and the alleged invention would have been obvious to the skilled person​​.

Justice Narula remarked, "The mere presence of individual elements of an invention in prior art documents does not, in itself, conclusively establish obviousness. There must be a clear coherent thread from the prior art(s) to the invention, suggesting a logical and foreseeable progression of technology or methodology"​​.

The Delhi High Court's ruling underscores the judiciary's commitment to ensuring a fair and thorough evaluation of patent applications. By remanding the application for fresh consideration, the judgment emphasizes the importance of detailed analysis in patent law, particularly in assessing inventive steps and novelty. This decision is expected to influence future patent assessments, reinforcing the need for comprehensive and reasoned evaluations by the Patent Office.

Date of Decision: May 14, 2024

Alimentary Health Limited v. Controller of Patents and Designs