Introduction
In a recent judgement dated May 14, 2024, in Alimentary Health Limited vs. Controller of Patents and Design[i], the Delhi High Court set aside a patent refusal order issued by the Indian Patent Office in respect of Indian patent application 3989/DELNP/2012, which had been denied, stating that the invention lacked an inventive step and was not significantly different from existing knowledge.
This is yet another case wherein the Controller of Patents has been directed to provide persuasive and detailed analysis as required by the law in the rejection order. The court in this matter held that the order lacks a substantive examination as to how the claimed subject matter is obvious or lacks an inventive step in view of cited documents. Read on to explore a detailed analysis of this case and the implications of this judgement.
Background of the Case
Appellant filed the Indian patent application No. 3989/DELNP/2012, which involves formulation of a probiotic bacterium, specifically the strain of Bifidobacterium longum designated as NCIMB 41676 (AH1714).
The First Examination Report (FER) issued on March 27, 2017, objected inter alia, that the claims lacked inventive step under Section 2(1)(ja)[ii] of the Indian Patents Act, 1970 (hereinafter ‘the Act’) and were non-patentable under Section 3(c)[iii], 3(d)[iv] and 3(i)[v] of the Act.
Subsequently, the Appellant filed a response where the claims were amended and limited to a total of 13 claims from the original 38 claims. Consequently, the Controller (Respondent) issued a notice of hearing with the objections under Section 2(1)(ja) over cited prior art documents D1 to D5, objecting that the subject matter of claims 1-13 as not inventions under Section 3(c), (d) and (e)[vi] of the Act.
During the hearing, the Appellant provided thorough responses to the objections of the hearing notice and further supplemented these responses with written submissions post-hearing. In an effort to address the concerns raised, the Appellant revised the principal claim by incorporating elements from claims 6 and 10 into claim 1, aiming to clarify and strengthen the patentability of the invention. Despite these efforts, the Controller was not persuaded by the amendments and the arguments presented. Consequently, the application was denied pursuant to Section 15 of the Act on the ground that the claims lacks inventive step under Section 2(1)(ja) of the Act.
Contentions of the Appellant
The Appellant argued that the Respondent has merely quoted paragraphs related to different strains of Bifidobacterium from cited documents from D1 to D5 without actually analysing and interpreting the cited documents in entirety. None of the cited documents provide any teaching or suggestion to arrive at a novel strain of Bifidobacterium longum NCIMB 41676 (AH 1714) which works synergistically.
The Appellant contended that the Respondent overlooked the grant of the corresponding patent applications, in Europe and United States, despite similar prior art citations. Reliance was placed on the decisions of the now abolished Intellectual Property Appellate Board (IPAB) of India in in the matter of Arthritis Relief Plus Ltd. v. Controller of Patents and Designs[vii]. The IPAB in this case set aside the Controller’s order, emphasizing that “remarkable activity” is not a requirement in law and that synergism can be demonstrated through comparative data provided during prosecution.
The Appellant further argued that the experimental data in the specification which establishes the technical advancement of Bifidobacterium longum NCIMB 41676 (AH 1714) over other strains was disregarded by the Respondent.
Furthermore it was contended that Respondent has presented a contradictory stance in their evaluation. On one hand, they have acknowledged that the formulation claimed in Claim 1 is patentable under Section 3(e), which excludes ‘inventions’ from patentability. On the other hand, they have denied the patent application on the grounds of lacking an inventive step. Given that the Respondent has already recognized the formulation as patentable, it logically follows that an acknowledgement of the inventive step is implicit.
Contentions of the Respondent
The Respondent argued that the prior art clearly discloses the significant health benefits associated with probiotics, such as strains of Bifidobacterium and Lactobacillus. Consequently, for a person skilled in the art, it would be a routine undertaking to explore well known probiotics like Bifidobacterium longum, isolate a strain demonstrating beneficial activity, and then develop and claim a formulation for therapeutic applications. The ability to achieve predictable results from such an exploration renders the claim obvious and lacks the requisite inventiveness as stipulated by patent law.
The Respondent further argued that the instant application is not inventive as the application of edible probiotic formulations of Bifidobacterium strains, in the claimed amount, having excellent health benefits (including depression, cytokine interleukin (IL)-10 and pro-inflammatory cytokine tumour necrosis factor (TNF) – production) is already known and explored herein without any inventive merit. There is “no surprising element” in the instant formulation when seen in the light of prior arts.
Issues before the Court
Whether the characteristics and benefits of the NCIMB 41676 strain represent a substantial improvement in therapeutic efficacy over existing solutions satisfying the criteria of inventive step beyond the known properties of other Bifidobacterium strains.
Observation and Decision of the Court
The Court observed that claim 1 describes a formulation comprising a strain of Bifidobacterium longum NCIMB 41676 (AH1714). In this formulation, the strain is present in an amount of more than 106 cfu per gram of the formulation, combined with an ingestible carrier and none of the cited prior art documents D1-D5 either alone or in combination motivate a Person Skilled in the Art (PSITA) to arrive at a formulation comprising a strain of Bifidobacterium longum NCIMB 41676 wherein the strain is present in an amount of more than 106 cfu per gram of the formulation.
The Court clarified that the critical question is, whether the formulation of Bifidobacterium longum NCIMB 41676 demonstrating this synergism or enhanced efficacy would have been obvious to a person skilled in the art. The court noted that the prior arts do not refer to a formulation involving Bifidobacterium longum 1714, and the closest prior art, D1, discloses a different strain, Bifidobacterium infantis 35624. The data presented by the Appellant shows that the invention significantly reduces cytokine levels, nearly 50% compared to D1, thereby enhancing its anti-inflammatory efficacy. This marked reduction underscores not merely an incremental adjustment but a substantial improvement in clinical outcomes.
The Court held that while commonality in prior arts and the subject invention might be traced to the species Bifidobacterium longum and its general therapeutic properties, this broad similarity does not justify a generalization of effects across all strains as even prior art D4 explicitly states that each strain may possess unique and sometimes entirely opposite properties, emphasizing the individuality of each strain’s therapeutic potential.
The Court held that the formulation with its unique cytokine modulation profile claimed in the subject patent application, has shown enhanced efficacy, deviating significantly from what was previously known. Consequently, it would be reasonable to infer that the invention did not follow a predictable path but represented a significant and non-obvious leap in the application of probiotic science. This marked departure from existing knowledge is an indication that the subject patent application was not obvious to those skilled in the art, on the priority date of the invention and thereby meets the requirements for patentability.
The Court held that for analysis on inventive steps, the decision of the Supreme Court in Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd. [3] serve as the foundation. Here, the Court had established that an inventive step must constitute a feature that marks a technical advance as compared to the existing knowledge or that has economic significance or both, and that makes the invention not obvious to a person skilled in the art. This framework was also supported by Hoffmann-La Roche Ltd & Anr. v. Cipla Ltd. [4].
The Court further held that the Patent Office must issue a ‘speaking order,’ with detailed comparative analysis of the existing knowledge and the claimed invention while deciding the objection of Section 2(1)(ja) of the Act.
Finally, the refusal order of the Respondent was set aside and remanded for a fresh consideration. The court directed the Controller to render the final decision within a period of four months from the date of conclusion of the hearing.
Our Analysis
This ruling is again a wake-up call for Controllers at the Indian Patent Office to issue a reasoned order. In the Court’s decision, the concept of Person Skilled in the Art has been identified and it has been emphasised that for assessment of inventive step the Controller must specifically address three crucial aspects: (i) the disclosures of the prior art, (ii) the invention claimed in the current application, and (iii) the reasoning why the claimed invention would be obvious to a person skilled in the art in light of the prior art.
This ruling also bring into focus that while drafting final orders, Controllers must carry out substantive examination. In the present case, the court directed the Controller to specifically identify how the specific Bifidobacterium longum NCIMB 41676 strain presented in the patent application is obvious or lacks an inventive step in light of the detailed disclosures from prior art documents D1-D5. The court has identified several inadequacies in the impugned order and specifically indicated that the decision misses out a thorough analysis of the distinct characteristics or enhanced efficacy of the NCIMB 41676 strain-based formulation.
The judgment also underscores the critical aspect of avoiding hindsight bias in patent law when evaluating the inventive step. The Court’s decision highlights that the inventive step must be assessed based on prior public knowledge without using knowledge gained from the patent application itself.
Conclusion
The judgment underscores the importance of a thorough and precise inventive step analysis in patent adjudications. By remanding the case for a fresh examination, the court highlighted that the inventive step must be evaluated with a detailed comparison to prior art, demonstrating technical advancements and non-obvious improvements. This ruling reinforces the need for patent examiners to critically assess the inventive contributions of a patent application, ensuring that true innovations receive the protection they merit, thereby fostering a robust and transparent patent examination process in India.
[i] C.A.(COMM.IPD-PAT) 458/2022
[ii] Inventive step’ means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.”
[iii] “The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature [is not patentable]”
[iv] “the 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 [is not patentable].”
[v] any process for the 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 [is not patentable]”
[vi] “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance [is not patentable]”
[vii] OA/16/2016/PT/KOL
[1] C.A.(COMM.IPD-PAT) 458/2022
[1] Inventive step’ means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.”
[1] “The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature [is not patentable]”
[1] “the 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 [is not patentable].”
[1] any process for the 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 [is not patentable]”
[1] “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance [is not patentable]” [1] OA/16/2016/PT/KOL