India – Bifidobacteria Breakthrough: Delhi High Court’s Landmark Ruling In Alimentary Health Limited Case.

In a significant ruling, the High Court of Delhi pronounced judgment in the case of Alimentary Health Limited versus the Controller of Patents and Design on May 17, 2024. This case has far-reaching implications, particularly in the realm of intellectual property rights and the patenting of innovations in the healthcare sector. This ruling delves into the intricate balance between innovation, access to healthcare, and the protection of intellectual property rights. Specifically, it re-establishes the importance of assessing an invention in whole width and breadth while determining its inventive step. In biological sciences, it is pertinent that the inventive step is examined considering various essential aspects, one of which is acknowledging the negative teachings in the art.

Factual Background of the Case

Alimentary Health Limited [hereinafter referred to as “the appellant”] sought to obtain a patent for its invention titled “PROBIOTIC BIFIDOBACTERIUM STRAIN” and filed the patent application number 3989/DELNP/2012 on May 07, 2012, as national phase entry of PCT application at the Indian Patent Office (IPO). The First Examination Report (FER) issued on March 27, 2017, inter alia, held that the claims lacked inventive step under section 2(1)(ja) and were non-patentable under Section 3(c), 3(d) and 3(i) of the Patents Act, 1970 [herein after referred to as “the Act”]. The appellant filed a response to the FER on August 31, 2017. The claims were amended and limited to a total of 13 claims from the original set of 38 claims. Subsequently, respondent [the Controller of Patents and Design] issued a notice of hearing dated July 10, 2018, with the objections under Section 2(1)(ja) over cited prior art Documents D1 to D5 and the subject matter of claims 1-13 as not inventions under section 3 (c), (d) and (e) of the Act. The hearing was scheduled and conducted on August 10, 2018.

In response to the hearing notice, 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 and also providing a thorough response. Despite these efforts, the Controller of Patents and Designs was not persuaded by the amendments and the arguments presented. Consequently, the application was denied pursuant to Section 15 of the Act via order dated November 27, 2018 [herein after referred to as ‘impugned order’] on the ground of lack of inventive step under Section 2 (1) (ja) of the Act, leading to the appeal C.A. (COMM.IPD-PAT) 458/2022 at the Hon’ble Delhi High Court.

Arguments

Appellant’s arguments were as follows:

• 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 their entirety. None of the cited documents provides any teaching or suggestion to arrive at a novel strain of Bifidobacterium longum NCIMB 41676 (AH1714), which works synergistically.
• The respondent overlooked the corresponding patent applications; for instance, the appellant has been granted a patent in Europe and the United States despite similar prior art citations. Reliance is placed on the decisions of the Intellectual Property Appellate Board dated January 11, 2021, in OA/16/2016/PT/KOL in the matter of Arthritis Relief Plus Ltd. v. Controller of Patents and Designs.
• The respondent has disregarded the experimental data in the specification, which establishes the technical advancement of Bifidobacterium longum NCIMB 41676 (AH 1714) over other strains.
• The respondent has made a critical error in the appreciation of facts. While acknowledging the novelty of both the strain and the formulation comprising this strain and further recognising that neither the strain itself falls under the ambit of Section 3(c) nor do the strain and its formulation fall under Sections 3(d) or 3(e) of the Act, they have nonetheless overlooked a crucial aspect. The respondent failed to acknowledge that the formulation comprising the said strain possesses inventiveness, which sets it apart from the prior art cited in the proceedings.
• The 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) — a section that typically 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 recognised the formulation as patentable, it logically follows that an acknowledgement of the inventive step is implicit. To hold otherwise would be inconsistent with the initial finding of patentability under Section 3(e).
• The claimed formulation of the subject patent application contains a non-obvious strain of Bifidobacterium longum, which is neither present in any of the prior arts nor sufficient teachings that can be found in prior arts D1- D5.

Respondent’s contentions are provided here below:

• The claims in the patent application are obvious to a person skilled in the art, and therefore, since the prior arts disclosed the claim invention, the application has been rightly refused on the grounds of lack of inventive step. In this respect, the respondent detailed the features of the cited prior arts which led to the present invention. For instance, the respondent mentioned that D1 discloses the use of Bifidobacterium longum as a probiotic in composition for treating depression. D2 discloses edible compositions that include Bifidobacterium longum, ranging from 104 to 1010 CFUs. D3 discloses a composition comprising a probiotic bacteria selected from the group consisting of Lactobacillus casei F19 (LMG P-17806), Lactobacillus acidophilus NCFB 1748 and Bifidobacterium lactis Bb12, and combinations thereof comprising at least one of milk, a cereal, a fruit. D4 discloses the ability of different strains of Bifidobacterium longum to induce cytokine production by peripheral blood mononuclear cells (PBMCs), which has been evaluated. D5 discloses the anti-inflammatory activity of probiotic Bifidobacteria in Bifidobacteria-fermented milk (BFM), which is effective against active ulcerative colitis (UC) and exacerbations of UC, and explores the immunoregulatory mechanisms.
• The appellant’s oral as well as written arguments and documents were considered, but not found persuasive. The prior art clearly advocates for and discloses the significant health benefits associated with probiotics, such as strains of Bifidobacterium and Lactobacillus. It suggests these probiotics can be formulated for various health benefits. 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 stipulated by patent law.
• Prior arts disclose that probiotics such as Bifidobacterium and Lactobacillus strains have excellent health benefits and could be explored as a formulation for various health benefits. Further prior art also discloses edible compositions comprising probiotic Bifidobacterium
• The instant formulation contains only 1 active ingredient Bifidobacterium longum NCIMB 41676 (AH1714) in the amount of more than 10⁶ cfu per gram.
• It is further submitted 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. Whatever is emphasised in the instant application is obvious in light of prior arts, referred hereinabove.

Court’s Analysis

The Hon’ble Justice Mr. Sanjeev Narula Court established the legal standards for assessment of inventive steps by re-emphasising the pertinent framework from the Hoffmann-La Roche Ltd & Anr. v Cipla Ltd. and crucial findings in the case of Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd. The Court, relying on the legal precedents, noted that in the evaluation of the inventive step in patent law, the jurisprudential guidelines established through judicial precedents emphasise the importance of avoiding hindsight bias. This is crucial to ensure that the inventive step is assessed based solely on the information that was available to the public before the priority date of the patent application.

Going forward, the Court analysed key distinctions between the cited prior art documents D1-D5 and the present invention. It was observed that none of the cited documents teach or suggest the specific strain of Bifidobacterium, i.e. Bifidobacterium longum NCIMB 41676 (AH1714), let alone the formulation comprising the same. Further, the Court pointed out that the appellant provided sufficient comparative data with respect to technical advancement during the prosecution. The Court listed the following unique therapeutic benefits of B. longum NCIMB 41676:

1. Anti-inflammatory Benefits: NCIMB 41676 has demonstrated efficacy in reducing undesirable inflammatory activity, as detailed in Examples 3, 4, 5, and 6 of the specification (pages 155 to 162).
2. Gastrointestinal Health: It is effective in the treatment and prevention of ulcerative colitis and irritable bowel syndrome, detailed in Example 5 (page 161, lines 10-18).
3. Cytokine Modulation: This strain modifies the levels IL-10 and reduces pro-inflammatory cytokines, as shown in Examples 3 and 4.
4. Mental Health Applications: NCIMB 41676 has been found effective in the treatment or prevention of depression, mood disorders, and anxiety disorders, with specific findings presented in the description of the invention (pages 161 and 164) and reinforced by Example 7.

The Court particularly mentioned that ‘it is well established within the scientific community that significant diversity exists within species. Different strains within these species distinctly influence immune responses, which can be directed toward pro-inflammatory or regulatory outcomes. These variations play a crucial role in impacting human health, either positively or negatively.’ Considering the vast potential for variation among these strains, the key issue of whether the characteristics and benefits of the NCIMB 41676 strain represent a substantial improvement in therapeutic efficacy over these existing solutions was analysed, and the Court highlighted the therapeutic benefit (supra) of the same.

Further, the cited prior art document D4 (M. Medina et al.) was closely analysed by the Court and the following was observed (cf. page 18 of the order):

“…..The scientific consensus, as reflected in D4, advises against generalisations concerning the probiotic effects of Bifidobacterium strains, highlighting the complexity and specificity required in developing therapeutically functional probiotics. In conclusion, D4 illustrates that developing new, therapeutically useful strains of Bifidobacterium longum involves overcoming significant scientific challenges. It is not merely a matter of identifying a new strain but ensuring that the selected strain meets specific therapeutic criteria, a process that lacks any guarantee of success and involves extensive empirical testing….”

In continuation with the above, while evaluating the obviousness of the invention in view of the disclosure in the prior art and judicial decisions, the Court acknowledged that the subject invention “lies so much out of the track of what was known before” as document D4 underscores that strains of Bifidobacterium longum can exhibit widely divergent effects, negating any reasonable expectation of success.

The Court re-emphasised the improvement that is required for issuing a ‘speaking order’ by the respondent and referred to the decision in Agriboard International, which reiterates this requirement, drawing upon the Supreme Court’s ruling in Manohar v. State of Maharashtra & Ors. The following aspects were advised to keep in mind while issuing an order:

• the disclosures of the prior art;
• the invention claimed in the current application;
• The reasoning why the claimed invention would be obvious to a person skilled in the art in light of the prior art.

Court’s Order

The inventive step under Section 2(1)(ja) of the Act of the invention has been acknowledged by the Court after a detailed analysis of prior art documents and data submitted with the submissions during the prosecution, and the appeal has been disposed of with the directions of fresh examination by the respondent. The Court also framed a set of questions that are to be addressed by the respondent in the final order (within a period of four months from the date of conclusion of the hearing) after providing the appellant with an opportunity to respond to said question. These are:

• Is the strain of Bifidobacterium longum designated as NCIMB 41676 (AH1714), and is the specific formulation claimed in Claim 1 novel or not? For the said analysis, the Controller shall consider whether the patent publication WO2010055499 (and its priority documents), and specifically Claim 15 of the publication, constitutes prior art, given that the earliest priority date of said claim is November 11, 2008, and the priority date of the subject patent application is November 11, 2009.
• Does the claimed formulation pertain to a specific dosage or method of administration for using the strain, and is the same responsible for the technical advancement of the subject patent application? If yes, whether such a patent can be granted under the Act?
• Whether the Claims in the subject patent application are directed towards the second medical use of Bifidobacterium longum NCIMB 41676 (AH1714). If so, are claims concerning second medical use permissible under the relevant guidelines of the Patent Office and the Act?

Future Outlook

The Delhi High Court’s ruling in the Alimentary Health Limited case carries significant implications for the pharmaceutical industry, patent law jurisprudence, and public health policy. By affirming the inventive merit of the probiotic formulation, the Court reaffirmed the importance of incentivising innovation in healthcare and the importance of analysing the non-obviousness of the invention without a hindsight approach.