Delhi High Court Sets-forth the Innovation Assessment: A Case of Patent Rejection for Probiotic Formulation


Case No.: C.A.(COMM.IPD-PAT) 458/2022

Order on.: MAY 14, 2024



The prima facie of the case deals represents that Alimentary Health Limited, herein the appellant, applied for a patent in India for a probiotic formulation containing a specific strain of bacteria called Bifidobacterium longum NCIMB 41676 (AH1714). This formulation is proposed to be used in various forms like capsules, tablets, or food products. The Indian patent office rejected their application, stating that the invention lacked an inventive step and was not significantly different from existing knowledge about similar probiotics. The office cited several prior studies and patents involving similar bacterial strains and their health benefits. Alimentary Health Limited responded by amending their claims and providing additional data, but the patent office remained unconvinced. They argued that the specific strain and its formulation did not show enough innovation over what was already known. The company appealed the decision, highlighting that similar patents were granted in Europe and the US and that their formulation had unique and beneficial properties. The case is now being reviewed by the High Court of Delhi.

Contentions of the Appellant

The primary contention of the appellant relied upon their argument, highlighting the point that their probiotic formulation, containing a specific strain of Bifidobacterium longum (NCIMB 41676 or AH1714), is unique and inventive. They contended that the Patent Office inappropriately rejected their patent application by not fully considering their experimental data showing the superior benefits of this strain compared to others. They also pointed out that similar patents were granted in Europe and the United States, suggesting that the formulation meets global standards for innovation. Additionally, they argued that the Patent Office’s assessment relied too heavily on prior documents without adequately analysing how their specific strain differed and offered significant advancements in health benefits.

Contentions of the Respondent

The respondent, i.e., Controller of Patents and Design, argued that Alimentary Health Limited’s patent application for their probiotic formulation was not inventive or new. They claimed that similar strains of Bifidobacterium longum and their health benefits were already known from prior research. The respondent believed that any skilled person could have created a similar formulation using existing knowledge. Therefore, they concluded that the probiotic formulation did not meet the requirements for a patent under Indian law, as it did not show a significant improvement or unique invention over what was already known

Legal Provisions:

Section 15 of the Patent Act, 1970: It empowers the Controller to refuse or ask for amended applications if it doesn’t stand to be satisfied.

Section 2(1) (ja) of the Patent Act, 1970: It defines the term ‘inventive step’ within the context of patent law.

Section 3(c) of the Patent Act, 1970: It outlines what cannot be patented, which includes mathematical or business methods or computer programs etc. or posits a mere discovery.

Issues framed by the Court

  1. Whether the formulation of Bifidobacterium longum NCIMB 41676 (AH1714) demonstrates a sufficient inventive step beyond what is already known in prior art, as required under Section 2(1) (ja) of the Patent Act, 1970.
  2. Whether the claimed probiotic formulation can be considered non-patentable under Section 3(c) of the Act.
  3. Whether the claimed invention falls under provisions of the Act.
  4. Whether the granting of similar patents in other jurisdictions should influence the patentability assessment in India.

Court’s Analysis and Judgement:

In this case, the appellant applied for a patent for a probiotic formulation using a specific strain of Bifidobacterium longum bacteria. Based on the court’s analysis it had to decide if this formulation was unique and inventive enough to warrant a patent. Further, the court looked at whether this formulation was significantly different from what was already known in the field. Despite arguments from both sides, the court agreed with the decision to reject the patent application. They found that the formulation wasn’t different enough from existing knowledge, so it didn’t meet the requirements for a patent. Essentially, the court said that the formulation wasn’t special or new in a way that deserved legal protection.

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Judgement Reviewed By- Shramana Sengupta

Click here to read the judgement

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