Here we are discussing refusal of Indian Patent Application No. 3989/DELNP/2012 concerning a probiotic formulation utilizing the Bifidobacterium longum strain NCIMB 41676 (AH1714). The Assistant Controller of Patents and Designs rejected the application on grounds of obviousness under Section 15 of the Patent Act, 1970. The central legal issue involves determining whether the claimed probiotic formulation exhibits an inventive step and technical advancement over existing prior art. The Court ultimately set aside the refusal, remanding the case back to the Controller for a fresh evaluation.

Facts:
The Indian Patent Application No. 3989/DELNP/2012 describes a probiotic formulation incorporating the Bifidobacterium longum strain NCIMB 41676 (AH1714) at concentrations exceeding 10^6 colony-forming units (cfu) per gram, combined with an ingestible carrier. These carriers can be pharmaceutical forms like capsules or food products such as yogurt. The formulation is claimed to have unique synergistic effects and significant technical advancements over prior art.

The Prior Arts:
The Assistant Controller of Patents and Designs cited prior art documents, specifically:

• D1: US 20040265279
• D2: WO 2009127566
• D3: WO 2006SE01117
• D4: Medina et al.
• D5: Imaoka et al.

The Controller concluded that the use of the Bifidobacterium strain as a probiotic was already known and did not exhibit an inventive step.

Evaluation of Inventive steps and Obviousness:
The Court reviewed the Assistant Controller's decision, focusing on whether the claimed formulation was obvious in light of the prior art documents. The prior art indicated that the specific strain of Bifidobacterium and its use in probiotic formulations were known, but the claimed concentrations and the specific combination with carriers were scrutinized for their inventive step.

The Court emphasized the need to avoid hindsight bias in evaluating the inventive step, underscoring that the assessment should be based solely on information available before the priority date of the application. The Court found that none of the prior art documents, either individually or in combination, provided sufficient motivation to a person skilled in the art (PSITA) to arrive at the claimed formulation.

Legal Implication:
The judgment 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. This case illustrates the judiciary's role in ensuring that patent applications are assessed fairly, respecting the boundaries of known prior art while recognizing genuine innovation.

Ratio:
The Court's ratio decidendi hinged on the principle that the inventive step must be evaluated without hindsight and must be evident based on prior public knowledge. The claimed probiotic formulation with the Bifidobacterium longum strain at specified concentrations and combined with particular carriers was found to be non-obvious, as prior art did not motivate a PSITA to arrive at this specific formulation.

Concluding Note:
The decision to remand the case for reevaluation reflects the judiciary's commitment to fair patent adjudication, ensuring innovations are not unjustly denied protection due to improper application of legal standards. This case reaffirms the importance of a meticulous and unbiased approach in evaluating inventive steps, crucial for fostering innovation and protecting genuine advancements in technology.

The judgment highlights the nuanced balance between prior art and genuine invention, reiterating the importance of a fair and thorough evaluation process in patent law. The Court's decision serves as a precedent in reinforcing the correct application of inventive step analysis, promoting an equitable patent system that duly recognizes and rewards innovation.

Case Title: Alimentary Health Limited Vs Controller of Patent and Design
Order Date: 14.05.2024
Case No. CA Comm IPD PAT 458 of 2022
Neutral Citation:2024:DHC:3920
Name of Court: Delhi High Court
Name of Hon'ble Judge: Sanjeev Narual, H.J.

Disclaimer:
Ideas, thoughts, views, information, discussions and interpretation expressed herein are being shared in the public Interest. Readers' discretion is advised as these are subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the fact and issue involved herein.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539