In the case of Manu Chaudhary v. Controller of Patents and Designs, the Delhi High Court set aside the refusal of a patent application relating to an oral herbal painkiller composition. The Court stated that the Controller had erred in rejecting the application primarily on the ground of non-submission of approval from the National Biodiversity Authority (NBA), despite the Applicant having already applied for the approval, and remanded the matter for fresh consideration.<\/p>\n
Manu Chaudhary (Appellant) filed patent application IN 201711047431 relating to an oral herbal painkiller composition comprising specific herbal components in predefined ratios to achieve synergistic pharmacodynamic efficacy, along with a process for its preparation. The First Examination Report (FER) raised objections on lack of inventive step, as well as under Sections 3(d), 3(e), and 3(p). Section 3(d) concerns new forms or uses of known substances without enhanced efficacy, Section 3(e) concerns mere admixtures lacking synergistic effect, and Section 3(p) concerns traditional knowledge. The FER also required submission of approval from the National Biodiversity Authority (NBA). The Applicant responded and amended the claims, after which the objections were narrowed down primarily to NBA approval and Section 3(p) (excludes inventions based on traditional knowledge or mere aggregation\/duplication of known properties of traditionally known components). Following a hearing and written submissions, the Controller refused the application under Section 15, citing, inter alia, non-submission of NBA approval, non-patentability under Section 3(p), and improper representation at the hearing.<\/p>\n
Manu Chaudhary argued that she had duly applied for NBA approval and had informed the Controller of the same prior to the impugned order, and that the delay in grant of approval was beyond her control. It was submitted that neither the Patents Act nor the Biological Diversity Act mandates rejection of a patent application merely for non-submission of NBA approval at the time of examination, and that approval is only required prior to grant. Manu Chaudhary further contended that the Controller ought to have exercised discretion under Section 15 and deferred the decision. It was also argued that the objections under Section 3(p) and procedural irregularities were misconceived and that an opportunity should have been granted to rectify any defects.<\/p>\n
The Controller contended that NBA approval ought to have been submitted along with the application or at least before the passing of the impugned order, and that the subsequent grant of approval could not cure the defect. The Controller also supported the refusal on merits, including non-patentability under Section 3(p), and objected to Manu Chaudhary being represented by an unauthorized representative during the hearing.<\/p>\n
The Court stated that the requirement under Section 6(1A) of the Biological Diversity Act is that NBA approval must be obtained prior to grant of patent, and not necessarily at the time of examination. The Court noted that Manu Chaudhary had applied for approval and had informed the Controller prior to the impugned order, and that the delay in grant of approval was not attributable to Manu Chaudhary. The Court observed that there is no provision mandating rejection of a patent application solely due to pending NBA approval. The Court further opined that the Controller failed to exercise discretion under Section 15 appropriately, as the proper course would have been to defer the decision until the approval was received. The Court asserted that the Applicant cannot be penalized for delays beyond her control and that procedural requirements must be applied reasonably. The Court did not examine the merits of patentability and left the issue under Section 3(p) open for fresh consideration.<\/p>\n
The Court set aside the impugned order and remanded the matter to the Patent Office for re-examination. The Controller was directed to reconsider the application after granting a fresh hearing and taking into account the NBA approval and submissions of Manu Chaudhary. The Court clarified that no new material, except the NBA approval, shall be filed, and that the issue of patentability under Section 3(p) shall be decided afresh in accordance with law. The decision was directed to be made within two months.<\/p>\n
Citation: Manu Chaudhary vs Controller Of Patents And Design on 7 February, 2026, C.A.(COMM.IPD-PAT) 36\/2024<\/p>\n