The Delhi High Court, in the case of VIB VZW & Anr. vs The Controller of Patents and Designs[C.A.(COMM.IPD-PAT) 30/2025, decision dated April 29, 2026], set aside the order passed by the Controller in patent application number 201917035558, entitled titled “Means and Methods for Oral Protein Delivery”.

The Court found that while refusing the application, the Controller failed to engage with the applicants’ detailed submissions, overlooked material disclosures concerning the source of biological material, and did not follow the five-step test laid down in F. Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd to determine lack of inventive step.

The decision is significant for emphasising that when an applicant specifically addresses the cited prior art documents, explains the technical differences in the claimed invention, and relies upon precedents concerning the permissible scope and construction of the claims, the Controller is required to engage with those submissions and provide reasons for rejecting them.

The subject application covered product-by-process claims for oral delivery of therapeutic proteins using a dried formulation derived from the culture medium of a recombinant yeast host. The invention sought to address the difficulties associated with oral administration of therapeutic proteins. The final claim set included, inter alia, a claim to:

“A dried formulation obtained by i) subjecting the culture medium of a recombinant yeast host cell to a membrane separation process or a depth filtration process followed by ii) drying the culture medium…”. The claim further specified that the culture medium comprised a recombinant polypeptide fused to an IgA Fc domain secreted by the recombinant yeast host cell. Dependent claims covered, inter alia, an oral pharmaceutical composition, food or feed products, and an IL22 IgA Fc-fusion. A key technical advancement asserted by the applicant was that the therapeutic protein did not require purification from the culture medium prior to use.

The Controller refused the application on the following grounds:

• Lack of inventive step in view of prior art documents D1-D8. The Controller considered the features of the amended claims to be obvious to a person skilled in the art (PSITA) and concluded that the applicants had not demonstrated any technical advancement over the cited prior art.
• Non-disclosure of the source and geographical origin of the biological material under Section 10(4)(ii)(D), and
• Failure to satisfy the requirements of Sections 10(4)(a), 10(4)(c) and Section 10(5). According to the Controller, the claims formulation did not fully and particularly define the scope of the product for which protection was sought. The order recorded that the claimed formulation was devoid of technical features i.e., components of the composition. Further, the Controller raised concerns regarding the absence of SEQ ID numbers for the recombinant polypeptide used in the composition and considered that the absence of such identification rendered the claims vague and excessively broad. The Controller also distinguished the judicial precedents relied upon by the applicants on the validity of product-by-process claims observing that the manner in which the claims had been framed in those cases was different from the claims in the subject application.

The Court, however, found that the impugned order was unreasoned and did not engage with the applicants’ substantive written submissions. The applicants had elaborately addressed the inventive-step objection and distinguished document D1-D8, but that these submissions had not been considered. The Court remarked that failure to consider the applicant’s written submissions violates the principles of natural justice and “defeats the whole exercise of calling for response to FER and permitting filing of post-hearing written submissions”.

The Court noted that the Controller erred in holding that the source and origin of biological material were undisclosed, as the applicant had explicitly disclosed the geographical origin (“van Belgium”) in both the FER response and post-hearing submissions.

Further, the Court observed that none of the steps from the five-step test formulated in F. Hoffmann-La Roche Ltd. vs Cipla Ltd. had been followed by the Controller in determining obviousness. The Controller had failed to identify the PSITA and had not explained why a PSITA would combine D1-D8 to arrive at the claimed sequence (membrane filtration, drying, and obtaining an orally deliverable dried formulation).

The Court also emphasised that the Controller failed to address substantive arguments on the validity of product-by-process claims where structural characterization is impractical. Dismissing reliance on judicial precedents with a brief observation that the claims in those cases were framed differently was held to be insufficient. The Court accordingly held that the application had not been examined in the manner required under the Patents Act and the judicial precedents on the subject, resulting in the loss of an important right of the applicants to have their application fairly considered.

Setting aside the impugned order, the Court remanded the matter to the Patent Office for fresh consideration in accordance with law.