Delhi High Court Sets Aside Rejection Of Patent For VIB's Oral Protein Delivery Invention

The Delhi High Court has set aside the Controller of Patents' refusal of a patent application filed by VIB VZW, a Belgium-based life sciences research institute for an invention relating to oral delivery of therapeutic proteins, holding that the patent authority failed to consider the applicant's submissions and passed an unreasoned order.

Justice Jyoti Singh held that the failure to engage with the applicant's detailed response defeated the patent examination process itself.

“Not according any consideration to the points raised by the Appellants is not only violation of principles of natural justice but also defeats the whole exercise of calling for response to FER and permitting filing of post-hearing written submissions,” the court said.

The appeal arose from the rejection of VIB's Indian patent application titled “Means and Methods for Oral Protein Delivery.” The invention concerns dried pharmaceutical formulations obtained by drying yeast culture medium containing recombinant proteins fused to an IgA Fc domain for oral delivery of therapeutic proteins.

Justice Jyoti Singh noted that the appellants had responded in detail to objections raised in the First Examination Report and had also filed post-hearing written submissions, but the refusal order failed to deal with those submissions.

The court found merit in the argument that the impugned order had effectively reproduced the earlier objections without meaningful analysis. Referring to an earlier precedent, the court said this alone justified setting aside the refusal order.

The appellants argued that the invention addressed a longstanding pharmaceutical challenge, oral delivery of protein-based therapeutics, which are typically degraded in the gastrointestinal tract and therefore usually require injectable administration.

According to the appellants, the invention uses dried culture medium from recombinant yeast host cells secreting therapeutic proteins, with the yeast extracellular medium acting as a protective matrix around the protein to prevent or slow degradation in the gut. A major claimed advantage was that the therapeutic protein did not require purification before use.

The court also found a factual error in the refusal order, which had rejected the application partly on the ground that the source and geographical origin of the biological material had not been disclosed.

Calling this a “glaring fallacy,” the court noted that the applicants had expressly disclosed in both their reply to the First Examination Report and post-hearing written submissions that the biological material originated from Belgium and was not sourced from India.

The court further held that the Controller had failed to properly examine the inventive step objection.

Justice Singh noted that Delhi High Court precedents require the patent authority to identify the person skilled in the art, determine the closest prior art, identify differences between the prior art and the claimed invention, and assess whether those differences would have been obvious without hindsight.

The court found that none of these steps had been followed.

The appellants had argued that the cited prior art documents did not disclose the specific claimed combination of membrane filtration of yeast culture medium followed by drying the unpurified medium to create an orally deliverable dried formulation with a protective matrix effect.

The court observed that the Controller had not examined the distinctions drawn by the applicants between the cited prior art and the claimed invention.

The court also noted that the applicants had argued that their Pichia-derived dried culture medium formulation showed superiority over plant-derived compositions in clearing F4+ETEC infection, which they relied upon as objective evidence against obviousness.

“The Court is unable to discern from the impugned order if this point even crossed the mind of the Respondent,” Justice Singh observed.

The court also found fault with the Controller's handling of objections that the claims were vague and overly broad because sequence ID numbers for recombinant polypeptides were absent.

The applicants had argued that the inventive feature lay not in the identity of a particular polypeptide, but in the dried yeast culture medium formulation and its protective matrix effect. The court found that this contention had not been properly addressed.

The court further noted that the Controller had cursorily dismissed case law cited by the applicants on product-by-process claims without proper analysis.

Finding that the patent application had not been examined in the manner required under law, the court partially allowed the appeal and set aside the refusal order dated March 28, 2025. It directed the Controller to reconsider the patent application after giving the applicants a fresh hearing.

A reasoned, speaking order must now be passed within four months. The Controller has also been directed to decide the matter independently, without being influenced by either the earlier refusal order or the High Court's observations.