The Delhi High Court set aside the Controller’s refusal of Fresenius Kabi’s Sugammadex patent, citing procedural flaws under Section 14 of the Patents Act. The order underscores strict compliance with hearing requirements and warns against hindsight bias in inventive step analysis.
Section 14 Compliance Essential, Says Delhi HC in Sugammadex Case
In Fresenius Kabi v. Controller of Patents, the Delhi High Court quashed the rejection of a patent application for Sugammadex, a pharmaceutical compound used in anaesthesia reversal. The Controller had rejected the application under Section 25(1) on grounds of obviousness and lack of inventive step. However, the Court found that the rejection violated Section 14 of the Patents Act, 1970, which mandates a fair hearing before refusal.
The Court emphasized that the applicant must be given a meaningful opportunity to respond to all grounds of objection, including the specific prior art combinations relied upon. It noted that the Controller had relied on a mosaic of prior art references without affording Fresenius Kabi an adequate chance to rebut the composite case. The ruling cautioned against the use of hindsight in assessing inventive step, reiterating established Supreme Court principles from Novartis v. Union of India.
A decision based on undisclosed combinations of prior art violates principles of natural justice under Section 14.
This judgment reinforces procedural rigor in patent prosecution. Practitioners must ensure that all objections are clearly communicated during examination and that applicants are given full opportunity to address them before final refusal. The case also highlights the importance of challenging decisions where technical evidence is dismissed without proper engagement.
Citations
- Fresenius Kabi v. Controller, 2026
- Novartis v. Union of India (2013) 6 SCC 1
