The Delhi High Court has reinforced an important procedural safeguard in Indian patent examination: a hearing granted during a pre-grant opposition under Section 25(1) of the Patents Act, 1970 cannot substitute the applicant’s independent right to be heard under Section 14. In FRESENIUS KABI IPSUM SRL v. Assistant Controller of Patents and Designs & Anr., the Court also flagged concerns regarding hindsight analysis and unsupported mosaicking of prior-art documents in assessing inventive step.
Background of the dispute
Fresenius Kabi challenged the Controller’s refusal of Patent Application No. 201611009993, filed for an improved process for preparing sugammadex using an isolated salt of 3-mercaptopropionic acid, particularly its disodium salt. The application had faced pre-grant opposition and was ultimately refused on grounds including lack of novelty, lack of inventive step and non-patentability under Section 3(d).
The principal procedural issue before the Court was whether the hearing afforded during the pre-grant opposition was sufficient, or whether the applicant was separately entitled to a hearing under Section 14 read with Rule 129 of the Patents Rules.
Section 14 and Section 25 are separate proceedings
The Hon’ble Court held that the two statutory mechanisms operate in distinct fields. Section 14 concerns examination of the patent application following the Examiner’s report, whereas Section 25(1) provides a mechanism for third parties to oppose the grant.
The Court relied particularly on the Division Bench decision in Novartis AG v. Natco Pharma Limited & Anr., which held that examination and pre-grant opposition are independent statutory processes. A pre-grant opponent assists the Controller by bringing additional objections and evidence, but the opposition process does not replace the Controller’s independent examination of the application.
The Court also relied on Ferid Allani v. Union of India, 2008 SCC OnLine Del 1756, where it was held that Rule 129 casts a statutory duty on the Controller to provide an applicant an opportunity of hearing before exercising discretionary power likely to adversely affect the applicant. The Court regarded the absence of such hearing in the present case as going to the root of the decision-making process.
Inventive step cannot be evaluated with hindsight
Although the Court did not finally determine the patentability of the claimed process, it identified significant concerns with the substantive reasoning in the refusal order.
The Controller had relied upon several prior-art documents D1, D3, D4 and D7, to conclude that the claimed process was obvious. The Hon’ble Court observed that the order did not adequately explain why a person skilled in the art would select D1 as the starting point and combine it with the teachings of the other documents.
This raised the familiar problem of hindsight reconstruction. The Court referred to Avery Dennison Corporation v. Controller of Patents and Designs and reiterated that prior art should not be assembled retrospectively using knowledge of the invention itself as a guide.
The Court also noted that the claimed use of an isolated salt could have technical consequences for purity, reaction reproducibility, yield and scalability. These issues, together with the experimental data submitted by the applicant, had not been adequately addressed by the Controller.
Why the judgment matters
The decision carries an important procedural and practical message for patent applicants and practitioners. A pre-grant opposition does not eliminate the applicant’s statutory right to a Section 14 hearing. The Controller must independently examine the application and provide the applicant an opportunity to respond before refusing it.
The decision also reinforces the need for a reasoned inventive-step analysis. Simply combining multiple prior-art references is insufficient. The decision-maker must explain the relevant starting point, the distinguishing technical features and why the skilled person would have been led toward the claimed invention.
Conclusion
The judgment does not hold that Fresenius Kabi’s process is patentable. Instead, it sets aside the refusal because the statutory procedure was not properly followed and remands the application for fresh consideration within six months. The Controller has been directed to comply with Sections 14, 15 and 25 and provide the parties an opportunity of hearing.
For Indian patent practice, the decision is a useful reminder that procedural fairness and substantive patent examination are closely connected. A properly reasoned patent decision requires not only a sound assessment of prior art but also adherence to the statutory opportunity of hearing before an application is refused.
Disclaimer: This article is intended for general educational and informational purposes only and does not constitute legal advice. The law and applicable procedures may change, and readers should seek professional advice based on their specific circumstances.