Summary
The Calcutta High Court reversed a patent rejection citing procedural violations including failure to disclose prior art in the hearing notice. The judgment underscores the importance of legal fairness in patent prosecution and mandates re-evaluation under proper statutory procedures.
Introduction
The Calcutta High Court recently overturned the Controller’s decision to reject a patent application in the case of UCB Pharma GmbH & Anr. v. The Controller of Patents and Designs, citing procedural infirmities. The Court also observed that the refusal order was issued without any proper evaluation of the substantive merits of the application.
Facts of the Case
The present appeal arises from an order dated 16th August 2019 passed by the Deputy Controller of Patents and Designs (“Controller”), wherein the patent application filed by UCB Pharma GMBH (“UCB Pharma”), titled “Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-crystalline Form of Rotigotine”, was refused.
The patent application entered national phase in India with 14 claims focusing on a solid dispersion comprising rotigotine (used in the therapy of Parkinson’s disease) and polyvinylpyrrolidone (PVP), particularly within a specific weight ratio range to ensure long-term stability and prevent crystallization of rotigotine in a transdermal therapeutic system (TTS).
Over the course of prosecution, the appellant amended the claims twice, initially in response to the first examination report (FER) and subsequently in response to the hearing notice, eventually reducing them to 8 claims. The amended claims related to a solid dispersion and a transdermal patch with specific technical features, such as rotigotine in free base form along with PVP in a specific ratio, and its dissolution limits in silicone adhesives. While the hearing notice cited three documents (D1 to D3), the Controller introduced two additional prior arts, D4 (EP2177217) and D5 (US2005/0079206), for the first time during the hearing.
Despite amendments and written submissions, the patent application was refused by the Controller primarily on the grounds of lack of inventive step, lack of clarity under Section 10(4), and Section 2(1)(j) of the Patents Act, 1970.
Grounds of Refusal by the Controller
With respect to the objection of lack of inventive step under Section 2(1)(j) and Section 2(1)(ja) of the Patents Act, 1970, the Controller contended that rotigotine, its use in TTS, its combination with PVP, the use of both PVP as a crystallization inhibitor, as well as silicone adhesive matrices were already known from prior art documents D1 to D5. Moreover, the Controller emphasized that the selection of a specific rotigotine:PVP ratio in the appellant’s invention amounted to nothing more than a routine experimentation, lacking inventive ingenuity or technical advancement.
Arguments Provided by UCB Pharma
UCB Pharma argued that their invention addressed a long-standing technical challenge associated with instability of rotigotine in TTS due to crystallization over time. They pointed out that their earlier product, TTS – Neupro® patch with a 9:2 ratio of rotigotine to PVP, had stability issues requiring maintenance through cold chain. They contended that the present invention claimed improved ratios in the range of 9:4 to 9:6, which enabled room temperature stability. To substantiate the argument, UCB Pharma also provided comparative data demonstrating superior performance and long-term stability of TTS within the claimed ratio range. They contended that none of the cited documents (D1–D5) disclosed or suggested the criticality of the claimed ratios to ensure stability of rotigotine in TTS.
Court’s Analysis
The Court identified several procedural and substantive infirmities in the impugned order, specifically the introduction of new prior arts D4 and D5 during the hearing stage without prior notice, thereby violating the principles of natural justice. Moreover, the refusal of claims 4 to 7 on grounds not raised in the hearing notice was also deemed procedurally improper. The Court further found violations of Section 13(3) of the Patents Act and Rule 24B of the Patent Rules due to lack of proper re-examination of the application after amendment. Furthermore, the Court also identified that the impugned order lacked clarity and reasoning, rendering it a non-speaking order.
While analyzing the case, the Court reaffirmed the importance of established tests for assessing inventive step, including the “Obvious to Try,” “Problem-Solution,” “Could-Would,” and TSM (Teaching-Suggestion-Motivation) approaches. Further, reliance on documents D4 and D5 which were not cited in the hearing notice was held to be in violation of statutory requirements under Section 13(3) of the Act and principles of natural justice aligning with established judicial precedents in cases such as Guangdong Oppo Mobile Telecommunications Corp., Ltd., Man Truck Bus Se, Otsuka Pharmaceutical Co. Ltd., Perkinelmer Health Sciences Inc, Protean Electric Ltd., where courts have consistently disapproved of introducing new prior art at an advanced stage without due notice.
Conclusion
The Calcutta High Court set aside the impugned order, and the matter was remanded back to the Patent Office for fresh consideration by a different officer, distinct from the one who passed the original order. The Court directed that:
- The appellant be given the opportunity to respond to D4 and D5;
- The matter be decided on merits and without prejudice to prior findings; and
- The fresh decision should be rendered within six months of receipt of the Court’s order.
The matter now awaits reconsideration by the Patent Office under judicial supervision.
Citation: Ucb Pharma Gmbh & Anr (Appellant) vs The Controller Of Patents And Designs, IPDPTA No. 117 of 2023, OA/1/2020/PT/KOL, (H.C. Calcutta April 8, 2025). Available at: https://indiankanoon.org/doc/145554557/
Article Author: Dr. Rukaya Amin Chowdery
Article Review: Neetha Mohan
Accessibility Review: Gaurav Mishra