Calcutta High Court Quashes Patent Refusal Citing Procedural Violations: "Any Objection to Prior Art Must Be Known Before Hearing; Patent Office Is Not an Adversary of the Applicant"
Safiya Malik
The Calcutta High Court, Single Bench presided by Justice Krishna Rao, set aside the refusal order issued by the Deputy Controller of Patents and Designs and remanded the patent application filed by UCB Pharma GMBH & Anr. for fresh consideration. The judgment was delivered on 8 April 2025, following a hearing concluded on 4 March 2025.
The Court directed that a different officer from the one who issued the impugned order must re-hear the matter, allowing the appellants to respond to documents D4 and D5 which were introduced for the first time during the hearing. The Court ordered that the re-evaluation be conducted within six months.
The case pertained to an appeal filed against the order dated 16 August 2019 by the Deputy Controller of Patents and Designs, refusing the application number 1574/KOLNP/2012 for a patent titled "Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-crystalline Form of Rotigotine."
The appellants initially submitted 14 claims in their national phase application. These included claims regarding a method for stabilizing rotigotine using polyvinylpyrrolidone (PVP), a solid dispersion composition, and a transdermal therapeutic system (TTS) containing specific ratios of rotigotine to PVP.
In response to the First Examination Report, the claims were amended to 14 revised claims, focusing on refining the chemical ratios, inclusion of molecular weight ranges for PVP, and details regarding the adhesive matrix. A further revised set of eight claims was later submitted, stating solid dispersions and TTS with defined component ratios and manufacturing methods.
The Deputy Controller of Patents and Designs refused the grant of patent citing lack of inventive step under Section 2(1)(j) of the Patents Act, 1970. The respondent argued that the components and their usage were already disclosed in prior art documents, particularly citing D1: WO 03/092677, D2: EP 1669063, and D3: WO2009006787A1. However, during the hearing, additional documents D4: EP2177217 and D5: US2005/0079206 were cited.
According to the impugned order, "finding out a particular ratio of rotigotine and PVP is a routine experimentation, because all the components and their use are already known from cited prior art documents." It was further stated that "use of PVP as crystallization prevent[er] is also disclosed in cited document D4."
The appellants contended that claims 4 to 7 were rejected under Section 2(1)(j) despite no such objections being raised in the original hearing notice. Additionally, the claims introduced novel ratios that resolved known stability issues associated with the commercial TTS Neupro®, which previously had to be cold-stored due to the emergence of Form II rotigotine crystals.
The judgment noted that long-term stability problems in existing patches reduced drug release efficiency. It was found that specific ratios between 9:4 and 9:6 of rotigotine to PVP significantly improved drug stability and release, supported by empirical data presented in figures and tables.
Justice Krishna Rao observed that "the impugned order dated 16th August, 2019 passed by the Deputy Controller of Patents and Designs is set aside and the matter is remanded back to the respondent for fresh consideration."
It was recorded that "documents D5: US2005/0079206 (US 8246979) and D4: EP2177217 were cited by the respondent for the first time during the hearing. The appellant was not aware of the objection of the respondent with regard to the said two documents."
The Court referenced multiple judgments to support procedural requirements for re-examination upon amendment of claims. In Guangdong Oppo Mobile Telecommunications Corp., Ltd. v. Controller of Patents and Designs, it was held that "when a complete specification is amended, such amended specification should be re-examined and a Report issued."
The Court also cited Man Truck Bus SE v. Assistant Controller of Patents and Designs, stating: "The two new prior art documents cited in the hearing notice are in violation of the mandate of section 13(3) of the Act and alters the entire character of the examination."
The Calcutta High Court recorded that objection based on newly introduced documents without prior notice breached the principle of natural justice. The Court stated: "Any objection to the prior art must be known to the applicant before the date of hearing."
It further added that the Patent Office, exercising quasi-judicial power, "is not an adversary of the patent applicant."
The Court directed:
"The impugned order dated 16th August, 2019 passed by the Deputy Controller of Patents and Designs is set aside and the matter is remanded back to the respondent for fresh consideration."
It further ordered that:
"The respondent other than the officer who passed the impugned order shall hear the parties after permitting the appellant to place on record their replies/response to the documents being D4: EP2177217 and D5: US2005/0079206."
The Court concluded that the matter must be reconsidered "on merits, in accordance with law without being influenced by any observations made by this Court in this order or in the impugned order dated 16th August, 2019" and instructed that the new decision be issued "not later than six months from the date of receipt of the copy of this Order."
Advocates Representing the Parties:
For the Appellant: Ms. Archana Shankar, Ms. Mini Agarwal
For the Respondent: Mr. Nandlal Singhania, Mr. Sunil Kr. Singhania
Case Title: UCB Pharma GMBH & Anr. vs The Controller of Patents and Designs
Case Number: IPDPTA No. 117 of 2023 (OA/1/2020/PT/KOL)
Bench: Justice Krishna Rao
[Read/Download order]
