The present article deals with a noteworthy decision of the Indian Patents Office (‘IPO’) on the pre-grant opposition under Section 25(1) of the Patents Act, 1970 (‘Patents Act’). The said order was issued pursuant to the Delhi High Court (‘High Court’) remanding the matter to the Assistant Controller of Patents & Design (‘Controller’). The said decision of the Controller is essentially a reasoned up-gradation of its earlier non-speaking order. This article also outlines the intervention of higher judicial forums in matters where quasi-judicial authorities have not dealt with a case in compliance with the principles of natural justice. Under the pillar of natural justice, a party is entitled to be made aware of the reasons for the decision. Pursuant to the direction of remand by the High Court, the Controller delivered a detailed and reasoned order in the said pre-grant opposition while examining submissions of the parties at some length on the grounds of inventive step, non-patentability, and sufficiency of disclosure.
Facts and issues
Original hearing and order on pre-grant opposition
A pre-grant opposition under Section 25(1) of the Patents Act was filed by Precise Bio Pharma Pvt. Ltd. (‘Opponent’) on 24 December 2020, against Patent Application No. 2471/DELNP/2013 (‘Application’) filed on 20 March 2013, in the name of Ferring B.V. (‘Applicant’). The Controller, after considering the oral and written statements by both the parties in relation to the said pre-grant opposition, concluded that the Opponent failed to establish all the grounds of opposition, dismissed the said pre-grant opposition, and subsequently granted the patent (IN 387567) with the amended set of claims on 27 January 2022 (‘impugned order’). The granted claims of the patent recite an aqueous carbetocin composition with a pH from 5.2 to 5.65, a concentration of carbetocin from 0.05 mg/mL to 0.5 mg/mL, and an antioxidant selected from the group consisting of methionine or EDTA or methionine and EDTA.
Writ before the High Court
The Opponent challenged the impugned order on the ground of not disclosing detailed reasoning for its conclusion and filed a writ petition W.P.(C)-IPD 3/2022 before the High Court seeking the remedy of remand. The High Court set aside the impugned order and stated that it was bereft of any reasoning and therefore a non-speaking order in the eyes of the law. The High Court vide order dated 3 March 2022 remanded the matter and directed the Controller to pass a reasoned order after hearing the parties. Subsequently, pursuant to a review petition, the High Court vide order dated 22 March 2022, clarified that the Controller has to pass a reasoned order, not necessarily resulting into a rejection of the pre-grant opposition and that the Controller was free to adjudicate the remanded matter based on the facts, circumstances, and merits of the case, in accordance with law.
Hearing and order on remand
Following the High Court’s directions, an opportunity of hearing was offered to both the parties. The parties were given an opportunity to submit written submissions. However, the Opponent filed additional documents and requested for de novo hearing proceedings, which was rejected. After hearing and considering the submissions of the parties, the Controller dismissed the pre-grant opposition. In addition, the Controller noted that the conduct of the Opponent, post the High Court’s direction, has been indicative of abuse of process and law.
The issues in the case before the Controller were as follows:
- Whether de novo hearing is allowed at this stage when the matter is being re-heard on remand.
- Whether the claimed composition lacks inventive step in the light of the cited prior art documents.
- Whether the invention is non-patentable and lacks sufficiency of disclosure.
Decision and analysis
The Controller addressed the preliminary issue of having de novo proceedings on a remanded matter, as was proposed by the Opponent. The Opponent interpreted the High Court’s order in the sense that it directed for the de novo hearing proceedings and filed additional documents for the said purpose. The Controller noted that no such direction was issued by the High Court. The Opponent’s proposal of conducting a de novo hearing was held to be a misinterpretation/ misrepresentation of the High Court’s order. It was held that admitting the additional documents or grounds filed by the Opponent in the remanded matter would be equivalent to a fresh pre-grant opposition proceeding and would be contrary to the intent of the High Court’s order. Therefore, no additional documents or grounds were taken on record by the Controller.
The Controller noted that the Opponent was not remediless in case of rejection of pre-grant opposition. The Opponent had other options available under the Patent Laws and they could pursue a post-grant opposition under Section 25(2) or revocation petition under Section 64 of the Patents Act, rather than making a leap-frog approach to the High Court and bypassing the established procedures laid down in the law. The Controller relied upon the landmark decision of the High Court in the case UCB Farchim SA v. Cipla Ltd. & Ors., wherein the Court adjudicated the question of maintainability of a writ petition under Article 226 of the Constitution to challenge an order passed by the Controller rejecting a pre-grant opposition filed under Section 25(1) of the Patents Act. In the said decision it was noted that there are two scenarios depending on whether the opponent is an ‘interested person’ or not. (i) The High Court was of the view that the statutory remedy against rejection of a pre-grant opposition by an ‘interested person’, was to file a post-grant opposition or revocation petition. (ii) The High Court further held that in case of rejection of a pre-grant opposition by any person other than ‘interested person’, there appeared to be no statutory remedy available and a writ petition under Article 226 might be maintainable in such case. In the present matter, the Controller found the Opponent to be falling under the former scenario. Therefore, the Opponent was held to have alternate statutory remedies available and should have sought them first.
It was also held that the object of pre-grant opposition was to assist the Controller in the prosecution of the patent application.
Lack of inventive step
The Controller stated that the inventive step should be assessed by asking: ‘given the known prior art, would the claimed invention be obvious to a person skilled in the art, and is there any technical advancement over the prior art.’
Based on the submissions provided by both parties, the Controller reasoned that there is no teaching or indication in the cited prior art documents to arrive at a stable carbetocin composition having a specific concentration and pH range as recited in the claims.
Further, the Controller stated that the specification of the Application provides sufficient experimental data to demonstrate that the composition comprising carbetocin within the specific pH range has improved stability as compared to very similar compositions but outside the recited pH range. Therefore, the Controller held that the composition recited in the claims of the Application was inventive over the cited prior art documents.
Non-patentability of invention
The Controller referred to the erstwhile IPAB order in Ajantha Pharma Limited v. Allergan, wherein it was held that the ‘combination mentioned in the Explanation of the Section 3(d) of the Patents Act can only mean a combination of two or more of the derivatives mentioned in the Explanation or a combination of one or more of the derivatives with the known substance which may result in a significant difference with regard to the efficacy. A combination of two active drugs like Brimonidine and Timolol cannot be considered derivatives of each other.’ The Controller noted that the claimed composition of the Application comprises different substances like methionine and EDTA apart from carbetocin. The methionine and/or EDTA cannot be considered as a form of carbetocin, and thus, the Controller held that Section 3(d) of the Patents Act did not apply to the claims of the instant application.
Further, the Controller opined that the exemplification provided in the specification of the Application demonstrates that the claimed composition has significantly improved stability. The Controller held that by virtue of the technical effect, the composition of the Application does not fall under the ambit of Section 3(e) of the Patents Act.
Sufficiency of disclosure
The Controller noted that the effect of the composition comprising methionine alone, EDTA alone, and a combination of methionine and EDTA have been demonstrated and well exemplified in the specification of the Application. Thus, it is sufficient to enable a person skilled in the art to work the invention and the said ground of the pre-grant opposition was rejected.
Consequently, considering the facts and circumstances of the case, statements, evidence, and arguments of both the parties, the pre-grant opposition against the Application was dismissed, and IN 387567 patent was held to be maintained.
This decision highlights the need for quasi-judicial authorities to issue reasoned orders. This will obviate the need for protracted proceedings involving multiple judicial forums and ensure that precious judicial time is not spent on mere procedural matters.