Scope of referral in pre-grant oppositions
This article discusses a remarkable decision by the Indian Patent Office (‘Initial Public Offering‘) on pre-grant opposition under section 25(1) of the Patents Act 1970 (‘patent law‘). The said order was made under the Delhi High Court (‘Supreme Court‘) referring the matter to the Assistant Comptroller of Patents and Designs (‘Controller‘). Said decision of the Monitor is essentially a reasoned update of his previous silent order. This article also describes the intervention of higher courts in cases where quasi-judicial authorities have not dealt with a case in accordance with the principles of natural justice. Under the pillar of natural justice, a party has the right to be informed of the reasons for the decision. Pursuant to the High Court’s Order for Reference, the Controller issued a detailed and reasoned order in said pre-grant opposition while considering in detail the parties’ submissions on the grounds of inventive step, non-patentability and sufficiency of disclosure.
Facts and issues
Initial Hearing and Pre-Grant Objection Order
A pre-grant opposition under Section 25(1) of the Patent Act was filed by Precise Bio Pharma Pvt. ltd. (‘Opponent‘) on December 24, 2020, against patent application no. 2471/DELNP/2013 (‘Application‘) filed on March 20, 2013, in the name of Ferring BV (‘Applicant‘). The Controller, having considered the oral and written representations of both parties regarding the said pre-grant opposition, concluded that the opponent had not established all the grounds for opposition, dismissed the said pre-grant opposition and then granted the patent (IN 387567) with the amended set of claims on January 27, 2022 (‘disputed order‘). The granted patent claims list an aqueous carbetocin composition with a pH of 5.2 to 5.65, a carbetocin concentration of 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. .
Appeal to the High Court
The Opponent challenged the Impugned Order on the ground that it had failed to disclose the detailed reasoning for its conclusion and filed a written petition WP(C)-IPD 3/2022 in the High Court seeking the remedy of detention provisional. The High Court quashed the contested order and declared it to be devoid of any reasoning and therefore silent in law. The High Court see the order of March 3, 2022 referred the case and ordered the Controller to issue a reasoned order after hearing the parties. Subsequently, following a petition for review, the High Court see order dated March 22, 2022, clarified that the Monitor must issue a reasoned order, not necessarily leading to a rejection of the pre-grant opposition and that the Monitor was free to rule on the referred case on the basis of the facts, circumstances and merits of the case, in accordance with the law.
Hearing and referral order
As instructed by the High Court, an opportunity for a hearing was offered to both parties. The parties were given the opportunity to submit written observations. However, the Opponent filed additional documents and requested de novo hearing process, which was dismissed. After having heard and examined the observations of the parties, the Controller rejected the opposition before delivery. Further, the Comptroller noted that the opponent’s conduct, after the High Court’s instruction, was indicative of an abuse of process and of law.
The issues raised in the case before the Monitor were:
- Whether de novo the hearing is allowed at this stage when the case is reconsidered on remand.
- If the claimed composition lacks inventive step in light of the prior art documents cited.
- If the invention is not patentable and not sufficiently disclosed.
Decision and analysis
The Monitor addressed the preliminary issue of having de novo proceeding on a referred matter, as proposed by the Opponent. The Opponent interpreted the High Court’s order to mean that it ordered the de novo hearing process and has filed additional documents for this purpose. The Monitor noted that no such direction had been issued by the High Court. The Opponent’s proposal to carry out a de novo the hearing was held to be a misinterpretation/misrepresentation of the High Court order. It was held that the admission of the additional documents or grounds filed by the Opponent in the referred matter would amount to an Costs pre-grant opposition proceedings and would be contrary to the intent of the High Court’s order. Therefore, no additional documents or grounds were recorded by the controller.
The Controller noted that the Opponent was not without recourse in the event of rejection of the opposition prior to grant. The opponent had other options under the patent laws and could pursue a post-grant opposition under Section 25(2) or a revocation request under Section 64 of the Patents Act. patents, rather than taking a leapfrog approach to the High Court and circumventing the established procedures provided for by law. The Monitor relied on the historic High Court decision in the case UCB Farchim SA v. cipla ltd. & Golds., in which the Court ruled on the issue of the maintainability of a written motion under Section 226 of the Constitution challenging an order made by the Controller dismissing a pre-grant objection filed under Section 25, paragraph 1, of the patent law. In 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 legal remedy against the dismissal of a pre-grant objection by an ‘interested person’ was to file a post-grant objection or motion for revocation. (ii) The High Court further held that if a pre-grant objection was dismissed by anyone other than the “interested person”, there appeared to be no legal remedy available and that a motion written under section 226 could stand in this case. In this case, the Monitor found that the Opponent fell under the first scenario. Accordingly, it was held that the Opponent had other remedies available to it at law and should have sought them first.
It was also held that the purpose of the pre-grant opposition was to assist the Controller in the prosecution of the patent application.
Lack of inventive step
The Controller stated that inventive step should be assessed by asking: ‘given the known state of the art, would the claimed invention be obvious to a person skilled in the art and is there a technical advance over the state of the art?.’
On the basis of the observations provided by both parties, the controller considered that there was no teaching or indication in the cited prior art documents to arrive at a stable composition of carbetocin having a concentration and a specific pH range as stated in the claims.
Further, the Controller stated that the application specification provides sufficient experimental data to demonstrate that the composition comprising carbetocin within the specific pH range has improved stability over very similar compositions but outside the range. pH indicated. Therefore, the controller found that the composition cited in the claims of the application was inventive over the cited prior art documents.
Non-patentability of the invention
The Monitor referred to the former IPAB order in Ajantha Pharma Limited v. Allerganin which it was judged that the ‘combination mentioned in the explanation of section 3(d) of the Patent 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 that can make a significant difference in effectiveness. A combination of two active drugs like brimonidine and timolol cannot be considered derivative of each other. The controller noted that the composition claimed in the application includes different substances such as methionine and EDTA apart from carbetocin. Methionine and/or EDTA cannot be considered a form of carbetocin and therefore the Controller held that Section 3(d) of the Patent Act did not apply to the claims herein. request.
Further, the Controller has found that the example 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 was not covered by section 3(e) of the Patent 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 has been demonstrated and well illustrated in the application specification. Thus, it suffices to allow a person skilled in the art to exploit the invention and said ground for opposition prior to grant has been rejected.
Therefore, in view of the facts and circumstances of the case, statements, evidence and arguments of both parties, the pre-grant opposition against the application was dismissed and patent IN 387567 was upheld.
This decision highlights the need for quasi-judicial authorities to issue reasoned orders. This will avoid the need for lengthy proceedings involving multiple judicial instances and will ensure that valuable judges’ time is not spent on mere procedural matters.