Patent Examination and Pre-Grant Opposition are independent processes

Patent Examination and Pre-Grant Opposition are independent processes, says the Delhi High Court

In an appeal filed by Novartis from the decision of a Single Judge, the Division Bench of the Delhi High  Court considered if a pre-grant opponent would have the right to participate and get a hearing with respect to amendments made by the patent applicant based on directions of the Controller of Patents. The pre-grant oppositions in the case were filed by NATCO and several others, and the Single Judge held that pre-grant opponents have to be heard with respect to all amendments as the patent examination and pre-grant opposition processes merge once a representation is accepted by the Controller. Disagreeing with the Single Judge, the Division Bench held that patent examination and pre-grant opposition are independent and separate processes.

The Court stated that pre-grant representation is meant to aid the Controller of Patents in carrying out a holistic examination of a patent application and that opponents do not get any right to participate in the examination process independent of the grounds of opposition. As per the Court, opponents get the right to respond and be heard only with respect to the grounds of opposition. If the patent applicant makes any amendments voluntarily, the pre-grant opponents get the opportunity to be given an appropriate opportunity and hearing to respond to the same, but if the amendments are directed by the Controller, pre-grant opponents do not get any right of hearing. In other words, the Controller of Patents need not keep the pre-grant opponents in the loop with respect to amendments carried out in response to his direction or requirement for the grant of a patent.

Relevant Portion of the Judgment

The Court has succinctly outlined the principles with respect to examination of patent applications and pre-grant oppositions, and their intersection in para 128, which is reproduced hereunder.

“128. In summation we deem it apposite to elucidate our conclusions as follows: –

1. The examination process is one which is initiated by the Controller in discharge of the statutory duty and obligation cast upon that authority. The examination of the patent application is a duty cast upon the Controller exclusively and proceeds independent of the objections that may or may not be preferred. While an objection does act in aid of the examination process, the same is intended to merely facilitate and assist the Controller in holistically examining the patent application. It does not detract from the independent duty and obligation cast upon the Controller to be satisfied that the application merits grant.
2. The pre-grant opposition stage opens the floor for eliciting a multitude of opinions extending beyond direct stakeholders to persons opposing the application for varied reasons. It enables the Controller to gather insights from a broad spectrum of sources as opposed to those who may have a direct stake in the matter. The opposition procedure structured as above leads to a comprehensive exploration of objections and perspectives aiding the Controller in making an informed decision.
3. Snehlata C. Gupte correctly understood oppositions to grant as facilitating the Controller in the examination of the patent application. The opposition to the grant thus fosters and stimulates a broader consideration of the patent application.
4. The process is thus an open and participatory exchange ensuring that the evaluation process benefits from views expressed by a diverse body of opponents. While persons interested may also be in the fray, the Controller invites objections for the purposes of ascertaining and eliciting the views of a large cross section of persons who may for varied reasons seek to oppose the grant.
5. The opposition process as envisaged under the Act has a specific and a targeted purpose. Its primary objective is to provide a platform for any person to express objections and concerns regarding a patent application. The objections received during the opposition process play a crucial role enabling the Controller to have the benefit of diverse views on the question of grant including whether the application should be rejected or if amendments to the complete specifications are warranted. The opposition process therefore serves the avowed purpose of allowing external inputs to be placed for the consideration of the Controller enabling it to make a well- informed decision regarding the grant of the patent application.
6. However, the opposition by itself is not the sole determinative of whether the patent is liable to be granted. This since the mere rejection of the opposition would not inevitably result in the grant of a patent. The rejection of an opposition would not, ipso facto, lead to the grant of the patent or compel and bind the Controller to allow the patent application. Notwithstanding the rejection of an opposition, the Controller is legally as well as statutorily bound to independently examine the patent application based on the FER as well as on its enquiry on whether the patent is liable to be granted in law.
7. The examination process serves a wider and significant objective. This stage involves an in-depth assessment of the patent application, ensuring it complies with the statutory requirements for patent approval and facilitates a thorough and independent evaluation of the application by the examiner and the Controller. Maintaining a clear distinction between the examination and the opposition process is essential to not only fulfil the underlying objectives sought to be achieved but are also fundamental in ensuring that the sanctity and efficacy of each stage is maintained.
8. This separation helps in striking a balance between the need for a rigorous examination and the task of including various perspectives in the decision-making process. The examination process demands a focused evaluation of the patent application against set legal standards wherein the Controller is tasked with the duty to ensure that only deserving inventions are granted patent protection. On the other hand, the opposition process serves as a forum for external stakeholders or any person to voice concerns and provide valuable insights thus contributing to a more comprehensive evaluation of the patent application.
9. To merge the process would be to compromise the rigors of examination since external inputs, though valuable, are best considered within the distinct and specific framework of the opposition. Merging these distinct processes would render the entire system unwieldy and counterproductive quite apart from negatively impacting the legislative policy of expeditious consideration. The separation, thus, subserves the legislative intent and allows for a more structured and organized approach where objections from various sources are factored in without disrupting the streamlined process of examination of the patent application.
10. The hearing that is contemplated in Rule 55 clearly appears to be confined to the representation alone, a position which clearly emerges upon a conjoint reading of sub-rules (3), (4) and (5). It is pertinent to note that sub-rule (3) visualizes the applicant being placed on notice if the Controller “on consideration of the representation” be “of the opinion” that the application for patent should either be refused or the complete specification amended. The process of a hearing thus gets triggered upon the Controller on a consideration of the representation being of the opinion that the opponent has raised issues which either warrant the patent application being rejected or the specification being amended. Once the Controller is satisfied that the representation raises questions worthy of consideration, it would proceed to place the applicant on notice enabling it to file its statement and evidence.
11. However, these proceedings are unconcerned with issues that the Controller may have flagged in the course of the examination process. Thus, the right to oppose and to be heard is indelibly pivoted to the representation for opposition as distinct from questions that may arise from the FER or those that the Controller may identify as germane and material in the examination process.
12. It is also relevant to note that the opponent can claim a right of hearing only if the Controller is satisfied and is of the opinion that the representation merits consideration. A mere filing of a representation would not prompt or precipitate issuance of notice under Rule 55(4). The matter becomes contentious only once the Controller takes cognizance of the representation and issues notice to the applicant. It is at that stage and for the aforesaid reasons that the principles of natural justice become applicable.
13. It is thus apparent that the right of hearing that is contemplated in Rule 55(5) is one which is concerned solely with the adjudication and disposal of the representation for opposition. The opponent cannot be countenanced to have a right of hearing in the examination process merely because the statute confers such an opportunity at the stage where the Controller is considering the representation. While the pre grant opposition indisputably facilitates the decision-making function of the Controller, we find ourselves unable to accept the contention that the opponent must consequentially be recognised to have the right of participation or audience in the examination process.
14. We are also convinced that the statutory scheme as articulated by us above does not amount to either a denial or exclusion of the natural justice principles as was contended by the respondents. As was noted in the preceding parts of this decision, the opponent stands conferred a right to raise objections once the application is advertised. However, the examination process comprises of an independent evaluation and assessment of the patent application. The said exercise is not dependent upon an objection that may be raised. The provisions contained in Chapter IV of the Act do not envisage opponents or objectors being accorded an audience either before the examiner or the Controller. Consequently, the question of denial of a right of hearing does not arise at all.
15. The invocation of the doctrine of the principles of natural justice being liable to be read into the statute in the absence of an express exclusion is equally misconceived when one bears in mind the scheme underlying Chapter IV. The provisions enshrined in that part are fundamentally concerned with the examination and evaluation of the patent application by the examiner and the Controller. That is an obligation placed upon the Controller and one which is disassociated from opposition proceedings which form the subject matter of Chapter V.
16. As we observed earlier, the rejection of an opposition would not ipso facto lead to the grant of a patent. The statute in any case neither deprives a person from opposing the grant nor does it leave an interested person with a fait accompli. The rights of interested persons stand sufficiently safeguarded and preserved by Section 25(2). In both contingencies, the opponent can claim and is in fact conferred a right of hearing compliant with the principles of natural justice.
17. More fundamentally, the right of hearing as asserted by the respondents proceeds in ignorance and disregard of the nature and extent of the opposition process. We have already held that the representation for opposition is principally aimed at aiding and facilitating the examination of the patent application. The representation is per se neither adversarial nor contentious. The pre grant opponent merely aids the Controller in a holistic examination of the patent application. Secondly, the opposition in any case is confined to the grounds specified in Section 25(1). It is thus obligatory for the Controller to hear the opponent on the grounds of challenge that are raised. We fail to appreciate how the objector could claim a right of hearing in respect of grounds which were neither raised nor urged at its behest. It is this which convinces us to hold that the opponent can assert a right of hearing only in respect of the representation and cannot be recognised to have a right to intervene in the examination process.
18. In opposition proceedings, the focus primarily is on the grounds brought forward by the opponent, confining its examination to the issues raised in the opposition. This examination is triggered by information that emerges and is deemed prima facie to affect the application for grant and the claim for a patent. Thus, the significance of opposition lies in its role in aiding the Controller in conducting a comprehensive examination of the patent application.
19. Unlike an adversarial process, the opposition merely contributes to the overall assessment of the patent application and thus would not sustain a right of hearing being claimed in the examination process. The opponent’s right to a hearing is circumscribed by the grounds specified in Section 25(1). The right of hearing is tethered to the grounds articulated in the opposition, ensuring that the opponent has a platform to present arguments and evidence in connection with the challenges they have raised. This reinforces our view that the opponent’s right to a hearing pertains specifically to the representation stage and does not grant them the entitlement to intervene in the broader examination process.
20. An amendment proposed by the applicant in order to comply with a directive of the Controller is placed on a pedestal distinct from any voluntary amendment that the applicant may choose to introduce. Section 57(6) thus not only liberates the applicant from the rigours of contestation which follows amendments proposed at its discretion, it additionally highlights the intent of the statute to draw a clear line of distinction between amendments traceable to Section 57(1) and those covered by sub-section (6). The hearing and the adjudicatory process envisaged in Section 57 (4) of the Act would thus be limited to amendments proposed by the applicant of its own volition as opposed to amendments stimulated by a directive of the Controller.
21. Our finding that an amendment based upon the directions of the Controller would not fall within the ambit of Section 57(6) lends additional credence to our conclusion that the examination process is one which is separate and independent of proceedings of opposition. As observed hereinabove, the representation for opposition merely constitutes input and material which the Controller may take into consideration while evaluating the patent application. Those representations do not absolve the Controller from examining the application and being satisfied that the patent is liable to be granted. That function is to be performed and the statutory duty discharged by the Controller irrespective of the merits or otherwise of the objection or even in a case where no objections may have been preferred.
22. We find that the impugned judgment failed to test the allegation of violation of the natural justice principles on the bedrock of prejudice and manifest injustice. It also failed to bear in consideration the highly belated objection which was preferred by Dr. Kanchan Kohli, a day after the closure of hearing on PGOs and for which no plausible explanation was proffered. Bearing in mind the legislative mandate of Section 43(1), the Controller as well as Courts would be well advised to ensure that the pre grant opposition right is not abused and the examination process inordinately delayed or derailed by the filing of serial objections.
23. The learned Single Judge also misconstrued the Rule 55 hearing and which stands confined to the objections that may come to be preferred. The aforesaid Rule cannot be interpreted or recognised as seeking to either accord a participatory role upon the objector in the examination process or conferring a right to be heard in the course thereof.
24. For reasons noted in the body of this judgment, we are of the firm opinion that the examination and opposition process though statutorily structured to proceed parallelly are independent and separate. It would be wholly incorrect to understand the provisions of the Act and the Rules as contemplative of convergence or merger.”

Citation: Novartis Ag vs Natco Pharma Limited & Anr., Decided by the Delhi High Court on 9 January, 2024 (LPA 50/2023).

Conclusion

The pre-grant representation process is viewed as an opportunity to contribute to the examination of patents and is not considered as an adversarial process. While pre-grant opponents must be given sufficient opportunity, such an opportunity does not rise to the level of an adversarial process. Involuntary amendments do not come within the scope of the pre-grant representation process, and the Controller of Patents must uphold the legislative mandate of expediting the process after giving due importance to the role of the public in the examination of patents.

Disclaimer

The case notes in this blog post have been written by IP attorneys at BananaIP Counsels based on their review and understanding of the Judgments. It may be noted that other IP attorneys and experts in the field may have different opinions about the cases, or arrive at different conclusions therefrom. It is advisable to read the Judgments before making any decisions based on the case notes.

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