By Renu Bala and Bani Mittal
INTRODUCTION
A patent application goes through several stages before it is ultimately granted in a jurisdiction. Qua the Patents Act, 1970 (hereinafter referred to as the Act), the stages comprises the filing of specification; publication of application; examination; hearing and grant/refusal of application.
The examination of a patent application under section 12 of the Act is a mandatory stage wherein after the request for examination is filed, a thorough examination of application is initiated. The examiner (who is referred by Controller) searches existing patents and prior art; issues an examination report with objections and directs the applicant to respond within 6 months or within an extended period of upto 9 months. After the response to Examination is filed, the Controller can either grant a patent or issue a hearing under Section 14 of the Act to give a fair chance to the applicant.
Parallely, a pre-grant opposition under section 25(1) of the Act may be filed against a patent application. The Controller shall not consider the opposition if the request of examination has not been filed. This opposition process allows third parties to challenge patentability of the application without interfering with the ongoing prosecution process.
The Patent Amendment Rules 2024, have laid down the amended procedure for pre-grant opposition vide the notification dated March 15, 2024. These rules have been designed to address concerns regarding “Benami (or proxy) oppositions” along with “serial oppositions” wherein an opposition is filed on behalf of a party that is not directly involved or affected and such oppositions unnecessarily delay the grant of a patent. Under the Patent Amendment Rules, 2024, the process involves the following steps:
- The Controller makes an uniteral determination of whether a “prima facie” case has been established.
- The Controller provides an opportunity to the opponent to be heard in the matter, if no “prima facie” case is made out in the representation.
- The Controller passes an order for either refusal or prima facie acceptance of representation and notifies the applicant if the “prima facie” case exists.
- The applicant on receipt of the notice files reply statement within two months from the date of notice. The case shall thereafter be decided after hearing the parties.
During the course of examination or hearing under Section 14, the Applicant can amend the Claims to satisfy the Controller that the said application is novel and inventive. However, that does not imply that the applicant or Controller shall share the amendments with any opponent unless those amendment arise due to objections in opposition proceedings under Section 25(1).
In the case of Novartis AG versus Natco Pharma Limited & ANR[1], the Hon’ble High Court of Delhi vide its order dated January 9, 2024 delivered a significant ruling in this regard. The Hon’ble Court’s judgment addressed a critical issue of the extent of engagement of an opponent under the Patents Act, 1970 in the course of pre-grant opposition proceedings initiated by the Controller (requiring the Applicant for a patent to amend or modify the Application, the complete specifications thereof or any other related document). The Hon’ble Court emphasized that the right to hearing under Rule 55(5) applies only to the Opposition process, not the Examination process. Thus, the Opponents can only claim a right to a hearing on the specific grounds they raise and not on other Examination process. Conclusively, the court affirmed that the Examination and Opposition process though statutorily structured to proceed parallelly are independent and separate. It would be completely incorrect to understand the provisions of the Act and the Rules suggest the “merger” of two processes.
BACKGROUND AND FACTS OF THE CASE:
Novartis AG (hereinafter referred to as the Appellant) filed a National Phase Patent Application on June 08, 2007 with Application no. 4412/DELNP/2007 (now granted Indian Patent No. IN414518) based on PCT Application no. PCT/US2006/043710 dated November 08, 2006 claiming priority from US Application no. 60/789,332 dated April 04, 2006. The patent application faced multiple and serial pre-grant oppositions, including one from Indian Pharmaceutical Alliance (1st Pre-Grant Opponent [hereinafter abbreviated as PGO]); Natco Pharma Limited (Respondent no. 1 & 2nd PGO); Kumar Sushobhan (3rd PGO); Dr. Reddy (4th PGO); Hiren Darji (5th PGO); G. Srinivasa Rao (6th PGO); Dr. Charanjit Kumar Sehgal (7th PGO); Dr. Ketakee S. Durvee (8th PGO); Mrs. Hemavathi R (9th PGO) and Dr. Kanchan Kohli (10th PGO).
After multiple Hearings (comprising both, Pre-grant opposition hearing(s) under section 25(1); Rule 55 and followed by hearing under section 14), the Controller of Patents directed Novartis to amend their Application. However, such amendments arose out of the hearing process under section 14. Novartis complied, leading the Patent being granted on December 14, 2022. Natco Pharma Limited later filed a writ petition in Delhi High Court and challenged the grant decision, arguing that the amendments were made without giving them a chance to be heard. A single judge bench accepted Natco’s argument and revoked the granted patent.
Aggrieved by the revocation decision, Novartis filed an appeal in the Hon’ble High Court of Delhi.
CONTENTIONS OF NOVARTIS AG (APPELLANT)
The appellant’s counsel, challenged the single Judge’s decision, arguing that the Pre-grant Opposition (PGO) process was abused by the Respondents to delay the patent application by over 16 years by filing serial oppositions and the delay is evident since it consumed most of the 20 year patent term. This delay violated the principles of Section 43 of the act, which aims for the expeditious granting of patents. The Learned Counsel also argued that the Ld. single judge misinterpreted the relationship between sections 12 to 15 (which deal with the Examination process) and section 25(1) with Rule 55 (dealing the Pre- Grant Opposition procedure). Appellant’s Counsel further argued that the Hon’ble court failed to recognize the statutory distinction between the examination and opposition processes. According to Learned Counsel, supporting such a process would clearly violate the legislative intent underlying Sections 43 and 53 of the Act.
NATCO’s SUBMISSIONS (RESPONDENT)
The counsel representing the respondent, Natco, argued that once a Pre-grant Opposition is filed, the process becomes adversarial, requiring the Opponent’s involvement at every stage. He also emphasized that the Opponent(s) have a right to participate in all proceedings, especially because they cannot appeal under section 117A. He also emphasized that the Rule 55 mandates the Controller to consider the Opponent’s representation, ensuring their right to participate until the Patent is granted. Respondent’s counsel further argued that Natco was prejudiced based on the fact that, during 05 September 2022 pre-grant hearing [under Rule 55], eight claims were discussed, including claims 4 and 5. However, Claim 4 was later deleted after 14 December 2022 hearing [under section 14], but no corresponding limitation was added to claim 1, which still included the crystalline form. Natco contended that these amendments failed to address the Controller’s objection under 3(d) of the Act and that Natco was denied the opportunity to address this issue before the Controller. Based on these points Natco urged the Hon’ble Court to dismiss the Appeal by Novartis.
STAND OF INDIAN PHARMACEUTICAL ALLIANCE (INTERVENER)
The Counsel from Indian Pharmaceutical Alliance, who participated as an intervener, emphasized that Rule 55, particularly sub-rules (3), (4) & (5), clearly reflect the legislative intent to keep the Opponent informed about all developments with respect to the concerned Patent Application starting from the time a Pre-grant Opposition is filed until it is resolved. He further stressed that Rule 55(4) requires copies of all filings to be provided to the Opponent and Rule 55(5) mandates the Controller to make a final decision only after considering the submissions of all the parties concerned. All the parties should be provided the opportunity to be heard.
CONCLUSION
Upon considering the contentions from the Appellant, Respondent & Intervener, the Hon’ble Court concluded that the opponent’s right of being heard pertains specifically to the pre-grant (Section 25(1)) and post-grant (Section 25(2)) representation stage and it does not imply that they can get the privilege to participate in examination or hearing process (Section 12 & 14) despite both the processes run parallel.
The pre-grant opposition proceedings can assist the Controller to evaluate external inputs (by an opponent) to perform a holistic examination of the patent application. Such oppositions are per se neither adversarial nor contentious. On the other hand, the examination and hearing process comprises of an autonomous & independent evaluation of the patent application and it is an obligation of the Controller to execute the same.
It is pertinent to highlight that rejection of a pre-grant opposition does not imply, in any stretch of imagination, an automatic grant of a patent. The rights of opponent stand sufficiently safeguarded and preserved by a post grant opposition. If a patent application stands granted after an applicant fulfills patentability criteria, the opponent have a statutory right of hearing within 12 months of the grant. The hearing is compliant with the principles of natural justice and can be availed by post grant opposition under section 25(2) of the Patents Act.
Arguendo, if an opponent were to be recognized to have a right of participation in the examination or/and hearing process, it would clearly derail such process and inevitably adversely impact the expeditious conclusion wherein ten serial oppositions are filed.
OPERATIVE DIRECTIONS
Accordingly, for aforenoted reasons, the Hon’ble Court allowed the instant Appeal by Novartis. It was emphasized further that the decision does not prevent anyone from raising Objections to the Patent under Section 25(2).The Judgement does not address the merits of the Patent itself, and all parties retain their rights to contest it. The division bench also emphasized clear dichotomy between the Opposition proceedings and Examinations and further highlighted that a Controller is authorized to ask amendments independently in order to satisfy the patentability criteria.
Nilima Chaturvedi, Intern at S.S. Rana & Co. has assisted in the research of this article.
[1] LPA 50/2023