Novartis Ag Vs Natco Pharma Limited and another

The Locus of Pre-Grant Patent Opponent in Patent Examination Process

Introduction:

The realm of patent law is characterized by a delicate balance between fostering innovation and ensuring that patents are granted on meritorious grounds. Central to this balance is the mechanism of pre-grant opposition, designed to facilitate a rigorous examination of patent applications. This article delves into the nuanced legal principles governing pre-grant opposition, emphasizing its facilitation role in the examination process and delineating its limitations.

The Division Bench, High Court of Delhi , Comprising of Hon'ble Judges namely Shri Yashwant Varma and Shri Dharmesh Sharma was having an occasion to answer this issue while passing the Judgement dated 09.01.2024 in Appeal bearing LPA No. 50 of 2023 titled as Novartis Ag Vs Natco Pharma Limited and another, delved into the critical examination of the order dated 14.12.2022 passed by controller of Patent , which allowed certain amendments and ultimately resulted in grant of Indian Patent. IN414518. This grant of Patent to Novartis subsequently led to litigation. The Hon'ble Division Bench, High Court of Delhi rejected the argument of the pre grant Opponent that the same had any right to be heard in Patent Examination process. Thereby  affirmed the order of controller , granting the subject matter Patent.

Background:

Novartis AG was the Applicant of the subject matter patent IN‘518, originated from PCT application no. PCT/US2006/043710 dated 08.11.2006, which was filed as Indian national phase application bearing no. 4412/DELNP/2007 on 08.06.2007 before the Controller of Patents. Natco and few other entities were pre grant opponent. The subject matter order dated 14.12.2022 passed by the controller which resulted in filing of the subject matter writ and subsequent thereto the present Letters Patent Appeal , whereby certain amendments in Indian Patent Application No. IN4145 were allowed without granting any opportunity to pre grant opponent , to be heard. 

The crux of the controversy lies in the alleged violation of the principles of natural justice. The opponent contended that the order permitting amendments to the patent application was issued without granting them a fair hearing. Specifically, all five pre-grant opposition hearings had concluded on 03 November 2022. Despite this, the Controller of Patents directed the applicant to carry out amendments, which were eventually allowed on 14.12.2022.

The Core Legal Question:

The pivotal issue at hand is whether an opponent possesses the right to participate in the patent examination process, especially when amendments are under consideration. Stated differently, does the opponent have a stake in the examination process, mandating their participation when modifications to the patent application are being evaluated? 

Judicial Interpretation:

The Hon'ble Division Bench's ruling provided a nuanced interpretation of the relevant legal provisions. According to Rule 55(5), the right of hearing is primarily associated with the adjudication and disposal of the representation for opposition. The court opined that conferring an opportunity for a hearing at the representation stage does not automatically translate to an inherent right for the opponent to participate in Patent examination process.

Furthermore, the court elucidated that while pre-grant opposition undoubtedly aids the Controller in decision-making, it does not ipso facto grant opponents an inherent right to participation or an audience during the Patent examination process. This interpretation upholds the procedural autonomy of the Controller in conducting examinations while balancing the interests of both applicants and opponents.

 Implications:

it is imperative to understand that the representation for opposition is not inherently adversarial or contentious. Instead, its primary objective is to aid and facilitate the examination of the patent application. This facilitative role underscores the constructive intent behind pre-grant opposition, which aims to ensure that patents are granted based on valid and meritorious grounds.

 The scope and limitations of pre-grant opposition are circumscribed by Section 25(1) of the relevant statute. This provision specifies the grounds on which opposition can be raised, thereby confining the opposition's ambit to statutory parameters. Consequently, any challenge raised by an opponent must align with the grounds delineated in Section 25(1), ensuring that the opposition remains tethered to statutory constraints.

The Division Bench's interpretation provides clarity on the locus of a pre-grant patent opponent within the patent examination framework. By distinguishing between the stages where opponents have a right to be heard, such as during pre-grant opposition, and stages where their participation is not mandated, the court ensures a balanced and efficient patent examination process.

The Concluding Note:

Pre-grant opposition serves a pivotal yet circumscribed role in the patent examination landscape. Its facilitative nature aims to aid the Controller in conducting a holistic examination of patent applications, ensuring adherence to statutory criteria and principles of natural justice. However, this role is not without limitations, as evidenced by the Court's observations emphasizing the pre grant opponent's restricted right to intervene in the process of grant of Patent only by way of pre grant opposition , however the same has no right to be heard in examination process of the Patent, which is solely the domain between Controller of Patent and the Applicant for Patent. 

The Case Law Discussed:

Case Title: Novartis Ag Vs Natco Pharma Limited and another 

Date of Judgement/Order:09.01.2024

Case No. LPA 50/2023 

Neutral Citation: 2023:DHC:84:DB

Name of Hon'ble Court: Delhi  High Court

Name of Hon'ble Judge: Yashwant Varma+Dharmesh Sharma, H.J. 

Disclaimer:

Ideas, thoughts, views, information, discussions and interpretation expressed herein are being shared in the public Interest. Readers' discretion is advised as these are subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the fact and issue involved herein.

Written By: Advocate Ajay Amitabh Suman,

IP Adjutor - Patent and Trademark Attorney,

Email: ajayamitabhsuman@gmail.com,

Ph No: 9990389539