Successful Novartis appeal provides critical clarification on India’s pre-grant opposition process

Indian patent regulation supplies a number of methods to problem a patent utility. One technique is pre-grant opposition, which might be filed by any get together after an utility is revealed, however earlier than it proceeds to grant. In Novartis v Natco Pharma (9 January 2024, LPA 50/2023), a Delhi Excessive Courtroom division bench clarified an important distinction between the facilitation and examination of patent functions, particularly when they’re challenged by way of pre-grant oppositions. 

Case background

Natco Pharma and different pre-grant opponents objected to the Indian Patent Workplace (IPO)’s examination and supreme grant of a Novartis patent utility, asserting that pre-grant opponents have the fitting to take part and be heard within the examination course of after the IPO accepts their opposition. Thus, the opponents ought to have been made events to the method of amendments to the claims, which passed off between Novartis and the IPO. They contended that whereas the pre-grant opposition hearings concluded on 3 November 2022, the IPO later directed Novartis to hold out amendments with none discover to the opponents. 

On the first stage of attraction, a Delhi Excessive Courtroom choose agreed with the opponents and held that pre-grant opponents have the fitting to be heard on the subject of amending the appliance, as a result of the examination and pre-grant opposition processes merge as soon as the IPO accepts the opposition. Nevertheless, on Novartis’s attraction to the division bench, the court docket disagreed with the choose and dominated that patent examination and pre-grant opposition proceedings are impartial and separate processes. Which means pre-grant opponents are restricted on the subject of illustration as much as and together with the pre-grant listening to. After that, the examination course of is between the applicant and the IPO.

Courtroom determination

To succeed in this determination, the division bench delved into the Patents Act (present and former editions), the Patent Guidelines, the legislative intent and the dealing with of oppositions by different jurisdictions. After its exhaustive evaluation, the bench highlighted the next factors. 

• The Patents Act and Guidelines envision a separation between the examination and opposition processes. The examination of a patent utility lies completely and independently with the IPO.
• An opponent’s proper to a listening to pertains particularly to the illustration stage and doesn’t entitle it to intervene within the broader examination course of.
• Pre-grant opposition proceedings had been added as an modification to the Patents Act to assist the examination course of. The opinions introduced in such an opposition enabled the IPO to collect insights that support a complete examination of the appliance and an knowledgeable determination – that is supported by prior judgments.
• The opposition course of can’t be the only real determiner of whether or not a patent utility must be granted. The rejection of an opposition doesn’t imply that the patent will probably be granted, or vice versa. Subsequently, the examiner is statutorily certain to independently consider the appliance, helped solely by the factors made within the pre-grant opposition.
• In keeping with the Patent Guidelines, a listening to can solely be triggered as soon as the IPO accepts the opposition. Nevertheless, this listening to can’t lengthen to points that the IPO might have to handle throughout the examination course of, which “serves a wider and [more] important goal”. 
• Amendments to the claims primarily based on a directive from the IPO are distinct from voluntary amendments that the applicant might select to introduce because of the listening to and are, due to this fact, a part of the broader examination course of. 
• Even from a pure justice rules perspective, a pre-grant opposition is neither adversarial nor contentious. The opponent can’t have the fitting to a listening to throughout the examination course of as a result of the Patents Act doesn’t define such a proper.
• The rules of pure justice have to be balanced with the patentee or applicant’s proper to keep away from inordinate delays or derailment by serial objections and hearings.
• The rights of events are already sufficiently safeguarded beneath post-grant opposition and revocation proceedings, the place opponents are given the fitting to a listening to compliant with the rules of pure justice.

Key takeaways

The Novartis determination acknowledges that the pre-grant course of can be utilized (and abused) “in order to delay and derail the legislative goal of expeditious consideration”. Via detailed evaluation, the court docket has made a transparent distinction between the examination and opposition procedures, finalising a course of that ought to support a extra streamlined and environment friendly dealing with of pre-grant oppositions whereas safeguarding the pursuits of either side. This highlights how the judiciary is main the way in which in bringing India’s IP regime consistent with that of different jurisdictions.