In a Patent pre grant Opposition proceeding, the Opponent must be aware of the final claims of the Patent, which the same is going to meet at the time of hearing

Can an Opponent be kept in dark of the amendment applications filed by the Applicant? Is examination process of the Patent is different from pre grant opposition process. Can an applicant keep on filing the amendment application in reply to objection raised by the controller of Patent , which making aware of these final claims? Or some transparency is required in the pre grant opposition proceeding.

One of such issue crop up in writ Petition W.P.(C)-IPD 91/2021 titled as Natco Pharma Vs Union of India before the Hon'ble High Court of Delhi. This Writ Petition was filed against the order of controller of Patent, where by application filed by the Petitioner to seek cross examination of the expert of Respondent No.2 was not allowed.

The Petitioner namely NATCO was the Opponent while Respondent No.2 namely NOVARTIS was the applicant for Patent.

NOVARTIS filed PCT application being PCT/US2006/043710 on 8th November, 2006 which had 85 claims.

Subsequently Indian application bearing no. 4412/DELNP/2007 titled "PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INIBITOR" was filed on 8th June, 2007 with the Indian Patent Office.

During the pendency of pre grant opposition's filed by inter alia the Petitioner herein, the Respondent No.2 kept on filing applications seeking amendment of the claims.

The Petitioner filed pre grant Oppositions against the impugned Patent of the Respondent No.2, which was at that time, containing 17 claims.

In the meanwhile Suit No. CS(COMM) 62/2019 was filed by NOVARTIS against NATCO. The Opponent namely NATCO filed application before the controller of Patent to file pleadings of said suit.

Subsequent there to the Applicant namely NOVARTIS filed amended sets of claims along with expert affidavit. This was the expert , which was sought to be cross examined by the Petitioner/Opponent namely NATCO.

The Opponent argued that the Patent Office ought to have first given a ruling as to whether the amendments filed by the Applicant were allowed and if allowed, which is the final set of claims being considered for grant. Though it was sought to be rebutted by the Applicant that the final set of amended claims which are on record are all claims which are included in Claim Set 3 consisting of claim 1 to 17 which has been supplied to the Opponent.

Thus it was contended by the applicant that the Opponent has had the opportunity to oppose all the claims as they currently stand with the final amendment.

The Hon'ble High Court of Delhi was pleased to dispose of the said Writ Petition bearing W.P.(C)-IPD 91/2021 titled as Natco Pharma Vs Union of India vide its Judgement dated 12.07.2022.

The Hon'ble Court relied upon the Judgement namely UCB Farchim SA v. M/s Cipla Ltd. [W.P.(C) No. 332/2010 order dated 08th February, 2010] to the effect that a pre-grant opposition proceeding is in aid of the examination of the patent application. In the said Judgement , distinction
between pre grant opposition and post grant opposition was made out. The
relevant portion of the said Judgement is reproduced as under:

Distinction between pre-grant and post-grant opposition
13. In the first instance a distinction has to be drawn between a pre-grant opposition and a post-grant opposition. While a pre-grant opposition can be filed under Section 25 (1) of the Patents Act at any time after the publication of the patent application but before the grant of a patent, a post-grant opposition under Section 25(2) of the Patents Act has to
be filed before the expiry of one year from the date of the publication of the grant of patent.

A second significant difference, after the amendment of 2005, is that a pre- grant opposition can be filed by 'any person' whereas a post-grant opposition under Section 25(2) can be filed only by 'any person interested'. It may be noticed that the application for revocation of a patent in terms of Section 64 of the Patents Act can also to be filed only by 'any person interested'. In other words, the post-grant opposition and the application for revocation cannot be filed by just about any person who is not shown to be a person who is 'interested'.

A third significant difference is that the representation at the stage of pre-grant is considered by the Controller himself. Rule 55 of the Patents Rules requires the Controller to consider the 'statement and evidence filed by the applicant' and thereafter either refuse to grant the patent or require the complete specification to be amended to his satisfaction.

Of course, in that event notice will be given to the applicant for grant of patent who can file his reply and evidence. This Court finds merit in the contention that the pre-grant opposition is in fact 'in aid of the examination' of the patent application by the Controller.

The procedure is however different aspect as far as the post-grant opposition is concerned. There in terms of Section 25 (3), the Controller has to constitute an Opposition Board consisting of such officers as he may determine and refer to such Opposition Board the notice of opposition along with other documents for its examination and recommendations.

After receiving the recommendations of the Opposition Board, the Controller gives the patentee and the opponent an opportunity of being heard. The Controller then takes a decision to maintain, amend or revoke the patent.

The fourth major difference between the pre-grant and the post-grant opposition is that while in terms of Section 117 A an appeal to the IPAB is maintainable against the order of the Controller in a post-grant opposition under Section 25(4) of the Patents Act, an appeal has not been expressly been made available against an order made under Section 25(1) of the Patents Act."

Though the pre grant opposition is considered to be in aid of examination process, still there has to be clarity in this process. In order to incorporate transparency and clarity in the pre grant opposition proceeding , pertaining to the patent. while adjudicating the subject matter Writ Petition, the Hon'ble High Court of Delhi observed as under:

The proceeding in a pre-grant opposition and simultaneous examination of a patent application, however, cannot also result in a situation where the pre grant opponent is kept in dark about the developments taking place in the examination process.

For example, when amendments are filed by the Applicant, an immediate decision ought to be taken on allowing or disallowing the amendment so that there is transparency and clarity as to what are the claims being considered by the Controller.

A short and brief order should be passed in respect of the amendments which should be uploaded on the website of the Patent Office so that everyone concerned would know the decision on the amendment.

In any event, if an amendment is being carried out during the pendency of a pre-grant opposition.

This Judgement will off course pave way for bringing out the transparency in adjudication of examination of patent process as well as pre grant Opposition proceeding. The Opponent can not be put in dark. This order ensures that while hearing the Pre grant Opposition proceeding, the Opponent must be aware of as to what is the final claims, the same is going to meet at the time of hearing. Other wise whole process of pre grant opposition proceeding will become otiose.

Case Law Discussed:
Date Of Judgement: 12.07.2022
Case: W.P.(C)-Ipd 91/2021
Name Of Hon'ble Court: High Court Of Delhi
Name Of Hon'ble Judge: The Honourable Justices Prathiba M Singh
Case Title: Natco Pharma v/s Union Of India

Written By: Ajay Amitabh Suman, IPR Advocate, Hon'ble High Court of Delhi
Email: [email protected], Ph no: 9990389539