Pre-grant Opposition

1Opposition before the grant or ‘pre-grant opposition’ proceedings attained importance in India due to a variety of reasons. First, the large number of mail-box applications filed between 1999 and 2005 has stirred the curiosity of the pharmaceutical industry which has witnessed a comparatively low number of new molecules being developed during that period. Pre-grant opposition has emerged as the first instance to check the validity of these applications. Secondly, the relatively simple and cost-effective procedure of pre-grant opposition has attracted many to the Patent Office. Thirdly, challenging patents is a business strategy in itself which is bound to be employed in India, given the presence of a strong home-grown generic industry. Fourthly, the unrestricted status of an opponent is likely to attract more persons who have the expertise to question the validity of a patent.

2The TRIPS Agreement provides for administrative revocation procedure which is not inter partes in nature. (See the TRIPS Agreement, art 62.4.) As pre-grant opposition under the Act is a form of administrative revocation, the procedure for opposition before the grant complies with and conforms to the TRIPS Agreement. As the pre-grant opposition proceeding happens in the application stage, it is considered to be a part of the application procedure. Section 25(1) of the Patents Act mentions that any person may give a written representation and request for a hearing, if the person so desires. Pre-grant opposition procedure is devised in such a manner so as to take into account the case presented by opponents who are not a party to the proceedings.

3Section 25(1) of the Patents Act contains an exhaustive list of grounds on which an application can be challenged before the grant. The words ‘but on no other ground’ in the sub-section gives no room for any further ground other than the ones stated therein.

4The scope of challenging the maintainability of the pre-grant opposition is very narrow. An opposition does not become inadmissible purely because the person named as opponent is acting on behalf of a third party. However, such an opposition would become inadmissible if the involvement of the opponent is to be regarded as circumventing the law by abuse of process. In the EPO, an opposition by a third party will be inadmissible in the following cases: (G03, 04/97 Indupack, Genentech/Third-Party Opposition [2000] EPOR 81, p 94 (Enlarged Bd App).)

(1) where the opponent is acting on behalf of the patent proprietor and (2) where the opponent is acting on behalf of a client, in his professional capacity, without possessing the relevant qualification.

5In Dr Snehlata C Gupte v Union of India (2010) the Delhi High Court held that “if this Court were to hold that the date of the grant of patent is only the date on which the factum of such grant is entered in the Register, then there would be no end to filing of pre-grant oppositions as long as on account of some delay on the administrative side the factum of grant of patent is not entered in the Register.” (para 62) It held that “the filing of pre-grant opposition by Dr. Gupte and Dr. Rindani subsequent to 23rd August 2006 was, apart from being not maintainable in law, also an abuse of the process of law”, and that “There has not been any effective denial of the fact that both Petitioners were associated with SDL” (“Span Diagnostics Ltd.”) “in some capacity or the other.” (para 68)

6The procedure with regard to the conduct of pre-grant opposition is contained in s 25(1) of the Patents Act and r 55 of the Patents Rules. A representation of pre-grant opposition needs to be filed in Form 7A with a copy to the applicant. (Patents Rules 2003, r 55(1)). Rule 55 encompasses the full procedure of pre-grant opposition. A representation under Form 7A carries a fee of ₹ 4,000 for individuals, small entities, startups and educational institutions and ₹ 20,000 for other entities. (Patents Rules 2003, The First Schedule, Entry 9.)

7The representation for pre-grant opposition shall be considered by the Controller only when a request for examination of the application has been filed. (Ibid, r 55(2).) A request for examination may be filed either by the applicant or by any other interested person. (Patents Act 1970, s 11B (1). The ‘interested person’ mentioned in the section includes an opponent.) It is to be noted that though pre-grant opposition proceedings can be instituted by ‘any person’, only a ‘person interested’ can file a request for examination under the Act. An application for a patent in which a pre-grant opposition is filed and notice has been issued by the Controller under sub-rule (3) shall be examined under rule 24C. (Patents Rules 2003, r 55(5B).)

Prima facie case of opposition

8The 2024 Amendment has introduced the requirement of a prima facie case which did not exist before allowing the Controller to refuse an opposition summarily. The Controller shall consider the representation and if he is satisfied that no prima facie case is made out in the representation, he shall notify the opponent and pass an order of refusal of opposition within one month, unless the opponent requests for a hearing. (Patents Rules 2003, r 55(3)(a)(i).) In case the opponent requests a hearing, the Controller shall pass an order within one month of the hearing recording his reasons for refusal or prima facie acceptance of the representation. The Controller shall also notify the applicant. (Patents Rules 2003, r 55(3)(a)(ii).) If a prima facie case is made out in the representation, the Controller shall within one month pass an order recording his reasons and notify the applicant. (Patents Rules 2003, r 55(3)(b).) In UPL Ltd v Union of India (2025), the Calcutta High Court held that the amended r 55(3) applies to oppositions filed before the amendment that had not yet been acted on in substance. In Merck Sharp & Dohme BV v Union of India (2026), the Madras High Court held that the Controller must apply his mind and be prima facie satisfied that there is a case of opposition and should not issue notices mechanically.

9The applicant shall file its statement and evidence within two months from the date of notice with a copy to the opponent. (Patents Rules 2003, r 55(4).) After considering the statement and evidence by both the applicant and the opponent, the submissions made by the parties and after hearing them, the Controller may either reject the representation or require the complete specification and documents to be amended before the patent is granted or refuse the grant of a patent on the application. The Controller has to pass a speaking order on the application and the representation of opposition within one month from the completion of proceedings. (Patents Rules 2003, r 55(5).)

10The procedure specified for hearing under sub-rules (2) to (4) of rule 62, pertaining to post-grant opposition, shall apply to pre-grant opposition proceedings as well. (Patents Rules 2003, r 55(5A).)

11The decision of the Controller refusing the application or amending the same can be appealed to the High Court. (Patents Act 1970, ss 15 and 117A(2).) An application for review can also be made to the Controller for the review of his decision within the stipulated time. (See the Patents Act 1970, s 77(1)(f) and the Patents Rules 2003, r 130.)

12The scope of rule 55 before the amendment was discussed in a few cases. In Neon Laboratories v Troikaa Pharma (2010) the Division Bench of the Bombay High Court held that the interpretation of the Madras High Court, that “the expression ‘may’ give the opponent an opportunity to be heard has been replaced by the word ‘shall hear’” (para 36), “cannot be brushed-aside” (para 39), and declined to hold that “in all cases of pre-grant opposition the Court must call upon the aggrieved party to produce proof of prejudice, independent of denial and violation of natural justice” (para 39). It held that the “opportunity contemplated by sub-section (1) must be effective, meaningful and purposeful” (para 41). Of Glochem, that “the enquiry contemplated at the stage of pre-grant opposition is a summary enquiry. Nevertheless, the principles of natural justice will have to be adhered to even during that enquiry” (para 42), it held that “the opportunity provided in Section 25(1) is not an empty formality”, and that “If the original claim/application is amended, as in this case, and the amendments are also opposed, then, a personal hearing to the objector on the amended claims is required to be given if specifically requested. That is the scheme of Section 25(1) and Rule 55 which are to be considered and read together.” (para 43) It held that “alleging that the patent was wrongfully obtained and must, therefore, be revoked, is no opportunity contemplated by Section 25(1). That is an opportunity prior to the grant.” (para 44)