In a recent case[1], Novartis AG[2] v. Natco Pharma Ltd.[3], the Division Bench (DB) of the Delhi High Court (DHC) adjudicated on the extent of engagement a pre-grant opponent should be allowed under the Patents Act, 1970, in the course of proceedings initiated by the Controller, requiring the patent applicant to amend or modify the patent application.
Novartis AG had filed a patent application before the Controller of patent. Subsequently, the application was published for inviting pre-grant oppositions. Various oppositions were filed against the application, including one by Natco Pharma Ltd. Hearing on all Pre-Grant Oppositions were concluded on November 3, 2022. The Controller asked Novartis to carry out amendments in the patent application and issued a notice dated November 25, 2022, to the effect. In the hearing, Novartis agreed to revise claim 4 and reword claim 5. Novartis submitted amended claims on December 5, 2022, and consequently the patent came to be granted on December 14, 2022, as IN4145184.
Thereafter, Natco Pharma Limited filed a writ petition against the order of the Controller of Patents, dated December 14, 2022, and argued that the amendments in IN4145184 filed by Novartis were made and allowed without Natco being afforded an opportunity of hearing. The submissions advanced by Natco, in the said writ petition were essentially that a pre-grant opponent would have the right to represent against both voluntary amendments as well as those that may be directed by the Controller. Natco also argued that the consideration of the application, alongside the representations of opposition are not liable to be viewed as operating in separate silos. The opposition and examination proceedings, according to Natco, clearly merge, thus obligating the Controller to place all pre-grant opponents on notice of any amendments that may be directed by it. Natco’s submissions were accepted by the learned Single Judge, leading to the institution of the present appeal.
The DB allowed the appeal and set aside the impugned judgment. The DB held that the Controller, as per Section 13[4], has the jurisdiction to independently require an amendment to be made in the application, the specification or any other document filed, post an independent evaluation of the application by virtue of Section 15[5] of the Act. The DB further held that the rejection of an opposition does not inevitably result in a patent application being granted. The DB was, therefore, of the opinion that, the Controller must be independently satisfied that the application merits acceptance. This independence is vital to uphold the credibility of the patent system, ensuring that decisions are made impartially, based on the merits of the application rather than external and interested influences. The DB, therefore, held that, both the Act as well as the Rules clearly envisage a dichotomy between the examination process and opposition process. The Controller may consider any opposition that has been filed during examination, but it would be incorrect to say that this warrants the opponent being accorded participation in the examination process.
The main findings of the decision are:
- The Controller must statutorily conduct an examination process, irrespective of any opposition being filed.
- The objections/ oppositions aid the Controller in taking a holistic view in consideration of a patent application.
- The objective of the pre grant opposition process is to provide a platform to “any person” to express objections regarding a patent application. The opposition cannot solely determine whether a patent is liable to be granted. The Controller is bound to consider other factors in accordance with the Act, too.
- The examination process serves a wider purpose and involves in depth assessment of the patent application. During examination, a thorough and independent evaluation of the application is carried out by the examiner and the Controller. Thus, the two processes, examination and opposition, are distinct from each other and this difference is necessary for achieving the underlying objectives of each process.
- On a conjoint reading of Rule 55[6](3), (4) and (5), it can be concluded that hearing under Rule 55 is limited to representation alone.
- The sub-Rule 55(3) provides discretionary power to the Controller. Once the Controller is satisfied that the representation filed by an opponent raises questions worthy of consideration, it would proceed to place the applicant on notice, enabling it to file its statement and evidence. Thus, the process of hearing in respect of an opposition begins only when opposition warrants rejection or amendment of the application.
- A mere filing of a representation would not prompt issuance of notice under Rule 55(4).
- Right of hearing that is contemplated in Rule 55(5) is one which is concerned solely with the adjudication and disposal of the representation for opposition. The opponent cannot be said to have a right of hearing in the examination process.
- Voluntary amendment by the Applicant and amendment pursuant to a direction of the Controller are two distinct concepts under the Act. The hearing and adjudicatory process under Section 57[7] (4) are limited to voluntary amendments by the Applicant and do not apply to amendments pursuant to the direction of the Controller.
For further information, please contact:
Swati Sharma, Partner, Cyril Amarchand Mangaldas
swati.sharma@cyrilshroff.com
[1] LPA 50/2023
[2] Novartis
[3] Natco
[4] Search for anticipation by previous publication and by prior claim.
(1) The examiner to whom an application for a patent is referred under section 12 shall make investigation for the purpose of ascertaining whether the invention so far as claimed in any claim of the complete specification—
(a) has been anticipated by publication before the date of filing of the applicant’s complete specification in any specification filed in pursuance of an application for a patent made in India and dated on or after the 1st day of January, 1912;
(b) is claimed in any claim of any other complete specification published on or after the date of filing of the applicant’s complete specification, being a specification filed in pursuance of an application for a patent made in India and dated before or claiming the priority date earlier than that date.
(2) The examiner shall, in addition, make such investigation for the purpose of ascertaining whether the invention, so far as claimed in any claim of the complete specification, has been anticipated by publication in India or elsewhere in any document other than those mentioned in sub-section (1) before the date of filing of the applicant’s complete specification.
(3) Where a complete specification is amended under the provisions of this Act before the grant of patent, the amended specification shall be examined and investigated in like manner as the original specification.
(4) The examination and investigations required under section 12 and this section shall not be deemed in any way to warrant the validity of any patent, and no liability shall be incurred by the Central Government or any officer thereof by reason of, or in connection with, any such examination or investigation or any report or other proceedings consequent thereon.
[5] Power of Controller to refuse or require amended applications, etc., in certain case
Where the Controller is satisfied that the application or any specification or any other document filed in pursuance thereof does not comply with the requirements of this Act or of any rules made thereunder, the Controller may refuse the application or may require the application, specification or the other documents, as the case may be, to be amended to his satisfaction before he proceeds with the application and refuse the application on failure to do so.
[6] Rule 55
Opposition to the patent
(1) Representation for opposition under sub-section (1) of section 25 shall be filed in Form 7(A) at the appropriate office with a copy to the applicant, and shall include a statement and evidence, if any, in support of the representation and a request for hearing, if so desired.
(1A) Notwithstanding anything contained in sub-rule (1), no patent shall be granted before the expiry of a period of six months from the date of publication of the application under section 11 A.
(2) The Controller shall consider such representation only when a request for examination of the application has been filed.
(3) On consideration of the representation if the Controller is of the opinion that application for patent shall be refused or the complete specification requires amendment, he shall give a notice to the applicant to that effect.
(4) On receiving the notice under sub-rule (3), the applicant shall, if he so desires, file his statement and evidence, if any, in support of his application within three months from the date of the notice, with a copy to the opponent.
(5) On consideration of the statement and evidence filed by the applicant, the representation including the statement and evidence filed by the opponent, submissions made by the parties, and after hearing the parties, if so requested, the Controller may either reject the representation or require the complete specification and other documents to be amended to his satisfaction before the patent is granted or refuse to grant a patent on the application, by passing a speaking order to simultaneously decide on the application and the representation ordinarily within one month from the completion of above proceedings.
[7] Section 57
Amendment of application and specification or any document relating thereto before Controller
(1) Subject to the provisions of section 59, the Controller may, upon application made under this section in the prescribed manner by an applicant for a patent or by a patentee, allow the application for the patent or the complete specification or any document relating thereto to be amended subject to such conditions, if any, as the Controller thinks fit:
Provided that the Controller shall not pass any order allowing or refusing an application to amend an application for a patent or a specification or any document relating thereto under this section while any suit before a court for the infringement of the patent or any proceeding before the High Court for the revocation of the patent is pending, whether the suit or proceeding commenced before or after the filing of the application to amend.
(2) Every application for leave to amend an application for a patent or a complete specification or any document relating thereto under this section shall state the nature of the proposed amendment, and shall give full particulars of the reasons for which the application is made.
(3) Any application for leave to amend an application for a patent or a complete specification or a document related thereto under this section made after the grant of patent and the nature of the proposed amendment may be published.
(4)Where an application is published under sub-section (3), any person interested may, within the prescribed period after the publication thereof, give notice to the Controller of opposition thereto; and where such a notice is given within the period aforesaid, the Controller shall notify the person by whom the application under this section is made and shall give to that person and to the opponent an opportunity to be heard before he decides the case.
(5)An amendment under this section of a complete specification may be, or include, an amendment of the priority date of a claim.
(6) The provisions of this section shall be without prejudice to the right of an applicant for a patent to amend his specification or any other document related thereto to comply with the directions of the Controller issued before the grant of a patent.
