Patents Act | Pre-Grant Opponent Merely Aids In Holistic Examination Of Patent Application, Can't Intervene In 'Examination Process': Delhi HC

The Delhi High Court has held that a pre-grant opponent under the Patents Act, 1970, merely aids the Controller in a holistic examination of the patent application and does not have a right to intervene in the “examination process” of the patent.

A division bench of Justice Yashwant Varma and Justice Dharmesh Sharma observed that, unlike an adversarial process, the opposition to a patent merely contributes to the overall assessment of the patent application and thus, would not sustain a right of hearing being claimed in the examination process. It said:

“It is this which convinces us to hold that the opponent can assert a right of hearing only in respect of the representation and cannot be recognised to have a right to intervene in the examination process,” the court said while underscoring that the patent examination and pre-grant opposition are independent processes."

It added that while an objection to a patent does act in aid of the examination process, it is intended to merely facilitate and assist the Controller in holistically examining the patent application and does not detract from the independent duty and obligation cast upon the Controller to be satisfied that the application merits grant.

“… we are of the firm opinion that the examination and opposition process though statutorily structured to proceed parallelly are independent and separate. It would be wholly incorrect to understand the provisions of the Act and the Rules as contemplative of convergence or merger,” the court said.

Furthermore, the court observed that rejection of an opposition would not, ipso facto, lead to the grant of the patent or compel and bind the Controller to allow the patent application.

“Notwithstanding the rejection of an opposition, the Controller is legally as well as statutorily bound to independently examine the patent application based on the FER as well as on its enquiry on whether the patent is liable to be granted in law,” the court said.

It added that the examination process of a patent serves a wider and more significant objective as it involves an in-depth assessment of the patent application, ensuring it complies with the statutory requirements for approval and also facilitates independent evaluation of the application by the examiner and the Controller.

“Maintaining a clear distinction between the examination and the opposition process is essential to not only fulfil the underlying objectives sought to be achieved but are also fundamental in ensuring that the sanctity and efficacy of each stage is maintained,” the court said.

It also said that the representation for opposition merely constitutes input and material which the Controller, who is not absolved from examining the application and being satisfied that the patent is liable to be granted.

“That function is to be performed and the statutory duty discharged by the Controller irrespective of the merits or otherwise of the objection or even in a case where no objections may have been preferred,” the court said.

The bench made the observations while dealing with an appeal filed by medicines company Novartis AG challenging a single-judge order which ruled in favour of Natco Pharma.

The single judge had decided a petition filed by Natco Pharma, the opponent, in respect of pre-grant opposition proceedings against the patent application of Novartis A.G. The plea challenged an order passed by the Assistant Controller refusing Natco's application seeking cross-examination of Novartis' witnesses.

The single judge had permitted Natco to file affidavits of its experts in rebuttal to the three expert affidavits filed by Novartis. 

Setting aside the single judge's order, the division bench clarified that its decision shall not detract from the right of an interested person to raise or pursue objections to the grant of the patent in terms of Section 25(2) of the Patents Act, under law.

“The present judgment is also not liable to be construed as having ruled upon the merits of the grant of the subject patent. All rights and contentions of parties in that respect are kept open,” the court said.

Counsel for Appellant: Mr. Hemant Singh, Ms. Mamta Rani Jha, Mr. Siddhant Sharma, Mr. Abhay Tandon and Ms. Garima Mehta, Adv

Counsel for Respondents: Mr. J. Sai Deepak, Mr. Guruswamy Nataraj, Mr. Shashikant Yadav and Mr. Rahul Bhujbal, Advs. for R-1; Mr. Harish Vaidyanathan Shankar, CGSC along with Mr. Srish Kumar Mishra, Mr. Sagar Mehlawat, Mr. Alexander Mathai Paikaday, Mr. M. Sriram and Mr. Krishnan V., Advs. for R-2; Mr. Rajiv Nayar, Sr. Adv. with Ms. Bitika Sharma, Ms. Vrinda Pathak, Mr. George Vithayathil and Mr. Manjunathan, Advs. for Intervener- Indian Pharmaceutical Alliance

Title: NOVARTIS AG v. NATCO PHARMA LIMITED & ANR.

Citation: 2024 LiveLaw (Del) 42

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