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Enzalutamide Case: The Regents Of The University Of California V. Union Of India And Others (2019)


The High Court of Delhi on 16.05.19 has set aside the impugned order delivered by the Controller on 08.11.16 in the case of ‘The Regents of the University of California (hereinafter referred as the petitioner) v. Union of India & Others’ (hereinafter referred as the respondent), further remanding the controller to decide the case on merits afresh and let the pending application be disposed of. The single bench had delved deep into length and breadth of section 25(1) of Indian Patent Act, 1970 and Rule 55 of Patent Rules, 2003 and their application upon which the Court held that the order passed by the controller was erroneous as judgement was passed in favour of respondents by ignoring the affidavits submitted by the petitioner.


The petitioner is a research organization based in California, whose invention titled “Diarylhydantoin Compounds” with Indian application number 9668/DELNP/2007 and PCT international application number PCT/US2006/011417 seeks patent protection for the principal claim – the formula of ENZALUTAMIDE is given below.

The impugned order of the Ld. Controller rejected the patent application based on the pre-grant representations filed by respondents – which forms the main contention of the present intention.


The main issues or heart of the case is to decide whether the Ld. Controller violated the principles of natural justice and overlooked the affidavits placed by the petitioner while arriving at the impugned order of rejecting the patent application.


The Petitioner contended that the Bohl document, on the basis of which the Ld. Controller rejected the patent application, was filed at the time of oral hearing and the petitioner has no opportunity to effectively deal with the same thereby the principle of natural justice has been violated.

Single Bench of Delhi High court dismissed the petitioner’s contention of violation of principles of natural justice due to the reason that the petitioner had made the oral submission and the written submission on said document at pre-grant stage though the document was filed at the time of hearing.

Based on sub rule (5) of Rule 55 of the Indian Patents Rules, the learned single Judge observed that the proceedings relating to a pre-grant representation are part of the process of examination and the Ld. Controller should not ignore any document at pre-grant stage. In view of this, Single Bench of Delhi High court dismissed the petitioner’s contention to ignore the Bohl document as the document was not part of pre-grant representation and was filed during the hearing proceedings.

The court held that the petitioner’s contention to submit the evidence in the pre-grant representation by way of affidavit is erroneous and rejected by referring the case, M/s UCB Farchim SA v. M/s Cipla Ltd. &Ors.: (2010) II AD Del. 713. Single Bench of Delhi High court observed that the section 25(1) of the Patents Act merely requires the representation to be in writing and there is no requirement of a pre-grant opposition to be supported by an affidavit.

The judge opined that the plain reading of the impugned order clearly indicates that the conclusions drawn by the Ld. Controller are not directly related to the issues addressed in one of the affidavit. Further, the court observed that even if the affidavits are irrelevant, the Ld. Controller has to indicate the same in the order. As the impugned order is completely silent on the affidavits placed by the petitioner, the court set aside the impugned order of Ld. Controller.

The court had also rejected the plea made by the respondent that the petitioner had notreferred to the affidavits of the experts at the hearing or in the writtensubmissions and, therefore, it was not open for the petitioner to assertthat theaffidavits had been ignored. The High Court stresses on the petitioner’s initial paragraphs of its written submissions which clearly stated as under:-

“As the pre-grant opposition procedure is acontinuation of theprosecution of the application, it issubmitted that our response to the First ExaminationReport, reply statements to the representation made by Fresenius Kabi Oncology Limited, and all thedeclarations of Dr. Sawyers, Dr. Jung and Mr. Schafer (the petitioners) be taken as part and parcel of the present submissionsand the same are not being reproduced herein for thesake of brevity.” (para 57, page 36).


The High Court had finally held that the impugned order is set aside for the reasonthat the Ld. Controller had failed to consider the affidavits of the expertsplaced by the petitioner and the matter is remanded to the Controller to decide the decision afresh.

Author:  Dhakshina Moorthy C, Associate Director and Rajasri Thota, intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at [email protected].

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