TIMING THE FILING OF ADDITIONAL EXPERIMENTAL DATA – A SIGNIFICANT FACTOR

TIMING THE FILING OF ADDITIONAL EXPERIMENTAL DATA – A SIGNIFICANT FACTOR

In the matter of FMC CORPORATION vs THE CONTROLLER OF PATENTS, the Hon’ble Delhi High Court set aside the order of the Controller refusing the application on the ground that, post-hearing, the written submission and comparative data called upon was not filed within the prescribed time period. The court remanded the application back for fresh consideration by the Controller who has since granted a patent on this application. 

Conceding that “patent rights are valuable rights and rejection of the patent application can have serious consequences on the Applicant” this order recognizes the importance of patent rights, which if denied without a reasoned order could be detrimental to Applicant’s interests. Conversely, however the court censored the Applicant for allegedly delaying prosecution of their application purposefully and imposed costs for INR 1,00,000 for the perceived deliberate intent of delaying prosecution. 

We dissect this decision for its precedential impact towards strategic timing of filing comparative data, wherever required, rather early on in the examination proceedings of an Indian Patent Application. 

REASONS FOR REFUSAL OF THE APPLICATION 

Upon completion of the hearing on 23rd March 2022, the written submissions in conformity to Rule 28(7) ought to have been filed on 07 April 2022. The first extension vide a petition u/r 138 was filed on 07 April 2022 extending the deadline to 07 May 2022. However, on 03 May 2022, a second petition u/r 137 was filed seeking exercise of the Controller’s discretion to correct the irregularity in the contemplated delay in submitting the additional data. This led to the Controller rejecting the application on the account of the written submissions not being filed within the stipulated period. 

TIMING OF PRESENTING EXPERIMENTAL DATA  

The Hon’ble Court held as follows, while holding the Applicant responsible for delaying the prosecution proceedings on purpose.  

“..perusal of the FER would show that all the relevant objections were raised by the Patent Office way back in March, 2021 in the FER itself. The data relating to efficacy ought to have been submitted by the Applicant in response to the FER itself. The Applicant, however, chose to amend the claims. Despite the hearing being held almost one year post the issuance of the FER, efficacy data appears to have not been submitted. In the opinion of the Court, there was sufficient time for furnishing of efficacy or synergistic data by the Applicant.” 

The order at paragraph 14 is suggestive of the fact that data relating to efficacy/synergy ought to have been submitted at the time of filing the response itself, when the objection was raised in the First Examination Report. However, it is not uncommon among Applicants to attempt to refute such objections with claim amendments in the first instance. Customarily, it is believed with reasonable certainty that such amendments may nullify the objection and avoid the need to file additional experimental data.  Hence, Applicants may not always file experimental data called upon on the premise of (i) lack of tenability of the objection (ii) claim restrictions rendering said objections moot (iii) attempting rebuttal of the objection in the first instance. 

CLARITY ON THE PURPOSE OF RULE 28(7) 

The order has shed light on the legal premise for Rule 28(7). Placing reliance on Hawar Technologies Limited v. The Assistant Controller of Patents [OA/56/2020/PT/DEL, decision dated 12th October 2020]  it has been considered that “The purpose of Rule 28(7) of the Rules is thus to capture the submissions made during the course of the hearing and to take any steps which the Controller may have directed in terms of filing of forms or amendments, if any. The written submissions and filing of relevant documents under Rule 28(7) of the Rules cannot be used as a tool to reopen the entire debate. It is meant as a sort of primer of the submissions made and discussions agreed upon during the course of hearing. The purpose of Rule 28(7) is to bring the matter to a closure rather than to reopen the consideration of the patent application.” 

In the written submissions filed by the Applicant on 10 May 2022, it is submitted as follows: 

“It humbly submitted that during the official hearing the learned Controller held that claims can be allowed only for those compositions for which surprising synergistic effect can be established. Therefore, the applicant wishes to submit affidavit from technical expert as evidence for the surprising synergistic effect of the claimed compositions.” 

Hence, it could be garnered that the decision to file additional comparative data was made not until after culmination of the hearing, realizing that the prospects of addressing the non-patentability objection with only arguments/amendments were slim.  It is not clear at what stage the decision to file the additional data was made since, the petitions for extensions filed were also mute with regard to the ‘sufficient cause’ for seeking such extensions. However, the deferment in this decision to file the warranted data quite led to the derailment of the present application.  

Intriguingly though, subsequent to the fresh reconsideration of this matter by the Controller, the IPO records reflect no filing of any supplementary synergistic data by the Applicant, yet the application has been finally granted by the Controller!! 

This order clearly encapsulates that the filing of written submissions under Rule 28(7) are aimed towards finality of the prosecution rather than commencing it by introduction of new data and related arguments. Yet, it is equivocal as to the plight of the Applicant where such realization arises retrospectively only upon culmination of the hearing developments.

Author | Divya Shekar, Patent Attorney