Case Title: Arcturus Therapeutics Inc. v. Assistant Controller of Patents and Designs
Citation: C.A.(COMM.IPD-PAT) 40/2023
COURT: High Court of Delhi (Commercial Division, Intellectual Property Division)
Coram/Judges: Hon’ble Mr. Justice Amit Bansal

ABSTRACT
The Delhi High Court in the 2025 court ruling set aside the refusal order issued by the ACP to
the Appellant’s patent application solely for a procedural shortfall in filing additional written
submissions with comparative data and not on the merits of the patent application such as
Inventive Step and Non-Patentability Under Sections 3(d) and 3(h). The Delhi High Court
opined that patent rights are valuable commercial rights, and it would be a denial of the
principles of natural justice to deny patent rights for purely technical defects in the absence of
an adequately reasoned order over and above the subject matter and issues related to the
invention(s). The matter was remitted back to the Controller for re-determination of the
application on the basis of the entire record including the belated filed submissions.
Keywords: Patents Act 1970; Natural Justice; Procedural Deficiency; Substantive Justice;
Inventive Step; Reasoned Order; Section 15; Section 43; Delhi High Court.

INTRODUCTION
The Indian Patent System is thus founded on two fundamental principles: one, to encourage
innovation by granting monopolies on genuine new discoveries, and two, to protect the public
interest by rejecting applications that fail to meet the requirement for patentability. The
administrative procedure of the Indian Patent Office, enshrined in the Indian Patents Act,
1970 and its Rules, binds the applicants to adhere to specific procedures. The present cases
demonstrate how a rigorous adherence on the part of the Indian Patent Office to the
procedural requirements could cause serious injustices to inventors under the “Moral Right of
Natural Justice” as well as the intended spirit of the patent regime as far as substantive review
of the invention is concerned. The judgment passed by the Delhi High Court in the case
Arcturus Therapeutics Inc. v. Assistant Controller of Patents and Designs served as a strong
reminder to the Patent Office and the legal community that while adherence to established

procedures is important, procedures must only serve as an extension of justice and not control
their outcome.

FACTS
Arcturus Therapeutics Inc. has filed an application for a patent in India-application number
201617019205-for an invention titled “Ionizable Cationic Lipid for Delivery of RNA”.
FER and Objections: An FER was issued by the Indian Patent Office on February 15, 2019,
which contained substantive objections; the main objection was for no inventive step under
Section 2(1)(ja) and also Section 3(d) (new use of a known substance) and Section 3(h)
(methods of agriculture/horticulture – the latter objection has less relevance to the main
issues).
1. Prosecution History: The Appellant has filed a response to the FER and also
attended hearings. A second hearing was held on May 2, 2023, where the Assistant
Controller had requested comparative empirical data to overcome the substantive
objections.
2. Procedural Delay: Arcturus filed a request for an extension of time of one month
under Rule 138 to submit its additional submission with data, given that the
generation of the data involves much time and complexity. The request was granted,
and Arcturus was given until June 17, 2023 to file its submission.
3. Refusal Order: The refusal order did not include any analysis or consideration of the
substantive objection to patentability that was raised in the failure to meet the
extended deadline for filing the application.
4. Core of Dispute: The refusal was based entirely on procedural grounds. However, the
Appellant was able to file the closing date for the additional submissions only on 25
July, 2023. By this time, the Assistant Controller had already passed the order
refusing to accept the application on the ground that the applicant had not lodged the
necessary documents by the extended closing date, which was 17 June, 2023.

ISSUES
The first question that came up for consideration before the Delhi High Court was whether
the Assistant Controller had acted rightly in refusing the grant of patent purely on the basis of
the procedural defect such as the non-filing of additional information in due time, but he was
not called upon to give an opinion on the merit of the innovation itself under the Patents Act,

1970. The other question was whether the lapse on the part of the Assistant Controller in not
      rendering a reasoned order to meet the various substantive objections voiced by the appellant
      had infringed the principles of fair play.
      REASONING
      While setting aside the order passed by the Assistant Controller, Judge Bansal relied on
      natural justice principles, the importance of protection of patent rights, and the proper
      application of the statutory duty of the Controller in arriving at his decision.
1971. The Principles of Natural Justice and the Importance of Reasoned Orders
      The Court observed that it is an entrenched principle of administrative law that officials are
      under a duty to provide reasons for administrative decisions. The Assistant Controller’s
      decision to decline to advertise was rendered in a mechanistic fashion, resting as it did on a
      finding that since the supporting documents were filed belatedly, the objections set out in the
      Assistant Controller’s letter were “open,” and were accordingly sufficient to warrant the
      Assistant Controller refusing the application under sections 15 and 43 of the Act.
      The Court held that even if an applicant failed to meet a deadline, the Controller still has to
      issue an opinion with grounds relating to the merits of their application. In so doing, the
      Controller must examine all of the following:

• Any objections raised in the First Examination Report (FER);
• Any responses to the FER by the Applicant;
• All previous written submissions made by the Applicant;
• All oral submissions made in connection with both hearings.
  The Controller had failed to apply the audi alteram partem principle and, thus, had not
  substantively analyzed or considered the application at all.

1970. The Value of Patent Rights vs. Procedural Rigidity
      The Rights of Invention Subject Matter of the above-described invention, “Ionizable Cationic
      Lipid for RNA Delivery”, were judicially noticed to be in a complicated and business-focused
      field of RNA therapeutics.
      The court emphasized that Patent Rights are “valuable” Intellectual Property Rights and to
      refuse such rights would have “serious effects” on the applicant.

In this sense, the court held that to deny a meritorious invention for “merely procedural
deficiency” (for only a few weeks), is inappropriate. The court reiterated that “procedures
should facilitate the furtherance of Justice rather than act to further obstruct Justice”.

3. Consideration of Late Submissions
   Importantly, the court directed the Office of the Assistant Controller to consider the belatedly
   filed written submission made on the date of (25 July 2023) while reviewing the subject
   matter afresh before the Office.
   Rule 138 thus provides for Extensions and restricts the discretion of the Controller to condone
   delays to a period not exceeding 1 month. But the court invoked its extraordinary powers
   under Article 227 of the Constitution, and/or the inherent Appellate powers available under
   the Patents Act for granting a full and sufficient hearing. The Delay with regard to filing was
   sufficiently explained as having been necessitated for carrying out the lengthy empirical
   research required as instructed by the Controller.
   The court, by routing the documents that were submitted belatedly, ensured that any new
   determinations made will be based on the most comprehensive scientific record available. CRITIQUE:
   The judgment, while hailed as a positive statement on behalf of Natural Justice, also deserves
   a critical view regarding its effects upon administrative functionality and in regard to the
   strict letter of the Patent Rules.
   Positive Criticism: Due Process is being upheld
   Checks and Balances: The judgement provides for checks and balances on the Patent Office,
   as the latter sometimes, in its extension of its efficiency and backlog disposal goals, issues
   mechanical and non-substantive orders. The fact that the Delhi High Court has time and again
   intervened in patent appeals also points to the same issue of insufficient quality of rejection
   orders, as in the cases of Blackberry Limited and Ulm University. Direct reference is made by
   the judgement to this systemic failure with respect to the evaluation of innovations.
   Substance Over Form: The judgement rightly favours an evaluation of the substantive
   aspects of a technical invention over strictly adhering to complete and timely compliance
   with deadlines, especially because the need for required (empirical) data brought about the
   requisite inability to adhere to strict deadlines. Thus the judgement preserves the integrity of

the Indian patent system and maintains the recognition and completion of true and accurate
innovation.
Negative Criticism: The Administrator’s Authority under Rule 138
 Devalued Rule 138: The judgment’s requirement of the Controller to take into
consideration the submission made after the expiry of the prescribed timeframe-in
addition to the one-month extension allowed under Rule 138-may provide a necessary
as well as important judicial exercise of authority and discretion in this particular case,
but on the whole, it may tend to devalue/help to lessen the importance of Rule 138.
 Case-Specific Precedent: The Court was eager to indicate that it had premised its
guidance on the “peculiar facts of this case,” involving a request by the Controller for
certain empirical data, an insufficient refusal order, and the severe impact on the
applicant. Yet Patent Office Examiners may now be under increased pressure to
accept materials submitted long after the statutory period, complicating the process of
granting patents.

IMPACT
The Arcturus ruling has stood the test of time and immediately impacted the Indian patent
prosecution process for applicants and staff of the Patent Office.
As It Pertains to the Patent Office – the Controller:
Mandatory Reasoned Orders: The Controller shall give a clear, written reasoning for
rejecting each refused application, stating the particular ground for refusal, including but not
limited to the statutory grounds under 2(1)(ja), 3(d), etc. and the prior art citations given, and
giving a full and logical reasoning of the decision taken. Controllers who prepare mere
standard templates of refusal or mechanical language will have no further consideration from
this office.
Fair Hearing: Whereas a controller may reject an application on the basis of non-compliance
with procedure, there are obviously circumstances under which an application that has not
complied with procedure may be granted because an applicant has given the controller
substantive information either at the time of the original application or within a reasonable
time after the initial filing, sufficient to reconsider the denial. A controller must therefore
consider very seriously the ability and responsibility of securing a fair and impartial
evaluation.

As It Pertains To Patent Applicants And Practitioners:
Appellate Strategy: Applicants can make an Arcturus-based argument for the remand of any
controller order that does not adequately explain its reasoning regarding the substantive
issues. All applicants may, in fact, rely on the case for success on obtaining a remand, citing
to the controller’s lack of adequate engagement with their reply to the FER and supporting
documents.
Weight of Submissions: The case further emphasizes that full documentation should be
submitted during the whole prosecution process, even when the applicant replies to the FER
and any documents presented before or during the hearing.

CONCLUSION:
The decision of the Delhi High Court in Arcturus Therapeutics Inc. v. Assistant Controller of
Patents and Designs has once again restored and emphasized substantive justice over and
above procedural technicalities in so far as intellectual property rights are concerned. In other
words, the High Court held that an order which solely rests its decision on the ground of
lateness of filing additional data for rejection of an application for grant of patent rights is
rejected and runs counter to the basic principles of due process, protection of rights, and the
essential requirement for reasoned analysis being requisite to making decisions in a fair way
as enshrined by the Indian Judicial System. Also, this judgment reminds the Patent Office that
their duty is not limited to merely acting as administrative gatekeepers for applications but
much more fundamentally the responsibility to provide an adequate examination of the
application as to whether it deserves the grant of patent rights in protecting the rights of
inventors to their own intellectual property. The struggle to balance service and fairness will
always continue in these types of situations; however, this case tipped the scale completely to
a full and reasoned inquiry into the validity or otherwise of a patent.

REFERENCES

1. Arcturus Therapeutics Inc. v. Assistant Controller of Patents and Designs,
   C.A.(COMM.IPD-PAT) 40/2023 (High Court of Delhi)
2. Patents Act, 1970 (Particularly Sections 15, 43, 2(1)(ja), 3(d), 3(h))
3. The Patents Rules-particularly Rule 138
4. Constitution of India – Article 227
5. Principles of Natural Justice (Audi alteram partem)
6. Blackberry Limited (Cited for precedent on reasoned orders)
7. Ulm University: Referenced for precedent on reasoned orders