ABSTRACT — In
a significant decision touching the intersection of patent law and biodiversity
legislation, the Delhi High Court set aside the Controller of Patents’ order
refusing an herbal pain-killer patent application on the ground that the
applicant had not yet produced National Biodiversity Authority (NBA) approval
at the time of hearing. The Court held that the proper course was to defer the
final order until the approval was received, not to refuse
outright—particularly where the invention had been found novel on merits. The
judgment clarifies the timing requirements under the Biological Diversity Act,
2002 vis-Ã -vis the Patents Act, 1970, and reinforces the Controller’s duty to
exercise discretion humanely and purposively.
I. Introduction
The grant of a
patent for an invention based on, or derived from, biological material sourced
from India is conditional upon compliance with the Biological Diversity Act,
2002 (‘BD Act’). The Patents Act, 1970 (‘PA’) gives effect to this through
Section 10(4)(ii)(D), which mandates disclosure of the source of biological
material, and through the regulatory requirement that the National Biodiversity
Authority (‘NBA’) approval be obtained before any intellectual property right
is granted. The interplay between these two statutes has generated considerable
uncertainty in prosecution practice—when exactly must NBA approval be placed on
record, and what is the consequence of failure to do so by any particular date?
The Delhi High
Court’s decision in this appeal under Section 117A(2) of the PA directly
addresses these questions. It provides welcome clarity that the controller’s
power is not a binary ‘refuse or grant’ binary but includes a third, more
proportionate option: defer the final order while the applicant obtains the
requisite regulatory clearance.
II. Background Facts
2.1 The Invention
The patent
application in question related to an oral herbal pain-killer composition
targeting peripheral pain. The invention disclosed:
•
Synergistic herbal compositions in
specific, predefined ratios of selected herbal components (with particular
chemical constituents from identified plant parts); and
•
A simplified, reproducible process of
preparation maintaining safety, efficacy, and stability.
2.2 Prosecution History
Following filing,
the Patent Office issued a First Examination Report (‘FER’) raising multiple
objections, notably:
•
Lack of inventive step / obviousness;
•
Non-patentability under Sections 3(d),
3(e) and 3(p) of the PA;
•
Absence of NBA approval as required under Section
10(4)(ii)(D) of the PA.
The applicant
filed a substantive response, amended the claims to address the prior art
objections, and explained the distinguishing features of the invention. The
Controller thereafter issued a hearing notice, but retained only two
objections: (a) NBA approval; and (b) Section 3(p) non-patentability. This
narrowing was significant—it signalled that the Controller had been persuaded
on inventive step, novelty, and the other Section 3 exclusions.
2.3 The Hearing and Impugned Order
At the hearing,
the applicant appeared through an ‘authorised representative’ (as opposed to a
registered patent agent or advocate). Written submissions were also filed.
Critically, the applicant informed the Controller that an e-mail had been sent
on 28.12.2023 to the Controller enclosing the NBA acknowledgement,
demonstrating that the application for approval was pending. Notwithstanding
this, the Controller passed an order dated 22.02.2024 refusing the application
under Section 15 of the PA on three grounds:
•
NBA approval not obtained within 15
days
as allegedly prescribed;
•
Non-patentability under Section 3(p),
since the biological materials were already recognised as herbal medicines and
the composition amounted to a mere ‘new use’ without technical advancement;
•
Unauthorised representation:
the representative at the hearing was not a registered patent agent or advocate
as required under Sections 128 and 132 of the PA.
The NBA approval
was eventually received on 04.07.2024—months after the refusal order.
III. The Appeal: Arguments and Counter-Arguments
3.1 Appellant’s Case
The appellant
challenged the refusal on the following grounds:
•
Section 6(1A) of the BD Act requires the
applicant to register with the NBA before IP rights are ‘granted’—not at the
time of filing or hearing. Consequently, there was no obligation to produce NBA
approval at the hearing stage.
•
The Guidelines issued under the BD Act
confirm the same position: approval must be in place before the patent is
‘granted’, not as a condition precedent to the hearing or the Controller’s
deliberation.
•
Since the outcome of the NBA process is
not within the applicant’s control, the Controller ought to have deferred the
order pending receipt of the approval—particularly after the applicant had
notified the Controller of the pending application.
•
Section 15 of the PA empowers the
Controller to allow amendments rather than refuse outright, and such discretion
should have been exercised.
•
The refusal on grounds of representation
was unjust where the applicant was present through an authorised representative
who had filed written submissions.
3.2 Respondent’s Case
The respondent
(Controller) maintained that:
•
NBA approval ought to have been produced
with the application, at the hearing, or at the very least before the impugned
order was passed.
•
Approval received on 04.07.2024 post-dated
the order and could not rescue the application.
•
The Section 3(p) objection was
independently sustainable on merits.
•
The hearing representation violated
Sections 128 and 132 of the PA and was a procedural defect that infected the
hearing.
IV. The Court’s Analysis and Holding
4.1 On NBA Approval Timing
The Court
decisively rejected the Controller’s interpretation. Anchoring its analysis in Section
6(1A) of the BD Act, the Court held that the obligation is to register with
the NBA before IP rights are granted—not before the hearing or
before the order. The Court found this reading was fortified by two specific
paragraphs of the official Guidelines:
•
Paragraph 19:
The patent shall not be ‘granted’ unless NBA permission has been submitted.
•
Paragraph 22:
No patent shall be ‘granted’ without necessary permission where the invention
uses biological material from India.
Both provisions
operate as conditions precedent to ‘grant’, not conditions precedent to the
hearing or even to the Controller’s deliberation. The Court
observed—pointedly—that no provision of law had been cited by the respondent
prescribing that the application must be rejected if approval is not placed on
record by any earlier point in time.
The Court further
noted an inherently structural reason why flexibility is required: the timing
of NBA approval is not within the applicant’s control. An applicant cannot
‘insist’ on the authority granting approval within any particular timeframe. It
would be fundamentally unjust to penalise an applicant for the administrative
pace of a statutory authority over which the applicant has no dominion.
Given that: (i)
the applicant had informed the Controller that NBA approval was awaited; (ii)
the Controller was satisfied that the invention was novel; and (iii) the only
outstanding matter was regulatory clearance from a third body, the proper
course was plainly to defer the order. The Court held the Controller’s failure
to do so was an error warranting interference.
4.2 On the Scope of Section 15 of the PA
Section 15 of the
PA grants the Controller wide powers to require amendment of the application,
specification, or other documents. The Court emphasised that refusal is a
remedy of last resort under Section 15: the statute provides that the
application ‘shall be refused’ only where the applicant ‘fails to take steps’
for the amendment required. In the present case, the applicant had not failed
to take steps—it had proactively communicated the pendency of the NBA approval.
The discretion to defer, inherent in Section 15, ought to have been exercised.
4.3 Questions Left Open
The Court
deliberately refrained from entering into the merits of two subsidiary issues,
leaving them for the Controller on remand:
•
Section 3(p) non-patentability:
Whether the herbal composition amounts to a patentable invention or merely a
‘new use’ of known materials without technical advancement is left entirely
open. The Court made no observations on the merits of this ground.
•
Representation by authorised agent:
While the applicant undertook that she would be represented by a registered
patent agent and/or advocate at the remanded hearing, the Court did not decide
whether the earlier hearing was vitiated by the unauthorised representation.
4.4 Operative Directions
The Court disposed
of the appeal with the following directions:
•
The respondent shall re-examine the patent
application after granting a fresh opportunity of hearing to the applicant.
•
The NBA approval shall be taken into
account, along with all oral and written arguments previously advanced.
•
No fresh material shall be placed by the
applicant before the respondent except the NBA approval.
•
The Section 3(p) non-patentability
question is expressly left open to be decided by the Controller in accordance
with law.
•
The respondent shall take a decision
within two months of receiving the order.
V. Critical Analysis
5.1 Purposive Construction of Biodiversity-Patent
Interface
The decision
exemplifies purposive statutory construction. The BD Act and the PA pursue
complementary objectives—protection of biological diversity and equitable
benefit-sharing on one hand, incentivisation of innovation on the other. A
literalist reading that treats NBA approval as a condition precedent to any
stage before ‘grant’ would subordinate innovation incentives to administrative
timelines in a way the legislature did not intend. The Court’s reading
harmonises both statutes.
More practically,
it protects applicants from a ‘Catch-22’: they cannot control how quickly the
NBA processes an application, yet on the Controller’s approach they would lose
the entire 20-year patent term for an administrative delay over which they bear
no responsibility.
5.2 The Deferred-Order Doctrine
This judgment
effectively establishes what may be termed a ‘deferred-order doctrine’ in
patent prosecution: where a pending regulatory approval from a third authority
is the sole remaining obstacle to grant, and the applicant has communicated the
pendency to the Controller, the Controller must defer—not refuse. This doctrine
sits comfortably alongside the principle of natural justice and the
Controller’s general duty to act fairly.
Patent
practitioners should now routinely inform the Controller of pending NBA
applications and request deferment in writing. This creates a record and aligns
with the judgment’s rationale.
5.3 Implications for Section 3(p)
The Court’s
silence on Section 3(p) is itself instructive. By leaving the question open,
the Court acknowledges the complexity of applying the exclusion to synergistic
herbal compositions. Section 3(p) bars patents for ‘traditional knowledge’ and
‘aggregation or duplication of known properties of traditionally known
component or components’. The applicant’s argument that specific part-based
selection, defined chemical-constituent ratios, and demonstrated synergistic
pharmacodynamic efficacy constitute technical advancement beyond mere
aggregation is a strong one, but will need to be argued on the merits before
the Controller.
This aspect of the
remand will be watched closely by the ayurvedic and herbal pharmaceuticals
industry, for whom the boundary between traditional knowledge and patentable
innovation is of existential commercial importance.
5.4 Representation: A Cautionary Note
While the Court
did not decide the representation point adversely against the applicant, the
undertaking to appear through a registered patent agent and/or advocate at the
remanded hearing is itself a practical concession that the earlier hearing may
have been irregular. Sections 128 and 132 of the PA are unambiguous: only
registered patent agents and advocates are entitled to represent clients before
the Controller. Applicants and in-house IP teams must ensure strict compliance.
An unauthorised representative attending a hearing—even if armed with
well-prepared written submissions—risks providing a ground for the Controller
to discount or disregard those submissions.
VI. Practical Guidance for Patent Practitioners
Drawing on the
judgment, the following best-practice protocol is recommended for herbal and
biological patent applications involving Indian biological material:
1. File
the NBA application concurrently with, or as early as possible after, the
patent application. Document the filing date and acknowledgement carefully.
2. Upon
receipt of the FER, immediately check whether the NBA approval has been
received. If not, inform the Controller of the status in the FER response and
request that the final order be deferred pending receipt of approval.
3. Before
any scheduled hearing, submit a written request to defer the hearing or the
final order if approval is still outstanding. Attach the NBA acknowledgement.
4. Ensure
that all hearings before the Controller are attended only by a registered
patent agent and/or an enrolled advocate. Authorised representatives of the
applicant may accompany but should not lead the hearing.
5. If
a refusal order is nonetheless passed before NBA approval is received, file an
appeal under Section 117A(2) promptly and annex the NBA approval (if meanwhile
received) to the appeal. This judgment provides the legal hook to seek a
remand.
6. On
Section 3(p) strategy: prepare detailed technical evidence establishing (a)
specific part-based selection; (b) defined chemical-constituent ratios; and (c)
demonstrated synergistic pharmacodynamic efficacy, distinguishing the invention
from mere aggregation or new use of known properties.
VII. Conclusion
This judgment is a
meaningful contribution to Indian patent jurisprudence at the interface of
innovation law and biodiversity regulation. Its core holding—that NBA approval
is a condition precedent to ‘grant’, not to the hearing or the order, and that
the Controller must defer rather than refuse where approval is pending—is
grounded in text, purpose, and basic administrative fairness.
The decision also underscores a broader principle: the patent system must be administered with proportionality. Procedural or regulatory pendencies that lie outside the applicant’s control should not be weaponised to deny substantive rights that the inventor has otherwise earned. The Controller’s power under Section 15 is not merely a power to refuse; it is equally a power to accommodate, to defer, and to exercise discretion in a manner that advances rather than frustrates the twin goals of the patent system: rewarding innovation and enriching the public domain.
The Section 3(p) question—arguably the more substantive patent-law issue in the case—remains live. The remanded proceedings will provide an important opportunity to develop the law on the patentability of synergistic herbal compositions, and the outcome will bear watching by the pharmaceutical, traditional medicine, and biotechnology industries alike.
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