Vib Vzw & Anr. vs The Controller Of Patents And Designs
- Court
- Delhi High Court
$~7
* IN THE HIGH COURT OF DELHI AT NEW DELHI
th
% Date of Decision: 29 April, 2026
+ C.A.(COMM.IPD-PAT) 30/2025
VIB VZW & ANR. .....Appellants
Through: Mr. Sanuj Das and Ms. Aditi
Subramaniam, Advocates.
versus
THE CONTROLLER OF PATENTS AND DESIGNS .....Respondent
Through: Ms. Arunima Dwivedi, CGSC with
Ms. Himanshi Singh and Ms. Monalisha Pradhan,
Advocates.
CORAM:
HON'BLE MS. JUSTICE JYOTI SINGH
JUDGEMENT
JYOTI SINGH, J. (ORAL)
I.A. 17423/2025 (Exemption)
1. Allowed, subject to all just exceptions.
2. Application stands disposed of.
C.A.(COMM.IPD-PAT) 30/2025
3. This appeal is filed by the Appellants under Section 117A of The
Patents Act, 1970 (‘1970 Act’) challenging impugned order dated
28.03.2025, whereby Respondent has refused to grant patent on Indian
Application No. 201917035558 in favour of the Appellants.
4. To the extent necessary, the facts are that present invention relates to
‘MEANS AND METHODS FOR ORAL PROTEIN DELIVERY’.
European Priority Application No. 17158471.1 was filed on 28.02.2017 and
PCT International Application No. PCT/EP2018/054966 (later published as
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WO 2018/158335 A1) was filed on 28.02.2018 with a set of 17 claims.
Indian Patent Application No. 201917035558 was filed as a National Phase
Application out of PCT International Application on 04.09.2019. Request
for Examination was filed by the Appellants on 16.11.2020 and First
Examination Report (‘FER’) was issued on 18.10.2023, wherein Respondent
raised objections of lack of novelty, lack of inventive step and non-
patentability under Section 3(c), (d), (e) and (i) of the 1970 Act to which
response was filed by the Appellants on 16.04.2024 with amended set of 10
claims. After hearing on 12.09.2024, Appellants filed post-hearing written
submissions on 25.09.2024 along with amended set of 9 claims. By
impugned order dated 28.03.2025, the Indian Patent Application was refused
under Sections 2(1)(ja), 10(4)(a) and (c) and 10(5).
5. It is stated in the appeal that the present invention relates to Dried
Formulations Comprising Culture Medium of Recombinant Yeast Host
Secreting IgA Fc-Fused Recombinant Polypeptides and provides clear
solutions for shortcomings of current oral delivery of therapeutic proteins.
The invention concerns field of recombinant protein production in a host
cell, more particularly, field of oral protein delivery. More specifically,
invention provides oral pharmaceutical formulations comprising the culture
medium of the recombinant host secreting a recombinant protein. The
resulting oral pharmaceutical formulations are useful for treatment of gastro-
intestinal and/or buccal disorders. Additionally, the oral pharmaceutical
formulations are useful for prophylactic and vaccine purposes.
6. It is stated that peptides or proteins, including hormones, enzymes,
ligands or inhibitors, including antibodies, regulate various cellular
functions. Therefore, they are useful in the clinic to treat or prevent human
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disorders by modulating physiological or pathological processes. In contrast
to small-molecule drugs, the high selectivity of peptides or proteins to their
targets may reduce side effects and toxicity to host cell. It is expected that
the use of proteins or peptides for therapeutic purposes will continue to
increase in the treatment of cancer, metabolic disorders, gastrointestinal
diseases, buccal diseases, neurodegenerative and infectious diseases.
Currently, protein drugs are largely manufactured using mammalian, plant,
yeast or bacterial cell culture systems. These expressed proteins must be
extracted and purified, which requires expensive and complex processes and
cold storage and transportation. Biologies are generally delivered by
intravenous or subcutaneous injection, which is effective but not desirable
for patients, particularly, for chronic conditions. Injectable forms of protein
drugs often require health care personnel for administration, resulting in
frequent hospital visits and decreased patient compliance. Other routes of
delivery such as transdermal, intranasal, inhalation and oral administration
are under investigation, but oral delivery is generally considered as the most
desired route.
7. It is further stated that despite decades of effort, oral delivery of
peptides, proteins and antibody drugs remains a major pharmaceutical
challenge with only a handful of such proteins in the market. The
gastrointestinal (GI) tract is a hostile environment for polypeptides because
it is evolutionarily optimized to break down nutrients and deactivate
pathogens. While convenient for patients, there exist a number of technical
barriers which make this route of administration challenging for large-
molecule drugs. Certainly, the most important challenge is the enzymatic
and pH-dependent degradation of drugs in the stomach and intestines. In
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addition, there is the low permeability of epithelial cells that line the
gastrointestinal (GI) tract and the intrinsic instability of these compounds.
The highly acidic pH in the stomach results in protonation of proteins and
their unfolding, which exposes more motifs that are recognized by protein-
degrading enzymes. The enzymes in the stomach (pepsin), small intestines
(e.g., chymotrypsin, amino- and carboxypeptidases) and the enzymes
produced by the pancreas and bile, cleave the proteins into smaller
fragments and single units. Because therapeutically active polypeptides
(e.g., prophylactic, therapeutic of vaccine components) are also affected by
these processes, the fraction surviving these degradation processes is
generally low and variable, especially in the presence of food.
8. It is further stated that in addition, polypeptide drugs need to
overcome multiple barriers designed to prevent the entry of dietary and
bacterial antigens in order to reach the systemic compartment. To access the
epithelial cell layer, the polypeptide first needs to diffuse through the mucus
layer covering the intestinal epithelium. This epithelium is another important
barrier as the tight junctions which seal the epithelial cells restrict the para-
cellular transport (i.e., the passage between cells) to small molecules and
ions smaller than 600 Da. In addition, the passage across the cell is mediated
by luminally expressed endocytic receptors (e.g., vitamin B12 receptor,
transferring receptor) and therefore necessitates conjugation to the
respective ligands in order to be exploited in drug delivery. Yet another
access point to the systemic compartment is the phagocytotic M-cells of
Peyer's patches which sample luminal antigens and can take up particular
substrates in the low micrometer range. However, the proportion of M-cells
in the gut epithelium is small and varies greatly between species, which
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complicates predictions of absorption in humans based on animal data.
9. Appellants submit that the invention seeks to overcome the technical
problem that arises because plant production systems though capable of
producing high amounts of recombinant proteins, owing to the lengthy and
expensive regulatory procedures, would not be the best choice for producing
edible vaccines. Lower eukaryotic organisms are more desirable as they are
capable of producing higher amounts of recombinant proteins. It would be
an advantage to use lower eukaryotic hosts such as yeasts for production of
therapeutic proteins which can be orally delivered. It would also be desirable
to be able to use only the culture medium comprising the secreted
polypeptide instead of the recombinant yeast itself. Even more desirable it
would be not to purify the therapeutic polypeptide from the culture medium
and to use the culture medium as such.
10. Appellants claim that the invention provides clear solutions for
shortcomings of the current oral delivery of therapeutic proteins. Invention
involves a dried formulation obtained by drying the culture medium
comprising a plurality of macromolecules larger than 5kDa of recombinant
yeasts which secrete a therapeutic protein in the culture medium and which
can be used for oral delivery of the dried formulation. Significantly, the
formulation is not only protected by proteolysis and degradation in the
gastrointestinal tract but the therapeutic proteins present in the dried
formulation are also surprisingly biologically active. Further, at least one
mechanism of the present invention is that yeast extracellular medium acts
as a protected film around the therapeutic protein which prevents (or slows
down) the proteolysis of the therapeutic protein in the gut. This is different
from the situation wherein therapeutic proteins are expressed in plant seeds
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wherein the dried seed matrix protects the therapeutic protein from
degradation D8 - WO2014033313.
11. As stated, yet another possible mechanism is that the glycosylated
therapeutic protein consists of (high) mannose sugar structures only. These
bulky high-mannose structures might also protect the therapeutic peptide
from proteolytic degradation in the gut. Figure 5 in the ‘Summary’ of
invention depicts the bulky high-mannose glycosylation present on the V2A-
IgAFc fusion produced in Pichia pastoris which recombinant protein is used
in the present examples. Major advantage of the present invention is that
there is no need for a purification of the therapeutic protein, meaning that a
formulation comprising the medium as such or a dried formulation
comprising multiple macromolecules larger than 5kDa present in the culture
medium (including yeast produced own proteins) and the therapeutic protein
present in the culture medium can be used as an oral pharmaceutical
product. As brought forth, the pending claims were as follows:-
“1. A dried formulation obtained by i) subjecting the culture medium
of a recombinant yeast host cell to a membrane separation process
or a depth filtration process followed by ii) drying the culture
medium obtained in step i) wherein the culture medium comprises a
recombinant polypeptide fused to an IgA F c domain secreted into
the culture medium by the recombinant yeast host cell and wherein
the polypeptide is exogenous to the recombinant yeast host cell.
2. The dried formulation as claimed in claim 1, wherein an oral
admissible matrix is added to the separated or filtered medium prior
to the drying.
3. The dried formulation as claimed in claim 1 or 2, wherein the
recombinant polypeptide is an immunoglobulin single variable
domain.
4. The dried formulation as claimed in any one of claims 1 to 3,
wherein said exogenous peptide is a prophylactic or therapeutic
peptide or wherein said exogenous peptide is a vaccine or forms part
of a vaccine.
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5. The dried formulation as claimed in any one of claims 1 to 4,
wherein the drying is carried out by spray-drying or by
lyophilisation.
6. An oral pharmaceutical composition comprising a dried
formulation as claimed in any one of claims 1 to 5 and a
pharmaceutical excipient.
7. A food or feed product comprising a dried formulation as claimed
in any one of claims 1 to 5.
8. The food or feed product as claimed in claim 7 which is a
functional or medicinal food product.
9. The dried formulation as claimed in any one of claims 1 to 5 or a
pharmaceutical composition as claimed in claim 6, wherein the
polypeptide is an IL22 IgA Fc- fusion.”
12. It is stated in the appeal that corresponding foreign applications of the
present application have been granted patent in United States, Japan and
Korea, where far more stringent examination and searches using state-of-art
tools were conducted. However, Respondent has refused the application on
the ground that the claimed invention lacks inventive step owing to cited
prior art documents D1-D8 under Section 2(1)(ja) as also on the ground that
amended claims 1-9 do not meet the requirements of Sections 10(4)(a) and
(c) and 10(5) as the product-by-process claims 1-9 do not sufficiently define
the invention and are not defining the scope of the product fully and
particularly for which protection is sought. It is also held there is lack of
clear characterization in the product and claimed formulation is devoid of
technical features i.e., components of the composition. Respondent has
further held that in the absence of SEQ ID numbers of the recombinant
polypeptide used in the composition, claims seem vague and too broad.
Judgments cited by the Appellants have been distinguished by observing
that the way in which the product-by-process claims were framed in the said
cases is totally different from the instant application.
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13. Learned counsel for the Appellants submits that the impugned order is
non-speaking and unreasoned and devoid of application of mind and is a
verbatim reproduction of the hearing notice such that the objections listed
therein have been cut-copy-pasted in the impugned order, without dealing
with and analyzing Appellants’ submissions. In response to the FER,
Appellants reduced the claims to 10 and addressed each objection on merit,
followed by detailed post-hearing written submissions, however, none of
these submissions have been dealt with and thus, in light of the judgment of
this Court in Boehringer Ingelheim Vetmedica GMBH v. Controller of
Patents, 2024 SCC OnLine Del 8578, on ground of non-consideration of
written submissions, the order deserves to be set aside.
14. Another glaring illegality in the impugned order is that the application
has been refused on the ground that the source and geographical origin of
biological material has not been disclosed under Section 10(4)(ii)(D). This
finding is perverse on the face of the record inasmuch as in reply to FER
dated 16.04.2024, Appellants expressly stated that the origin (source) of the
biological material is ‘van Belgium’ and confirmed that the material was not
sourced from India. In post-hearing written submissions dated 25.09.2024,
the origin was again confirmed. Despite two unequivocal disclosures,
Respondent persisted with the objection and has failed to give any reason
why the disclosure by the Appellants was considered as a non-disclosure or
inadequate disclosure.
15. It is further urged that Respondent has erroneously refused the
application on ground of lack of inventive step owing to cited prior arts D1-
D8, holding that the claimed invention is obvious to the person skilled in the
art due to lack of technical features. Respondent has failed to identify a
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single document as closest prior art and has not detailed or explained the
difference between the alleged closest prior art and the claims of the
invention. [Ref.: Fresenius Kabi Oncology Limited, An Indian Company
of B-310, Som Datt Chambers-1, Bhikaji Cama Place, New Delhi-110066,
India v. Glaxo Group Limited, A Company incorporated in England of
Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex, UB6
ONN, England and Another, 2013 SCC OnLine IPAB 122]. In fact,
Respondent has also failed to identify person skilled in the art, which is the
first-step required to be followed as per the judgment of the Division Bench
of this Court in F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd., 2015
SCC OnLine Del 13619 , wherein a five-step test was laid down which the
Controller is required to follow while determining whether a claimed
invention lacks inventive step or not. This position of law was reiterated in
Tapas Chatterjee v. Assistant Controller of Patents and Designs and
Another, 2025 SCC OnLine Del 6369 by another Division Bench of this
Court.
16. It is urged that Respondent does not explain why a person skilled in
the art would combine D1-D8 to arrive at: (a) membrane filtration of yeast
culture medium, followed by (b) drying the unpurified medium, to yield (c)
an orally deliverable dried formulation with protective matrix effect. Several
cited documents related to purified proteins or plant-seed-based system,
however, they are structurally and functionally distinct from the claimed
formulation. The complete specification demonstrates that Pichia -derived
dried culture medium formulation is superior to plant-derived compositions
in clearing F4+ETEC infection and this constitutes objective evidence of
non-obviousness, which the Respondent completely failed to address and
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wrongly held that the instant application does not provide any technical
advancement in comparison to the cited documents.
17. It is urged that product-by-process claims are recognized and
permissible under Indian patent law being sub-species of product claims,
employed where the product’s distinguishing characteristics arises and
cannot be described adequately without reference to the process of
manufacture. Such a claim is necessarily directed to a novel and inventive
product, which cannot be fully described by its structure and is an amalgam
between product and process patents per se . Respondent’s finding that ‘the
claimed dried formulation is not defined by its composition, rather defined
in terms of obtaining the composition’ is fundamentally flawed and fails to
appreciate this claim format since Appellants are prosecuting a product-by-
process claim as it is not possible to define the formulation in terms of the
composition. Respondent acknowledges novelty and therefore, an adverse
finding of non-patentability solely on the basis that product is not defined by
its composition is illegal.
18. It is argued that Respondent’s findings on lack of clarity,
definitiveness and sufficiency of disclosure are patently illegal. While
rendering a finding that amended claims 1-9 do not meet the requirement of
Sections 10(4)(a) and (c) and 10(5) as the product-by-process claims do not
sufficiently define the invention and scope of the product fully and
particularly for which protection is sought, Respondent has simply copy-
pasted the objection from the hearing notice and has not considered a single
submission of the Appellants on this aspect. Appellants had submitted that
‘Fc domain’ in claim 1 has been particularly identified as ‘IgA Fc domain’;
fungal cell in claim 1 is particularly identified as yeast cell; and claims of
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the present application are sufficiently disclosed in and are technically
supported by the specification and functionality and structural characteristics
of dried formulation are sufficiently clear from the description and claims
and would not pose any difficulty to a skilled person. The observation that
SEQ IDs are absent and in absence of SEQ IDs numbers of the recombinant
polypeptide used in the composition, the claims seem vague and broad, is
misplaced. The inventive feature is not the identity of the specific
polypeptide, but the dried yeast culture medium formulation and its
unexpected protective matrix effect is. On the aspect of lack of clarity and
insufficiency, Respondent has merely pasted the objections from the hearing
notice without a single observation on Appellants’ detailed submissions
explaining: (i) the IgA Fc domain identification; (ii) the yeast host system;
(iii) the working examples and in vivo data; and (iv) how a skilled person
could practice the invention across the claimed scope without undue
experimentation.
19. Ms. Arunima Dwivedi, learned CGSC appearing for the Respondent
defends the impugned order and submits that the order is reasoned and
speaking and the application has been refused after considering the reply of
the Appellants to the FER and the written submissions as also provisions of
1970 Act. Hearing was granted to the Appellants to explain the objections
raised and there are no violations of principles of natural justice. Respondent
has rightly held that the claimed invention as seen from the amended claims
lacks inventive step owing to prior arts D1-D8 and the invention is very
much obvious to the person skilled in the art. D1-D5 disclose a dried
formulation, for example spray-dried or lyophilized, comprising a plurality
of macromolecules used for example as a medicament or as part of a food
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product. D6 discloses a dried lyophilized pharmaceutical composition
comprising IL-6 antibody produced and secreted by yeast (Pichia) as Fc-
fusion, for oral administration. D7 discloses a lyophilized formulation
containing IL22-Fc fusion molecules and therefore, all features of the
claimed invention, inspite of lacking technical features are obvious from
prior arts D1-D8. Respondent found that the Appellants have not provided
any technical advancement over the cited documents but claimed that anti-
ETEC (VHH)-IgA Fc fusions have a superior effect of clearing an
F4+ETEC infection, which is refuted from the teachings of D8. Moreover,
from the prior arts, it is known that Fc-fusion proteins are bioengineered
polypeptides that join the crystallizable fragment domain of antibody with
another biological active protein domain or peptide to generate a molecule
with unique structure-properties and significant therapeutic potential.
20. It is argued that amended claims 1-9 do not meet the requirements of
Sections 10(4)(a) and (c) and 10(5) as these are product-by-process claims
and do not define the scope of the product fully and particularly for which
protection is sought. In the absence of SEQ ID numbers of the recombinant
polypeptide used in the composition, the claims seem vague and too broad.
Hence, it is urged that there is no merit in the appeal and the same be
dismissed.
21. Heard learned counsels for the parties and examined their rival
submissions.
22. Present patent application relates to an invention titled ‘MEANS
AND METHODS FOR ORAL PROTEIN DELIVERY’ and was filed as
national phase application. When FER was issued, objections were raised by
the Patent Office on lack of novelty, lack of inventive step and non-
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patentability under Section 3(c), (d), (e) and (i) of 1970 Act. Appellants filed
response to the FER contesting the objections followed by detailed post-
hearing written submissions. Respondent has refused the application under
Section 15 of 1970 Act holding that substantive requirements of Sections
2(1)(ja) and 10(4)(a) and (c) and 10(5) have not been met. Appellants have
also failed to disclose the source and geographical origin of the biological
material used in the invention and if the biological material was used from
India, then permission from the competent authority i.e., National
Biodiversity Authority, India should have been submitted.
23. Appellants assert that present invention relates to the field of
recombinant protein production in a host cell, more specifically, field of oral
protein delivery and provides oral pharmaceutical formulations comprising
the culture medium of a recombinant host secreting a recombinant protein
and resulting oral formulations are useful for treating GI and/or buccal
disorders as also for prophylactic and vaccine purposes. It is claimed that
prior to the present invention plant-seed-produced antibodies survived the
gastric canal and were biologically active in the intestine. Plant production
systems though capable of producing high amounts of recombinant proteins
would not be the best choice for producing edible vaccines, however, owing
to lengthy and expensive regulatory procedures and lower eukaryotic
organisms are more desirable as they produce higher amounts of
recombinant proteins. Thus, the present invention provides clear solutions
for the shortcomings of current oral delivery of therapeutic proteins.
Inventors have found that a dried formulation obtained by drying the culture
medium comprising plurality of macromolecules larger than 5kDa of
recombinant yeasts which secretes a therapeutic protein in the culture
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medium, can be used for oral delivery of dried formulation. It is also
asserted that major advantage of the present invention is that there is no need
for purification of therapeutic protein, which means that a formulation
comprising the medium as such or a dried formulation comprising multiple
macromolecules larger than 5kDa in the culture medium and the therapeutic
protein present in the culture medium can be used as oral pharmaceutical
products.
24. The first and foremost contention of the Appellants is that the
impugned order is unreasoned and does not take into consideration the
written submissions of the Appellants, wherein response was given to each
of the objections raised in the FER. On perusal of the impugned order, this
Court finds merit in this submission. In Boehringer (supra), Court
remanded the matter to the Controller on the ground that despite detailed
submissions filed by the applicant seeking to distinguish the prior arts from
the subject invention, the impugned order was passed without going into the
explanation/justification offered and in a blanket manner, Controller
concluded that the arguments/submissions were ‘not fully persuasive’ but
even this finding was without any justification. In the instant case,
Appellants have elaborately addressed the objection of lack of inventive step
and distinguished the prior arts D1-D8, however, the submissions have not
even been considered by the Respondent. On this ground alone the
impugned order deserves to be set aside.
25. Appellants have also rightly flagged that Respondent has erroneously
refused the application under Section 10(4)(ii)(D) on the ground that
Appellants have failed to disclose the source and geographical origin of the
biological material used in the invention, overlooking that the origin was
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unequivocally disclosed on two occasions i.e., in reply to the FER dated
16.04.2024 and written submissions dated 25.09.2024 stating therein that the
origin (source) of the biological material is ‘van Belgium’ and the material
was not sourced from India. This, to my mind, is a glaring fallacy in the
order inasmuch as there is a disclosure by the Appellants of the source and
geographical origin of the biological material, both in reply to the FER and
in the written submissions.
26. Learned counsel for the Appellants is also right in arguing that
Respondent has failed to identify the person skilled in the art as also the
closest prior art apart from failing to appreciate the differences between the
cited prior arts D1-D8 and the claims in the invention. In F. Hoffmann
(supra) and Tapas Chatterjee (supra), the Division Benches of this Court
have emphasized on the importance of following five-step test to determine
obviousness/lack of inventive step. The first test is to identify an ordinary
person skilled in the art. Thereafter, the Controller is required to identify the
differences, if any, between the cited matter and the alleged invention and
ascertain whether the differences are ordinary application of law or involve
various different steps requiring multiple, theoretical or practical
applications and then to decide whether those differences, viewed in the
knowledge of alleged invention, constitute steps which would be obvious to
an ordinary person skilled in the art and rule out a hindsight approach. In
Tapas Chatterjee (supra), the Division Bench held that the five steps
elucidated in F. Hoffmann (supra) are to be followed sequentially. None of
these steps have been followed by the Respondent in the instant case and in
fact, even the person skilled in the art has not been identified.
27. The impugned order suffers from yet another illegality. Respondent
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has nowhere explained why a skilled person would combine D1-D8 to arrive
at: (a) membrane filtration of yeast culture medium, followed by (b) drying
the unpurified medium to yield (c) an orally deliverable dried formulation
with protective matrix effect. Respondent does not consider the differences
brought forth in the prior arts and the claimed invention as: (a) prior art D1
discloses a dried oral formulation of a lipase from the high-lipase producing
mutant yeast Yarrowia lipolytica. The difference in D1 and claim 1 is that
D1 does not disclose a recombinant yeast host cell and the lipase is not
exogenous to Yarrowia lipolytica and D1 does not cite or suggest an Fc
fusion; (b) D2 discloses growth hormone fragments produced in yeast cells
but no Fc fusions are disclosed or suggested; (c) D3 discloses single chain
antibodies targeting F4 fimbriae. These are made in plants or yeasts and are
purified and there is no reference to dried formulations of the culture
medium of a recombinant yeast cell and no Fc fusions are disclosed or
suggested. Hence, the claimed dried formulation is inventive over both D2
and D3 prior arts.
28. It is urged that D4 discloses H5 hemagglutinin made in yeast
expression systems. There is no mention/suggestion of Fc fusions. D5
discloses dried RHVD VP60 capsid protein expression in Pichia pastoris,
which is obtained after purification from the culture medium followed by
drying with lyophilization. Thus, there is no drying of the culture medium
comprising the exogenous recombinant protein in itself and there is no
mention of Fc fusion in D5. D6 discloses production of anti-human IL-6
antibodies in yeast. No dried formulations of the extracellular medium are
disclosed or suggested. Perusal of the impugned order shows that
Respondent has not even looked into the differences pointed out between
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prior arts D4-D6 and the claimed invention and the error of not considering
the differences qua D1-D3 has replicated qua D4-D6.
29. Impugned order further reflects that the differences brought forth qua
D7-D8 have also been glossed over. Appellants highlighted before the
Respondent that D7 discloses IL22-Fc fusion proteins expressed in yeast,
which are obtained by classical purification steps and there is no drying
described of the extracellular medium of yeast wherein the fusion proteins
are secreted. In other words, no dried formulation of the extracellular
medium is disclosed or suggested in D7, which is a crucial difference. D8
can also not serve as a prior art since the anti-ETEC VHHs are produced in
plants and not in yeast. Present invention involves the use of yeast host cell,
while D8 uses plant seeds for antibody production. Membrane separation
process or depth filtration, recited in the present claims reduce permeate
compounds from the culture medium, which is not described in D8 and D8
in fact focuses on producing antibodies in plant seeds without such a
filtration process, distinguishing the manner of obtaining the final product.
D8 focuses on whole seeds containing the antibody, rather than a filtered
culture medium, making the claimed product distinct and inventive. All
these differences flagged by the Appellants may have made a considerable
difference to the ultimate decision by the Respondent but are not even
considered. Not according any consideration to the points raised by the
Appellants is not only violation of principles of natural justice but also
defeats the whole exercise of calling for response to FER and permitting
filing of post-hearing written submissions.
30. Appellants are also right that there is yet another glaring illegality in
the impugned order inasmuch as Respondent has overlooked the unexpected
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Signing Date:25.05.2026
23:01:20
technical effect of the invention, where the specification demonstrates that
Pichia-derived dried culture medium formulation is superior to plant-derived
compositions in clearing F4+ETEC infection. This point is sidelined by
merely observing that D8 refutes this finding, which teaches that an
antibody can protect against ETEC infection in a passive immunization set
up, which as the Appellants point out focuses on whole seeds containing the
antibody, rather than a filtered culture medium. The distinctions brought
forth with prior art D8 do not even find mention in the impugned order.
31. Appellants have also endeavored to demonstrate that Respondent has
fundamentally misapprehended the claim format, which was a product-by-
process claim. It is urged that the entire purpose of prosecuting product-by-
process claims is precisely because it is not possible to define the
formulation by compositional features alone and therefore, the finding that
claimed dried formulation is not defined by its composition and rather
defined in terms of obtaining the composition, is erroneous. The observation
in the order that in absence of SEQ ID numbers of the recombinant
polypeptide used in the composition, the claims are vague and broad,
according to the Appellants, is misplaced since the inventive feature is not
the identity of the specific polypeptide but the dried yeast culture medium
formulation and its unexpected protective matrix effect. This Court is unable
to discern from the impugned order if this point even crossed the mind of the
Respondent. In fact, the case laws relied upon by the Appellants have been
cursorily dealt with by one line observation that the way in which the
product-by-process claim was framed in the cited decisions was totally
different from the instant application. Court, therefore, agrees with the
Appellants that the instant application has not been examined in the manner
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By:KAMAL KUMAR
Signing Date:25.05.2026
23:01:20
it ought to have been under the provisions of the 1970 Act and basis the
judicial precedents on the subject and resultantly, an important right of the
Appellants for a fair consideration of the patent application is lost.
32. For all the aforesaid reasons, I am of the view that the matter needs to
be remanded back to the Respondent. Accordingly, this appeal is partially
allowed, quashing the impugned order dated 28.03.2025 and directing the
Respondent to reconsider Indian Patent Application No. 201917035558 after
granting opportunity of hearing to the Appellants and taking into
consideration response to the FER and post-hearing written submissions.
Needless to state that Respondent shall pass a reasoned and speaking order
after dealing with all the issues flagged by the Appellants. Decision will be
taken within four months from today, uninfluenced by the observations in
this order or the impugned order.
33. Appeal is disposed of in the aforesaid terms.
JYOTI SINGH, J
APRIL 29, 2026/VP
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C.A.(COMM.IPD-PAT) 30/2025 Page 19 of 19
Digitally Signed
By:KAMAL KUMAR
Signing Date:25.05.2026
23:01:20