[Cites 8, Cited by 0]
Calcutta High Court
Viacyte Inc vs Deputy Controller Of Patents And ... on 16 January, 2026
Author: Ravi Krishan Kapur
Bench: Ravi Krishan Kapur
IN THE HIGH COURT AT CALCUTTA
ORIGINAL SIDE
Ordinary Original Civil Jurisdiction
BEFORE:
The Hon'ble JUSTICE RAVI KRISHAN KAPUR
IPDPTA/7/2025
VIACYTE INC
Vs
DEPUTY CONTROLLER OF PATENTS AND DESIGNS
For the appellant : Ms. Swati Mittal, Adv.
Ms. Shika Singh, Adv.
Mr. Abhirup Chakraborty, Adv.
For the Controller : Mr. Rashmi Bothra, Adv.
Mr. Priyanka Sarada, Adv.
Heard on : 24.12.2025
Judgment on : 16.01.2026
Ravi Krishan Kapur, J.:
1. This appeal is directed against an order dated 7 May 2024 passed by the
respondent no.1 refusing grant of an invention described as a bioreactor.
2. Briefly, the subject application relates to a bioreactor comprising of
primate pluripotent stem cell-derived cell aggregates in suspension in a
physiologically acceptable culture medium, wherein the primate
pluripotent stem cell-derived cell aggregates are substantially uniform in
size and shape and have a diameter of 50 microns to 600 microns, and
the primate pluripotent stem cell-derived cell aggregates are formed in
the bioreactor by rotational culture; wherein the said bioreactor is a
stirred tank bioreactor, a spinner flask bioreactor, a tissue culture dish,
rotating bottle or a vessel on an orbital shaker. Such a bioreactor is
specific and cannot be construed as encompassing any other bioreactor.
The bioreactor has a distinct component which essentially includes cells
which are also part of the bioreactor. It is suggested that the claimed
bioreactor provides an efficient system which overcomes the drawbacks
of any prior arts i.e., it provides a large-scale manufacturing ("scale-up")
for eukaryotic mammalian cells, and more particular, mammalian
pluripotent cells such as human embryonic stem (hES) cells.
3. By the impugned order, the application for patent has been rejected on
the ground that the same lacked inventive steps under section 2(1)(j) and
2(1)(ja) of the Act. The invention also fails to make disclosures under
section 10 of the Act and was found to be non-patentable under section
3 of the Act.
4. On behalf of the appellant it is contended that, the impugned order is
based on an incorrect understanding of the invention and the applicable
law. The subject invention does not lack novelty nor inventiveness. The
subject invention does not also fall within the ambit of section 3(d) or
section 3(j) of the Act and was not liable to be rejected. The specifications
provided by the appellant also adhered to all the requirements under
section 10(4)(a) and 10(5) of the Act and did not warrant any rejection. In
such circumstances, the impugned order is liable to be set aside and the
matter remanded to the Controller for hearing afresh.
5. On behalf of the respondent authorities, it is submitted that the
impugned order does not warrant any interference. The order is
adequately reasoned. The Controller has dealt with all the submissions
made on behalf of the parties. The order is justified and is based on
sound technical and scientific reasoning and was passed after
compliance with the mandatory requirements of invention under the Act.
The appellant has failed to disclose any infirmity or procedural
irregularity or error in legal interpretation which warrants any
interference with the order.
6. One of the principal objects of the Patents Act, 1970 is to promote
technological innovation in public interest while ensuring that patents
are not granted for subject matters excluded from patentability or which
do not comply with the requirements of novelty, inventive step or
sufficient disclosure.
7. Section 3(j) of the Act is as follows :
"3. what are not inventions - The following are not inventions
within the meaning of this Act- (j) plants and animals in whole or
any part thereof other than microorganisms but including seeds
varieties and species and essentially biological processes for
production or propagation of plants and animals,".
8. On a plain reading of the above provision, it is essential to identify the
true focus and substance of the invention. In the present case, the
Controller has identified that the claims are directed substantially towards
primate pluripotent stem-cell derived aggregates, including human
embryonic stem cell derived aggregates and that the bioreactor functions
merely as a container for maintaining such biological material in
suspension. These aggregates are unequivocally parts of animals, and the
invention though drafted in the form of a device or system, in effect seeks
protection over animal or human biological material which cannot be
patented.
9. By the impugned order, the Controller has concluded that the invention is
a mere use of a known apparatus - a bioreactor including stirred tanks
bioreactors, spinner flasks and rotating vessels are commonplace systems
extensively employed in the domain of culturing mammalian cells and
embryonic stem cells. The alleged novelty resides only in the parameters
such as rotational speed, aggregate size and biological markers of the
cells, which merely reflects optimization of known operating conditions.
The bioreactor functions solely as a vessel and no new technical feature,
reactant or product distinct from the prior art has been disclosed. The
appellant seeks protection over an end result achieved through the use of
known equipment under routine variations of process conditions, which is
barred under section 3(d) of the Act. A bioreactor, even if tailored for
biological applications, is universally recognized as a mechanical
apparatus, engineered to enable to precise control of environmental
variables such as temperature, pH, agitation, oxygenation, and nutrient
delivery. The present claims disclose no novel nor mechanical
configuration nor distinctive material composition nor any structural
adaptation which would distinguish the claimed bioreactor from known
designs.
10. Section 2(1) (j) of the Patents Act, 1970 defines "invention" as a new
product or process involving an inventive step and capable of industrial
application. The Controller has found that the appellant's invention is
wholly based on the desired outcome and process parameters and lacks
constructional features. The process parameters which the appellant has
specified for aggregate size (50-600 microns) and agitation speed (60-140
rpm) are not novel and any person skilled in the art could routinely
optimize to balance factors like stress and oxygen pressure. There exists
no structural advancement nor novel apparatus configuration which
distinguishes the claimed bio-reactor from existing or known systems. The
reliance on the prior art documents (D1-D6) in the impugned order has
been elaborately dealt with. D1 discloses the cultivation of human
embryoid bodies using bioreactors operated at rotational speeds between
13 rpm and 30 rpm to control aggregate size. D2 to D4 further describe
shear-controlled stirred suspension cultures of mouse embryonic stem
cells at higher agitation speeds, such as 100 rpm, establishing the
viability of manipulating shear forces to regulate cell aggregation. D5
details the formation of floating human embryonic stem cell aggregates in
suspension cultures supplemented with ROCK inhibitors, while D6
discloses undifferentiated hESC aggregates maintained in suspension
bioreactor systems. In summary, all these prior arts establish that the use
of known bioreactor formats for suspension-based cultivation of
pluripotent stem cells with defined rotational parameters and size control.
This is a routine and well-documented practice. The reliance by the
appellant on differences in cell types, specific size ranges, or rotational
speeds fails to raise the threshold requirement of inventive contribution,
particularly in the absence of any novel bioreactor structure or
operational mechanism. The claimed invention does not identify any
unique internal geometry, agitation system, gas exchange configuration,
or other technical feature distinguishing it from the prior arts.
11. Section 2(1)(ja) of the Patents Act, 1970 states that "inventive step means
feature of an invention that involves technical advancement as compared
to the existing knowledge or having economic significance or both and
which makes the invention not obvious to a person skilled in the art". In
the present case, it has been held by the Controller that the claimed
process involves rotational speed, aggregate size range, suspension
culture-are all adjustable within known margins and do not, singly or in
combination, yield a non-obvious technical effect. As such, the claims
represent no more than an application of routine experimentation within
the knowledge of the person skilled in the art and fails to disclose any
technical advancement or economic significance contemplated under
section 2(1)(ja) of the Act. The impugned order has appreciated the
disclosures in D1-D6 and correctly applied the test of inventive steps. It
has been found that the alleged technical problem which the appellant
claims to solve is large scale production of undifferentiated hESCs, and
this has already been addressed in multiple prior art disclosures relied on
in the impugned order.
12. Section 10(4) of the Patents, Act 1970 mandates that a complete patent
specification must fully describe the invention, its operation alongwith the
best method of performing it and ends with claims defining the scope,
ensuring that a person skilled in the art can understand and reproduce it
forming the core of the patent bargain for exclusive rights in exchange for
public disclosure. The application filed by the appellant does not
sufficiently describe the invention claimed and has been found to be
vague and incomplete which is in contravention of section 10(4) of the Act.
The amended claim 1 suffers from a fundamental defect in its claim
construction in that it remains a mixed-category claim improperly
combining elements of a product (bioreactor) with process-dependent
features such as the formation of uniform cell aggregates under specific
rotational conditions. It has been held in the impugned order that the
conflation of product and process without a clear technical specification of
the structural features of the claimed device violates the definiteness
requirement under sections 10(4)(a) to (c) and 10(5) of the Act. It has also
been held that the so-called "novel and inventive" element which
purportedly suggests rate optimization is merely a process variable, not a
structural or inventive feature of the bioreactor itself, and such
parameters are routinely adjusted by skilled artisans depending on
variables such as cell type and scale.
13. Section 10(5) mandates that all claims shall be clear, succinct and fairly
based on the matter disclosed and relates to a single invention or a group
of inventions linked as to form a single inventive concept. On the contrary,
the specification and claims have been found to be vague, ambiguous and
did not sufficiently define the invention since it did not disclose structural
features which would be necessary to achieve the claimed outcome.
14. In view of the above, the impugned order is well reasoned and is based on
sound technical and scientific evidence and data. The appellant has failed
to disclose any infirmity or procedural irregularity or error in legal
interpretation which warrants any interference with the order. In passing
the impugned order the Controller has examined the claims, the cited
prior arts and has applied the statutory tests for patentability with
adequate reasons. In such circumstances, there are no grounds which
justify any interference with the impugned order. IPDPTA 7 of 2025
stands dismissed.
(Ravi Krishan Kapur, J.)
