Calcutta High Court
Oramed Ltd. (Oa/14/2020/Pt/Kol) vs The Controller General Of Patents And … on 4 July, 2025
Author: Ravi Krishan Kapur
Bench: Ravi Krishan Kapur
IN THE HIGH COURT AT CALCUTTA
ORIGINAL SIDE
(Intellectual Property Rights Division)
BEFORE:
The Hon'ble Justice Ravi Krishan Kapur
IPDPTA/8/2022
ORAMED LTD. (OA/14/2020/PT/KOL)
VERSUS
THE CONTROLLER GENERAL OF PATENTS AND DESIGNS & ANR.
For the appellant : Mr. Subhatosh Majumdar, Advocate
Mr. K. K. Pandey, Advocate
Ms.Mitul Dasgupta, Advocate
Ms. Pooja Sett, Advocate
Mr. Teeshan Das, Advocate
Ms. Mallika Bothra, Advocate
For the Controller : Mr. Indrajeet Dasgupta, Advocate
Ms. Priti Jain, Advocate
Reserved on : 26.06.2025
Judgment on : 04.07.2025
Ravi Krishan Kapur J.
1. This is an appeal under section 117A of the Patents Act, 1970 against an
order dated 5 June, 2020 passed in Patent Application No.
3996/KOLNP/2010.
2. Briefly, the invention is an oral pharmaceutical composition comprising
of a protein (insulin) of molecular weight up to 100,000 Doltons, a first
protease inhibitor and a second protease inhibitor and each of the
protease inhibitors inhibits trypsin (thus preventing protein breakdown).
The composition further optionally comprises of EDTA (Ethylene diamine
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tetracaetaic acid) or a salt thereof (such as Na-EDTA), and an Omega-3
fatty acid.
3. Presently, the only route of insulin administration is injection. It is
contended that daily injection of insulin has side effects such as
lipodystrophy at the site of the injection, lipatrophy, lipohypertrophy and
occasional hypoglycaemia. In addition, subcutaneous administration of
insulin does not typically provide the fine continuous regulation of
metabolism which normally occurs when insulin is secreted from the
pancreas directly into the liver via the portal vein. The invention is aimed
towards addressing the need for an alternate solution for administration
of protein. The technical advancement which the invention seeks to
achieve is due to the use of two the protease inhibitors Aprotinin and
SBTI. The beneficial properties of the composition is in that substantial
amount of insulin administered orally retains its activity after
absorption.
4. For convenience, the relevant dates culminating in the filing of this
appeal are as follows:
DATES EVENTS
March 26, Patent application filed in the United States of America being Patent
2008 Application Number 61/064,779 for grant of patent in respect of "Methods
and Compositions for oral administration of proteins for treatment of
diabetes".
February International Application filed under the Patent Cooperation Treaty (PCT)
26, 2009 serialized as PCT/IL2009/000223
October Patent application being No. 3999/KOLNO/2010 filed at the Patent office
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25, 2010 as national Phase Entry in India from PCT/IL2009/000223 claiming
priority of application filed in USA 61/064,779 dated 26/03/2008
January Application published (Pre grant publication)
7, 2011
March 12, Request for examination filed and allotted the examination request serial
2012 number RQ No. 1104/RQ-KOL 2012
December First examination report (FER) being a substantive examination report
22, 2025 issued by Patent office
November Reply to the First Examination Report filed
14, 2016
December Hearing notice issued
28, 2016
January Matter heard by the Deputy Controller
18, 2017
February Written notes of Arguments submitted
2, 2017
April 18, Order passed by the Deputy Controller of Patents u/s 15 of the patents
2017 Act refusing the application
February The order dated 18.04.2017 received by the appellant's agent under
27, 2019 covering letter of Patent Office dated 25.02.2019
May 22, Writ Petition filed t the Calcutta High Court against the order dated April
2019 18, 2017 of the Deputy Controller of Patents since as the IPAB was not
functioning with appropriate quorum for hearing Patent matters.
May 25, Appeal filed at the IPAB simultaneously as a matter of abundant caution,
2019 which was later withdrawn pursuant to the order of the Hon'ble Calcutta
High Court
June 18, Order passed the Hon'ble Calcutta High Court in Writ Petition No. WP No.
2019 9575(W) of 2019 remanding the matter back to Patents Office for fresh
hearing
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September Hearing notice issued by the Patents Office for fresh hearing on November
25, 2019
November Matter heard afresh by the Deputy Controller of Patents
20, 2019
December Fresh Written notes of arguments submitted at the Patents Office
19, 2019
June 5, Impugned order passed by the Deputy Controller after hearing the matter
2020 afresh
June 5, Order received by the appellant's agent.
2020
5. As mentioned above, the appellant had filed a prior writ petition, being
WP/9575/2019 wherein by an order dated 18 th April, 2017 matter was
remanded to the Patents Office for fresh hearing with certain directions.
6. It is contended on behalf of the appellant that there are glaring
infirmities in the impugned order. In particular, though the hearing
notice referred to a combination of prior arts namely, D1 to D4 in
determining lack of inventive steps, nevertheless, in the impugned order,
the Deputy Controller has only relied on documents D1 and D4. Such a
change of view of the Deputy Controller was without any notice or
opportunity to the appellant. The arbitrary omission of the prior arts D2
and D3 in the impugned order is as fatal inasmuch as the same was
without notice to the appellant.
7. It is also contended that the Deputy Controller has neither referred nor
dealt with the data with reference to the figures and specifications which
has been furnished by the appellant in their submissions. Such scientific
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and technical data supported the technical advancement of the invention
and has not even been referred to in the impugned order although the
same were filed and fully elaborated upon. It is also contended that there
is no reference to the expert evidence in the impugned order which dealt
with both inventive steps and synergistic activities necessary in
determining the patentability of the invention. In such circumstances,
the impugned order is liable to be set aside and the matter be remanded
to a different Deputy Controller.
8. On behalf of the respondent authorities, it is fairly submitted that the
impugned order does not deal with the expert evidence or the scientific
technical materials which had been furnished by the appellant. In
particular, the expert evidence of Miriam Kidron has been ignored in the
impugned order.
9. Admittedly, the Hearing Notice referred to prior arts i.e. D1 to D4.
However, the impugned order concludes that the invention lacked
inventive steps only on the basis of the prior arts D1 and D4 and ignores
D2 and D3. Any such change ought to have been made known to the
appellant and an opportunity ought to have been provided to the
appellant to contest the new combination of documents D1 and D4
alone. The different combination of documents relied on in the impugned
order would entirely change the case of obviousness which is to be
answered by the appellant. In Guangdong Oppo Mobile
Telecommunications Corp., Ltd. vs The Controller of Patents and Designs
(Unreported decision dated 13.06.2023 in AID No. 20 of 2022) this Court
had held as follows:
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“………….If several prior art documents are to be read in
combination; there must be some common thread linking the
claim with the prior art documents obvious to a person skilled
in the art. It must be shown that the skilled person when
faced with the claim would turn to some other citation to
supplement the claim. Otherwise, the combined reading of the
prior art documents or mosaicing of the same is
impermissible.”
10. In Enercon (India) Limited v. Aloys Wobben (ORA/08/2009/PT/CH)
Order No.123 of 2013 dated 13 June 2013, it has been held as follows:
43. The mere existence in the prior arts, of each of the
elements in the invention, will not ipso facto mean
obviousness. For after all most inventions are built
with prior known puzzle-pieces. There must be a
coherent thread leading from the prior arts to the
invention, the tracing of the thread must be an act
which follows obviously. We must apply this reasoning
to test if indeed it is obvious, or if it seems to us to be
obvious to the person skilled in the art because of
what we know now. If it is the latter, it is hindsight
deduction and is not acceptable, but if it is the former,
then the patent must go.”
11. In such circumstances, the decision to exclude of documents D2 and D3
is arbitrary, unjustified and without basis. Any common thread linking
the claim with D1 and D4 and the decision to exclude D2 and D3 has
not even been discussed in the impugned order.
12. In determining inventive steps, the Deputy Controller has also not
referred to nor dealt with the data with reference to the figures in the
specification submitted alongwith the Written Submissions. On the
contrary, the Deputy Controller has proceeded to find components in the
prior arts ignoring the actual technical advancement achieved by the
present invention as a whole. There is also no reference to the expert
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affidavit in the impugned order, though the same highlighted both
inventive step and synergistic activity in dealing with section 3(e) of the
Act. Rather, the Deputy Controller while recording the submissions of
the appellant selectively and arbitrarily chose to omit portions of the
same including the expert evidence of Miriam Kidron who was not only
the inventor of the invention in hand but also of the cited document D1
and highlighted the surprising effects of the invention.
13. Significantly, the order of this Court dated June 19, 2019 passed in the
Writ Petition No. WP (9575) of 2019 had directed the respondent to take
into consideration all materials made available and filed by the appellant
in deciding the application which has been ignored in passing the
impugned order. On the aspect of inventive step, as well as section 3(e),
the Deputy Controller has regarded pharmaceutically acceptable pH
lowering agent or protease inhibitor to be present in a manner as if these
in combination amount to two protease inhibitors. On that basis, the
Deputy Controller held that D4 teaches the use of two protease
inhibitors. The above premise is based on an erroneous interpretation of
D4. D4 does not mention the presence of double or multiple protease
inhibitors. Thus, the Deputy Controller erred in its finding that D4
teaches two protease inhibitors. In view of the above, the conclusion of
obviousness cannot be supported.
14. The finding of the Deputy Controller that bioavailability alone does not
establish synergism and requires therapeutic efficacy for the purpose of
section 3(e) is incorrect and is based on a misconception of the
provisions. While the latter is a criteria for adjudication under section
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3(d) of the Act, it is wholly irrelevant for the purposes of interpreting
section 3(e) of the Act. The impugned order proceeds on the basis of
section 3(d) of the Act while considering the application for grant of
patent. On the contrary, the hearing notice was under section 3(e) read
with section 2(1)(ja) of the Act. This is a serious flaw in the impugned
order inasmuch as it brings elements of section 3(d) inter-alia
enhancement of therapeutic efficacy as well as bioavailability which are
wholly irrelevant and immaterial insofar as section 3(e) of the Act is
concerned.
15. In passing the impugned order, the Deputy Controller has also failed to
appreciate that section 3(e) is only applicable if there is an admixtures of
two or more substances resulting in the additive effect of the inherent
properties of each of the substances. In this regard, the Deputy
Controller failed to consider the description of the invention alongwith its
specification as well as the affidavit of the expert, which recommended
that the bioavailability of the composition was greatly enhanced, and
such composition is peculiar having regard to the inherent properties of
the individual components of the invention. In fact, there is sufficient
guidance to be found in the Patent Office Manual with regard to the
scope and applicability of sections 3(d) and 3(e) of the Act (Clauses
09.03.05.04 and 09.03.05.05 of the Patent Manual of Version 3.0 dated
November 26, 2019) which has been disregarded in passing the
impugned order.
16. The fact that the invention had been granted in other jurisdiction details
whereof had been adduced by the appellant in the filings before the
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Deputy Controller has also not been discussed in the impugned order.
Significantly, each of the prior arts singularly and in combination were
the subject matter of those proceedings. Despite the same being on
record and relied on by the appellant, the same were ignored in passing
the impugned order.
17. In view of the above, the following directions are passed:
1. The impugned order dated June 5, 2020, is set aside and the
matter is remanded back for fresh consideration by a different
officer.
2. The Controller is directed to consider all the documents including
the expert affidavit with reference to the data provided in the
specifications and the results thereof, while considering the
application afresh.
3. The Controller is also directed to furnish reasons on the
inferences drawn in arriving at any conclusion while adjudicating
the issue of patentability.
18. With the above directions, IPDPTA/8/2022 stands disposed of.
(RAVI KRISHAN KAPUR, J.)