Madras High Court
Shaperon Inc vs Assistant Controller Of Patents And ... on 6 March, 2025
Author: Senthilkumar Ramamoorthy
Bench: Senthilkumar Ramamoorthy
(T)CMA(PT) No.46 of 2023
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 06.03.2025
CORAM
THE HONOURABLE MR.JUSTICE SENTHILKUMAR RAMAMOORTHY
(T)CMA(PT) No.46 of 2023
(OA/27/2020/PT/CHN)
Shaperon Inc.
606,174-10, Jagok-ro, Gangnam-gu,
Seoul, Republic of Korea. ... Appellant
-vs-
Assistant Controller of Patents and Designs,
Government of India, Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy, Chennai - 600 032. ... Respondent
PRAYER: Transfer Civil Miscellaneous Appeal (Patents) filed under
Section 117-A of the Patents Act, 1970, praying that the order dated 22
April 2020 issued by the respondent be set aside and the application No.
1667/CHENP/2015 for patent be allowed to proceed to grant with claims
filed on 25th March 2020 in accordance with the provisions of the Act, and
the Rules.
1/15
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(T)CMA(PT) No.46 of 2023
For Appellant : Mr.P.V.Balasubramaniam, Senior Counsel for
Mr.A.Arvind Raj
for M/s.De Penning and De Penning
For Respondent : Mr.Rajesh Vivekanandan
JUDGMENT
The appellant applied for grant of patent for a claimed invention titled
“COMPOSITIONS FOR PREVENTING OR TREATING ALLERGIC
SKIN DISORDERS, CONTAINING GPCR19 AGENTS AS ACTIVE
INGREDIENTS”. Such application was rejected by impugned order dated
22.04.2020.
2. The above mentioned application was lodged on 05.03.2014.
Pursuant to a request for examination, the First Examination Report (FER)
dated 25.05.2018 was issued. In the FER, objections were raised inter alia
on grounds of lack of novelty and inventive step by citing prior arts D1 to
D4; and non-patentability under Section 3(e) of the Patents Act, 1970 (the
Patents Act). The appellant responded to the FER on 22.02.2019 and filed
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amended claims. A hearing notice was issued on 06.02.2020. Pursuant to a
hearing on 11.03.2020, the appellant filed written submissions on
25.03.2020 and submitted further amended claims on 25.03.2020. These
were the claims rejected under the impugned order.
3. Learned senior counsel for the appellant referred to the FER and
pointed out that the prior arts cited therein were distinguished in reply dated
22.02.2019. With regard to prior arts D1 and D3, he submitted that the
GPCR19 agonist referred to therein was intended as a therapeutic agent for
the treatment of sepsis, whereas the appellant's claims are limited to and
target infectious skin disorders. As regards prior art D2, he pointed out that
it relates to a new GPBAR1 agonist compound intended to treat
inflammatory disorders. As regards prior art D4, he submitted that it
discloses the GPCR19 agonist, chenodeoxycholic acid and ursodeoxycholic
acid, and not sodium taurodeoxycholate compound.
4. In spite of such reply, learned senior counsel contends that the
same objections were retained in hearing notice dated 06.02.2020 and that
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substantially similar language is used in the impugned order. By referring to
the impugned order, learned senior counsel submitted that conclusions were
recorded therein that the external preparation of claim 1 is not patentably
distinct from the product disclosed in D1. While recording such conclusion,
he contends that the Controller did not discuss or record any findings with
regard to the appellant's reply wherein prior art D1 was distinguished.
Likewise, he submits that the basis on which prior arts D2 to D4 were
distinguished was also not discussed in the impugned order. Instead, he
states that a conclusion was recorded that the claimed invention could have
been arrived at through routine experimentation by a person skilled in the
art on the basis of the disclosures made in prior arts D1 to D4.
5. As regards the conclusion that no details were provided by the
appellant for the advantages or surprising effects/unexpected effects of the
claimed invention in comparison to the prior arts, learned senior counsel
referred to the affidavit of Seong, Seung-Yong (the inventor) to submit that
the GPCR19 agonist has a very short half-life, if administered orally in the
form of an injection, whereas, if administered topically, it exhibits advanced
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therapeutic effect. For these reasons, learned senior counsel submits that the
matter requires reconsideration.
6. In response to these contentions, learned counsel for the respondent
submitted that the claimed invention would be obvious to a person skilled in
the art on the basis of the cited prior arts. By referring to a translated copy
of prior art D1, learned counsel submitted that the preferred GPCR19
agonist, as per D1, is sodium taurodeoxycholate. In support of this
contention, he refers specifically to paragraph [0042]. By referring to claim
25 of prior art D1, he submits that the composition disclosed therein is
intended to treat a range of inflammatory conditions, including atopic
dermatitis. By referring to paragraph [0038] of D1, he submits that it recites
administration of the GPCR19 agonist through multiple modes, including
transdermal administration. As regards prior art D2, by referring to claim 8
thereof, he points out that the monopoly claim therein is in respect of
treating disorders mediated by GPBAR1 activity. As regards prior art D3,
by referring to claims 15 & 21 thereof, he points out that the monopoly
claim therein also relates to a method of treating an inflammatory disease,
including through the topical route.
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7. Learned counsel referred to the principles pertaining to
obviousness analysis, as formulated in Windsurfing International Inc. v.
Tabur Marine (GB) Ltd. [1985] RPC 59(Windsurfing), and refined in
Pozzoli Spa v. BDMO SA, [2006] EWHC 1398 (Ch.)(Pozzoli), which were
extracted with approval in Indian Institute of Technology, Madras v. The
Controller of Patents & Designs, 2024 : MHC : 2264; 2024-4-L.W. 505.
According to learned counsel, if the Windsurfing and Pozzoli tests are
applied, the claimed invention would be obvious to a person skilled in the
art.
8. By way of a brief rejoinder, learned senior counsel for the
appellant submits that D1 is targeted at the treatment of sepsis, and this is
clear on examining the complete specification thereof. As regards claim 25
of D1, he states that all the inflammatory diseases, including atopic
dermatitis, are merely set out without providing any data with regard to the
efficacy of the claimed method for treating atopic dermatitis. He also
submitted that the claimed invention was granted patent in multiple
jurisdictions, such as the United States of America, Japan and Europe. With
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specific reference to the EPO grant, he pointed out that the same prior arts
were considered therein while granting the patent.
9. The complete specification of the claimed invention discloses that
it relates to a pharmaceutical composition containing a G Protein-coupled
Receptor19 (GPCR19) agonist, specifically sodium taurodeoxycholate
(HY2191), as an active ingredient for preventing or treating allergic skin
diseases. Thus, it is clear that the claimed invention is targeted solely and
exclusively at the treatment of allergic skin diseases. Current claim 1, which
is an independent claim, is as under:
“A form of external preparation containing a G
protein-Coupled Receptor19 (GPCR19) agonist as an
active ingredient for preventing or treating allergic skin
diseases, wherein the G protein-Coupled Receptor19
(GPCR19) agonist is sodium taurodeoxycholate.”
10. The respondent raised objections inter alia with regard to lack of
novelty and inventive step in the FER. In response to the FER, the appellant
stated, in relevant part, as under, with regard to the difference between prior
art D1 and the claimed invention:
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“The technical feature of D1 lies only in expanding
bone marrow-derived immune regulatory cells and
immune regulatory B cells by activating GPCR19
pathway in vivo or ex vivo. But it has no disclosure on the
use of GPCR19 agonist for treating allergic dermatitis at
all.
.. .. ..
Therefore, it can be derived from the disclosures of
Dl only that the GPCR19 agonist can be a therapeutic
agent for treating sepsis, in particular, H-MDSC
produced as a result of treating a GPCR19 agonist can be
a therapeutic agent for treating sepsis.”
Indeed, the appellant specifically dealt with claim 25 of D1 as under:
“Based on the examples and experimental data
disclosed in D1, it is so difficult to predict treating
GPCR19-agonist can show the therapeutic effect for all
the above exemplified diseases. The pathological
mechanism of diseases is complex and thus the
therapeutic effect and adverse effect can vary by the kind
of disease. Thus, the clinical trial should be conducted to
confirm the therapeutic effect of a candidate drug.”
11. As regards prior arts D2 and D3, the appellant stated as under:
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“D2 relates to new GPBAR1 agonist compounds, in
particular, D2 discloses that the new GPBAR1 agonist
compounds, 4-(3-hydroxy-10, 13-dimethyl-hexa deca
hydrocyclopenta[a]phenanthren-17-yl] pentanoic acid
amides, can be used for the treatment of disorders
(diseases) associated with inflammation, e.g. including
(chronic) inflammatory disorders... (omitted)..
hypotension... (omitted)..ischemic reperfusion injury,
..(omitted)... cancer and AIDS, reheumatoid arthritis,
inflammatory bowel disease, systemic lupus erytomatosis,
multiple sclerosis, psoriasis. (D2 [0083]-[0130]):
D3 discloses that the sodium taurodeoxycholate
can be used for the treatment of sepsis.
The following was stated with reference to prior art D4:
“D4 discloses that the specific compound which is
one of GPCR19 agonists also, chenodeoxycholic acid
and ursodeoxycholic acid, can be used for the treatment
of atopic dermatitis. ”
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12. On examining the impugned order, the following conclusion has
been recorded with regard to independent claim 1:
“The external preparation of claim 1 is not
patentably distinct from the product disclosed in D1 and
an intended use doesn't impart a patentable limitation to
a claimed product. ”
While recording the above conclusion with regard to the claimed invention
being obvious to PSITA from D1, the respondent did not discuss or record
any findings with regard to the appellant's contention that D1 is targeted at
sepsis and that no data was provided in D1 with regard to the efficacy of the
methods described or disclosed therein in the treatment of atopic dermatitis.
As would be evident from the extracts set out above, a similar contention
was raised with regard to prior art D3. As regards prior art D4, it was stated
in the reply to the FER and in the written submissions that D4 uses
chenodeoxycholic acid or ursodeoxycholic acid and not sodium
taurodeoxycholate. This aspect was also not discussed.
13. The impugned order also records as under:
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“The Applicant's agent's arguments in this regard
are not tenable as they failed to establish that claimed
external preparation is not obvious to a person skilled in
the art in view of the cited disclosures in Dl to D4 when
these documents clearly teaching or suggesting the active
agent of the claimed product. It is well known practice
and routine experimentation for a person skilled in the art
for devising the specific chosen form with the known
functional ingredient/s and hence external preparation
claimed in amended claim 1 is obvious to a person skilled
in the art vis-à-vis disclosures of DI to D4. .... There are
no details provided for the advantages or surprising
effects/unexpected effects by this selected form of the
external preparation vis-à-vis prior art known
formulations or forms. The applicant's agent have not
demonstrated any unexpected/surprising effect of the
claimed external preparation over the known
formulations/preparations and in the absence of that the
claimed external preparation is obvious to a person
skilled in the art in view of disclosures/teachings in cited
document D1 combined with D2, D3 and D4. Therefore, it
is concluded that the external preparation claimed in
amended claim 1 is obvious to a person skilled in the art
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vis-à-vis disclosures of D1 to D4.”
14. The appellant had placed on record the affidavit of Seong, Seung-
Yong, PhD from Seoul National University. He had opined with regard to
the unexpected therapeutic effect of (HY2191) when administered
transdermally for the treatment of atopic dermatitis in contradistinction to
the administration thereof orally or by injection. This aspect also does not
appear to have been considered.
15. Learned counsel for the respondent pointed out that the
transdermal administration of the GPCR19 agonist is recited in paragraph
[0038] of D1. This aspect would have to be considered upon remand in the
context of the contention of learned senior counsel for the appellant that D1
is targeted at the treatment of sepsis and not atopic dermatitis.
16. Before concluding, one final aspect should be noticed. The
claimed invention was granted patent in multiple jurisdictions, including the
United States of America, Japan and Europe. It appears from the EPO grant
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that all four prior arts cited by the respondent were considered by the EPO.
Undoubtedly, the determination by the EPO is not binding on the Patent
Office. Nonetheless, in view of the prior arts being considered by the EPO,
the grant by the EPO and the other jurisdictions should have been taken into
consideration as one of the factors in the decision-making process.
17. For reasons set out above, impugned order dated 22.04.2020 is set
aside and the matter is remanded for reconsideration on the following terms:
(i) In order to preclude the possibility of pre-determination, an officer
other than the officer who issued the impugned order shall undertake
reconsideration.
(ii) After providing a reasonable opportunity to the appellant, a
reasoned order shall be issued within four months from the date of receipt of
a copy of this order.
(iii) For the avoidance of doubt, it is made clear that no opinion has
been expressed herein on the merits of the patent application.
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18. Therefore, (T)CMA(PT) No.46 of 2023 stands disposed of on the
above terms, without any order as to costs.
06.03.2025
Index : Yes / No
Internet : Yes / No
Neutral Citation: Yes / No
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To
Assistant Controller of Patents and Designs,
Government of India, Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy, Chennai - 600 032.
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SENTHILKUMAR RAMAMOORTHY,J
kj
(OA/27/2020/PT/CHN)
06.03.2025
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