Madras High Court
M/S.Guangzhou Ocusun Ophthalmic vs Joint Controller Of Patents & Designs on 8 August, 2024
Author: Senthilkumar Ramamoorthy
Bench: Senthilkumar Ramamoorthy
2024:MHC:3058
CMA(PT)/23/2024
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 08.08.2024
CORAM
THE HONOURABLE MR.JUSTICE SENTHILKUMAR
RAMAMOORTHY
CMA(PT)/23 of 2024
M/s.Guangzhou Ocusun Ophthalmic
Biotechnology Company Limited,
Room No.402, No.223, West Huanshi Avenue,
Nansha District, Guangzhau City, China. ... Appellant
-vs-
Joint Controller of Patents & Designs,
The Patent Office, Intellectual Property Building,
G.S.T.Road, Guindy, Chennai-600 0032, India. ... Respondent
PRAYER: Transfer Civil Miscellaneous Appeal (Patent) filed under
Section 117-A (2) of the Patents Act, 1970, pleased to pass an order
setting aside the impugned order dated 15.02.2024 passed by the
Respondent in respect to the Application No.202147005676 and allow
Patent Application No.202147005676.
For Appellant : Mr.Tarun Khurana
for Khurana and Khurana
1/13
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For Respondent : Mr.S.Janarthanam, SPCGSC
**********
ORDER
This appeal is directed against the order dated 15.02.2024 by
which Patent Application No.202147005676 was rejected.
2. The appellant filed the above mentioned patent application
titled “CRYSTAL FORM OF LANOSTEROL PRODRUG
COMPOUND AND APPLICATION THEREOF” before the Patent
Office, Chennai, on 10.02.2021. The said application was filed as a
national phase application, which was derived from PCT application
No.PCT/CN2019/097773. The appellant claimed priority from
25.07.2018. Pursuant to a request for examination, the First
Examination Report(FER) was issued on 21.06.2022. By such FER,
objections were raised inter alia on the ground that the claimed
invention is patent ineligible under Section 3(d) of the Patents Act,
1970 and that it lacks an inventive step in view of prior art
documents D1 and D2. The appellant replied to the FER on
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21.12.2022 and also amended the claims by filing amended claims 1
to 5. After a hearing on 23.01.2024, the application was rejected by the
order impugned herein.
3. Learned counsel for the appellant submits that the
application was in respect of a crystal form of lanosterol prodrug
compound and not in respect of a crystal form of lanosterol. He
points out that a prodrug exhibits pharmacological activity only
upon being metabolized in the body after the drug is administered.
He submits that the appellant applied for and obtained a patent in
respect of the lanosterol pro-drug compound from the Indian Patent
Office. He also submits the crystal form of the pro-drug was granted
patent in multiple jurisdictions, including China, United States of
America, Europe and Japan.
4. With regard to the rejection under Section 3(d) of the Patents
Act, learned counsel contends that the Joint Controller failed to
identify the known substance. He submits that the lanosterol pro-
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CMA(PT)/23/2024
drug compound for which the appellant was granted a patent was
published after the priority date in respect of the current application.
Consequently, he contends that D1 is not really a prior art document.
For this principle, he relies upon the judgments in Mr.Tony Mon
George, Constituted Attorney of AbbVie Inc. v. Deputy Controller of
Patents and Designs, judgment dated 20.12.2023 in (T)CMA(PT)No.150
of 23 and Pfizer Products Inc. v. Controller of Patents & Designs, 2020
SCC OnLine IPAB 19.
5. Without prejudice to this contention, and assuming without
admitting that Section 3(d) of the Patents Act applies, he submits that
the appellant demonstrated therapeutic efficacy by including
experimental results in the complete specification. Consequently, he
contends that the claimed invention passes through the exemption
filter in Section 3(d). He relies upon experimental examples 2 and 3
at internal pages 16 to 21 of the complete specification, in this regard,
and points out that it is categorically stated therein that the cataract
symptoms were significantly reduced after lanosterol pro-drug 026
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eye drops were administered for 42 days compared to the symptoms
before administration, and that the cataract symptom showed no
evident change before and after administration of Kary Uni eye
drops and lanosterol eye drops.
6. As regards the inventive step analysis, learned counsel
submits that D2 discloses a Markush structure with hundreds of
prophetic compounds. Without the benefit of hindsight, learned
counsel submits that it would not be obvious to PSITA to even arrive
at lanosterol on such basis. As regards the pro-drug of lanosterol, he
contends that it would not be obvious from D2 by any stretch of the
imagination.
7. Mr.Janarthanan, learned special panel counsel, appears on
behalf of the respondent. By relying upon the counter affidavit of the
Deputy Controller of the Patent and Designs, Dr.V.Parimalavarsini,
and on the impugned order, he contends that the crystal form of
lanosterol can be easily derived from prior art document D2. He also
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CMA(PT)/23/2024
contends that the crystal form of the pro-drug of lanosterol merely
increases stability and permeability and that these properties, at best,
enhance bioavailability and not therapeutic efficacy.
8. D1 is on record and the date of publication thereof is
24.01.2020. The priority date of the application forming the subject of
this appeal is 25.07.2018. Consequently, as noticed by the respondent
in the impugned order, D1 cannot be construed as prior art. In such
circumstances, in order to apply Section 3(d) of the Patents Act, it
would be necessary for the respondent to identify the known
substance. On reading the impugned order, while it appears that the
respondent considered lanosterol as the known substance, no
explanation is provided for doing so in view of the claims being in
respect of a crystal form of the pro-drug lanosterol.
9. Even proceeding on the assumption that Section 3(d) is
applicable, it becomes necessary to examine whether the new form
exhibits enhanced efficacy, including significant enhancement in
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properties, in terms of Section 3 (d) and the Explanation thereto. In
the complete specification, the appellant has set out the experimental
data and results from internal pages 11 to 21 thereof. By way of
illustration, paragraphs 90, 91, 94 and 95 are set out below:
“[0090] 4. Experimental results
[0091] 1)Slit lamp observation:Fig. 5 shows that
sodium selenite could induce cataract in neonatal
New Zealand rabbit lens. Slit lamp observation
shows the cataract symptoms were
significantly reduced after lanosterol prodrug
026 drops were administered for 42 days (Fig.
5-I) compared with the symptoms before
administration (Fig. 5-J). The cataract
symptoms showed no evident change before
and after the administration of Kary Uni eye
drops (Fig.5-E, 5-F) and lanosterol eye drops
(Fig. 5-G, 5-H).
[0094] 5. Conclusion
[0095] The above results indicate that the
lanosterol prodrug 026 eye drops are capable of
alleviating the cataract symptoms of neonatal
New Zealand rabbits induced by sodium selenite
and improving lens transparency and lens GSH-
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PX activity.”
Similar conclusions are recorded with regard to experimental
example 3.
10. In the impugned order, the following findings were
recorded in the penultimate paragraph:
“In context to the above discussion I do not
find substantial therapeutic efficacy of claimed
compound 1 as pharmacokinetic and
pharmacodynamics activities in treating cataract
of crystal form A of compound of formula 1 is
better than of Lanosterol as claimed as shown in
Table 1 to 6 in the disclosure are related to
pharmacokinetic and pharmacodynamics
properties and indicated AUC value. Further, it is
known that increased steability and permeability
is related to drug bioavailability, which is directly
proportional to total amount of unchanged drug
that reaches systematic circulation. So in my
consideration the said data is not related to
therapeutic efficacy which is maximum response
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achievable to elicit a therapeutic response. A
drug's efficacy is a measure of the ability of the
drug to treat whatever condition it is indicated
for. Efficacy means therapeutic efficacy data per se
needs to be substantiated by the comparative
clinical data w.r.t the closest compound(s) of prior
art/commercial product for establishing
patentability. Nowhere in the written submission
as well as in specification I found that the trial of
applicant to prove upon the therapeutic efficacy
other that data related to pharmacokinetic and
pharmacodynamic properties as discussed above.
Finally, I opine that the subject application failed
to overcome section 3(d) of the Act as well as
section 2(1)(j) of the Act being a mere crystal with
regard to above discussion and as a result of the
same the application is not patentable within
provision of the law.”
While there is a reference to Table 1 to 6 in the above extracts, there is
no consideration of the claim made in the experimental results,
especially in the portions emphasised in bold font in the above
extract, with regard to therapeutic efficacy. It is pertinent to notice in
this regard that both experimental example 2 and 3 are described as
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pharmacodynamic studies, i.e. studies that deal with the effect of the
drug on the body as opposed to pharmacokinetic studies that deal
with the effect of the body on the drug. The significance and
implication thereof has also not been appreciated. Therefore, the
impugned order cannot be sustained and the matter requires
reconsideration.
11. For reasons set out above, impugned order dated 15.02.2024
is set aside and the matter is remanded for reconsideration on the
following terms:
(i) In order to preclude the possibility of pre-determination,
reconsideration shall be by an officer other than the officer who
issued the impugned order.
(ii) The observations set out in this order shall be taken into
consideration while undertaking reconsideration, but it is made clear
that no opinion has been expressed on the merits of the patent
application.
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(iii) After providing a reasonable opportunity to the appellant,
a reasoned decision shall be issued within six months from the date
of receipt of a copy of this order. There shall be no order as to costs.
08.08.2024
Index : Yes / No
Internet : Yes / No
Neutral Citation: Yes/No
kal
To
The Joint Controller of Patents & Designs,
The Patent Office, Intellectual Property Building,
G.S.T.Road, Guindy, Chennai-600 0032, India.
https://www.mhc.tn.gov.in/judis
CMA(PT)/23/2024
SENTHILKUMAR RAMAMOORTHY J.
kal
CMA(PT)/23/2024
https://www.mhc.tn.gov.in/judis
CMA(PT)/23/2024
08.08.2024
https://www.mhc.tn.gov.in/judis
