Madras High Court
The Trustees Of Columbia University vs The Assistant Controller Of Patents And ... on 13 February, 2025
Author: Senthilkumar Ramamoorthy
Bench: Senthilkumar Ramamoorthy
CMA(PT)/34/2024
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 13.02.2025
CORAM
THE HONOURABLE MR.JUSTICE SENTHILKUMAR RAMAMOORTHY
CMA(PT)/34/2024
and C.M.P.No.16244 of 2024
The Trustees of Columbia University
In the City of New York
Address for service in India
HASAN AND SINGH,
No.04, Sree Nilayam, Plot No.12, Camelot Layout,
Kondapur, Hyderabad-500 084. ... Appellant
-vs-
The Assistant Controller of Patents and Designs,
Patent Office Branch,
Intellectual Property office Building,
G.S.T.Road, Guindy, Chennai – 600 032. ... Respondent
PRAYER: Civil Miscellaneous Appeal (Patents) is filed under Section
117A of the Patents Act, 1970, pleased to set aside the impugned order dated
28.02.2024 issued by the respondent.
For Appellant : Mr. R.Sathish Kumar
For Respondent : Mr.S.Janarthanam,
Senior Standing Counsel
**********
1/10
https://www.mhc.tn.gov.in/judis
CMA(PT)/34/2024
JUDGMENT
This appeal is directed against the order dated 28.02.2024 rejecting
the amended claims of the appellant as being impermissible under Section
59 of the Patents Act, 1970 (the Patents Act) and, consequently, rejecting
Patent Application No.202047004043.
2. The appellant applied for a patent under the above mentioned
application for a claimed invention titled “METHODS AND
COMPOSITIONS FOR TREATMENT OF AMYLOID DEPOSITION
DISEASES”. Such application was the national phase application derived
from the PCT application. As required by law, the application was
originally filed on identical terms as the corresponding PCT application.
Upon request, First Examination Report dated 01.06.2022 (the FER) was
issued, wherein multiple objections were raised, including by citing Section
3(i) of the Patents Act. By response dated 24.02.2023, the appellant
submitted amended claims 1 to 19 by also indicating the foundation for such
claims in the complete specification. The impugned order was issued
thereafter by holding that these amended claims do not fall within the scope
of Section 59 of the Patents Act.
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CMA(PT)/34/2024
3. Learned counsel for the appellant invited my attention to the
complete specification. By referring to paragraph [0011], he submitted that
the summary of the invention describes such invention as compositions and
methods for treating amyloid deposition diseases. Further, by referring to
paragraph [00115] of the complete specification, he pointed out that
pharmaceutical compositions are recited therein and that specific reference
is made to the ingredients thereof, including specific types of antibodies and
antibody fragments. Therefore, learned counsel contends that the amended
claims fall wholly within the scope of the complete specification. By relying
on the judgment of the Delhi High Court in Allergan Inc. v. The Controller
of Patents (Allergan), 2023 SCC OnLine Del 295 and, in particular,
paragraphs 23 and 24 thereof, he contends that the impugned order calls for
interference. He also points out that the judgment of the Delhi High Court
was cited before the respondent, but the respondent erroneously concluded
that amended claims 1 to 19 lack corresponding explicit disclosure in the
originally filed specification.
4. In response to these contentions, Mr.Janarthanam submits that the
claimed invention was in respect of methods of treatment of amyloid
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CMA(PT)/34/2024
deposition diseases. In the guise of amending the claims, he submits that the
appellant should not be permitted to alter the fundamental nature of the
invention. In support of his contention, he relies upon the judgment of the
Delhi High Court in Nippon A&L Inc. v. The Controller of Patents, 2022:
DHC:2434 (Nippon A&L Inc.), particularly paragraphs 40 and 41 thereof. In
effect, his contention is that an amendment application should be rejected
unless it satisfies all the requirements set out in paragraph 40 thereof.
5. The claimed invention of the appellant is titled “METHODS AND
COMPOSITIONS FOR TREATMENT OF AMYLOID DEPOSITION
DISEASES”. Paragraph [0011] thereof is as under:
“[0011] Described herein are compositions
and methods for treating amyloid deposition
diseases, specifically primary (AL) amyloidosis.
The disclosed compositions and methods employ
humanized or chimeric antibodies or fragments
thereof that specifically bind to amyloid fibrils
(e.g. Amyloid light chain fibrils) to target the
fibrils for clearance by the immune system.”
6. The method of production of a chimeric antibody, which can be
https://www.mhc.tn.gov.in/judis
CMA(PT)/34/2024
used in the compositions, is set out at paragraph [0014] of the complete
specification, which is as under:
“ A chimeric antibody useful in the sub
methods and pharmaceutical compositions may be
produced by co-transfection in mammalian cells of
the vector constructs 11-1F4VK.pKN100 and 11-
F4VH.pG1D200 or transfection in mammalian
cells of the supervector construct pG1KD200-11-
1F4. In some embodiments, the co-transfection of
the vector construct pG1KD200-11-1F4 takes
place in COS cells. The antibody produced is
designated “chimeric 11-1F4 antibody”.”
Paragraphs [0097 to 00114] disclose the different kinds of antibodies which
may be used in the composition.
7. Paragraphs 115 to 120 deal with pharmaceutical formulations and
indicate that those pharmaceutical compositions include the disclosed
humanized or chimeric 11-1F4 antibodies, humanized antibodies or antigen-
binding antibody fragments and a pharmaceutically acceptable carrier or
diluent.
8. The appellant's reply to the FER sets out amended claims 1 to 19
and the foundation or support for such claim in the complete specification.
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CMA(PT)/34/2024
Such foundation is referenced with great specificity, including the relevant
pages and lines of the complete specification.
9. In the impugned order, at paragraph 16, in relevant part, it is
recorded as under:
“It is observed that the presently amended
claims 1-19, which pertain to a specific
pharmaceutical composition, lack corresponding
explicit disclosure in the originally filed
specification. While the initial specification
mentions a pharmaceutical composition useful in
treating human amyloid deposition disease, it fails
to explicitly disclose the claimed composition.”
While recording this finding, the respondent has failed to deal with the
paragraphs of the complete specification discussed above or the references
set out in the appellant's reply to the FER.
10. In Allergan, the Delhi High Court examined the scope of Section
59 of the Patents Act and concluded that amended claims cannot be rejected
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CMA(PT)/34/2024
solely because the claims were originally method claims and were
subsequently sought to be converted into product claims. The test laid out
therein was that the amendment should be permitted if it falls within the
scope of disclosures made in the complete specification. In Commonwealth
Scientific and Industrial Research Organization and Another v. The
Assistant Controller of Patents and Designs in(T)CMA(PT) No.14 of 2023, I
cited Allergan with approval and concluded that if the amended claims fall
within the scope of the complete specification, the amendment is liable to be
allowed in terms of Section 59. The judgment of the Delhi High Court in
Nippon A&L Inc. emphasizes that all the conditions in Section 59 should be
cumulatively fulfilled. While holding that all the conditions are required to
be fulfilled, the respondent has failed to indicate as to which condition has
not been fulfilled in the case at hand.
11. For reasons aforesaid, the order impugned herein is set aside and
the matter is remanded for reconsideration. In order to preclude the
possibility of pre-determination, an officer other than the officer who issued
the impugned order shall undertake such reconsideration. After providing a
reasonable opportunity to the appellant, including a personal hearing, a fresh
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CMA(PT)/34/2024
order shall be issued within a period of four months from the date of receipt
of a copy of this order. For the avoidance of doubt, it is made clear that no
observation has been made herein on the merits of the application.
12. Therefore, CMA(PT)/35/2024 is disposed of on the above terms
without any order as to costs. Consequently, C.M.P.No.16244 of 2024 is
closed.
13.02.2025
kal
Index : Yes / No
Internet : Yes / No
Neutral Citation: Yes / No
To
The Assistant Controller of Patents and Designs,
Patent Office Branch,
https://www.mhc.tn.gov.in/judis
CMA(PT)/34/2024
Intellectual Property office Building,
G.S.T.Road, Guindy, Chennai – 600 032.
SENTHILKUMAR RAMAMOORTHY,J
kal
https://www.mhc.tn.gov.in/judis
CMA(PT)/34/2024
CMA(PT)/34/2024
13.02.2025
https://www.mhc.tn.gov.in/judis
