Madras High Court
Akebia Therapeutics vs The Controller Of Patents And Designs on 20 March, 2025
Author: Senthilkumar Ramamoorthy
Bench: Senthilkumar Ramamoorthy
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 20.03.2025
CORAM
THE HONOURABLE MR.JUSTICE SENTHILKUMAR RAMAMOORTHY
CMA(PT)/64/2024
Akebia Therapeutics, INC.
Represented by its Power of Attorney
Mr.Raghavan Ravindran Nair
Cambridge, MA 02142, USA.
Nationality: USA ... Appellant
-vs-
The Controller of Patents and Designs,
Government of India, Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy,
Chennai 600 032. ... Respondent
PRAYER: Civil Miscellaneous Appeal (Patents) is filed under Section 117-
A of the Patents Act, 1970, pleased to set aside the impugned order dated
26.11.2021 passed by the Assistant Controller of Patents & Designs
rejecting the grant of patent and consequently direct grant of the patent in
respect of the appellant's Application No.201647000423.
1/11
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For Appellant : Mr.P.V.Balasubramaniam, Senior Advocate
for M/s.BFS Legal
For Respondent : Mr.J.Madanagopal Rao, SPC
**********
JUDGMENT
This appeal is directed against the order dated 26.11.2021 rejecting
Patent Application No.201647000423.
2. The appellant filed the above mentioned application as the national
phase application derived from the original PCT application. The
application pertains to an invention titled "composition and methods for
treating anemia". As obligated by Section 138(4) of the Patents Act, 1970
(the Patents Act), the application mirrored the PCT application. By
examination report dated 08.01.2019, the respondent raised objections inter
alia on grounds of lack of novelty and inventive step and on the ground of
non patentability under Section 3(i) and 3(d) of the Patents Act. The
appellant replied to the FER on 07.10.2019. By second extended hearing
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notice dated 05.10.2021, the respondent maintained objections under Section
59, Section 2(i)(j) and Section 3(i) and 3(e) of the Patents Act. The
objection under Section 59 was on the ground that amended claim 1 recites a
pharmaceutical composition in contrast to the original claim 1, which
pertained to a method of treating anaemia. On that basis, the objection was
that it does not meet the requirements of Section 59. The appellant filed
written submissions pursuant to the hearing. The order impugned herein
was issued thereafter on 26.11.2021.
3. By inviting my attention to the impugned order, learned senior
counsel for the appellant submitted that the claimed invention was
eventually rejected solely on the ground that the amended claims do not fall
within the scope of Section 59 of the Patents Act. By emphasizing the fact
that the appellant was constrained to make the national phase filing by
retaining the complete specification from the PCT application, learned
counsel submitted that the amended claims fall substantially within the
scope of the original claims and clearly within the scope of the complete
specification. In particular, he referred to the table set out in the written
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submissions, wherein a comparison is made between original claim 1 and
amended claim 1. By referring to decisions such as Allergan Inc. v. The
Controller of Patent, 2023 SCC OnLine Del 295 (Allergan), learned senior
counsel submitted that re-consideration is necessary since the principles
formulated in such decisions apply squarely to this case.
4. In response, Mr.J.Madanagopal Rao referred to the impugned order
and pointed out that sub-section (1) of Section 59 only permits amendments
by way of disclaimer, correction or explanation. He contends that the
change from a claim relating to a method of treatment to a composition
claim does not fall within the scope of Section 59.
5. In the written submissions of the appellant, the appellant has drawn
a comparison between the original claim 1 and amended claim 1. The said
table is as under:
Original Claim 1 Amended Claim 1 Amendments and
Restrictions
A method for A pharmaceutical The composition of claim
treating anemia, composition comprising 1 is still directed treating
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Original Claim 1 Amended Claim 1 Amendments and
Restrictions
comprising administering to a patient anemia.
administering to a having anemia an The compound is the
patient having effective amount of a same.
anemia an effective compound which is {[5- The range of compound
amount of a (3-chlorophenyl)-3- defined in claim 1 is the
compound which is hydroxypyridine-2- same.
{[5-(3- carbonyl]amino} acetic Infact, the scope of claim
chlorophenyl)-3- acid, 1 is restricted in that the
hydroxypyridine-2- Compound 1 claim now requires that
carbonyl]amino} or a pharmaceutically composition ought to also
acetic acid, or a acceptable salt, solvate, or comprise microcrystalline
pharmaceutically hydrate thereof, wherein cellulose, sodium starch
acceptable salt, the pharmaceutical glycolate.
solvate or hydrate composition comprises
thereof wherein a microcrystalline cellulose,
daily dose comprises sodium starch glycolate,
about 150mg, about and 150 mg to 750 mg of
300mg, about 450 Compound 1
mg, about 600mg or
about 750 mg of the
compound
6. Section 59(1) of the Patents Act reads as under:
“(1) No amendment of an application for a patent or a
complete specification or any document relating thereto shall be
made except by way of disclaimer, correction or explanation,
and no amendment thereof shall be allowed, except for the
purpose of incorporation of actual fact, and no amendment of a
complete specification shall be allowed, the effect of which
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would be that the specification as amended would claim or
describe matter not in substance disclosed or shown in the
specification before the amendment, or that any claim of the
specification as amended would not fall wholly within the scope
of a claim of the specification before the amendment.”
7. The above provision was construed in multiple judgments of the
Delhi High Court and this Court. In particular, while construing Section
59(1) in Allergan, the Delhi High Court concluded that amended claims
cannot be rejected under Section 59 solely on the ground that the patent
applicant modified a method claim to a product or composition claim. The
text of Section 59(1) indicates that amendments should only be by way of
disclaimer, correction or explanation. It also stipulates that the amendment
should not have the effect of modifying the specification in such a manner
that a claim is made or a matter is described, which in substance, was not
disclosed in the original application; and that the amended claim should fall
wholly within the scope of the original claim.
8. In the impugned order, it is recorded, in relevant part, as under:
“Applicant's submissions dtd. 18/11/2021 as above are
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NOT persuasive. Pending Claim-1 reciting a
“Pharmaceutical composition “actually defines the nature
and proportion of the specific active ingredient namely {[5-(3-
chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino} acetic
acid, or it's acceptable salt, solvate or hydrate with
microcrystalline cellulose, sodium starch glycolate, whereas
originally filed Claim-1 defines a Method for treating
anemia, comprising administering to a patient having anemia
an effective amount of a compound which is {[5-(3-
chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino} acetic
acid or a pharmaceutically acceptable salt, solvate, or
hydrate thereof. Originally filed Claim-1 read along with
Description of present PCT National application, para
[0036], para [0095], para [00101] clearly indicates that said
Claim-1 is a method of treatment claim specifically defined by
an administration step with a dosing regime.
Further, Written submissions dtd. 18/11/2021 are NOT
clear with the overall scope of the pending pharmaceutical
composition Claim-1. Pending Claim-1 reading as ...”A
pharmaceutical composition comprising administering to a
patient having anemia an effective amount of a compound
which is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-
carbonyl]amino} acetic acid....”, infact includes an
expression - “comprising administering to a patient having
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anemia...”. It is to be noted that a pharmaceutical
composition can only be defined by critical features like
nature and proportion of it's ingredients and NOT by the
treatment method like steps of administering it to the patients.
Mere inclusion of said expression “comprising administering
to a patient having anemia...” into the revised
pharmaceutical composition claim-1 does not imply that said
claim falls within the scope of Method of treatment claim-1 as
originally filed.”
9. In effect, the respondent has rejected the claim substantially, if not
entirely, on the ground that the appellant has amended the claim from a
claim for a method of treating anaemia to a claim for a pharmaceutical
composition which may be used for treating anaemia. As held in Allergan
and concurred by me in an earlier decision in Commonwealth Scientific &
Industrial Research Organization and Anr. v. The Assistant Controller of
Patents & Designs 2023/MHC/4501, the rejection substantially or solely on
such ground is not tenable. On comparing the original claims with the
amended claims, I find that the scope of the claims remains the same, but the
nature of the claims have changed from method to composition claims.
Since objections were also raised on grounds of lack of inventive step and
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with reference to Sections 3(i) and 3(e), and those aspects were not
discussed or determined in the impugned order, a remand is necessary.
10. Therefore, impugned order dated 26.11.2021 is set aside and the
matter is remanded for re-consideration 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 re-
consideration.
(ii) After providing a reasonable opportunity to the appellant, a
reasoned decision shall be issued within a period of 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 observation
has been made on the merits of the patent application.
11. CMA(PT)/64/2024 is disposed of on the above terms without any
order as to costs.
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20.03.2025
rna
Index : Yes / No
Internet : Yes / No
Neutral Citation: Yes / No
To
The Controller of Patents and Designs,
Government of India, Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy,
Chennai 600 032.
SENTHILKUMAR RAMAMOORTHY,J
rna
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CMA(PT)/64/2024
20.03.2025
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