Madras High Court
Starpharma Pty Ltd vs The Assistant Controller Of ... on 12 October, 2023
1
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 12.10.2023
CORAM:
THE HON'BLE MR. JUSTICE SENTHILKUMAR RAMAMOORTHY
(T) CMA (PT) No.22 of 2023
(OA/13/2021/PT/CHN)
STARPHARMA PTY LTD
of Baker Building 75 Commercial Road,
Melbourne Victoria 3004 Australia
Through its Authorized Representative ... Appellant
Vs.
The Assistant Controller of Patents and Designs
Bouddhik Sampada Bhawan
CP-2, Sector-V, Salt Lake City,
Kolkata - 700091 . ... Respondent
PRAYER : This Civil Miscellaneous Appeal filed under Section
117-A of the Patents Act, 1970, prays (i) allow the present Appeal
and set aside/quash the impugned order dated September 11,
2020 passed by the Respondent in Indian Patent Application No.
10044/CHENP/2013; and (ii) allow said Indian Patent Application
No. 10044/CHENP/2013 and direct grant of patent in respect
thereof.
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1/10
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For Appellant : Mr. Shatadal Ghosh
Mr.Abhishek Jan
Mr.Muthuselvam for
M/s. K and S Partners
For Respondent : Mr.Rajesh Vivekanandan,
Deputy Solicitor General
JUDGMENT
The appellant assails an order dated 11.09.2020 by which
Indian Patent Application No.10044/CHENP/2013 was rejected.
The appellant had filed an application for grant of patent in
respect of an invention entitled “METHOD OF TREATMENT OR
PROPHYLAXIS OF BACTERIAL VAGINOSIS“. The said
application was the national phase filing derived from the original
application under the Patent Cooperation Treaty.
2. The appellant filed 38 claims along with the application
[the original claims]. The said claims were in respect of a Method
of treatment or prophylaxis of bacterial vaginosis, including by
administration of a gel formulation. On 15.05.2015, the appellant
requested for permission to amend its claims and submitted
amended claims. Such amended claims were in respect of a gel
formulation which inhibits bacterial vaginosis. By the impugned
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order, the amended claims were rejected as not allowable under
Sections 57 and 59 of the Patents Act, 1970 (the Patents Act). The
present appeal was filed in the said facts and circumstances.
3. Learned counsel for the appellant invited my attention
to the original claims. With particular reference to original claims
1, 5 and 10, learned counsel contended that the amended claims
are within the scope of these original claims. In order to
substantiate his contention, learned counsel also referred to the
complete specifications. By inviting my attention to lines 20 to 29
of the complete specification [Page 62 of the appeal paper book],
learned counsel submitted that the gel formulation is referred to
therein. Learned counsel further referred to page 76 of the appeal
paper book wherein the structure of an exemplary dendrimer is
set out.
4. Thereafter, learned counsel placed for consideration
the amended claims. With respect to claim 1 of the amended
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claims, learned counsel pointed out that the structure of
dendrimer set out at page 76 of the appeal paper book and that set
out at page 149 of the appeal paper book is identical.
5. Since the amended claims fall within the scope of the
original claims and the complete specification, learned counsel
submitted that the rejection of the amended claims is untenable. In
support of this submission, learned counsel placed for
consideration the judgment of the Delhi High Court in Allergan
Inc. v. The Controller of Patents, 2023/DHC/000515. Learned counsel
submitted that the original claims in the said judgment were
method claims pertaining to the treatment of an ocular condition.
In view of Section 3(i) of the Patents Act, the said method claims
were modified into device claims. In that factual context, learned
counsel pointed out that the Delhi High Court concluded that the
request for amendment should be accepted as long as the
amended claims fall within the scope of the original claims read
with disclosures made in the complete specification.
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6. In response to these contention, Mr.Rajesh
Vivekanandan, learned Deputy Solicitor General, submitted that
the impugned order does not call for interference. He further
submitted that the claims have not been considered on merits as
on date. Consequently, he submits that any remand should be
made without expressing any opinion on the merits of the
application.
7. Claims 1, 5 and 10 of the original claims are set out
below:
“1. A method of treatment or prophylaxis of
bacterial vaginosis in a subject, said method comprising
administering to the subject an effective amount of a
macromolecule comprising a polylysine, polyamidoamine,
poly(etherhydroxylamine) or poly(propyleneimine)
dendrimer of 1 to 5 generations and one or more sulfonic
acid-containing moieties attached to one or more surface
amino groups of the outermost generation of the
dendrimer, wherein said effective amount is 40 mg to 100
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mg of macromolecule per day.
5. A method according to any one of claims 1 to
4 wherein the macromolecule is administered in a gel
formulation.
10. A method according to any one of claims 6 to
9 wherein the macromolecule is administered in gel
formulation.”
8. Claim 1 of the amended claim is as under:
“1. A gel formulation inhibitory against one or more
Gardnerella vaginalis, Prevotella bivia and B. ovatus
comprising a macromolecule or a pharmaceutically
acceptable salt thereof comprising a dendrimer with the
following structure
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and a rheology modifying agent which
is Carbopol polymer in an amount of 2-10%, a chelating
agent in an amount of 0.005% to 1%, a preservative
selected from methyl paraben and propyl paraben, and
having a pH between 4.5 and 5.5.”
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9. Lines 20 to 29 of the complete specifications under the
heading “Description of the invention” are as under:
20. In a particular embodiment, the
macromolecule is formulated as a gel, especially a gel
formulated with a pH between 4.5 and 5.5, especially about
pH 5. Advantageously, this formulation may assist in
reducing vaginal pH to between 4 and 5 or maintaining
vaginal pH between 4 and 5. In some embodiments, the gel
formulation of macromolecule comprises a rheology
modifying agent, especially a Carbopol® polymer such as
Carbopol® 971P. The rheology modifier may be present in
an amount of 2-10%, especially about 5%. The gel
formulation of macromolecule may also include a chelating
agent, such as a polyaminocarboxylic acid. A particularly
useful chelating agent is ethylenediamine tetraacetic acid
(EDTA) and its salts. Suitable amounts of chelating agent
are in the range of 0.001% to 2%, especially 0.005% to 1%.
10. When the amended claims are compared with the
original claims set out above in the light of the disclosures and
descriptions contained in the complete specification, the request
for amendments should not have been rejected. Therefore, the
impugned order calls for interference.
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11. For reasons set out above, the impugned order dated
11.09.2020 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 the 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) No opinion is being expressed on the merits of the
patent application.
(iii) (T)CMA(PT) No.22 of 2023 is disposed of on the
above terms. There shall be no order as to costs.
12.10.2023
Index : Yes/No
Internet : Yes/No
Neutral Citation : Yes/No
kal
https://www.mhc.tn.gov.in/judis
SENTHILKUMAR RAMAMOORTHY J.
kal
(T) CMA (PT) No.22 of 2023
(OA/13/2021/PT/CHN)
12.10.2023
https://www.mhc.tn.gov.in/judis
