DRAFT OF OPPOSITION- SAMPLE

IN THE MATTER OF THE PATENTS ACT, 1970

(as amended by The Patents (Amendment) Act, 2005)

and

IN THE MATTER OF THE PATENT RULES, 2003

(as amended by The Patents (Amendment) Rules, 2006)

and

IN THE MATTER OF INDIAN PATENT APPLICATION NO.

5012/DELNP/2010 FILED BY [.], INC.
………………….Applicants

and

IN THE MATTER OF REPRESENTATION BY WAY OF OPPOSITION

UNDER SECTION 25(1) AND RULE 55 THERETO BY [.]
…………………Opponents

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 REPRESENTATION BY WAY OF OPPOSITION U/S 25(1)

1. It is respectfully submitted on behalf of [.](hereinafter referred as the

“Opponents”), that a pre-grant Opposition under Section 25(1) of the Patents
Act, 1970 and rule 55(1) of the Patents Rules, 2003 (as amended by the
Patents (Amendment) Rules 2006), is hereby presented by the “Opponents”
against Indian Patent Application No. [.] (hereinafter referred as the “Opposed
Application”) in the name of [.], INC. (hereinafter referred as the
“Applicant”).

It is respectfully submitted that,

2. The Opponents are an association of persons registered under the [.] in the
name and style of [“.”] having its registered office [.], the main object of as
follows:-

a) To support the development of international and regional policies, which

seek to ensure, access to medical care for all customers.
b) To promote balanced and generic friendly intellectual property rights in
the pharmaceuticals sector to ensure that timely access to markets is
guaranteed for new and generic pharmaceutical products.
c) To promote the global harmonization relating to generic products.
d) To support the right of all governments to regulate their own pricing,
substitution, prescribing and reimbursement policies.
e) To suggest measures for enhancing pharmaceutical research in India,
both in the areas of basic as well as applied research.
f) To interact with the environmental protection agencies to evolve uniform
standards of environmental protection measures across the country and
ensure implementation of the same.
g) To suggest measures to strengthen the pharmaceutical pricing framework
that ensures an equitable pricing system for industry and consumers.
h) One of the further object of the society is to promote cause of generic
pharmaceutical industry and to provide support for the development of
competition on the off Patent pharmaceutical sector and to prepare
position papers for representing India at international for a to highlight
the problems faced by generic pharmaceutical companies in international
market. It also aims at strengthening regulatory agencies for patenting
registration and quality assurance of drugs and pharmaceuticals by
providing gaudiness to government and international organization in
improving the regulatory and legal expertise relating to registration and
marketing of drugs and pharmaceutical. It also further aims at interacting

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 with the regulatory authorities to streamline the guidelines for clinical
trials and bio-equivalence studies, to ensure expeditious registration of
new as well as existing drugs.

2.1. The subject matter of the opposed specification discloses a

composition comprising a main species HER2 antibody and binds to
domain II of HER2, and acidic variants of that main species antibody
wherein the acidic variants include a disulfide reduced variant and a
non-reducible variant.

2.2. The present invention relates to a composition comprising a main

species HER2 antibody that comprises variable light chain and heavy
chain amino acid sequences in SEQ ID NOs. 3 and 4 as mentioned in
the complete specification and binds to domain II of HER2, and acidic
variants of that main species antibody wherein the acidic variants
include a disulfide reduced variant and a non-reducible variant.

2.3. Although a representation of Opposition can be made by “any person”,

“in writing” under Section 25(1) of The Patents Act, 1970; however,
the Opponents interest in opposing this application is, substantial and
real. The Opponents, therefore, have locus standi in opposing this
application.

2.4. It is respectfully submitted that the Opposed Application entitled

“Composition comprising antibody that binds to domain II of HER2
and acidic variants thereof” has been filed on July 13, 2010 and
published in the Official Journal of the Indian Patent office on
February 03, 2012. The specification of Opposed Application is
attached herewith as Document 7 (D7).

2.5. The Opponents are filing this Representation by way of Opposition

against Indian Patent Application No. [.] (the Opposed Application),
along with documentary evidence and facts in support thereof.

2.6. In this representation by way of opposition, the following grounds

enumerated in Section 25 (1) of The Patents Act, 1970 are relied upon
(hereinafter referred as the “Act”):

a) that the applicant for the patent or the person under or through
whom he claims, wrongfully obtained the invention or any part

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 thereof from him or from a person under or through whom he
claims;

b) that the invention so far as claimed in any claim of complete

specification has been published before the priority date of the
claim –

i) in any specification filed in pursuance of an application for

a patent made in India on or after the 1st day of January,
1912; or
ii) in India or elsewhere, in any other document

Provided that the ground specified in sub-clause (ii) shall not be

available where such publication does not constitute an
anticipation of the invention by virtue of sub-section (2) or
sub-section (3) of section 29;

c) that the invention so far as claimed in any claim of the complete

specification is claimed in a claim of a complete specification
published on or after the priority date of the applicant’s claim
and filed in pursuance of an application for a patent in India,
being a claim of which the priority date is earlier than that of the
applicant’s claim;

d) that the invention so far as claimed in any claim of the complete

specification was publicly known or publicly used in India before
the priority date of the claim.

Explanation:- For the purpose of this clause, an invention

relating to a process for which a patent is claimed shall be
deemed to have been publicly known or publicly used in India
before the priority date of the claim if a product made by that
process had already been imported into India before that date
expect where such importation has been for the purpose of
reasonable trial or experiment only;

e) That the invention so far as claimed in any claim of the complete

specification is obvious and clearly does not involve any
inventive step having regard to the matter published as
mentioned in clause (b) or having regard what was used in India
before the priority date of the applicant’s claim;

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 f) that the subject matter of any claim of the complete specification
is not invention within the meaning of this Act, or is not
patentable under this Act;

g) that the complete specification does not sufficiently and clearly

describe the invention or the method by which it is to be
performed;

h) that the applicant has failed to disclose to the Controller the

information required by section 8 or has furnished the
information which in any material particular was false to his
knowledge;

i) that in the case of convention application, the application was

not made within twelve months from the date of the first
application for protection for the invention made in a convention
country by the applicant or a person from whom he derives title;

j) that the complete specification does not disclose or wrongly

mentions the source or geographical origin of biological material
used for the invention;

k) That the invention so far as claimed in any claim of the complete

specification is anticipated having regard to the knowledge, oral
or otherwise, available within any local or indigenous community
in India or elsewhere;

The present Representation by way of Opposition U/S 25(1) takes into

consideration the following documents. It is humbly submitted that all the
following mentioned documents are cited herein the instant representation in
their entirety.

Document 1 [D1] [.]; Date of publication-[.]

Document 2 [D2] [.]; Date of Patent-[.]
Document 3 [D3] [.]; Date of publication of Application-[.]; Post Grant Journal
Date-[.]
Document 4 [D4] [.]; Date of Patent-[.]
Document 5 [D5] [.]
Document 6 [D6] [.]
Document 7 [D7] Specification of opposed application

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 At the outset, it is respectfully submitted that claims of the impugned
application have been severally amended by the Applicants. The last amended
set of claims filed on [.]contains only Nine (9) claims. Therefore the
Opponents understand that the claims which are now on record are the last
amended claims of [.] and the earlier sets of claims before such an amendment
are therefore no longer available to the Applicants and also that the impugned
application will now proceed with these Nine (9) claims (filed on [.]).
Therefore the Opponents’ comments and arguments regarding
non-patentability of the allegedly claimed subject matter are restricted to the
amended claims of [.].

The Opponents have reproduced the last amended set of claims (of [.]) for the
Ld. Controller’s ready reference.

1. A composition comprising a main species HER2 antibody that comprises

variable light chain and heavy chain amino acid sequences in SEQ ID
NOs. 3 and 4 respectively and binds to domain II of HER2 and acidic
variants of that main species antibody, wherein the acidic variants
include a disulfide reduced variant and a non-reducible variant.
2. The composition as claimed in claim 1 wherein the acidic variants
comprise glycated variant, deamidated variant, and sialylated variant.
3. The composition as claimed in claim 1 or claim 2 wherein the amount of
the acidic variant is less than 25%.
4. The composition as claimed in claim 1 or claim 2 wherein the main
species HER2 antibody and the acidic variants are all intact antibodies.
5. The composition as claimed in claim 1 wherein the main species HER2
antibody comprises light chain and heavy chain amino acid sequences in
SEQ ID NOs. 15 and 16, respectively.
6. The composition as claimed in claim 1 comprising an amino-terminal
leader extension variant of the main species antibody.
7. The composition as claimed in claim 6 wherein the amino-terminal
leader extension comprises or consists of VHS-.
8. The composition as claimed in claim 1 comprising an amino acid
sequence variant of the main species HER2 antibody comprising a
C-terminal lysine residue on one or both heavy chains thereof, and/or
one or more oxidized methionine residues.
9. A pharmaceutical formulation comprising the composition as claimed in
claim 1 or claim 2 in a pharmaceutically acceptable carrier.

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 3. Lack of Novelty [Section 25(1)(b)]

As far as novelty of the alleged claimed subject matter is concerned, the

Opponents take following documents into consideration in their entirety. All
the following documents were published before the priority date of the
impugned invention and therefore form part of the state-of-the-art.

Document 1 [D1] [.]; Date of publication-[.]

Document 2 [D2] [.]; Date of Patent-[.]
Document 3 [D3] [.]; Date of publication of Application-[.]; Post Grant Journal
Date-[.]
Document 4 [D4] [.]; Date of Patent-[.]

3.1. Prior Art Document D1

It is respectfully submitted that the prior art document D1 discloses a

composition comprising a main species HER2 antibody that binds to
domain II of HER2, and an amino acid sequence variant thereof
comprising an amino-terminal leader extension. The “Pertuzumab or
rhuMAb2C4” is the exemplified antibody.

D1 further on page 5 defines that amino acid sequence variants include

an acidic variant (e.g. a deamidated antibody variant), a basic variant,
the antibody with an amino-terminal leader extension (e.g. VHS-) on
one or two light chains thereof, antibody with a C-terminal lysine
residue on one or two heavy chains thereof, antibody with one or more
oxidized methionine residues, etc. and includes combinations of
variations to the amino acid sequences of heavy and/or light chains. D1
further teaches that the antibody variant of particular interest herein is
the antibody comprising an amino-terminal leader extension on one or
two light chains thereof, optionally further comprising other amino
acid sequence and/or glycosylation differences relative to the main
species antibody.

D1 further on page 20 teaches HER2 antibody variant compositions

wherein the preferred HER2 antibody is Pertuzumab (Please see lines
16-19). D1 further teaches that the composition comprises a mixture of
the main species HER2 antibody and an amino acid sequence variant
thereof comprising an amino-terminal leader extension (Please see
page 20; lines 20-21). As discussed above amino acid variant includes
acidic and basic variants, D1 teaches compositions comprising

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 Pertuzumab and amino acid variants which include acidic variants,
basic variants and amino-terminal extensions.

As per currently amended Claim 1 of the opposed application claims

“A composition comprising a main species HER2 antibody that
comprises variable light chain and heavy chain amino acid sequences
in SEQ ID NOs. 3 and 4 respectively and binds to domain II of HER2,
and acidic variants of that main species antibody, wherein the acidic
variants include a disulfide reduced variant and a non-reducible
variant.” Here, the main species HER2 antibody is Pertuzumab.

Now, the Opponents would like to invite the kind attention of the Ld.
Controller towards the explanation of the words “Comprising” and
“Consisting” provided by the European Patent Office Guidelines for
Examination (Please see D6).

“4.21 “Comprising vs. consis ng”

While in everyday language the word “comprise”
may have both the meaning “include”, “contain” or
“comprehend” and “consist of”, in dra ing patent
claims legal certainty normally requires it to be
interpreted by the broader meaning “include”,
“contain” or “comprehend”. On the other hand, if a
claim for a chemical compound refers to it as
“consis ng of components A, B and C” by their
propor ons expressed in percentages, the presence
of any addi onal component is excluded and
therefore the percentages should add up to 100%
(see T 759/91 and T 711/90).”

Therefore, use of the word “Comprising” in the currently amended

Claim 1 of the opposed application itself indicates that the composition
of alleged Claim 1 must contains other amino-acid variants also, e.g.
amino-terminal extension. Similarly, the composition comprising
Pertuzumab and amino acid sequence variants disclosed and taught in
D1 must also contain acidic and basic variants along with
amino-terminal extensions.

Further, the Applicants of the opposed application have not defined the
amount of the acidic variants in the allegedly claimed composition.
Claim 3 claims the amount of the acidic variants less than 25%. This
means the composition allegedly claimed in the currently amended

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 Claim 1 contains acidic variants from below detectable limit to less
than 25%.

Since, D1 also discloses composition comprising Pertuzumab and

amino acid sequence variants it is also possible that the composition of
D1 comprises acidic variants allegedly claimed in the opposed
application. Further, the Applicants have not provided comparison
between the composition taught in D1 and the alleged composition of
the opposed application. In absence of such comparison there is no
reason to believe that the composition of D1 does not contain acidic
variants as allegedly claimed in the opposed application.

Therefore it is respectfully submitted that the composition of the

opposed application allegedly claimed in Claims 1 to 9 lacks novelty
over D1.

3.2. Prior Art Document D2

It is respectfully submitted that the prior art document D2 teaches

ErbB2 (HER2) antibody Pertuzumab. Further, D2 in column 9 defines
amino acid sequence variant which refers to polypeptides having amino
acid sequences that differ to some extent from a native sequence
polypeptide. Ordinarily, amino acid sequence variants will possess at
least about 70% homology with at least one receptor binding domain of
a native ErbB ligand or with at least one ligand binding domain of a
native ErbB receptor, and preferably, they will be at least about 80%,
more preferably at least about 90% homologous with such receptor or
ligand binding domains. The amino acid sequence variants possess
substitutions, deletions, and/or insertions at certain positions within the
amino acid sequence of the native amino acid sequence. Thus,
Pertuzumab comprising amino acid sequence variant is already known
in D2.

Further, the Applicants of the opposed application have not defined the
amount of the acidic variants in the allegedly claimed composition.
Claim 3 claims the amount of the acidic variants less than 25%. This
means the composition allegedly claimed in the currently amended
Claim 1 contains acidic variants from below detectable limit to less
than 25%.

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 Since, D2 also discloses Pertuzumab comprising amino acid sequence
variants it is also possible that the composition of D2 comprises acidic
variants allegedly claimed in the opposed application. Further, the
Applicants have not provided comparison between the composition
taught in D2 and the alleged composition of the opposed application. In
absence of such comparison there is no reason to believe that the
composition of D2 does not contain acidic variants as allegedly
claimed in the opposed application.

Therefore it is respectfully submitted that the composition of the

opposed application allegedly claimed in Claims 1 to 9 lacks novelty
over D2.

3.3. Prior Art Document D3

The prior art document D3 is an Indian Patent bearing number [.]

which was granted on Application number [.]. Claim 1 of D3 claims a
composition comprising a mixture of anti-HER2 antibody and one or
more acidic variants thereof, wherein the amount of the acidic
variant(s) is less than 25%. Though D3 exemplifies huMAb4D5-8,
neither description nor claims of D3 excludes Pertuzumab from the
scope of invention disclosed and taught in D3. Thus, Pertuzumab is
intrinsically covered within the scope of the invention of D3.

Therefore it is respectfully submitted that the composition of the

opposed application allegedly claimed in Claims 1 to 9 lacks novelty
over D3.

3.4. Prior Art Document D4

The prior art document D4 is a granted US Patent bearing number [.].

Claim 1 of D4 claims a composition comprising a mixture of
anti-HER2 antibody and one or more acidic variants thereof, wherein
the amount of the acidic variant(s) is less than 25%. Though D4
exemplifies huMAb4D5-8, neither description nor claims of D4
specifically excludes Pertuzumab from the scope of invention disclosed
and taught in D4. Thus, Pertuzumab is intrinsically covered within the
scope of the invention of D4.

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 Therefore it is respectfully submitted that the composition of the
opposed application allegedly claimed in Claims 1 to 9 lacks novelty
over D4.

3.5. Claimed composition lacks novelty over known “Pertuzumab”

It is respectfully submitted that before the priority date of the impugned

invention anti-HER2 antibody-Pertuzumab was very well known.
Further, in absence of the comparative study that how much earlier
known Pertuzumab significantly differs from the Pertuzumab now
claimed in the opposed application, the impugned invention is nothing
but a mere characterization of a known product-Pertuzumab and is
therefore not novel. The impugned invention is a discovery rather than
an invention (Please see D6).

Further, the Applicants have themselves on page 69 admitted that

“forms identified in acidic variants generated by main peak incubated
with media were same as those identified in pertuzumab starting
material.”

Further, the Applicants admitted that “acidic fraction isolated from

pertuzumab starting material and those generated by incubation of
CEX main peak contained the same forms.” This means the
Pertuzumab comprising acidic variants as claimed in the opposed
application is already known in the prior art.

4. Lack of Inventive Step [Section 25(1)(e)]

As far as inventive step of the alleged claimed subject matter is concerned, the
Opponents take following documents into consideration in their entirety. All
the following documents were published before the priority date of the
impugned invention and therefore form part of the state-of-the-art. The Ld.
Controller is respectfully prayed to consider following submissions separately
along with the arguments made u/s 25(1)(b).

Document 1 [D1] [.]; Date of publication-[.]

Document 2 [D2] [.]; Date of Patent-[.]
Document 3 [D3] [.]; Date of publication of Application-[.]; Post Grant Journal
Date-[.]
Document 4 [D4] [.]; Date of Patent-[.]

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 4.1. Obviousness in view of Documents D1 to D4 and in further view of
general teachings and knowledge available to a skilled person

The Opponents would like to rely on the foregoing submissions for

showing lack of novelty. The arguments made above are not
reproduced for the sake of brevity.

D1 teaches composition comprising Pertuzumab and amino acid

sequence variants. D1 further exemplifies and teaches what these
amino acid sequence variants are, e.g. acidic variants, basic variants,
amino-terminal extensions etc. D1 also teaches process for the
preparation of composition comprising Pertuzumab and amino acid
sequence variants.

D2 teaches the HER2 antibody Pertuzumab which comprises amino

acid sequence variants. D3 & D4 teaches composition comprising a
mixture of anti-HER2 antibody and one or more acidic variants thereof,
wherein the amount of the acidic variant(s) is less than 25%. Though
D3 & D4 exemplifies huMAb4D5-8, neither description nor claims of
D4 specifically excludes Pertuzumab from the scope of invention
disclosed and taught in D3 & D4. Thus, Pertuzumab is intrinsically
covered within the scope of the invention of D3 & D4.

Thus, at the priority date of the present invention the Applicants knew
that a composition comprising HER2 antibody and acidic variants can
be prepared. From D1 the Applicants also knew that the composition
comprising HER2 antibody and acidic variants possess the same effect
as compared to main species antibody.

Even if it is accepted for the sake of arguments that prior art documents
do not teach composition comprising Pertuzumab and acidic variants
thereof as claimed in the opposed application, knowing the fact that
composition comprising Pertuzumab and amino-terminal extension
(VHS-) (from D1) and compositions comprising other HER2
antibodies (e.g. rhuMAb4D5-8/ huMAb4D5-8/Trastuzumab) and acidic
variants (from D3 & D4), any person who is reasonably skilled in the
art will be motivated to use teachings of D1, D2, D3 and D4 to prepare
composition comprising Pertuzumab and acidic variants as allegedly
claimed in the opposed application.

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 It should be noted that the Applicants have followed a very well known
process for the preparation of the alleged composition. The Applicants
themselves have admitted on page 67 of the specification of the
opposed application that the purpose of the study of the opposed
application was to better understand the impact of cell culture and
recovery process on Pertuzumab acidic variant formation,
characterize the predominant acidic variants of Pertuzumab and
evaluate the impact of acidic variants on pharmacokinetics.

Further, the Applicants themselves have admitted that the Rat

pharmacokinetic results show that the area under the curve for the
acidic variant fraction and main peak fraction were equivalent to
Pertuzumab starting material. This means even the PK profile is same
and therefore it can be concluded that the alleged composition does not
show any surprising or superior technical effect over the earlier known
Pertuzumab.

Therefore it is humbly submitted that the composition allegedly

claimed in the currently amended Claims 1-9 lacks inventive step and
is obvious over the teachings contained in D1 to D4 in further view of
general teachings and knowledge available to a skilled artisan.

4.2. No surprising or superior technical effect associated with the

alleged invention “composition comprising Pertuzumab and acidic
variants”

The Applicants themselves have on page 67 admitted that Rat

pharmacokinetic results show that the area under the curve for the
acidic variant fraction and main peak fraction were equivalent to
Pertuzumab starting material. The Applicants have further admitted
that these results demonstrate that although acidic variants are
chemically different from the main peak they have equivalent
pharmacokinetics.

The Applicants further on page 69 admitted that acidic variants, main

peak, and Pertuzumab starting material had the same
pharmacokinetics. This means the alleged composition of the opposed
application does not possess any superior effect over prior known
Pertuzumab.

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 4.3. The pharmaceutical formulation allegedly claimed in the currently
amended Claim 9 of the opposed application lacks inventive step
over general teachings and knowledge of a skilled person

It should be noted that the Applicants of the opposed application have

not provided any example illustrating preparation of the alleged
formulation of Claim 9. This means the alleged formulation can be
prepared by any technique known in the prior art and to a skilled
person. The fact that the Applicants did not require to provide an
example for the alleged formulation, itself shows that the formulation
is so obvious that it can be prepared by any person reasonably skilled
in the art and does not require special teachings for the same.

It should be also noted that the Applicants have not provided surprising
or superior effect of the alleged formulation rendering the claimed
formulation obvious over prior art (say for example that taught in D1
and D2).

Therefore it is humbly submitted that the currently amended Claim 9 is

obvious and not patentable.

5. Non-Patentable Subject Matter [Section 25(1)(f)]

5.1. Section 3(d)

According to Section 3(d) of the Patents Act, 1970 as amended by the

Patents (Amendment) Act, 2005, “the mere discovery of a new form of
a known substance which does not result in the enhancement of the
known efficacy of that substance or the mere discovery of new property
or new use for a known substance or of the mere use of a known
process, machine or apparatus unless such known process results in a
new product or employs at least one new reactant;”

Explanation.--- For the purpose of this clause, salts, esters, ethers,

polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known
substance shall be considered to be the same substance, unless they
differ significantly in properties with regard to efficacy.”

5.1.1. It is respectfully submitted that currently amended Claim 1 and

Claims 2-8 dependent on Claim 1 of the opposed application

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 are not patentable under Section 3(d) of the Patents Act, 1970
as amended by the Patents (Amendment) Act, 2005.

The Applicants have on page 67 of the opposed application

themselves have admitted that acidic variants of monoclonal
antibodies are modified forms of the desired product (i.e.
known compound). Thus, the composition allegedly claimed in
currently amended Claim 1 as well as dependent Claims 2-8
thereof is the new form of a known substance and therefore
attracts provisions of Section 3(d) of the Act.

The Applicants of the opposed application on page 67 of the

specification have themselves admitted that Rat
pharmacokinetic results show that the area under the curve for
the acidic variant fraction and main peak fraction were
equivalent to Pertuzumab starting material. The Applicants
have further admitted that the pharmacokinetic study results
demonstrate that although acidic variants are chemically
different from the main peak they have equivalent
pharmacokinetics. The Applicants’ this statement is self
explanatory that the alleged composition does not show
enhancement in the known therapeutic efficacy over
Pertuzumab which is the known substance.

The Applicants further on page 69 of the opposed application

admitted that acidic variants, main peak and Pertuzumab
starting material had the same pharmacokinetics. Thus, the Ld.
Controller may please note that the Applicants have not shown
enhancement in the known therapeutic efficacy and therefore
the allegedly claimed composition does not satisfy the
requirements of Section 3(d) and is therefore not patentable.

5.2. Section 3(e)

According to Section 3(e) of the Indian Patent Act, “a substance

obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such
substance;”

5.2.1. It is respectfully submitted that currently amended Claim 9 of

the opposed application is not patentable under Section 3(e) of

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 the Patents Act, 1970 as amended by the Patents (Amendment)
Act, 2005. The Applicants of the opposed application have not
shown any surprising or superior effect of the claimed
pharmaceutical formulation. The Ld. Controller may please
note that the Applicants have also not provided comparison
between the alleged formulation and prior known formulation
of Pertuzumab. In absence of such surprising effect, the alleged
formulation is considered to be a substance obtained by mere
admixture resulting only into aggregation of the properties of
the components thereof and is therefore not patentable under
Section 3(e) of the Act.

The Ld. Controller may also note that the Applicants have not
provided any example for the alleged pharmaceutical
formulation. Since the Applicants have not provided example
for the alleged pharmaceutical formulation, question of
possessing surprising properties does not even arise.

6. Lack of Clarity and Insufficiency [Section 25(1)(g)]

6.1. It is respectfully submitted that Claim 1 of the opposed application

lacks clarity and sufficiency and is not enabled in view of the
disclosure and teachings provided in the specification of the opposed
application.

The Ld. Controller may please note that the Applicants have not
provided biological source of the biological material (i.e. cell culture
media) used in Example 1 for the preparation of the alleged
composition of the opposed application. According to Example 1 of the
opposed application the main peak of Pertuzumab was collected from a
cation exchange column and incubated in cell culture media. The
acidic variants were formed upon incubation of main peak with
cell culture media components. Here, the Applicants have not
mentioned which cell culture media was used and also the biological
source thereof.

The Ld. Controller would very well appreciate that the Applicants
themselves have mentioned in Example 1 that the purpose of this study
was to better understand the impact of cell culture and recovery
processes on Pertuzumab acidic variant formation. Thus, it is self

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 explanatory that the cell culture media has impact on the formation of
Pertuzumab acidic variants.

Therefore it is humbly submitted that the Applicants have neither

sufficiently disclosed which cell culture media (biological material) is
to be used nor disclosed source or geographical origin thereof. In
absence of such mandatory requirements the specification of the
opposed application does not enable a person to work the invention to
its fullest. Since, the cell culture media has impact on the Pertuzumab
acidic variant formation, which cell culture will provide the desired
composition of an antibody and acidic variants is not clear.

Further, the Applicants have also not mentioned in how much amount
the claimed acidic variants are present in the claimed antibody, i.e.
Pertuzumab. Thus, the claimed composition is claiming from
non-detectable amount of acidic variants to less than 25% (as per
currently amended Claim 3 of the opposed application) of the acidic
variants.

If the scope of the currently amended Claim 1 of the opposed

application covers composition comprising Pertuzumab and any
amount of acidic variants from non-detectable limit to less than 25%
then it is anticipated by the cited prior art documents because prior art
documents also teach Pertuzumab. Since the Applicants have not
defined the lowest limit of acidic variants contained in the claimed
composition, the claimed acidic variants must have been present in the
earlier taught Pertuzumab. Therefore the claimed composition is
anticipated by the teachings and disclosure of the prior art documents
which teach Pertuzumab.

Further, the Applicants have also not provided comparison between the
prior known Pertuzumab and allegedly claimed Pertuzumab. How the
allegedly claimed Pertuzumab is superior or beneficial over prior art is
also not clearly disclosed in the specification of the opposed
application.

6.2. Ld. Controller may please note that the Applicants have not provided
any example teaching pharmaceutical formulation allegedly claimed in
currently amended Claim 9 of the opposed application.

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 The Applicants have also not provided which pharmaceutically
acceptable carrier is useful or has been used for preparing the alleged
pharmaceutical formulation. The Applicants have also not provided
how many pharmaceutically acceptable carriers have been used and
what is the role of each and every pharmaceutically acceptable carrier
used.

The Applicants have also not provided exact ratio in which the active
ingredient, i.e. alleged composition and the pharmaceutically
acceptable carrier is to be mixed.

The Applicants have also not provided what is that surprising effect
which has been achieved by means of the alleged pharmaceutical
formulation.

In absence of all of the above mandatory teachings and disclosure, the

alleged invention is not considered to be sufficiently disclosed and
lacks clarity. The specification of the opposed application therefore
does not enable a person skilled in the art to carry out or work the
invention to its fullest.

7. Section 25(1)(h)

It is respectfully prayed that the Ld. Controller should check whether the
Applicants of the impugned application have dutifully informed the status of
their co-pending applications, their prosecutions in the other convention
countries as required under Section 8 of the Patents Act, 1970. If such
information is not provided, it is respectfully submitted that the impugned
application is liable to be rejected on this ground alone.

8. Section 25(1)(j)

The Ld. Controller may please note that the Applicants have not provided
biological source of the biological material (i.e. cell culture media) used in
Example 1 for the preparation of the alleged composition of the opposed
application. According to Example 1 of the opposed application the main peak
of Pertuzumab was collected from a cation exchange column and incubated in
cell culture media. The acidic variants were formed upon incubation of
main peak with cell culture media components. Here, the Applicants have
not mentioned which cell culture media was used and also the biological
source thereof.

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 The Ld. Controller would very well appreciate that the Applicants themselves
have mentioned in Example 1 that the purpose of this study was to better
understand the impact of cell culture and recovery processes on Pertuzumab
acidic variant formation. Thus, it is self explanatory that the cell culture
media has impact on the formation of Pertuzumab acidic variants.

Therefore it is humbly submitted that the Applicants have neither sufficiently

disclosed which cell culture media (biological material) is to be used nor
disclosed source or geographical origin thereof.

9. The Opponents humbly submit that Claims 1-9 as amended in the impugned
Indian Patent Application No. [.] are neither novel nor inventive or are
otherwise not patentable under the Act. The impugned application also does
not sufficiently and clearly describes the alleged invention for it to be carried
out by a person skilled in the art.

10. In view of the aforementioned submissions, it is respectfully submitted that the

impugned application lacks clarity and sufficiency, i.e. the description of the
impugned application does not enable a person reasonably skilled in the art to
achieve the results of the present invention as claimed, without inventive
merit.

11. Accordingly, it is respectfully submitted that the impugned application does

not contain sufficient information to enable the person skilled in the art to
perform the invention disclosed in the impugned Indian Patent Application
No. [.]. Therefore, this ground of opposition has been established and the
entire impugned application ought to be rejected on this ground alone.

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Prayers

12. In view of the submissions presented above, we humbly pray that,

1. the Indian Patent Application No. [.] be dismissed in toto;

2. the opponent be granted leave to file further evidence;
3. the copy of the reply statement and evidence filed by the applicant in
the matter of the present opposition proceedings be made available to
the opponent;
4. the opponent be permitted to file further response and evidence to the
reply or evidence produced by the applicant;
5. the opponent be granted leave to make further submissions in case the
applicant makes any amendments in the claims and the complete
specification;
6. any other relief as the Learned Controller may deem fit be awarded in
favor of the opponents.

As a matter of precaution we request the Learned Controller to grant us an oral

hearing before disposing of this representation.

Dated this the day of 2017 __________________

Divya Dutta
Constituted Attorney for
the Opponent
IPA no. [.]

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