Template - Draft of Patent Opposition Application-1587132532
Template - Draft of Patent Opposition Application-1587132532
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REPRESENTATION BY WAY OF OPPOSITION U/S 25(1)
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:-
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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.
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;
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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;
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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.
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3. Lack of Novelty [Section 25(1)(b)]
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Pertuzumab and amino acid variants which include acidic variants,
basic variants and amino-terminal extensions.
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).
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%.
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.
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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.
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).
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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
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.
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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 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).
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are not patentable under Section 3(d) of the Patents Act, 1970
as amended by the Patents (Amendment) Act, 2005.
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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.
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.
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.
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.
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.
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.
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Prayers
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