Calcutta High Court
Pharmacyclics Llc vs Deputy Controller Of Patents & Designs on 2 September, 2025
IN THE HIGH COURT AT CALCUTTA
ORIGINAL SIDE
COMMERCIAL DIVISION
Present:
The Hon'ble Justice Krishna Rao
I.P.D.P.T.A. No. 4 of 2024
PHARMACYCLICS LLC
Versus
DEPUTY CONTROLLER OF PATENTS & DESIGNS
Ms. Archana Shankar
Ms. Mini Agarwal
... For the appellant.
Mr. Swatarup Banerjee
Ms. Sarda Sha
... For the respondent.
Hearing Concluded On : 05.08.2025
Judgment on : 02.09.2025
Krishna Rao, J.:
1. This is an appeal under Section 117(A) of the Patents Act, 1970 against
the order passed by the Deputy Controller of Patents and Designs dated
5th March, 2024 rejecting the grant of patent to Indian Patent
Application No. 201838043708. The said application is a dismissal
application filed under Section 16 of the Indian Patents Act being
3985/KOLNP/2012. The claims of patent application was directed to
"A compound (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-
d]pyrimidin- 1-yl)piperidin-1-yl)prop-2-en-1-one for use in treating
relapsed or refractory non-Hodgkin's lymphoma".
2. On 20th November, 2018, the appellant filed divisional application in
order to claim an invention directed to a combination of compound
of formula I an anti-CD20 antibody selected from
rituximab and ofatumumab disclosed in the patent specification. The
said divisional application was filed with 15 claims. The pending claims
of the divisional application are directed to a combination of ibrutinib
with an anti-CD20 antibody, such as rituximab or ofatumumab. The
said combination demonstrates unexpected results which supports the
inventiveness of the claims.
3. The claim of the appellant was rejected by an impugned order dated 5th
March, 2024, on the following grounds:
a. The parent application was filed with 133 claims directed to
method for treating a hematological malignancy in an
individual a need thereof, comprising :
i. administering to the individual an amount of an
irreversible Btk inhibitor sufficient to mobilize a
plurality of cells from the malignancy; and
ii. analyzing the mobilized plurality of cells.
b. On 24th December, 2012, the Applicant amended the claims of
the parent application into product claims (33).
c. At the time of filing the divisional application, the Applicant
changed the scope of the originally filed claims and amended
the claims into combination claims.
d. The reason provided for the amendment filed on 24th December,
2012 was given to be voluntary amendment and clearly stated
to be restricted in nature.
e. The appellant ought to have provided reasons for making the
said amendment.
4. In the divisional application, the appellant pursued claims directed a
combination of two active ingredients, namely: (a) Ibrutinib and (b)
rituximab/ofatumumab.
5. For the first time in the hearing notice, the respondent raised the issue
with regard to the maintainability of the divisional status of the Indian
Patent Application No. 201838043708 as well as amendment of the
claims as not permissible under Sections 57-59 of the Indian Patents
Act.
6. First Examination Report was issued on 18th December, 2019 in the
said report, the following objections were made :
i. Lack of novelty in view of document US2010041677 (D1) and an
observation was made that :
"The applicant has said that the mother
application covers the inventive concept of A
Heterocycle-Substituted Piperidine of Formula D'
wherein the instant divisional application claims
the group from which a Piperidine compound is
selected. Hence the instant application deserves
the merit of a divisional application. But It is also
observed that the claimed markush claims of the
mother application fall within the scope of claim 1
of the instant application. Hence, amended claims
1 of the instant purported divisional application is
anticipated by claims 33 of the purported mother
application under Section 13 of the Act and
therefore is not patentable and the subject-matter
of the claims of the instant application inconsistent
with the subject matter of claims of purported
mother application."
7. In the First Examination Report, no objection with regard to either the
maintainability of the divisional application or amendment of the claims
was raised. In the First Information Report, the respondent made an
observation that the claims of the divisional application are adequately
supported by claim 33 of the mother (parent) application which
effectively means that the claims were supported by the mother
application. In the divisional application, the appellant pursued claims
directed a combination of two active ingredients, namely : (a) Ibrutinib
and (b) rituximab/ofatumumab. The request for amendment was filed
in the parent application which is not a divisional application that was
pending adjudication before the respondent.
8. In the case of Guangdong Oppo Mobile Telecommunications Corp.,
Ltd. vs. The Controller of Patents and Designs reported in
MANU/WB/1263/2023, the Coordinate Bench of this Court held that
on the question of issuance of the Second Examination Report, Section
13(3) of the Act makes it apparent that upon amendment of the claims,
the amendment application ought to be examined in a manner similar
to the original application. When a complete specification is amended,
such amended specification should be re-examined and a Report issued
in the manner stipulated under Section 12 of the Act.
9. The subject matter of the divisional application under Section 16 is in
relation to combination of two active ingredients, namely : (a) Ibrutinib
and (b) rituximab/ ofatumumab which was disclosed in the parent
complete specification, now forms the subject matter of the divisional
application.
10. Section 16 of the Patents Act, 1970, reads as follows :
"16. Power of Controller to make orders
respecting division of application.-- (1) A
person who has made an application for a patent
under this Act may, at any time [before the grant of
the patent], if he so desires, or with a view to
remedy the objection raised by the Controller on the
ground that the claims of the complete specification
relate to more than one invention, file a further
application in respect of an invention disclosed in
the provisional or complete specification already
filed in respect of the first mentioned application.
(2) The further application under sub-section
(1) shall be accompanied by a complete
specification, but such complete specification shall
not include any matter not in substance disclosed
in the complete specification filed in pursuance of
the first mentioned application.
(3) The Controller may require such
amendment of the complete specification filed in
pursuance of either the original or the further
application as may be necessary to ensure that
neither of the said complete specifications includes
a claim for any matter claimed in the other.
[Explanation.-- For the purposes of this Act,
the further application and the complete
specification accompanying it shall be deemed to
have been filed on the date on which the first
mentioned application had been filed, and the
further application shall be proceeded with as a
substantive application and be examined when the
request for examination is filed within the
prescribed period.]"
Section 16 of the act provides that a further divisional application
shall be accompanied by complete specification but such complete
specification shall not include any matter not in substance disclosed in
the complete specification filed in pursuance of first mentioned
application. According to Section 16(3), the complete specification of the
divisional application should not include a claim for any matter claimed
in other application. The parent application is directed to method for
treatment which was later amended to compound (R)-1-(3-(4-amino-3-(4-
phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin- 1- yl)piperidin-1-yl)prop-2-
en-1-one for use in treating relapsed or refractory non-Hodgkin's
lymphoma whereas the present divisional application. Therefore, the
divisional application is filed during the pendency of the parent
application, disclosed in the complete/provisional specification and
relates to plurality of inventions. The parent application is for
"Compound" whereas the claims for the divisional application is for "a
combination of two active ingredients".
11.
CLAIM 1 OF PARENT CLAIM 1 OF DIVISIONAL
APPLICATION AS FILED APPLICATION
A method for treating a A combination comprising a com
hematological malignancy in an pound having structure
individual in need thereof,
comprising:
a. administering to the
individual an amount of an
irreversible Btk inhibitor
sufficient to mobilize a
plurality of cells from the
malignancy and
b. analyzing the mobilized And an anti-CD20 antibody
plurality of cells. selected from rituximab and
ofatumumab.
Claim 1 as amended on
December 26, 2012:
A compound (R)-1-(3-(4-amino-3-(
4-phenoxyphenyl)-1H-
pyrazolo[3,4-d]pyrimidin-1-
yl)piperidin-1-yl)prop-2-en-1-one
for use in treating relapsed or
refractory non-Hodgking's
lymphoma.
12. The requirement of Section 16(3) of the Patents Act, 1907 is met if that
divisional application claims is based on the disclosure in the complete
specification, there will be no overlapping of the claims of the parent
and divisional application and there is no requirement that the claims
of the divisional application should be based on the original PCT claims
filed with the parent application. In the present divisional application,
no voluntary amendment was filed. The application was filed in relation
to a combination, specifically, based on the Patent Amendment Rules,
2004. The subject-matter of the divisional application is not limited to
what was claimed in the parent application, as long as the divisional
claims are supported by the entire specification as originally filed.
13. The unexpected technical advantage of the combination of the two
active ingredients are:
i. The problem with administering anti CD20 antibody was that it
resulted in infusion related reactions [symptoms experienced
by patient during infusion of a drag or an antibody
(biological agent following the first day of drug
administration)] that resulted in discontinuation of treatment.
ii. When a BTK inhibitor (Ibrutinib) is given with anti CD20
antibody, it reduces the immune mediated reactions caused by
the anti CD20 antibody and therefore, there is clearly
synergistic effect. The patent specification extensively provides
different forms of pharmaceutical compositions according to the
present invention.
iii. The data filed along with the response to the first examination
report by the appellant demonstrates that the combination of
Ibrutinib with anti-CD20 antibodies provided excellent efficacy.
14. In the case of Syngenta Limited vs. Controller of Patents & Designs
reported in 2023: DHC: 7473-DB, the Hon'ble Division Bench of the
Delhi High Court held that:
"31. We find ourselves unable to subscribe to
the view expressed in Boehringer Ingelheim and
when it seeks to base its conclusions on the precept
as formulated by Lord Russel for the following
additional reasons. It would be apposite to recall
that Section 16 speaks both of a provisional or a
complete specification. However, in the case of a
provisional filing, claims need not be specified at
all. If the view as expressed in Boehringer
Ingelheim were to be accepted no Divisional
Application would be maintainable in a case where
a provisional specification has been presented. This
since the decision bids us to discover the invention
solely in the claim.
32. We thus find ourselves unable to concur
with the view as expressed in Boehringer
Ingelheim and the said judgment shall
consequently stand overruled. We hold that a
Divisional Application moved in terms of Section 16
of the Act would be maintainable provided the
plurality of inventions is disclosed in the
provisional or complete specification that may have
been filed. We are further of the considered opinion
that Section 16 does not suggest or conceive of a
distinction between the contingency of a Divisional
Application when moved by the applicant of its own
motion or where it comes to be made to remedy an
objection raised by the Controller. In either of those
situations, the plurality of inventions would have to
be tested based upon the disclosures made in
either the provisional or complete specification. The
Reference stands answered accordingly.
15. In the case of Gensquare LLC vs. The Assistant Controller of
Patents and Design passed in CMA(PT) No. 35 of 2023 dated 13th
March, 2024, the Madras High Court held that:
"3. Heard both sides. The learned counsel for
the appellant submitted that the authority relied on
by the Patent Controller was since overruled by a
Division Bench of Delhi High Court in Syngenta
Limited Vs Controller of Patents and Designs [2023
SCC OnLine Del 6392]. She further added that
Sec.16 of the Patent Act only requires that the
divisional application must flow from the
specification in the parent application, and does not
say that the claims made in the divisional
application must flow from the claims made in the
parent application. This precisely is the reason why
in Syngenta Limited case the Court chose to
overrule the earlier view of the learned Single
Judge."
16. In the case of Victaulic Company vs. The Controller of Patents and
Designs passed in CMA(PT) No. 14 of 2024 dated 26th July, 2024,
the Madras High Court held that:
"6. The Judgment of the Delhi High Court has
been followed by this Court also in CMA (PT) No. 35
of 2023 dated 13.03.2024 in the case
of GENSQUARE LLC v. Assistant Controller of
Patents and Design, Patent Office, Chennai, where
this Court, taking note of the decision of the Hon'ble
Division Bench of the Delhi High Court, held that
the Patent Act only requires that the divisional
application ought to flow from the specifications in
the parent application, and it does not say that the
claims made in the divisional application to flow
from the claims made in the parent application.
Hence, the issue is no longer res judicata.
Unfortunately, the respondent has acted against
the ratio laid down by the Hon'ble Division Bench
of the Delhi High Court in Syngenta Limited's
case and on this limited ground alone, the rejection
order passed by the respondent deserves to be set
aside.
7. In fine, the appeal is allowed and the
matter is remitted to the respondent
for denovo examination, after affording an
opportunity by way of a fresh hearing to the
appellant. In order to avoid embarrassment to
parties, a different Patent Controller shall be
assigned for the scrutiny of the patent application
and such exercise shall be completed within a
period of three months from the date of receipt of
copy of this judgment. There shall be no order as to
costs."
17. In the case in hand, the respondent by an order dated 5th March, 2024,
rejected the divisional application of the appellant by placing reliance
on the claims of the parent application. Under Section 16(4) of the
Patents Act, 1970 once having recognized the maintainability of the
divisional application in the First Examination Report, under Section
16(3) explanation, the respondent should have proceeded as a
substantive application wherein the outcome of the parent has no
bearing on the examination of the divisional application.
18. Section 16(3) of the Act provides that divisional application (further
application) "shall be proceeded as a substantive application and be
examined when the request for the examination is filed within the
prescribed period". The appellant has not filed any amendment
application as the claims filed along with the divisional application and
filed along with written submissions were identical. There is no conflict
between claim 1 of the divisional application and the claim 33 of the
parent application, as claim 33 is for a compound for Formula D and
claim 1 of the divisional is for combination of two actives.
19. In the case of Allergan INC vs. The Controller of Patents reported in
2023/DHC/000515, the Delhi High Court held that:
"43. The very use of the expression "scope of
a claim" in the concluding part of Section 59(1)
would, therefore, in my considered opinion and
keeping in mind the avowed purpose of the Patents
Act, required taking into consideration the complete
specifications of the pre-amended claim, and not
merely a textually cabined reading of the pre-
amended claims themselves, de hors the complete
specifications."
As regard to the amendments are concerned, no amendments were
effected in the divisional application. An amendment of claim is
permissible as long as it is supported by description.
20. Considering the above, this Court finds that the order passed by the
respondent dated 5th March, 2024 is not sustainable under law and the
same is set aside and quashed. The matter is remanded back to the
respondent for consideration of the case of the applicant afresh after
giving an opportunity of hearing to the applicant and to pass a
reasoned and speaking order within a period of six (6) months from the
date of receipt of this order. The case of the applicant shall be heard
and disposed of by the competent authority within the specified period
as mentioned above other than the Deputy Controller of Patents and
Designs who passed the impugned order dated 5th March, 2024.
21. I.P.D.P.T.A. No. 4 of 2024 is allowed.
(Krishna Rao, J.)
