1. The present appeal has been filed under Section 117A of the Patents
Act, 1970 (hereinafter 'Act') and is directed against the order dated 18th June,
2021 (hereinafter 'impugned order') passed by the Assistant Controller of
Patents and Designs (hereinafter 'Controller'), whereby the Indian Patent
Application No. 7283/DELNP/2014 titled 'Novel Piperidine Compound or
Salt thereof' (hereinafter 'subject patent application') has been refused.
2. Brief facts necessary for deciding the present appeal are set out below:
2.2. The subject patent application was filed as a national-phase application
under the Patent Cooperation Treaty ('PCT'), claiming priority from a
Japanese Patent Application with a priority date of 27 th August, 2012. The
appellant had filed the subject patent application on 29 th August, 2014, with
the Indian Patent Office, Delhi. The bibliographic details of the application
are given below:
Applicant TAIHO PHARMACEUTICAL
CO. LTD.
Priority Application No. JP2012186534;
& Date
Dated 27th August, 2012
International PCT/JP2013/055064;
Application No. & Filing
Dated 27th February, 2013
Date
PROSECUTION
India Filing Date 29th August, 2014
Date of publication u/s 24th April, 2015
11A
Request for Examination 29th August, 2014
First Examination 28th March, 2018
Report Issue Date
First Examination 20th September, 2018
Report Response Filed
on
Hearing Notice Issued 10th October, 2019
Date
Date of Hearing 18th November, 2019
Written Submissions 29th December, 2019
under Section 14 filed by
Applicant on
Controller Decision 18th June, 2021
2.3. A request for examination of the said application was filed by the
appellant on 29th August, 2014, and the First Examination Report (hereinafter
'FER') was issued on 28th March, 2018. The following substantive objections
were communicated to the appellant via the said FER:
a. Lack of inventive step under Section 2(1)(ja) of the Act;
b. Non patentable under Section 3(d) and 3(i) of the Act;
2.4. In reply to the objections raised in the FER, the appellant's agent
submitted a detailed response vide letter dated 20th September, 2018.
2.5. Thereafter, a hearing was scheduled for 10th October, 2019, and the
following objections were communicated to the appellant vide the hearing
notice:
a. Lack of inventive step under Section 2(1)(ja) of the Act;
b. Non patentable under Section 3(d) of the Act;
2.6. Post hearing, written submissions along with amended claims were
filed by the appellant before the Patent Office on 29th November, 2019.
3. The impugned order was passed by the Patent Office on 18th June, 2021,
refusing the subject patent application on the ground that the claims of the
subject patent application lack inventive step as required under Section
2(1)(ja) of the Act and is non patentable under the Section 3(d) of the Act.
4. The impugned order holds that the compound claimed in the subject
patent application constitutes a new form of known substances already
disclosed in the prior art D11, and fails to demonstrate enhanced therapeutic
efficacy over the compounds disclosed therein as required under Section 3(d)
of the Act. Furthermore, the claimed compound in the subject patent
application is considered obvious to a person skilled in the art in view of the
closest prior art D1, particularly with reference to Examples 15 and 16, and
therefore does not meet the requirement of inventive step under Section
2(1)(ja) of the Act.
5. The relevant extracts from the impugned order are set out below:
5.1. Regarding objection under Section 2(1)(ja) of the Act, the Controller
has held as under:
"E. Disclosures from closest Cited Prior art Dl.
(WO 2009/104802 A1, BANYU PHARMA CO. LTD [JP]; KATO TETSUYA [JP]; KAWANISHI
NOBUHIKO [JP], dated 27 August 2009
_D1 WO 2009/104802 A1 (BANYU PHARMA CO LTD [JP]; KATO
TETSUYA [JP]; KAWANISHI NOBUHIKO [JP];) 27 August 2009 (2009-
08-27)
D1 is most relevant and closest prior art. D1 relates to amino-pyridine
derivatives which are useful in the pharmaceutical field, and more
particularly, to those which inhibit the growth of tumor cells based on an
Aurora A selective inhibitory action and exhibit an antitumor effect, and
also to an Aurora A selective inhibitor and an antitumor agent containing
them having molecular formula I as given below,
X3 is CH, CX3a, or N wherein X3a is a lower alkyl which may be
substituted; provided, however, that among X1, X2 and X3, the number of
nitrogen is 0 or 1;
From above disclosed information molecular formula of compounds of
D1 it is clear that the said pharmaceutical/ therapeutic activity is because
of substituted amino pyrimidine ring wherein the amino substituted
pyrimidine of formula I is having substitution X1,X2,X3.
Thus, the provision of compounds encompassed by the general teaching
of D1 for the same use has to be seen as obvious therefore the problem
of the present application has to be seen in the provision of further
substituted piperidine compounds with an aurora A kinase inhibitory
effect, and their use in cancer therapy exhibiting superior unexpected
effects in relation to the rest of the range of D1.
The presently claimed subject matter in claims 1-4 does not appear to
comply the requirements Section (2)(1)(ja) of The Patents Act, 1970
because the application relates to substituted piperidine compounds with
an aurora A kinase inhibitory effect, and their use in cancer therapy.
Similarly the compounds of D1 are described to have selective Aurora A
inhibitory action from same backbone chemical structure (skeleton ) of
the compounds from D1. In present application the derivatization
occurred in terms of R1,R2,R3, R4 at different sites of the molecule of
formula (I) however the basic backbone structure remained same as of
disclosure of D1. As for as substituents in terms of R1,R2,R3, R4 concern
in the present formula, it is obvious selection from the narrow range of
same substituents available in Prior art D1. Further, Selection of
substitution at R groups again, is very comfortable choice from narrow
range. For instance, the compounds 15, 16 of D1 are closest compounds
as claimed in instant application which is considered as obvious choice
to the person skilled in art to come to the compounds of present
application therefore claims lacks inventive step and does not comply the
requirements of section 2(1)(ja) of the Act.
Measurements of the activity of Aurora B from prior art D1.
"
[Emphasis supplied]
5.2. Regarding the objections under Section 3(d) of the Act, the Controller
has held as under:
"The subject matter of claims 1-14 describes the piperidine compound
having Aurora-A-selective inhibitory activity and useful as an anti-cancer
agent. Aurora-A is a member of serine-threonine kinase and the inhibiting
activities of these compounds are due to the presence of nitrogenated
saturated heterocyclic group skeleton which is known in prior arts D1.
Applicant has provided the comparison of activates of compounds of
instant application with Paclitaxel which is not from same group of
compounds or it is not having similar skeleton as of compounds of
instant application. Because the closed available compounds from D1
share the same backbone structure with that of Instant application and
that skeleton is basically responsible for the desired activity therefore
compounds of instant application are considered the further/ other
derivatives of the known compounds from prior art D1 as discussed
above. A new form of compounds of instant application of a known
substance from prior art D1 which does not result in the enhancement of
the known efficacy of that substance for a known substance is considered
to be the same substance, therefore subject matter of claims 1-14 falls
within the scope of section 3(d) of the Patents Act 1970.
"
[Emphasis Supplied]
SUBMISSIONS BY THE PARTIES
6. The counsel appearing on behalf of the appellant has made the
following submissions:
6.1. Regarding the objection under Section 2(1)(ja) of the Act, the
Respondent has cited D1 as the closest prior art, which fails to provide a clear
and explicit suggestion as to how a person skilled in the art will be directed
towards the subject patent application.
6.2. The specific examples 15 and 16 of the prior art D1 do not have a
halogen atom or a C1-C6 alkoxy group at the 3-position (R2 position). Instead
X3 or lower alkyl group is present in D1.
6.3. The presence of R2 in the compound claimed in the subject patent
application provides increased oral absorbability and enhanced therapeutic
activity compared to prior art D1.
6.4. Regarding the objection under Section 3(d) of the Act, the Controller
has failed to identify the 'known substance' in the closest prior art D1 while
referring to it in the hearing notice and in the impugned order. Reliance is
placed on the judgment passed by this court in DS Biopharma Ltd. v.
Controller of Patents & Designs2.
6.5. The Controller has also not considered the research data of enhanced
efficacy due to increased oral absorbability provided in Table 21 of the
Complete Specification of the subject patent application.
6.6. Patent applications corresponding to the subject patent application
have been granted in major jurisdictions, thereby affirming the patentability
of the subject patent application.
7. Per Contra, Mr. Premtosh K. Mishra, CGSC, appearing on behalf of
the respondent, has made the following submissions:
7.1. The compounds similar to those of the subject patent application with
the same core chemical structures are already disclosed in the closest prior art
D1. The only change made in the subject patent application is in the
derivatisation carried out at the positions R1, R2, R3 and R4 of the molecule
2022 SCC OnLine Del 5206
represented by formula (I). This substitution appears to be an obvious choice
from a narrow range of similar substituents disclosed in prior art D1, for
instance, compounds 15 and 16 of the prior art D1. Hence, the claimed
compounds lack inventive step and do not comply with the requirements of
Section 2(1)(ja) of the Act.
7.2. The appellant has provided a comparison of the activities of the claimed
compounds with Paclitaxel, which is not related to the compounds of the
subject patent application. The claimed compounds are derivatives of the
known compounds from prior art D1. A new form of a known substance from
the prior art D1, which does not result in the enhancement of the known
efficacy of that substance, is considered to be the same substance. Therefore
subject matter of claims 1-14 falls within the scope of Section 3(d) of the Act.
ANALYSIS AND FINDINGS
8. I have heard the learned counsel for the parties and examined the
records of the case.
9. From a perusal of the impugned order, it is apparent that the subject
patent application has been rejected under Sections 3(d) and 2(1)(ja) of the
Act.
10. The Supreme Court in Novartis AG v. Union of India3 has held that
Section 3(d) of the Act places the threshold for patentability, particularly in
relation to pharmaceutical and chemical substances, on a higher pedestal in
comparison to the general standard under Section 2(1)(j) of the Act. The
relevant extract from Novartis (supra) is given below:
"104. We have so far seen section 3(d) as representing "patentability", a
concept distinct and separate from "invention". But if clause (d) is isolated
(2013) 6 SCC 1
from the rest of section 3, and the legislative history behind the
incorporation of Chapter II in the Patents act, 1970, is disregarded, then
it is possible to see section 3(d) as an extension of the definition of
"invention" and to link section 3(d) with clauses (j) and (ja) of section
2(1). In that case, on reading clauses (j) and (ja) of section 2(1) with
section 3(d) it would appear that the Act sets different standards for
qualifying as "inventions" things belonging to different classes, and for
medicines and drugs and other chemical substances, the Act sets the
invention threshold further higher, by virtue of the amendments made in
section 3(d) in the year 2005."
[Emphasis supplied]
11. From the above-extracted paragraph, it is clear that Section 3(d) of the
Act plays an important role in determining the patentability of pharmaceutical
or chemical substances. However, the focus of Section 3(d) is on the 'new
form of known substance'. For clarity, Section 3(d) of the Act is reproduced
hereunder:
"3. What are not inventions.--The following are not inventions within
the meaning of this Act,--
***
(d) 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 any 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 purposes 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;"
[Emphasis supplied]
12. A reading of Section 3(d) of the Act would show that Section 3(d) bars
the patentability of a 'new form' of a 'known substance' unless it demonstrates
enhanced therapeutic efficacy. In this regard, a reference can be made to DS
Biopharma (supra) wherein a coordinate bench of this Court has laid down
the steps to be followed by the Patent Office before holding an invention to
be barred by Section 3(d) of the Act. Relevant extracts from DS Biopharma
(supra) are given below:
"15. The Appellant in the reply to the hearing notice submits that the Ld.
Controller has not specified under which part of Section 3(d) of the Act
does the objection fall. The Appellant goes on to assert that as per its
understanding of the Fresenius Kabi judgement (supra), for an objection
under non-patentability to be raised, the patent office needs to specifically
allege and identify at least the following:
(i) What is the specific 'known' substance in question?
(ii) How and why the claimed molecule(s) or substance(s) is a
derivative or is otherwise a new form of a known substance?
(iii) Basis to assert that the alleged 'known' substance and the
claimed molecule or substance have the same 'known' efficacy?
16. The Ld. Controller in the hearing notice has failed to identify any of
the above three factors. It is also submitted by the Appellant that in the
absence of identification of the 'known' compound it is unable to
respond clearly to this objection, severely hampering its right to be given
a reasonable opportunity to defend its patent application. It further
submits that it is under no legal obligation under Section 3(d) of the Act
to demonstrate the efficacy of the claimed compound in the absence of
identification of the 'known' compound.
17. In the present case, the finding of the Controller is as under:
"The claimed compounds differ from the compounds of the prior
art only on the account of minor modifications, namely the
presence of an oxo group at position 15 of the carboxylic acid
chain instead of a OH group of H atom with respect to the
compounds of D1 and D4 respectively, and the presence of a
double bound between C17-C18 of the carboxylic acid chain
instead of a single bond with respect to the compound of D6."
18. Thus, the Controller clearly holds in the impugned order that the
identified compounds are in D1 and D4 in which at position 15, a
substitution has been made by the Appellant. The identified known
substances are also in D6 where the presence of double bond between C17
and C18 of the carboxylic acid chain, instead of the single bond in the
claim of the Appellant. These facts could have been contained in the
hearing notice, upon which, the Appellant could have responded as to how
the objection under Section 3(d) was not attracted. The Appellant could
have also established that the subject compounds had enhanced
therapeutic efficacy to satisfy the pre-conditions under Section 3(d).
19. Therefore, holistically read, the Appellant has not had adequate
opportunity to deal with the objection under Section 3(d) in as much as
apart from merely specifying the said objection for the first time in the
hearing notice, the manner in which the said objection was attracted was
completely absent.
20. In the absence of the proper identification of the known substance in
the hearing notice and a lack of proper opportunity being afforded to
respond to the objection under Section 3(d), the impugned order is not
sustainable."
[Emphasis supplied]
13. From the above extracted paragraphs, it can be inferred that in order to
sustain an objection under Section 3(d) of the Act, the following factors have
to be clearly identified by the Controller:
i) the 'known substance' with 'known efficacy';
ii) clear explanation as to how and why the claimed substance is a
derivative or otherwise a new form of a 'known substance';
iii) an objective comparison between the therapeutic efficacy of the
claimed invention and that of the known substance.
14. The aforesaid aspects have to be identified by the Controller in the
hearing notice, so as to afford a reasonable opportunity to the applicant to
respond to it.
15. The ratio of DS Biopharma (supra) is fully applicable in the facts and
circumstances of the present case. In the present case as well, the hearing
notice failed to properly identify the 'known substance'. The hearing notice
only refers to D1 as the closest prior art and makes a general observation
regarding structural similarity between the compounds of the subject patent
application and those disclosed in D1. To be noted that the prior art D1
identified by the Controller in the hearing notice is a Markush structure
encompassing numerous potential compounds with various substitutions at
multiple positions. The Controller in the hearing notice failed to identify a
specific 'known substance' from D1 against which the claimed invention was
being assessed. The appellant cannot be expected to infer a 'known substance'
and furnish efficacy data based on such inference.
16. By not identifying any particular 'known substance' in the hearing
notice, the appellant was not afforded a fair opportunity to respond to the
same, by demonstrating, through comparative research data, that the claimed
compound possesses enhanced therapeutic efficacy over the particular
'known substance'. In the absence of such identification, the rejection on the
ground of Section 3(d) is not sustainable and warrants a remand for fresh
consideration.
17. In light of the analysis above, the Controller's rejection under Section
3(d) of the Act is not sustainable.
18. With regard to the objection under Section 2(1)(ja) of the Act, the
Controller, in the impugned order, has relied on the closest prior art D1,
particularly referring to Examples 15 and 16 as the closest compounds. Since
the reasoning under Section 2(1)(ja) of the Act, pertaining to lack of inventive
step, is closely intertwined with the assessment under Section 3(d) of the Act,
the objection under Section 2(1)(ja) also warrants reconsideration upon proper
identification of the 'known substance' from the closest prior art and
comparison of the enhanced efficacy data thereof by the appellant.
19. Accordingly, while reconsidering the objection under Section 3(d), any
research data demonstrating enhanced therapeutic efficacy, if submitted by
the appellant, may also be duly considered while examining the inventive step
under Section 2(1)(ja) of the Act.
20. In light of the foregoing analysis, the impugned order is set aside in the
above terms, and the matter is remanded back to the Patent Office for fresh
consideration.
21. The Controller would afford a fresh opportunity of hearing before
deciding the subject patent application, after giving a hearing notice to the
appellant.
22. Needless to state that the fresh order passed by the Controller will deal
with valid submissions raised on behalf of the appellant.
23. The present appeal stands disposed of in terms of the aforesaid.
24. The Registry is directed to supply a copy of the present order to the
office of the Controller General of Patents, Designs & Trade Marks of India
on the e-mail- [email protected] for compliance.
AMIT BANSAL
(JUDGE)
MAY 15, 2025
at/ds
