Madras High Court
Signal Pharmaceuticals vs Deputy Controller Of Patents And ... on 21 November, 2024
Author: Abdul Quddhose
Bench: Abdul Quddhose
(T)C.M.A.(PT)No.145 of 2023
IN THE HIGH COURT OF JUDICATUE AT MADRAS
DATED: 21.11.2024
CORAM
THE HONOURABLE MR. JUSTICE ABDUL QUDDHOSE
(T)C.M.A(PT).No.145 of 2023
Signal Pharmaceuticals
4550 Towne Centre Court,
San Diego, CA 92121
USA .. Appellant
Vs
Deputy Controller of Patents and Designs,
Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy,
Chennai – 600 032. .. Respondent
Prayer: This Appeal is filed under Section 117-A of the Patents
Act, 1970, against the order dated 17.05.2019 passed by the respondent.
For Appellant : Mr.Rahul Balaji
for M/s.DE Penning and DE Penning
For Respondent : Mr.Rajesh Vivekanandan,
Standing Counsel
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1/16
(T)C.M.A.(PT)No.145 of 2023
JUDGMENT
This appeal has been filed challenging the order dated 17.05.2019
passed by the respondent refusing to grant patent in favour of the
appellant on the ground that the appellant's claimed invention is not an
inventive step as per Section 2(1)(ja) of the Patents Act and is not
patentable under Section 3(d) of the Patents Act.
2. The appellant has challenged the impugned order primarily on
the ground that it is a non-speaking order with regard to the appellant's
invention process as claimed in its patent application and the amendments
made thereafter. According to the appellant, the impugned order reflects
the clear lack of reasoning or even consideration of the appellant's
contentions. The appellant's invention is titled “mTOR kinase inhibitors
for oncology indications and disease associated with the
mTOR/P13K/AKT Pathway” and the claims consist of heteroaryl
compound and the pharmaceutically acceptable derivatives, and they
assist in cancer detection through their high mTOR activity. Under the
impugned order, the respondent has rejected 19 claims of the appellant.
3. The learned counsel for the appellant drew the attention of this
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Court to the impugned order and would submit as follows:-
(a) The respondent has not properly appreciated
the evidence placed on record.
(b) The respondent has ignored the clear gap
between the amended claims and prior art;
(c) Contrary to the legal principles on uniqueness
and inventiveness, the respondent has passed the
impugned order refusing to grant patent;
(d) The submission of the appellant has not been
considered by the respondent;
(e) The responses submitted by the appellant to
the objections made by the respondent which detail the
inventive features of the appellant's invention have not
been considered by the respondent.
(f) The amended claims in compliance to
objections raised by the respondent pursuant to the First
Examination Report (FER) have not been considered
under the impugned order; and
(g) the respondent has wrongly raised the
grounds of lack of inventive step and non-patentability
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under Section 3(d) of the Patents Act.
4. The learned counsel for the appellant relies upon a decision of
the Delhi High Court in Avery Dennison Corporation Vs. Controller of
Patents and Designs [2022/DHC/004697] and would submit that since
the appellant's invention is a technical advancement, the appellant has
satisfied the inventive step requirement as defined under Section 2(1)(ja)
of the Patents Act.
5. He would further submit that the cited document WO
2008/051493 has a different structure from the claims submitted by the
appellant, as the claims of the appellant have a significantly higher
biological activity than prior art, but, the said considerable improvement
has not been properly analyzed by the respondent and by a non-speaking
order, the respondent has refused to grant patent to the appellant.
6. The learned counsel for the appellant would further submit that
the core rings of the structure of the compound in Claim-1 have six
variable positions, wherein carbon or heteroatom is present with 3
positions where variable substituents are present; and the prior art (D1)
in no way teaches any preferred combination of carbon and heteroatoms
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in core ring structure along with substituents, that is similar to claim-1.
According to him, the prior art is clearly distinguishable, and the
biological activity of the claimed compound is significantly higher than
prior art.
7. The learned counsel for the appellant would submit that the
respondent under the impugned order has not considered several essential
technical elements of the appellant's invention. He would once again
reiterate that the amended claims as well as their explanation in the reply
to FER and written submissions have not been considered by the
respondent in the impugned order.
8. The learned counsel for the appellant would also submit that the
expert affidavit dated 19.03.2019 submitted by the appellant in respect of
their invention has also not been considered by the respondent in the
impugned order. He also relies upon a decision of this Court passed in
(T)CMA(PT) No.33 of 2023 and would submit that while analyzing
Section 3(d) of the Patents Act, this Court has made it clear that if the
patent applicant has been able to establish that there is reasonable
enhancement of efficacy to the satisfaction of the Controller of Patents,
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the Controller of Patent has to grant patent. According to the learned
counsel for the appellant, the appellant has satisfied the said test as its
invention establishes therapeutic efficacy. According to him, despite the
same, by total non-application of mind to the invention of the appellant,
the respondent has refused to grant patent under the impugned order.
9. The learned counsel for the appellant also drew the attention of
this Court to a decision of the Hon'ble Supreme Court in Novartis AG vs.
Union of India [(2013) 6 SCC 1], wherein the Hon'ble Supreme Court
extensively analyzed Section 3(d) and interplay with pharmaceutical
claims. In the said decision, it is held that if the patent applicant
establishes therapeutic efficacy over the known substance, in such an
event, Section 3(d) of the Patents Act does not get attracted. According
to the learned counsel for the appellant, since the appellant has satisfied
the test of therapeutic efficacy as laid down by the Hon'ble Supreme
Court in Novartis's case (cited supra), the respondent, by total non-
application of mind, has refused to grant patent without giving reasons as
to why the appellant's invention does not satisfy the test of therapeutic
efficacy.
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10. According to the learned counsel for the appellant, the claimed
invention of the appellant is overwhelmingly directed to compounds
possessing a different core structure and the prior art (D1) is primarily
with respect to compounds containing a fused 5-membered ring disclosed
in Table 1 of D1, as opposed to the appellant's invention (R1), that is a
heterocyclyl with pyrazino pyrazine core. Therefore, according to him,
the appellant has clearly demonstrated the difference in core structure
between the prior art (D1) and the claimed invention of the appellant.
11. The learned counsel for the appellant also drew the attention of
this Court to a decision of the Delhi High Court in Blackberry Ltd. Vs.
Assistant Controller of Patents and Designs [(C.A.(Comm.IPD-PAT)
301/2022] and would submit that the Delhi High Court had cautioned
passing of unreasoned orders by the Patent Office and in the said
decision, the Delhi High Court had set aside the order passed by the
Assistant Controller of Patents and Designs on the ground that the
Controller has merely reproduced objections made during FER and has
failed to consider the amended claims or the data. The learned counsel
for the appellant would also submit that the respondent has failed to take
note of the fact that the appellant has obtained patent for similar
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inventions in US and Europe.
12. On the other hand, the learned standing counsel for the
respondent would submit that the prior art document (D1) and the core
structure of the appellant's claimed inventions are one and the same.
According to him, the appellant has failed to establish with documentary
evidence to prove that the appellant's claimed invention is different from
the prior document (D1). He drew the attention of this court to the
impugned order and would submit that since the appellant's claimed
invention does not satisfy the test of therapeutic efficacy, the respondent
has rightly refused to grant patent under the impugned order. He would
also submit that the impugned order is a speaking order with regard to the
contentions of the appellant insofar as their claimed invention is
concerned, and therefore, the question of interfering with the impugned
order by this Court does not arise.
13. He would further submit that the grounds raised by the
appellant in this appeal do not deserve any merit as only by giving proper
reasons, the appellant's patent application has been rejected on the ground
of lack of inventive step and non-patentability under Section 3(d) of the
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Patents Act. According to him, there is no technical advancement made
by the appellant in its invention and therefore, the appellant's claimed
invention squarely falls is hit by Section 3(d) of the Patents Act. Since
there is no inventive step in the appellant's invention, the respondent has
rightly refused to grant patent to the appellant under the impugned order.
14. This Court has carefully analyzed the evidence available on
record before the respondent. The appellant has placed several
documents in support of their invention and they have also submitted
explanation to the queries raised by the respondent in the FER. They
have also filed their written arguments and amended claims to comply
with the objections raised by the respondent in the FER. A categorical
assertion has also been made by the appellant that their invention is a
technical advancement, which may satisfy the inventive step requirement
of Section 2(1)(ja) of the Act. The learned counsel for the appellant also
drew the attention of this Court to the core structure of the appellant's
invention and would point out that the core structure of the appellant's
invention is different from the prior art document (D1), which discloses
the core structure of the known substance.
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15. On a prima-facie consideration of the impugned order, it is seen
that the respondent has ignored the clear gap between the amended claims
and the prior art document. The written submissions of the appellant has
not been considered by the respondent under the impugned order. The
appellant had also filed responses to the objections raised by the
respondent with regard to the inventive step requirement as per Section
2(1)(ja) of the Patents Act; and the appellant had also filed amended
claims; but, as seen from the impugned order, the respondent erred in not
giving sufficient reasons for rejecting the appellant's amended claims.
16. As seen from the decision relied upon by the learned counsel
for the appellant in Avery Dennison Corporation (cited supra), the Delhi
High Court has held that a significant technical advancement is sufficient
to satisfy inventive step required under Section 2(1)(ja) of the Patents
Act. The core structure of the appellant's claimed invention as well as
prior document (D1) seem to be different and no proper reasonsing have
been given for the purpose of coming to the conclusion that prior
document (D1) is similar to the core structure of the appellant's invention.
The appellant has categorically contended that the appellant's invention
has significant technical elements than that of the prior art and therefore,
there is inventive step in the appellant's invention.
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17. This Court, after careful perusal of the impugned order, is of
the considered view that no sufficient reasoning has been given by the
respondent for coming to the conclusion that there is no inventive step in
the appellant's claimed invention. The Hon'ble Supreme Court in the case
of Novartis AG (cited supra) has also made it clear that in the case of a
medicine that claims to cure a disease, the test of efficacy can only be
therapeutic efficacy. But, however, as seen from the impugned order, the
respondent has not given any reason as to why the appellant's claimed
invention does not satisfy the test of therapeutic efficacy. The prior art
document (D1), on a prima-facie consideration, is primarily with respect
to compounds containing a fused 5-membered ring disclosed in Table 1
of D1, as opposed to R1 (appellant's invention), that is, heterocyclyl with
pyrazino pyrazine core. However, as seen from the impugned order, the
prior art document (D1) as well as the appellant's invention (R1) have not
been properly analyzed and there is no proper reasoning given for coming
to the conclusion that the core structure of R1 and the core structure of
D1 are one and the same.
18. It is settled law, as laid down by various decisions including the
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decision of the Delhi High Court in Blackberry (cited supra), that
unreasoned orders (non-speaking orders) cannot be passed by the
Controller of Patents and the Controller should not merely reproduce the
objections made during FER while refusing to grant patent. Only through
a speaking order by giving proper reasons as to why the applicant's
contentions has to be rejected, a patent application can be rejected.
19. In the case on hand, as seen from the impugned order, there is
no proper appreciation of evidence by the respondent. The respondent
seems to have ignored the gap between the amended claims and the prior
art; and has not given reasons as to why the amended claims and the prior
art are one and the same; and the respondent has also ignored the legal
principles rendered by the Constitutional Courts on uniqueness and
inventiveness. While passing the impugned order, the respondent has
also not considered the written submissions of the appellant; responses to
objections raised by the respondent; and the amended claims of the
appellant in compliance to objections raised by the respondent. Through
a non-speaking order, the respondent under the impugned order has
refused to grant patent to the appellant on the ground of lack of inventive
step over the prior art and that the claims are non-patentable under
Section 3(d) of the Patents Act.
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20. On the ground that the impugned order is a non-speaking order
in respect of several aspects of the appellant's contentions, necessarily the
impugned order has to be quashed and accordingly, the impugned order
dated 17.05.2019 passed by the respondent is quashed and the matter is
remanded back to the respondent for re-consideration on merits and in
accordance with law by issuing the following directions to the
respondent:-
(a) In the interest of justice and in order to avoid the possibility of
pre-determination, an officer other than the officer who issued the
impugned order shall undertake the re-consideration;
(b) such re-consideration shall be undertaken by taking into
account the observations set out in this judgment;
(c) amendment applications, if any, to the complete specification or
claims shall be permitted if within the frame work of the complete
specification; and
(d) a fresh order in Application No.3500/CHENP/2011 shall be
passed within a period of six months from the date of receipt of a copy of
this judgment.
No Costs.
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21.11.2024
rkm
Index:yes/no
Neutral citation: yes/no
To
Deputy Controller of Patents and Designs,
Patent Office,
Intellectual Property Rights Building,
GST Road, Guindy,
Chennai – 600 032.
https://www.mhc.tn.gov.in/judis
ABDUL QUDDHOSE,J.
rkm
https://www.mhc.tn.gov.in/judis
21.11.2024
https://www.mhc.tn.gov.in/judis
