Rayner Surgical Ireland Limited Previously Omeros Corporation vs The Deputy Controller Of Patents And Designs

$~1
* IN THE HIGH COURT OF DELHI AT NEW DELHI
th
% Date of Decision: 15 May, 2026
+ C.A.(COMM.IPD-PAT) 26/2024
RAYNER SURGICAL IRELAND LIMITED PREVIOUSLY
OMEROS CORPORATION .....Appellant
Through: Ms. Ardra Goodwin and Mr. Pallaash
Shankhdhar, Advocates.

versus

THE DEPUTY CONTROLLER OF PATENTS AND DESIGNS
.....Respondent
Through: Ms. Anubha Bhardwaj, CGSC with
Ms. Ananya Shamshrey and Ms. Manavi Dhingra,
Advocates.

CORAM:
HON'BLE MS. JUSTICE JYOTI SINGH
JUDGEMENT
JYOTI SINGH, J. (ORAL)
1. This appeal is filed on behalf of the Appellant under Section 117A
of the Patents Act, 1970 (‘1970 Act’) challenging order dated
31.01.2020 passed by the Respondent refusing Indian Patent Application
No. 3029/DELNP/2015 and for a direction to the Respondent to grant the
patent.
2. To the extent necessary, the facts are that the subject invention relates
to ‘STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-
INFLAMMATORY SOLUTION FOR INJECTION’. Appellant filed a PCT
International Application on 23.10.2013 bearing No. PCT/US2013/066349,
claiming priority from US Application No. 61/718,026 dated 24.10.2012 and
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US Application No. 61/736,179 dated 12.12.2012. Appellant filed Indian
Patent Application No. 3029/DELNP/2015 on 10.04.2015 with complete
specification comprising claims 1-27 and drawings.
3. It is stated in the appeal that Request for Examination by way of
Form-18 was made on 27.05.2015 and Form-13 was filed on 02.07.2015
requesting to place on record amended set of claims 1-13 by way of
correction and explanation. First Examination Report (‘FER’) was issued by
the Respondent on 09.03.2018, to which Appellant filed a response on
07.12.2018 along with amended set of claims 1-9. Hearing was conducted
on 25.09.2019, whereafter post-hearing written submissions were filed by
the Appellant on 04.10.2019. On 31.01.2020, Respondent passed the
impugned order and refused the application on ground of lack of inventive
step under Section 2(1)(ja) of 1970 Act and non-patentability under Section
3(e).
4. Learned counsel for the Appellant submits that present invention
relates to a stable, preservative-free and antioxidant-free liquid
pharmaceutical formulation of Ketorolac and Phenylephrine for injection
into intraocular ophthalmologic irrigation solutions. Claimed invention
recites a sterile liquid pharmaceutical formulation comprising
Phenylephrine, Ketorolac and a 20mM sodium citrate buffer system in an
aqueous carrier, wherein the formulation is preservative free and antioxidant
free, which is claim 1. Further, the formulation is a solution which is free of
solubilizing agents and free of visible precipitation and crystallization and is
o o
stable for 6 months when stored at a temperature from 5+/-3 C to 25+/-2 C.
The formulation can be suitably injected into an intraocular irrigation carrier
and is used to irrigate ocular tissues during surgery. Additionally, this
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formulation avoids the potential toxicity that may be associated with
preservatives and antioxidants and still has stability.
5. It is submitted that present invention provides a solution to the
problem as to how to maintain long-term stability for a liquid intracameral
ophthalmic solution, which is a mixer of two disparate active pharmaceutical
ingredients (APIs), one of which is a weak aromatic base (Phenylephrine)
and one of which is a weak aromatic acid (Ketorolac) without use of either
antioxidant or preservatives, that are typically required for stability but can
be injurious to intracameral tissues. Therefore, the invention provides a
sterile formulation of irrigation solutions for perioperative local application
to ocular tissues, including intraocular and topical application, where
Phenylephrine is used as a mydriatic agent and Ketorolac as an anti-
inflammatory and both are free of preservatives and antioxidants and yet
document unexpected good stability. They are preferably packaged in
single-use containers for injection and can be injected into a larger volume
of intraocular irrigation carrier prior to and during intraocular procedures
such as Cataract extraction and lens replacement and refractive lens
exchange procedures.
6. It is submitted that conventionally used mydriatic agents such as
Phenylephrine with preservatives have been associated with a condition
known as Toxic Anterior Segment Syndrome (TASS), which is widely
regarded as a serious complication arising in ophthalmic surgeries and even
in cases where mydriatic formulation is preservative free i.e., devoid of
antimicrobial preservatives. Such formulations may nevertheless contain
antioxidant agents, which are known to cause toxicity to the eye.
Phenylephrine, particularly, is not approved in United States in a
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preservative and antioxidant free form for single use injection. Post-
operative pain and irrigation can be reduced by using NSAID, which again
has limitation. Ketorolac, known to be a weak aromatic acid, is an NSAID
i.e., commercially available for ocular use but may include Benzalkonium
Chloride as a preservative. Conventional ocular formulations suffer from the
drawback that therapeutic agents may be rapidly cleared due to blinking and
the eye’s natural circulatory processes. This may require repeated or large
volume administration to maintain therapeutic efficacy. However, where
such formulations include preservative or antioxidant agents, including
formulations containing Phenylephrine and Ketorolac, the administration of
larger volumes may be undesirable owing to associated risk of ocular
toxicity, including TASS. Present invention is for a formulation comprising
Phenylephrine and Ketorolac and 20mM sodium citrate buffer system,
where formulation is preservative free and antioxidant free and stable.
7. It is urged that Respondent has wrongly refused the patent application
and the impugned order suffers from grave errors on merits as also
violations of principles of natural justice and is wholly unreasoned and non-
speaking. While the impugned order rejects the application under Section
2(1)(ja), owing to prior arts D1-D3 as also 2(1)(j) and Section 3(e) but there
is no reasoning to support the conclusions. There is no reason in the order as
to why the experimental data provided in the complete specification was
insufficient to establish patentability of the claimed invention. Appellant
provided complete experimental data in the detailed description in the
complete specification, which demonstrates that claim formulation is stable
for more than 30 months as opposed to 6 months, where formulations
include antioxidant or preservative. Respondent does note the presence of
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stability data but holds that achieving stability of such pharmaceutical
formulation without preservatives and antioxidants is not surprising at all
and for coming to this conclusion, Respondent has given no reasoning as to
how stability will be achieved in the absence of preservative and
antioxidant. Further, Respondent not only ignores the conventional state-of-
art, where such formulations have consistently included preservatives and
antioxidants but also ignores the generally known nature of Phenylephrine,
which is a weak aromatic base and Ketorolac, which is a weak aromatic
acid. It is generally known that when combined the two would ordinarily be
expected to undergo an acid-base reaction and this alone, combined with the
single formulation, would give rise to credible and strong concerns
regarding incompatibility and instability and would necessitate preservatives
and/or antioxidants. There is not a shed of reasoning in the impugned order
as to how stability will be achieved considering these aspects. In fact, while
observing that a pharmaceutical formulation has certain stability,
Respondent has ignored that in conventional compositions, stability was
achieved only through use of preservatives and antioxidants.
8. It is submitted that Respondent has erred in concluding that amended
claims 1-7 lack inventive step under Section 2(1)(ja) in view of prior arts
D1-D3. Respondent has wrongly observed that the formulation claimed in
the instant application, which contains Phenylephrine, Ketorolac and sodium
citrate buffers and is preservative free and antioxidant free is disclosed in D1
and/or that D2 discloses buffer and pH of the solution and D3 discloses
fluticasone formulation, which also contains Phenylephrine and/or that D3
also discloses about the stability of the solution. There is a manifest error in
the observation that D3 may or may not contain preservative and therefore,
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formulation disclosed in D3 may or may not contain a preservative. There is
a glaring error in holding that composition which contains Phenylephrine,
Ketorolac and sodium citrate buffers is well known to a person skilled in the
art to combine the knowledge of cited prior arts D1-D3. A person skilled in
the art would have certainly expected Phenylephrine and Ketorolac to be
both unstable and incompatible together in a liquid concentrate for 6 months
or longer. Chemical properties of Phenylephrine and Ketorolac would have
discouraged a person skilled in the art from combining them in a liquid
solution for extended storage. Phenylephrine is an organic weak base prone
to oxidation and person skilled in the art would have expected that these two
compounds, when combined in a solution, would undergo oxidative
degradation even more rapidly. The prior art taught that Phenylephrine and
Ketorolac salts i.e., cations and anions in solutions, were the most likely
chemical compounds to undergo acid-based reaction and precipitate. A
person skilled in the art would thus certainly have expected Phenylephrine
and Ketorolac to be both unstable and incompatible together in a liquid
concentrate for 6 months or longer. This aspect of present invention i.e.,
unexpected lack of physical incompatibility of the two APIs in a solution
that not only does not include antioxidant and preservative but also does not
include any solubilizing agents, is reflected in the amended claims of the
instant application. With this backdrop, nothing in D1-D3 would have
motivated a person skilled in the art to arrive at the claimed invention and
hence, the entire analysis of lack of inventive step is manifestly incorrect.
9. It is further submitted that Respondent has failed to follow the five-
step test laid down by the Division Bench of this Court in F.Hoffmann-La
Roche Ltd. & Anr. v. Cipla Ltd., 2015 SCC OnLine Del 13619 , for
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determining the inventive step and obviousness. D1 relates to clinical study
evaluating OMS302, described as a liquid drug product containing
Phenylephrine and Ketorolac in a certain ratio with sodium citrate buffer.
D1 discloses that OMS302 investigational drug product is free from
particulates of foreign matter, which are distinct from precipitates or crystals
of APIs and does not disclose that formulation is free of solubilizing agents
and has no visible precipitates and crystals. Moreover, D1 does not disclose
that formulation of Phenylephrine and Ketorolac is preservative and
antioxidant free. D2 teaches converse of the instant application, which is the
preferred use of antioxidants. It also discloses that to ensure stability a
standard ophthalmic irrigation solution should be mixed just prior to use,
which means that such solutions will not be stable for any extended period
prior to use. D3 discloses an ophthalmic formulation of fluticasone,
however, this is a corticosteroid and has no relevance to the instant
formulations of Ketorolac and Phenylephrine. In light of these prior arts, it is
not understood how even remotely person skilled in the art would arrive at
the claimed invention.
10. Rejection under Section 3(e), submits learned counsel, is equally
untenable for the reason that there is no reasoning to come to the conclusion.
Respondent has in one line upheld the ground of non-patentability stating
that instant claims do not pass the test of Section 3(e) in the absence of any
surprising or synergistic effect. Prior arts recognize that use of preservatives
and antioxidant agents in mydriatic formulations employed for pupil dilation
were associated with corneal toxicity and related adverse effects. In this
background, the claimed formulation comprising Phenylephrine and
Ketorolac provides a synergistic effect by simultaneously maintaining
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formulation stability and preventing clinically meaningful miosis and
reducing the likelihood of toxicity associated with post-operative ophthalmic
procedures.
11. Ms. Anubha Bhardwaj, learned CGSC appearing on behalf of the
Respondent submits that the instant application has been rightly refused for
lack of inventive step, lack of technical feature and non-patentability under
Section 3(e). Combination of Phenylephrine, Ketorolac and sodium citrate
buffer, all known substances individually disclosed in prior arts D1-D3 do
not result in a composition exhibiting any technical advancement or
unexpected synergistic effect. D1 discloses composition for intraocular use
comprising Phenylephrine and Ketorolac tromethamine in sodium citrate
buffer. D2 and D3 further support the knowledge of using such
combinations in aqueous solutions for ophthalmic purposes. D2 also
discloses the buffering agent. Technical challenge of formulating a
preservative free and antioxidant free combination with stability is not non-
obvious, especially since D3 already suggests preservatives are not essential.
D3 also exemplifies a formulation, which is antioxidant free. No
comparative data was filed by the Appellant to show any improvement over
the prior arts or to demonstrate enhancement of efficacy and hence, the
claimed invention lacks inventive step.
12. It is submitted that claims 1 and 3 describe stability at specific
temperature ranges. Such a statement is a result to be achieved and not
technical feature of the formulation. Specification lacks sufficient disclosure
as to how such stability is technically ensured without preservatives or
antioxidants. Claimed formulation is mere admixture of known components,
each performing its well understood function. Ethanol (solvent), sodium
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citrate (buffer), Phenylephrine (mydriatic) and Ketorolac (NSAID) are
individually known and no data or comparative study was provided to
demonstrate synergistic effect. Thus, there is no infirmity in the impugned
order warranting interference.
13. Heard learned counsels for the parties and examined their
submissions.

14. Appellant filed the instant application on 10.04.2015 with complete
specification comprising claims 1-27 with drawings. FER was issued on
09.03.2018 objecting to the invention on grounds of lack of inventive step,
lack of technical features and non-patentability under Section 3(e). Five
prior arts D1-D5 were cited to support lack of inventive step. Appellant filed
response to FER pointing out that at the time of receipt of FER, claims 1-13
were pending and Appellant had suitably amended the pending claims and
only claims 1-9 remained pending. Prior arts were sought to be distinguished
by detailed narrative in the reply, to bring home the point that the claimed
invention did not lack inventive step as none of the cited prior arts taught or
suggested or motivated the subject matter of the claimed invention, which
was thus non-obvious to a person skilled in the art to be able to arrive at the
invention. Response was also given to the objection under Section 3(e) and
Section 2(1)(j), asserting that none of these objections were made out,
however, the application was refused.
15. Claimed invention relates to stable, preservation-free and antioxidant-
free pharmaceutical formulation intended for use in ophthalmic surgery,
more particularly, pupil dilation (mydriasis), which is required during
ophthalmic surgical procedures and is conventionally achieved through pre-
operative topical administration of a mydriatic agent. Respondent has
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refused the application on three grounds: lack of inventive step; lack of
technical features; and non-patentability under Section 3(e) due to lack of
synergistic effect. D1-D3 have been taken as prior arts in the impugned
order to refuse the application for lacking inventive step. From the order, it
is apparent that substantial part of the order focuses on referring to the
disclosures/teachings in D1-D3. One paragraph is dedicated to the findings
and the conclusion that the claims in the instant application do not involve
an inventive step as being obvious over the teachings of D1-D3. In coming
to this conclusion, Respondent holds that composition, which contains
Phenylephrine, Ketorolac and sodium citrate buffer, is well known to the
person skilled in the art and further that it will be obvious to such a person to
maneuver all components as needed as a matter of judicious selection. It is
observed that Phenylephrine is a mydriatic agent and Ketorolac is a NSAID
drug and use of buffer for maintaining the pH of formulation is known from
D1. D2 and D3 are actually further work to find out more suitable
pharmaceutical formulation and hence, it is within the ambit of a skilled
artisan to try some more suitable formulations by combining D1, D2 and D3
and arrive at the subject invention. It is further observed that Appellant has
provided comparative stability data in the specification, wherein stability of
various formulations have been presented, with and without preservative and
antioxidant and Appellant tries to solve the problem of how to maintain
long-term stability without use of either the preservative or the antioxidant
but in view of D1-D3, stability is not surprising but is obvious and that
claimed stability of the formulation is an inherent property in the
formulation disclosed in the prior arts.
16. Having carefully perused the impugned order, this Court finds merit
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in the contention of the Appellant that the order is not only unreasoned but
also violative of the directions passed by the Division Bench of this Court in
F.Hoffmann (supra) to follow a five-step test to determine whether the
claimed invention has or lacks inventive step. The five steps elucidated by
the Division Bench are as follows:-
Step No. 1 - To identify an ordinary person skilled in the art;
Step No. 2 - To identify the inventive concept embodied in the
patent;
Step No. 3 - To impute to a normal skilled but unimaginative
ordinary person skilled in the art what was common general
knowledge in the art at the priority date;
Step No. 4 - To identify the differences, if any, between the matter
cited and the alleged invention and ascertain whether the differences
are ordinary application of law or involve various different steps
requiring multiple, theoretical and practical applications; and
Step No. 5 - To decide whether those differences, viewed in the
knowledge of alleged invention, constituted steps which would have
been obvious to the ordinary person skilled in the art and rule out
hindsight approach.

17. As the response to FER and post-hearing written submissions
indicate, Appellant had laboured hard to point out what in its perception
were stark differences in the prior arts and the claimed invention but none of
these points have been considered by the Respondent. To begin with,
Respondent has overlooked that according to the Appellant, the
experimental data, which was admittedly provided in the detailed
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description, does demonstrate that the claimed formulation with Ketorolac,
Phenylephrine and sodium citrate buffer is stable for more than 30 months
without preservative and antioxidant, as opposed to a period of 6 months
even where preservatives and antioxidants are included. No part of the order
deals with this submission, which is a crucial point in relation to the claimed
invention. Respondent observes that achieving stability of pharmaceutical
formulation without preservative and antioxidant is not surprising but there
is no reasoning on how extended stability could be achieved in the absence
of preservative and antioxidants. Respondent has also not dealt with the
stand of the Appellant that conventional state-of-art formulations have
consistently included preservatives and antioxidants and that Phenylephrine
being a weak aromatic base and Ketorolac being a weak aromatic acid, when
combined will ordinarily undergo an acid-base reaction and this alone,
combined with a single formulation, would give rise to credible and strong
concerns regarding incompatibility and instability and would necessitate
preservatives and/or antioxidants. In such a backdrop, how stability will be
achievable, is not explained in the order.
18. Learned counsel has shown that Respondent has not given an iota of
reason to disregard the response of the Appellant that combination of
Phenylephrine and Ketorolac would not be obvious to the person skilled in
the art, who would certainly have expected them to be both unstable and
incompatible together in a liquid concentrate for 6 months or longer and
chemical properties of both Phenylephrine and Ketorolac would discourage
a person skilled in the art to combine them in a liquid solution for extended
storage. Both Phenylephrine and Ketorolac are known to be prone to
oxidation and contrary to the finding of the Respondent, in fact, a person
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skilled in the art would have expected that if combined in a solution,
Ketorolac and Phenylephrine would undergo oxidative degradation even
more rapidly. There is absolutely no analysis on this stand of the Appellant
by the Respondent. Appellant is right that Respondent ought to have dealt
with this issue as also the points flagged by the Appellant that Phenylephrine
was not approved for sale in US as a preservative/antioxidant free form.
Respondent has also not considered the differences brought forth by the
Appellant that D1 fails to specifically describe a formulation which is free of
preservative/antioxidant and D2 albeit describes a composition of
Phenylephrine and Ketorolac but specifically describes use of antioxidant as
also that D3 is corticosteroid and has no bearing on the instant formulation.
In my view, Respondent was under an obligation to consider the points
raised by the Appellant in response to the objections raised and also follow
the five-step test while determining lack of inventive step. Court also finds
that there is no reasoning for refusing the application under Section 3(e) and
all that is stated in the impugned order in one line is that in the absence of
any surprising or synergistic effect, the instant application does not pass the
test of Section 3(e). Courts have consistently held that reasons must
accompany every decision and many cases have been remanded to the
Controller only on the ground of unreasoned orders. Yet the orders continue
to be non-speaking and unreasoned and to compound, the orders do not even
reflect consideration of the points raised by a patent applicant, both factual
and legal, be it in response to the FER or in the detailed written submissions.
The result is that the purpose of seeking response to FER and/or permitting
filing of post-hearing written submissions is defeated and is reduced to a
mere formality. Consequence is that Courts have to remand the matters and
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the already long procedure of grant of patent becomes longer.
19. For all the aforesaid reasons, the impugned order dated 31.01.2020 is
set aside and the matter is remanded to the Respondent for fresh
consideration of Indian Patent Application No. 3029/DELNP/2015.
Respondent shall take a decision within four months from today after
granting opportunity of hearing to the Appellant and considering the detailed
response to the FER as also the written submissions. Needless to state that
the order will be a speaking and reasoned order. It is made clear that Court
has not expressed any opinion on the merits of the case.
20. Appeal is partially allowed and disposed of.



JYOTI SINGH, J
MAY 15, 2026/YA

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