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7th Symbiosis-B.

Krishna Memorial National IPR Moot Court Competition, 2015


MOOT PROBLEM
BEFORE THE HIGH COURT OF MUNAIN,
REPUBLIC OF BHARANESIA

O.S. No. 707/2014


BETWEEN
1. B.Z. Mate University
Plaintiff
AND
1. Bristo Pharmaceuticals Pvt. Ltd. and Bristo Pharmaceuticals Inc.
..Defendants

BEFORE THE INTELLECTUAL PROPERTY APPELLATE BOARD (IPAB) OF


BHARANESIA
OA/7/2014/PT/DH
BETWEEN
1. Bristo Pharmaceuticals Pvt. Ltd.
AND
1. B.Z. Mate University
2. Controller of Patents, Bharanesia
AND

..Appellant

..Respondents

ORA/14/2014/PT/DH
BETWEEN
1. Bristo Pharmaceuticals Pvt. Ltd.
AND
1. B.Z. Mate University

..Applicant
Respondent

a) This hypothetical problem is conceived and prepared by Sunil B Krishna, Disha Jeswani
and Rahul Vartak and scrutinized by R Muralidharan, Manish Saurastri and Vinod
Kotabagi of Krishna & Saurastri Associates.
b) The authors assert the moral right to be identified as the creators of this fictional legal
educational tool. The authors would encourage Law Schools to use the Problem either as
study material or instructional tool after due acknowledgement to the authors.
c) To the knowledge of the authors, there is no similar proceeding pending anywhere in the
world. The problem is purely hypothetical and fictional. Any similarity with situations or
names is purely
coincidental and unintentional.
e) One speaker shall argue on the matter pending before the IPAB and the other speaker
on the matter pending before the High Court of Munain.

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
1.

B.Z. Mate University (hereinafter referred to as Mate) is a University based in the


Republic of Bharanesia. Bharanesia is a Sovereign Nation located in South Asian
Region. Its Constitution, Laws, Institutions and Social Ethos are substantially similar
to that of Union of India.

2.

Mate has a well established Intellectual Property Cell which protects its inventions in
various fields. The research and development at Mate is mostly conducted by the
Professors of Mates various departments. Mate is the leading educational institute
which applies for patent applications before the Patent Office of the Republic of
Bharanesia. It is also amongst the top 100 PCT applicants in the world in the category
of universities & educational institutes.

3.

Bristo Pharmaceuticals Pvt. Ltd. (hereinafter referred to as Bristo) is a company


registered under the laws of Bharanesia. Bristo is a wholly owned subsidiary of Bristo
Pharmaceuticals Inc. The business activities of Bristo Pharmaceuticals Pvt. Ltd. are
controlled by Bristo Pharmaceuticals Inc. Bristo Pharmaceuticals Inc. is registered
under the laws of Federation of Pandora whose constitution, laws and social ethos are
substantially similar to that of the United States of America.

4.

Prof. Dr. M. Vaidya and Prof. Dr. P. Bhattacharya have been working with Mate for
many years and are the most active researchers who are named as inventors in many
PCT and national applications filed by Mate. The inventors published their provisional
conclusion on a possible pain killer employing ABC Receptor antagonists in June 2008
in a leading publication, which was available to public on June 5, 2008. The research
project continued at Mate after the said publication. After months of research, the
Researchers were able to develop a line of pharmaceutical products and filed patent
application 8456/MN/2009 on June 5, 2009 titled Abc receptor antagonist for the
treatment of chronic pain. The inventors named in the application were Vaidya M.
and Bhattacharya P.

5.

When the application 8456/MN/2009 was examined, the Examiner vide his letter dated
December 12, 2011 objected the grant of patent. The copy of the First Examination
Report is enclosed as Exhibit-A.

6.

Mate, through their Attorneys letter dated December 10, 2012, responded to the First
Examination Report. Regarding the missing signatures on Form 1 and assignment,
2

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
Mate stated that the inventors moved to a company outside Bharanesia and their
whereabouts are not known. Mate pointed out that the inventors were on the Rolls of
the University. The Standing Rules of the Contract of Employment (which has the force
of law) specifically stipulates that only the University will be the owner of any IP
generated by their employees in the course of their employment. There were documents
available with the Patent Office that the same inventors, during the past, had assigned
all their inventions to the Mate University. Non-signing of Form 1 endorsement by the
inventors in this case was due to an oversight. Hence, Mate was entitled to apply for the
patent. Mates submissions were taken on record by the Examiner. Before the final
decision could be made by the Examiner, Bristo filed a pre-grant opposition against the
grant of a patent for the application 8456/MN/2009 inter-alia on the following grounds:
i.

that Mate wrongfully obtained the invention from the inventors as duly signed
Form 1/ assignment which is mandatory was not submitted;

ii.

that the claimed Compound of formula I is obvious in view of earlier


disclosures known in the art;

iii.
7.

that the invention does not involve an inventive step;

The notice of opposition was taken on record and Mate was informed accordingly. Mate
responded with a written statement with primarily the same submissions and evidence
as provided at the time of responding to the First Examination Report. A hearing was
held and both parties were allowed to present their arguments. Based on Mates
submissions, the Controller of Patents dismissed the pre-grant opposition proceedings
filed by Bristo. The Controller, in an elaborate order, stated the reasons for dismissing
the pre-grant opposition. A patent was granted to the application 8456/MN/2009 which
was given the Patent No. 1234567 on January 11, 2013. A copy of the granted patent
No. 1234567 is enclosed as Exhibit B. The decision of grant was published in the
journal on March 10, 2013.

8.

On June 10, 2013, Bristo filed a post grant opposition to the Patent No. 1234567 with
further documents claiming that the piperidine derivates were obvious to a person
skilled in the art.

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015

Bristo relied upon several prior art documents to show that many compounds
were structurally and functionally similar to Compound of formula I claimed
and the latter is a new form of earlier compounds;

Bristo further alleged that the inventors Vaidya M and Bhattacharya P were
working on pain receptor antagonists for many years and hence their level of
skill in the art was high. It was obvious for them to come up with the claimed
piperidine derivatives when earlier compounds were known.

A lot of the inventors own earlier publications and similar patents have been
relied upon to state that the invention was obvious.

9.

While the post-grant opposition proceedings were going on, an RTI application by
Mate revealed that Bristo had applied for a manufacturing licence before the Drug
Controller Licensing Authority, Munain for manufacturing abc bulk drug. Also, Bristo
Inc.s website has listed abc in their product list under developed antagonist APIs.
Mate also realized that Bristo Inc. had applied for marketing approval with the FDA of
Pandora and has advertised its intention of launching the product abc in India and
Pandora through various media. Mate, sent a letter dated September 15, 2013 through
their Attorneys addressed to Bristo and Bristo Inc. which inter alia contained the
following:
a. that Mate is the owner of the patent bearing no. 1234567 which is
registered with the Bharanesian Patent Office, in relation to Compound of
formula I and compositions thereto;
b. that the impugned product is identical to the product which forms a part of
the subject matter of Patent bearing No. 1234567 and the actions of Bristo
and Bristo Inc. clearly amount to infringement of the said Patent;
c. that Bristo and Bristo Inc. should immediately cease and desist from
advertising, manufacturing, marketing and using in any way the impugned
product;

10.

The said letter was not responded to by Bristo and Bristo Inc. Mate filed a quia timet
suit for infringement before the District Court of Suriya (a district in Munain) on

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
January 10, 2014 for restraining Bristo and Bristo Inc. from advertising, manufacturing,
marketing and using in any way the impugned product. Mate, in its plaint also
mentioned Bristos zealous efforts at opposing the patent which indicated Bristos
intentions to launch the product. The Honble District Court while taking note of
Mates submissions and evidence, vide an order dated January 15, 2014, granted a quia
timet

ex-parte injunction restraining Bristo and Bristo Inc. from manufacturing,

marketing and in any way using the impugned product in Bharanesia and exporting the
same outside Bharanesia.
11.

In the opposition proceedings, the Controller of Patents constituted an Opposition


Board who conducted a fresh examination. Both parties made their submissions along
with evidence by experts in the field of pharmaceuticals. After thorough examination,
the Opposition Board recommended that the claimed invention was obvious due to the
following reasons:
R2

Compound of formula I(Mates invention as claimed in Patent 1234567)

The Compound of formula I can be considered to be a derivative of Compound T


as it is structurally very similar to earlier Compound T, which is as follows:
R2
H3C

O
NHR 1

OH
X

H3C

Compound T as taught by Hensky

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015

Compound of formula I is different in that methylbenzene is attached to


cyclopentane ring and the presence of the methyl group (-CH3) [instead of ethyl
group (-CH2-CH3)] on the piperidine ring. However, Compound of formula I can
be said to be a new form of a known substance under section 3(d) of the Patents
Act. Also, one skilled in the art would have been motivated to modify the
structure of compound T to remove deficiencies in the art and arrive at the
Compound of formula I. By virtue of the vast amount of publications and due to
the high level of skill of the inventors, Compound of formula I can be considered
to be obvious. The finding of the Opposition Board is enclosed as Exhibit-C.

12.

Nonetheless, the Controller, after hearing both parties, ignored the recommendations of
the Opposition Board and maintained the patent. The complete order of the Controller is
enclosed as Exhibit D. The earlier order of the Controller under Sec. 25 (1) stated as
follows:

Compound of formula I is structurally different from compound T and the


structural difference does not make Compound of formula I fall under section 3(d)
by virtue of explanation to 3(d);

Compound of formula I is structurally and functionally advanced than compound


T and all other known compounds. The inventors own earlier publications cannot
be considered for obviousness or lack of inventive step. Reliance is placed on
decisions of other countries which state that the inventors own publications
should not be considered for determining obviousness;

Compound of formula I is more efficacious and has more beneficial properties


than other known antagonists due to the positive effects such as mood elevation,
lack of side effects and withdrawal symptoms as demonstrated in the specification
and based on independent expert evidence submitted by Mate.

13.

Dissatisfied with the decision of the Controller, Bristo appealed the decision at the
IPAB. Simultaneously, it also filed for a revocation of the patent IN 1234567 at the
IPAB on the following grounds:
a. that Mate was not entitled to apply for the patent as duly signed Form 1/ assignment
which is mandatorily required to be submitted was not submitted. Bristo provided

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
the whereabouts and details of the inventors and alleged that Mate had in fact made
false submissions before the Patent Office that the inventors Vaidya and
Bhattacharya were not traceable;
b. that the claimed compound is obvious in view of earlier disclosures and inventors
own earlier publications relating to neuropathic antagonists;
c. that the claimed compound is a new form of a known substance (compound T)
disclosed in prior art. The claimed Compound of formula I has almost negligible
structural and functional difference with compound T.
d. that the invention does not involve an inventive step;
14.

Since the appeal and the application for revocation involved the same patent, both the
matters were taken up simultaneously at the IPAB.

15.

While the IPAB matters were pending, Bristo challenged the claims of the patent IN
1234567 in a counter-claim of infringement. The suit, along with the counter- claim got
transferred to the High court of Munain.

16.

The IPAB and the High Court matters are listed for final disposal on February 8, 2015.

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
The Moot Court problem involves the adjudication of the following issues:

1. The obligation to provide a Proof of right if the assignment is not in place and if the
inventors are not traceable. Whether the Patent Office can conclude on ownership of a
patent from other circumstances?
2. Obviousness in case the level of skill is high.
3. Whether prior publication by the inventors can defeat novelty?
4. If a pre-grant opposition is filed and dismissed, is the aggrieved party stopped from
filing a post-grant opposition on primarily the same grounds?
5. If a Post Grant opposition has been filed, can the same party file for a revocation and
also challenge the patent in a counter claim for infringement.
6. Can a quia timet injunction be granted to a party for a patent whose validity is under
challenge before various bodies?

The participants are advised that if there be real need, additional issues can also be
formulated with the permission of the Court/Board

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
EXHIBIT-A
GOVERNMENT OF BHARANESIA
PATENT OFFICE
MUNAIN
LETTER NO.: CHEM/2011/E-1440

DATE: 12/12/2011

To
______
______
______
SUB: First Examination Report

Application No
Date of Filing
Date of Request for Examination
Date of Publication

:
:
:
:

8456/MN/2009
05/06/2009
10/06/2009
15/02/2011

a) With reference to the Request for Examination dated 10/06/2009 in the above mentioned
application for Grant of Patent, Examination has been conducted under Sec.12 and 13 of
the Patents Act 1970, the following objections are hereby communicated.

b) Objections:
1. The applicant has not furnished credible proof of ownership of the invention.
The inventors have not signed the Form 1.
2. The application relates to non-patentable subject matter more specifically
falling under Sec.3 (d) and its Explanation.
3. The specification does not disclose any inventive step.
4. Considering that the reactants, process steps and other parameters are known to
the industry, the invention lacks absolute novelty.
5. The experimental data as shown in the specification does not disclose that the
composition has a new, significant and different beneficial property of the
composition.

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
6. There is no verifiable data available in the specification to show there is a
significant improvement of the therapeutic efficacy of the product.
c) You are requested to comply with the objections by filing your reply by way of
explanation and/or amendments within 12 months from the date of issue of FER failing
which your application will be treated as Deemed to have been abandoned under Sec.
21(1) of the Act. The last date is 12/12/2012.
d) You are advised to file reply at the earliest so that the office can proceed with application
and complete the process within the prescribed period.

Sd/Examiner of Patents & Designs


Patent Office, Bharanesia

10

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
EXHIBIT-B
FIELD OF INVENTION
This invention relates to compounds used for the treatment of chronic pain.
BACKGROUND
Pain is a sensory as well as emotional disturbance associated with actual or potential tissue
damage. The two basic types of pain are acute pain and chronic pain.
Chronic pain is persistent pain, which persists over a long period after the onset of any known
or suspected physical cause, usually of duration greater than 6 months. Chronic pain can be
mild or excruciating, episodic or continuous, merely inconvenient or totally incapacitating.
The most common sources of pain include injuries, muscular dystrophy, headaches, joint
pain, etc.
Neuropathy is an example of chronic pain and is considered to be a result of damage to
peripheral nerves or to regions of the central nervous system (CNS). However, abnormal
functioning of pain-related regions of the nervous system can also occur with chronic
inflammatory conditions such as certain types of arthritis and metabolic disorders such as
diabetes.
Currently the main classes of drugs used to treat neuropathic pain include serotoninnorepinephrine reuptake inhibitors, opiates and opiate-like substances, and topical
medications. Side effects related to serotonin-norepinephrine reuptake inhibitors include
drowsiness, dizziness, fatigue, headache, and increase in suicidal thoughts, nausea /vomiting,
sexual dysfunction, and urinary retention.
U.S.Pat. No. 4,176,186 discloses similar agents suggested in the prior art for alleviating the
constipation problems of chronic pain patients suffer from a number of drawbacks. Although
these substances do not cross the blood-brain barrier, and therefore do not substantially
interfere with those analgesic effects of the opioid agents that are mediated through the brain,
the antagonists suggested by the prior art may well interfere with analgesic activity mediated
through the spinal cord, the peripheral sensory system, the pituitary gland and possibly the
basal hypothalamus, all of which are believed to contain important opioid receptors.

11

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
Indian patent application 7987/MUMNP/2008 discloses synthesis of novel abc receptor
antagonists wherein the document teaches that a lower alkyl groups must be attached to a 5
membered ring. However substitution of a higher alkyl groups to a 5 membered ring would
decrease the activity of the compound as an antagonist, thus decreasing the effect of such a
compound.
Presently known compounds and formulations fail to provide complete relief from chronic
pain and are accompanied by side effects and withdrawal symptoms. Also they do not
provide for mood elevation which is necessary as the conditions such as chronic pain are
often accompanied by depression or trauma. Further the compounds are difficult to
administer especially for geriatric and pediatric patients as they are not available in different
formulations.
Therefore, there is a need to solve the problems mentioned above.
SUMMARY OF THE INVENTION
The present invention relates to a Compound of formula I:
R2

Wherein R1 is selected from H, C1-C10alkyl, C2-C10 alkenyl, C3-C20 cycloalkyl, C3-C20


cycloalkenyl group
R2 is selected from C1-C10alkyl, C2-C10 alkenyl, C3-C20 cycloalkyl, C3-C20
cycloalkenyl group, NH2, CN
X is selected from halogens such as chlorine, bromine

12

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
Brief description of the drawings
Fig. 1 is a graphical representation of the pain intensity (%) on administering the present
invention of compound of formula Ic at a dosage of 45 mg/day in comparison with a placebo.
Fig. 2. is a graphical representation of the pain intensity (%) on administering compound of
formula Ia , drug M and Drug N at a dosage of 125mg/day.
Fig3. is a graphical representation of reduction in pain and mood elevation on administering
the present invention.

DETAILED DESCRIPTION
The present invention discloses a compound used for the treatment of chronic pain which
results from nerve injury, wherein the compound acts as an antagonist to the abc receptors.
Definitions
The term antagonist used herein refers to a substance that acts against and blocks an action.
The term receptors used herein refers to regulatory protein macromolecules located on the
cell surface membrane or within the cytoplasm. The receptors referred to in the present
invention are glutamate receptors.
The term receptor antagonist used herein is a type of receptor ligand or drug that blocks or
dampens agonist-mediated responses rather than provoking a biological response itself upon
binding to a receptor.
The term abc is the name of a selective agonist that binds to abc receptors but not to other
glutamate receptors.
The abc receptor is a specific type of glutamate receptor.
The abc receptor antagonist refers to a class of of anesthetics that work to antagonize, or
inhibit the action of, the abc receptors and are used as anaesthetics for humans. They are used
for pains that result from nerve injury.

13

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
The term ligand used herein refers to molecules that bind to receptors. A ligand may
activate or inactivate a receptor; activation may increase or decrease a particular cell
function.
Various embodiments of the present invention disclose an abc receptor antagonist and its
pharmaceutical composition used for the treatment of chronic pain and its varieties.
An embodiment of the present invention discloses compounds of formula I, and
pharmaceutically acceptable salts thereof.
Compound of formula I:
R2

Wherein R1 is selected from H, C1-C10 alkyl, C2-C10 alkenyl, C3-C20 cycloalkyl and
C3-C20 cycloalkenyl group
R2 is selected from C1-C10 alkyl, C2-C10 alkenyl, C3-C20 cycloalkyl, C3-C20
cycloalkenyl group, NH2 and CN
X is selected from halogens such as bromine
An embodiment of the present invention relates to non-toxic substances belonging to a group
of compounds that are capable of binding to the abc receptors and blocking the abc receptors
thus acting as antagonists.
In another embodiment of the present invention, a pharmaceutical composition containing the
non toxic abc receptor antagonist is disclosed.
The composition comprises of adding one or more pharmaceutically acceptable excipients
thereof.

14

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
The pharmaceutically acceptable excipients are selected from colorants, sweetening agents
combinations thereof.
The colorants are selected from ponceau, quinoline yellow WS and titanium dioxide.
The sweetening agents are selected from sucrose, saccharin or sodium or calcium cyclamate,
glycerol, sorbitol. The sweetening agents are preferably selected from sorbitol, sucrose or a
combination thereof.
The pharmaceutical excipients, include a pharmaceutically acceptable carrier selected from
one or more diluents or fillers; one or more binders; one or more lubricants; one or more
disintegrants; one or more preservatives
The diluents or fillers are selected from but are not limited to lactose, hydroxyethylcellulose,
sodium carboxymethylcellulose, carboxymethylene, and other cellulose derivatives, starches
or modified starches, or their combinations thereof.
The binders are selected from but are not limited to cellulosic bingers, gelatine, gum acacia,
or mixtures thereof.
The lubricants are selected from but are not limited to purified water and Magnesium
Stearate.
The disintegrants are selected from but are not limited to hydroxylpropyl cellulose (HPC),
low density HPC, carboxymethylcellulose (CMC), sodium CMC, calcium CMC.
The Preservative are selected from but are not limited to ethyl or n-propyl-p-hydroxy
benzoate.
In an embodiment of the present invention the composition may be in the form of a liquid,
powder, elixir, injectable solution, capsules, suspensions, syrups.
In the aforementioned embodiments, the abc receptor antagonist can be formulated as a hard
gelatin capsules or soft gelatin capsule, aqueous suspensions.
In yet another embodiment of the present invention, the non toxic abc receptor antagonist is
administered by way of oral administration, intravenous, intramuscular, subcutaneous,
intrathecal, epidural or intracerebroventricular injection. Preferably, the abc receptor
antagonist is administered intravenously.

15

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
Effective dosage levels vary from 10 to 400 mg/day depending on the form of administration.
In the synthesis of the present invention compounds of formula P and Q are mixed under the
required temperature conditions. The mixture is then further distilled and the residue obtained
is poured onto ice wherein the product precipitates. The slurry obtained is stirred and the
product is then filtered and dried to obtain compounds of the present invention.
R2
H3C

N
CH3

Compound P

NHR 1
HO

OH

H3C

Compound Q

Table 1: Certain exemplary compounds of the present invention.


Compound
CH3

CH3

O
H3C

NH

OH
Br

(1a)

H3C

CH2

CH3
O
H3C

NH

OH
Br

(1b)

H3C

16

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
CH3
CH3

O
H3C

NH

OH
Br

(1c)

H3C

Use of Invention
Compounds of the present invention act as antagonists to abc receptors and are used for the
treatment of chronic pain which result from nerve injury. abc receptor antagonism results
in analgesia by preventing central sensitization in dorsal horn neurons; in other words, the
actions of the compounds of the present invention interfere with pain transmission in the
spinal cord.
Further, the compounds of the present invention are used for the treatment of a wide range of
conditions such as, neuropathic pains, memory loss, arthritis related pains, and diabetes
related pains such as diabetic peripheral neuropathy amongst others. The compounds of the
present invention also result in mood elevation.
The compounds of the present invention are preferably used in paediatric and geriatric
patients as it is non-toxic and there are no withdrawal symptoms observed.
Another advantage of the compounds of formula I is that it can be administered in various
forms.
The advantageous process of the present invention is demonstrated in the experimental data.
Example 1
50g of compound P [1-(4-bromo-1,6-dimethylpiperidin-2-yl)] ethanone] was reacted with
20g of compound Q [1-(ethylamino)-4-(3-methylphenyl)cyclopentane-1,3-diol]
at a temperature of 50C for 3 hours. The mixture was then further distilled and the residue
obtained was the poured onto 200ml ice wherein the product precipitates. The slurry obtained
is then stirred for another 30 minutes and the product is further filtered and dried to obtain a
45g of the desired product of the compound of formula Ia.

17

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
H3C
H3C

N
CH3

Br

Compound P

CH3
NH
HO

OH

H3C

Compound Q

Experimental data
The compound was administered to a group of 40 individuals suffering from neuropathic pain
and thus suffering from chronic pain. 45mg/day of the compound of formula Ic, was
administered to such individuals intravenously for a period of 28 days. After the given
duration the pain was observed to be reduced by 65% and mood elevation of the patient was
also observed. Fig. 1 is a graphical representation of pain intensity (%) on administering the
compound of formula Ic in comparison with a placebo.
The compound of formula Ia was administered to a group of 30 individuals at a dosage of
125mg/day wherein the drug was administered orally over a period of 28 days. Another set of
30 individuals suffering from chronic pain were administered with the same dosage as the
present invention with drug M and an additional 30 individuals were administered with drug
N. Drugs M and N are commonly available drugs in the market. The effects of the three drugs
was studied and compared. The reduction of pain observed in individuals administered with
the present invention was much more as compared to patients administered with drugs M and
N as shown in Fig. 2 indicates the reduction in pain Moreover, mood elevation was also
observed which is indicated in graph 3.

18

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
Compound

IC50 against xyz receptor


(nM)

M (prior art)

=270

CH3
O
H3C

CH3

NH

OH
Br

H3C

(1a)

50
CH3

CH3

O
H3C

NH

OH
Br
H3C

(1b)

70
CH2

CH3
O
H3C

NH

OH
Br
H3C

(1c)

130
CH3
CH3

O
H3C

NH

OH
Br
H3C

IC 50 values of the present invention at 125mg/day

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7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015

We claim:
1. A compound formula I:
R2

Wherein R1 is selected from H, C1-C10alkyl, C2-C10 alkenyl, C3-C20 cycloalkyl, C3C20 cycloalkenyl group
R2 is selected from C1-C10alkyl, C2-C10 alkenyl, C3-C20 cycloalkyl, C3-C20
cycloalkenyl group, NH2, CN
X is selected from halogens such as chlorine, bromine
2. The compound according to claim 1, wherein R1 is preferably a methyl
3. The compound according to claim 1, Wherein R2, is preferably ethyl
4. The compound according to claim 1, wherein X is preferably bromine
5. A pharmaceutical composition comprising of compound of formula I as claimed in
claim 1 and pharmaceutically acceptable excipients.
6. The compound as claimed in claim I, wherein the compound is selected from the
compounds delineated in Table A and pharmaceutically acceptable salts thereof.
(1a)
CH3

CH3

O
H3C

NH

OH
Br
H3C

20

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
CH2

CH3
O
H3C

NH

OH
Br
H3C

(1b)

CH3
CH3

O
H3C

NH

OH
Br

(1c)

H3C

Table A
Dated 5th day of June 2009.

FOR B.Z. Mate University

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7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
Abstract
Title: abc Receptor antagonist for the treatment of chronic pain.
The present invention discloses compounds used in the treatment of chronic pain and its
varieties more specifically for neuropathic pain which results from nerve injury. The
compounds disclosed in the present invention acts as an antagonist to the abc receptors and
have the formula I.

R2

(I)

22

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
120

pain intensity (%)

100
80
60

Compound of formula Ic
placebo

40
20
0
day 0

day 7

day 14

day 21

day 28

Days

Fig. 1

day 28

days

day 21

drug N

day14

drug M
Compound of formula Ia

day 7

day 0
0

20

40

60

80

pain intensity (%)

Fig 2.

23

100

120

7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015

100
90
80
70

60
50

pain

40

mood elevation

30
20
10
0
day 0

day 7

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7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
EXHIBIT-C
FINDINGS OF THE OPPOSITION BOARD.
1) Findings on proof of ownership filing: Even though the Examiner had raised a question
on the proof of ownership, the applicant has furnished credible evidence to show that during
the relevant period of the genesis of the invention, the inventors had a contract of
employment which explicitly stipulated that all the inventions of their employees in the
course of employment automatically vest in the company. Hence, the applicant sought
withdrawal of the objection. However, even assuming that this is correct, since patents are
territorial, the assignment clause contained in the earlier and later application will not ipso
facto convey the right to file patent applications. The patent offices have a right to demand
proof of ownership of the invention in every case, specifically in respect of their territory.
Hence, on the ground of applicants failure to furnish credible proof of ownership, the
application deserves rejection.
2) Contrary to the objection of the Examiner, the Board finds the existence of relative novelty
if not absolute novelty.
3) The Examiners Board is of the opinion that the Patent Specification does not disclose any
inventive step. Inventive step, in addition to the statutory definition, should also be decided in
the light of teaching, suggestion and motivation available in the industry. Pharmaceuticals,
specially, pain killers, are among the highly researched areas and a person skilled in the art
can arrive at the composition after reasonable trial and error. Hence, the Board is of the
opinion that the application lacks inventive step.
4) Regarding the applicability of Sec. 3(d) and its Explanation, it is found that the actions of
the composition under issue interfere with pain transmission in the spinal cord. In addition to
that, the compound results in mood elevation, which is an important factor in reduction of
pain. Considering that the composition has fewer toxic side effects, we believe that the
operation of sec.3 (d) and its explanation is not attracted.
In view of our findings on Point 1 and 3, we recommend the Controller to revoke the patent.

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7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
EXHIBIT-D
GOVERNMENT OF BHARANESIA
PATENT OFFICE
MUNAIN
IN THE MATTER OF POST-GRANT OPPOSITION FILED IN PATENT NO. 1234567
TITLED ABC RECEPTOR ANTAGONIST FOR THE TREATMENT OF CHRONIC
PAIN DATED 05/06/2009

BETWEEN
OPPONENT

BRISTO PHARMACEUTICAL PVT LTD

AND
PATENTEE

B.Z. MATE UNIVERSITY

ORDER OF THE CONTROLLER


1. The opponent originally filed a representation under Sec. 25 (1) of Bharanesian Patent Act
against the grant of Patent. The grant of patent was opposed on the grounds of:
(a) failure to furnish proof of ownership of invention
(b) the application lacks novelty
(c) the specification does not disclose any inventive step
(d) the application falls under the non-patentable invention category as enumerated
under Sec. 3(d) and its Explanation.
2. The pre-grant representation of the opponent was considered and order on merit was
passed by the Patent Office rejecting the opposition and ordering the grant of patent. The
same applicant, on the very same grounds albeit on additional material, has sought to avail
the other procedure available under Sec. 25 (2) of the Patents Act.
3. At the outset, I am of the opinion that sec.25 (1) adopts a summary procedure for
determining the issues in controversy. No elaborate evidence is taken. A right of oral hearing
by Opponent is not even mandatory if it is not specifically sought either by the Opponent or
by the Applicant. The Patent Office, more particularly, the Examiner has to prima facie
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7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
satisfy himself that the representation is either tenable or untenable and accordingly decide to
reject or grant the patent. Furthermore, the order passed under Sec. 25(1) is not an appealable
order. However, I am aware that since the doctrine of judicial review is part of the basic
structure of the Constitution, if the opponent is aggrieved by the order of the Controller under
Sec. 25 (1) of the Patent Act, they could have availed the constitutional remedies. Failure to
do so would normally mean that as between the parties and in the given application, the order
of the Patent Office becomes final and it cannot be re-agitated again on the same grounds.
4. However, subsequent to the opponent availing the statutory right of post-grant opposition
under sec. 25 (2), the Patent Office had constituted an Opposition Board as required under
Sec. 25 (2) and Rule 55-A to 62 of the Patent Rules 2003. The Opposition Board did not
include the Examiner who originally issued the First Examination Report and recommended
the grant of Patent. The members of the Board had actually found that there is relative
novelty in the application and the specification does not attract the vice of Sec. 3(d) and its
Explanation. However, the Board in its wisdom, found that the applicant has not furnished
credible proof of ownership of the invention and that the patent specification does not
disclose inventive step. The Board has also further found that the composition and the
process of making the composition are obvious to a person skilled in the art in view of the
high level of inventive activity prevalent in pharmaceutical industry, particularly, the pain
killers sector.
5. In light of the above factual situation, the following issues arise for consideration.
(a) Whether the opposition board is correct in holding that the Applicant has not furnished
credible proof of ownership to the invention covered under the patent specification?
(b) Whether the specification under adjudication evinces inventive step?
6. My findings on Issue (a): It is not in dispute that the inventors were employed as full time
scientists of the applicants. The invention, undoubtedly, is in the course of employment of
evolving new drugs. It is also not in dispute that the applicant has filed hundreds of PCT
applications all over the world. Even assuming that this particular application does not
contain endorsement from the inventors, earlier, the same inventors have several assignments
in respect of different inventions. On the relevant date, they were shown on the rolls of the
Applicant as full time employees. Assuming that the inventors may have a right to retain
ownership in respect of an invention which they have already assigned to the employer, such

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7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
assumptions can only be on credible documentary proof. The inventors, being accomplished
scientists, should be aware (or capable of being aware of it, had they exercised due diligence)
of the patent filings of their invention. If they do not file objections on the ground of
wrongful obtaining in Patent Office, the Patent Office may well be within its rights to hold
that the fact and duration of the full time employment is proved, the patent offices should not
once again demand proof of ownership. Furthermore, the ownership of an invention, more
particularly, the right to file patent applications in respect of a original invention which was
already assigned to the employer in pursuant of a contract of employment is a legal question
and not a technical issue. Because of this, I chose to disregard the findings of the Opposition
Board.
7. My findings on Issue (b): The Examiners Board itself has found despite objections from
the Examiner, that:
(a) the specification discloses Relative Novelty
(b) the specification does not attract the operation of sec. 3(d) and its
Explanation.
8. However, the Board came to a conclusion that the level of inventive activity in the
pharmaceutical industry is high and the inventive step should be decided in the light of
teaching-suggestion-motivation test. This test is alien to the Bharanesian Patent Act. The
Bharanesian Patent Act defines inventive step as a feature of an invention that involves
technical advance as compared to the existing knowledge or having economic significance
or both and that makes the invention not obvious to a person skilled in the art. While
assessing the concepts like novelty and inventive step, examiners have a tendency to avail the
benefit of hindsight and conclude erroneously that the specification does not disclose
inventive step. It is well known that mere simplicity of invention is no bar to its patentability.
Considering that the employment of a receptor and an antagonist to block the receptor has the
twin advantages of interfering with pain transmission and mood elevation, it solves an
existing problem which the person skilled in the art did not earlier know. Absence of
withdrawal symptoms and possibility of pediatric and geriatric prescription of the same
compound substantially increases the ease of administration and could revolutionalize, in
future, the treatment to pain. Furthermore, being an Organic Chemist with a substantial
experience in examining pharmaceutical compositions, I have no hesitation in holding that
the Opposition Board was incorrect in its conclusion that there is no inventive step.
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7th Symbiosis-B. Krishna Memorial National IPR Moot Court Competition, 2015
ORDER
In view of my above findings, I uphold the finding of the Examiner of Patents and the
post-grant opposition is hereby dismissed.
In the circumstances of the case, parties to bear their own costs.

Sd/Controller of Patents & Designs


Patent Office, Bharanesia

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