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DELHI METROPOLITAN EDUCATION NATIONAL MOOT COURT 2021

MEMORIAL ON BEHALF OF THE PLAINTIFF
TEAM CODE: TC 06

1st SJCL-ALMT National Moot Court Competition 2021

BEFORE

THE HON’BLE HIGH COURT OF MELHI

M/s. COVITECH LABORATORIES

……………………....PLAINTIFF
V.

M/s. REE SAW TECHNOLOGIES ……………………RESPONDENT

MEMORIAL ON BEHALF OF RESPONDENT

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 TABLE OF CONTENTS

TABLE OF CONTENTS........................................................................................................................1
INDEX OF AUTHORITIES...................................................................................................................2
STATEMENT OF JURISDICTION.......................................................................................................6
ISSUES RAISED.................................................................................................................................... 7
STATEMENT OF FACTS...................................................................................................................... 8
SUMMARY OF ARGUMENTS...........................................................................................................10
PLEADINGS INCLUDING CONCLUSION/ PRAYER FOR RELIEF...............................................12

ISSUE 1: WHETHER THE SUIT FILED BY M/S COVITECH TECHNOLOGIES IS

MAINTAINABLE AND THE PATENT GRANTED TO M/S COVITECH IS
VALID…………….15
ISSUE 2: WHETHER AN PRELIMINARY INJUNCTION SHOULD BE GRANTED AGAINST M/S
COVITECH LABORATORIES.......................................................................................................... 23
ISSUE 3: WHETHER COMPULSORY LICENSE SHOULD BE GRANTED TO M/S REE SAW
AND TECHNOLOGIES ...................................................................................................................... 2

PRAYER..............................................................................................................................................30
 TABLE OF AUTHORITIES

[A.] CASES

1. 3M Innovative Properties Company v. M/S Venus Safety & Health Pvt Ltd, 2016

2. American Cyanamid Co v Ethicon Ltd, [1975] A.C. 396

3. Anuj Garg v. Hotel Association of India (2008) 3 SCC 1.

4. Bajaj Auto Limited v. TVS Motor Company Limited 2008 ILLJ 726 Mad

5. Bayer Corporation v Union of India & Ors, LPA No 359/2017

6. Bayer Intellectual Property GMBH & Anr v Alembic Pharmaceuticals Ltd

7. Biswanath Prasad Radhey Shyam v. Hindusthan Metal Industries, AIR 1982 SC, 144

8. Chameli Singh v. State of UP (1996) 2 SCC 549.

9. Eli Lilly & Co. v. S & U Chemicals Ltd 26 C.P.R. (2d) 141

10. F. hoffmann-La Roche Ltd. and anr. v. Cipla Ltd

11. Godrej Soaps v. Hindustan lever (1994) IPLR 60 (Cal)

12. HC Bilcare v. Amartara Pvt. Ltd (2007) 2 M.I.P.R. 42.

13. M. C. Mehta v. Union of India (1999) 6 SCC 9

14. Natco Pharma v. Union of India

15. National Research and Development Corporation of India vs. Delhi Cloth &General Mills Co.
Ltd., AIR 1980 Del. 132

16. Ram Narain Kher v. Ambassador Industries ( AIR 1976 Del 87 )

17. Shanks v Unilever plc and others [2019]

18. V. Manicka Thevar v Star Plough Work, A.I.R. 1965 Mad. 327.

[B.] CONSTITUTIONS
1. The Constitution of India, 1950.

[C.] STATUTES
1. Patents Act,1970.
2. Information Technology act, 2000.

[D.] INTERNATIONAL CONVENTIONS

 3. TRIPS, 1995.
4. Patent Cooperation Treaty, 1970.
5. Washington Treaty on Intellectual Property, 1989.
6. Paris Convention, 1883.
7. Patent Law Treaty, 2005.
8. Patent Cooperation Treaty, 1970.
9. Budapest Treaty, 1977.

[E.] BOOKS
1. P.M. Bakshi, The Constitution of India, 15th Edition, 2018.
2. Durga Das Basu, Commentary on the Constitution of India, 8th Edition, 2007.
3. Mr Sagar Kishore Savale, Indian Patents Act, 1970.
4. Pavan Duggal, Cyber Law, 2nd Edition.
5. Vakul Sharma, Information Technology, 5th Edition.
6. V.K. Ahuja, Intellectual Property Rights, 2nd Edition.
7. Adarsh Ramanujan, Patent Law, 2nd Edition.

[F.] DICTIONARIES REFERRED

1. Law Lexicon, P. Ramanatha Aiyar, 6th Reprint Edition 1995.
2. Oxford Advanced Learner’s Dictionary, 4th Edition.

[G.] ONLINE SOURCES

1. Manupatra Online Resources, http://www.manupatra.com.
2. SSC Online, http://www.scconline.co.in.
3. Lexis Nexis Academica, http://www.lexisnexis.com/academica.
4. Lexis Nexis Legal, http://www.lexisnexis.com/in/legal.
 STATEMENT OF JURISDICTION

 JURISDICTION- SECTION 104 OF PATENTS ACT, 1970

It is humbly submitted that the plaintiff has invoked the jurisdiction of The Hon’ble Melhi High
Court, Tianzhu under Section 104 of The Indian Patent Act, 1970. The defendants humbly submit to
the same.
 POWER OF HIGH COURTS TO MAKE RULES

The Hon’ble Melhi High Court has Jurisdiction to entertain this suit by virtue of powers
conferred on High Courts under Section 158 of The Patents Act, 1970.

The High Court may make rules consistent with this Act as to the conduct and procedure in
respect of all proceedings before it under this Act.

Page | 6
 ISSUES RAISED

ISSUE: 1
WHETHER THE SUIT FILED IS MAINTAINABLE AND THE PATENT GRANTED TO
M/S COVITECH T LABORATORIES IS VALID

ISSUE: 2
WHETHER PRELIMINARY INJUNCTION SHOULD BE GRANTED AGAINST M/S
REE SAW TECHNOLOGIES

ISSUE: 3

WHETHER COMPULSORY LICENSE SHOULD BE GRANTED TO M/S. REE SAW

TECHNOLOGIES
 STATEMENT OF FACTS

BACKGROUND

M/s. Covitech Laboratories is a pharmaceutical product research and development company

situated in Xalonia, Federal States of Averna (FSA). The company is dedicated to making the
world a healthier place for everyone for more than 50 years, chasing it down, battling it for
answers, and encircling it in search of a way in. They have worked relentlessly to bring life-
saving drugs to the market.

GRANT OF PATENT TO M/S. COVITECH LABORATORIES

The company, in collaboration with an academic institution in Tianzhu called NEMDPER

(National Education for Medical Devices and Pharmaceutical Education and Research), has
developed a drug called "Releiver" that will relieve lung congestion caused by viral infections
such as SARS-CoV-2 or Covid-19, as well as other influenza (Flu). Covitech Laboratories
provided the research outline, but NEMDPER handled all experiments and investment for the
Research and Development and subsequent clinical trials. Mrs. Divya Viswanath, Assistant
Professor, and Mr. Rajesh, Post-Doctoral student at NEMDPER, were named inventors and
M/s. The Patent Application named Covitech Laboratories and NEMDPER as Applicants.
After a thorough examination of the Patent Application, a patent was granted. M/s. Covitech
Laboratories began manufacturing the drug quickly after receiving valid approval from drug
regulatory authorities in Tianzhu and FSA. NEMDPER, as an academic institution, was unable
to begin commercialization of the drug "Releiver."

Covid-19 spread

Covid-19 has spread all over the world, affecting every country, and the demand for the
"Releiver" has risen tremendously. The only drug that effectively reduced congestion in the
lungs of people treated with the Covid-19 virus was “Releiver.”. Until early 2020 M/s 
Covitech Laboratories was only responsible for the drug's manufacturing and distribution. Due
to increased demand of the medicine and a few compulsory licence applications made by
Tianzhuan firms, voluntary licences for the manufacturing and distribution of "Releiver" were
issued to selected Pharma companies and those who approached for compulsory licencing.
 SUMMARY OF ARGUMENTS

ISSUE: 1
WHETHER THE SUIT FILED AGAINST M/S COVITECH LABORATORIES IS
MAINTAINABLE AND THE PATENT GRANTED TO M/S COVITECH T
LABORATORIES IS VALID

It is most humbly submitted before the Hon’ble Melhi High Court that the suit filed by M/s
Covitech against M/s. REE SAW Technologies is not maintainable as any process for the medical,
surgical, curative,prophlatic or other treatments of human beings are not patentable under section 3
(i) According to sec. 107 of the Patents Act, 1970, in a suit for infringement of patent, every ground
on which the patent may be revoked under sec. 64 shall be available as a ground of defence. Under
sec. 64 (k), where the subject matter of the claim is not patentable, it can be revoked. Since the
patent granted for ‘Reliever’ falls outside the purview of patentable subject matter, M/s. Ree Saw
Technologies has not infringed the patent by manufacturing “Reliever”.

ISSUE: 2
WHETHER PRELIMINARY INJUNCTION SHOULD BE GRANTED AGAINST
M/S REE SAW TECHNOLOGIES

It is humbly submitted that Preliminary Injunction should not be granted in this case. There were 3 essentials
laid down for granting a preliminary injunction in case F. hoffmann-La Roche Ltd. and anr. v Cipla Ltd.1, first
was the American Cyanamid Test, second is presumption of invalidity and last is genuine challenge. These
essentials are favouring the defendant in this case.
A credible challenge is also presented before the Hon’ble Court related to the validity of the patent on the
grounds under section 3 (i) of The Patents Act, 1970.The Patent granted to M/S CovidTech Laboratories is not
sufficiently old that preliminary injunction can be granted. Furthermore, non-granting of preliminary
injunction will not cause irreparable damage to the plaintiff as there are number of pharma companies in the
market right now manufacturing and distributing drug “Releiver” with the license provided by the plaintiff.
Hence, Patent should not be granted to ensure that no further injustice is done to the defendants an unfair
advantage is not given to the plaintiff.

ISSUE: 3

WHETHER COMPULSORY LICENSE SHOULD BE GRANTED TO M/S. REE SAW

TECHNOLOGIES

It is most humbly submitted that license should be granted to M/S Ree saw Technologies as section
92 (3) (II) says that compulsory license by the central government can be provided when the
controller is satisfied on consideration of the application referred to the clause 92 (1) (I) that it is
necessary in circumstances of National Emergency or circumstances of extreme urgency or a case
of public non-commercial use which may arise or be required including Public Health crisis
required to acquired immune deficiency syndrome human immune deficiency virus Malaria or
other epidemics. In the present situation, when the world is fighting a pandemic Compulsory
licensing will allow the production of affordable drugs and increases availability and supply of the
vaccine Reliever.

Thus, M/S Ree saw Technologies should be licensed to increase production, improve affordability
and control the current situation by making vaccine available for all patients in adequate quantities.

1
F. hoffmann-La Roche Ltd. and anr. v. Cipla Ltd.
 WRITTEN PLEADINGS

ISSUE: 1
WHETHER THE SUIT FILED AGAINST M/S COVITECH LABORATORIES
IS MAINTAINABLE AND THE PATENT GRANTED TO M/S COVITECH T
LABORATORIES IS VALID

1.1 NO PRESUMPTION OF VALIDITY

It is submitted that section 13(4) of The Patent Act 1970 mandates that there is no presumption of validity
in respect of a patent granted under the act the grant of a patent under the provision of the Act does not by
itself guarantee the validity of the patent moreover the actual user and duration of the patent alone cannot
give rise to a presumption of validity of the patent. Further, no presumption of validity of a patent in a suit
for infringement, and the plaintiffs are required to establish prima facie validity of the patent (Section 13
and 107 of the Patents Act). Hence, the patent granted to M/S Covitech Technologies cannot be presumed
to be valid.
In the case of V. Manika Thevar vs. Star Plough Works, AIR 1965 Mad 327,2 it was held that the
patent is a very recent one, and the decisions have uniformly taken the view that any patent which is less
than six years old is regarded as a recent one. The statement of the law in Terrel on Patent, 9th Edn pages
318-320 shows that a patentee should show undistributed possession of the enjoyment of the patent at least
for six years before the controversy arose.

In National Research and Development Corporation of India vs. Delhi Cloth &General Mills Co.
Ltd., AIR 1980 Del. 132 it was again held that if a patent is a new one, a mere challenge at the Bar would
be quite sufficient for a refusal of a temporary injunction.

1.2 PATENT DOES NOT CONFER ABSOLUTE MONOPOLY

The patent right is not absolute. It is a fettered right and is subjected to certain prescribed constraints.
The Patents Act balances well between the individual rights of the patentee and the interest of the general
public. A patent does not grant an absolute monopoly. Along with giving protection to the right-holder
for his invention, the Act is also aware of the interest of the public; the main purpose of the Act being
encouragement of the development of technology and innovation.
 Patents are not granted merely to enable patentees to enjoy a monopoly for the importation of the
patented article. It aims to see that the patent right is not abused by the patentee or person deriving title or
interest on patent from the patentee does not resort to practices that unreasonably restrain trade or
adversely affect the international transfer of technology. Patents are granted to make the benefit of the
patented invention available at reasonably affordable prices to the public. Patents granted do not in any
way prohibit Central Government from taking measures to protect public health.

1.3 THE DRUG RELEIVER IS NOT PATENTABLE UNDER THE PATENT ACT 1970
Section 3 of the Patents Act, 1970 excludes certain inventions from the ambit of patentability. Though
there is an exhaustive list of fifteen exclusions from patentability mentioned in the Act, only three
exclusions enumerated in clauses (d), (e), and (i) of section 3 are relevant from the perspective of
pharmaceutical products in India. These clauses exclude new use of the known substance, a mere
admixture of components, and methods of treatment respectively from the ambit of term ‘invention’ and
hence render them unpatentable. All these exceptions have been provided in conformity with the
categories for exclusions mentioned in the TRIPS Agreement3
in the case of substances intended for use or capable of being used as food, drugs or medicines, or
substances produced by chemical processes. Hence, pharmaceutical products are currently not granted
patent protection under Indian law.
So as per Section 3(i), medicinal treatment includes a process of administering medicines orally (in form of
tablets, capsules, etc.) or through injectables, or topically or through a dermal patch and method of treatment
by surgery for therapeutic or cosmetic purpose are not considered patentable. For instance, a stitch-free
incision for cataract removal cannot be patented. The curative method includes a method of cleaning plaque
from teeth whereas a prophylactic treatment includes a method of vaccination that is not patentable. Also, “a
method of sampling body fluid”, which comes under diagnostic purpose, can not be patented.4 Therefore,
claims related to the method/process of treatment by medicinal, surgical, curative, prophylactic, diagnostic,
therapeutic are statutorily non-patentable.

2
https://indiankanoon.org/doc/1302906/
3
https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm
4
https://www.stratjuris.com/section-3i-of-indian-patent-act-1970-patent-eligibility-of-method-of-treatment-claims/
For instance, in application 4981/DELNP/2008, the invention was found to be novel, inventive, and
otherwise patentable, but was refused under Section 3(i) of the Act. 5

Another application, 1492/CHENP/2010, relating to a method of detecting the presence or absence of a

Chikungunya virus (CHIK) strain in a biological sample, was also refused under Section 3(i) of the Act. 6

Hence, under section 3(i) the patent granted to M/S Covitech Technologies is invalid and thus the suit filled
against M/S Ree Saw will not be maintainable.

1.4 REASONABLE ROYALTY

Under section 40(1), an employee may apply for compensation from his employer in respect of an invention
he has made which belongs to his employer and for which a patent has been granted, where that patent is of
outstanding benefit to the employer.

In Shanks v Unilever plc and others [2019] Professor Shanks' long-running lawsuit with Unilever came to a
head in the Supreme Court, where he was awarded £2 million in compensation for his innovation under the
Patents Act 1977's employee inventor compensation provisions.

In the instant case where M/S Covitech filed for the infringement of the patent is not valid as inventors of the
drug “Releiver”, they have not received any compensation from either M/s. Covitech Laboratories or
NEMDPER and thus they are free to use the drug.7

1.5 BOLAR PROVISION

The Division Bench of the Delhi High Court, decided on the two appeals filed by Bayer against the
Natco Pharma Limited (Bayer Corporation v Union of India & Ors, LPA No 359/2017)and the second,
in Bayer Intellectual Property GMBH & Anr v Alembic Pharmaceuticals Ltd, both appeals involved
identical issues pertaining to the interpretation of Section 107A of the Patents Act, 1970 (the Act),
commonly known as the ‘Bolar’ provision.8

Section 107A of the Act provides an exception to patent infringement. It allows making, constructing,
selling or importing of a patented invention solely for reasonable use related to research and
development and for the submission of such information generated during the experimentation, before
regulatory authorities for approvals. The intent of this exception was to ensure the prompt availability
of patented products, particularly pharmaceutical products with the necessary regulatory approval for
market launch, immediately after expiry of the term of the patent.9

In one of the statements by an Indian Pharma company it was said that, "Bolar exemption was

5
https://www.lakshmisri.com/insights/articles/scope-of-section-3-i-an-analysis-on-diagnostic-methods-of-treatment/#
6
https://www.lakshmisri.com/insights/articles/scope-of-section-3-i-an-analysis-on-diagnostic-methods-of-treatment/#
7
Moot Problem
8
https://indiankanoon.org/doc/691258/
9
Dr Elizabeth Verkey, Law of Patents | 19. Pharmaceuticals and Patents
 provided to encourage competition. The greater the competition, the better it is for the protection of
public health". 10

Hence in the present case the suit filed by the covitech is invalid as When an invention is made, either
used or sold by a third party for certain purposes for further research and development. It doesn’t count
as an infringement. Further, this provision assumes that the cost of any generic medicine is very less
comparative to the parallel patented drugs and so every individual can afford it.

ISSUE: 2
WHETHER PRELIMINARY INJUNCTION SHOULD BE GRANTED AGAINST M/S
REE SAW TECHNOLOGIES.

[2.1] It is humbly submitted that Preliminary Injunction should not be granted in this case. The patent is
relatively new and its credibility is also being questioned in issue 2 under section 3(i) of The Patents Act,
1970. Granting of Preliminary Injunction will be an unfair advantage to the plaintiff.

[2.2] Standard Test for Granting Preliminary Injunction

In the case of F. Hoffman- LA Roche Ltd. and anr. v. Cipla Ltd11, the Delhi High Court set the following
guidelines as a test for granting Preliminary Injunction-
“(i) In patent infringement actions, the courts should follow the approach indicated in American
Cyanamid, by applying all factors;
(ii) The courts should follow a rule of caution, and not always presume that patents are valid, especially
if the defendant challenges it;
(iii) The standard applicable for a defendant challenging the patent is whether it is a genuine one, as
opposed to a vexatious defense. Only in the case of the former will the court hold that the defendant has
an arguable case.”
All the above-mentioned tests are discussed in the subsequent points.

10
https://www.mondaq.com/india/patent/691036/bolar-exemption-in-india
11
F. Hoffman- LA Roche Ltd. and anr. v. Cipla Ltd (2008) 148 D.L.T. 598.
 [2.3] American CynamideApproach

In the case of American Cyanamid Co v Ethicon Ltd12, it was held that-

“As to that, the governing principle is that the court should first consider whether, if the plaintiff were to
succeed at the trial in establishing his right to a permanent injunction, he would be adequately compensated
by an award of damages for the loss he would have sustained as a result of the defendant's continuing to do
what was sought to be en joined between the time of the application and the time of the trial. If damages in the
measure recoverable at common law would be adequate remedy and the defendant would be in a financial
position to pay them, no interlocutory injunction should normally be granted, however strong the plaintiff's
claim appeared to be at that stage.”

In order to narrow it down, the main questions are-

 Whether there is a serious question to be tried.

 What would be the balance of convenience of each party should the order be granted (in
other words, where does that balance lie?)
 Whether there are any special factors.

Now, all the above mentioned questions are supported in favour of the defendant in the subsequent
arguments.

[2.4] NO PRIMA FACIE CASE

It is humbly submitted that the burden to prove that there is a Prima Facie Case is on the Plaintiff. Now, as per
Section 13(4) of The Patents Act, 1970 which states that-

“The examination and investigations required under section 12 and this section shall not be deemed in any
way to warrant the validity of any patent, and no liability shall be incurred by the Central Government or any
officer thereof by reason of, or in connection with, any such examination or investigation or any report or
other proceedings consequent thereon.”

In the light of this section, the Supreme Court in the case of Biswanath Prasad Radhey Shyam v. Hindusthan
Metal Industries13 held that there is no presumption that the patent will be necessarily valid by mere grant or
sealing of patent, provided in section 13(4) of the Act and the injunction was not granted.
12
American Cyanamid Co v Ethicon Ltd, [1975] A.C. 396
13
Biswanath Prasad Radhey Shyam v. Hindusthan Metal Industries, AIR 1982 SC, 144
As argued in the Issue 1 that the Patent itself is not valid, hence it can be concluded that there is no prima facie
case from the Plaintiff.

[2.5]CREDIBLE CHALLENGE AND PRESUMPTION OF INVALIDITY

I. It is humbly submitted that the credibility of the patent is questioned in Issue 2. In suits of alleged patent
infringement, the Court ought not to grant a preliminary injunction when there is a credible challenge for the
validity of the Patent. "Credible challenge" means that there is a serious question to be tried in the suit with
respect to the validity of the patent. In the case of Bajaj Auto Limited v. TVS Motor Company Limited 14, the
Supreme Court held that-
“In suits alleging patent infringement, the court ought not to grant any interim injunction in cases where
either the plaintiffs fail to prove a prima facie case or where the defendant presents a “credible” challenge to
either the validity of the patent or to the factum of infringement. Rather, the matter ought to go to the trial for
a final decision on the merits”

II. In the case of Bilcare v Amartara Pvt. Ltd.15, the High Court held that the mere grant of a patent doesn’t
guarantee its validity. Thus, it is most humbly submitted that a preliminary injunction should not have been
granted in favour of the plaintiff for protecting rights arising out of a disputed patent.

III. In the case of Ram Narain Kher v. Ambassador Industries16, it was held by the Delhi High Court that-

“interlocutory order will be refused if there is a serious attack on validity of patent”

IV. In the case of Godrej Soaps v. Hindustan lever17, it was held that-

“Credibility of the challenge presented by the defendant against the plaintiff’s claim is of immense importance
to the court while taking a decision regarding grant of injunctions. Where the evidence disclosed a genuine
intention to defend the action upon the grounds that the patents were invalid, it could not be said that the
defence was frivolous or vexatious, it was held to be a serious triable issue”

In the light of the above judgment given by Calcutta High Court, it can be said that in the present case even if
we were to believe for the sake of argument that the plaintiff is able to establish a prima facie case in their
favour, injunction cannot be granted as the validity of the patent is being questioned by the Defendant with a
credible challenge.
Also, therefore, there is no presumption of validity based on above argument presented.

[2.6] Six Year Rule

The six year rule was initially created in the case of V. Manicka Thevar v Star Plough Work18. As per this rule,
14
Bajaj Auto Limited v. TVS Motor Company Limited 2008 ILLJ 726 Mad
15
HC Bilcare v. Amartara Pvt. Ltd (2007) 2 M.I.P.R. 42.
16
Ram Narain Kher v. Ambassador Industries ( AIR 1976 Del 87 )
17
Godrej Soaps v. Hindustan lever (1994) IPLR 60 (Cal)
18
V. Manicka Thevar v Star Plough Work, A.I.R. 1965 Mad. 327.
injunction cannot be granted in cases where the patent is not more than 6 years old.
In the case of 3M Innovative Properties Company v. M/S Venus Safety & Health Pvt Ltd19, the court held that-

“court will not grant an interim injunction in the case of recently granted patents – with 'recent' being less
than six years. The rule presumes that patents older than six years are valid and therefore removes the need to
examine the validity of the patent at the interim stage. The granting of injunction by the court examined the
validity of the patent at issue in light of the prior art produced by the defendant and concluded that the
validity of the patent was in serious doubt. Therefore, the court concluded that the patentee had failed to
establish a prima facie case”
Thus, it is humbly submitted that the Patent is relatively new, so a Preliminary Injunction cannot be granted on
this.
National Research and Development Corporation's case11 that if the patent is not less than six years old, injunction
should not be granted

[2.7] NO IRREPARABLE LOSS

It is humbly submitted that as Mrs. Divya Viswanath and Mr. Rajesh are the inventors of the “Releiver”
drug, thus, there is no chance of manufacturing any sub-standard product by them. Thus, it will not cause
any irreparable loss to the goodwill of the plaintiff. Also, the Plaintiff has already granted voluntary
licenses to big Pharma Companies and they are manufacturing and selling “Releiver” Drug, so it can also
be said that there are already sharing market with other big Pharma Companies20. Hence, the Plaintiff will
not face any economic irreparable loss. Therefore, there is no irreparable loss caused to the plaintiff in
this case.

[2.8] BOLAR PROVISION AND BALANCE OF CONVENIENCE

As per Bolar provision, manufacturers of pharmaceutical products have right to conduct research on various
patented products so that the products can be brought into the market for the welfare of the general public. In
this case, there is a huge demand and lack of availability of the drug “Releiver” in the market. Hence, for the
welfare of general public, the Defendant started the manufacturing and distribution of “Releiver” drug in good
faith.
Section 107A is the example of Bolar Provision or Bolar Exception in India. Section 107A states that-

“107A Certain acts not to be considered as infringement. -For the purposes of this Act,-
(a)  any act of making, constructing,  using, selling or importing] a patented invention solely for uses
reasonably related to the development and submission of information required under any law for the time
being in force, in India, or in a country other than India, that regulates the manufacture, construction,    [use,
sale or import] of any product;
(b) importation of patented products by any person from a person  [who is duly authorised under the law to
19
3M Innovative Properties Company v. M/S Venus Safety & Health Pvt Ltd, 2016
20
Para. 6, Moot Problem
 produce and sell or distribute the product],
shall not be considered as a infringement of patent rights.]”

Now, as per Section 107A, M/S REE SAW Technologies has the right to research, manufacture and sell
“Reliever” Drug. Thus, it can clearly be said that there is no mischief from the side of the Defendant.
It is humbly submitted that in the light of above arguments presented, preliminary injunction should not be
granted in favour of the plaintiff. The Defendant has already started the manufacturing and granting injunction
will cause huge inconvenience. There is a huge demand and lack of availability of the drug in the market right
now, thus it is a balance of inconvenience not only to M/S REE SAW Technologies but also to the public at
large.
Therefore, in the light of the arguments presented it is humbly submitted that the Preliminary Injunction should not be
granted on this.
 ISSUE: 3
WHETHER COMPULSORY LICENSE SHOULD BE GRANTED TO M/S REE
SAW TECHNOLOGIES

It is contended by the Counsel for the respondent that the claim for a compulsory license filed by the
respondent under section 92 is justified it is further submitted that the controller was justified in hearing and
deciding such a claim under section 92 claim for a compulsory license is justified.

3.1 CLAIM FOR COMPULSORY LICENSE IS JUSTIFIED

In the light of the facts of the case, it is humbly stated that M/S Ree Saw Technologies should be given a
compulsory license for the manufacturing of the drug reliever. As the compulsory license is a weapon in the
hands of the government to supplied citizens with a generic version of patented drugs. section 92 of the Patent
Act 1970 empowers the central government on its satisfaction to make a declaration in the official gazette after
such notification the controller general of patents designs and trademarks Mein Grand license to applicants
were willing and can manufacture the said drugs through the compulsory licensing the government can allow
Pharma manufacturer to produce a generic version of patented medicines for the larger public good in simple
words if the patented the drug cost thousand of rupees we can make it through the fraction and increase the
availability and supply of the drug reliever since covid-19 is a National Public Health emergency critical drugs
like reliever should be licensed to increase production and improve affordability.
In the wake of the public health crisis afflicting many developing and least-developed countries, especially
those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics, the ministerial conference of WTO
adopted ‘The Doha declaration on TRIPS and Public Health’ (2001). The Doha declaration provided a
mechanism for compulsory licensing to supply medicines to countries with insufficient or no-manufacturing
Guidelines For Examination Of Patent ApplicationsIn The Field Of Pharmaceuticals Office of the Controller
General of Patents, Designs and Trademarks Page 4 capacities. The declaration also explicitly stressed that the
TRIPs Agreement can and should be interpreted and implemented in a manner supportive of WTO members
right to protect public health and, in particular, to promote access to medicines for all. Consequently, a
provision (Section 92A) was introduced in the Patents Act for Compulsory Licensing for the purpose of export
of pharmaceuticals products to any country having insufficient or no manufacturing capacity

Article 31 of TRIPS also relates in particular to non-voluntary licenses granted to third parties. Although the
term “compulsory license” does not appear, TRIPs affirms the right of Member States to
grant compulsory licenses and confirms their autonomy to determine the grounds upon which such licenses
can be granted. In many countries the government is allowed to make use of a patented invention without
previous license for reasons related to the public interest. In France the government may rely on the Public
Health Act to use a patented invention without the need for a license in case of an emergency.21
The Doha Declaration also held that compulsory licensing is one of the flexibilities present in the TRIPS
system to address public health concerns. Countries which lacked capacity to manufacture drugs could resort
to compulsory licensing to address public health issues. Governments could also grant compulsory licenses if
they determined public health problems to be of "extreme urgency"22
The Paris Convention stipulates that each country may take legislative measures that allow for the grant
of compulsory licenses “to prevent the abuses which might result from the exercise of the exclusive rights
conferred by the patent, for example, failure to work”. As failure to work is clearly stipulated as only an
example, the Paris Convention allows Member States to grant compulsory licenses on many other grounds as
well.23 Recently, it has been reconfirmed that the compulsory license mechanism can be invoked to address in
particular the potentially hindering effects of patents on public health.
It is submitted that in the case of Eli Lilly & Co. v. S & U Chemicals Ltd 24The Supreme Court noted that “the
legislative policy behind compulsory licensing, namely, is to avoid any practical monopoly of the manufacture
of drugs by patented processes and to foster competition”.
Article 31 of the TRIPS Agreement makes an explicit provision for compulsory licensing  Such a process can
be resorted to by a member nation in case of national emergency or other circumstances of extreme urgency or
in In the case of public non-commercial use where the member nation can allow the use of the subject-
matter of the patent without the authorization of the patent holder and to have waited for a reasonable time for
the negotiations to not come through.  Nevertheless, the Doha Declaration marks a considerable leap with
compulsory licenses, as it establishes in Article 5.b that each member has the right to grant compulsory
licenses and the freedom to determine the grounds on which such licenses are granted. Further, Article 5.c
establishes that each member has the right to determine what constitutes a national emergency or other
circumstances of extreme urgency. Clause 5(c) provides that: “public health crises, including those relating to
HIV/AIDS, tuberculosis, malaria and other epidemics” can constitute “a national emergency or other
circumstances of extreme urgency”.

In Bayer’s Corporation V. Union of India25- the court held observation of the Tribunal that the proceedings
under section 84 of the acting public interest are because the entire basis of grant of the compulsory license is
based on the objective that a patented article is made available to the society inadequate number and at a
reasonable price this is a matter of public interest the law of patent is a compromise between the interest of the
inventor and the public in this case we are concerned with the patented drug that is medicines to heal patients
suffering from cancer public interest is and should always be fundamental in deciding a list between the
parties while granting a compulsory license for medicines or drugs.

Natco Pharma v Bayer Corporation - Natco Pharma Ltd. is an Indian generic pharmaceutical company.
Natco Pharma proposed Bayer for a voluntary license of the drug, but Bayer Corporation denied it. Natco
Pharma later approached the controller of patents court for a compulsory license. The applicant i.e. Natco
Pharma claimed for compulsory license by section 84 (1) of the Patent (Amendment) Act, 2005. It argued

21
International Review of Intellectual Property and Competition Law from IIC 2011, 42(1), 4-40
22
Pooja Van Dyck, Importing Western Style, Exporting Tragedy: Changes in Indian Patent Law and Their Impact on AIDS
Treatment in Africa 6 NW. J. TECH & INTELL. PROP. 138, 145 (2007-08)
23
Convention (1967) https://www.wto.org/english/tratop_e/dispu_e/repertory_e/p2_e.html
24
Eli Lilly & Co. v. S & U Chemicals Ltd 26 C.P.R. (2d) 141
25
https://indiankanoon.org/doc/85364944/
upon this section and stated that the patentee i.e. Bayer Corporation did not comply with the provisions under
section 84 (1) The decision was based upon the test laid down under section 84 (1) of the Patent (Amendment)
Act, 2005. being the first case of compulsory license in India it opened doors for many debates. This was a big
step towards the usage of compulsory licenses especially in the field of the pharmaceutical industry. It is the
responsibility of the government to efficiently maintain the balance between the rights of the innovator and
that of the public. In the present case, the compulsory license was granted by the given provisions and facts of
the case. In the battle between the patients and patients, the patients were favored.
Granting compulsory licenses to M/S Ree Saw Technologies was in the interest of the public. By refusing the
grant to M/s Ree Saw Technologies M/S Logitech wants to hold the monopoly over the manufacturing of the
drug Reliever. This leads to unfair competition.

3.2 THAT THE PATENTED DRUG IS NOT AVAILABLE TO THE PUBLIC AT LARGE
It is humbly submitted that it is rightly said that The public interest needs to be balanced with individuals'
rights, and it is the responsibility of the courts or administration in each respective country to determine this26
hence compulsory licenses may be appropriate if the public benefits of increased use of the patented invention
outweigh the long term public costs of reduced disclosure and innovation; and the public interest in expanded
working of the patented invention outweigh the patentee’s private interests. In the case of public benefits the
patentee’s consent is not required27
It is also submitted that section 92 satisfies the condition to grant the compulsory license to M/S Ree Saw
Technologies because there was a huge demand of the Product and due to the restriction of M/S Covitech is
not able to fulfill the demands of the public. Also The code of federal Regulations of US says that “patent by
its very nature is affected with the Public Interest”28, public interest must be kept in mind deciding compulsory
licence cases and in the case of Hoffmann-La Roche Ltd v. L.D. Craig Ltd29 the Supreme Court of Canada
affirmed, ”In my view, No absolute monopoly can be obtained in a process for the production of food or
medicine” it is also to be stated that countries with limited industrial development could consider a
compulsory patent to develop its national industries as for public interest.30Hence the license should be granted
to the M/S Ree Saw Technologies. .

3.3 VIOLATION OF ARTICLE 21

it is the duty of the state to protect the citizens at large and give them healthy environment as held in M.C.
Mehta v. Union of India.31 Ensuring good health by improving the “quality of life” will also include a major
part of Art 21. Thus Right to Life will include right to food, water, decent environment , education, “medical
care” and shelter.32
One of the substantive rights recognized by the Covenant is “the right of everyone to the enjoyment of the
highest attainable standard of physical and mental health”. In particular, parties are obliged to take steps
26
Correa, Carlos M. “Intellectual Property Rights and the.” Trade Related Agenda Development and Equity (1999): 3
27
Reichman, J. and Hasenzhal, C. “Non-voluntary licensing of patented inventions.Historical perspective, legal framework under
TRIPS, and an overview of the practice in Canada and the USA” (2003), ICTSD Programme on IPRs and Sustainable Development
Issue paper no. 5 at 10.
28
Code of Federal Regulations - US Government Publishing Office https://www.gpo.gov/fdsys/browse/collectionCfr.action?
collectionCode=CFR
29
Hoffmann-La Roche Ltd v. L.D. Craig Ltd (1967) 48 C.P.R. 137
30
Fauver, Cole M. “Compulsory Patent Licensing in the United States: An Idea Whose Time Has Come.”Northwestern Journal of
International Law and Business 8.3 (1988): 666–685. Print. p67118
31
(1999) 6 SCC 9 (para 1).
32
Chameli Singh v. State of UP (1996) 2 SCC 549.
necessary for “the prevention, treatment and control of epidemic, occupational and other diseases”, and “the
creation of conditions which would assure to all medical service and medical attention in the event of
sickness33
Thus, By merely issuing compulsory licence for the pharmaceutical patent in the interest of public does not
impose any physical restraint to the patent owners.

3.4 The Doctrine of parens patriae applies in the present case

This means that the state is the parent of the country and it has a legal obligation to protect the citizen
especially when there is a threat to the health and security of the nation. The subject matter of parens patriae
power can be adjudged on two counts (i) In terms of necessity (ii) assessment of any trade-off or adverse
impact, if any.34

PRAYER

Wherefore it is prayed, in light of the issues raised, arguments advanced, and authorities cited, that this Hon'ble High Court may be
pleased to hold that:
1. Compulsory licensing should be provided to M/s Ree Saw Technologies.
2. The patent should be revoked.
3. Preliminary Injunction should not be granted.
4. Compensation should be provided to the inventors, Mrs. Divya Viswanath and Mr. Rajesh.

And Pass any other Order, Direction, or Relief that it may deem fit in the Best Interests of Justice, Fairness, Equity, and Good
Conscience.

For This Act of Kindness, the Respondent Shall Duty Bound Forever Pray.

Sd/-
(Counsel for the Respondent)

33
ICESCR, Art. 12(1); ICESCR, Art. 12(2)(c), ICESCR, Art. 12(2)(d).
34
Anuj Garg v. Hotel Association of India (2008) 3 SCC 1.