8 N M C C, 2023: Ational OOT Ourt Ompetition

8TH NATIONAL MOOT COURT COMPETITION, 2023
13-R
BEFORE THE HON’BLE HIGH COURT OF ZUMBAI

APPELLATE JURISDICTION
APPEAL NO. _____/2023
(FILED UNDER SECTION 117A OF THE PATENT ACT, 1970)
IN THE MATTER BETWEEN
ORNAMEL…………………………………. APPELLANT
VERSUS
ULTRON……………………………………. RESPONDENT
COUNSEL FOR THE RESPONDENT
WRITTEN SUBMISSION ON BEHALF OF THE RESPONDENT
MEMORIAL ON BEHALF OF RESPONDENT Page 0 of 29

TABLE OF CONTENTS
1. TABLE OF CONTENTS ............................................................................................... 1
2. TABLE OF CASES ....................................................................................................... 2
3. LIST OF ABBREVIATIONS ........................................................................................ 3
4. INDEX OF AUTHORITIES .......................................................................................... 4
5. STATEMENT OF JURISDICTION .............................................................................. 5
6. STATEMENT OF FACTS ............................................................................................. 6
7. STATEMENT OF ISSUES ............................................................................................ 7
8. SUMMARY OF ARGUMENTS ................................................................................... 8
9. ARGUMENTS ADVANCED ........................................................................................ 9
Issue I: Whether Ultron Is Practising Evergreening Of Patents That Violates The
Principle Of Intellectual Property Law, Competition Law And Public Health Policy?. 9
[A] The Medicine, After The Addition Of PD-1, Fulfils The Criteria That Is Required
To Get Patent Protection. Hence, The Respondent Is Not Practising Evergreening Of
Patents That Violates The Principle Of Intellectual Property Law- ............................... 9
[B] Grant Of Secondary Patent Rights Does Not Violate Competition Law- ............. 13
[C] Grant Of Secondary Patent Rights Does Not Violate Public Health Policy- ........ 16
Issue II: Whether Right To Public Health Prevails Over Right To Intellectual
Property? ...................................................................................................................... 19
[A] Balance To Be Maintained Between Public Health And Intellectual Property
Rights ........................................................................................................................... 19
[B]It Is An Invention As Per The Patents Act .............................................................. 21
[C] The Drug Manufactured Is A Life-Saving Drug .................................................... 23
10. PRAYER ...................................................................................................................... 26
11. BIBLIOGRAPHY ........................................................................................................ 27

TABLE OF CASES
Page
S.No Case Name Citation
No.
1. M/S Bishwanath Prasad Radhey Shyam v.
AIR 1982 SC 1444. 10
M/S. Hindustan Metal Industries.
2. Blakey and Co. v. Lathem and Co. (1889) 6 RPC 184 (CA) 11
3. Bayer Corporation vs Union of India. 2013 SCC OnLine IPAB 25 16
4. Novartis AG v. UOI & Ors. MANU/SC/0281/2013. 20, 23
5. Glenmark Pharmaceuticals Ltd. v. Merck (2015) 6 SCC 807.
11
Sharp & Dohme Corpn.
6. Lundbeck v. Generics. [2008] EWCA (Civ) 311 [1]. 14
7. 534 F. Supp. 2d 146 (D.D.C.
Walgreen Co. v. AstraZeneca Pharma. 14
2008)

LIST OF ABBREVIATIONS
S.NO ABBREVIATION EXPANSIONS

1. ¶ Paragraph
2. @ At
3. & And
4. A.I.R. All India Report
5. Anr. Another
6. Art. Article
7. Const. Constitution
8. Ed. Edition
9. F.R. Fundamental Right
10. Govt. Government
11. HC. High Court
12. Hon’ble Honorable
13. Ltd. Limited
14. Ors. Others
15. Pg. Page
16. Pvt. Private
17. S.C. Supreme Court
18. S.C.C. Supreme Court Cases
19. S.C.R. Supreme Court Reporter
20. Sec. Section
21. U/S Under Section
22. UOI. Union of India
23. URL. Universal; Resource Locator
24. v. Versus
25. Vol. Volume
26. w/r/t With respect to

INDEX OF AUTHORITIES
A: STATUTES
1. The Competition Act, No. 12 of 2002.
2. The Constitution of India, 1950.
3. The DOHA Declaration, 2001.
4. The Indian Patents Act, No. 39 of 1970.
5. The TRIPS Agreement, 1994.

STATEMENT OF JURISDICTION
The Appellant has approached this Hon’ble High Court of Zumbai under Section 117A1 of
The Patent Act, 1970 after being aggrieved by the decision of the Controller alleging
violation of principles of Intellectual Property and Competition Law. The respondents
maintain that there has been no such violation and hence the court need not entertain the
petition.
1
Appeals to Appellate Board - (1) Save as otherwise expressly provided in sub-section (2), no appeal shall lie
from any decision, order or direction made or issued under this Act by the Central Government, or from any act
or order of the Controller for the purpose of giving effect to any such decision, order, or direction. (2) An appeal
shall lie to the Appellate Board from any decision, order or direction of the Controller or Central Government
under section 15, section 16, section 17, section 18, section 19, section 20, sub-section (4) of section 25, section
28, section 51, section 54, section 57, section 60, section 61, section 63, section 66, sub-section (3) of section
69, section 78, sub-sections (1) to (5) of section 84, section 85, section 88, section 91, section 92 and section 94.
(3) Every appeal under this section shall be in the prescribed form and shall be verified in such manner as may
be prescribed and shall be accompanied by a copy of the decision, order or direction appealed against and by
such fees as may be prescribed. (4) Every appeal shall be made within three months from the date of the
decision, order, or direction, as the case may be, of the Controller or the Central Government or within such
further time as the Appellate Board may, in accordance with the rules made by it allow.

STATEMENT OF FACTS
1. Ultron, a pharmaceutical giant situated in Zumbai, Bindia has patent over the drug
‘Vasonax’ which is used to cure Nasopharyngeal. The said patent was granted on 5th
January 2007.
2. The present formula of the used a medical composition of Alkylating Agent
(chemotherapy medicine) and Monoclonal Antibodies (medicine which slows down or
stops the growth of cancer cells).
3. During the clinical trials Ultron realized that the drug was only 90% effective on the
patients and hence made an addition of PD-1 (medicine which helps immune system to
attack cancer cells) to the present composition to strengthen the drug. As a result, it
showed a non-obviousness usefulness of the medicine.
4. Ultron wants to extend the patent protection for the drug and hence reinvented the original
formula. The changes made in the drug aimed at enhancing the efficacy, convenience of
the drug. Ultron filed for grant of secondary patent for changes claiming the drug to be
novel, non-obvious and useful.
5. Ornamel, a pharmaceutical company who has been in the pharmaceutical industry for more
than 20 years raised concerns about practicing of evergreening to the controller of patent
who found addition of PD-1 to be non-obvious according to sec 2(1)(j) of Bindia Patent
Act,1970.
6. Aggrieved by decision of the controller of the patent, Ornamel, approached to the High
Court, raising concerns on evergreening of patent under sec 3(d) of the Bindia Patent Act,
1970 and the controller of patent. They argued that evergreening erodes competition,
innovation, and access to affordable medicine particularly in developing countries where
people cannot afford high prices of medicine.
Hence the matter before the Hon’ble Court

STATEMENT OF ISSUES
ISSUE I: Whether Ultron is practicing evergreening of patent that violates the principle of
Intellectual Property Law, Competition Law, and Public Health Policy?
ISSUE II: Whether right to Public Health prevails over Intellectual Property Rights?

SUMMARY OF ARGUMENTS
ISSUE I: Whether Ultron is practicing evergreening of patent that violates the principle
of Intellectual Property Law, Competition Law, and Public Health Policy?
No. the medicine, after the addition of PD-1, fulfils the criteria that is required to get patent
protection. Hence, the Respondent is not practising evergreening of patents that violates the
principle of Intellectual Property Law. This issue has been put forth in a three-fold argument:
[A] The Respondent humbly submits that even though there might be a grant of secondary
patent right by the Controller of patents with respect to a Vasonax after the addition of PD-1,
it does not amount to evergreening of the patent as PD-1 has a different effect on the overall
efficiency of the drug which is said to have improvised through the course of clinical trials;
[B] Grant of secondary patent rights does not violate competition law; [C] Grant of secondary
patent rights does not violate public health policy.
ISSUE II: Whether right to Public Health prevails over Intellectual Property Rights?
No. the Respondent humbly submits that there must be a balance between Right to Public
Health and Right to Intellectual Property. It is submitted that Right to Intellectual Property is
a right that is to be enjoyed by all companies and the argument is threefold, namely, [A]
Intellectual Property Rights, Competition Law etc all come under the same umbrella
therefore a conflict with Right to Public Health will always arise and there needs to be a
balance between the two; [B} The invention is an invention as per Section 2(j) and 2(ja) of
the Patent Acts, 1970 and also satisfies the test of being an invention under Sec. 3(d), [C] The
drug manufactured is a life-saving drug therefore public health is already being prioritized
but the company’s right also needs to be prioritized. It is submitted that the amended portion
of section 3(d) clearly sets up a second tier of qualifying standards for chemical
substances/pharmaceutical products in order to leave the door open for true and genuine
inventions but, at the same time, to check any attempt at repetitive patenting or extension of
the patent term on spurious grounds.

ARGUMENTS ADVANCED
ISSUE I: WHETHER ULTRON IS PRACTISING EVERGREENING OF PATENTS THAT VIOLATES
THE PRINCIPLE OF INTELLECTUAL PROPERTY LAW, COMPETITION LAW AND PUBLIC
HEALTH POLICY?
1. The Respondent humbly submits that the grant of secondary patent rights to the
reinvented drug does not amounts to violation of principles of Intellectual Property Law,
Competition Law, and Public Health Policy. This argument can be brought out in a three-
fold manner: [A] The Respondent humbly submits that even though there might be a
grant of secondary patent right by the Controller of patents with respect to a Vasonax
after the addition of PD-1, it does not amount to evergreening of the patent as PD-1 has a
different effect on the overall efficiency of the drug which is said to have improvised
through the course of clinical trials; [B] Grant of secondary patent rights does not violate
competition law; [C] Grant of secondary patent rights does not violate public health
policy.
[A] The Medicine, After The Addition Of PD-1, Fulfils The Criteria That Is Required To
Get Patent Protection. Hence, The Respondent Is Not Practising Evergreening Of
Patents That Violates The Principle Of Intellectual Property Law-
2. According to the World Intellectual Property Organisation, A patent is an exclusive right
granted for an invention, which is a product or a process that provides, in general, a new
way of doing something, or offers a new technical solution to a problem. To get a patent,
technical information about the invention must be disclosed to the public in a patent
application2. According to Section 2(m) of the Indian Patent Act, 19703 “patent” means a
patent for any invention granted under this Act.
3. An invention is patentable subject matter if it meets the following criteria – i) It should be
novel. ii) It should have inventive step or it must be non-obvious iii) It should be capable
of Industrial application. iv) It should not attract the provisions of section 3 and 4 of the
Patents Act 20054.
4. The Respondent humbly submits that the medicine is a patentable subject matter after the
addition of PD-1 as it satisfies the above criteria which is explained below.
2
Patents, https://www.wipo.int/patents/en/index.html (last visited Jun 23, 2023).
3
The Patents Act, Sec. 2(m), No.39, Acts of Parliament, 1970 (India).
4
IIPRD, Novelty & Non- Obviousness as Concepts of Patent, IIPRD BLOG - INTELLECTUAL PROPERTY
DISCUSSIONS (2020), https://iiprd.wordpress.com/2020/05/28/novelty-non-obviousness-as-concepts-of-patent/
(last visited Jun 23, 2023).

5. Novelty simply means newness based on what is existing as of the priority date of the
patent application. An invention will be considered to be novel if it is different from what
is already existing, which is referred to as ‘prior art’ 5. In the case at hand, the Respondent
has filed for secondary patent rights pertaining to the change made to the composition of
Vasonax by claiming the drug to be novel as it is different and showed enhanced efficacy
from the prior existing drug through the addition of PD-16. In case of M/S Bishwanath
Prasad Radhey Shyam v. M/S. Hindustan Metal Industries7, it was held that there must be
novelty in application. And also observed in case of Blakey and Co. v. Lathem and
Co.8 is that to be new in patent only novelty or subject matter can show invention.
6. Section 2(ja) of the Patents Act defines inventive step as follows: “(ja) “inventive step”
means 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;9” The concept of inventive step in India laid
down by Supreme Court in case of M/s. Bishwanath Prasad Radhey Shyam Appellant v.
M/s. Hindustan Metal Industries 10 as the combination of new result. In case of Vasonax,
there has been a technological advancement over the existing knowledge which also has
an economic significance11. Moreover, it is not obvious to a person skilled in the art and
hence this drug can be said to be arrived at through an inventive step of adding PD-1.
Reliance is placed on para 105 of the Merck v. Glenmark12 in which it was observed as
follows:
"It is worth pointing out here that the biological activity of a molecule and its utility as a
medicine is completely dependent on the structure as a whole. That is, each part of the
molecule makes some contribution to the overall biological effect".13
7. In a case between Cipla and Roche14, the Delhi High Court reviewed some Indian and
foreign cases relating to the utility or industrial applicability requirement and observed
that an invention must be commercially viable. It must have a commercial use, and
5
Novelty & Non-Obviousness As Concepts Of Patent - Patent - India,
https://www.mondaq.com/india/patent/949550/novelty--non-obviousness-as-concepts-of-patent (last visited Jun
23, 2023).
6
Compromis ¶4.
7
Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511.
8
Blakey and Co. v. Lathem and Co 70 N.C. 368 (N.C. 1874).
9
The Patents Act, Sec. 2(1) (ja), No.39, Acts of Parliament, 1970 (India).
10
Supra Note 10.
11
Compromis ¶ 3.
12
Merck v. Glenmark (2015) 6 SCC 807.
13
Merck Sharp & Dohme Corporation vs. Glenmark Pharmaceutical Ltd. On 7 October, 2015.
14
F. Hoffmann-La Roche Ltd. v. Cipla Ltd., 2015 SCC OnLine Del 13619.

commercial success need not be proved. At a basic level, the invention must have a
practical use and has to be useful for the purpose claimed in the patent specification.
Nothing more will be required to prove utility of an invention for patentability.
8. Industrial applicability requirement checks if an invention is capable of being made or
used in an industry (Section 2(1) (ac))15. If a product can be manufactured repeatedly and
has at least one use in an industry, it will be considered as industrially applicable. In a
case between MSD and Glenmark16, the Delhi High Court applied principles for
industrial applicability laid down by the UK Court of Appeals to arrive at the conclusion
that a pharmaceutical compound is industrially applicable. The principles cited by the
Court are as follows:
i. “The patent must disclose “a practical application” and “some profitable use” for
the claimed substance, so that the ensuing monopoly “can be expected [to lead to]
some … commercial benefit;”
ii. A “concrete benefit,” namely the invention’s “use … in industrial practice” must
be “derivable directly from the description,” coupled with common general
knowledge;
iii. A merely “speculative” use will not suffice, so “a vague and speculative
indication of possible objectives that might or might not be achievable” will not
do;
iv. The patent and common general knowledge must enable the skilled person “to
reproduce” or “exploit” the claimed invention without “undue burden”, or having
to carry out “a research programme”; …”
By applying the aforesaid principles, the Court concluded that the invention is
industrially applicable. In the present case, it can be concluded that the drug satisfies the
above conditions to prove that there is industrial application after the addition of PD-1 to
Vasonax17.
9. Lastly, Vasonax (after the addition of PD-1) does not attract the provisions of Section 3
and 4 of the Indian Patent Act, 200518. Section 3 talks about subject matters that are not
inventions whereas Section 4 states that inventions relating to atomic energy are not
patentable. The Respondent would like to contend that PD-1 does not attract Sections 3
and 4. First of all, the above can be said as all the properties required for a subject matter
15
The Patents Act, Sec. 2(1) (ac), No.39, Acts of Parliament, 1970 (India).
16
Glenmark Pharmaceuticals Ltd. v. Merck Sharp & Dohme Corpn., (2015) 6 SCC 807.
17
Compromis ¶4.
18
The Patents Act, Sec. 3 & Sec. 4, No.39, Acts of Parliament, 1970 (India).

to acquire patent rights have been proved in this argument namely- novelty, inventive
step and industrial application. Although PD-1 is not a new substance invented by the
Respondent, it is essential to note that it is new to the combination of the excipients and
Active Pharmaceutical Ingredients (APIs) already existing in Vasonax. This has
incredibly brought about a change in the effectiveness of the drug. As mentioned in the
facts of the case, it is true that after making changes to the drug, it was marketed as
“innovative” and “life-saving” which means that the addition of PD-1 strengthened the
existing potent formula which showed a non-obvious usefulness of the medicine. The
above can be proved with the help of the existing scientific studies which prove the
novelty of PD-119.
10. In a study, it has been said that targeting PD-L1 and PD-1 interactions is a relatively new
therapeutic strategy used to treat cancer. Inhibitors of PD-1/PD-L1 include peptides,
small molecule chemical compounds, and antibodies. Several approved antibodies
targeting PD-1 or PD-L1 have been patented with good curative effect in various cancer
types in clinical practices. While the current antibody therapy is facing development
bottleneck, some companies have tried to develop PD-L1 companion tests to select
patients with better diagnosis potential. Meanwhile, many companies have recently
synthesized small molecule inhibitors of PD-1/PD-L1 interactions and focused on
searching for novel biomarker to predict the efficacy of anti-PD-1/PD-L1 drugs. This
review summarized clinical studies and patent applications related to PD-1/PD-L1
targeted therapy and also discussed progress in inhibitors of PD-1/PD-L120.
11. Another source also claims that the programmed cell death protein 1 (PD-1) pathway has
received considerable attention due to its role in eliciting the immune checkpoint
response of T cells, resulting in tumour cells capable of evading immune surveillance and
being highly refractory to conventional chemotherapy21.
12. The grant of secondary patent by the Controller of Patent does not amount to
evergreening of patent:
i. The Respondent humbly submits that even though there might be a grant of
secondary patent right by the Controller of patents with respect to a Vasonax after
the addition of PD-1, it does not amount to evergreening of the patent as PD-1 has
19
Compromis ¶4.
20
Clinical and Recent Patents Applications of PD-1/PD-L1 Targeting Immunotherapy in Cancer Treatment—
Current Progress, Strategy, and Future Perspective - PMC,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7358377/ (last visited Jun 23, 2023).
21
Xiaomo Wu et al., Application of PD-1 Blockade in Cancer Immunotherapy, 17 COMPUT STRUCT
BIOTECHNOL J 661 (2019).

a different effect on the overall efficiency of the drug which is said to have
improvised through the course of clinical trials.
ii. The campaign against secondary patents is motivated in large part by a concern
that follow-on patents facilitate “evergreening” of pharmaceutical products. The
assumption is that follow-on patents are used to extend the effective term of patent
protection for a drug beyond that provided by an initial patent. Even in cases
where a pharmaceutical active ingredient came to market with the protection of a
primary patent that provided a substantial period of exclusivity, it is important to
bear in mind that a follow-on patent directed towards a new use or new
formulation cannot extend the term of the original patent.
iii. Once the primary patent expires, there is no patent-based restriction on the ability
of generic competitors to bring competing versions of the original formulation to
market.22 In Lundbeck v. Generics23, a court in the United Kingdom specifically
pointed out that a follow-on patent claiming escitalopram, a purified enantiomer
of citalopram, did not prevent a number of manufacturers from selling generic
versions of the original racemate drug in the U.K. once the original patent had
expired.
iv. In Walgreen Co. v. AstraZeneca Pharma24, brand manufacturer AstraZeneca
introduced heartburn drug Nexium onto the market right as its older formulation,
Prilosec, approached patent expiration. In 2008, the District of Columbia Court
rejected a finding of “product hopping,” ruling that AstraZeneca had actually
“added choices” for patients by marketing Nexium25.
[B] Grant Of Secondary Patent Rights Does Not Violate Competition Law-
13. Intellectual Property Right is an exception to Competition Law:
The Respondent humbly submits that Intellectual Property Right is an exception to
Competition Law under Section 3(5)26 of the Competition Act. Intellectual property
rights grant the holders of IP a temporary right to exclude others from using that IPR.
This economic exclusivity is granted with the purpose of benefitting the owner for their
22
Eric M. Solovy and Pavan S. Krishnamurthy, TRIPS Agreement Flexibilities and Their Limitations: A
Response to the UN Secretary-General's High-Level Panel Report on Access to Medicines, 50 Geo. Wash. Int'l
L. Rev. 69, 106 (2017).
23
Lundbeck v. Generics, [2008] EWCA (Civ) 311 [1].
24
534 F. Supp. 2d 146 (D.D.C. 2008).
25
Phebe Hong, Stopping the Pharmaceutical “Product Hop,” BILL OF HEALTH (2019),
https://blog.petrieflom.law.harvard.edu/2019/10/11/stopping-the-pharmaceutical-product-hop/ (last visited Jun
27, 2023).
26
The Competition Act, Sec. 3(5), No.12, Acts of Parliament, 2002 (India).

creative efforts and promoting investment in creations. While the grant of IPR may
sometimes result in monopoly or even confer market power, such monopolisation and
dominant position is not always a case of anti-competition and therefore, needs to be
examined with a view of maintaining a balance between intellectual property rights and
competition law. The Indian competition regime explicitly puts an exemption for
imposing reasonable conditions in protection of IP rights in relation to anti-competitive
agreements under Section 3 of the Competition Act, 2002, however, no such exception is
granted for abuse of dominant position under Section 4 of the Act27.
14. The Respondent is not at a dominant position in the market:
Dominant position is a position of economic and monetary strength enjoyed by the
enterprises and entrepreneurs that empowers them to forestall effective competition being
maintained on the relevant market. A dominant position is acquired by an enterprise over
a period of time and factor such as state of technology, barriers to entry, scale of
operations, etc., influence the achievement of a dominant position. Ways in which an
enterprise can exploit its dominant position are as follows:
i. Imposition of discriminatory practices or trading conditions or predatory prices
ii. Limitation on supply of goods or services
iii. Denial of market access
iv. Using its dominant position in one relevant market to enter into another relevant
market28
The Respondent contends that there is no existence of their dominant position in the
market as they are not exploiting their position in the market as stated above. The
Respondent is merely trying to obtain patent rights for the innovation that has proven to
have enhanced efficacy in its usage on cancer patients. Since there is no dominant
position in the market, there is no requirement to look into the abovementioned ways in
which there could be a possible exploitation of the dominant position by the Respondent
in the market.
15. It is by and large observed that IPR and competition law have conflicting goals.
Economic activities of a country are operated through two systems i.e., free market and
regulated market systems. The reason behind adopting the two different mechanisms is
27
Extension of IPR Exemptions under the Indian Competition Law – An Analysis – CCLE,
https://www.icle.in/resource/extension-of-ipr-exemptions-under-the-indian-competition-law-an-analysis/ (last
visited Jun 23, 2023).
28
ABUSE OF DOMINANT POSITION UNDER COMPETITION ACT, 2002,
https://articles.manupatra.com/article-details/ABUSE-OF-DOMINANT-POSITION-UNDER- (last visited Jun
23, 2023).

for better working of the country’s market. While going with the operation of
Competition law and IP invention is indispensable, price needs to be stable so that the
supplier along with the buyer is able to fulfil their needs. The economy ought not to be a
static one but open with the regulating bodies to keep it under control. One of the
safeguards could be Compulsory Licensing.
A compulsory license is where an IPR owner is authorized/forced by the state to
surrender his exclusive right over the intellectual property, under article 31 of the Trade-
Related aspects of Intellectual Property Rights (TRIPS)29. Compulsory licenses are
granted under exceptional circumstances such as: in the interest of public health, national
emergencies, nil or inadequate exploitation of a patent in the country, and for an overall
national interest.
16. The Patents Act, 1970 also contains provisions with regard to compulsory licensing. In
India the Controller General has the authority to grant patents to enterprises and to review
applications received from persons interested for grant of compulsory licensing subject to
following conditions.
According to Section 84 of the Patents Act, 1970, the controller general can grant
compulsory license for patents only on the following grounds that are as follows:
i. That the reasonable requirements of the public with respect to the patented
invention have not been satisfied, or
ii. That the patented invention is not available to the public at a reasonably
affordable price, or
iii. That the patented invention is not worked in the territory of India.30
17. Further, compulsory license could also be granted suo-moto by the government under
Section 92 of the Patents Act, 1970 pursuant to a notification specified in the official
gazette under the following grounds- national emergency or extreme urgency or in cases
of public non-commercial use.
18. In, Bayer Corporation vs Union Of India (also known as Natco vs Bayer), it was India's
first ever compulsory license which was granted by the Patent Office on March 9, 2012 to
Natco Pharma for the generic production of Bayer Corporation's Nexavar, a lifesaving
drug used for treating Liver and Kidney Cancer. Bayers Corporation sold this drug at
exorbitant rates, with one month's worth of dosage costing around Rs. 2.8 Lakh. Natco
29
Agreement on Trade-Related Aspects of Intellectual Property Rights, Sec.31, 15 April 1994, Marrakesh
Agreement Establishing the World Trade Organization (entered into force 1 January 1995).
30
The Patents Act, Sec. 84, No.39, Acts of Parliament, 1970 (India).

Pharma offered to sell it around for Rs 9000, making it reasonable and affordable for
individuals belonging to every stratum of society. All the 3 conditions of Section 8431 of
Patents Act were fulfilled and the decision was taken for the benefit of general public32.
[C] Grant Of Secondary Patent Rights Does Not Violate Public Health Policy-
19. The Respondent humbly submits that there is no violation of public health policy when a
secondary patent right is granted to a drug through the following arguments:
20. The National Health Policy, 201733 emphasises on reinforcing trust in Public Health Care
System in clause 2.3.2 which mentions about strengthening the trust of the common man
in public health care system by making it predictable, efficient, patient centric, affordable
and effective, with a comprehensive package of services and products that meet
immediate health care needs of most people. Moreover, clause 2.3.3 focuses on aligning
the growth of private health care sector with public health goals, i.e., to influence the
operation and growth of the private health care sector and medical technologies to ensure
alignment with public health goals, to enable private sector contribution to making health
care systems more effective, efficient, rational, safe, affordable and ethical as well as
strategic purchasing by the Government to fill critical gaps in public health facilities
would create a demand for private health care sector, in alignment with the public health
goals34. Hence, the above were the major healthcare principles provided by the
Government of India as a part of the National Health Policy.
21. One of the key objectives of the patent system is to reward innovation by allowing
innovators to charge "prices" for protected products. It has been argued that a fully
functional patent system would result in an inverse relationship between the cost of such
products and affordability of access.35 Although it is suggested by some that the global
intellectual property system may be facing a crisis of public legitimacy as questions are
being raised, for example, on how patents may be blocking the access of ordinary people
to medicines36 and their "right to health"37, the Respondent contends that the views
31
Supra Note 26.
32
Bayer Corporation v. Union of India, 2013 SCC OnLine IPAB 25.
33
National Health Policy, 2017.
34
Supra Note 29.
35
Sanjaya Lall, Indicators of the relative importance of IPRs in developing countries.
36
Martin Khor, Patents system facing legitimacy crisis, https://twn.my/title/et0110.htm (last visited Jun 24,
2023).
37
Promotion and Protection of All Human Rights, Civil, Political, Economic, Social and Cultural Rights,
Including the Right to Development | United Nations Enable,
https://www.un.org/development/desa/disabilities/promotion-and-protection-of-all-human-rights-civil-political-
economic-social-and-cultural-rights-including-the-right-to-development.html (last visited Jun 24, 2023).

expressed by those in the pharmaceutical industry that it is "more strongly dependent on

the patent system than most other industrial sectors to recoup its past R&D [research and
development] costs, to generate profits, and to fund R&D for future products'"38 Indeed,
the CIPR noted that:
Surveys have shown that the pharmaceutical companies, more than any other sector,
think patent protection to be very important in maintaining their R&D expenditures and
technological innovation. The industry understandably takes a close interest in the global
application of IPRs [intellectual property rights], and generally resists the contention that
they constitute a major barrier to access or a deterrent to development in developing
countries.
22. In the case at hand, the Respondents are in compliance with the Public Health Policy of
the country thereby ensuring that the healthcare system has been made more efficient and
affordable to the population at large. Therefore, grant of secondary patent rights to the
Respondent would not violate these principles. A stronger patent regime provides the
incentive39 for pharmaceutical firms to discover new treatments for some "third world"
diseases40. However, the public health crisis has focused international attention on its lack
of ability to generate research and development into diseases where patients lack the
financial ability to pay the price necessary to allow private sector recovery of research
and development costs.41 Indeed, the "reality is that private companies will devote
resources to areas where an optimal return can be made". 42 The Respondent hereby
submits that the private healthcare sector will be able to contribute to public healthcare if
they are provided with the required patent protections.
23. Apart from the IP issues, access to affordable medicine also involves a complex web of
intricate "non-patent related" obstacles such as poverty; corruption; civil strife, economic
and societal problems, poor healthcare infrastructure, diagnostics and medical workforce;
poor supply, distribution and delivery systems particularly to rural areas; substandard
38
Keith E. Maskus, Integrating Intellectual Property Rights and Development Policy, 62 JOURNAL OF
INTERNATIONAL ECONOMICS 237 (2004).
39
Global-economic-prospects-and-the-developing-countries-2002-making-trade-work-for-the-worlds-poor.pdf,
https://documents1.worldbank.org/curated/en/285571468337817024/310436360_20050012013328/additional/G
lobal-economic-prospects-and-the-developing-countries-2002-making-trade-work-for-the-worlds-poor.pdf (last
visited Jun 24, 2023).
40
Elizabeth Siew Kuan Ng, Balancing Patents and Access to Medicine, 21 SAcLJ 457 (2009).
41
Global strategy and plan of action on public health, innovation and intellectual property, WIPO Doc
A/PHI/IGWG/2/INF. DOC.16
42
Supra Note 35.

medicines; financial and administrative mismanagements, taxes and custom duties,

complexity of medical therapy, etc. As a “person interested”, the Appellant is concerned
only about the secondary patent rights that might be granted to the Respondent and
therefore it can be concluded that the Appellant will be at an advantageous position if the
Respondent’s patent rights are interfered with and thus causing grave injury to the
Respondent.
24. Hence, from the above arguments it can be argued that the grant of secondary patent
rights to Ultron is not violative of Intellectual Property Law, Competition Law and Public
Health Policy.

ISSUE II: WHETHER RIGHT TO PUBLIC HEALTH PREVAILS OVER RIGHT TO INTELLECTUAL
PROPERTY?
25. The Respondent humbly submits that there must be a balance between Right to Public
Health and Right to Intellectual Property. It is submitted that Right to Intellectual
Property is a right that is to be enjoyed by all companies and the argument is threefold,
namely, (A) Intellectual Property Rights, Competition Law etc all come under the same
umbrella therefore a conflict with Right to Public Health will always arise and there
needs to be a balance between the two; (B) The invention is an invention as per Section
2(j)43 and 2(ja)44 of the Patent Acts, 1970 and also satisfies the test of being an invention
under Sec. 3(d)45; (C) The drug manufactured is a life-saving drug therefore public
health is already being prioritized but the company’s right also needs to be prioritized. It
is submitted that the amended portion of section 3(d) clearly sets up a second tier of
qualifying standards for chemical substances/pharmaceutical products in order to leave
the door open for true and genuine inventions but, at the same time, to check any attempt
at repetitive patenting or extension of the patent term on spurious grounds.46
[A] Balance To Be Maintained Between Public Health And Intellectual Property Rights
26. It is humbly submitted that Right to Public Health and Right to Intellectual Property are
two coins of the same umbrella. The link between human rights and IP has been a global
topic of discussion for a long time.47 The Universal Declaration of Human Rights
(UDHR) of 1948 states clearly that everyone is afforded a right to the protection of their
moral and material interests owing from artistic, literary, as well as scientific production
of which they are the author.48 This is clearly an IP right afforded to everyone and it,
therefore, acknowledges the link between human rights and IP. In this context, it can be
submitted that the UDHR acknowledges the fact that there indeed exists a link between
human rights and IP.
27. The UDHR also provides that everyone has the right to a standard of living that is
adequate to their and their family’s health, which includes housing, food, as well as
medical services.49 Furthermore, the UDHR provides everyone with the right to own
43
The Patents Act, 1970, § 2(j), No. 39, Acts of Parliament, 1970 (India).
44
The Patents Act, 1970, § 2(ja), No. 39, Acts of Parliament, 1970 (India).
45
The Patents Act, 1970, § 3(d), No. 39, Acts of Parliament, 1970 (India).
46
Novartis AG v. UOI & Ors. MANU/SC/0281/2013.
47
Mpasi Sinjela Human Rights and Intellectual Property Rights: Tensions and Convergences (Leiden: Martinus
Nijhoff Publishers (2007).
48
Art. 27(2) of the UDHR.
49
Art. 25(1) of the UDHR.

property and affords protection against the unlawful deprivation of such property.50 The
right to property is a clear human right in the context of the UDHR. Therefore, it is
humbly submitted that Right to Property in itself is a human right like right to health
hence a balance between the two needs to be maintained.
28. The Patents Act, 1970 is drafted in compliance to the TRIPS Agreement. The TRIPS
Agreement allows member-states of the World Trade Organization (WTO) to take the
necessary measures to protect public health when formulating or amending their IP
laws.51 It can therefore, be submitted that the TRIPS Agreement acknowledges the fact
that IP is directly linked and relevant to public health.
29. Section 3(d) can help strike this balance by protecting only those new forms of known
pharmaceutical substances that represent genuine incremental innovations. However, this
would hinge on the interpretation of the term "efficacy". If it is interpreted too strictly to
mean only "therapeutic efficacy", it would harm innovation prospects in the
pharmaceutical sector. Moreover, given the difficulty in proving such efficacy, it might
effectively restrict patents to only new chemical entities.52 On the other hand, too liberal
an interpretation would dilute the efficacy standards. Thus, a proper balancing of these
two conflicting interests requires that standard of efficacy to be fixed.
30. Therefore, when the provision w/r/t IP is made in compliance with statutes that
recognizes the importance of Right to Public Health and Right to Intellectual Property
and links the two it can be said that there must be a balance that must be maintained
between the two.
31. It is humbly submitted that the pharmaceutical industry is "more strongly dependent on
the patent system than most other industrial sectors to recoup its past R&D [research and
development] costs, to generate profits, and to fund R&D for future products.”53 The
CIPR also noted that: “Surveys have shown that the pharmaceutical companies, more
than any other sector, think patent protection to be very important in maintaining their
R&D expenditures and technological innovation. The industry understandably takes a
close interest in the global application of IPRs [intellectual property rights], and generally
50
Art. 17 of the UDHR.
51
Art. 8 of the TRIPS Agreement.
52
Shamnad Basheer, The Glivec Patent Saga: A 3-D perspective on Indian Patent Policy and TRIPS
Compliance, available at http://www.atrip.org/upload/files/essays/Shamnad
53
CIPR, Integrating Intellectual Property Rights and Development Policy (2002) at p 29 at (accessed 5
February 2009).

resists the contention that they constitute a major barrier to access or a deterrent to
development in developing countries.”54
32. It is humbly submitted that the incentive theory explains the patentee’s right to exploit as
a reward and motivation to innovate.55 It is necessary to understand that in context of
modern pharmaceutical innovation involving high development, testing and regulatory
costs. A key factor in pharmaceutical access is IP protection. New pharmaceuticals, or the
new use of existing pharmaceuticals, can be protected under IP laws around the world as
patentable inventions as defined in relevant patent legislation. The Agreement on Trade
Related Aspects of IP Rights (TRIPS) requires WTO member states to adhere to
international IP laws protecting patents and ensure their enforcement (the general
obligation is at Article 41, as pointed out by others).56 Patent monopolies facilitate profits,
new and improved medicines and drive knowledge-based economies. Cutting-edge
translational research leads to technology transfer and celebrates local innovation.57
Monopoly granted through patent rewards inventor for often risky, lengthy and expensive
innovation. This incentive is necessary for every company to ensure innovations take
place which will in turn help with public health as it will lead to production of
medicines.58
[B]It Is An Invention As Per The Patents Act
33. It is humbly submitted that the PD 1 was added to the manufactured drug VASONAX as
the during clinical trials the drug showed only 90% efficacy rate.59 The addition of PD 1
satisfies the test laid down in Sec. 3(d) and also comes within the definition of Sec. 2(j)
and Sec. 2(ja). Sec. 2(j)60 reads as follows: “invention” means a new product or process
involving an inventive step and capable of industrial application and Sec. 2(ja)61 reads as
follows: “inventive step” means 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. Sec. 2(ja) basically means
that a feature of an invention that involves technical advance as compared to the existing
54
ID.
55
Machlup F., Penrose E. The patent controversy in the nineteenth century, Journal of Economic History. 1950;
10:2–25.
56
Stoianoff N.P., The influence of the WTO over China’s intellectual property regime, Sydney Law
Review. 2012; 34:74.
57
Van Norman G.A., Eisenkot R. Technology transfer: from the research bench to commercialization: part 1:
intellectual property rights – basics of patents and copyrights, JACC Basic Translational Science.2017;2:85–97.
58
Roger Collier, Drug Patents: The Evergreening Problem, NLM, 2013 Jun 11; 185(9).
59
Compromis, ¶3.
60
Supra Note 41.
61
Supra Note 42.

knowledge, or having economic significance or both and that makes the invention not
obvious to a person skilled in the art. To paraphrase, the invention that creates the product
must have a feature that involves technical advance as compared to the existing
knowledge or having economic significance or both.
34. Therefore, it can be inferred that for any product to qualify as a new invention it must
satisfy three conditions:62
i. It must be “new,” that is to say it must not have been anticipated;
ii. It’s coming into being must involve an “inventive step;” and
iii. It must be “capable of industrial application,” that is to say it must be capable of
being made or used in an industry [section 2(1) (ac)].
In the present case, addition of PD 1 involves technical advance as compared to existing
knowledge. The addition makes the drug more efficient therefore, has an economic
significance to the country.
35. Sec. 3(d) of the Act states that, “What are not inventions.– The following are not
inventions within the meaning of this Act,— (d) the mere discovery of a new form of a
known substance which does not result in the enhancement of the known efficacy of that
substance or the mere discovery of any new property or new use for a known substance
or of the mere use of a known process, machine or apparatus unless such known process
results in a new product or employs at least one new reactant. Explanation.—For the
purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle
size, isomers, mixtures of isomers, complexes, combinations and other derivatives of
known substance shall be considered to be the same substance, unless they differ
significantly in properties with regard to efficacy.”63 The amendment (i) adds the words
“the mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or” at the beginning of the
provision; (ii) deletes the word “mere” before “new use”; and (iii) adds an explanation at
the end of the clause.64
36. Therefore, a combined reading of the main part of the § along with the explanation shows
that "only those pharmaceutical derivatives of the original substance which show
"significantly" enhanced "efficacy" are patentable.65 As per, the SC, “the fundamental
62
Novartis AG v. UOI & Ors. MANU/SC/0281/2013.
63
Supra Note 43.
64
Supra Note 43.
65
Shamnad Basheer & T. Prashant Reddy, The "Efficacy" of Indian Patent Law: Ironing out the Creases in 3(d),
SCRIPTED, Volume 5, Issue 2, August 2008.

principle of Patent Law is that a patent is granted only for an invention which must be
new and useful i.e., to say, it must have novelty and utility.”66
37. It is humbly submitted that PD 1 is an addition and not merely a new form of a known
substance but a different compound on a whole. The substances that already existed in the
drug Vasonax are different than PD 1 therefore, the addition of PD 1 not only increased
the efficacy of the drug but also is a genuine addition to enhance the drug. It has been
proven in a lot of studies that PD 1 increases efficacy. One of the studies even stated that,
early clinical studies of PD-1 antibodies used as monotherapy have demonstrated activity
only in HL, hypermutant tumours, and also in some rare paediatric tumours.67 It is further
submitted that Nasopharyngeal is a rare type of paediatric cancer.68
38. It is further submitted that as the substance PD 1 increases efficacy that means that it is a
non-harmful substance therefore, it can be used in the clinical trial stage to check further
efficacy of the product.
[C] The Drug Manufactured Is A Life-Saving Drug
39. It is humbly submitted that the drug manufactured is a life-saving drug. When it comes to
life-saving drugs and a pharmaceutical company they rely on patents the most as they are
strongly dependent on the patent system than any other industry.69 It is also necessary to
note that every company has the right to practice their profession, business.70 The costs
that are incurred during the R&D are way too high for a pharmaceutical company and
therefore, it is essential for them to recover these costs and generate profits or else they’ll
go under a loss. A patent regime which protects only new chemical entities would fail to
provide any incentive to domestic majors like Ranbaxy which undertake considerable
R&D efforts for improving existing drugs.71
40. The CIPR72 also stated that:
Surveys have shown that the pharmaceutical companies, more than any other sector, think
patent protection to be very important in maintaining their R&D expenditures and
technological innovation. The industry understandably takes a close interest in the global
application of IPRs [intellectual property rights], and generally resists the contention that
66
M/s. Bishwanath Prasad Radhey Shyam -vs- M/s. Hindustan Metal Industries (MANU/SC/0255/1978: AIR
1982 SC 1444),
67
Sara Zalba & all, Quantification of Pharmakionetic Profiles of PD 1, 2023, NLM.
68
Compromis, ¶1.
69
Elizabeth Siew Kuan NG, Balancing Patents and Access to Medicine, 2009, 457.
70
INDIA CONST. art. 19.
71
Meghna Banerjee & Yajnaseni Roy, Patentability of Incremental Innovation Vis-à-vis § 3(D) of the Indian
Patents Act: Striking a Balance, 2 NIJS L. Rev. 607 (2009).
72
Supra Note 51.

they constitute a major barrier to access or a deterrent to development in developing

countries.
41. It is submitted that healthcare considerations are the main objectives of a pharmaceutical
company therefore, any live-saving drug that is manufactured is made with the intention
of ensuring public health is the top consideration but it is also essential for the company
to recover the heavy costs that are incurred while manufacturing the drug. The Patents
Act, provides for Sec. 8473 which talks about compulsory licensing. The method of
compulsory licensing is the perfect method to strike a balance between IPR and Right to
Public Health.
42. It is therefore submitted that Right to Public Health and Right to Intellectual Property
should be placed at an equal pedestal and one doesn’t prevail over the other.
73
The Patents Act, 1970, § 84, No. 39, Acts of Parliament, 1970 (India).

THE RESPONDENTS RESERVE THE RIGHT TO RAISE ADDITIONAL GROUNDS

AND/OR ISSUES DURING THE COURSE OF ORAL ARGUMENTS

PRAYER
Whereof, in the light of the issues raised, arguments advanced and authorities cited, it is most
humbly prayed that this Hon’ble Court may be pleased to-
1. Declare that the present appeal should be dimissed.
2. Declare that the Respondent is not practicing evergreening of patents.
3. Declare that the present act of the respondent does not violates the principles of
Intellectual Property Law, Competition Law, and Public Health Policy.
4. Declare that the present act of the Respondent does put public health in jeopardy.
AND/OR
May pass any other relief that this Hon’ble Court may deem fit and proper in the interest of
justice, equity, and good conscience.
All of which is humbly prayed.
Sd/-
Date: --/--/2023 Counsel on behalf of Respondent

TC-13

BIBLIOGRAPHY
1. Advika Photumsetty, Acceptability of Ever Greening Method in India, 1, IJLSI, 2019.
2. Benjamin N. Roin, Unpatentable Drugs and the Standards of Patentability, 87 TEX. L.
REV. 503 (2009).
3. Commission on Intellectual Property Rights ("CIPR"), Integrating Intellectual Property
Rights and Development Policy (2002) at p 29.
4. Dealing With Anti-Competitive Practices in the Indian Pharmaceuticals and the Health
Delivery Sector, CUTS-C-CIER, CUTS Centre for Competition, Investment &
Economic Regulation.
5. Elizabeth Siew Kuan NG, Balancing Patents and Access to Medicine, 2009, 457.
6. Kant A, Section 3(d): ‘New’ Indian Perspective, Journal of Intellectual Property Rights,
14 (9) (2009) 385-396.
7. Keith E. Maskus, Integrating Intellectual Property Rights and Development Policy, 62
Journal of International Economics 237 (2004).
8. Machlup F., Penrose E. The patent controversy in the nineteenth century. Journal of
Economic History. 1950.
9. Meghna Banerjee & Yajnaseni Roy, Patentability of Incremental Innovation Vis-à-vis §
3(D) of the Indian Patents Act: Striking a Balance, 2 NIJS L. Rev. 607 (2009).
10. Mpasi Sinjela Human Rights and Intellectual Property Rights: Tensions and
Convergences (Leiden: Martinus Nijhoff Publishers 2007).
11. Nidhi Joshi, “Data Protection for Pharmaceutical Products under TRIPS: Data
Exclusivity Legislation a Necessary Evil for India” 1 Delhi law review 104 (2005).
12. Niloufer Sohrabji and Kaitlyn Maloney, Section 3(d), and Pharmaceutical Patents in
India, 25, Journal of Intellectual Property Rights, 65, (2020).
13. Odour Ong'wen, "Crocodile Tears: How 'Trips' Serves West's Monopoly" The East
African (2001).
14. Prerna Raturi, IPR v. Human Rights: Protection of Pharmaceuticals and Drugs by Means
of Patents at the Cost of Right to Health of People, 9, ISSN, 239.
15. R. C. Bird, Developing Nations, and the Compulsory License: Maximizing Access to
Essential Medicines while Minimizing Investment Side Effects, 37(2) J of L, Medicine &
Ethics 209, 216 (2009).
16. Shamnad Basheer & T. Prashant Reddy, The "Efficacy" of Indian Patent Law: Ironing
out the Creases in 3(d), SCRIPTED, Volume 5, Issue 2, August 2008.

17. Shubhi Trivedi, Access to Medicine and Patent Rights in the Globalized World, 3,
International Journal of Law Management & Humanities (IJLMH), 144, 2020.
18. Stoianoff N.P. The influence of the WTO over China’s intellectual property
regime. Sydney Law Review. 2012.
19. Sudhir Krishnaswamy, "India's Experience with TRIPS: The Patents (Amendment) Act,
2005," Journal of World Intellectual Property 9, no. 2 (2006): 125-47.
20. Van Norman G.A., Eisenkot R. Technology transfer: from the research bench to
commercialization: part 1: intellectual property rights – basics of patents and
copyrights. JACC Basic Translational Science. 2017.
21. WIPO Patent Agenda: Options for Development of the International Patent.
22. World Trade Organization, 'Ministerial Declaration of 14 November 2001‟ (November
2001) WT/MIN (01)/DEC/1, 41 ILM 746, para 4.

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8TH NATIONAL MOOT COURT COMPETITION, 2023

8TH NATIONAL MOOT COURT COMPETITION, 2023

BEFORE THE HON’BLE HIGH COURT OF ZUMBAI

IN THE MATTER BETWEEN

COUNSEL FOR THE RESPONDENT

WRITTEN SUBMISSION ON BEHALF OF THE RESPONDENT

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S.NO ABBREVIATION EXPANSIONS

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Hence the matter before the Hon’ble Court

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expressed by those in the pharmaceutical industry that it is "more strongly dependent on

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medicines; financial and administrative mismanagements, taxes and custom duties,

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they constitute a major barrier to access or a deterrent to development in developing

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THE RESPONDENTS RESERVE THE RIGHT TO RAISE ADDITIONAL GROUNDS

MEMORIAL ON BEHALF OF RESPONDENT Page 25 of 29

All of which is humbly prayed.

Date: --/--/2023 Counsel on behalf of Respondent

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