Amity Institute of Advanced Legal Studies

Amity University Uttar Pradesh

Subject: Patent Law

Topic of Assignment:

Case Analysis of Novartis AG vs. Union of India

Submitted to:
Dr. __________________

Submitted By:
Mumrita Gaurdwaj
LLM (IPR Law)
Enrolment No. A03_____________
Batch: 2021-22
 INDEX

INTRODUCTION........................................................................................................2

BACKGROUND OF THE CASE.................................................................................3

FACTS OF THE CASE................................................................................................4

OBSERVATIONS OF THE MADRAS HIGH COURT AND THE IPAB..................6

ISSUES BEFORE THE SUPREME COURT...............................................................7

HON’BLE SUPREME COURT’S JUDGMENT..........................................................7

ANALYSIS OF THE JUDGMENT..............................................................................7

DOMESTIC IMPACT..................................................................................................9

INTERNATIONAL IMPACT....................................................................................10

CONCLUSION...........................................................................................................11
ABSTRACT

The paper will highlight the issues in legislative and commercial interests that were the
contentious issues before the court in the ‘Novartis AG case’. The paper also seeks to
highlight how the issues and circumstances of the case had major ramifications in intellectual
property as well as for the consumer welfare too. Since the case, in one perception at least,
reconciled the age-old debate on individual profit vs community benefit within IPR, it not
only made governments and individuals more aware of their role in the struggle for “latest
innovation” but also their rights and duties concerning the same. The paper will also focus on
the instrumental legislative changes that were brought about as a result of the landmark
judgment.

INTRODUCTION

The Novartis AG v Union of India case1 (hereinafter referred to as the “Novartis judgment”)
is one of the most landmark disputes settled by Indian judiciary. However, what is more
academically relevant is the repercussions of the judgment in the world of IPR. For ages
mankind has been in the pursuit of “the next best thing”. One innovation after the other, not
only stamped with the authority of the brilliance of the human mind but also its scientific
temperament, all of which has been for one common objective. The goal of all inventions and
innovation from the discovery of fire and invention of wheel up until this point in scientific
age has been to realise the goal of simplifying the human effort i.e. to reduce effort and
further development of the human race.
Intellectual Property Law since then has facilitated the role of harmonizing the paradox of
“mind over matter” or “matter over mind”. This is so because although Intellectual Property
seeks to appreciate an innovative idea but Intellectual Property Law protects a “product” born
from such idea and not just the idea itself. If welfare is the underpinning of innovative spirit
why should private profiteering be at the expense of such intended welfare? Regardless, of
what take we might have then Hon’ble Supreme court in the Novartis case clearly laid down
the guidelines for protecting welfare at all costs, even to the exclusion of private rights over
that of the community.
The Novartis case is therefore one of the most interesting academic studies for observing the
general trends in Intellectual Property Law owing to the many paradoxes that the court

1
Novartis AG & Ors. .v. Union of India & Ors. , AIR 2013 SC 1311.
reconciles in this case. Not only did the judgment attempt to harmonise state’s priorities of
public health accessibility with that of inventor’s rights, it also showcased the humbling of
individual interest against community interest. Standing tall against MNC bullying tactics the
Supreme Court paved the way in a better, far greater analysis of the TRIPS Agreement 2 by
utilizing the space for individual policy discretion by nation states that serves as a precedent
even to this day.

BACKGROUND OF THE CASE

Intellectual Property assigns and/or protects intangible rights of which Patent is a subset. So,
accordingly, grant of a patent confers a statutory right on an individual by the state. Such
statutory right, emanating from the Patent Act, 1970 provides the inventor protection over his
invention by excluding others from making, using, or selling their invention for a period of
20 years.
According to the statute a patent application must showcase “novelty”. The element of
novelty can be an invention or an inventive step. The clause pertaining to inventive step
elucidates a new method, manner, or matter for creating such invention. Accordingly, the
statute opens room for scientific advancement and innovativeness even in an existing
invention.3
In this scenario, the statute is prone to misuse as well especially in the Pharmaceutical sector.
By involving alternative elements to recreate generic drugs, most pharmaceutical companies
indulged in profiteering practices because though such alternate element, that can be a
substitute salt or chemical, does qualify within inventive step, it does not necessarily mean
“inventive” stricto sensu. Despite this, mere technicality or loophole served as a tool for
companies to drive up prices of important generic drugs that keeps it out of the reach of the
masses who desperately need it.
As the matter progressed Novartis threatened to withdraw its pan-India operations while the
matter was sub-judice in an attempt to coerce the judgment in its favour. The courts and the
legislature however, had a proactive objective in the matter which was to set a higher
standard of patentability in India, in consonance with the needs of the demographics and also
to ensure a curb on evergreening especially in the pharmaceutical sector.

2
Peter K. Yu, The Objectives and Principles of TRIPS, Houston Law Review, 46 (2009)
3
Rebecca S. Eisenberg, Patents, Product Exclusivity and Information Dissemination: How Law directs
Biopharmaceutical Research Development, Fordham Law Review, 477 (2003)
 FACTS OF THE CASE

Novartis International AG is one of the largest international pharmaceutical companies. In

1998, in accordance with the TRIPS agreement, the company had preferred a patent
application for an anti-cancer treatment drug that it wanted to roll out into the Indian market.
The Chennai Patent office received the application for the grant of patent for the drug
“Glivec”4. The drug was to be used for the treatment of Leukemia and specifically Chronic
Myeloid Leukemia (CML) as well as Gastrointestinal Stromal Tumours (GIST). The drug
was created from Beta crystalline form of “Imatib Mesylate” which was supposed to be
effective in prevention of cancerous cell clusters in certain cases.

The company had preferred similar applications internationally and accordingly had
received patent (status and protection) in over 35 countries. Grant of Patent at that time was
restricted to the methods or processes and not for products in India, as per Section 5 of the
Patent Act, 1970. After the act was amended vide the Patent (Amendment) Act, 2005 the
section was repealed and patent protection was extended not only for methods or processes
but also products. However, since the Indian Patent regime was in a transitional phase
during 1995 to 2005, as per the TRIPS Agreement, Novartis’s patent application remained
dormant in the “Mailbox Procedure”.5 The application was revived subsequently and taken
up for consideration only after amendments in compliance with the TRIPS Agreement
were made in 2005.
It was contended that a product patent should be granted to Novartis on grounds of
enhanced efficacy. The enhanced efficacy was asserted by Novartis with respect to the
better flow properties and thermodynamic stability, but the most important being
bioavailability. Bioavailability refers to the proportion of the pharmaceutical product which
is absorbed into the blood during circulation and thus is an indicator of its efficiency. The
Beta Crystalline form was contended to have 30% increased bioavailability which would
enhance the effectiveness of Glivec.
In 2005, patent application filed by Novartis for the drug Glivec was rejected by the
Assistant Controller of Patents and Design, Chennai office on the ground of –
a) obviousness to a person skilled in the art under scrutiny

4
The Mesylate salt of Imatinib, a tyrosine kinase inhibitor with antineoplastic activity. Glivec is the name under
which this compound is marketed: National Cancer Institute U.S.A , NCI Medical Dictionary: Glivec , ( October
22 , 2013 ) http://www.cancer.gov/drugdictionary?cdrid=37862
5
WTO, Pharmaceutical patents and the TRIPS agreement, TRIPS Drug Patents Technical Note (September,
2006) accessed at: https://www.wto.org/english/tratop_e/trips_e/pharma_ato186_e.htm
 b) novelty
To elucidate it further, this meant that the assigned authority found that the drug was
anticipated by prior publication which would consequently showcase lack of novelty and
non-obviousness. Furthermore, the alleged invention was reasoned to be un-patentable
under Section 3(d) of the Patent Act, 19706 because the drug failed to exhibit “any major
changes in therapeutic efficacy over its pre-existing form” which was the Zimmermann
patent.7

OBSERVATIONS OF THE MADRAS HIGH COURT AND THE IPAB

Consequently, in 2006, the company preferred two writ petitions in the Hon’ble Madras
High Court under Article 226 of the Constitution of India. In its leave for appeal the
petitioner company (Novartis) challenged the constitutionality of Section 3(d) of the
Patent Act, 1970 on the grounds of non-compliance of the TRIPS agreement. The
petitioners further contended that the provision contravened Article 14 of the Constitution
of India and was manifestly arbitrary.8 The other writ petition was preferred against the
order of the Madras Patent Office.
In 2007, the Madras High Court transferred the petitions challenging the orders of the
Assistant Controller to the IPAB (Intellectual Property Appellate Board), as it did not have
the jurisdiction in the matter.

The Intellectual Property Appellate Board heard and dismissed the contentions of Novartis
in the matter. The order of IPAB held that though the invention satisfied the tests of novelty
but the product could not be patented due to Section 3(d). The tribunal further reasoned that
patentability of beta crystalline form of Imatinib Mesylate was affected by Section 3(d) of

6
What are not inventions. —The following are not inventions within the meaning of this Act, —
(a) an invention which is frivolous or which claims anything obviously contrary to well established natural
laws;
(b) an invention the primary or intended use or commercial exploitation of which could be contrary public
order or morality or which causes serious prejudice to human, animal or plant life or health or to the
environment;
(c) the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any
living thing or non-living substance occurring in nature;
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
7
Novartis Judgment at para ¶5. See also Novartis AG vs. Union of India and Ors. [SLP(C) Nos. 2706-2716 of
2013]. Accessed at: https://indiankanoon.org/doc/165776436/
8
Mohammad Suleman Palwala, A Study on Novartis AG v. Union of India, Mondaq (2013). Accessed at:
https://www.mondaq.com/india/patent/826478/a-study-on-novartis-ag-v-union-of-india
 the Act, although the requirements of novelty and non obviousness were being met. The
provisions of Section 3(d) were interpreted strictly and it was observed that with respect to
India, the grant of patents require a “higher standard of inventive step”.9 IPAB’s judgment
was given to prevent “ever-greening” of already patented products by introducing minor
changes and to ensure ease of access of life-saving drugs by common citizens. The
observations of IPAB were made keeping in view the state’s obligation of access to
healthcare apart from curbing “evergreening”.
The impugned order of the IPAB was challenged before the Hon’ble Supreme Court of India
in 2009 when the company preferred an SLP (Special Leave Petition) against the order
under Article 136 of the Constitution of India.

ISSUES BEFORE THE SUPREME COURT

1. What is a “known substance” as per Section 3(d) of the Patent Act, 1970?
2. What is meant by “Efficacy” within the context of the provision as laid down in Section
3(d) of the Patent Act, 1970?
3. Whether increase in “bioavailability” falls squarely within the meaning of “increase in
therapeutic efficacy” as per Section 3(d) of the Patent Act, 1970?
4. Whether the invention “Beta crystalline form of imatinib mesylate” claimed by Novartis
is more efficacious than the substance that it was derived from i.e., “Imatinib mesylate”?

HON’BLE SUPREME COURT’S JUDGMENT

The division bench of the Hon’ble Supreme Court decided the issues before it in its detailed
judgment in April, 2013. The Hon’ble court rejected the appeal filed by Novartis and upheld
the beta crystalline form as a new form of the well-known Imatnib Mesylate whose efficacy
was well documented.10 The judgment detailed that in the case of medicines “efficacy”
within the form and meaning of Section 3(d) only refers to “therapeutic efficacy” and
therefore all properties of the drug are irrelevant.
While dealing with the third issue the division bench opined that about 30% increase in
bioavailability qualifies as increase in therapeutic efficacy within the meaning of the
concerned provision, if there is evidence supporting the claim. The Hon’ble Supreme Court
9
Yousuf A. Vawda, After the Novartis judgment- ‘Evergreening’ will never be the same again!, 18 Law
Democracy & Development essays, Scielo Org (2014). Accessed at:
http://www.scielo.org.za/pdf/ldd/v18/15.pdf
10
Patent case brief – Novartis v Union Of India, Case Notes blog (2018). Accessed at:
https://blog.ipleaders.in/analysis-novartis-g-vs-union-india/
 compared the efficacy of “Beta Crystalline form of Imatinib Mesylate” with “Imatinib
Mesylate” with reference to its flow properties, better thermodynamic stability and lower
hygroscopicity, and held that none of these properties contribute to increase in therapeutic
efficacy according to section-3(d) of Patent Act, 1970 as there was no document provided by
the petitioners to showcase the efficacy of “Beta Crystalline form” over the known “Imatnib
Mesylate” form. 11

ANALYSIS OF THE JUDGMENT

The Supreme Court gave a detailed and comprehensive judgment in the instant matter,
taking into account the history of patent laws in the country. The reports of Justice
Ayyangar, which ultimately led to the framing of the Indian Patent Act 1970 was discussed
to demonstrate the evolution of patent laws in India.12 Owing to the Constitutional
obligations of the State towards its citizens, the national interests outweigh the interests of
an individual inventor. Here, “national interest” refers to the easy accessibility of life saving
drugs to the masses.
Novartis’ application for patent was rejected as it failed the test of invention under Section
2 (j), 2(ja) and 2(1) and test of patentability under Section 3(d). 13 The Court interpreted
Section 3(d) in accordance with the text of the statute and context of the legislation or the
legislative intent, to mean that it was meant to deal with pharmaceutical products and
chemical substances only. Major objective of this section was to prevent discourage
monopoly of certain players in the market through “Evergreening” which may be defined
as a process of extending the term of patent protection on a drug while making minor
changes which do not affect the efficacy of the drug. 14 Therefore, a second tier, or a higher
threshold of qualifying standards was set up for pharmaceutical products.

In light of the above discussion, it is clear that “efficacy” under Section 3(d) means
“therapeutic efficiency”. Novartis had relied upon better flow properties, increased
thermodynamic stability and bioavailability of the product as grounds for grant of patent.

11
Harsha Jeswani, Analysis of Novartis AG vs. Union of India, iPleaders Blog (2016). Accessed at:
https://blog.ipleaders.in/analysis-novartis-g-vs-union-india/
12
Prashant Reddy, Deconstructing the judgment of the Supreme Court in the Novartis-Glivec patent case,
Decoding Intellectual Property Law series by Spicy IP (2013). Accessed at:
https://spicyip.com/2013/04/deconstructing-judgment-of-supreme.html
13
Banana IP Counsels, Novartis Case Review, Banana IP Reporter (2019). Accessed at:
https://www.bananaip.com/ip-news-center/novartis-case-review-business-legal-implications/
14
Swaraj P. Baruah , A Purposive Patent Policy : Reigniting The Section 3(d) Debate in the light of India's
International Obligations, Nalsar Student Law Review , Vol. 6 , 143 (2011)
 However, the Court held that the above-mentioned properties of the beta crystalline form
did not enhance the efficacy of the treatment as compared to the free base form. All
beneficial and advantageous properties are not relevant, but only such properties which
directly relate to the efficacy.11 Thus, the Court gave a strict and narrow interpretation to
the term “efficacy”.

The Indian Parliament, supported by the Supreme Court, has decided that Indian
consumers should only pay for expensive patented products when those products represent
a genuine advance over older versions. It is important to note what the Supreme Court did
not say. It did not say that a new form of known compound may never be patented. It did
not say that improving the bioavailability characteristics of the drug may never result in
enhanced efficacy. It left open the question whether enhanced efficacy refers narrowly to
curative effect, or more broadly to improved safety profile and reduced toxicity.

DOMESTIC IMPACT

In India, the amended patent legislation included an explanation Section 3(d) whereunder it
clarified that salts, isomers and other complexes, derivatives or combinations shall mean
the same substance unless they differ significantly in properties with regard to efficacy.
Under Section 47 (4) of the Act, the usage, importation as well as distribution of medicine
is authorized to the government through its regulated health infrastructure of the
government hospitals, dispensaries or other medical institutions maintained by or on behalf
of the government.
Short of a decade later, the debate regarding usage of “generic medicines” and “essential
treatment drugs” continues to get embroiled within the labyrinths of inventor’s rights vs.
state’s obligation towards general welfare. However, the Hon’ble Supreme Court’s
judgment not only inspired the state’s modicum in providing accessible and affordable
healthcare but also driving down the prices of essential medicines.15
The TRIPS Agreement contains special provisions for countries such as India, which did
not allow the patenting of medicines, to transition to the new regime. 16 Effectively, India
was granted until 1 January 2005 to become compliant with this aspect of the TRIPS
Agreement. In terms of the Agreement, members are obliged to grant patents for any

15
Aftermath of judgment on Novartis, The Hans India (2013). Accessed at:
https://www.thehansindia.com/posts/index/Opinion/2013-07-24/Aftermath-of-judgment-on-Novartis/20162?
infinitescroll=1
16
Article 65, TRIPS Agreement
 inventions that are “new, involve an inventive step and are capable of industrial
application.”17 Beyond this general prescription, the TRIPS Agreement does not define the
scope and meaning of these criteria for patentability. Indian legislators exploited the
latitude or flexibility allowed in the Agreement to exercise their freedom “to determine the
appropriate method of implementing the provisions of this Agreement within their own
legal system and practice.”18 Thus, when crafting their amended patent law in 2005, 19 in
addition to defining “invention” and “medicine or drug”, 20 the legislature refined the
patentability criteria in respect of the inventive step requirement, by substituting the
existing sub-section 3(d) with a new sub-section which is clearly designed to counteract the
effect of ‘evergreening’.
First, the Court’s analysis of India’s patent laws drew substantially upon the intent of the
legislature, as deliberated in Parliament – foregrounding the objective of limiting practices,
such as evergreening which affect access to affordable medicines. 21 It confirmed the notion
of the will of Parliament as an important tool of judicial interpretation. Secondly, it adopted
an expansive approach to deciding legal questions, placing the dispute in a larger economic
and political context, venturing beyond the specific technical and legal questions raised by
the challenge to the patent legislation, and linking patenting with “net benefits to society”.22
Thirdly, it underscored the value and critical role of an independent judiciary which can
stand up to both executive authority, as well as powerful transnational corporate interests.23
Fourthly, it interpreted the term “efficacy” to mean therapeutic efficacy in the context of
pharmaceutical products, providing patent offices with clear guidelines for determining the
scope of this legal requirement. Finally, the judgment makes a strong case for taking
cognizance of the specific conditions of a country in determining the most appropriate
patenting regime, and that even under the TRIPS provisions “countries have some
flexibility to frame their own patent laws to suit their national interests.”24

17
Article 27(1) TRIPS Agreement
18
Article 1 TRIPS Agreement
19
Patents Act, 1970 as amended by the Patent (Amendment) Act, 2005
20
Section 2(1)(j) and 2(1)(l) respectively the Patents Act, 1970 (as amended)
21
Jackson E Law and the regulation of medicines (Oxford: Hart Publishing 2012) at 81.
22
Baker BK “Analysis: India’s Supreme Court upholds strict patent standards and patient’s right to access to
affordable medicines; court dismisses unmeritorious court challenge by drug giant Novartis” (April 2013)
Health GAP. Available at http://healthgap.org/blog/2013/4/1/aids-activists-applaudindian-supreme-court-
novartis-decision (accessed 20 November 2021);
23
Stiglitz J & Jayadev A “India’s patently wise decision” (April 2013) Project Syndicate – A world of ideas.
Available at http://www.project-syndicate.org/commentary/the-impact-of-the-indian-supreme-court-spatent-
decision-by-joseph-e--stiglitz-and-arjun-jayadev (accessed 19 November 2021).
24
Chaudhuri S “The larger implications of the Novartis-Glivec judgment” (2013) 48(17) Economic &
Political Weekly at 17. Available at: http://www.epw.in/authors/sudip-chaudhuri (accessed 20 November 2021)
 The judgment not only flexed the might of welfare over the nexus of private profiteering
but also ensured that “evergreening”, especially in India, would be dealt with, sternly and
absolutely.

INTERNATIONAL IMPACT

The verdict in the Novartis case in 2013 left footprints in the International Domain as is
visible in the Report of the United Nations Secretary-General’s High-Level Panel on
Access to Medicines. The report which was release in 2016 recommended WTO members
to utilize the full measure of the policy space provided by Article 27 of the TRIPS
Agreement to suit their domestic needs and conditions prevalent in their own countries.
This could be done by ensuring and applying rigorous definitions of conventions and
laying down the criteria for patentability with a view to curb the “evergreening”. This
would help to ensure recognition to genuine innovations.
Taking a leaf out of the Indian diaspora, South Africa drafted its Intellectual Property
Rights policy to propose stricter patent criteria and patent oppositions. The Indian
judiciary’s firm stance in the wake of pressure exerted by big pharma giants showcased the
need to pursue welfare and improve access to medicines without submitting to “corporate
bullying tactics”.
While Novartis during the pendency of the case threatened to withdraw its operations from
India only to enlarge its investments after the judgment, the flurry of protests against
pharmaceutical lobbying practices rang a bell with many least developed countries.
The approach in India has inspired similar struggles to wrestle free from the control of such
MNCs across the world such as in Colombia and many other Latin American and African
nations.
Apart from South Africa, Thailand too is now on the path to implement a model that
advocates a stricter patentability criteria with their government.
In 2012, Argentina, despite the predicable and similar backlash, also made use of the right
to define patentability criteria (in accordance with the TRIPS Agreement) for the
application of the legal requirements of novelty, inventive step and industrial application
and subsequently, the government established even more strict and pro-health, anti-
evergreening guidelines for the examination of pharmaceutical patent applications.25

25
Patralekha Chatterjee, Five Years After the Indian Supreme Court’s NOVARTIS verdict, Intellectual Property
Watch (2018). Accessed at: https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-
verdict/
 CONCLUSION

The decision of the Supreme Court is appropriate keeping in mind India’s position as “The
Pharmacy of the World”.26 It is the largest exporter of life saving generic drugs ,70% out of
which goes to the developing countries.27 Life saving drugs for diseases like AIDS and
malignant cancers were exported to developed, developing and the least developed
countries from India at minimal prices. The current decision of the Supreme Court is in
sync with the constitutional obligations of the State to promote social welfare. Further, it
also serves the interests of a large number of least developed countries which depend upon
India for medical assistance.
“In every case generic prices present an opportunity for cost savings; in some
cases, the branded price per pack of a drug is up to 11 times the cost of the approved
generic version.”28

According to Jeremy Bentham’s principle of Utilitarianism , ‘pain’ and ‘pleasure’

are the sovereign masters under which every human being is bound. 29 Legislations are
made for the people and utility of legislation is judged on its capability of maximizing the
pleasure and minimizing the pain of the subject. The Benthamite perspective, instead of
focussing on ‘whose rights’ or ‘who deserves’, thinks of the welfare of the largest number
of people. The Court's decision is a major setback to the interests of the major
pharmaceutical companies. But , it caters to the interests of the people of India and of the
countries to which India exports the generic drugs and who are unable to afford the
branded drugs.30

“India is a welfare state governed by a Constitution which holds the pride of place in the
hearts of its citizens. It lays special emphasis on the protection and well-being of the weaker
sections of society and seeks to improve their economic and social status on the basis of
constitutional guarantees spelled out in its provisions.”31

Article 27.1 of the TRIPS Agreement provides for three strict standards (novelty, non-
26
Novartis Judgment at para ¶3.
27
World Medicines Situation, 2004, WHO (WHO/EDM/PAR/2004.5)
28
Bringing Hope: Supplying ARVs for HIV/AIDS treatment, PEPFAR, May 2006 (with partial data available
for fiscal year 2006).

29
Jeremy Bentham , An Introduction to the Principles of Morals and Legislations, 1 , Dover Publications (2007)
30
Will the lifeline of affordable medicines for poor countries be cut? Consequences of medicines patenting in
India, available at http://www.who.int/hiv/amds/MSFopinion.pdf (last visited 20th oct 2013).
31
Vikram Deo Singh Tomar .v. State of Bihar , AIR 1988 SC 1782
obviousness and industrial application) based on which patents are given. However these
terms are not defined anywhere and the level of strictness on judging a product for patent is
dependent on the country. Article 3.2 of the World Trade Organization Dispute Settlement
Understanding (“WTO DSU”) provides that provisions of an agreement should be clarified
in accordance with the “customary international law”. Article 31 of the Vienna Convention
on the Law of Treaties, 1969 states that interpretation must be in accordance to the
“context”, “object”, and “purpose”. Thus when Article 7 and Article 8 of the agreement are
interpreted taking into account the reference from Article 31 of VCLT and Article 3.2 of
WTO DSU, the judgment of the Supreme Court of India is appreciable.
Thus, in light of the above discussion , the observations made by the Supreme
Court in the instant case should be lauded.. The decision is an attempt to prevent the
practice of abuse of patents through Evergreening, thus preventing anti - competitive
practices in the market. The Court has also laid down a very strict and high standard for
the qualification of a product as an "invention", thereby upholding the principle of social
welfare.