Alliance Journal of Intellectual Property Law (AJIPL)

Volume: 1, Issue: 1, 2023 | e-ISSN: 2584-0363

ISSUES RELATED TO EQUITABLE ACCESS TO MEDICINES:

A PATENT LAW PERSPECTIVE
Ms. Sri Bhavanisha K S1

ABSTRACT distribution of medicines and support health care.

Striking an essential balance between Therefore, to improve the access to medicines,
Intellectual Property protection and the protection there have been ‘flexibilities’ introduced in the
of health by ensuring equitable access to international Intellectual Property conventions
medicines has always been an important point through compulsory licensing and parallel
of consideration. The rationale for providing importation. But even so, there exist limitations in
Intellectual Property protection is to incentivize the the practical implementation of these flexibilities in
innovator for successful research and development developing and least developed nations. So, in this
and recoup the initial financial investments made regard, the challenge exists in striking a balance
in order to innovate the drug. As per the economic between incentivizing the innovator and ensuring
theory, denial of patent protection to the innovators equitable access to medicines at affordable prices.
of pharmaceutical products will discourage them Keywords: Access to Medicines, Compulsory
from investing further and innovating drugs in Licensing, Flexibilities, Parallel Imports, Patents.
order to treat diseases. This will ultimately affect
the standard of health care worldwide in the INTRODUCTION
long run. Whereas, providing patent protection Intellectual Property Rights (IPR) are
for pharmaceutical innovations also acts as an described as rights that people have in the form
impediment to equitable access to medicines. The of protection over their ideas, work, inventions or
essential drugs that are protected by patents are any creative expressions, and are regarded as the
priced very high. This means they are not affordable creator’s property. The authors of such works are
to the developing and least-developed countries granted certain exclusive rights or financial rewards
which lack resources to provide for equitable as an incentive for their efforts and to encourage

1 Legal Counsel, IP Horizons, Bengaluru

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 Issues Related to Equitable Access to Medicines: A Patent Law Perspective
others to develop works or ideas. This right to these ‘flexibilities’ has been inhibited by a number
profit commercially is restricted to the originator of practical limitations, thus, leading these to be
or someone lawfully authorized by them. IPRs aim ineffective in some circumstances.
to encourage invention by granting the creator or The interlink between Intellectual Property
innovator time-limited commercial rights over the laws and the public health sector exists by way
use of their product.2 of the dichotomy between the IP policies which
One of the most instrumental and fundamental incentivize the innovators in the pharmaceutical
elements of the human rights system across sector thereby providing a monopoly. Further, its
the world is the right to health.3 The inherent result negatively impacts sustainable and equitable
challenge of equitable distribution of medicines access to medicines.7 Stringent protection of
has always been a lurking problem. Accessibility Intellectual Property, therefore, leads to an increase
of essential medicines in a sustainable manner still in the non-accessibility of prescribed essential
remains at the heart of this issue. The Sustainable drugs. The developing and the least- developed
Development Goals 2030 (SDG 2030)4 founded nations are affected the most in the sense that they
by the United Nations marks under Goal 3 of lack the resources, money, and power to control,
‘Good Health and Well-Being’5, Universal Health and distribute essential lifesaving drugs, if they
Coverage (UHC) as a key aim to be achieved in are patented, and hence, sold at exorbitant prices.
order to promote equitable access to medicines6. This also poses a risk to the key aim of the UN
The Intellectual Property policies, along with its Sustainable Development Goal in order to provide
administration and enforcement, aim to attain a Universal Health Coverage.8
balance between a range of legitimate interests in Hereby, it becomes essential to understand the
order to promote overall welfare. need for improving access to medicines and the
The major components of international current problems in providing equitable access. It
Intellectual Property regulations are the WTO is also important to analyse the interlink between
Trade-Related Aspects of Intellectual Property IPR policies and the policies that look to effectively
Rights Agreement (TRIPS) and the treaties/ improve equitable access to medicines.
conventions that are administered by the World
Intellectual Property Organisation (WIPO). The INTERLINK BETWEEN IPRs AND
national legal systems incorporate principles from
ACCESS TO MEDICINES
these international conventions and agreements
in order to regulate and streamline their domestic In the major policy discussions regarding the
Intellectual Property law mechanisms. The Intellectual Property sector, the pharmaceutical
international framework also provides for a range industry occupies an unusually conspicuous
of options that can be adopted in accordance with position worldwide. This is especially because,
the domestic policy objectives in the manner of when the interrelation between the IP sector and the
“flexibilities”. The proper implementation of pharmaceutical industry is taken into consideration,

2 Kwok, Kelvin Hiu Fai, A New Approach to Resolving Refusal to License Intellectual Property Rights Disputes, World
Competition 262 (2011)
3 Victoria E Hopkins, Analysis of International Patent Protection and Global Public Health, 17 JPIA (2006).
4 The 17 Goals, United Nations, https://sdgs.un.org/goals
5 Ensure healthy lives and promote well-being for all at all ages, United Nations, https://sdgs.un.org/goals/goal3
6 Universal health coverage (UHC), World Health Organization, (Dec. 12, 2022), https://www.who.int/news-room/fact-
sheets/detail/universal-health-coverage-(uhc)
7 Nithyananda K.V, COVID-19 Vaccines Legal and Consumer Issues, 56 EPW 17 (2021)
8 Benjamin Coriat, Fabienne Orsi and Cristina d’Almeida, TRIPS and the International Public Health Controversies: Issues and
Challenges, 15 IND CORP CHANGE 1033-1062 (2006)

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Ms. Sri Bhavanisha K S
critical issues arise.9 These issues usually revolve other pharmaceutical products, as a result of actual
around multifaceted debates regarding the research competition relating to the demand and supply
and development of pharmaceutical products, between the various competitors of drugs present
the pricing of pharmaceutical products, equitable in the market. Whereas, the ‘dynamic gains’ stand
access to medicines and other pharmaceutical for the gains that are received by the innovator that
products, the incentives in protecting the encourages him to further innovate.
pharmaceutical invention under the patent laws, the There is an obvious tussle that exists in every
protection of the brand name of a pharmaceutical nation that tries to constitute a balance between
company under the trademarks law, and so on. the two forms of gains that notably accrue to
The Intellectual Property Regime impacts the two varied stakeholders in the pharmaceutical
pharmaceutical market in two critical areas. These industry. On one side of the spectrum, the
expanses of influence are namely, the issue relating innovators continue to face hardships due to the
to the pricing of a particular pharmaceutical drug constant rise in the costs invested in research and
or product, and the other issue concerning the development. This is also coupled with the threat
research and development incentives that are made of possible shrinkage of the patent protection
available to the inventors/patentees of a drug/ period due to rising complexities in the patent
pharmaceutical product.10 registration procedure. On the other side, there
The issue relating to the pricing of the arises the concern of the affordability of patented
drugs relates to the patent law regime, with anti- drugs. The patented pharmaceutical products often
competitive concerns and repercussions regarding cost high and questions of equitable access made
the exclusion of competitors from the market it a major political and economic problem for all
coming to the forefront. The next issue regarding nation states. This effect is specifically felt by the
research and development incentives pulls in vulnerable and disadvantageous groups of society,
question the incentive of the inventor/patentee in who are not in a position to afford such products.
order to further innovate. This issue will invariably This then encircles in a bigger consideration by
affect factors that determine equitable access to nation-states when they discuss the allocation of
medicines such as the expenditure on research public health care resources and budgets.
and development, and selective apportionment of
expenses across various diseases, jurisdictions, INTERNATIONAL INTELLECTUAL
and different organizations. These two issues are PROPERTY LEGAL REGIME
intertwined to a large extent, and present crucial The initial development and recognition of
economic and political conflicts. the patents as a legal right or protection can be
When the use of Intellectual Property is brought seen to be granted in countries like Vienna and
into question regarding the pharmaceutical sector, Greece.11 After which the surge of developments
it is pertinent to note the conflict between the and technology and science flooded all markets
‘static’ and ‘dynamic’ gains that come into play. On of the world, enabling substantial efforts to make
one hand, the ‘static gains’ can be associated with a harmonised international set of basic rules and
the consumers of the products. This is a consumer guidelines for the protection of Intellectual Property
gain occurring due to low prices on drugs and Rights.12 One of the oldest and most extensive

9 Qian, Y., Do National Patent Laws Stimulate Domestic Innovation in a Global Patenting Environment? A Cross Country
Analysis of Pharmaceutical Patent Protection 89(3) REVIEW OF ECONOMICS AND STATISTICS 436-453 (2007)
10 Schankerman, M., How Valuable is Patent Protection? Estimates by Technology Field, 29 (1) RAND JOURNAL OF
ECONOMICS 77-107 (1998)
11 WIPO, https://www.wipo.int/about-wipo/en/history.html (last visited Mar. 26, 2023).
12 Ikechi Mgbeoji, The Juridical Origins of the International Patent System: Towards a Historiography of the Role of Patents in
Industrialization, 5(2) Journal of the History of International Law 403-422 (2003).

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 Issues Related to Equitable Access to Medicines: A Patent Law Perspective
conventions that dealt with the subject matter of the obtaining of monopoly rights related to process
intellectual property was the Paris Convention patents.17 Though at present the Agreement on
which was enacted as early as that of 1883.13 But Trade Related Aspects of Intellectual Property
one important consideration in this regard is that puts forward a non-flexible mandate / obligation in
the Paris Convention as is, did not protect all the order for the member nations of the treaty in order to
forms of Intellectual Property that we know and recognise both the product and process patents, the
practice today. obligation as laid down under the Paris Convention
differs from that of the TRIPS agreement.18 The
a) Paris Convention for the Protection of provision under the Paris Convention in the first
Industrial Property, 1883 place was most ambiguously worded, giving rise
The 1883 Convention dealt with in specific to many vague and confusing interpretations. What
the protection and basic standards with regards was attempted through the provision, was in order
to ‘industrial property’.14 While the Convention to extend the scope of protection provided for the
prescribed that its objective was in order to process patents to that of the product patents.19 The
establish and ensure for equal protection of all the developing countries feared, not without basis, that
industrial properties in the nations of the member if such a thing as to the extension of protection to
countries that ratified the convention, the ground the product patent was to take place it would cause
reality was however very different.15 One of the irreparable loss to the pharmaceutical and food
major problems was the attempt made to effectuate manufacturing and distribution industries.20 This
product monopolies. Article 5 quarter of the Paris is because in the developing countries very limited
Convention deals with the control regarding the monopoly rights, if not, no monopoly rights at all
importing of specific products into the importing were granted with respect to the pharmaceutical
country for which the process of acquiring such industry and the food and agriculture industry.21
products enjoys patent that is exclusive monopoly This was because of taking into consideration the
under the regime of the importing country. This public interest quotient involved.22
particular article had created a lot of confusion and
drew major criticism.16 b) The Agreement on Trade Related Aspects of
Intellectual Property Rights
The wordings of this particular article when
construed meant that the international law was The World Trade Organisation enacted and
trying to effectuate product monopolies through brought in force the Agreement on Trade Related
Aspects of Intellectual Property Rights.23 This

13 Karnika Seth, History And Evolution Of Patent Law – International & National Perspectives, SETH ASSOCIATES https://
www.karnikaseth.com/wp-content/uploads/history-and-evolution-of-patents1.pdf
14 WIPO, https://www.wipo.int/about-wipo/en/history.html (last visited Mar. 26, 2023).
15 WIPO, https://www.wipo.int/treaties/en/ip/paris/summary_paris.html (last visited Mar. 26, 2023).
16 Paris Convention for the Protection of Industrial Property, 1883, Article 5 quarter.
17 WIPO, https://www.wipo.int/edocs/pubdocs/en/intproperty/611/wipo_pub_611.pdf (last visited Mar. 26, 2023).
18 WIPO, https://www.wipo.int/edocs/pubdocs/en/intproperty/611/wipo_pub_611.pdf (last visited Mar. 26, 2023).
19 Mahima Puri and Anjali Varma, Intellectual Property Conventions and Indian Law, ICRIER Working Paper Series, No. 166
(2005) https://icrier.org/pdf/wp166.pdf.
20 Jorge M. Katz, Patents, the Paris Convention and Less Developed Countries, CENTER DISCUSSION PAPER, NO. 190,
YALE UNIVERSITY, ECONOMIC GROWTH CENTER, NEW HAVEN, CT (1973).
21 Cícero Gontijo, Changing The Patent System From The Paris Convention To The Trips Agreement, The Position Of Brazil,
Global Issue Paper No. 26, HEINRICH BÖLL FOUNDATION (2005).
22 WTO, https://www.wto.org/english/docs_e/legal_e/ursum_e.htm (last visited Mar. 26, 2023).
23 Safia Gupta, From GATT to WTO, LEGAL SERVICE INDIA (Mar. 26, 2023, 11:10 AM), https://www.legalserviceindia.com/
article/l378-From-GATT-to-WTO.html.

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Ms. Sri Bhavanisha K S
Agreement has since the time of its enactment and Now this particular condition regarding the
institution, continued to serve as one of the legal practice of compulsory licensing makes the main
instruments containing the basic and minimum objective behind the enactment of the provision
standards of protection in order for regulating redundant. Compulsory licensing is used as a
and controlling intellectual property rights.24 The mechanism in order to meet the growing need in
TRIPS agreement through its various provisions the least developed countries for the supporting of
attempted to enforce a harmonized set of intellectual public health emergencies.30 This is particularly
property laws. Articles 7 and 825 highlights the facilitated by the circulation and trade of
health and well-being of the people. Article 7 pharmaceutical products through the importation
provides that rights related to Intellectual Property from the countries who enjoy good manufacturing
Rights should not in general be of any hindrance capacity of medicines, such as that of India and
to the social and economic welfare of the people Korea.31 Now taking this in consideration with
in the particular country.26 This especially provides the Article 31(f) of the TRIPS agreement makes it
that Intellectual Property Rights as extended clear that the text under this article by restricting
protection under this international agreement the application of compulsory licensing provisions
should rather be able in order to help and act as for the mere ‘domestic production’ created a public
a catalyst for the improvement of the social and health concern.32 For this very reason the Doha
economic conditions of the people. This Article round was went underway in order to settle on the
gives priority to the furthering and improvement of provisions and make clear the rules with respect to
public health, nutrition and other such very crucial compulsory licensing.33
areas of importance to the particular country.27
c) The Doha Declaration on The Trips
However, controversies arose around provision
Agreement and Public Health
of Article 31(f) of the TRIPS agreement that
regulated the norms for compulsory licensing.28 Ministerial Conference at Doha was an attempt
Under this particular provision it was stated that in order to clear the controversies and make changes
the compulsory licensing should be practiced and suggestions relating to the mechanisms
‘predominantly for domestic / national purpose’.29 already in place under the TRIPS agreement for

24 Susan Ariel Aaronson, From GATT to WTO: The Evolution of an Obscure Agency to One Perceived as Obstructing Democracy,
EH.NET (Mar. 26, 2023, 10:42 AM), https://eh.net/encyclopedia/from-gatt-to-wto-the-evolution-of-an-obscure-agency-to-
one-perceived-as-obstructing-democracy-2/.
25 The WTO Agreement on Trade Related Aspects of Intellectual Property, Art 8
26 The WTO Agreement on Trade Related Aspects of Intellectual Property, Art 7
27 The WTO Agreement on Trade Related Aspects of Intellectual Property, Art 7
28 The WTO Agreement on Trade Related Aspects of Intellectual Property, Art 31(f).
29 David S Abrams, Did TRIPS Spur Innovation? An Analysis of Patent Duration and Incentives to Innovate, 157(6) UNIVERSITY
OF PENNSYLVANIA LAW REVIEW 1613–47 (2009) http://www.jstor.org/stable/40380275.
30 Kerry, V.B., Lee, K. TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting
access to medicines? 3(3) GLOBAL HEALTH (2007). https://doi.org/10.1186/1744-8603-3-3
31 The Doha Declaration on TRIPS and Public Health Ten Years Later: The State of Implementation, SOUTH CENTRE, POLICY
BRIEF 7 (Nov. 1, 2011) https://www.southcentre.int/wp-content/uploads/2013/06/PB7_-Doha-Declaration-on-TRIPS-and-
Health_-EN.pdf.
32 The WTO Agreement on Trade Related Aspects of Intellectual Property, Art 31(f).
33 Daksh Ghai, Doha health declaration: patent laws in developing countries with a special reference to India, IPLEADERS
(Oct. 1, 2021) https://blog.ipleaders.in/doha-health-declaration-patent-laws-in-developing-countries-with-a-special-reference-
to-india/.

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 Issues Related to Equitable Access to Medicines: A Patent Law Perspective
the improvement of public health.34 Paragraph actually being available to the citizens. In this
6 of the Doha Declaration was introduced in regard, a particular field study that was undertaken
order to provide legal recognition for the generic by M K. Kyle in the year 2006, is worthy of
manufacturers in order to distribute and sell the mention.38
licensed pharmaceutical products through exports The study undertaken by M K. Kyle brings
to other countries and not merely restrict the sale to the notice of the readers the rate of diffusion
of the pharmaceuticals in the domestic territory for of a particular pharmaceutical product in various
domestic use.35 So in actuality, para 6 should have territories or in other words, various nation-states of
aid for an easy and hassle-free procedure for the the world.39 The study noted a delay in the diffusion
export of medicines to less developed countries or spread of the sale and actual consumption of
facing public health emergencies.36 But in contrast pharmaceutical products by consumers. In this
to this, while in no doubt allowing for the exports, light, there was also another study taken up by
put forward cumbersome procedural conditions Lanjouw which highlights to a large extent the
to be fulfilled for the purpose of exporting the determinants that affect the diffusion of a particular
patented drugs by the generic manufacturers. drug in a foreign market and the patterns of demand
These over-exhausting procedures act as a huge noticed in the consumers depending on the price
detriment for the licensees to move forward with variations of the pharmaceutical product.40 As per
the export of pharmaceuticals to less developed the observation made by J.O. Lanjouw based on the
countries lacking manufacturing capacity.37 field study conducted, it was revealed that in fact,
there existed huge delays in the period between the
STRINGENT PATENT LAWS: A patenting of a particular pharmaceutical product in
CRITERION AFFECTING ACCESS one particular territory and the availability of the
The issues related to access and availability same pharmaceutical product in the territories that
marks of utmost concern and are at a critical were outside the scope of the patent protection.41
juncture in ensuring that there is an equal status quo Therefore, the access to medicines to a large
maintained between all human beings, irrespective extent was leaning towards the particular nation
of the external social determinants affecting them. states that ensured protection for their Intellectual
There have been numerous studies conducted in Property and thereby provided opportunities to
order to understand the diffusion of drugs into recoup the investments placed on the research and
marketplaces and a particular pharmaceutical drug development of the pharmaceutical drug. This also
coincided with the observation made by M. K. Kyle

34 Nilesh Zacharias and Sandeep Farias, Patents and the Indian Pharmaceutical Industry, MONDAQ (Nov. 20, 2019) https://
www.mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry
35 Kerry, V.B., Lee, K. TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting
access to medicines? 3(3) GLOBAL HEALTH (2007) https://doi.org/10.1186/1744-8603-3-3
36 James Thuo Gathii, the Doha Declaration on TRIPS and Public Health under the Vienna Convention of the Law of Treaties,
15 HARV. J. L. & TECH. 292-308 (2002)
37 Technical Panel to Look into IPR Issues, FIN. EXPRESS, (Apr. 5, 2005) http://www.financialexpress.com/fe_full_story.
php?content_id=87046 (last visited Mar. 24, 2023)
38 Kyle, M.K., The Role of Firm Characteristics in Pharmaceutical Product Launches, 37(3) RAND JOURNAL OF ECONOMICS
602-618 (2006)
39 Kyle, M.K. Pharmaceutical Price Controls and Entry Strategies, 89(1) REVIEW OF ECONOMICS AND STATISTICS 88-99
(2007)
40 Lanjouw, J.O., Patents, Price Controls, and Access to New Drugs: How Policy Affects Global Market Entry,
NBER WORKING PAPER No. 11321 (2005)
41 Ahlering, B., The Impact of Regulatory Stringency on the Foreign Direct Investment of Global Pharmaceutical Firms, Working
Paper No. 280, ESRC CENTRE FOR BUSINESS RESEARCH, University of Cambridge (2004)

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Ms. Sri Bhavanisha K S
regarding the extent of the exploitation of a patented specific territory. This difficulty is purely because
drug commercially. As per this observation, it was of the reason that a new active ingredient that
found that only a shocking amount of less than has been identified and patented could be sold in
4% of the prospects actually available in order to substantially different forms of variants that may
launch the new drug were in reality exploited. This be chemically distinct. In these cases, even though
leaves a whopping 90% of the drug developers and the clinical variation may never change, this aspect
innovators who did not want to extend the horizon alone cannot be depended upon in order to provide
of sale apart from the country in which the patent for clear identification and differentiation between
was granted protection.42 However, Kyle’s study is the pharmaceutical drugs. This makes assessing of
limited by the fact that only the G7 nations were the access and availability of particular drugs or
covered as a part of the research. In this regard, the pharmaceutical products in defined areas a rather
research done by J.O. Lanjouw compensated for daunting task. There are also other determinants
gaps in previous studies by widening the circles of such as the reliability of the data regarding the
research to include an extensive array of territories. price control that has been collected in order to
This research is particularly important because it is check the diffusion of the pharmaceutical drugs.
specifically related to the influence of Intellectual With all this said, it does not change the point
Property Rights and price control regulations that the factor of protection of intellectual property
in order to pinpoint the change or delay in the rights does play a very pivotal and indispensable
accessibility of particular medicines to countries part in the dissemination and exploitation
outside the jurisdiction of the patented country.43 of pharmaceutical drugs, thus leading to the
The results of this research clearly indicated that determination of access and availability of the
countries that did not have strong intellectual drugs.
property protection noticed a considerable delay in
the introduction and access to the pharmaceutical
drugs in question. Similarly, lesser affinity to PRICING AND DEMAND INDICATORS:
indulge pharmaceutical drugs in countries that AS A CRITERION DICTATING ACCESS
employed more forceful price control mechanisms It is a daunting task in order establish a
was also noted. It was also perplexing to note that correlation between the intellectual property
in certain countries that had a combination of both regime and the pharmaceutical industry by
weak intellectual property protection and undue using determinants of price and demand or cross
price control, the new pharmaceutical drugs were elasticity of demand as the criteria for evaluation.45
never launched or made available to the market for This is because there is a huge amount of practical
consumption in those territories.44 difficulty involved in collecting the price indicators,
However, it is important to consider these sales, and demand volumes of pharmaceuticals in
findings with caution. This is because there is no general.46 There are numerous concerns relating
straight jacket formula for the identification of to the actual reliability of the collected data, the
the marketing and availability of medicines in a difference in the market structure and government

42 Delgado, M., M.K. Kyle and A.M. McGahan, The Influence of TRIPS on Global Trade in Pharmaceuticals, 1994- 2005 NBER
Conference on Location of Biopharmaceuticals (2008)
43 Lanjouw, J.O. and M. MacLeod, Statistical Trends in Pharmaceutical Research for Poor Countries, Working Paper, UC
Berkeley (2005)
44 Lanjouw, J.O. and I.M. Cockburn, New Pills for Poor People: Empirical Evidence after GATT, 29(3) WORLD DEVELOPMENT
(2001)
45 Rapp, R.T. and R.P. Rozek, Benefits and Costs of Intellectual Property Protection in Developing Countries, NATIONAL
ECONOMIC RESEARCH ASSOCIATES, Working Paper No. 3 (1990)
46 Meyer, B.D., Natural and Quasi-Experiments in Economics, 13 JOURNAL OF BUSINESS AND ECONOMIC STATISTICS,
(1995)

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 Issues Related to Equitable Access to Medicines: A Patent Law Perspective
policies from one nation-state to another, etc. All for Health issued the first-ever Guide in the year
these factors make it nearly impossible to pinpoint of 1986. This Guide is typically updated every
the results from the research undertaken on the year.48 While this particular initiative has been
price correlation as being perfect. undertaken in regard to essential pharmaceutical
There have been research undertaken by products, there have been other attempts to
many in order to understand the price and classify a particular specialised class of drugs,
demand structure of pharmaceuticals. Many of such as that of the MSF’s guide for the price
the researchers point to various difficulties faced fluctuations in Antiretrovirals that is helpful in the
by them in the process. One of the common treatment of HIV patients.49 It should be noted that
difficulties that often come up in research is the research done by NGOs though, on one hand, are
difficulties of methodology in comparing the very useful, on the other hand, cannot be blindly
indicators. Moreover, it is highlighted that such accepted. This is because there can be no veracity
research can only be properly carried forward that can be attached to the data collected that can
by experimenting with a comprehensive sample adduce comparability, especially because of the
of pharmaceuticals and obtaining the results by reason that the results are collected from numerous
standard index number methods.47 When samples isolated sources around the world. 50
of medicines are collected for research purposes, Evidence regarding the corelation of patent
practical difficulty again arises in the fact that the law and price indicators of medicines can also
same clinical formula could be sold in different be extracted from the impact of various legal
variations, and dosages in different nation states. regulations such as the impact of patent expiration
There are also changes in brand names, changes in followed by the entry of generic medicines, impact
packaging of a particular pharmaceutical product, of compulsory licensing standards, and the impact
and substantial changes in the formulation of of parallel imports regulations on trade.
pharmaceutical compounds that are to be taken
into consideration. a) Impact of Patent Expiration and Generic
Entry
There have been attempts made by the World
Health Organisation (WHO) in partnership with This particular area of legal regulation
many Non-Profit Organisations in order undertaken adduces important evidence to the correlation
research and publish the price of certain selective sought between the Patent law in specific and the
pharmaceuticals that are very essential in nature. price indicators. Studies undertaken in these areas
International Medical Products Price Indicator prove that there is a substantial difference in price
Guide, formerly referred to as the International between countries that protect or grant product
Drug Price Indicator Guide is one such effort that patents in comparison with other countries that
has been undertaken. The Management Science do not grant product patents.51 In the US,52 for
example the pharmaceutical markets have always

47 Patricia Danzon & Jeong D. kim, International Price Comparisons for Pharmaceutucals 14(1) PHARMACOECONOMICS
(1998)
48 MANAGEMENT SCIENCE FOR HEALTH, (last visited Jan. 6, 2023) https://msh.org/resources/international-medical-
products-price-guide/
49 MEDICINES SANS FRONTIERES, (last visited Jan. 6, 2023) https://msfaccess.org/utw
50 Meyer, B.D., Natural and Quasi-Experiments in Economics, 13 JOURNAL OF BUSINESS AND ECONOMIC STATISTICS,
(1995)
51 Caves, R.E., M. Whinston and M. Hurwitz, Patent Expiration, Entry and Competition in the US Pharmaceutical Industry,
66(1) BROOKINGS PAPERS ON ECONOMIC ACTIVITY: MICROECONOMICS (1991)
52 Grabowski, H. and J. Vernon, Brand Loyalty, Entry, and Price Competition in Pharmaceuticals after the 1984 Drug Act, 35
JOURNAL OF LAW AND ECONOMICS, (1992)

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Ms. Sri Bhavanisha K S
been highly competitive in nature.53 This means licensing practices is that they help lower the
that as soon as the patent protection period for a exorbitant costs of pharmaceutical products that
particular pharmaceutical drug ends, the generic are protected by patents. This brings equitable
manufacturers rush into the market.54 This can access to pharmaceutical and affordable health
be clearly seen when the market share of the care to that section of the public that are vulnerable,
patented drug sees a sharp fall as soon as its patent socially and economically backward, or even
protection period expires. Then it should be kept in middle-income families.56
mind that this phenomenon is in relation to the US It should also be kept in mind that the impact
market which has a highly competitive market that of compulsory licensing cannot be absolutely
lets generic manufacturers flourish to a particular assessed, this is because of reasons that though
extent. There are other developed countries in the generic manufacturers are given the liberty
which the market structure is comparatively to manufacture the pharmaceuticals at a lower
different and therefore does not allow for higher cost, there might be instances when there is not
generic-brand price differentials. a significant price drop between the patented
pharmaceutical and the generic pharmaceutical
b) Impact of Compulsory Licensing
drug.
Compulsory Licensing adds a very critical area
wherein the intellectual property regime is able to In certain countries, like India, there has
affect the price of pharmaceutical products. By been a recorded decrease of up to a 90% drop in
means of compulsory licensing, the governments prices of generic drugs as compared to patented
of different nation-states are able to regulate the drug.57 Then, in some other countries, it is noticed
circulation and access to pharmaceutical products.55 that when there is a lack of rigorous competition
In this regard, the governments make available between the generic manufacturers for a particular
to the general public access to certain essential drug, there is a drop in price but it does not make
pharmaceuticals by lowering and regulating the a huge contrast in cost between the patented drug
domestic prices of the pharmaceuticals. The and its generic version. Thus, not leading to the
competition policy of a particular country can also desirable standards of affordable health.
impact and decide the enforcement of compulsory
licensing. When compulsory licensing provisions c) Impact of Parallel Imports and Trade
are embarked on by the governments as a resort, Parallel importing in trade is another area
the generic pharmaceutical manufacturers are in which the pricing and demand factors of the
benefited in the market. pharmaceutical sectors may be affected. Parallel
importing of medicines from foreign jurisdictions
In certain situations, compulsory licensing can may usually result in the lowering of prices of
result in a high level of competition between the pharmaceutical products. Parallel importing of
generic manufacturers in the supply of essential pharmaceuticals has been exercised keeping in
drugs to the consumers in the market. Apart from mind the developing countries as the primary
all this, the most positive impact of compulsory stakeholders. This is because developing countries

53 Frank, R. and D. Salkever, Generic Entry and the Pricing of Pharmaceuticals, 6 JOURNAL OF ECONOMICS AND
MANAGEMENT STRATEGY, 75-90 (1997)
54 Ellison, S., I.M. Cockburn, Z. Griliches and J. Hausman, Characteristics of Demand for Pharmaceutical Products: An
Examination of Four Cephalosporins, 28(3) RAND JOURNAL OF ECONOMICS 426-446 (1997)
55 Park, W., International Patent Protection: 1960-2005, Research Policy 37, 761-766 (2008)
56 Scherer, F.M. and J. Watal, Post-TRIPS Options for Access to Patented Medicines in Developing Countries, 5(4) JOURNAL
OF INTERNATIONAL ECONOMIC LAW 913-939 (2002)
57 Watal, J., Pharmaceutical Patents, Prices and Welfare Losses: Policy Options for India under the WTO TRIPS Agreement, the
World Economy, 733-752 (2000)

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 Issues Related to Equitable Access to Medicines: A Patent Law Perspective
cannot afford the excessive price of patented has entitled new ways of adopting to it. This goes
pharmaceutical products. One important benefit of to show that new technologies and innovations
parallel trade and import is that it might result in have to be brought in place in order to control
lowering the cost of the process of production in the spread of the pandemic. Especially in the
the importing country. Thus, this would provide pharmaceutical sector, research and development
a choice for the consumers of pharmaceutical initiatives have to be taken in order to innovate
products. With all this being said, it is also cures for disease. When looking at the impact of
pertinent to note that, research in this area denotes the pandemic, it leaves a hard footprint on patent
the contrary. In certain countries, the prices of law and regulations. Certain essential principles
pharmaceuticals have not been lowered to a great or and standards of working of the patent law are
substantial amount as could be desired from parallel under challenge due to this situation. Issues
imports.58 It was also noted during the research relating to the working of compulsory licensing in
that in fact the actual beneficiaries of parallel order to try to lower the pandemic also come into
trade do not seem to be the final consumers of the perspective.62
pharmaceutical products.59 The real beneficiaries In trying to provide for equitable distribution
seem to be the intermediaries that actually import of vaccines, many hurdles and challenges have
these pharmaceuticals.60 Hence, the relationship been met in the patent system, both nationally and
between Intellectual Property Rights and access internationally. There is a lack of international
to medicines can be observed in specific concerns coherence with respect to the principles and
such as the availability, pricing and demand of workings of the patents. In one aspect there still
pharmaceuticals, influenced by factors such as the exists an inherent conflict between patent law and
entry of generic medicines after a patent expires, pharmaceutical principles in themselves. While
the effects of compulsory licensing, and the impact patent law advocates for compulsory licensing
of parallel imports and trade. in order to provide better access to essential
medicines by providing an opportunity for generic
PATENTS AND THE GLOBAL manufacturers in order to supply medicines at
PANDEMIC affordable prices.63 Whereas in this light, the
With the onset of the global coronavirus pharmaceutical principles provide for and support
(COVID-19) pandemic, a can of worms has the data protection of the trials relating to the
been opened in relation to the accessibility of innovation of medicines. This is evident through
essential medicines. The ‘new reality’ after the the data exclusivity provisions embodied under
wake and effect of COVID-19 has caused chaos the laws of various countries. Now, if these both
in the normal working of various industries are construed together, then there is an obvious
worldwide.61 This effect is more so obviously felt impediment placed for the generic manufacturers
in the pharmaceutical sector. The ‘new reality’ by way of non-disclosure of data relating to
trial and research. In order to provide for better

58 Kyle, M.K., Strategic Responses to Parallel Trade, NBER WORKING PAPER NO. 12968, (2007)
59 Ganslandt, M. and K.E. Maskus, Parallel Imports and the Pricing of Pharmaceutical Products: Evidence from the European
Union, 23 JOURNAL OF HEALTH ECONOMICS 1035-1057 (2004)
60 Kanavos, P., J. Costa i Font, S. Merkur and M. Gemmill, the Economic Impact of Pharmaceutical Parallel Trade in European
UNION MEMBER STATES: A STAKEHOLDER ANALYSIS, SPECIAL RESEARCH PAPER, LSE HEALTH AND SOCIAL
CARE (2004)
61 James Bacchus, An Unnecessary Proposal A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines, 78 CATO
INSTITUTE (2020)
62 Andreas Oser, the COVID-19 Pandemic: Stress Test for Intellectual Property and the Pharmaceutical Laws, 70(9) GRUR
INTERNATIONAL 846–854 (2001)
63 WTO, (last visited Jan. 8 2023) https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm

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Ms. Sri Bhavanisha K S
accessibility to medicines, the legal provisions Some provisions which have to be strengthened
relating to patents have to be revamped in order in the laws of all nation-states in order to ensure
to cover status quo, taking the current pandemic better access to medicine are strong, proper and
for instance. The COVID-19 pandemic should be well-established laws regulating and promoting
able to work as a lesson for the modernization and pre-grant opposition of patents. Strict exceptions
revamping of the current legal system.64 In order relating to the patentability of the certain invention
to provide equitable access to medicines, there has or alleged inventions relating to the most essential
to be a balance struck between the public interest life-saving medicines. Laws in all nation-states
element and also that of the exclusive monopoly should clearly put forward the non-patentable
rights of the patentee. The situations attracting subject matter. Frivolous patents and patents
the exemptions of patent laws such as that of the that aid the ever-greening of patents should be
pandemic have to be clearly defined in the law. particularly and clearly weeded out.
These exemptions should be under clearly defined There should be well-established laws and
limits.65 procedures with respect to the compulsory
licensing of pharmaceutical products/drugs in
CONCLUSION AND SUGGESTIONS order to allow for equitable access to certain
In order to provide for better and equitable essential or lifesaving medicines at affordable
access to medicines, certain safeguards and prices. There should also be proper recognition
amendments have to be brought into the legal given to the parallel importation of medicines. All
system. Also, the mere availability of laws the cumbersome procedures of importation should
on paper will not promote access, but there be removed to enable effective and hassle-free
should be due enforcement of these laws. The parallel imports. This would ensure that there is
international framework provides the framework flexibility in trade and movement and hence better
and overarching concepts for the national legal access to medicines between territories. Last, but
systems in order to regulate and streamline their not the least, there should be regulations that allow
intellectual property law mechanisms. for the conduction and pursuing of research by the
Nonetheless, it also provides for a range of generic manufacturers of patented drugs. That is
options which can be adopted in accordance with to say that more research opportunities have to
the domestic policy objectives in the manner of be permitted to ensure that the protection of data
“flexibilities”. The proper implementation of these exclusivity does not hamper the predominant
‘flexibilities’ has been inhibited by a number of principles of public welfare. When all these basic
practical limitations like in the case of Compulsory regulations are in place then it can help address
Licensing and Parallel Imports, thus leading these the dichotomy that seems to exist between patent
to be ineffective in some circumstances. In order laws and equitable access to medicines around the
to achieve equitable access internationally, some globe.
basic legal regulations have to be ensured.

64 UNDP, Coronavirus v. Inequality, (last visited Jan. 8 2023) https://feature.undp.org/coronavirus-vs-inequality/?utm_

source=social&utm_medium=undp&utm_campaign=covid19-inequality&utm_source=EN&utm_medium=GSR&utm_
content=US_UNDP_PaidSearch_Brand_English&utm_campaign=CENTRAL&c_src=CENTRAL&c_src2=GSR&gclid=C
jwKCAjw6dmSBhBkEiwA_W-EoNh5AwFzPzkyKLnOsSd6vZT9-7c0btXZokSpFpOOukFVsxMEfK6vBRoCZ1IQAvD_
BwE
65 Padmavati Manchikanti and Michelle Dias, Pandemic, Patents and Public Health, 26 JOURNAL OF INTELLECTUAL
PROPERTY RIGHTS 187-198 (2021)

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