Critical Analysis of Compulsory Licensing Issues and Challenges with Special reference to Patenting of Covid Vaccines

I. Introduction

Patent provides exclusive right to the inventor to prevent others to make, use and sell the invention³ but however those rights can be taken over in the hands of government in few circumstances. The provisions for such an action, called compulsory licensing, are enshrined under chapter 16 of the Indian Patents Act 1970 and under section 31 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement⁴. Through this the government is able to take over the rights of the patentee over his patented invention and the government can proceed with the manufacturing of the patented products or provide compulsory license to any third party. With the advent of new inventions and getting them patented the patent act provides enormous rights to the patentee but however it is to be noted that such patented inventions by being industrially applicable should be made available to public at large. The government by having in built right to issue compulsory licensing against such withholding patent, shall grant licensing to any voluntary third party for manufacturing and selling of the patented invention. The patented vaccines are in need of the hour and that has to be immediately made available to all citizens all over the world. This medical emergency has created a huge impact economically and socially as an imbalance is created between developed and under developed countries because of the Covid Vaccines being administered majorly to developed countries while rest of the nations are not even given 1% of importance as that of the citizens and developed nations. For example, this is a new article which depicts the existing cry of most of the nations- “Most African countries have relied on doses delivered by the global platform, but less than 1 percent of the continent’s population have received a single dose of vaccine, according to Our World in Data. By contrast, the United Kingdom has given at least one shot to almost half of its population, compared with nearly 40 percent of people in the US and more than 19 percent in the EU⁵.

II. Covid-19

(A) The Transmission and the Measures to Control:

Corona viruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). A novel corona virus (nCoV) is a new strain that has not been previously identified in humans.⁶ Minimizing the transmission of infectious diseases is a core function of public health law. The appropriate exercise of legal powers will vary according to the seriousness of the disease, the means of transmission, and how easily the disease is transmitted.⁷

(B) The Race for Protection Gears

The World Health Organization has warned that severe and mounting disruption to the global supply of personal protective equipment (PPE) – caused by rising demand, panic buying, hoarding and misuse – is putting lives at risk from the new corona virus and other infectious diseases. Healthcare workers rely on personal protective equipment to protect themselves and their patients from being infected and infecting others. Since the start of the COVID-19 outbreak, prices have surged. Surgical masks have seen a six-fold increase, N95 respirators have trebled and gowns have doubled. Supplies can take months to deliver and market manipulation is widespread, with stocks frequently sold to the highest bidder. WHO has so far shipped nearly half a million sets of personal protective equipment to 47 countries, but supplies are rapidly depleting.⁸

With multiple options available, as safety gears in the time of corona virus, it becomes a challenge to choose the right one.⁹ The protection gears include Gloves, medical examination (non-sterile), Goggles, glasses protective, Gloves, surgical (sterile), Face shield, Fit test kit, Particulate respirator, Mask, medical for health care worker, Mask, medical for patient, Scrubs, tops, Pants, Apron, heavy duty, Apron, disposable, Gown, (isolation, Surgical), Alcohol-based hand rub, Biohazard bag, Safety box, Soap, Hand drying tissue, Chlorine.¹⁰

(C) The Race for Essential Medicines and Vaccine:

1. WHO site – recognized essential medicines, recognized vaccines:

Essential medicines, which include vaccines, hold considerable importance in the interpretive frameworks of the right to health, as they are critical to individual and population health. According to article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), states have obligations to prevent and control epidemics.¹¹ In General Comment 14, the Committee on Economic, Social and Cultural Rights notes that the provision of vaccines is critical to fulfilling this objective.¹² The committee has also firmly positioned the provision of essential medicines defined by WHO as a “core obligation” under the right to health. Such obligations are defined in General Comment 3 as the minimum standards that must be met by states in order to give meaning to the enjoyment of covenant rights.¹³ Core obligations to provide essential medicines under the right to health do not necessarily constitute a strictly binding (rather than authoritative) legal standard, even for the 171 states that have ratified the ICESCR.¹⁴ However, national governments have enshrined the state duty to guarantee access to essential or needed medicines for all in various domestic legal frameworks, from binding constitutional law and universal health coverage laws to national medicines policies guiding the pharmaceutical sector.¹⁵ For instance, at the height of the AIDS crisis, state provision of “essential” antiretroviral as part of the fulfilment of the right to health recognized in domestic constitutions and international treaties was enforced through domestic courts.¹⁶ This evidence suggests that core obligations hold a customary legal status. Given the lower evidentiary standards for EUAs relative to market licensure, political factors that can influence the issuance of EUAs, and the possibility that labelling such products “essential” could create the impression that the safety and efficacy of such products is more certain than it actually is, COVID-19 vaccines authorized for emergency use should not automatically be considered as candidates for essential medicine status. Irrespective of the precise legal status of core obligations to provide essential medicines, in a global pandemic such as COVID-19, a vaccine’s designation as an essential medicine by WHO would clearly invoke strong and urgent human rights and public health responsibilities of states articulated in international norms and domestic law, and raise fundamental questions about whether states should make such products widely available at an affordable price.¹⁷

2. Import ban, export ban on vaccines in India, UK, USA, EU:

COVAX, a global alliance to develop and equitably distribute Covid-19 vaccines and medicines, has said the 'terrible surge of the virus in India' has impacted its supply in the second quarter of this year. Covax fears it will face a shortfall of 190 million doses by the end of June. COVAX has delivered over 70 million doses to 126 countries around the world since February, in the largest and most complex rollout of vaccines in history. It plans to deliver 2 billion doses of vaccines worldwide in 2021, and 1.8 billion doses to 92 lower income economies by early 2022.¹⁸

Serum Institute of India (SII), one of the major suppliers to Covax alliance, could not meet its supplies in the past few months due to the second Covid-19 wave in India, forcing the Government to enforce ban on export of vaccines. The production of vaccines is highly concentrated, mainly in a small number of higher and middle-income countries. The necessary raw materials, too, are imported from only a handful of countries.¹⁹

The two top exporters of key ingredients, for instance, are the US and the EU – which account for half of total exports – followed by the UK, Japan and China, with significantly smaller shares. This implies that restrictions on exports of vaccines or other critical raw material and equipment by even one or two countries can easily send shockwaves through the rest of the world, derailing the entire vaccine production and distribution effort, as we see at present. Over 80 countries had resorted to banning exports of medical and personal protective goods in the early phases of the pandemic.²⁰

3. Patents for Covid vaccines, waiver request (covid vaccines patent waiver):

Every country should have the right to make its own vaccines during a pandemic. That’s the principle underpinning the campaign to temporarily waive intellectual property (IP) protection on corona virus vaccines. The campaign was initiated by India and South Africa, and is being backed by more than 100 countries, along with international organizations including the World Health Organization and the United Nations AIDS charity, UNAIDS.²¹ The goal is to reduce the barriers to countries producing their own vaccines — particularly for the lowest-income nations. At present, the proposal does not have the support of the pharmaceutical industry, nor that of most high-income nations. Instead, these countries are pledging to share more of their own vaccines with low-income nations and to provide more funding to charitable vaccine-provision schemes such as COVAX. However, in a surprising and welcome move earlier this month, the United States, Russia and China came out in support of an IP waiver on vaccines.²²

For decades, US governments have worked with industry, universities and other research-intensive nations in setting — and enforcing — IP rules, most recently through the World Trade Organization (WTO), where the IP waiver proposal is being discussed. One of the biggest concerns about IP waivers is that they provide a short-cut to competitors looking to acquire expensive technology. Companies also say that IP relief will not accelerate vaccine manufacturing, because materials are in short supply and it can take several years to build up capacity from scratch. Moreover, the governments opposing the waiver argue that current WTO rules already allow countries to apply for ‘compulsory licensing’ to override IP during emergencies. Right now, for example, Bolivia is applying to the WTO to use this process to allow it to manufacture Johnson & Johnson’s COVID vaccine. However, a group of researchers in the United Kingdom who study patent law point out in a draft paper on the waiver proposal that compulsory licence is extremely complex and time-consuming to apply for.²³ The EU has also pointed out that the United States has been blocking exports of COVID-19 vaccines and their components. The easing of such restrictions is essential in a pandemic.

These are important arguments, and need to be addressed. But they are not, in themselves, reasons for denying IP relief.²⁴ According to pharmaceutical-industry data, the industry expects to have made a total of about ten billion vaccine doses by the end of 2021. In a paper published on 19 May, they report that the industry is likely to have produced around six billion doses by the end of 2021. This potential shortfall increases the risk that people in low-income countries will need to wait even longer for their first doses. As Nature went to press, the number of vaccines given so far in Africa amounted to little more than one dose per person for some 2% of Africa’s 1.2 billion people. This is, among other factors, because the continent currently imports 99% of its vaccines, and because African countries lack the pre-order purchasing capacity of richer nations. It is why the African Union has announced a plan for 60% of Africa’s vaccines to be manufactured on the continent by 2040.²⁵

European Commission president Ursula von der Leyen is also proposing to ‘clarify and simplify’ the existing ways in which countries can implement compulsory licensing. And there is a strong possibility that the G7 group of the world’s biggest economies will pledge more funding for vaccination when member countries meet in the United Kingdom next month.²⁶These commitments are crucial in the race to end the pandemic. But they do not deal with the systemic issue — countries backing the IP waiver are not asking for charity, but for the right to develop and make their own vaccines, free from the worry that they will be sued by patent holders. Those backing the COVID IP waiver understand this core principle. The leaders of countries that are not currently in favour of the patent waiver must recognize it, too. As John Nkengasong, director of the Africa Centres for Disease Control and Prevention, says: they need to be on the right side when the history of the pandemic comes to be written.²⁷

4. Canada- vaccine pool fund for under developed countries- hoarding:

Canada is the only Group of Seven country to draw on a supply of COVID-19 vaccines meant primarily for developing countries. The COVAX program pools funds from wealthier countries to help buy vaccines for themselves and for 92 low- and middle-income countries that can’t afford to buy on their own. The vast majority of countries receiving the first vaccine shipments from COVAX are low- and middle-income countries. But Canada is among just a few rich countries exercising its options now to buy vaccines from the international group. For many poorer countries, COVAX will be the main source of vaccines. The World Health Organization’s director-general, Tedros Adhanom Ghebreyesus, has urged Canada and other wealthy countries to begin sharing their surplus as soon as their health workers and older people are vaccinated – a relatively early stage in the vaccine rollout. But it remains underfunded and is still seeking billions of dollars to meet its goals.²⁸

III. Monopolistic rights of a patent holder

The Paris Convention is the first major international agreement relating to the protection of industrial property rights. Patent Law Treaty is a treaty providing common and, as a general rule, maximum requirements for many of the formality matters involved in the procedures before national/regional patent offices. Patent Cooperation treaty is one establishing an international patent filing system. Strasbourg Agreement Concerning the International Patent Classification (A regularly updated international system for classifying inventions in patent applications in all fields of technology, allowing more efficient searching and retrieval of patent information).²⁹

(A) Patent Holder

Licensing allows a company to pay royalties to the patent-holder for using its patents. It also involves using third-party manufacturers that might not have the same expertise as the patent holders.³⁰ A patent owner has the right to decide who may – or may not – use the patented invention for the period in which the invention is protected. The patent owner may give permission to, or license, other parties to use the invention on mutually agreed terms. Once a patent expires, the protection ends, and an invention enters the public domain; that is, anyone can commercially exploit the invention without infringing the patent.³¹

TERM OF PATENT:

Patent protection is granted for a limited period, generally 20 years from the filing date of the application³².

(B) Rights of a Patent Holder

The patent holder enjoys various rights including the right to assign licenses to other persons and authorise them to manufacture and sell the patented item. However, these are not absolute rights and are subject to various constraints and limitations. Article 28 of the TRIPS agreement provides exclusive rights to the Patent holder. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts. Right to exploit patent, Right to assign and license, Right to surrender the patent, Right before sealing³³, Right to apply for patent of addition³⁴, Right in case of Infringement.³⁵

IV. Human rights and compulsory licensing for national emergency and international responsibility

(A) International Conventions on Health

In 1948, the Universal Declaration of Human Rights (UDHR) identified a cluster of rights associated with everyone's human right to "a standard of living adequate for health...and medical care" (Article 25) and "to share in scientific advancement and its benefits" (Article 27). A specialized agency of the UN created in 1946 and concerned with policies to fulfil basic human needs, the ILO moved the Commission toward contextualizing the right to health in terms of an "adequate standard of living.³⁶ Unlike many other International Rights the right to adequate health is not contained in a single specific treaty, but is subsumed under other treaties and resolutions.

1. States have the responsibility to guarantee their citizens the right to adequate health. When for whatever reason they are unable to do so, the international community must assume that responsibility.

2. States have the responsibility to ensure that none of their citizens are deprived of this right by state action.

3. These rights are guaranteed to all citizens, regardless of race, religion, gender, age, or social standing in the community, or other status.

The EU follows its convention(Convention for the Protection of Human Rights and Fundamental Freedoms (1950) and it is a guidance document that establishes the basic rights of all European citizens including protection from actions and conditions deleterious to good health.³⁷

International Conventions on Medicine:

1. Everyone has the right to medical care;

2. The State shall promote public health and safety; and

3. Everyone has the right to social security; the State shall maintain effective arrangements for the prevention of unemployment and for insurance against the risks of un-employment, accident, disability, sickness, old age, and other involuntary or undeserved loss of livelihood.³⁸

The draft seems rather advanced in its inclusion of three concepts:

(1) the social context of medicine,

(2) the community-based view of public health, and

(3) recognition of public responsibilities for health policy.³⁹

(B) Compulsory Licensing:

Doha declaration, WTO article:

Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner. Increased cost of patented medicines was a major hindrance for the economic medicinal access. Public health officials considered Doha Declaration on compulsory licensing a positive approach in prioritizing public health over intellectual property rights. It is necessary to strengthen the system of compulsory licenses in the developing and least developed countries because of their inability to cater to the needs of its people. Granting of compulsory licensing over the patent drugs shall give monetary benefits to the patented pharmaceutical companies. What has changed is a provision that used to say that compulsory licenses must be granted mainly to supply the domestic market (paragraph (f) of Article 31). Now the TRIPS Agreement has been amended to provide for an additional type of compulsory licensing. This change follows a decision at the 2001 Doha Ministerial Conference when Ministers recognized that countries unable to manufacture pharmaceuticals should be able to obtain cheaper copies produced under compulsory licenses elsewhere if necessary. The idea is that if such a country needs to turn to the option of compulsory licensing to produce needed affordable pharmaceuticals, producers overseas can step up and supply that need, even if a compulsory license is needed in that country. It's therefore a compulsory license specially for production in one country, for export, to meet the public health needs of one or more other countries.

The special compulsory licensing system in the amended TRIPS Agreement, and the earlier 2003 waiver decision, only deals with compulsory licences to produce medicines expressly for export. Many news stories are about compulsory licences issued primarily to supply domestic markets. That was always possible. And some proportion of production under 'regular' compulsory licences could always be exported, provided it wasn't the predominant part of production. Equally, compulsory licences issued to remedy anticompetitive practices were never limited to largely servicing the domestic market.⁴⁰

(C) International Conventions, USA, EU, India (92&92a):

No prudent IPR legalist would choose to stay oblivious to the commotion caused in the legal circuits as compulsory licensing under Section 92A does the rounds. The examination of the wavering possibilities between which the judgment floats expose the need for changes in the presently worded provisions so that both at the interpretation and implementation stages there will be more clarity and equity. The overall implications of the DOHA Declaration and the subsequent rules framed by the TRIPS Council for the utilization of the provisions under Para 6 on the Indian pharmaceutical industry as an instrument for growth of the industry are still not clear. So far, the impact has been minimal, but these are early days. Going by the experience of Indian Patents Act 1970, which had provisions for compulsory licences as well as licences of right (for pharmaceuticals), the present provisions, if they are not amended to make them user-friendly and practical are unlikely to be a major factor for either India as a supplier or for the recipients (patients in India, other developing and least developed countries).⁴¹

(A) Cases Pertaining to Grant of Compulsory

India's first ever compulsory license was granted by the Patent Office on March 9, 2012, to Natco Pharma for the generic production of Bayer Corporation's Nexavar, a lifesaving medicine used for treating Liver and Kidney Cancer. Bayers sold this drug at exorbitant rates, with one month's worth of dosage costing around Rs 2.8 Lakh. Natco Pharma offered to sell it around for Rs 9000, making it affordable for people belonging to every stratum. All the 3 conditions of section 84 were fulfilled and the decision was taken for the benefit of general public. In some more cases related to grant of compulsory license in pharmaceutical industry, the controller rejected the grant on various grounds like failing to prove prima facie case, not applying for a license of patent prior to applying for compulsory license and failure to prove public use of the product sought to be use by the compulsory license.⁴² It is said that in the law of patents, it is not sufficient merely to have registration of a patent. The Court must look at the whole case, the strength of the case of the patentee and the strength of the defence.⁴³

In certain cases, recently, the Indian courts have ruled that the provision against anti-competitive practices in the competition act and the provision of compulsory licensing in the patent act are not in exclusion of each other; in fact, they have to be read conjunctly. The question whether a patentee had adopted anti-competitive practices could also be considered by the Controller. However, if CCI has finally found a patentee's conduct to be anti-competitive and its finding has attained finality, the Controller would also proceed on the said basis and-on the principle akin to issue estoppel- the patentee would be estopped from contending to the contrary.⁴⁴ The judicial approach with respect to grant of compulsory license is that the provision is for public welfare and it cannot be misused to diminish the rights of the patent holders. There must a balance between the rights and making use of the product for welfare purposes.

(B) National Emergency

There is no definition for national emergency, many countries currently lack the minimum capacities necessary to rapidly detect and respond to known vulnerabilities and likely public health emergencies. The Supreme Court on 22^nd April called the crisis triggered by the second Covid-19 wave a “national emergency” as it initiated a public interest litigation on its own, and asked the Centre to present before it a national plan to combat the crisis that has now made India the worst hot spot of the entire global pandemic⁴⁵. “The situation in various parts of the country is grim. There seems to be a sudden surge in the number of Covid patients and mortality,” said the bench, headed by Chief Justice of India (CJI) SA Bobde, while taking a suo motu cognizance of the surge in infections, which have led to a shortage of hospital beds and crucial supplies such as medical oxygen and medicines.

Public Health Emergency of International Concern declaration:

The global imperative for the research community is to maintain a high-level discussion platform which enables consensus on strategic directions, nurtures scientific collaborations and, supports optimal and rapid research to address crucial gaps, without duplication of efforts.⁴⁶

(C) International Responsibilities:

1. In principle, developing country governments needing drugs at prices lower than those of the patentees could issue compulsory licenses under article 31 of the TRIPS Agreement. In reality, most of these countries lacked the capacity to manufacture the drugs in question, or otherwise to obtain the key active ingredients, in which case the granting of a compulsory license could amount to an empty gesture for lack of access to non-infringing generic substitutes. Of course, Good Samaritan countries that possessed manufacturing capacity might be willing to assist a needy country by issuing compulsory licenses of their own, with a view to exporting supplies of the drug in question for this purpose. But that type of assistance was limited by article 31(f) of the TRIPS Agreement, which expressly required products manufactured under a compulsory license to serve “predominantly for the supply of the domestic market” (thus limiting such exports literally to 49.9 per cent of the total output). Moreover, even middle-income countries with growing manufacturing capacity, such as India and Brazil, might themselves need a drug that they could not manufacture locally, in order to temper a patentee’s prices. In that case, any willing supplier to them — if one could be found in a developed country — would likewise be bound by the limitation on exports that article 31(f) imposed.

2. The tensions generated by these prospects for rising prices of essential medicines came to a head in the late 1990s, at the very time when the developed countries wanted the developing countries to agree to yet another round of Multilateral Trade Negotiations, to be known as the Doha Round.⁴⁷

3. Mobilize technical assistance and financial support to States Parties with insufficient capacity and financial resources for vaccine introduction and roll out.

4. Encourage all countries and support low- and middle-income countries to conduct research in line with WHO guidance and best practices. Research topics include COVID-19 vaccine efficacy and effectiveness with regards to infection, transmission, and disease including due to VOC, duration of protection against disease and asymptomatic infection, long-term protection after using different vaccination intervals, protection after one/two/booster dose schedules, and protection following mixed vaccine product schedules⁴⁸.

V. Observations- the mexican standoff

The recent developments relating to recognition of India’s Covishield⁴⁹ in Europe as a part of vaccine passport to avoid quarantine, India’s counter attack by warning to refuse recognition to European manufactured vaccines⁵⁰ and the subsequent recognition of Covishield by nine European countries show that the countries/states, blocks are at disagreement. It is observed through research that states have not only blocked exports of essential medicines and required gears but also availed vaccine reserves from the Covax program, showing their failure in executing their international responsibilities. Having national emergency poorly defined and international responsibilities poorly executed, states are seeking a waiver on patent of vaccines. This is a sacrifice on the part of patent holder community, being asked by states, for the welfare of the human society that the states themselves fail and obviously, refuse to execute⁵¹.

VI. Conclusion

This research clearly identifies that a Mexican standoff between national emergency, international responsibilities and recognition/waiver demand of patent holders' rights exist. This needs to be addressed to at the earliest and this seeks every stakeholder’s attention.

Recommendations

This research recognizes that it is unfair to subject the enumerated patent holders’ rights to undefined national emergency and international responsibility and thereby, recommends the world trade organisation to put in words, enumerate and enforce, what national emergency and international responsibilities mean and include, just like it has done with patent holders rights. Additionally, this research also recommends that the states sort their national and interstate issues among themselves, first, before greedily depriving the patent holders, off their rights, either through a waiver (which has no legislative backing), a compulsory licensing or any other mechanism.

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Footnotes

1. Author is an Advocate at High Court of Madras, Chennai.

2. Author is an Advocate at High Court of Madras, Chennai.

3. AmanPreet Kaur and Rekha Chaturvedi, ‘Compulsory Licensing of Drug and Pharmaceuticals: Issues and Dilemma’, Journal of Intellectual Property Rights, Vol 20, September 2015, P 279, http://nopr.niscair.res.in/bi tstream/123456789/33191/1/JIPR%2020%285%29%20279-287.pdf

4. Sambhavi Sinha ‘Should India Grant Compulsory Licences to Increase the Supply of Vaccines?’, government health law trade, https://thewire.in/health/india-patent-law-compulsory-licenses-covid-19-vaccines

5. Vergenia pietromarchi, ‘MSF urges rich countries to back COVID vaccine patent waiver’, https://www.aljazeera.com/news/2021/4/21/wto-to-hold-meeting-on-waving-property-rights-on-covid-vaccines

6. ‘About Covid-19’, World Health Organization, 2021, http://www.emro.who.int/health-topics/corona-virus/about-covid-19.html

7. ‘Controlling the spread of infectious diseases’, Advancing the right to health: the vital role of law, Chap 10, 2016, https://www.who.int/healthsystems/topics/health-law/chapter10.pdf

8. ‘Shortage of personal protective equipment endangering health workers worldwide, World Health Organization’, 2020, https://www.who.int/news/item/03-03-2020-shortage-of-personal-protective-equipment-endangering-health-workers-worldwide

9. Ruchika Garg, ‘Covid-19 protection: Right safety gear to use in the pandemic’, 2020 https://www.hindustantimes.com/more-lifestyle/covid-19-protection-right-safety-gear-to-use-in-the-pandemic/story-JM2sDM4lggiEr8byUeuR3N.html

10. ‘Technical specifications of personal protective equipment for COVID-19’ , WHO, 2020, file:///C:/Users/System3/Downloads/WHO-2019-nCoV-PPE_specifications-2020.1-eng%20(1).pdf

11. International Covenant on Economic, Social and Cultural Rights, G.A. Res. 2200A (XXI) (1966), Art. 12.

12. Committee on Economic, Social and Cultural Rights, CESCR, para. 44.

13. Committee on Economic, Social and Cultural Rights, General Comment No. 3: The Nature of States Parties’ Obligations, UN Doc. E/C.12/1991/23 (1990).

14. L. Forman, L. Caraoshi, A. Chapman, and E. Lamprea, “Conceptualizing the ‘morality of the depths’: How should we define and implement core obligations under the right to health?” International Journal of Human Rights 20/4 (2016), pp. 531–548.

15. K. S. Perehudoff, B. Toebes, and H. V. Hogerzeil, “Essential medicines in national constitutions: Progress since 2008,” Health and Human Rights Journal 18/1 (2016), p. 141; K. S. Perehudoff, N. V. Alexandrov, and H. V. Hogerzeil, “Legislating for universal access to medicines: A rights-based cross-national comparison of UHC laws in 16 countries,” Health Policy and Planning 34/Suppl 3 (2019), pp. 48–57; K. S. Perehudoff, N. V. Alexandrov, and H. V. Hogerzeil, “The right to health as the basis for universal health coverage: A cross-national analysis of national medicines policies of 71 countries,” PloS One 14/6 (2019), p. e0215577.

16. H. V. Hogerzeil, M. Samsoa, J. V. Casanovas, and L. Rahmani-Ocora, “Is access to essential medicines as part of the fulfilment of the right to health enforceable through the courts?” Lancet 368/9532 (2006), pp. 305–311.

17. Maxwell J. Smith, “Should COVID-19 Vaccines Authorized for Emergency Use Be Considered “Essential” Medicines?” Health Hum Rights. 2021 Jun; 23(1): 145–150, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8 233020/

18. PB Jayakumar, “India's export ban hits COVAX alliance; Covid-19 vaccine shortfall 190 million doses”, 2021, https://www.businesstoday.in/latest/economy-politics/story/india-export-ban-hits-covax-alliance-covid-19-vaccine-shortfall-190-million-doses-297228-2021-05-28

19. Vishnu Som, ‘Indian Vaccine Export Ban Makes 91 Nations Vulnerable To New Strains: WHO’, 2021, https://www.ndtv.com/india-news/indian-vaccine-export-ban-makes-91-nations-vulnerable-to-new-strains-who-2453195

20. Ibid

21. ‘A patent waiver on COVID vaccines is right and fair’, 2021, https://www.nature.com/articles/d41586-021-01242-1

22. ‘A patent waiver on COVID vaccines is right and fair’, 2021, https://doi.org/10.1038/d41586-021-01242-1

23. S. Thambisetty, ‘The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic’, 2021, https://ssrn.com/abstract=3851737

24. ‘A patent waiver on COVID vaccines is right and fair’, 2021, https://www.nature.com/articles/d41586-021-01242-1

25. MASOOD AHMED, “Would Exempting COVID-19 Vaccines from Intellectual Property Rights Improve Global Access and Equity?”, Centre for Global development, 2020, https://www.cgdev.org/debate/would-exempting-covid-19-vaccines-intellectual-property-rights-improve-global-access

26. European Commission, “Statement by President von der Leyen following the Global Health Summit”, 2021, https://ec.europa.eu/commission/presscorner/detail/en/statement_21_2622

27. Ibid

28. MARIEKE WALSH, ‘Canada the only G7 country to take vaccines from fund that helps developing countries’, 2021, https://www.theglobeandmail.com/politics/article-canada-the-only-g7-country-to-take-vaccine s-from-fund-for-developing/

29. ‘Patent-related Treaties administered by WIPO’, WIPO, 2021, https://www.wipo.int/patent-law/en/treaties.html

30. Collins, ‘Definition of Patent holder’, https://www.collinsdictionary.com/dictionary/english/patent-holder

31. ‘Frequently asked questions: Patent Basics’, WIPO, https://www.wipo.int/patents/en/faq_patents.html

32. The Patents Act 1970.

33. Section 24 of the Indian Patents Act

34. Sec 54-56 of Indian Patent Act

35. Ayush verma, ‘What rights are guaranteed to a patent holder’, 2020 https://blog.ipleaders.in/rights-guaranteed-patent-holder/

36. Commission on Human Rights, 3rd Session, Summary Record of the Seventy-First Meeting held June 14, 1948, U.N. Doc. E/CN.4/SR.71, p. 2.

37. David Almeida and Robert Berlin, ‘The Right to Means for Adequate Health’, 2003 http://hrlibrary.umn.edu/edumat/studyguides/righttohealth.html

38. United Nations, Yearbook on Human Rights for 1947 (Lake Success, NY: United Nations, 1949), p. 484

39. Covenant on Economic, Social and Cultural Rights, Art. 12

40. ‘Compulsory licensing of pharmaceuticals and TRIPS’, WTO, 2021, https://www.wto.org/english/tratop_e/t rips_e/public_health_faq_e.htm

41. Harshita Mathur, ‘Compulsory Licensing under Section 92A: Issues and Concerns’, National Law Institute University, 2008

42. Tanu Goyal, ‘Compulsory Licensing’, 2017, http://www.khuranaandkhurana.com/2017/08/03/compulsory-licensing/

43. Franz Xaver Huemer vs. New Yash Engineers (08.03.1996 – DELHC) : MANU/DE/0015/1997

44. Koninklijke Philips Electronics N.V. vs. Rajesh Bansal and Ors. (12.07.2018 – DELHC): MANU/DE/2436/2018.

45. Utkarsh Anand, 'National emergency': SC calls crisis triggered by 2nd Covid-19 wave’, 2021 https://www.hindustantimes.com/india-news/national-emergency-sc-calls-crisis-triggered-by-2nd-covid-19-wave-101619127828993-amp.html

46. ‘COVID-19 Public Health Emergency of International Concern (PHEIC) Global research and innovation forum’, WHO, 2020, https://www.who.int/publications/m/item/covid-19-public-health-emergency-of-international-concern-(pheic)-global-research-and-innovation-forum

47. Jerome H. Reichman, ‘Compulsory licensing of patented pharmaceutical inventions: evaluating the options’, J Law Med Ethics, 2010, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2893582/

48. Jerome H. Reichman, ‘Compulsory licensing of patented pharmaceutical inventions: evaluating the options’, J Law Med Ethics, 2010, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2893582/

49. ‘Not Received Covishield Approval Request, Says EU Medical Body’, NDTV, 2021, https://www.ndtv.com/v ideo/news/news/covishield-approval-not-received-covishield-approval-request-says-eu-medical-body-591865

50. Anindita Sanyal, ‘Accept Covishield, Covaxin Or Face Mandatory Quarantine, India Tells EU’, NDTV, 2021, https://www.ndtv.com/india-news/india-tells-european-union-accept-covishield-and-covaxin-or-face-man datory-quarantine-upon-arrival-in-india-sources-2476318?amp=1&akamai-rum=off

51. ‘Nine EU countries approve Covishield for 'green pass', India Today, 2021, https://www.indiatoday.in/a mp/coronavirus-outbreak/video/nine-eu-countries-approve-covishield-for-green-pass-1822847-2021-07-02