IPR: A barrier to equitable covid 19 vaccine supply?

Abstract

Intellectual property rights stands for creativity of mind in form of invention such as artistic works, designs, literary works etc. where these rights provides protection for creators to earn recognition of their work. Due to the alarming rise in covid-19 cases since year 2020, intellectual property rights have become an indispensable part of pharmaceutical industry that is required to develop covid-19 vaccine for treatment of patients urgently. The issues of research and development of vaccine and its further patent protection is closely linked. With this linkage comes the diverse opinions among several countries of the world. The non assignment of intellectual property rights to a vaccine would cause delay in its production, alternatively, an assignment of IP rights would allow multiple investors to build up manufacturing but may make the vaccine unaffordable for developing and under developed countries. This research paper seeks to analyze the issues surrounding the development of vaccine and its patent protection examining both sides of the coin in an unbiased way.

KEYWORDS: intellectual property rights, patent, covid-19 vaccine, pharmaceutical industry, patent protection, developed countries, developing countries.

Introduction

What are intellectual property rights?

Intellectual property rights (IPR) refers to the legal tool given to the inventor or creator to protect the right to his invention or creation for a certain period of time.[2] Intellectual property rights are protected by law in form of patents, copyright, trademarks etc. so that legal recognition can be given to the creativity of one’s work thus seeks to balance the interest of creator or inventor and the larger public interest technologies. It enables the inventors to create more by providing them security and monetary benefit thus keeping them diligent. IPR seeks to protect investments, time, money, efforts and mind of the inventor/creator that he put in his invention and to prevent any other from stealing his ideas without credit. Thus IPR, in this way helps in increasing the gross domestic product (GDP) of a country by promoting healthy competition and encouraging industrial development and fair globalization.[3]

There are various types of intellectual property rights based on the various fields they cover:

1. Copyright– legal term used to describe right over art or literary work like books, music, painting, films, short cinematography works etc. Thus it’s related to literary fields of research and development.
2. Patents– legal right of an innovator over an invention related mainly to scientific field which enables inventor to decide how and who may use his invention in the market thus he has power to restrict access to his innovation. In exchange he makes all the technical know how publically available.
3. Trademark– helps us in distinguishing between various innovators by their marks as one signature or mark can’t be repeated by other to protect the goodwill of the first innovator.
4. Industrial design– it protects ornamental and aesthetic design of an invention like shape, surface, texture, lines, pattern, color etc.
5. Geographical indications- Signs used on goods having specific geographical location, qualities, goodwill essentially attributable to that location.

However in this research paper we seek to restrict ourselves to ‘patent’[4] as a form of intellectual property rights as the pharmaceutical industry producing vaccines and medicines belong to a scientific field.

Treaties and agreements related to Intellectual property rights (India as a signatory)

1. Paris convention for protection of industrial property (1883)– any citizen of a signatory state can apply for the patent or trademark in any other signatory state with same legal and enforcement rights as is available to the citizen of that signatory state thus no discrimination on basis of States to seek protection.
2. Berne convention for protection of literary and artistic works (1886)– The Berne Convention deals with the protection of works and the rights of their authors. It contains common provisions determining the minimum protection to be granted, also enlisting some special provisions available to developing countries that are not that well of as compared to developed countries.[5]
3. TRIPs agreement (1995)[6]-this agreementis the most comprehensive multilateral agreement on intellectual property rights which sets minimum standards for the protection of IP rights provided by the members states by requiring them to fulfill the substantive obligations of the main conventions of the WIPO, the Paris Convention for the Protection of Industrial Property (Paris Convention)[7] and the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention)[8] must be complied with to ensure application of those conventions.
4. Madrid protocol- The Madrid System functions under the Madrid Agreement (1891) and the Madrid Protocol (1989) which functions under International Bureau of the World Intellectual Property Organization (WIPO) located in Geneva, Switzerland. The system allows the inventor to register trademarks in various and more than one jurisdictions worldwide provided that the countries are part of Madrid Union’s 85 member countries by filing an application in a trademark office.
5. Patent cooperation treaty– The Patent Cooperation Treaty (PCT) aids the applicants in seeking patent protection internationally apart from their domestic market for their inventions as well as it helps patent offices with their patent granting decisions, and grants public the access to the technical information relating to those inventions on the choice of the inventor.[9]
6. Treaty in intellectual property in respect of integrated circuit (Washington treaty 1989)-

Provides protection for the layout designs or topographic of the integrated circuits.

• Nairobi treaty on protection of Olympic symbol– the five interlaced rings symbol or the Olympic games symbol cannot be used by any of the member parties for any commercial purposes without authorization of international Olympics committee.
• WIPO copyright treaty- special agreement under the Berne convention which deals with work protection and rights of their authors in digital environment.
• WIPO performances and phonograms treaty– it deals with the rights of the two kinds of beneficiaries in digital environment that is the performers like actors, singers, musicians and the producers of phonograms like music producer.

Background

TRIPs agreement and COVID-19 vaccine

This agreement provides the basic framework for regulation of the intellectual property rights around the world but it cannot be said to be a universal law regarding the same. Every member of WTO (World Trade organization) shall include this agreement in their domestic intellectual property legislations or laws. For example in India, product patents were introduced by the Indian government in 2005 to comply with the requirements of the TRIPs agreement. It’s the most comprehensive and effective form of Multilateral agreement that came into force globally on intellectual property rights. The Agreement sets the minimum standards as to intellectual property rights by emphasizing that the substantive obligations of the main conventions of the WIPO, the Paris Convention for the Protection of Industrial Property (Paris Convention) and the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention[11]) must be complied with by the members to ensure their uniform application.[12] The TRIPS Agreement is thus sometimes referred to as a Berne and Paris-plus agreement due to its additional provision on the topics the above two conventions are silent about.

From the beginning of the pandemic, governments and stakeholders have considered how the innovation and distribution of the vaccine shall be promoted, regulated and managed, including through the IP system, and the contribution that the intellectual property rights could make to address the pandemic. A number of initiatives have addressed the voluntary sharing and pooling of IP rights (IPRs), thus responding with the spirit of teamwork that is required for any global effort to tackle the COVID-19 pandemic. Similarly a range of policy options confirmed under the TRIPS Agreement will remains available to WTO members as tools to deal with public health issues wherever needed.[13]

Covid-19 vaccine and IPR issue

With new developments in the pharmaceutical industry related to tackling the novel corona virus that has been declared as a pandemic by WHO[15] on 11^th March, 2020, an issue of patent protection arises and is continued till date. The question one may ask is- whether the vaccine be patent protected or not? The answer to this question isn’t as simple as it seems as it involves majorly two completely different opinions.

As the developed countries have made swift development with their vaccination programmes, much of the developing countries and underdeveloped ones have been left behind struggling to get access to Covid-19 vaccines due to its patent protection, a price to be paid for accessing the vaccine.[16] The issue that may be taken into consideration here is that if the vaccine is patent protected, rich developed countries can have access to it but the developing world including India will have to pay a huge price to get equitable access to the vaccine. The alarming rate by which the covid-19 cases are rising, world needs quick and easy access to the lifesaving drug at this time so, is the patent protection acting as a barrier to this? We seek to analyze this question by taking both sides into consideration.

IP waiver request by South Africa and India in WTO

In October, South Africa and India decided to address this inequitable situation at the World Trade Organization (WTO) where their representatives asked the WTO to allow member countries to waive patent rights related to Covid-19 vaccines and other technologies related to the pandemic for a specific time period. South Africa and India are considered as leaders of group of low- and middle-income countries thus they called for a waiver on intellectual property rights on products related to the pandemic — including personal protective equipment, therapeutics, and vaccines to protect interest of these nations and ensure supply of vaccine without it getting monopolized. China has also backed the measure. The request was submitted to the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and asked for the waiver to remain in place till most of the developed and developing nations have administered the vaccine to its population. There are several reports about intellectual property rights hindering or potentially hindering timely access to the affordable medical products to the patients. Beyond patents, other intellectual property rights may also pose problems as there seems to be no solution related to the particular issue. In addition, many underdeveloped and developing countries may face institutional and legal difficulties related to the use of the patent protected vaccine in the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement[19]). The main concern for these countries is their ineffective or no manufacturing capacity that is needed for Article 31b and also the lengthy process and complex mechanism for the trading of pharmaceutical products that seems to have no solution at the moment. Internationally, there is a need for unity among the member countries for global equitable sharing of development of vaccine in order to give urgent responses for the handling of COVID-19 pandemic. Thus these countries requested the Council for TRIPS recommends, to the General Council a waiver from the implementations of Sections 1[20],4[21], 5[22], and 7[23] of Part II[24] of the TRIPS Agreement[25] to help the needy in this crucial time.

Arguments of delegates: The delegates of both the countries laid down grounds to support their proposal of waiver contending that US, UK and  European union holds approximately 30 percent of over 200 million vaccine doses and only 10 countries have administered 75 percent of vaccine whereas 100 countries have not yet been able to give first does of the vaccine. This situation reflects the concentration of the vaccine in a small portion of the world that is with the rich countries resulting in inequitable distribution. The Indian delegate also pointed out that despite of purchasing the doses of vaccines in advance, there is an acute shortage in its supplies thus mutual agreement between countries to share vaccines cannot replace the need to waiver the IP rights.[26]

This contention made by India and South Africa is supported by MSF (Médecins Sans Frontières/Doctors Without Borders) as while urging small governments of different countries it put forward its opinion and said, “the waiver proposal offered in WTO allows several governments to show solidarity in dealing with the pandemic by developing and equitably distributing the vaccine without private monopolization by industries acting as a barrier in the same.”[27] If patent protection is provided, the private corporations may continue to pursue secretive and limited supplies of the vaccine consequentially which tends to exclude many low- and middle-income countries even at the crucial time of the pandemic. The waiver proposal could aid in removing legal uncertainties and risks for potential producers and governments to produce and supply the treatments, vaccines, and other essential medical tools that is the need of the hour.[28]Around 90 members of WTO supported the proposal of waiver laid by India and South Africa including 57 co-sponsors, supported by various delegations like Jamaica on the behalf of the African, Caribbean and Pacific Group, Afghanistan, Argentina, Bangladesh, Cambodia, Sri Lanka, Honduras, Nigeria, Cuba, Nepal, Nicaragua, Indonesia, Tunisia, Mali and Mauritius.[29]

Opposition by developed countries and pharmaceutical industry

Unsurprisingly many affluent countries including United States of America, Russia, Britain and European union have vocalized their concern and hostility towards the proposal propounded in WTO[31] by India and South Africa.[32]

Also the pharmaceutical companies are of the view that so far world has seen a stimulus in COVID-19 solutions and the partnerships to co-operate in research and development including scale-up manufacturing of vaccines and treatments, thus diluting national and international IP frameworks may prove to be a bane. It can be counterproductive to research and development or access and may also sabotage the well-functioning IP[33] system, that allows industry to partner with the academic and research institutes, foundations and other private companies, thus leading to research and development of new medicines to treat the worlds’ many unmet and unconventional medical needs. IP develops confidence in new innovators thus ensuring that the future generation of inventors and investors remain secured.[34]An European Union spokesperson explained that there was no evidence or the conclusive proof that intellectual property rights are a genuine barrier for accessibility and distribution of COVID‐19‐related medicines and technologies thus patent waiver cannot be said to be the only solution to this issue.[35]

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) is of the opinion that the demand to waive off intellectual property rights is nothing but a distraction from the real work of reinforcing supply chains that includes countries procurement, distribution and immunization of vaccines to the citizens of the country. Thus restricting intellectual property rights would hinder its effective development and timely administration for proper treatments presently as well as in future morbid times.

UK believes that a waiver to the IP rights set out in the TRIPS Agreement as proposed by the countries is an extreme measure to address the problem of inequitable distribution of vaccine. They think that pursuing the waiver would be counterproductive and would discourage a regime that offers solutions to the problem and is not effective in curbing it. Rather, countries should consider issues related to prevention, containment and treatment of COVID-19 pandemic. Thus the IP mechanism isn’t only about rights protection of the inventors but also to enhance equitable sharing of equipment and dissemination of useful information regarding the innovation. The waiver thus, may hinder the path of progress laid down by IP.[36]

Is there a middle way?

To speed up vaccination rates around the world, especially in developing and least developed countries, we need more global manufacturing capacity for all COVID-19 vaccine and pharmaceutical and therapeutically enhanced platforms.[37]But this can only be done by employment of risk-tolerant capital and an effective partnership platform to enable sharing of new technical knowledge around the world. This can only be achieved with mutual cooperation among both the sides which also shall have unfettered trust and confidence in the platform.[38]

WTO Members have a responsibility to ban the vaccine nationalism and monopolization and rather intensify cooperation on promising new vaccines, therapeutics, and diagnostic techniques.[39]The middle way that might be adopted by the WTO must facilitate technology transfer as per multilateral treaties to as to enable poorer countries to access the vaccine as well as it shall allow compulsory licensing[40] of medicinal products. AstraZeneca has been ahead in this proposal by licensing production in several countries and Johnson & Johnson also seems willing to follow the suit.

 The private sector, civil society, and parliamentarians are coordinators the WTO with whom collaboration will be further nurtured by transfer of the technology and apply the framework of multilateral rules, so as to encourage research and development without hindering the licensing agreements that help scale up manufacturing of pharmaceuticals. It’s  also crucial that countries do not impose export barriers on Covid-19 vaccines so that additional duties do not hinder the supply to least developed nations.[41] This might help the poor countries to afford the vaccination doses appropriate for their countries without the rich ones having to suspend patent rights of the manufacturers. If the world becomes ready to share the burden of the vaccine, no country whether rich or poor would feel left out and pandemic around the world will be treated properly.

Stephen Ezell and Nigel Cory of the Information Technology and Innovation Foundation also stressed on the need for balance between the two opinions by stating that WTO must achieve reasonable balance between the exclusiveness and access rights.[42]The way it may be done is provided in next topic that discusses about the measures taken by WTO at the time of development of HIV-AIDS drugs.

Balancing the IP rights and equitable access before the pandemic (compulsory licensing)

History repeats itself. This similar controversy arose at the time of development of the drug for HIV-AIDS before WTO thus analyzing this issue may help setting precedence for further steps to be taken by WTO in the covid-19 vaccine situation.

This complicated task of balancing the two sides together is not new to WTO. There was a long controversy regarding the access to HIV-AIDS drugs among the multilateral trading corporations approximately 2 decades ago. HIV-AIDS drugs were too expensive for the least developed countries specifically the Sub-Saharan African countries as they lacked infrastructure plus the money to import the supply of drugs. It was really tough consideration for WTO to give precedence to the patent protection over the affordable medicines for HIV-AIDS to these poor nations.

TRIPs agreement provides for the articles that are wide enough to include special health emergencies in which the members of WTO may take reasonable measures to ensure safety[44]. These articles are:

1. Article-7[45]: lays down that social and economic welfare must be kept in mind while exercising patent rights.
2. Article-8[46]: members have power to amend or alter the provisions in case of any health emergency to protect public health but in accordance to the provisions of TRIPs agreement.

In case of public health emergencies, one can use the ‘compulsory license’ to make use of the patented product without the authorization of the holder as it may be difficult to obtain voluntary license during such a time.[47]but in this case, use of such patent protected technology is to be supervised and controlled by patent holder partially.

Thus, compulsory licensing of medicines is not exactly favored by the private drug manufacturing companies because it is a derogation from their capitalistic benefits. However, these actions by WTO members in previous years demonstrate, compulsory licensing helps to strike a balance between protecting IP rights and ensuring access to essential medicines in public health emergencies like in this time of covid-19 pandemic that requires immediate medical assistance to poor countries.

Conclusion

By the above analysis we learn that, neither of the opinions fully satisfy or give a proper solution to the problem of the vaccine and its patent protection. Developing countries could not justify their demand of IP waiver in the debate despite of having right of compulsory licensing that is the biggest weapon against monopolization by their side. Similarly, developed countries and pharmaceutical industries seem to misuse the situation of public health emergency by contending that compulsory licensing would hinder the innovation of new vaccines, an argument that is completely baseless and behind the veil seems to protect capitalist and monopolistic practices of these private companies.

The only way forward if countries acting in solidarity and mutually building a trust among themselves and on various inter-regional treaties that ensure equitable distribution of the vaccine. The world also needs greater manufacturing capacity with great amount of funding that will curb the problem of patent price hike for developing countries as if supply increases with the growing demand timely, inflation in prices of vaccine won’t hinder its distribution. Also, an authority to keep a check on monopolistic practices of pharmaceuticals and private manufacturers would prevent unauthorized holding of vaccine doses.

World and WTO must consider the middle way of ‘compulsory licensing’ that as proven above would allow both the sides of the issue to compromise and benefit a little. After all, what is better than following precedence to ensure mutual benefit.

[1] Student at Amity law school Delhi (affiliated to IP University) studying in 4^th year BA LLB (hons.)

[2] Singh R. Vol. 1. New Delhi: Universal Law Publishing Co. Pvt. Ltd; 2004. Law relating to intellectual property (A complete comprehensive material on intellectual property covering acts, rules, conventions, treaties, agreements, case-Law and much more)

[3] Intellectual property rights: An overview and implications in pharmaceutical industry

Chandra Nath Saha and Sanjib Bhattacharya

[4] Supra note [2]

[5] WIPO administered treatises available at www.wipo.int/treaties/en/ip/berne/summary_berne.html. (last visited April 8, 2021)

[6] Overview: the TRIPS Agreement available at https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm#:~:text=The%20TRIPS%20Agreement%20requires%20Member,novelty%2C%20inventiveness%20and%20industrial%20applicability. (Last visited April 14, 2021)

[7] Ibid

[8] Ibid

[9] PCT the international patent system available at https://www.wipo.int/pct/en/ (last visited April 8, 2021)

[10] Supra note [6]

[11] Supra note [4]

[12] Overview: the TRIPs agreement available at https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm (last visited on 8th April 2021)

[13] TRIPs report e-pdf: The TRIPs agreement and covid-19

[14] Intellectual property rights

[15] World health organization

[16] Exploring the covid-19 vaccine IP waiver proposal at WTO available at https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-covid19-vaccine.( last modified March 12, 2021 at 16:21)

[17] Article IX:3 and 4 of the Marrakesh Agreement

[18] World Trade organization

[19] Ibid

[20] Copyright and related rights

[21] Industrial designs

[22] Patent protection

[23] Protection of undisclosed information

[24] Part II — Standards concerning the availability, scope and use of Intellectual Property Rights available at https://www.wto.org/english/docs_e/legal_e/27-trips_04_e.htm (last visited on 9th April, 2021)

[25] Ibid

[26] Editorial, “ South Africa IP waiver proposal gets support of about 90 WTO members” The Hindu (February 24, 2021)

[27] Countries must stop blocking and move towards formal negotiation on the pandemic monopoly waiver at WTO available at https://msfaccess.org/countries-must-stop-blocking-and-move-toward-formal-negotiations-pandemic-monopoly-waiver-wto (press release 19th March, 2021)

[28] WTO Weighs South Africa, India Proposal To Waive Intellectual Property Rights On COVID-19 Products available at https://www.kff.org/news-summary/wto-weighs-south-africa-india-proposal-to-waive-intellectual-property-rights-on-covid-19-products/ (December 17, 2020)

[29] Supra note [22]

[30] International federation of pharmaceutical manufacturers & associations

[31] World Trade organization

[32] Ibid

[33] Intellectual property rights

[34] Pharma delivers COVID-19 solutions, but calls for the dilution of intellectual property rights are counterproductive available at https://www.ifpma.org/resource-centre/pharma-innovation-delivers-covid-19-solutions-beyond-expectations-but-calls-for-the-dilution-of-intellectual-property-rights-are-counteproductive/ (published on 8^th December 2020)

[35] Collis, “WTO Members Reject IP Rules Waiver.”

[36] UK Mission to the WTO, UN, and Other International Organizations (Geneva), “UK Statement to the TRIPS Council: Item 15 Waiver Proposal for COVID-19,” UK Government, October 16, 2020.

[37] Would Exempting COVID-19 Vaccines from Intellectual Property Rights Improve Global Access and Equity? (Moderated by CGD PRESIDENT MASOOD AHMED).

[38] Supra note [33].

[39] Statement of Director-General Elect Dr. Ngozi Okonjo-Iweala to the Special Session of the WTO General Council (February 13, 2021).

[40] Article 31 of TRIPS agreement.

[41] Allie Nawrat, “ Exploring the Covid-19 vaccine IP waiver proposal at the WTO” (15^th March, 2021) available at https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-covid19-vaccine/#:~:text=Their%20representatives%20asked%20the%20WTO,the%20duration%20of%20the%20pandemic.

[42] Ezell and Cory, “Intellectual Property Internationally,” p. 18.

[43] James Bacchus, “Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines “ (December 16, 2020)

[44] Supra note [43]

[45] WTO ANALYTICAL INDEX TRIPS Agreement – Article 7 (Jurisprudence) available at https://www.wto.org/english/res_e/publications_e/ai17_e/trips_art7_jur.pdf (last visited 15 April, 2021)

[46] WTO ANALYTICAL INDEX TRIPS Agreement – Article 8 (Jurisprudence) ) available at https://www.wto.org/english/res_e/publications_e/ai17_e/trips_art8_jur.pdf ( last visited 15 April,2021)

[47] Jennifer Hillman, “Drugs and Vaccines Are Coming—But to Whom?,” Foreign Affairs, May 19, 2020.

Author-Nishtha Mittal (Amity law school Delhi affiliated to GGSIPU )