The ongoing Covid-19 crisis has challenged the healthcare systems of the most advanced, and the fledging economies, alike. Amidst all of this, a glimmer of hope came in the form of inoculations. Interestingly, while the larger pharmaceutical companies in the United States of America and the European Union offered several options, it was the Serum Institute of India (SII) which led the charge for low-cost availability for multinational corporations and is continuing to service not just the Indian population but has also that of other advanced and developing countries. While the SII has been manufacturing Covishield under a license from Astra Zeneca, in collaboration with the Oxford University researchers. Unfortunately, while several doses of vaccines are being exported, there is a large deficit of the same locally.
Amidst all of this, several developing countries led by India and South Africa had submitted a proposal in October 2020 to the World Trade Organization for a temporary waiver of Sections 1, 4, 5 and 7 of Part II of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) or the enforcement of these sections under Part III in relation to the COVID-19 vaccines, medicines, and diagnostic and medical technologies. The proposal emphasizes that the TRIPS waiver is key towards mounting an effective response to the pandemic and establishing rapid access to COVID-19 vaccines at an affordable price. While the developed nations and the western pharmaceutical industry have expressed their unwillingness to share confidential information regarding the intellectual property in relation to these requirements, USA has lobbied for a limited ‘vaccine patent waiver’ as against the proposal submitted by India and South Africa. The limited support which has come from the USA and France is with respect to the waiver limited to vaccines only, and not for the related, associated technology wherewithal. It is important to note that while this could mean that licenses will be awarded to local manufacturing units for the vaccines, there has been a lack of coordination in terms of availability of the necessary raw materials. The SII which has a license to produce Covovax, is unable to do so, because the company has been unable to procure raw materials from the US owing to the restrictions.
The Vaccine Types
In this backdrop, it is important to appreciate the vaccines so developed, and made available at this great pace. It is also important to consider the amounts and efforts which have been invested into these solutions. Additionally, much like most pharmaceutical drugs and molecules, the modern vaccine technology is a combination of several products, methods and techniques, to be put it simply. These are protected at multiple levels which are often licensed from several partners, to create the final product ready for distribution and consumption.
While the technological and R&D aspects of the vaccine formula are secured under patent protection, the associated technical designs and specifications, instruction manuals, process controls and monitoring, quality control procedures, and any other aspect in the development of the technology which may be necessary for a third party to adequately replicate/ develop the vaccines are protected as trade secrets.
mRNA is a single-stranded molecule which formulates instructions towards protein synthesis in the human body. Pertinently, the Moderna vaccine, mRNA-1273 SARS-CoV-2, employs the use of mRNA functionality to instruct the body to produce the SARS-CoV-2 spike protein, which triggers an immune response by the production of antibodies against the virus particles. However, the development of a single dose of the mRNA vaccine resembles an assembly line manufacturing process, with multiple steps in the production line essential to develop the final product.
The Moderna website indicates that mRNA-1273 SARS-CoV-2, is protected by a series of patents (at least 7), with each patent tasked towards the protection of a specific innovation made in mRNA technology and used towards the production of these vaccines.
The application of mRNA technology for vaccine development has been heavily researched upon in the past decade and is not just focused on the spread of the ongoing pandemic. These patents may have applications beyond their usage in the mRNA-1273 SARS-CoV-2 vaccine and could have potential applications in vaccine developments to treat HIV, HSV, RSV and cancer treatments. The fear shared by the major pharmaceutical companies, who have spent billions in the development, research, and proliferation of this technique, is stemming from the potential of long-term exploitation of this technology by third parties, which may be in possession of this information in lieu of such a waiver. Added to this quandary is the issue related to the wherewithal, the prowess, and the facilities which are available for the domestic manufacturers in the recipient countries to upscale to manufacturing such sensitive products.
While India’s capacity and potential as an effective, low-cost vaccine manufacturing destination has been recognized by world powers, and the domestic manufacturers have been contracted for the mass production of vaccine doses, there are several issues with respect to the support available from a supply and delivery perspective.
As the manufacturing units are grappling with new technologies, means and methods to speed up the process, it is highly suspect, argued by several technocrats, that the lack of requisite know-how and technological advancement, will likely lead to wastage and contamination of important raw materials, calibration and manufacturing of doses, as was recently experienced in an advanced jurisdiction like the USA, when. actions of Emergent Biosolutions led to the wastage of approximately 15 million shots of Johnson and Johnson vaccine, with another 85 million shots being held back by the US Food and Drug Administration, for the risk of contamination. This incident is also indicative of the potential of mix-ups, contamination taking place in highly regulated jurisdictions, in established, old, and regulated facilities. The argument questioning the efficiency of the facilities in developing countries has been fueled by incidents like this as well. It can be said that it was the rigorous safety and quality protocols which led to the identification of this contamination batch.
Greater good of greater numbers
To maximize availability of the vaccines to larger numbers, Astra Zeneca shared their license to allow production across several sites, following landmark agreements with the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance, and SII. The company stated that this was their commitment of broad and equitable global access of the AZD1222 vaccine. Similarly, Moderna stated that it will not enforce Covid-related patents; however, this is of little or no value, because the company is not undertaking to share its know-how to allow others to produce the vaccine. It is this associated, allied information which is being sought for amplification of production.
So far, Russia is the only country which is willing to engage in technology transfer and extend financial support for capital expenditure to its Covid-19 vaccine technology to India and other countries. The TRIPS procedure is a long-drawn process which requires text-based negotiations involving negotiators exchanging texts with their preferred wording, and all the WTO members must agree on one draft, and any member can veto it.
While health experts, human rights groups and international medical charities have argued for a waiver on a moral and humanitarian basis, any substantial wastage of raw materials and finances should conversely be viewed as a violation of these ethical principles.
Building upon an assumption that the WTO waiver is authorized, the technological gaps in the supply and delivery chain of the developed and developing nations must be addressed on priority. Technology transfer in the supply and delivery chain are essential for vaccine storage and transportation, with FDA recommending that the Pfizer vaccine doses be shipped in temperature controlled thermal shippers with a very low average temperature. This holds true for the Moderna vaccine as well.
In view of such specialized storage obligations, it is imperative to align the technological requirements for the supply and delivery chain in the developing countries with the necessary modifications to cater to any type of mRNA vaccine and associated drugs, treatment. So, while the waiver might enable the units here to manufacture the vaccine doses, it is still important to ensure that the associated requirements are also scaled up. For instance, the cold chain which has been a hindrance in large scale import of the m-RNA vaccines, would continue to persist even when the vaccine doses are locally manufactured. The necessary advancements are essential towards correcting the vaccine wastage rates, particularly as wastage rates tend to increase with the size of multi-dose vials.
The request from the countries seeking such waiver is to ensure that there be temporary removal of the IP protection extended to vaccines, treatments, diagnostics and other vital medical tools needed to battle Covid-19.
The TRIPS Agreement and WTO have been effectively armed to deal with the unequal distribution of vaccine technology and production, with Articles 31 and 31bis enabling compulsory licensing for domestic use and export operations respectively. However, the methodologies and economics of vaccine production in the pharmaceutical industry have potential for reform, with utilization of public funds for research and market forces at the production end, throttling delivery and production for the end consumers and parallel production laboratories.
It is paramount that the legislative bodies across jurisdictions scale up production in raw materials and subsequent components and engage in international diplomacy and move away from their policy of the nationalization of resources and production lines.
The Preamble of the TRIPS Agreement states that it is the desire of the Member nations “to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade.”
While this one-size fits all nature of the TRIPS Agreement has been subject to its fair share of critics, the Agreement includes several flexibilities to facilitate development and protect public interest, in the event the same is endangered by private IP rights enforcement. It is important to re-think the protocols which allow for waivers, and also imperative for the countries to come together, and negotiate the scope and extent of the waiver, to make the entire exercise worthwhile. For now, if the implementation fails, or scope is limited, it will not yield in favorable outcomes for anyone. The protection of IP rights s is not an end in itself, but rather the means to an end.
Ms. Bagmisikha Puhan, Associate Partner, TMT Law Practice
Bagmisikha is an Associate Partner at the Firm. She graduated in 2014, and specializes in Technology Law, advising clients in the ITeS, media, healthcare and pharmaceuticals, space sectors on regulatory, policy, compliance, and transactions. A member of the Telemedicine Society of India, Bagmisikha also conducts capacity-building and training programmes. Bagmisikha has worked in-house as part of the Global Data Privacy Team of an Indian MNC and worked extensively in matters pertaining to the data privacy and data protection laws of several jurisdictions.
Pro bono advisory also forms a significant portion of Bagmisikha’ work. A member of the Right to Free Education movement in Odisha, she provides free legal services to the students and their families.
Mr. Siddhant Gupta, Associate
Siddhant Gupta is an Associate with TMT Law Practice. He is a graduate of the 2015-2020 batch from Symbiosis Law School, Pune and his core areas of interest lies in the areas of Intellectual Property Laws, Media and Entertainment Laws. Siddhant has previous internship experience in intellectual property and litigation fields and interned with TMT Law Practice in 2020. During his time with TMT Law Practice, Siddhant gained valuable experience in the sectors of Telemedicine, Data Privacy, Gaming Laws and Corporate Laws.
Siddhant has obtained an online certification from the Duke University on ‘Copyright for Multimedia’. He’s also co-authored an article for Lexology titled ‘Project Red Card and Privacy Concerns’.
Outside of law, Siddhant is an avid fan of sports having represented his college’s football team in outstation fests.