key: cord-0863236-4yhupuv8
authors: Gurgula, Olga; Hull, John
title: Compulsory licensing of trade secrets: ensuring access to COVID-19 vaccines via involuntary technology transfer
date: 2021-12-01
journal: Journal of Intellectual Property Law & Practice
DOI: 10.1093/jiplp/jpab129
sha: 9acc583139718a475679974cf4fc48fdc48722a4
doc_id: 863236
cord_uid: 4yhupuv8

nan

On 30 March 2021, 25 heads of government and international agencies came together in an extraordinary joint call for a new international treaty for pandemic preparedness and response:

There will be other pandemics and other major health emergencies. No single government or multilateral agency can address this threat alone. The question is not if, but when. 1 As the world has been battling the coronavirus (COVID-19) pandemic, this call reflects the gloomy reality of the challenges that this pandemic has brought to us and the inadequacy of the current system to deal with it. While the first enormous challenge of swiftly developing a vaccine against this coronavirus has been successfully overcome by several pharmaceutical companies 2 and a number of vaccines are in the pipeline at various stages of development, 3 the second, no less significant hurdle, is to manufacture the required number of vaccines and distribute them across the globe equitably and affordably. However, this latter hurdle has proven to be a serious challenge. It is estimated that around 11 billion doses are required to vaccinate 70 per cent of the world's population. 4 According to the World Health Organisation (WHO), as of 5 May 2021, more than 1.1 billion doses *Email: olga.gurgula@brunel.ac.uk 1 Global leaders unite in urgent call for international pandemic treaty (WHO press release, 30 March 2021). Available at https://www. who.int/news/item/30-03-2021-global-leaders-unite-in-urgentcall-for-international-pandemic-treaty ( 

• This paper considers how vaccine technology to meet the challenges of the COVID-19 pandemic can be made available to increase the production of vaccines. Its primary focus is on trade secrets, which are one of the main intellectual property (IP) rights protecting the complex manufacturing processes of vaccine production.

• The compulsory licensing of trade secrets presents some unique obstacles, and consideration is given to some practical solutions that might balance the interests of technology owners and the public interest in increased access to vaccines. In particular, this paper suggests that to make the currently discussed proposals on accelerating the production of COVID-19 vaccines, including compulsory licensing of patents and the TRIPS IP waiver, work, an additional mechanism of compulsory licensing of trade secrets is required.

• It is believed that a proposal for a new mechanism of compulsory licensing of trade secrets coupled with a discussion on the content of such licences, the challenges that would need to be addressed and the potential wording of such a licence would provide useful guidance to governments on how to make their compulsory technology transfer mechanisms more effective.

of vaccine have been administered globally, but more than 80 per cent of those have been administered in highand upper-middle-income countries, with only 0.3 per cent in low-income countries. 5 It is argued that it may take several years for people in the lowest-income groups to be vaccinated. 6 This problem, therefore, has raised a key question, i.e. how can we accelerate the production of COVID-19 vaccines and ensure their equitable worldwide distribution at an affordable price?

While the COVID-19 pandemic has escalated the problem of access to vaccines, long before this pandemic, it was recognized that access to vaccines in low-and middle-income countries ('LMICs') lagged far behind access in higher-income countries. 7 To remedy this, access to manufacturing information protected by trade secrets and know-how held by pharmaceutical companies is necessary. One option to provide such access is through patent pools and technology transfer 'hubs' of the sort devised by the WHO in 2007 as a means of increasing the number of influenza vaccine producers in LMICs, which has had some success. 8 Nevertheless, a patent pool or a technology transfer hub is ill suited for accessing Property Relief ' (Nature 25 March 2021). Available at https://www. nature.com/articles/d41586-021-00727-3 (accessed 21 May 2021).

'Director-General's Opening Remarks at One Shared World Event' (WHO, 5 May 2021), available at https://www.who.int/director-general/ speeches/detail/director-general-s-opening-remarks-atone-shared-worldevent (accessed 21 May 2021); Mary B Marcus, 'Ensuring Everyone in the World Gets a COVID Vaccine' (Duke Global Institute, 20 January 2021), available at https://globalhealth.duke.edu/news/ensuring-everyone-worldgets-covid-vaccine (accessed 21 May 2021). (' As of mid-January, more than 7 billion vaccine doses had been purchased globally and the lion's share-4.2 billion doses-have gone to high-income countries. While high-income countries represent only 16% of the world's population, they currently hold 60% of the vaccines for COVID-19 that have been purchased so far. Canada tops the list having purchased enough vaccine to cover more than five times their population. ').

6 Irwin (n 4); see also 'Companies warn that 9 out of 10 people in poor countries are set to miss out on COVID-19 vaccine next year' (Oxfam Press Release, 9 December 2020), available at https://www.oxfam.org/ en/press-releases/campaigners-warn-9-out-10-people-poor-countriesare-set-miss-out-covid-19-vaccine ( 104 American Journal of Public Health e85 (suggesting the creation of an 'Intellectual Property, Technology and Know-How' ('IPTK') Bank which would merge process information and regulatory information on a single manufacturing trade secrets and associated know-how. 9 However innovative, such an approach could only be successful if the technology owners bought into the idea and were willing to disclose their trade secret process information to the patent pool. The question is: why should they? The risk of loss of secrecy in the process is simply too great to induce any of them to participate voluntarily. It is clear that trade secrets are seen by pharmaceutical companies as particularly valuable intellectual property (IP) rights. 10 This is evident from the developments around the COVID-19 Technology Access Pool ('C-TAP'), which was set up by the WHO in May 2020. 11 It calls the global community to action, and most importantly pharmaceutical companies, to voluntarily share knowledge, IP and data necessary to defeat COVID-19. 12 However, this initiative has attracted zero contributions since it was established, as pharmaceutical companies refuse to share their vaccine technologies with this and similar initiatives. 13 It is now increasingly recognized that there is no mechanism in IP laws to oblige trade secret owners to share their technology. 14 Another option for removing the barriers to the timely provisioning of affordable COVID-19 medical products was suggested in October 2020 by South Africa and India. 15 The aim of this paper, therefore, is to suggest certain solutions intended to accelerate the production of vaccines by focusing on the mechanism of compulsory licensing of vaccine technologies. While the current body of literature extensively discusses compulsory licensing of patents that protect vaccines, 24 there is currently very limited discussion about trade secrets that protect vaccines and the need to share such information in order to produce a vaccine. 25 This paper, therefore, aims to fill this gap by considering how trade secrets can be licensed and whether, in practice, the difficulties associated with this form of technology transfer are capable of being overcome.

The paper will briefly explain what a vaccine is and how it is typically protected by IP rights and data/marketing exclusivity. It will then explain why the current mechanism of compulsory licensing of patents is not sufficient to compulsorily licence a vaccine technology because vaccines are generally protected not only by patents but also by trade secrets for which there is no equivalent compulsory licensing mechanism. It will be suggested that to enforce an involuntary technology transfer for the production of a vaccine, governments must grant a complex/hybrid compulsory licence that would include not only patents but also their associated trade secrets. For this, it will be argued that compulsory licensing of trade secrets should be implemented in national and international IP laws to supplement the existing mechanism of compulsory licensing of patents. The paper will explain that the suggested mechanism of compulsory licensing of trade secrets is in line with international law related to trade secrets. It will also discuss a specific set of elements that would need to be considered when granting a compulsory licence of trade secrets so that this mechanism could work effectively and will provide suggestions on the specific wording of such a compulsory licence. The paper will conclude with some further considerations that governments may face when considering compulsory licensing of vaccine technologies, i.e. the need to holders should also disclose related information around the working of that invention, such as know-how and trade secret information. ' implement exceptions from data and marketing exclusivity when granting a compulsory licence (both of patents and/or trade secrets). It is important to note that the suggested mechanism of compulsory licensing of trade secrets would be useful both in case of implementation of the IP waiver by the World Trade organisation and if no such waiver were to be agreed upon. This is because in either scenario, access to trade secrets related to vaccine manufacture would be required, and if pharmaceutical companies did not voluntarily share such information potential manufacturers would require developing their own know-how, which may take a great deal of time and effort. Finally, while the discussion in this paper is focused on the compulsory licensing of trade secrets to facilitate access to COVID-19 vaccines, it may also be useful for any involuntary technology transfer of complex biological medicines, which are becoming prevalent in health care.

Vaccines are a critical tool for defeating the COVID-19 pandemic. They work by prompting the body's immune system to recognize and beat the viruses and bacteria that attack it. Once vaccinated, the body is able to prevent illness by fighting off disease-causing organisms when exposed to them. 26 Some vaccines, such as inactivated and protein-based vaccines, contain dead virus or tiny fragments of the disease-causing organism to trigger an immune response; others, such as adenovirus-and RNAbased vaccines, contain genetic material from the virus that triggers the production of virus proteins after injection and generates an immune response. 27 There are currently several types of COVID-19 vaccines, including inactivated virus, 28 live-attenuated vaccine, 29 31 The latter type of vaccine, messenger RNA ('mRNA'), is currently the most challenging to produce because it is based on an entirely new technology 32 for which there is a very limited manufacturing capacity and a shortage of expertise and essential components. 33 As vaccines are complex biological products, their production involves a lengthy and complicated process of manufacture and control. 34 While each vaccine has a unique manufacturing process, certain stages are common, including the propagation of active components, purification, formulation, fill and finish and sampling and testing. 35 This production is challenging for various reasons and involves, among other things, complex processes, specialist knowledge and experience, 36 as well as requiring appropriate manufacturing facilities. 37 Moreover, while the manufacture of conventional drugs involves relatively simple chemical syntheses, biological products, such as vaccines, require highly specific standards and procedures for all steps of production. 38

vector, or carrier, to deliver immunity instructions to cells in the body. The body then follows those instructions to build an immune response to the intended virus … The virus vector being used in the Johnson & Johnson and AstraZeneca vaccines is an adenovirus, a common type of virus that typically causes mild cold symptoms when it infects someone'). 31 WHO 'The Different Types of COVID-19 Vaccines' (12 January 2021) (n 28) ('… a nucleic acid vaccine just uses a section of genetic material that provides the instructions for specific proteins, not the whole microbe. DNA and RNA are the instructions our cells use to make proteins. In our cells, DNA is first turned into messenger RNA, which is then used as the blueprint to make specific proteins. A nucleic acid vaccine delivers a specific set of instructions to our cells, either as DNA or mRNA, for them to make the specific protein that we want our immune system to recognize and respond to. The nucleic acid approach is a new way of developing vaccines. Before the COVID-19 pandemic, none had yet been through the full approvals process for use in humans…' . 38 ibid ('Vaccines, especially more sophisticated products, are subject to relatively lengthy and costly quality control requirements. … Controls must exist at every stage of the manufacturing process to ensure the safety and quality of the completed batch. They include tests for physicochemical properties, such as pH and osmolality, component identity and stability analyses for antigens, excipients and adjuvants, microbiological testing for sterility, concentration, and potency testing and animal-based testing for toxicity. The tests imposed on vaccine manufacturers may vary according to the national legislation and requirements on the part of national regulatory agencies' (internal citations deleted)).

By way of illustration, the method required to make the mRNA vaccines currently supplied by Moderna and Pfizer-BioNTech is briefly outlined below. 39 The process consists of six discrete steps as follows:

Step 1: using an appropriate bacterial culture, produce the precise DNA sequence that needs to be transcribed into mRNA.

Step 2: in a bioreactor, using appropriate enzymes, produce the mRNA using the DNA from step 1.

Step 3: produce lipids with positively charged groups on them. Producing these at scale is a complex step.

Step 4: is the most complex step in the chain. It consists of combining the Step 2 mRNA and Step 3 lipids into lipid nanoparticles. This requires the production of a '…well-defined mix of solid nanoparticles with consistent mRNA encapsulation…' . 40 This, in turn, requires a bespoke microfilter device that enables the manufacture of very precisely created nanoparticles. Such a device enables very precise mixing, flow rates, concentrations and temperature controls necessary to produce the end product.

Steps 5 and 6: consist in the fill and finish steps and distribution (in the case of the Pfizer-BioNTech vaccine, at very low temperatures) to the desired destinations.

While some of these steps and the constituents needed to make the vaccines are well known, the combination of steps and the technology (particularly at step 4) required to produce the end product are the result of extensive trial and error and are accompanied by extreme levels of testing at each stage to ensure consistency and purity of the product.

The combination of steps required, the method of production, the equipment (particularly at step 4) and the experience of the engineers controlling the process taken together constitute the kind of trade secret that, along with any patents protecting, say, the vaccine formula, creates all-round protection for the product and the process by which it is produced.

Vaccines are protected by a range of IP rights. 41 The most prominent IP right relevant for vaccines and vaccine-related technologies is patents. Patents allow ARTICLE Journal of Intellectual Property Law & Practice, 2021, Vol. 00, No. 0 pharmaceutical companies to control and protect the results of their research and development by bestowing exclusive rights upon their owners. The patent holder has the right to prevent others from using his or her invention and thus controls the manufacture, distribution and pricing of such products. 42 In relation to vaccines, patents may protect, for example, their formulations, including the combination of medicinal components and devices for vaccine administration (eg, an injection delivery system or a capsule designed to release the product in a particular area of the human body). 43 The other significant IP right relating to vaccines is trade secrets. Trade secrets broadly include all types of information that provide an economic or competitive advantage to their owner because the information is not generally known. 44 These relate to their methods of manufacture (see, for instance, the example given above), although test data, specific (unpatented) medical formulae, cell lines, genomic information and other biological materials may also be protected as trade secrets. In addition, pharmaceutical companies consider results collected from clinical trials to be trade secrets. 45 Such information is protected by data protection regulations 46 and is based on the provisions of Article 39(3) TRIPS, which requires WTO members to protect test data submitted to regulatory authorities against unfair commercial use and disclosure.

In case of a refusal to voluntarily licence a vaccine technology, governments may need to rely on compulsory licensing. This section will explain the currently available mechanism of compulsory licensing of patents and 

To accelerate access to COVID-19 vaccines, one of the often-suggested mechanisms is compulsory licensing. 47 As pharmaceutical companies are actively patenting the results of their research into COVID-19 vaccines, 48 these exclusive rights to COVID-19 vaccines may, therefore, restrict or even block access to such a therapy. However, international laws contain specific mechanisms relating to compulsory licensing and government use for noncommercial purposes, which permit limiting the exercise of exclusive rights under the patent. A compulsory licence is an authorization granted by a state authority that allows the person who receives it to use the invention without the agreement of the patent holder. 49 This mechanism can be found in the TRIPS Agreement. 50 Achal Prabhala and Ellen 't Hoen, 'We'll find a treatment for coronavirus-but drug companies will decide who gets it' (The Guardian, 15 April 2020) ('…there is every indication that treatments for coronavirus may soon emerge, the mere fact of their existence is no guarantee that people will be able to access them. In fact, Covid-19 is more likely to end in the same way that every pandemic ends: treatments and vaccines will be buried in a thicket of patents -and pharmaceutical companies will ultimately make the decisions about who lives and who dies'…'Remdesivir, a medicine developed for Ebola by the biotechnology company Gilead, has major patents across the world that last until 2038') all accessed 21 May 2021. This mechanism has been implemented in the majority of jurisdictions worldwide and may be relied upon to address public health needs. 53 A specific type of compulsory licence is 'government use' , 54 under which the state authorises its own use of a patented product by granting authorization to a state agency or department or even to a private entity. 55 This may be an effective tool as the government does not need to send a formal request to the patent holder and can act upon its own initiative to resolve public health matters. 56 When relying on this mechanism, governments would not need to spend time on negotiating a licence, as required by TRIPS in relation to a normal compulsory licence, and can grant government use when necessary. 57 Certain limitations apply to compulsory licensing. A compulsory licence can typically be granted in relation to existing patents. 58 The mechanism cannot be applied to patent applications. 59 As some of the COVID-19 technologies are new, patent applications are currently being filed and will be granted in the coming years. 60 Until the time of the patent grant, this mechanism of compulsory licensing will not, therefore, be applicable. Thus, national IP laws may need to be amended to allow compulsory licensing of patent applications.

Moreover, while compulsory licensing of patents may be useful in improving access to certain medicines (eg, small-molecule medicines), this mechanism may not be effective in relation to biologics, such as vaccines, because their manufacturing technology may be protected by trade secrets. Unlike small-molecule drugs, which are easier for others to reverse engineer and reproduce without the need to know a specific manufacturing process, the knowledge on how to produce a complex biological therapy, such as a vaccine, may be critical. 61 Some argue that in the area of vaccines 'a manufacturing process is a product' . 62 Therefore, without such knowledge, a compulsory licence of patents would be insufficient, 63 and there is no obligation for patent owners to provide any additional information under a compulsory licence beyond what is included in a patent specification. 64 Currently, however, there is no equivalent mechanism in IP laws for compulsory licensing of trade secrets similar to the compulsory licensing mechanism developed for patents.

Moreover, concerned about being subjected to compulsory licensing of patents, pharmaceutical companies may be inclined to rely even more on trade secrets. 65 This has led some authors to argue that trade secrets can be considered 'among the most powerful legal weapons against [the] public' . 66 Currently, however, IP laws provide no mechanisms to force pharmaceutical companies to disclose their lifesaving COVID-19 vaccine technologies without their consent to voluntary sharing, (there are, however, some limited tools in other laws, as those, for instance, available under competition law discussed below). 67 This results in a dependence of countries, both developed and developing, upon pharmaceutical companies and the inability of countries to protect public 61 McMahon (n 23) 338; Crager (n 8) e87 (arguing that for a successful vaccine access strategy '[a]ccess to manufacturing process information protected by trade-secret law, as well as access to technology and know-how held by the innovator company, will likely be necessary'). 62 For a discussion see Nicola Searle, 'The process may (or may not) be the product: trade secrets and COVID research' (The IPKat, 3 August 2020). Available at https://ipkitten.blogspot.com/2020/08/the-process-may-ormay-not-be-product.htm (accessed 21 May 2021). 63 McMahon (n 23) 338; Crager (n 8) e87 (arguing that 'although patent protection remains the major barrier to the production of affordable small-molecule generics, access to trade-secret -protected information and know-how present major additional obstacles to generic production of vaccines' laws where the public interest in, for example, the acquisition of life-saving technology takes precedence over the protection of a trade secret.

In the pharmaceutical field, a third party has the right to access certain information submitted as part of a marketing authorization dossier, including clinical trial data. 73 For example, in the EU, the European Medicines Agency ('EMA') provides third parties with access to clinical trial data under Regulation 1049/2001/EC on access to documents and the EMA's Policy 0070. 74 These two policy instruments contain the right to access documents held by public authorities, including the EMA. 75 Such access, however, is subject to exception in the event that the disclosure would undermine the commercial interests of a natural or legal person, including IP rights (the socalled commercially confidential information ('CCI')), unless there is an overriding public interest. 76 In 2020, the Court of Justice of the European Union ('CJEU') issued several decisions in disputes, where originators sought to annul the EMA's decisions to grant a third-party access to a document containing data submitted in the context of a marketing authorization application. 77 The CJEU confirmed that there was no general presumption of confidentiality for clinical and toxicological study reports and upheld the General Court's refusal to dismiss EMA's decisions granting access.

However, there are no specific provisions in IP law either in the EU or the USA that allow compulsory access to trade secrets in order for them to be shared with competitors or the state. 78 was denied by vaccine producers. 80 For example, Biolyse, a Canadian manufacturer of cancer drugs, which is able to manufacture two million doses a month and thus has the potential to contribute to the global scale-up of vaccine manufacturing capacities, sought to manufacture and export the Johnson & Johnson ('J&J') adenovirus vaccine to developing countries. However, J&J refused to licence its technology to Biolyse. 81

An important element of public interest is incorporated in trade secret laws. In the UK, for example, Lord Goff in the Spycatcher case 82 said that there was a 'public interest in the maintenance of confidence…[and]…the law will provide remedies for their protection' . 83 A countervailing public interest defence against an action for breach of confidence, developed by the English courts, acknowledges that there are circumstances that may enable the recipient of confidential information to disclose that information to an appropriate person (a regulator) or, in some circumstances, to the media because the public interest recognizes the justification for doing so. 84 That notion of public interest would not, however, stretch to providing justification for the enforced disclosure of trade secret technology by way of a compulsory licence.

The role of the public interest in trade secret law involves a balancing of the interests of trade secret holders against the public interest in disclosing trade secrets. While such a balancing exercise is typically undertaken when considering a defence against the unauthorised dis- Computer Sys., Inc, 85 for example, a case involving a proprietary computer software licensed to a hospital, the US court granted a preliminary injunction and forced the trade secret holder to provide confidential access to the hospital's third-party service provider. When deciding whether to grant access to confidential information, the court undertook a balancing exercise and weighed, on the one hand, the public interest in protecting public health and, on the other hand, the interest in protecting confidential information. The court concluded that 'the public's interest in receiving adequate medical care outweighs its general interest in the performance of such [confidentiality] agreements' . 86 It could be argued that in the case of compulsory licensing of trade secrets related to COVID-19 vaccines, there is an overarching public interest for disclosure of such trade secrets. Public interest disclosure would not presuppose public disclosure. On the contrary, it would require disclosure (or transfer) to another company, accompanied by a strict obligation of confidentiality. Therefore, such a mechanism is less damaging for the owner than the 'public interest defence' currently available in law. It is argued that the public interest argument in trade secret law should be extended from merely being relied upon as a defence against unauthorised disclosure to its use as a specific ground for granting a compulsory licence of trade secrets. This is especially important in a time of global pandemic, which serves as the perfect ground for invoking public interest.

While Article 39 of the TRIPS Agreement may be considered to be the guiding world standard for the protection of trade secrets, it is useful to consider whether there are other elements of the TRIPS Agreement that may act to counterbalance the protection given to them.

Article 39 is drafted in terms of protection against unfair competition. 87 It requires members to protect undisclosed information '[i]n the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967)' . The regime of unfair competition essentially protects against unfair commercial practices. The law of trade secrets, as set out in TRIPS, protects against misappropriation of trade secrets, which is actionable if the trade secrets were acquired improperly and are either used or disclosed or in violation of a duty to maintain confidentiality. 88 Specifically, an acquisition of a trade secret by improper means occurs 'if it was obtained through theft, bribery, misrepresentation, breach or inducement of a breach of a duty to maintain secrecy, or through espionage, including electronic espionage. ' 89 At the same time, the TRIPS Agreement and the Doha Declaration lay down important principles and objectives in relation to the protection of public health. In particular, Article 7 TRIPS provides that '[t]he protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and the transfer and dissemination of technology, … in a manner conducive to social and economic welfare, …. ' (emphasis added). In addition, Article 8 states that 'Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health' and that '[a]ppropriate measures may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which …. adversely affect the international transfer of technology' (emphasis added). Finally, paragraph 4 of the Doha Declaration states that 'the TRIPS Agreement does not and should not prevent members from taking measures to protect public health' and that it 'can and should be interpreted and implemented in a manner supportive of WTO members "right to protect public health and, in particular, to promote access to medicines for all"' . 90 Therefore, the interpretation of these provisions may lay down the grounds for a compulsory licensing of trade secrets under TRIPS to ensure the protection of public health, especially during the COVID-19 pandemic, by facilitating the production of vaccines through an international technology transfer. 91 Moreover, the TRIPS Agreement contains no specific exclusions that would prevent compulsory licensing of trade secrets. In particular, while TRIPS has a provision on compulsory licensing of patents, it expressly prohibits compulsory licensing of trade marks. Article 21 states that it is 'understood that the compulsory licensing of trade marks shall not be permitted' . It could be argued that had the drafters intended to exclude this mechanism from being applied to trade secrets, they would have explicitly stated so. Instead, the TRIPS Agreement remains silent on this issue, thus, arguably, leaving this matter for national legislation. Therefore, this could be construed as allowing governments to issue compulsory licensing of trade secrets when required, including for the protection of public health.

As can be seen from the above discussion, compulsory licensing of trade secrets is arguably in line with the TRIPS Agreement. While there are currently no specific provisions in the law regarding compulsory licensing of trade secrets, the fundamental basis for their granting may stem from the states' obligations under national and international laws to protect public health. 92 During the pandemic, this could be granted under laws that mandate the protection of citizens against the pandemic. A number of countries have recently enacted emergency laws for this reason. For example, France has implemented emergency law n • 2020-290 of 23 March 2020 to deal with the COVID-19 epidemic that introduced a new article L.3131-15 into the Public Health Code. This article allows the Prime Minister, when a state of health emergency is declared and for the sole purpose of guaranteeing public health: (i) to order the requisition of all goods and services necessary to fight the health disaster and of any person necessary for the operation of these services or the use of these goods and (ii) to take all 'measures to make available to patients appropriate medicines for the eradication of the health disaster' (emphasis added). 93 This provision provides broad powers to the Prime Minister enabling him/her to issue a compulsory licence/government use of any patent or patent application, 94 as well as trade secrets that relate to a vaccine. This is because this provision generally refers to 'goods' and 'all measures' and, therefore, goes beyond protection by patents. 95 Moreover, the US Defense Production Act ('DPA') 96 allows the President to require businesses to prioritize contracts that promote the national defence. 97 It has been argued that, based on the DPA, the President has the power to require pharmaceutical companies that have developed and are producing COVID-19 vaccines to share information and data needed to facilitate increased production. 98 Based on these various legal provisions, as well as the public interest considerations mentioned above, compulsory licensing of trade secrets may be possible by governmental orders (similar to 'government use' of patents), which would oblige vaccine producers to disclose and provide access to all the information, including trade secrets, required to manufacture a vaccine. However, while some emergency laws discussed above may provide a basis for granting a compulsory licence of trade secrets, it is advisable to implement this mechanism more specifically in the IP law, thus supplementing compulsory licensing of patents with a similar mechanism for trade secrets. This will ensure that governments can facilitate access to medicines effectively by granting compulsory licensing of patents and trade secrets. This is important because more and more medicines, including vaccines, are characterized as complex biologics, protected not only by patents but also by a significant number of trade secrets. Moreover, without such an additional mechanism, compulsory licensing of patents may become a 'shallow' and ineffective tool and, hence, the flexibilities envisaged in the TRIPS Agreement that were implemented to balance strong proprietary patent rights would have no effect. Therefore, since TRIPS is silent about compulsory licensing of trade secrets, countries are free to implement such provisions in their national laws. It would also be desirable to harmonize this instrument at an international level by including relevant provisions in the TRIPS Agreement.

This section will explain in more detail what trade secrets are and the particularities of trade secrets licensing compared to other IP rights, which will lay down the grounds for the discussion of compulsory licensing of trade secrets in the next section.

7.1 What are the characteristics of trade secrets that potentially make them so valuable in the field of life sciences?

A trade secret represents the foundation of every IP right, or, as the European Commission described it in a report analysing the field of trade secrets, 'every intellectual property right starts life as a trade secret' . 99 An as-yet unpatented invention, the idea in a designer's head for a new innovative product or the plot for a new film or novel all have value based on their confidential status. Once the invention takes the form of a patent application or the idea becomes recorded, the status of the right changes but until the application is published or the idea becomes available, their value rests on confidentiality. Trade secrets, like other IP rights, are national rights, protected under the laws of the country in which the owner (or controller-see below) is based or of the country where an infringement action is pursued. 100 2016. The UK and other countries that follow the English common law base their protection predominantly on case law and the development of the breach of confidence action. 102 Signatory countries to the TRIPS Agreement are obliged to provide protection to trade secrets as part of their national laws. Article 39 of the TRIPS Agreement is as follows:

1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3. 2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information:

(a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (b) has commercial value because it is secret; and (c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

The reference to a 'manner contrary to honest commercial practices' in paragraph 2 means: …at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition.

Although drafted in terms of protection against unfair competition, Article 39 makes it clear that a 'manner contrary to honest commercial practices' will include actions such as breach of contract (for example, breach of a standard non-disclosure agreement) or breach of confidence, the latter defining the legal action by which trade secrets are enforced in the UK and other common law countries.

The TRIPS definition borrows its 'reasonable steps' language from the US Uniform Trade Secrets Act 1985. The definition has also been used in its entirety in the EU Trade Secrets Directive, 103 introduced in 2016 to harmonize trade secrets laws in EU countries.

That the EU chose to harmonize national laws in this way reflects another feature of trade secrets: they are becoming more, rather than less, important. In a survey carried out by an international law firm in 2017, CEOs in companies across a range of business sectors said that they considered their trade secrets to be more important than their patents, copyrights or trade marks. 104 This is in line with the detailed analysis carried out by the European Commission before the EU Trade Secrets Directive was introduced and is consistent with a number of other studies carried out in recent years. 105

To answer the question: how compulsory licensing of trade secrets might be achieved as a matter of law and of practice, it is necessary to consider what a trade secret licence is and how it, in its various guises, operates.

A licence conveys no proprietary interest in the underlying IP. It simply authorises the licensee to do something by contract, which, in the absence of the licence, would be an infringement of the licensor's rights. There is relatively little material about trade secret licensing. 106 A licence of a trade secret has some clear similarities with other IP licences. But it also has some fundamental differences. If a licensor licenses its patent to a licensee, which later commits a breach of the licence, entitling the licensor to terminate the licence, the licensor still has its patent and can find an alternative licensee. By contrast, if a trade secret licensor licenses its rights to a licensee, which breaches the confidentiality provisions of the licence by deliberately or inadvertently disclosing the secret to the public domain, the licensor has, in effect, nothing left to commercialize. Since the commercial value of the trade secret is its secrecy, and that secrecy disappears, so too does the substance of the licensable right. The licensor may have a significant claim for damages against the guilty licensee, but that may hardly compensate it for the loss of its licensing business.

This, in turn, reflects a significant difference between trade secrets and other IP rights. Trade secrets rely for their value on being kept secret. Once secrecy disappears, so too does the value of the right. That explains why, in many countries, trade secret protection is not a function of property rights but of the relationship of confidence between the 'owner' and the recipient of the information. 107 A trade secret licence will tend to be one of four types of licence: a) A hybrid patent-trade secret licence. This is usually called a patent and know-how licence and recognizes the fact that much patented technology is more usefully applied if you know how to put the technology into practical effect. 108 So, the patent element might protect the key technology, but the trade secret (or know-how) element represents the most effective way of implementing it, by, for example, operating a machine or mixing components in a particular way. There are two key aspects to a hybrid licence that are worth mentioning, which are also features of the other licences discussed below. The first is the ability to define what the trade secret consists of. The ability to define the secret is one of the most difficult but important aspects of trade secret law. It is important for licensor and licensee alike. A licensee is entitled to know what it is entitled to use (and what it is paying for) and, hence, what it must be careful to protect by keeping it secret. Definition is also important to distinguish any improved method devised by the licensee and to which it may lay claim and, perhaps, licence back to the licensor. The second is a comprehensive confidentiality provision designed to impose strict obligations on the licensee to protect the secrecy and value of the information. Confidentiality terms will range from maintaining password-protected access to documents to disclosure on a need-to-know basis to manufacturing process operatives. Without these, there would be no effective way for the licensor to control or police how its information was being used. 109 b) A 'pure' trade secret licence in which the technology is the trade secret information. In practice, these are relatively rarely encountered. Their effectiveness depends to a great extent on the kind of detailed confidentiality provisions outlined above, designed to give the licensor maximum control over how the licensee uses and protects the information in question. c) A Technical Assistance Agreement. This is a combination of a licence and training by the licensor of the licensee's operatives on how to use the technology concerned. In such a licence, in addition to defined technology and detailed confidentiality terms, there will be usually quite extensive provisions on how and where instruction and training of the licensee's operatives will take place, in what language and for how long. Training will almost always be at the licensee's expense. A technology assistance agreement recognizes that it can take a great deal of time to understand, operate and maintain highly complex processes (such as vaccine technology). In many cases, it will simply be insufficient to hand over some instruction manuals and hope that the licensee's operatives are able to get the process to work. They need to be shown how the technology works in practice, hence the fact that agreements of this sort are also often called 'show-how' licences. This essential attribute of technical assistance is recognized in the wider context of technology transfer from developed to less developed economies:

Transfer of know how is largely a question of training and teaching sometimes accomplished through formal educational programmes and international exchanges, but usually through informal learning and on-the-job training. 110 d) A 'turn-key' agreement. This is an altogether more complex arrangement, consisting of a combination of licence, training and constructing the plant or process line that encompasses the technology concerned. The additional element-actually constructing the physical plant or production line, gives the licensor some additional degree of protection, particularly if certain aspects of the plant or line are 'black box' components that conceal the secret technology and to which the licensee's operative has no access. There is one common feature to these licensing transactions, which is not so common in other IP licensing arrangements, and that is how and why the licensor chooses its licensee. The relationship between licensor and licensee is assumed to be a purely commercial one, in which the licensor's interest is in earning an income from allowing the licensee to use the technology under licence. The same is true of other IP transactions. But the fact that the IP concerned-trade secrets-is different from other IP rights because of its unique fragility to being disclosed makes the relationship between licensor and licensee a different one. As previously explained, a licensor entitled to terminate a licence with a licensee still has its IP and can find another licensee. But a licensor of trade secrets, which have been, deliberately or inadvertently, disclosed to the world at large, has nothing left to licence.

This, in turn, explains why a trade secret licensor must make a different assessment of its licensee: is the licensee likely to be a trustworthy business into whose hands the licensor is prepared to put its secret information? Due diligence on the licensee thus assumes a higher level of significance than in other cases. The licensor will ask itself a number of questions about the licensee:

• What is its status-a limited liability company, a partnership, a limited liability partnership and, in any of these, how long has it been established? • What do its published or disclosed accounts say about its financial strength? • What experience does its management have in operating a complex technology-based business? • What controls and processes does it have in place to maintain security of the information against internal and external threat? • In particular, can the licensee create a 'culture of confidentiality' in the workplace to enhance the protection given to the licensor's trade secrets? 111 • What is its track record of compliance with licences-in? • In which country is it based and what legal mechanisms (particularly early-stage injunctions and the like) are available to enable the licensor, should the need arise, to enforce its contractual terms against the licensee.

In short, can the licensee be trusted with the licensor's trade secret information? 

The manufacture of a complex vaccine is unlike the manufacture of a small-molecule drug where the beneficiary of a compulsory licence does not need access to details of the manufacturing process in order to produce an identical product. 112 A licence of the patent would be sufficient to do this. 113 It is also not necessary to duplicate a potentially patent-protected manufacturing process to ensure an identical product, and a third-party licensee may use an alternative method of manufacture to produce the desired end product. By contrast, vaccines are complex biologics and their production requires a set of specific knowledge and expertise, including knowledge about the manufacturing process extending to the use of specific items of equipment unique to the process (possibly designed by the vaccine manufacturer itself). Any government intent on putting a compulsory licence into the hands of a licensee must, as a first step, identify a potentially suitable licensee. That licensee must at least have a plant, equipment and some degree of expertise in this kind of manufacturing. The licensee would need to 'set up, calibrate and test equipment, and train scientists and engineers to run it' . 114 The licence must identify the scope of technology transfer, including the scope of information necessary for production and, as the section above on trade secret licensing made clear, much would depend on the need for technical assistance or 'show how' to enable the licensee to make effective use of the technology. As a leading article in The Times newspaper put it: 'publishing blueprints to allcomers would be like handing out a vastly complex recipe without the skills or access to ingredients required to execute it' . 115

There are a number of elements that a compulsory licence of trade secrets must contain, which are akin to those that would typically be included in a voluntary licensing agreement. In general, a voluntary IP licence includes, among other things, identification of the licensor and licensee, specification of the rights licensed, type of licence (exclusive, sole or non-exclusive), restrictions imposed on the licensee and remuneration, usually based on royalty payments. In addition, there are measures to ensure confidentiality and probably warranties from the licensor as to entitlement to grant the licence and from the licensee on the quality of products manufactured, sometimes backed by an indemnity designed to protect the licensor from product liability claims. The licence will include termination provisions, the usual range of 'boilerplate' provisions dealing with issues such as force majeure and, crucially, a dispute resolution mechanism and governing law clause. 116 A trade secret licence normally contains additional 'provisions that define the area of technology with precision, establish a confidential legal relationship between the parties, furnish proprietary information for a specific purpose only, oblige the recipient to hold information in confidence, and spell out exceptions to secrecy obligations' . 117 Where then would a compulsory trade secret licence differ from a voluntary licence agreement? The following are likely to be the key areas of difference:

Given the element of compulsion, the licence is likely to be structured as a three-party licence, i.e. compulsory licensor, compulsory licensee and the government imposing the order to grant the licence. The government as a third party would also be necessary to act as guarantor of the licensee's obligations to maintain the confidentiality of the technology.

It would be a non-exclusive, non-sublicensable and nonassignable licence so that the licensor could use and licence the technology to other licensees and the government concerned could compulsorily licence it to other companies to accelerate vaccine production.

A compulsory licence must specify precisely what is being licensed, ie, 'what specific technology and proprietary information attaches to the transfer' . 118 This is one of the key provisions and must be clearly defined in order to ensure full access to everything the licensee needs to successfully manufacture the vaccine in question. If the process is adequately described and defined in documentary form-formulae, production methods, standard operating procedures, plant design blueprints and so on-the licence will set out the array of documents needed to equip the licensee with what it needs to undertake manufacturing.

The real difficulty emerges when access to documents is simply not enough to enable the licensee to manufacture the vaccine and what is needed is the technical assistance ('show how') of the licensor. Usually, this will take the form of the physical presence of the licensor's scientific or technical staff to supervise or assist in the setting up of the plant, its operation and the training of its staff. How would the licence document prescribe this often vital aspect of a trade secret licence? How would the licence impose an obligation on the licensor to detach key members of its staff and send them, possibly to a foreign country and possibly for months on end to undertake this work? Is this akin to the granting of a mandatory injunction to the licensor compelling it to make its staff, possibly against their will, attend the licensee's premises?

More to the point, how could this be enforced? Assume a compulsory licence imposed by a government in country A against a licensor-technology owner in country B, which requires an element of 'show how' training (which is currently the case for most developing countries). If the putative licensor refused to comply with country A's order, some form of reciprocal enforcement of a foreign government or foreign court order would be necessary in country B to oblige the licensor to comply. The reciprocal recognition and enforcement of foreign judgments depends on whether countries, sometimes as a block such as EU countries, or on an individual basis, have concluded treaties to recognize and enforce another country's court orders. For many countries no such reciprocal system exists.

And even then, the imposition of a requirement to force employees from the employer's workforce to attend a process plant in country A to provide training and supervision of operatives there is difficult to envisage. Of course, one outcome of the COVID-19 pandemic has been an explosion of remote working, so the assistance of Teams or Zoom or similar technology could, at least in part, provide a solution to the problem. Nonetheless, if the 'show how' element of the licence required the physical presence of the licensor's personnel, then the enforcement, on a cross-border basis, of that obligation poses real problems to which there is no immediately obvious solution. Other aspects of the enforcement of a compulsory licence also need to be considered. What, for example, would be the position if the compulsory licensee claimed that the supervision or training provided by the licensor were not of a sufficiently high standard to equip its technicians with the skills to operate the process? What would be the licensee's remedy? Not to terminate the licence or even claim damages for breach because that would not solve the alleged problem. Instead, it would demand specific performance of the licence, enforced, presumably, by a local court or by the government party obliging the licensor's technical staff to do a better job. Again, this assumes ease of enforcement by way of reciprocal enforcement of a judgment or government order, which, as pointed out above, in many judicial systems will simply not be available.

The grant clause lies at the heart of any licence since it defines the scope of what the licensee can do with the licensor's rights. Use within the scope of the grant is non-infringing use. Use outside is both infringing and in breach of contract. The grant clause in a vaccine production and supply licence would therefore be to manufacture, store, sell and distribute the vaccine.

During the use of the licensed trade secrets, the licensee might make certain improvements to the technology, eg, to the manufacturing process. The licence would need to deal with the ownership of the licensee's improvements. Given that the licence would be a compulsory one, it would seem reasonable to assign any improvement back to the licensor, but local competition law might prohibit that.

The length of the licence should cover the period of the pandemic and potentially could be extended as long as the government considered it necessary to utilize this technology for the protection of public health, for example, for repeat or supplementary vaccinations to maintain protection.

It is axiomatic that confidentiality and its preservation is at the heart of any trade secret licence, which is why, in normal circumstances, a licensor would need to be assured by its due diligence that the licensee was a fit and proper person to act as a licensee and custodian of the licensor's trade secret material. A compulsory licensee would be chosen by the government concerned and hence any element of choice by the licensor would be displaced.

A compulsory licence could impose an express obligation on the government to exercise its best efforts to select a suitable licensee and to indemnify the licensor against any breach of the licensee's confidentiality obligations. The interpretation of 'best efforts' will differ from one legal system to another. Governments in some countries may not even have the luxury of an array of suitably equipped or qualified licensees to choose from. And what would the government's position be if the chosen licensee simply flouted the terms of the licence by disclosing the technology, thereby destroying its secrecy and value? As guarantor of the licensee's obligations, the government's position to protect the interests of the licensor seems clear. On the other hand, there may be little a licensor could do to prevent a government from evading its obligations by reference to some form of sovereign immunity.

The licence would need to impose strict obligations to introduce and observe security for the information. These provisions would include, for example, secure IT and document access systems, concealed production areas, the use of confidentiality provisions in operatives' employment contracts and so on.

How the licensee would enforce confidentiality provisions against employees is, of course, a major issue in any such licence. It is well recognized that employees are the main source of trade secret misappropriation. This is not the place for a discussion of what employees can and cannot take when they leave an employer's employment. 119 That will always be a matter for local law. But if the licensee's employees are the main threat to the licensor's trade secrets, the licensor is at the mercy of two things. The first is what local law says (if it says anything at all) on the freedom of an employee to change jobs and to use skill and experience acquired in previous employment. There is no bright line (at least in, eg, English law) between an employer's (or in this case, a licensor's) trade secrets and an employee's skill and experience. Local law might well struggle with a case, particularly one where the only effective remedy would be an early-stage injunction, to restrain an employee moving from one job to another for an increased salary or a higher-level position. The second issue, related to the first, is whether it would be possible to oblige the licensee to take action against a former employee threatening to use or disclose the licensor's trade secrets. The licensee might have perfectly good reasons not to do so, not least if local legal advice was that any such case would fail. Even if the compulsory licensor had taken the precaution of having a direct contractual relationship with process operatives (for example, by way of a non-disclosure agreement), the same question of local law enforcement would be likely to arise.

Since this is a compulsory licence, the royalties paid to the licensor should be set by the government at a level that, on the one hand, would not impede the rationale of such a compulsory licence and, on the other hand, would adequately compensate the owner for the use of its technology. The royalties could be calculated following the approaches taken to calculate royalties with respect to compulsory licensing of patents. This is typically a rate of 2-4 per cent based on generic product price. 120

An important provision in the compulsory licence would be the effective date of termination of such a licence. The licence should be terminated when the circumstances due to which it was granted cease to exist, ie, upon eradication of the pandemic. In addition, because trade secrets must be protected and kept confidential at all times, the obligation of confidentiality must continue after the agreement is terminated and, therefore, the licensee may be required to protect trade secrets from disclosure for an additional period of time. 121 The reservations expressed above about the possible effectiveness of confidentiality obligations during the licence term apply with added emphasis here. Additionally, the rights and obligations of the parties upon termination or expiration of the licence may include the obligation of the licensee to return, destroy and cease to use the proprietary information and all the related documents. 122 It is questionable how effective this would be if the licence had enabled the licensee to construct an entire plant or production line and whether the obligation would mean, in effect, the destruction of something that had allowed local expertise and employment to be developed.

Given that the licence would be compulsory, it would seem unreasonable for the government or licensee to demand any warranties from the licensor on the 120 effectiveness of the technology or its end result-the vaccine produced. By contrast, it would seem reasonable for the licensor to be protected by a warranty from the licensee that it would hold the licensor harmless from any product liability claim arising from the licensee's use of the technology to manufacture and use of the vaccine concerned.

It is foreseeable that a government-imposed licence would involve the imposition of a local law and forum provision. This is unlikely to be of much comfort to a compulsory licensor, particularly if local law and courts were unfamiliar with complex technology-based licences or lacked the essential means to enforce, as discussed above, say, the confidentiality provisions that are at the heart of the licence.

This brief summary provides some examples of how difficult the implementation and enforcement of a compulsory trade secrets licence might be for licensor and licensee alike. But it is the licensor's position that is the most vulnerable. There is no doubt that the licence could include elaborate provisions to protect the licensor's rights. That is not the point. The real issue lies in cross-border enforcement of confidentiality provisions under local law, which may have little or no experience of trade secrets or effective remedies to prevent their misuse or disclosure. The fact remains that once the information leaks to a competitor or to the public, there is no simple way it can be recaptured. Therefore, to make compulsory licensing of trade secrets work effectively, some jurisdictions, along with implementing this mechanism, may also need to reform their enforcement regime to address the challenges discussed above.

Given the reservations expressed in the previous section, the question remains: would it be feasible to introduce such a compulsory licence? The answer is a qualified yes, and a template for such a licence exists. The US Federal Trade Commission ('FTC') recently imposed a compulsory licence on a pharmaceutical company in the Mallinckrodt Ard Inc. (Questcor Pharmaceuticals) case, 123 according to which the company had to share its technology related to a biological drug, adrenocorticotropic hormone, including patents and trade secrets, with a designated third-party licensee.

The licence imposed on the defendant technology owner was in the form of a perpetual, irrevocable, fully paid up, sublicensable, assignable, exclusive licence to commercialize the licensor's pharmaceutical product in a defined field and territory. The licence extended to a licence (on the same terms) to use the licensor's trade marks and its medical and regulatory information. The licence dealt with the problem of putting the licensor's trade secrets into the licensee's hands in the following way (in the following extract, the licensee is identified as the 'Sublicensee'):

C. … Defendants shall provide the… Sublicensee with a full and complete copy of all tangible documentation and records embodying the Licensed IP and Manufacturing Technology 124 in the Defendants' possession or control, which if in electronic form shall be readily useable with off-theshelf commercially available software and equipment. Defendants shall deliver all such documentation and records to the… Sublicensee in good faith, in a timely manner (i.e., as soon as practicable, avoiding any delays in transmission of the respective documents and records), and in an organized and comprehensive manner that ensures completeness and accuracy and that fully preserves the usefulness of such documents and records. Pending complete delivery of all such documents and records to the…. Sublicensee, Defendants shall provide the…. Sublicensee and the Monitor (if any has been appointed) with access to all such documents and records and employees of the Defendants who possess or are able to locate such information for the purposes of identifying the books, records, and files directly related to the Licensed IP and Manufacturing Technology and facilitating the delivery in a manner consistent with this Order.

G. Upon the…. Sublicensee's request, Defendants shall provide access to the … Sublicensee to any manufacturing site (whether or not owned or controlled by the Defendants; provided, however, that, for any manufacturing site not owned or controlled by Defendants, Defendants are only required to provide access to the extent that Defendants have access and as permitted under any agreement(s) with the manufacturing site) that Defendants use to manufacture [the product] and make such arrangements with any Third Party necessary to permit that access for the purposes of evaluating and learning the manufacturing process…and discussing the process with Persons involved in the manufacturing process (including, 124 ibid (' According to the decision the "Manufacturing Technology" means all technology, trade secrets, know-how and proprietary information in each case to the extent necessary for the manufacture, validation, packaging, release testing, stability and/or shelf life of [the product] and/or the Drug Substance, including the …drug product formulations and/or other records. ').

without limitation, use of equipment and components, manufacturing steps, time constraints for completion of steps, methods to ensure batch consistency), pharmaceutical development, and validation of the manufacturing of [the product] at that facility.

H. … Defendants shall provide reasonable access to Defendants' personnel to provide instructions and answer questions regarding the application of the Licensed IP and Manufacturing Technology (to the extent known by Defendants).

The reference to the 'Monitor' is to an independent third party appointed by the FTC to oversee the performance by the licensor of its obligations under the licence, including the provision of documents and granting of access to personnel to provide manufacturing technology information.

This compulsory licence was granted in very different circumstances dealing with an anti-trust violation. The granting of a compulsory licence to make COVID 19 vaccine technology available has the public interest at its core. But the public interest must also have regard to the interests of the licensor technology owner, the latter having potentially spent a great deal of time and money on creating commercial value in its confidential technology. How is the licence meant to protect the licensor's rights to its technology against misappropriation by an employee of the licensee or against unauthorised access caused by poor security management by the licensee?

The role of the monitor, introduced in the Mallinckrodt case, shows that an independent third party might play a significant role in overseeing access to and protection of the licensor's technology, in essence to oversee fair play in what would be an enforced contractual relationship far removed from the normal commercial technology licensing arrangement between commercial parties. In particular, some of the problem issues relating to the enforcement of cross-border obligations considered in Section 8 above might be dealt with by the intervention and supervision of a trusted third-party monitor.

When granting a compulsory licence of a vaccine, some further challenges may arise. One of the barriers that also needs to be overcome when issuing a compulsory licence on a medicine or vaccine relates to data and marketing exclusivity that protects clinical test data submitted by the originator to the relevant regulator. Such exclusivity aims to prevent other pharmaceutical companies from relying on such data during the term of protection to obtain a marketing authorization for their generic or biosimilar version of the originator's medicine. For example, the EU pharmaceutical regulation provides for 8 years of data exclusivity, plus 2 years of market exclusivity during which generic companies can apply for their marketing authorization (but they cannot market their generics during this 2-year period). 125 This EU exclusivity regime covers both small molecules and biological products. 126 After the expiration of such exclusivity, generic companies can rely on the originator's data submitted to the regulator, thus avoiding the need to duplicate extensive clinical trials to prove that their generic version of a brand-name drug is safe and effective. Generic companies only need to show that their generic version is bioequivalent to an originator's already approved product. Also, applicants for biosimilar medicines (generic biological medicines) can refer to data submitted by the originator. 127 They are required to 'demonstrate through comprehensive comparability studies with the "reference" biological medicine that: (a) their biological medicine is highly similar to the reference medicine, notwithstanding natural variability inherent to all biological medicines; and (b) there are no clinically meaningful differences between the biosimilar and the reference medicine in terms of safety, quality and efficacy' . 128 In the context of compulsory licensing, this means that such exclusivity would prevent a compulsory licensee from obtaining a marketing authorization for its vaccine. Several authors have suggested that such exclusivity should be waived to allow the licensees under compulsory licences to obtain their marketing authorizations before it expires. 129 Moreover, a biosimilar manufacturer is typically required to conduct more testing and submit more data to demonstrate the similarity of its product to the approved original biological medicine than a generic manufacturer of a traditional generic medicine. This may present an additional barrier to increasing vaccine manufacture and supply. Therefore, while Article 39 TRIPS requires providing regulatory data exclusivity, the regime must be reconsidered by removing such a barrier when there is a need to protect public health as mandated by the key principles in the TRIPS Agreement discussed above.

The COVID-19 pandemic has brought significant challenges to the world community and revealed the inability of the current system of access to medicines to effectively address the devastating effect of this pandemic at the global level. To defeat this pandemic, an accelerated production of COVID-19 vaccines and their equitable distribution worldwide are urgently needed. This is not an easy task, as there is currently not enough manufacturing capacity to produce the billions of doses that are needed to swiftly inoculate the entire world population. In addition, there is another, perhaps even more serious, hurdle-to accelerate vaccine production, access to vaccine technologies is required. However, such technologies are protected by an array of IP rights that are owned by pharmaceutical companies. To remove this IP barrier, various proposals have been put forward, including voluntary technology pools (C-TAP and other initiatives), compulsory licensing and the TRIPS IP waiver. However, each of these solutions has a major drawback: the process of vaccine manufacture is protected by trade secrets and there exists no mechanism to oblige pharmaceutical companies to share them. This paper suggests that to make compulsory licensing of patents or the IP waiver work, an additional mechanism of compulsory licensing of trade secrets is required. It is argued that there is an overarching public interest for the disclosure of trade secrets related to COVID-19 vaccines. This mechanism will also be in line with the TRIPS Agreement, which, on the one hand, does not explicitly prohibit compulsory licensing of trade secrets and, on the other hand, mandates that its principles should be construed in a manner supportive of WTO members' rights to protect public health. Without such an additional mechanism, the flexibilities envisaged in the TRIPS Agreement in the form of compulsory licensing of patents, which were implemented to balance strong proprietary patent rights, will have no effect.

It is believed that the proposal for a new mechanism of compulsory licensing of trade secrets coupled with a discussion on the content of such licences, challenges that would need to be addressed and the potential wording of such a licence would provide useful guidance to governments on how to make their compulsory technology transfer mechanisms more effective. Importantly, this mechanism would be relevant both in case of the adoption of the TRIPS IP waiver, as well as if such a mechanism were not agreed upon and thus WTO members needed to rely on the existing compulsory licensing mechanism related to patents. More fundamentally, as more and more drugs on the market are complex biologics and are thus protected by trade secrets, the suggested mechanism would remain relevant after the pandemic.

Final Study on Trade Secrets and Confidential Business Information in the Internal Market

See Trevor Cook, Trade Secret Protection: A Global Guide (Globe Law and Business 2016); also 'Trade Secrets' (WIPO)

Uniform Trade Secrets Act

The Board Ultimatum: Protect and Preserve

The Corporate Preference for Trade Secrets

The Importance of Trade Secrets

The Trade Secrets Handbook

Trade Secret Licensing: the Art of the Possible

The Licensing of Trade Secrets and Know How

Practical Considerations in Trade Secret Licensing

OJ L136/34. In the USA, the Biosimilar Price Competition and Innovation Act (BPCIA), enacted as part of the Patient Protection and Affordable Care Act (Public Law 111-148) on 23 March 2010, has created an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product. The term of exclusivity for biologics in the USA is 12 years in total

Data Exclusivity in the European Union: Briefing Document

Biosimilar medicines: marketing authorisation

Data Exclusivity Exceptions and Compulsory Licensing to Promote Generic Medicines in the European Union: A Proposal for Greater Coherence in European Pharmaceutical Legislation