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David S Levine, Trade secrets and the battle against Covid, Journal of Intellectual Property Law & Practice, Volume 15, Issue 11, November 2020, Pages 849–850, https://doi.org/10.1093/jiplp/jpaa164
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The unprecedented Covid-19 global pandemic has brought to the forefront many challenges associated with exclusive rights, information sharing, affordability of medical treatment, and innovation. As I wrote for STAT in July1, it has raised questions like how we provide effective diagnostics, treatments and vaccines quickly and safely to the public. More specifically, how do we ensure that sufficient quantities of these health products are produced, that they are affordable, and that they are equitably distributed globally?
Trade secrets play an enormous role in vaccine development, as well as the creation of diagnostics and treatments. From information like genomic data, to biologic resources, manufacturing know-how and negative information like research dead-ends, trade secrets pervade the battle against Covid.2 In that sense, finding Covid vaccines is no different from any other innovation schema, with trade secrecy operating alongside and in conjunction with patents, copyrights, and trade marks on the incentive side of the ledger.
However, in the Covid space, there are a few significant differences. At their centre is the basic issue of whether the sharing of certain trade secret information would be a net benefit for the world, resulting in more rapid development and expanded supply capacity of and/or more affordable vaccines, treatments, and diagnostics. These are open questions, but there are good reasons to think that the answers would be “yes” because of three public health priorities: speed, adequacy of supply, and affordability.
While the development of a Covid vaccine may be similar in process and methodology to any other vaccine development process, the continual loss of life, scale of economic impact, and general rendering of lives untenable, puts an enormous premium on speed. Speed, however, must not come at the cost of sacrificing oversight, safety, and efficacy. Therefore, in the interest of public health, there may be trade secrets, like discovery of vaccine development process dead-ends, that should be shared with competitors, researchers, and governments in order to speed development by avoiding time-wasting re-invention of the wheel.
To be sure, sharing valuable secret information may lead to less overall revenue for an individual manufacturer, but does not automatically mean that the endeavour would be unprofitable. Pooling of resources could lead to safer and more effective vaccines, treatments, and diagnostics, which would create higher demand than a more suspect product. Given the billions of vaccine doses required by a desperate world, not to mention the related diagnostics and treatments, there should be plenty of revenue earned across related industry sectors.
Moreover, because this is a global public health crisis, there is a moral and ethical mandate to assure that not only are Covid vaccines and treatments affordable for all, but that nationalism does not render them available first (or only) to wealthy countries and individuals. Unfortunately, nationalism has reared its ugly head in this battle, as governments vie for exclusive deals with pharmaceutical manufacturers, while the manufacturers seek the most lucrative results for their efforts. As Nature recently reported, “Wealthy countries have struck deals to buy more than two billion doses of coronavirus vaccine in a scramble that could leave limited supplies in the coming year. Meanwhile, an international effort to acquire vaccines for low- and middle-income countries is struggling to gain traction.”3
In countries like the United States, where the dominant utilitarian theory calls for intellectual property law to create incentives for innovation, there is no corollary that requires intellectual property owners to earn every last dime from their rights. Public health concerns can predominate. However, before one condemns these true statements as too extreme, it is important to note that they may make the point too strongly by overstating the costs of information sharing. Affordability through sharing trade secret information (and thereby driving down research and development costs) does not have to come at the price of profits.
As I have explained in the articles cited above, voluntary licensing can be cost-prohibitive, although the possibility exists for less costly licensing and technology transfer through the World Health Organization’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool, if utilized. Additionally, there are no legislatively codified compulsory avenues for requiring non-registration and non-clinical trial trade secrets to be shared with competitors, much less civil society groups, or other “watchdog” or advocacy entities. Nonetheless, the gravity of the crisis requires creative thinking, bold measures, and a certain amount of policy risk-taking (which, as I’ve previously explained, is supported by the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)).
Compulsory trade secret licensing of relevant trade secrets, in which trade secret owners are compensated for their investments and compelled sharing (assuming that the existence of a trade secret is proven, a separate necessary step), should now be considered. Unfortunately, creating a compulsory trade secret licensing mechanism would require legislative action, which would likely be contentious and time-consuming. Therefore, the short-term route to information sharing might have to come from global efforts by civil society groups and like-minded public officials, as well as the public itself, to convince researchers and manufacturers to share necessary information in the interest of global public health and welfare. While it may be true that industry would like to control their trade secrets and maximize profits, public concern and the general policy aversion to monopoly pricing that is baked into intellectual property law theory could be brought to bear in finding an industry consensus around access to and sharing of trade secrets.
If adopted for purposes of addressing this unprecedented public health crisis, voluntary trade secret information sharing and/or compulsory trade secret licensing could be extended to any number of other areas where trade secrecy has been a barrier to more rapid information sharing and innovation, from climate change, to energy production, to the next pandemic. Because empirical studies have shown that few blanket modes of behaviour or application apply to trade secrets broadly, and because trade secret law usage is considered on an individualized and sector level, robust trade secret information sharing and/or compulsory trade secret licensing could become a logical advance in open innovation and equitable-access modelling on an individual sector, product, or process basis. The time for considering how to share trade secrets, in the interest of global public health and all of our lives, is now.
Footnotes
David S. Levine, Covid-19 should spark a reexamination of trade secrets’ stranglehold on information, STAT (10 July 2020), available athttps://www.statnews.com/2020/07/10/covid-19-reexamine-trade-secrets-information-stranglehold/.
See David S. Levine, COVID-19 TRADE SECRETS AND INFORMATION ACCESS: AN OVERVIEW, InfoJustice.org (July 10, 2020), available athttp://infojustice.org/archives/42493.
Ewen Callaway, The unequal scramble for coronavirus vaccines — by the numbers, Nature (August 27, 2020), available athttps://www.nature.com/articles/d41586-020-02450-x. On September 1, The Wall Street Journal reported that the United States, “the European Union, Japan and the U.K. have agreed to purchase at least 3.7 billion doses from Western drugmakers developing vaccines …” Saeed Shah, In Race to Secure Covid-19 Vaccines, World’s Poorest Countries Lag Behind (September 1, 2020), available athttps://www.wsj.com/articles/in-race-to-secure-covid-19-vaccines-worlds-poorest-countries-lag-behind-11598998776.
