“While seeking compulsory licensing or IP waivers may seem an attractive solution to address technological disparities across human populations, these mechanisms ignore some of the more technical hurdles to increasing accessibility to vaccination.”
Though it is not over, it seems that the end of the Covid-19 pandemic may be in sight. A select group of countries has managed to bring vaccines to the market in record time. Take the United States, for example. At the time of this writing, three U.S. companies have managed to produce vaccines that received approval from the U.S. Food and Drug Administration (FDA). The intellectual property that underlies these products quite literally has life-saving potential.
This achievement no doubt represents a significant feat in human ingenuity, but it also presents a ripe issue in the intellectual property space — namely, compulsory licensing and intellectual property (IP) waivers. Some feel that the cost of sharing this information represents a bold degradation of the intellectual property system. In developing countries, however, the lack of vaccine availability is proving particularly difficult to manage.
While seeking compulsory licensing or IP waivers may seem an attractive solution to address technological disparities across human populations, these mechanisms ignore some of the more technical hurdles to increasing accessibility to vaccination. This post will first briefly explain what compulsory licensing and IP waivers are and then examine three possible causes for why compulsory licenses and IP waiver are not a feasible solution to the current COVID-19 pandemic.
One of the agreements that countries must ratify upon joining the World Trade Organization (WTO) is the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement was negotiated in 1994 to harmonize intellectual property laws across different countries and to establish minimum standards for protecting and enforcing intellectual property rights for all WTO member countries.
There are several provisions under TRIPS that allow governments to provide for limitations to intellectual property rights. In Article 31, for instance, TRIPS allows governments to order domestic manufacturers to make a patented product without permission from the patent holder. This practice is known as compulsory licensing. Article 31 permits countries to engage in compulsory licensing if there is a “case of a national emergency or other circumstances of extreme urgency,” or in cases of “public non-commercial use.” Under these circumstances, the country is first required to negotiate with, or seek approval from, the patent holder of the drug, but if the negotiations fail, is ultimately just permitted to manufacture patented products, such as essential medicines, for its domestic market.
For countries that cannot manufacture drugs themselves, and who would thus not be able to issue compulsory licenses under Article 31, Article 31bis was created to permit a developed country to export a generic drug under a compulsory license to a less developed country.
Contrary to compulsory licensing, IP waivers simply ask that countries be exempt from the provisions of TRIPS that require countries to protect and enforce patent rights to COVID-19 treatments and vaccines. In October 2020, India and South Africa petitioned the WTO for a temporary waiver from specific provisions of the TRIPS Agreement that could essentially put entire realms of existing intellectual property law on hold at the international level until widespread vaccination has become globally implemented. Perhaps unsurprisingly, this proposal was met with strong resistance from developed nations while developing and less developed nations were more welcoming towards it. In March 2021, the proposal failed to pass resolution at the WTO.
Covid-19 Vaccines are New
What these proposals fail to take into account is the nature of the Pfizer and Moderna vaccines. The efficacy of both of these proposals turns on a country’s internal technological capabilities to recreate and administer the vaccine. The Pfizer and Moderna vaccines, however, are not typical vaccines. Whereas traditional vaccines functioned by introducing parts of a virus — or a weakened form of a virus — Pfizer’s and Moderna’s vaccines use messenger RNA to cause host cells to produce the protein themselves. These are the first vaccines to utilize this type of technology.
The novelty of these vaccines potentially degrades the utility of a compulsory license or IP waiver. For instance, remdesivir received a great deal of focus early in the pandemic. Bangladesh managed to recreate the drug without Gilead Science’s approval because it is exempt from Article 31 of TRIPS, and Bangladesh was able to produce a sufficient supply for the country by the summer of 2020 because information about the drug was available. Given the fact that Pfizer’s and Moderna’s vaccines represent a new form of vaccine, lacking technical information on how to make this new form of vaccine could lead the countries to create entirely ineffective vaccine replicas.
These issues may be compounded by the fact that many vaccine manufactures rely on trade secret protection more heavily following the Ass’n for Molecular Pathology v. Myriad Genetics, Inc. decision. These trade secrets can withhold critical scientific know-how that might be necessary for replicating a vaccine.
Thus, the new technology behind these messenger RNA vaccines and the lack of accessibility to the related know-how might deter countries from attempting to manufacture them.
Lack of Information
Yet another more fundamental problem exists for replicating these vaccines. Not only do these vaccines represent a new form of vaccine, but information about these particular vaccines is simply unavailable. Even if the Pfizer and Moderna vaccines do not utilize any trade secrets, the discovery of these vaccines is fundamentally different than remdesivir’s timeline, which resulted in Bangladesh’s recreation of the drug. A patent for remdesivir was filed as early as 2015, and thus the information had been publicly available for years.
While the technology underlying mRNA vaccines has been in development for decades, there are likely specific technological hurdles associated with, for instance, the coronavirus, mass production and scale up, and delivery mechanisms that needed to be developed for this specific application of the legacy technology. This additional information will not be found in scientific journals or magazine articles, nor can it be found in any patent application, yet. Patents, moreover, can take up to 18 months from filing to be published. BioNTech made an F-1 filing with the SEC on July 21, 2020, in which it acknowledged its partnership with Pfizer to develop the vaccine. If this filling is at all indicative of when a patent could have been filed, then this would mean the patent may not be available to the public until late-2021–mid-2022.
With Novelty Comes Difficulty
The newness of these vaccines also creates problems due to the complexity in how these types of vaccines function and how to produce them. According to a Wall Street Journal report, manufactures say that vaccine production is difficult both “because some steps are difficult to scale up quickly or because they simply haven’t been done before.” Even Pfizer is having difficulty obtaining the necessary materials for vaccine production.
Here, the complexity of these vaccines demonstrates the potential futility of a compulsory license or IP waivers. Even if other countries could compel manufactures to license the underlying intellectual property and provided them with the information about how to do so, the complexity of manufacturing these types of vaccines could be a particularly high barrier to overcome.
Countries face roadblocks for producing a viable vaccine candidate based on Pfizer’s and Moderna’s vaccines. The new technology that utilizes messenger RNA vaccines, coupled with the lack of public information about these vaccines and the vaccines’ complicated nature, present significant hurdles to seeking compulsory licenses or IP waivers.
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