Intellectual Property Rights in Times of Crisis

disagreements about at what point an element of nature can be considered man-made (Hamilton, 2008; Straus, 2017). Another important element of intellectual property in the bioeconomy is the Bayh-Dole Act of 1980. This US legislation allowed small businesses, nonprofits, and universities to keep intellectual property rights from federally-funded research and, some have argued, is the single most important reason for the expansion of intellectual property rights in the bioeconomy (Straus, 2017). Straus (2017) states that it is not until after the passage of the Act that the biotechnology industry began to grow into what it is today. Others, however, have argued the Bayh-Dole had a much smaller impact than it is often given credit for. Gold et al. (2007) states “While Bayh-Doyle is often credited with the rise of the biotechnology industry, this is clearly false...the world’s experience in transplanting Bayh-Doyle to other countries – without marked effect on innovation – indicates that Bayh-Doyle is not responsible for changes in research and development outside the United States” (p. 8). Thus, technology transfer was already occurring before the legislation was passed and therefore didn’t have as large an impact as it is credited with. Regardless of the exact impact of Bayh-Dole on the expansion of the bioeconomy, most scholars believe that patents and other intellectual property protections have had an important impact on biotechnology development. Some remaining challenges include the relatively arbitrary nature of the intellectual property system and the difference in capabilities between countries (Gold et al., 2007). The current intellectual property system has a tendency to overprotect some patent holders, but under protect others (Gold et al., 2007). This problem is further exacerbated when examining how intellectual property functions differently in different countries. Some countries, like the US and many countries in Europe, have implemented a strong intellectual property rights system and others, such as China and Brazil, have acquired the industrial and scientific capability to do so recently. Some, such as Kenya and Indonesia, may still consider the establishment of such a system as a cost rather than a benefit, because such a system would be expensive to create and enforce at a time when there is limited intellectual property to protect (Gold et al., 2007). In order to continue promoting development within the bioeconomy it is important to address these intellectual property mismatches and continue strengthening the intellectual property system.

Intellectual Property Rights in Times of Crisis

The COVID-19 pandemic raised a number of questions about how intellectual property rights should function in times of global crisis. In the face of these questions, scholars have developed several suggestions for paths that might be taken in times of extreme crisis, such as the COVID-19 pandemic. The first, called compulsory licensing, has been implemented by several countries including Canada. Under compulsory licensing, patents are issued by the government but other individuals are able to make, use, sell, or import the product without permission from the patent holder (Molloy, 2020). In this scenario, the product is able to be more widely distributed than it would be under normal patent conditions and the government typically reimburses the patent holder in the form of royalties.

The second way to address intellectual property issues in the bioeconomy may be patent pledges. In this case the holder of the intellectual property makes a public statement saying that others have permission to use their intellectual property. While this allows for widespread use of intellectual property, the patent

holder often sets limits on usage (Molloy, 2020). Lastly, intellectual property might be shared through “IP pooling.” In this case patent holders make their intellectual property available to a select group. All three of these actions – compulsory licensing, patent pledges, and IP pooling – can provide some intellectual property protections, while also making it more available in a crisis like the COVID-19 pandemic.

RECOMMENDATIONS

1) Address the importance of patent protection in the development of the bioeconomy

While there is debate about the extent of the effectiveness of the Bayh-Dole Act in expanding the biotechnology industry, research is in agreement that patent protection leads to greater investment in research and development within the bioeconomy. We must continue looking for ways to strengthen the intellectual property rights system to foster greater development.

2) Develop mechanisms that balance intellectual property protection with information sharing during a crisis

The COVID-19 pandemic has shown why information sharing is important in a crisis. It has also, however, demonstrated the feelings of researchers and firms that intellectual property protection should still be a priority in a crisis. For these reasons it is important that we examine ways to create a system, such as compulsory licensing, patent pledges, or IP pooling that appropriately balances intellectual property protection with information sharing during a national or international crisis.