Gene patenting is vital to vaccine innovation

There has long existed a debate on the patenting of genomic and biomedical data.10 Since the beginning of the COVID-19 global pandemic, healthcare advocates, governments, and scholars worldwide have expressed concern that patents would slow the manufacturing of medical supplies, vaccines, equipment, and therapies as well as distribution of supplies to those who really need them.11 On the other hand, countless scientists and researchers have called for patent protection for genomic and biomedical discoveries because patents allow pharmaceutical companies to recoup the massive investments they put into researching and developing.12 The potential patent protections of genomic and biomedical data act as incentives to spur the development of methodologies and technologies that can prevent future pandemics and foster innovation.13 In combating modern pandemics, patent law and protections for genomic and biomedical data have played a significant role in incentivizing vaccine innovation and cures related to viral infections. 14 While many assume that limiting patent protection allows for more vaccines to be produced, this assumption fails to recognize that being allowed to produce vaccines is starkly different from having the ability to produce vaccines to the same degree of effectiveness and safety.15 Creating clean and safe vaccines requires a high degree of knowledge, experience, and technological infrastructure.16 Having this knowledge, experience, and technological capability is especially important when producing vaccines based on the new mRNA technology, such as those produced by Pfizer, Moderna, and others.17 The new mRNA-based vaccines are significantly more expensive and complex to manufacture than the established vector vaccine. 18 For example, the vaccines are extremely sensitive to variations in temperatures and mostly require a constant set temperature. 19 Due to the unique challenges of manufacturing a COVID-19 vaccine, simply releasing patents will not guarantee that previously inexperienced pharmaceutical manufacturers worldwide will be suddenly able to produce clean and safe vaccines.20

Additionally, a single drug costs about $1.3 billion to $2.8 billion to produce.21 The government-initiated restriction on patent protections does not consider the complicated and cost-intensive development of drugs.22 It also fails to consider that the research and development of a medicine do not guarantee success.23 In the worst-case scenario, pharmaceutical manufacturers are expending billions of dollars to gain nothing in return.24 In the face of these multibillion-dollar R&D costs, pharmaceutical companies rely on patents to incentivize them to embark on costly and time-consuming research and development of new, breakthrough drugs.25