Downstream innovation can be patented now – COVID shows it’s common despite the lack of patents
Jorge L. Contreras, 2023 - James T. Jensen Endowed Professor for Transactional Law and Director of the Program on Intellectual Property and Technology Law, University of Utah S.J. Quinney College of Law. Adjunct Professor, Department of Human Genetics, University of Utah School of Medicine “ PATHOGEN GENOMES AS GLOBAL PUBLIC GOODS (AND WHY THEY SHOULD NOT BE PATENTED)”, 55 N.Y.U. J. Int'l L. & Pol. 533, Nexis Uni, Accessed via University of Michigan //DH
4. There Are Ample Opportunities to Patent Downstream Innovations Beyond Pathogen Sequences
It is not necessary to patent underlying pathogenic sequences in order to protect novel and innovative technologies such as diagnostics, vaccines, therapeutics, and genetic modifications. There are, in fact, numerous innovative aspects of these technologies that can be and routinely are patented.132 [*562] For example, the manufacture and delivery of vaccines involves multiple complex technologies and processes including active ingredients, adjuvants, delivery vectors and manufacturing, storage, and transport processes.133 According to a 2012 WIPO study, there were more than 50,000 patents and published patent applications in fifty-seven countries that claimed the active ingredients of vaccines for pneumonia, typhoid and influenza alone.134 Similar levels of variety and opportunities for innovation exist in the area of therapeutics.135 For instance, Regeneron filed more than one hundred patent applications around the world for its Ebola drug Inmazeb,136 even though the viral sequence was publicly available in GenBank.
The broad availability of patents protecting innovation directed toward the containment and prevention of pathogenic disease outbreaks was clearly demonstrated during the COVID-19 pandemic. While, as noted in Part III.B, there are no known patents claiming the SARS-CoV-2 genomic sequence or its variants, several diagnostics and vaccines for COVID-19 were developed, tested, and administered to the public in record time. Even without patents covering the viral genomic sequence, the governmental and private sector researchers that [*563] developed these technologies applied for large numbers of patents. For example, one 2020 study found that with respect to mRNA vaccine technology alone, fifty-six different entities ranging from large pharmaceutical companies such as Bayer, Bristol Myers Squibb, and GlaxoSmithKline to small and medium-sized firms including Moderna, CureVac, and BioNTech, controlled nearly 120 different patent families.137 Several reports and studies describe the different patented vaccine technologies developed to address COVID-19, from novel spike proteins to lipid nanoparticle delivery mechanisms to specialized adjuvant excipients.138 Perhaps the most convincing evidence that sizeable numbers of patents have been issued in this field is the patent litigation being waged by half a dozen vaccine manufacturers and technology developers, recently dubbed the "COVID-19 Patent Wars".139 All of these examples demonstrate that COVID-19 technology innovations - and vaccines in particular - have been amply protected by patents and are extremely profitable, all without patents on pathogenic sequences.