Pathogen patenting creates patent thickets that block innovation and inhibit information sharing necessary for pandemic response

Thus, PERA would threaten the ongoing discovery of new biomarkers relevant to personalized or precision medicine that depends on the characterization of the specific variants of a patient’s genes. PERA would permit all such new discoveries to be patented and privatized. The result would be the great proliferation of patents covering the many genetic variants for which clinicians would want to test a patient. A patent thicket would emerge that would impede patient care by making it very hard to conduct genetic testing comprehensively for a patient.

However, the threats to the life sciences research, innovation and patient care are not limited just to concerns about our unfolding appreciation of additional biomarkers and their effective incorporation into precision medicine. Had PERA been the law at the start of the COVID-19 pandemic it would have severely interfered with and almost certainly impeded the progress of COVID-19 diagnostics and vaccines. The severe acute respiratory syndrome (SARS) coronavirus 2 was new at the time and therefore its characteristic DNA and protein sequences would have been patentable under PERA. Indeed, the virus itself, for example in an attenuated (or “killed”) form would have been patentable as a traditional vaccine. And the sequences needed to make an RNA vaccine would also have been privatized and constrained research and development of the vaccines that were the cornerstone of the response to the pandemic. The opportunity to patent would translate into a competitive imperative to patent and would have dramatically curtailed sharing of information which was critical to the rapid public health response in the development of diagnostics and vaccines.

The fact that the pandemic preceded PERA does not mean that PERA would not pose future harm. Under PERA, one could patent an unpublished viral gene by claiming the gene in its isolated, purified or enriched form. Note that practically all genetic sequencing involves an enrichment step and thus such a patent would cover anyone sequencing a sample of the virus’s DNA for research or diagnostic purposes. Even the whole virus could be patented if its virality is attenuated or killed. A traditional form of vaccine is made of attenuated virus which could hinder the development and access to necessary vaccines. The potential to patent newly observed viruses would impede public health goals reliant upon data sharing because there would be an incentive to make a patent filing before disclosing publicly a newly observed virus. This could even apply to new variants of the SARS coronavirus 2 that may yet emerge.