Editor’s Note: Jorge Contreras is a professor at the University of Utah S.J. Quinney College of Law and an adjunct professor in the Department of Human Genetics at the University of Utah School of Medicine. He is the author of the new book, “The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA” (Algonquin, 2021). The opinions expressed here are his own. View more opinions on CNN.
In January 2020, when the SARS-CoV-2 virus was first identified, researchers quickly sequenced its genome and uploaded it to the GenBank public database. They then raced to develop vaccines and treatments to combat Covid-19. One thing that enabled them to do so in record time was the absence of patents covering the virus and the hundreds of thousands of genetic variants that have emerged since. Without a doubt, this patent-free zone contributed to the speed at which the scientific community was able to respond to this global threat.
It might seem intuitive that you can’t patent a basic scientific discovery or a genetic sequence that is found in a living organism, but from the 1980s through 2013, you could. Thousands of human genes linked to diseases ranging from cystic fibrosis to cancer were patented during this period. By 2005, researchers at MIT estimated that almost 20% of known human genes were subject to some form of patent protection. But that practice – known as “gene patenting” – ended in 2013 with a unanimous Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics.
That landmark decision enabled women at risk for hereditary breast and ovarian cancers, who were being charged exorbitant fees to learn whether they carried cancer-causing mutations in their BRCA genes, to access their own genetic material. It eliminated patents not only on the BRCA genes, but on all naturally occurring genes in the human body and every other living organism.
The current prohibition on gene patents, however, could change. The biotechnology industry criticized the Myriad decision when it was released and has worked tirelessly to overturn it, along with other key Supreme Court decisions limiting patents. These opponents claim that unless the reach of patents is expanded, biomedical innovation will be stifled, research will not be funded and lives will be lost. But, as the unprecedented effort to analyze the virus responsible for Covid-19 has shown, this is not true.
Where research and collaboration on earlier viral outbreaks such as SARS and H5N1 were stymied by races to patent their genetic sequences, this did not occur with SARS-CoV-2. Patents are still available to protect biomedical innovations such as vaccines, drugs and test kits, but no one can claim ownership over the genetic sequences that exist within naturally occurring organisms.
Nevertheless, in 2019, with strong industry backing, Senators Chris Coons (D-Del) and Thom Tillis (R-NC) drafted a bill that would have overridden all judicial decisions limiting the patentability of natural phenomena and laws of nature. This legislation would once again have permitted the patenting of natural substances and genomic sequences such as the human BRCA genes, the SARS-CoV-2 virus, and other natural products that are rightfully in the public domain.
The Coons-Tillis legislation did not advance in 2019, after opposition was voiced by a range of advocacy groups, Nobel Laureates, and private companies. However, a group of legislators, industry representatives and patent lawyers have again escalated the campaign to revive gene patenting. Recently, at the request of Senators Tillis, Coons and others, the Patent Office issued a request for public input on how current law has “impacted investment and innovation, particularly in critical technologies like … precision medicine, diagnostic methods, and pharmaceutical treatments.”
This effort seems designed to create a public record of opposition to the Supreme Court’s ban on patents covering natural phenomena. It is likely that patent advocates will point to this public input to blame insufficient patent protection for flagging investment, declining innovation, and the loss of ground to foreign competition.
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But this is not the case. Contrary to the pro-patenting narrative that’s likely to emerge, the patent laws were never intended to allow private companies to control the use of substances found within nature. The ban on these patents has resulted in dramatically lower pricing for diagnostic tests as well as unprecedented global research cooperation on Covid-19 and other diseases. And, contrary to the patent narrative, investment in the biotechnology sector has grown substantially in recent years. Congress should remember the hard lessons that we have learned over the years, including through the Covid-19 pandemic: A return to the days of patenting genes and other products of nature would enrich a few companies and lawyers at the expense of public health and human life.