Here’s a disconcerting thought: for the past thirty years, genes have been patentable. And we’re not just talking genetically modified corn – your genes, pretty much as they exist in your body, can and have been patented. The US government reports over three million gene patent applications have been filed so far; over 40,000 patents are held on sections of the human genome, covering roughly 20% of our genes.
Upset? You’re not alone. Critics argue that the patents stifle potential research into disease, keep new treatments off the market, and bring in serious money to Big Pharma – all by exercising property claims that shouldn’t exist. After all, genes aren’t inventions, which are patentable – they’re discoveries, which aren’t. As Luigi Palombi noted recently at the Open Science Summit, “You can’t patent Mount Everest; why can you patent a gene?” Here, we review the history of genetic law, the current state of affairs, and interview David Koepsell, an attorney and author of a recent book on gene patenting, Who Owns You? The Corporate Gold Rush To Patent Your Genes.
The ACLU has been waging a legal war against gene patenting, and some forward progress has been made. A few months back, a major (and unexpected) victory against gene patenting came when a district judge struck down patent claims by Myriad Genetics. Back in 1998, Myriad patented several genes of the BRCA family; mutations along these genes increase susceptibility to breast and ovarian cancer. The patents gave Myriad proprietary rights over diagnostic tests for the mutations – tests they sold for over $3,000 each.
On March 29, 2010, District Judge Robert W. Sweet invalidated seven of the BRCA patents owned by Myriad. The decision shocked supporters and critics alike, and Myriad has appealed the decision. What remains to be seen is whether it will reach and survive a federal court, and thereby become precedent to strike down further gene patents owned by biotech companies.
So how are genes patentable in the first place? Parts of your body have actually been patented for over a century. Adrenalin was patented in 1906; insulin was patented in 1923. The argument for chemical patents was basically that isolated and purified forms of the naturally occurring molecules are more medically valuable than the forms floating around in your bloodstream. A comparable logic is what allows the FDA to outlaw DMT – a chemical also produced within your body, but which acts as a powerful hallucinogenic in its concentrated form.
But gene patents got their big start in 1980 in the case of Diamond v. Chakrabarty. A GE engineer developed a bacterium capable of breaking down crude oil, and filed a patent for it. After a series of rulings and appeals, the case landed in the Supreme Court. On June 16, 1980, the court ruled in GE’s favor, and the first living organism was patented in the United States. The key distinction in the Diamond case was that the bacterium was man-made, and therefore constituted an invention.
Human gene patenting works on the logic that if a patent applicant has “isolated and purified” genetic material, it constitutes an invention on their part – even if the strand is identical to the DNA sequence found in nature. Proponents of gene patenting (i.e. generally, the companies or their patent lawyers) argue that patent protection is essential to retaining strong investment in genetic research, which speeds up progress in the field. It’s true that patents are important to the biomedical industry’s ability to attract capital – Myriad stock took a nose dive after the Supreme Count shot down their BRCA patents. But the claim that a world without gene patents would stifle genetic research (or even make it unprofitable) seems overstated at best, and disingenuous at worst.