Supreme Court Strikes Down Patenting of Human Genes

Can we patent human genes? After years of debate, the Supreme Court of the United States (SCOTUS) has ruled unanimously that the answer is “No.” The majority of Americans are simply unaware that approximately 25% of their genes have been patented by companies and research institutions over the last few decades by the U.S. Patent and Trademark Office. However, the SCOTUS’ decision has determined that your genes are not patentable.

There is a fine article about this in the June 13th edition of the Wall Street Journal.

The SCOTUS decision is a victory for scientists, physicians and patients who argued that such patents interfere with the practice of medicine, patient care and scientific research. In handing down its decision, SCOTUS has made one of the most significant rulings in this age of molecular medicine, since it ultimately decides who may own the fundamental building blocks of life.

In writing for the court, Justice Clarence Thomas, said the genes Myriad Genetics, Inc isolated are products of nature, which aren’t eligible for patents. Thomas penned, “Myriad did not create anything,” Justice Thomas wrote in an 18-page opinion. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

Justice Thomas and the court essentially followed the legal framework established by Solicitor General Donald Verrilli when he rejected the views of both the U.S. Patent and Trademark Office and the specialized tribunal that hears patent appeals, the U.S. Court of Appeals for the Federal Circuit.

Justice Thomas credited Myriad for a “medical breakthrough,” since they had identified, isolated, and characterized the BRCA1 and BRCA2 genes. These genes can predict if a woman has a 50% – 80% likelihood of breast cancer, in comparison to the average American woman’s 12% to 13% risk. However, Thomas opined that “”groundbreaking, innovative, or even brilliant discovery does not by itself satisfy” federal law’s requirements for a patent. To demonstrate his reasoning, Thomas made reference to a 1948 case, in which the court decided that a product that combined several different species of bacteria that were useful for improving soil-nitrogen levels was unpatentable because the bacteria themselves were naturally occurring.

Justice Thomas also wrote that “separating (a) gene from its surrounding genetic material is not an act of invention.” Thomas also rejected an argument put forward by the company seeking the patent, Myriad, that patenting BRCA1 and BRCA2 would promote innovation. Instead, Thomas and his colleagues thought that patenting these genes and other would stifle innovation and frustrate progress.

In a nutshell: even if a discovery is brilliant or groundbreaking, that doesn’t necessarily mean it’s patentable, according to SCOTUS.

Now what do I think? I think that this is probably good news for patients. Even though you are not aware of it, gene patenting has affected you. Once a company legally “owns” a human gene, they control who can conduct research on that gene and who can run tests on that gene. If you have a genetic disease and you need a genetic test to confirm that you have it, medical labs are limited on what genes they can offer tests for because of gene patents. This limits the range of services medical labs can offer to patients. Medical laboratories that offer particular genetic tests are only allowed to do so because they pay royalties to the companies that own the genes, and this jacks up the cost of those tests. Consequently, many labs do not offer genetic tests in order to spare themselves the cost, time, paperwork, lawyers’ fees, and hassles.

Gene patents also stifle research. You see once a company owns a patent on a gene, they sit on the patient and do not conduct any research on those genes. Gene patents also prevent other scientists from researching the gene as well. This ties the hands of medical geneticists who want to define the exact mechanisms by which particular mutations cause or contribute to specific genetic diseases. Since many diseases have a genetic component, gene patents get in the way of further research. Dr. Iris Schrijver, president of the Association for Molecular Pathology, which opposes gene patents, made this observation:

Because variation in gene sequences plays an important role in the development and progression of many diseases, through gene patents, patent holders can essentially gain ownership of the understanding of some diseases and of certain areas of patient care itself.

Fortunately, SCOTUS has put the kibosh on such occurrences. Now, we hope that there will be a new era of genetic research where our genes are not claimed by one company or another, and researchers are free to work on whatever gene they choose.

As a postscript, Justice Thomas did leave the door open for companies to patent synthetically made versions of genes.  This would allow companies the ability to patent creations of their own for further use and research and development.  As noted in the Wall Street Journal piece:

Still, a footnote gave Myriad little reason to cheer. Justice Thomas added that the court took no position on whether cDNA met the other requirements for a patent, such as being “nonobvious.” He referred to a brief filed by the Obama administration, which observed that “given the prevailing level of knowledge in biotechnological fields, future patent applications directed to cDNAs and other synthesized DNA molecules may be rejected as obvious.”