By Dr. Diane Allingham-Hawkins, Senior Director, Genetic Test Evaluation Program and Technical Editing at Hayes, Inc.
The U.S. Patent and Trademark Office (USPTO) has granted patents to inventors for more than 2 centuries, giving them exclusive rights to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States. What many people don’t realize, however, is that the USPTO awards patents for not only drugs, medical devices, and other medical products, but also for genes, cell lines, human proteins, and biomedical materials and processes such as cloning. And it’s been awarding such patents for nearly 3 decades, ever since the U.S. Supreme Court ruled in Diamond v Chakrabarty that a life form could be patented. To date, the USPTO has granted thousands of patents on human genes and tens of thousands of patents on inventions that involve genetic material despite the objections of many in the genetics community that genes are products of nature rather than inventions. Our latest white paper, Gene Patenting in the United States – Where Have We Been, Where Are We Going?, provides a detailed look at the history of gene patenting in the United States and highlights some of the ongoing controversies.
Do you think the genes in our bodies should be patented? It’s a hotly debated issue. Advocates of gene patenting claim that patents generate revenue to develop new diagnostics and therapeutics and deliver them to the patients who need them. Opponents of gene patenting question the ethics of patenting any part of the human genome and assert that gene patents may restrict access to biomedical materials and processes, thus inhibiting biomedical research.
We’ve already seen how gene patents can stifle competition and research. The case against Myriad Genetics is a good example. Myriad Genetics holds patents on genes that are associated with increased risk of breast and ovarian cancer. As the patent holder, Myriad Genetics has the legal option to exercise its monopoly rights and prevent testing for these genes from being performed at laboratories other than its own. And it has done just that. Thus, women who want to know whether they carry those genes are forced to use Myriad laboratories for testing. Furthermore, they can’t seek second opinions from other laboratories. Similarly, researchers have been restricted from using Myriad’s genes in their clinical research, even for clinical trials sponsored by the National Cancer Institute.
The scientific community challenged the validity of Myriad’s claims by filing a lawsuit in 2009.
This case may finally reach an end this year, when the U.S. Supreme Court hears arguments in the cases beginning on April 15, 2013. You can be sure this case will be closely watched by members of the scientific and medical communities.
The Court has 2 choices: it can either uphold or invalidate Myriad’s patents. Although invalidating Myriad’s patents would not automatically invalidate other existing gene patents, Hayes believes it would affect patent holders’ ability to enforce their patents. Regardless of the outcome, this case is sure to have a far-reaching impact on the availability and quality of genetic and genomic testing in the United States and around the world.
Where does Hayes stand? Hayes’ position is that genes are naturally occurring substances that are not substantially altered by isolation and identification. Gene patenting should never have been allowed and now is the time to right that wrong.