The question of whether gene sequences are patentable has been long contentious, but a potential landmark decision by a U.S. federal court in late March could serve to make the issue clearer. For years, lawyers have argued that DNA in an isolated form differs from how it exists in the human body, thus permitting the patenting of human genes or DNA segments. But on March 29, 2010, this argument was rejected, thereby invalidating two breast-cancer gene patents and having the potential to affect thousands of others.
In the heyday of genome sequencing, many companies were submitting hundreds, if not thousands, of patent applications on newly discovered sequences without knowledge of their true biological meaning. Today, more than 2,000 human genes—including several associated with Alzheimer's disease, colon cancer, and asthma—have been patented. And, since most are designed to cover a vast array of applications, they severely limit the potential for others to make use of patented materials in almost any context.
Many groups strongly suspect that patents on genetic material limit the development of cheaper genetic tests, novel drug discovery, and the possibilities for new basic research advances. This concern led one group, the Association of Molecular Pathology—acting on behalf of several breast cancer advocacy groups and other scientific associations representing more than 150,000 researchers and laboratory professionals—to file a lawsuit challenging patents granted by the United States Patent and Trademark Office for genes associated with increased breast cancer risk, BRCA1 and BRCA2. The patents had been granted to Myriad Genetics and the University of Utah.
Robert Sweet, a U.S. District judge in New York, rejected the viability of the patents. It is a judicial decision with far-reaching implications.
In the opinion, Judge Sweet stated, “DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA's existence in an ‘isolated’ form alters neither this fundamental quality as it exists in the body nor the information it encodes.”
Acknowledging the concerns of various advocacy groups and physicians—who have claimed that patenting has thwarted development of cheaper, faster testing—as well as the decision's potential impact on patent holders and investors, Judge Sweet wrote, “…the resolution of the issues presented to this Court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors, and those seeking to advance public health.”
While it is critical to preserve important discoveries and protect the rights of companies and individuals through patents, the ability to patent an unmodified discovery, a piece of our genetic code found in nature, will only limit our understanding of basic biology and slow the development of therapeutics and clinical diagnostic tests. Our ability to sequence DNA and peer into the genome has advanced tremendously in the past decade. The arrival of genomic medicine, when disease risk is assessed and therapeutics chosen by decoding an individual's genome, will create new issues when it comes to previously patented genes, and only broaden the issues surrounding gene patent protection.
The patenting of human genes seems to be a relic of a bygone era, a time when our understanding of the human genome was in its infancy. Genomics has grown up, and it is nice to see that legally, we could be moving in the same direction. As always, post your thoughts and comments at our Molecular Biology Forums under “To the Editor” (http://molecularbiology.forums.biotechniques.com) or send an email directly to the editors (bioeditor@biotechniques.com).
