Gene patenting has long been a controversial topic that many people have strong opinions about. The Supreme Court has finally spoken on the subject, and reversed three decades of practice by the U.S. Patent and Trademark Office (PTO). On June 13, in The Association for Molecular Pathology v. Myriad Genetics, Inc., a unanimous Court held that isolated human genes are not eligible for patenting under U.S. law. The decision will affect thousands of U.S. patents.
The gene patents in Myriad are based on the discovery of the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase a person's risk of developing breast and ovarian cancer. Myriad, in conjunction with scientists at the University of Utah and elsewhere, developed tests to detect the mutations in a patient's genes, permitting it to assess whether the patient has an increased risk of cancer. The patents gave Myriad the exclusive right to isolate an individual's BRCA1 and BRCA2 genes, which are then used to conduct the genetic tests.
Earlier this year, actress Angelina Jolie elevated the BRCA test to prominence when she revealed she had been diagnosed as carrying one of the mutations. She underwent a double mastectomy to substantially lessen the chance she would develop cancer.
In its decision, the Supreme Court acknowledged that Myriad's scientists had accomplished a medical breakthrough. Before Myriad's discovery, scientists knew that heredity played a role in a person's risk of developing breast and ovarian cancer, but it was not known which genes or which mutations were associated with those cancers.
Once the location and sequence of the BRCA1 and BRCA2 genes and mutations were found, Myriad and its collaborators filed for a number of patents. The PTO had been issuing gene patents since the landmark 1980 Supreme Court decision in Diamond v. Chakrabarty. At issue in that case were life forms such as bacteria that had been genetically engineered to degrade oil. Chakrabarty set a relatively low threshold for patent eligible subject matter, at one point stating that "anything under the sun that is made by man" was patent eligible.
Since then, patents to isolated human genes have been issued to cover a variety of extraordinary new medical treatments, such as human tissue plasminogen activator, human erythropoietin, human interferon, and others. Biotechnology and pharmaceutical companies invested billions of dollars during the 1980s and '90s to identify and isolate genes encoding new proteins and develop therapeutic and diagnostic products.
When the DNA sequence of the complete human genome was first published in 2001, the issue of patenting human genes became the focus of much public discussion and consternation. After substantial public comment, the PTO announced it would continue to grant patents on genes as long they had been isolated from the environment in which they naturally occur (e.g., cells of the human body) and they had a recognizable and practical use.
The Patent Act provides, "Whoever invents or discovers any new and useful ... composition of matter ... may obtain a patent therefor."1 The courts have long held that there are three important exceptions: Laws of nature, natural phenomena (such as products of nature), and abstract ideas. These exceptions are regarded as the basic tools of scientific and technological work. The Court in Myriad recognized that all inventions at some level are based upon or apply laws of nature, natural phenomena or abstract ideas. Patent law attempts to strike a balance between creating incentives for invention while not impeding information and advancements that should be available for all to use.
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