Myriad Genetics, a molecular diagnostics company, was at the center of a legal battle that reached the Supreme Court. The case revolved around the company’s patents on human genes, sparking a national debate on intellectual property, scientific discovery, and patient rights. This confrontation questioned the boundaries of what can be owned within the human body. The lawsuit’s outcome ultimately reshaped the landscape of genetic research and diagnostics in the United States.
The Basis of the Legal Challenge
At the heart of the dispute were the BRCA1 and BRCA2 genes, which are linked to a significantly higher risk of hereditary breast and ovarian cancer. After identifying and sequencing these genes, Myriad Genetics secured patents on them. These patents gave the company a monopoly, making it the sole provider of tests to detect mutations in these genes.
The cost of Myriad’s BRACAnalysis test was high, often running into thousands of dollars. The patents also prevented other laboratories from developing alternative testing methods for the BRCA genes. This lack of competition meant patients could not seek a second opinion, and researchers were limited in their ability to study the genes without risking patent infringement.
The Parties and Their Arguments
The lawsuit against Myriad Genetics was initiated in 2009 by a coalition of plaintiffs led by the Association for Molecular Pathology (AMP) and the American Civil Liberties Union (ACLU). The group included researchers, genetic counselors, patients, and scientific organizations. Their argument was that products of nature are not patentable inventions. They contended that human genes, even when isolated, fall into this category and cannot be owned by a company.
In its defense, Myriad Genetics argued that its work was more than a discovery of nature. The company asserted that isolating the BRCA1 and BRCA2 DNA from the human genome was an act of human ingenuity. This act, they claimed, transformed the DNA into a “composition of matter” distinct from its natural state and eligible for patent protection. Myriad’s stance was that its patents were a reward for the investment required to identify and sequence the genes.
The plaintiffs countered that the genetic information itself, the DNA sequence, was the valuable component created by nature, not by Myriad. They argued that the company did not invent the genes but simply found them.
The Supreme Court’s Landmark Decision
In 2013, the case of Association for Molecular Pathology v. Myriad Genetics, Inc. reached the Supreme Court, which delivered a unanimous verdict. The Court ruled that naturally occurring DNA segments are products of nature and cannot be patented just because they have been isolated. Justice Clarence Thomas, writing for the court, stated that Myriad did not create the genetic information in the BRCA genes; it only uncovered their location and sequence.
However, the Court made an important distinction. It found that synthetic, complementary DNA (cDNA) is eligible for patent protection. cDNA is created in a laboratory from messenger RNA (mRNA) and lacks the non-coding regions (introns) found in natural DNA. Because cDNA is not naturally occurring, the Court deemed it a human-made invention and therefore patentable. This decision invalidated Myriad’s patents on isolated DNA but upheld its patents on cDNA.
Ramifications for Science and Medicine
The Supreme Court’s decision had immediate effects on medicine and scientific research. With the invalidation of Myriad’s patents on the BRCA genes, other laboratories were free to offer their own diagnostic tests. This new competition led to a rapid decrease in the price of BRCA testing, making it more accessible.
For the scientific community, the ruling removed a barrier to research. Scientists could now study the BRCA1 and BRCA2 genes without fear of patent infringement. This freedom accelerated the pace of discovery into the genes’ functions and their role in cancer, fostering a more open research environment.
The biotechnology industry also shifted its focus. The ruling clarified that naturally occurring genetic sequences were no longer a viable subject for patents. As a result, companies directed their efforts toward creating new applications, diagnostic methods, and synthetic DNA constructs like cDNA, which the court had affirmed as patentable. This change spurred innovation in genetic engineering and therapeutic development.