The U.S. Supreme Court recently decided Association for Molecular Pathology, et al. v. Myriad Genetics, Inc. et al., a case involving U.S. patents issued to a Utah company called Myriad Genetics, Inc. (“Myriad”). The patents were based on Myriad's discovery of the precise location and sequence of two human genes (BRCA1 and BRCA2). Mutations of these genes can substantially increase a person's risk of developing breast and ovarian cancer. The issue before the Court was whether a naturally occurring segment of DNA is eligible for a U.S. patent by virtue of its isolation from the rest of the human genome, as well as the patent eligibility of synthetically created DNA known as complimentary DNA (“cDNA”).
The patents issued to Myriad gave it the exclusive right to isolate a person's BRCA1 and BRCA2 genes (or strands of nucleotides within the genes) by breaking the covenant bonds that connect the DNA to the rest of the person's genome, as well as the exclusive right to synthetically create BRCA cDNA.
After Myriad's discovery, other entities proceeded to offer BRCA genetic testing services, which involved isolation of the genes. Myriad asserted that the genetic testing conducted by these other entities infringed Myriad's patents, ultimately leading several individuals and advocacy groups to file a lawsuit seeking a declaration that Myriad's patents were invalid under 35 U.S.C. § 101 of the U.S. Patent Act (“Section 101”).
Enter the U.S. Supreme Court
The Court started its analysis by reciting Section 101, which provides that “[w]hoever invents or discovers any new and useful... composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” The Court also noted, however, that there is an implicit exception to this provision for laws of nature, natural phenomena and abstract ideas, which are the basic tools of scientific and technological work and are not patentable. It explained that without this exception, the grant of patents would “tie up” the use of such tools and “inhibit future innovation premised upon them,” which would be at odds with patent law's interest in promoting creation.
The Court ultimately held, in a unanimous decision, that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated...” It reasoned that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes, which existed in nature before Myriad found them, and did not create or alter the genetic structure of DNA. Rather, Myriad's main contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within certain chromosomes. In other words, Myriad found an important and useful gene, but separating that gene from its surrounding genetic materials is not an act of invention.
The Court drew a distinction, however, between DNA that appears in nature and cDNA created in a laboratory. It held that cDNA is patent-eligible because it is not naturally occurring, explaining that cDNA is not a “product of nature” and, except in some circumstances, is eligible for patent protection under Section 101.
What Does It Mean?
There has been significant interest in genetic testing over the past decade, including ongoing debate over the interplay between medical science, business interests and individual rights. The BRCA1 and BRCA2 genes in particular gained recent attention when actress Angelina Jolie announced that she had a double mastectomy after undergoing genetic testing and learning that she had an increased risk of developing breast cancer.
Supporters of the Myriad Genetics decision argue that prohibiting patents on naturally occurring human genes should increase access to genetic testing for disease risk by increasing competition and reducing the price of such testing. They also argue that it should empower scientists to engage in genetic research without the fear of a patent lawsuit. But it's important to remember that the ruling also affirmed the patentability of cDNA created in the laboratory, providing a partial victory to companies that invest in genetic research. It remains to be seen how this distinction is implemented in practice. What is clear is that the Court's decision will play an important role in scientific research and will impact the genetic research and biotechnology industries for years to come.
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