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Following their discovery and isolation of the BRCA1 and BRCA2 genes, mutations which are associated with an increased risk of breast cancer, Myriad Genetics applied for and received patents for the isolated stretches of DNA that make up those genes and the complementary DNA (cDNA) strands made from them. In their ruling in Association for Molecular Genetics v. Myriad Genetics, Inc, the United States Supreme Court held that while isolated genes themselves that occur in the human body cannot be patented, products of those genes—in this case the complementary DNA (cDNA) of the isolated genes—are patentable. Specifically, this ruling held:

  • While identifying and isolating the BRCA1 and BRCA2 genes represents a groundbreaking and innovative discovery, that criterion alone does not entitle the discoverer to a patent; furthermore, because the location and order of the nucleotides existed in nature before Myriad Genetics found them, the isolated genes themselves are considered a part of nature, like gravity, and cannot be patented as the Supreme Court held in Funk Seed Brothers Co v Kalo Inoculant Co ;
  • Additionally, in a reversal of the judgment of the United States Court of Appeals for the Federal Circuit, the Supreme Court found that isolating the BRCA1 and BRCA2 genes from the larger strand of DNA does not represent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” of that DNA by Myriad Genetics. Patents are granted for inventions, which can include useful methods or processes if they are novel and inventive enough. Here the Supreme Court held that isolating specific stretches of DNA from the molecule, while an impressive technical achievement, did not represent a fundamentally inventive thing. Thus, being a part of the laws of nature and a natural phenomenon, isolated DNA alone is not patentable ;
  • However, Myriad Genetics retained the patents on the cDNA of both the BRCA1 and BRCA2 genes, as they are synthetically created and contain a sequence of nucleotides different than those found in the isolated genes. 
The facts 

In 1994, Myriad Genetics Inc., in collaboration with the University of Utah, McGill University, and the National Institutes for Health (NIH), identified and sequenced the first known hereditary breast and ovarian cancer susceptibility gene, BRCA1, and applied for a patent on the isolated sequence the same year. The following year, Myriad isolated and sequenced the second such gene, BRCA2, and applied for a patent on the isolated sequence in 1995.

In 1996, backed by the patents for the isolated gene sequences, Myriad launched a breast-cancer diagnostic test, called BRCA Analysis, to detect specific mutations in the BRCA1 and BRCA2 genes linked to an increased risk of breast or ovarian cancer in women. Many doctors worried that the exclusivity granted on isolated genes would impede their ability to test and diagnose patients. Eventually the Association of Molecular Pathology, joined by researchers at the University of Pennsylvania, sued Myriad Genetics in the United States District Court for the Southern District of New York.

On March 29, 2010, Judge Robert W. Sweet of the Southern District invalidated all patent claims brought by Myriad Genetics, ruling that “DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes”. Therefore, genes simply isolated from the human genome cannot be patented. Myriad Genetics filed an appeal, and the case went to the United States Court of Appeals for the Federal Circuit.

On appeal, the Court of Appeals for the Federal Circuit agreed in part and reversed in part the district court’s ruling. Judge Alan Lourie, writing the majority opinion, reasoned that because isolated genes were “markedly different” than genes found in the body, the isolated genes represented a composition of matter and could be patented. After the ruling, the Association of Molecular Pathologists petitioned for a writ of certiorari to the Supreme Court.

The Supreme Court granted the writ of certiorari, vacated the Federal court’s ruling, and remanded the case to the US Court of Appeals for the Federal Circuit. The Supreme Court had recently issued the Mayo v Prometheus decision. In it, the Court established as precedent that some methods of medical diagnosis —which could include Myriad’s BRAC Analysis—could not be patented as they are natural phenomena.

The FC CoA again ruled Myriad’s isolated gene sequences were patentable. The court did not agree that Mayo’s precedent applied, interpreting Mayo as inapplicable to gene patents. Instead, the Federal Court again found that the BRCA1 and BRCA2 genes, once isolated, were different from genes found in the body, and therefore were a patentable invention rather than a reflection of a natural phenomenon.  The case was then appealed to  the Supreme Court again, leading to the June 2013 decision.

Relevant Science 

Genes are the basic unit of heredity that form heritable traits in living organisms. Each gene is composed of stretches of deoxyribonucleic acid (DNA) that code for a particular protein. The unique sequence of four different types of nucleotides—marked by the presence of the nitrogenous bases adenine, thymine, cytosine, or guanine—is what defines a gene as the basic unit of heredity. Within a gene, some stretches of nucleotides code for proteins; some stretches do not. Within the protein-coding sequences, each set of three adjacent nucleotides codes for a particular amino acid. In turn, amino acids are the building blocks of proteins; thus the sequence of As, Ts, Cs and Gs within a gene codes for the amino acids that make up a complete protein. Scientists are able to isolate, extract and read specific stretches of DNA (including protein-coding genes) using methods that do not alter the order of nucleotides within the isolated region.

cDNA is a type of DNA synthesized in a lab that is a copy of the original DNA sequence with one important distinction: cDNA only contains exons, stretches of nucleotides that code for proteins. 

Where & When 

The United States Supreme Court delivered its ruling on June 13, 2013. 

Primary Author 
Bryan McMahon
Editor(s) 
Thomas Williams, JD, MBE
Recommended Citation 

Duke SciPol, "Association for Molecular Pathology v. Myriad Genetics" available at http://scipol.duke.edu/content/us-supreme-court-rules-patent-rights-attributed-identification-genes-association-molecular (12/08/2016).