Supreme Court rules on patent rights attributed to identification of genes (Association for Molecular Pathology v. Myriad Genetics, Inc.)

The Policy

What it does

Rules on the patentability of identified gene sequences by biotech companies that has reconceptualized our understanding of patent application in the field of biotechnology.

Synopsis

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. 

Context

The Science

Science Synopsis

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.