The Supreme Court unanimously held in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. that a naturally occurring DNA segment is a product of nature and not patent eligible merely because a company has isolated the segment from the rest of the human genome. However, cDNA (complementary DNA) is patent eligible because it has been manipulated in a laboratory and is not naturally occurring. The case arose after Myriad identified the exact location and sequence of the BRCA1 and BRCA2 genes on certain chromosomes; mutations of these two genes can dramatically heighten an individual’s risk of developing breast or ovarian cancer. Myriad registered multiple patents on a variety of gene sequences, both naturally occurring and laboratory-manipulated sequences, effectively creating a monopoly on the genetic-testing market for identifying BRCA1 and BRCA2 mutations. The legality of Myriad’s patents on both the naturally occurring DNA segments and cDNA was the subject of the dispute and the Supreme Court opinion. The Supreme Court’s holding agreed with the position taken by the U.S. Government in its amicus curie brief. The impact of the decision remains to be seen, especially in regards to future research, drug discovery and the price of genetic testing.
Law of Nature Exception: The Court held that Myriad’s DNA claim falls within the “law of nature exception.” Myriad did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA. Myriad’s principle contribution was determining the precise location and genetic sequence of BRCA1 and BRCA2, but the Court reasoned that finding an important and useful gene, even if a groundbreaking or brilliant discovery, does not satisfy the requirements that must be met in order for the DNA segment to be patentable.
cDNA: The Court held that cDNA is not a “product of nature,” so it is patent eligible. cDNA is a kind of laboratory-manipulated, synthetic DNA that can be used for various genetic research purposes. The Court found that a lab technician unquestionably creates something new when a DNA sequence is changed into cDNA. cDNA is used in research, gene cloning, and drug development.
Other Issues Not Considered: The Court was quick to point out that the case did not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of naturally occurring nucleotides has been altered.
As personalized medicine, genetic testing for a variety of medical conditions, bio-banking and the field of medical genetics continue to rapidly evolve, the impact of the Court’s decision may alter the willingness of businesses to invest in the tremendously expensive research and development necessary for isolating and understanding genetic material. However, the decision likely will also provide additional business opportunities for companies as the extent of DNA patentability is better clarified.