On June 13, 2013, the US Supreme Court ruled that certain patent claims owned by Myriad Genetics, the US biotech company that holds the patents covering a test for a breast-cancer related genes (BRCA1 and BRCA2), are invalid as products of nature.
The Court held that a naturally occurring DNA segment is “a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.”
Key to the decision was the finding that isolating DNA from the human genome does not change the chemical structure, nor does it alter the genetic information encoded in the BRCA1 and BRCA2 genes. In other words, the sequence and coding information is inherent in that gene, isolated or not.
The Court noted that “The Patent Act permits patents to be issued to "[w]hoever invents or discovers any new and useful . . . composition of matter," but laws of nature remain beyond the domain of patent protection. Myriad's DNA claims were found to fall within this law of nature exception and while Myriad determined the precise location and genetic sequence of the BRCA1 and BRCA2 genes, Myriad did not create or alter the genetic information encoded in the BCRA1 and BCRA2 genes or the sequence of the DNA.
The decision does allow for complementary DNA, or cDNA, to be patent eligible under 35 U.S.C. §101: the Court said that cDNA is not a “product of nature” but, rather, is created in the laboratory and does not exist naturally. cDNA is created from messenger RNA (mRNA) and therefore only includes the coding region of the gene, or the exons, while the non-coding (also referred to as “junk”) regions, or introns, are excised. The Court reasoned that this production of cDNA creates something new when introns are removed from a DNA sequence. This perspective is interesting because the sequence of cDNA is essentially the same as naturally occurring mRNA (though one is DNA, one is RNA).
It is important to note that the decision does not involve method claims, patents on new applications of the use of BRCA1 and BRCA2 genes, or the patentability of DNA in which the naturally occurring nucleotide sequence has been altered.
The implications for this decision may not be as far reaching in the biopharma industry as some have speculated. The Supreme Court both took away and left certain subject matter intact as far as being patent eligible. Full genes, including coding and non-coding regions as they occur naturally, are no longer patentable merely by snipping them from the genome. However, genes which have been manipulated in the lab (e.g., cDNA) are patentable. Most patentees with gene patents have claims that include cDNA, so those patent claims remain valid (e.g., the Myriad patents on cDNAs expire in 2015).
Our understanding of genomics and of genetic-based disease has come a long way since the BRCA genes were patented. Today, most diseases and accompanying therapies are based on much more than just full-length gene sequences. That is, while the decision will impact certain gene-based diagnostics directly, the biopharma industry will not likely be significantly altered. Synthetic DNA sequences made in the lab and not naturally occurring are not only useful but commonly used in diagnostic tests, so such tests will be unaffected by this decision.