The US Supreme Court has ruled that certain patent claims owned by Myriad Genetics, the US biotech company that holds the patents covering a test for breast cancer related genes (BRCA1 and BRCA2), are invalid as products of nature.
The implications for this decision, handed down on June 13, may not be as far reaching in the biopharma industry as some have speculated. The decision is not likely to deter the innovation that is driving critical discoveries and therapies in the sector. In a decision that leaves some important questions unanswered, the Court both took away and left certain subject matter intact as patent eligible. Full genes as excised from the genome, including coding and non-coding regions as they “occur naturally,” are no longer patentable. However, genes which have been manipulated in the lab (e.g., cDNA) are patentable and valid.
Key to the Court’s decision that a naturally occurring DNA segment is “a product of nature and not patent eligible merely because it has been isolated” 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 genes. In other words, the sequence and coding information is inherent in that gene, isolated or not.
The Court noted: “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 since they did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes or the sequence of the DNA.
Importantly, the decision allows for complementary DNA, or cDNA, to be patent eligible under 35 U.S.C. §101.
The Court specifically noted 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 regions, or introns, are excised. The Court reasoned that the production of cDNA creates something new when introns are removed from a DNA sequence. While this holding is crucial for the protection of important areas of biopharma innovation, this aspect of the Court’s ruling – however welcome – is remarkable because the sequence of cDNA is the same as naturally occurring mRNA.
The Myriad decision did not involve method claims, the use of BRCA1 and BRCA2 genes, or the patentability of DNA in which the naturally occurring nucleotide sequence has been altered. Interestingly, challenges on gene patents in Australia and Europe have all resulted in law in this area remaining unchanged, where new inventions relating to isolated biological materials, including genes, remain patentable.
Among the questions left unanswered by the decision is the effect it will have on patents for other isolated biological materials and other organisms. For example, a strict reading of the decision would imply that bacterial DNA is no longer patentable because bacterial genes do not contain introns. Although produced in the lab, cDNA for a bacterial gene looks like the naturally occurring gene (i.e., only exons). In Myriad, cDNA was not considered “a product of nature” and patent eligible “except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”
While the decision will impact patents for certain gene-based diagnostics, the biopharma industry will not likely be significantly altered. Our understanding of genomics, genetic-based disease and accompanying therapies today is different from the days when BRCA1 and BRCA2 were cloned and diseases were thought to be triggered by single genes. Further, many gene patents are old and will expire in one to five years (Myriad’s patents on cDNAs expire in 2015). New testing methods, such as whole-genome sequencing, are replacing the approach Myriad and others use, also lessening the impact of this decision. Synthetic DNA sequences (e.g., cDNA) made in the lab are more commonly used in diagnostic tests, so patents covering such tests will be unaffected by this decision and will remain enforceable.
Given that patents on full-length, naturally occurring genes with introns and exons will no longer be a barrier to entry for diagnostic companies, going forward the market will see more competition. In fact, after the Myriad decision, several companies, including Pathway Genomics, Ambry Genetics, GeneDx and DNATraits, all immediately announced plans to launch competing BRCA breast and ovarian cancer tests. Some are pricing the test as low as $995, compared with the $3,000 or more Myriad charges. So it appears the decision is a partial victory for all involved, including the patients and the companies delivering genetic tests.