The Supreme Court’s ruling last month to strike down gene patents is unlikely to have a widespread impact on the genetic field, as is already being made evident by new lawsuits from Myriad Genetics against rival gene testing services. In the long run, it may be technological advances rather than legal maneuvers that end the debate.
The case generated quite a buzz at the time, as a large group of molecular pathologists and other plaintiffs charged that they couldn’t properly treat their patients without being able to test genes linked to breast cancer, the most well-known of which were locked up in patents held by Myriad and a few other organizations. For years, Myriad defended these patent holdings, preventing other labs from testing BRCA1 and BRCA2 genes.
As the case approached the Supreme Court, the biotech community itself was split on the desired verdict. A ruling that declared genes ineligible for patents would put testing laboratories on an even playing field, allowing anyone with the proper clinical certification to test a patient for any gene, regardless of whether a company or person had laid legal claim to it. On the other hand, conventional wisdom said that a ruling upholding patents on genes would support the continued viability of the biotech industry as a whole. The certainty of intellectual property, the argument said, is necessary to motivate companies to invest millions in developing diagnostics.
The Supreme Court ruling in June managed an awkward balancing act that will essentially preserve the status quo, despite the spate of lab announcements to the contrary. The court ruled that genes cannot be patented, but that cDNA—a material named for complementary DNA, which is a chemically derived inverse of the original DNA—can be. While Myriad lost its patent claims for the DNA sequence behind the BRCA genes, the ruling upheld the patent claims for cDNA related to those same genes. Scientifically, many methods of diagnostic testing require the production of cDNA, so the gene patents that also cite cDNA are still in effect. Though the court’s decision to invalidate gene patents could be considered a sweeping change, the reality is that many gene patents also list cDNA as a claim, keeping those patents in force.
In the days following the Supreme Court ruling, many service labs announced that they would begin offering testing for the BRCA genes—a step based on what they interpreted as the elimination of those gene patents. After all, this freedom to test a patient’s genes was the original foundation of the lawsuit against Myriad and its fellow patent-holders. But Myriad and the others have already filed suit against two of those labs, charging that they are violating the many parts of the BRCA patent estate that were upheld by the Supreme Court ruling.
IP wonks are already speculating that these patents could be brought to court again, this time with the charge that cDNA should not be eligible for patenting because it is an obvious extension of naturally occurring genes. However, the original BRCA patents will expire in the next few years, so there is not much to gain by taking these particular patents back to court. The real question is whether gene patenting, and now cDNA patenting, would have sparked the interest of the ACLU and gotten so much public sympathy were it not for the vocal and mobilized community of breast cancer patients, survivors, and supporters. It is rare for any type of disease to have such an engagement factor as we see with breast cancer, and rarer still for such a community to map perfectly to a particular gene.
Ultimately, however, the march of technology may settle the issue long before the lawyers can. Clinical laboratories today are still primarily testing individual genes, which puts them directly in the line of fire for groups controlling IP around specific genes. But more comprehensive approaches are making their way into diagnostic labs, and in the long term, it is likely that whole-genome sequencing will be a standard clinical test. That makes an important difference: sequencing the whole genome does not require the isolation of individual genes and can also avoid the production of cDNA. A patient’s entire genome can be sequenced, and all those patent-protected genes analyzed, without overstepping the claims made on most of these gene patents. Whether the interpretation of those genes will be a legal problem depends on how each patent was worded.
In the meantime, the legal skirmishes around BRCA1 and BRCA2 will continue, fueled by an equivocal ruling from the Supreme Court.