This week a US federal court heard a case that may decide whether it is legal to patent human genes.
On Tuesday 2nd February, a Manhattan court presided by Judge Robert Sweet heard attorneys argue for and against a federal lawsuit filed by American Civil Liberties Union (ACLU) and the Public Patent Foundation against the Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation.
The lawsuit challenges the government’s granting of control of patents on BRCA1 and BRCA2 to Myriad Genetics. The BRCA1 and BRCA2 genes are implicated in inherited breast and ovarian cancers. Myriad Genetics have developed a genetic test where for a fee, a person can have their blood tested to see if they carry mutations of those genes that put them at higher risk of developing those cancers.
The ACLU is representing 20 plaintiffs, including the American College of Medical Genetics, the Association for Molecular Pathology, and various individuals, including Lisbeth Ceriani, a 43-year-old woman from Massachusetts whose doctors last year suggested she have a genetic test for BRCA1 and BRCA2 mutations following a breast cancer diagnosis.
When they submitted her blood to Myriad Genetics, they refused to do the test because they didn’t accept her insurance. Ceriani couldn’t afford to pay for the test herself (according to a report in Discover magazine it costs in the region of $4,000), so in the end she didn’t have one. Since Myriad hold all the relevant patents, there is only one test for the BRCA mutations, and the company also holds power over who can and can’t research the genes.
The essence of the lawsuit is that the plaintiffs contest the right of companies to be able to patent “products of nature” and “laws of nature”.
Both sides agree on a number of points: researchers should be free to patent new drugs, new treatments, devices, and even specific DNA sequencing methods. And both sides agree that patent law forbids the patenting of natural phenomenal and laws of nature since these weren’t invented by humans and patent law does not allow the patenting of something that occurs in nature.
According to an ACLU press statement, both sides also agree that DNA in the body is also a product of nature and therefore should not be patented. However, at this point they part company: the defendants claim that “isolation” of the BRCA genes from the rest of the DNA (they have to be separated from the rest of the DNA to study and test them), makes them patentable.
The plaintiffs refute this claim and say that patents on human genes should never have been granted because “genes are identified, not invented”. They argue that no matter how ingenious the isolation process is, it does not alter the structure of the DNA itself and so the genes essentially remain “products of nature”.
They also refute Myriad’s patent claims over the correlations between mutations and cancer because mutations are a “law of nature”: Einstein discovered that e=mc2 but he would not have been allowed to patent it.
Also involved in this case are issues around the First Amendment and the constitution, where by granting patents on the genes themselves, the government has essentially given Myriad exclusive control of all knowledge about the gene, which the plaintiffs argue is a clear violation of the First Amendment.
It is not like a patent for a carburettor, where someone else can invent another kind of carburettor; other researchers cannot “invent around” a gene that has been patented, said the ACLU, which argues that this goes against Article I of the Constitution since gene patents do not “promote the progress of science and useful arts”. Instead, they hamper research, testing and development, they said.
Myriad argues that patents are a necessary incentive for researchers to discover the BRCA genes and develop commercial tests. Also, to disallow them would wreck the basis on which the entire biotech industry is based. According to a CNN report the company is also pushing the point that court precedent is on its side.
The plaintiffs refute these claims. For instance, on the incentive angle, they pointed out that researchers were doing BRCA testing before the patents were granted and Myriad stopped anyone else doing research once it got the patents.
Today, said ACLU, thousands of researchers and clinicians who could be doing BRCA testing and give women the results they want can’t do it because of the patents. Six of the plaintiffs are individual women who say they have been pre-empted from knowing about their gene status because of the patents.
At the end of the 2-hour hearing, after hearing the arguments for both sides, Judge Robert Sweet thanked the attorneys for their clarity and skill, acknowledged the sharp difference of opinion, and touched on the fact this case is of great concern to science and industry and anyone concerned about breast cancer, pointing out that nearly everyone has been affected by the disease in one way or another either directly or because they know people who have, or they care for them.
A ruling is expected in the next few months, according to a statement on the ACLU website.
As we get to know more and more about breast cancer, a disease that affects one woman out of every eight, we are learning that it is not one disease but many, and perhaps even specific to individuals. The chances are that we will need to know more and more about the genetic basis of the disease so treatments can be tailored to suit individual patients.
Should ACLU and the plaintiffs they represent win the case, it could mean a huge change in the field of genetic research, where the race is on daily to patent more and more genes.
About 20 per cent of human genes are now covered by patent claims (including genes linked to Alzheimer’s disease, muscular dystrophy, colon cancer, asthma and many other conditions).
Sources: ACLU, CNN, Discover Magazine.
Written by: Catharine Paddock, PhD