Opinions

The Supreme Court should invalidate the patent on human DNA

Jeffrey Rosenfeld is an assistant professor of medicine at the New Jersey Medical School and a member of the High Performance and Research Computing Group. Christopher E. Mason is an assistant professor of computational genomics at Weill Cornell Medical College and affiliate fellow of the information society project of Yale Law School.

Asked in 1955 whether his polio vaccine was patented, Jonas Salk replied, “There is no patent. Could you patent the sun?” With that, Salk debunked the misguided notion of patenting objects found in nature. His polio vaccine was not a new invention but an inactive form of the natural polio virus.

Today, Salk would be shocked to find that your DNA belongs not to you but rather to many companies and institutions that have patents on the DNA from your cells. Forty-one percent of the genes in your genome are not legally yours, according to a long list of gene patents that have been granted since the 1980s. These patents cover thousands of human genes and restrict a doctor’s ability to look at your DNA and plan your medical treatment. These patent claims contradict an intuitive sense that your DNA is no less yours than your lungs or kidneys.

Fortunately, the Supreme Court has a chance to rectify this genetic injustice. The justices will hear oral argument April 15 over a lower federal court’s decision that human genes can be patented. The case involves Myriad Genetics, which received patents in the 1990s for the exclusive right to examine any isolated DNA that contains the BRCA1 and BRCA2 genes. Most people have normal versions of these genes, but those who carry mutations of BRCA usually have an 85 to 90 percent risk of developing breast or ovarian cancer. Doctors cannot independently look at the genetic code in a person’s BRCA genes, because as soon as blood is drawn and DNA is isolated to examine those genes, it is immediately the legal property of Myriad Genetics.

Like many scientists, we believe that these patents never should have been granted and that the genes of the human genome, like other natural body parts, belong to their owners, not to companies seeking to exploit monopolies. If the court allows these types of patents to stand, it will put the endeavors of openly researching, preventing and treating lethal diseases on a lower level of importance than a set of ill-conceived property rights.

Because of Myriad’s patents, any American who wants to have his or her DNA tested for the potentially life-threatening BRCA mutations has to use the services of Myriad Genetics. There is no possibility of an independent test. Myriad charges about $3,000 for the testing, but hundreds of clinical laboratories nationwide could do it for less than $200.

Worse, the restrictions of Myriad’s patents are not limited to breast cancer genes. The company claims any piece of DNA having “at least 15 nucleotides” of the BRCA1 gene. In work we recently published in the journal Genome Medicine, we found that these short sequences in BRCA1 also appear in 689 other genes that have a wide variety of functions, including brain development and proper cardiac functioning.

Myriad’s claim is outrageous but must be understood in context. All of the genes in the human genome share 15 nucleotide sequences with numerous other genes. So the broad reach of a patent on a single gene is not unique to Myriad’s claims on BRCA1. If patents allow claims for 15 nucleotide sequences, then a patent that was issued for bovine improvement to Cargill, an agricultural company that provides advice on cattle breeding, covers 84 percent of human genes, even though Cargill is interested only in cows. This lack of specificity underscores why patents on short, indiscriminate DNA sequences never should have been issued.

Patenting such a fundamental piece of the human genome has been opposed by thousands of scientists and clinicians, hundreds of medical organizations, and many Nobel laureates. Some have likened it to patenting elements of the periodic table. Such patents grant an exclusive claim that covers an entire landscape of rights in non-related fields. In the case of BRCA1, data from large-scale cancer projects such as the Cancer Genome Atlas have shown that BRCA1 is mutated in not only breast and ovarian cancer but also at least 21 other types of cancer that afflict both men and women. Myriad’s patent means it owns the monopoly on testing DNA from any patient for any of those cancers, even though the company does not do work on the majority of those diseases. So Myriad’s control extends far beyond just breast cancer testing, inhibiting the creation of optimal tests for many other cancers.

Some argue that patents to genes are essential to encourage pharmaceutical companies to invest the resources required to produce new therapies and to identify unknown genes. But the sequencing of genetic variants is a very small part of drug design. Of course, once a pharmaceutical company has developed a novel therapeutic agent to target a specific disease, that treatment can be patented and should be rewarded for its innovation.  Others argue that the testing company must be compensated to encourage it to develop new tests. But companies such as Quest Diagnostics and LabCorp are extremely profitable while performing routine tests that are not covered by exclusive patents.  

All Americans should have the freedom to test their DNA as their doctors deem necessary. It is imperative that the Supreme Court invalidate Myriad’s patent, defend genomic liberty and make clear that one’s genes belong to that person alone. 

 
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