Since the 1980s, patent lawyers have been claiming pieces of humanity's genetic code. The United States Patent and Trademark Office has granted thousands of gene patents. The Federal Circuit, the court that hears all patent appeals, has consistently ruled such patents are legal.
But the judicial winds have been shifting. The Supreme Court has never ruled on the legality of gene patents. And recently, the Supreme Court has grown increasingly skeptical of the Federal Circuit's patent-friendly jurisprudence.
Meanwhile, a growing number of researchers, health care providers, and public interest groups have raised concerns about the harms of gene patents. The American Civil Liberties Union estimates that more than 40 percent of genes are now patented. Those patents have created "patent thickets" that make it difficult for scientists to do genetic research and commercialize their results. Monopolies on genetic testing have raised prices and reduced patient options.
On Monday, the high court will hear arguments about whether to invalidate a Utah company's patents on two genes associated with breast cancer. But the legal challenge, spearheaded by the American Civil Liberties Union and the Public Patent Foundation, could have much broader implications. A decision could invalidate thousands of patents and free medical researchers and clinicians to practice medicine without interference from the patent system.
Life-or-death stakes
The ACLU has cast a Utah biotech company called Myriad Genetics as the villain in its campaign against gene patents. Almost two decades ago, the University of Utah (a defendant in the original lawsuit) sequenced two genes, called BRCA1 and BRCA2, that are associated with an elevated risk of breast cancer. The University patented their findings before eventually licensing them to Myriad. Since the company began using said patents, it has enjoyed a de facto monopoly over testing and research related to the genes. Currently, Myriad even has a monopoly on the implications of various genetic differences, though some people are trying to undercut that as well.
"When Myriad genetics began cracking down and closing labs, no one else could offer the test," said Ellen Matloff, a cancer genetic counselor in an ACLU-produced video. Researchers began to suspect that Myriad's test was giving false negatives for some mutations of the BRCA genes. But Matloff says that when she asked for permission to offer a supplemental test for patients who got a negative result from Myriad's test, she was told that doing so would violate Myriad's patent.
Kathleen Maxian, a woman with late stage ovarian cancer, believes that Myriad's patents may have prevented her from catching the disease soon enough to get a hysterectomy. A few years earlier, her sister was diagnosed with breast cancer and took Myriad's test to see if the cancer might have a genetic basis. Because her sister's test came up negative, Maxian chose not to get tested herself.
Myriad eventually offered Maxian's sister a more comprehensive test that showed her family had a genetic predisposition toward breast and ovarian cancer. But it was too late to help Maxian. She believes that without Myriad's patent restrictions, other labs would have offered a more comprehensive test earlier, potentially saving her life.
Product of nature of human invention?
A fundamental principle of the Supreme Court's patent precedents is that only inventions, not discoveries of natural phenomena, are eligible for patent protection. In last year's Mayo v. Prometheus decision, for example, the high court examined a patent that instructed doctors to adjust the dose of a drug based on the level of a particular chemical in the patient's blood. Justice Stephen Breyer, writing for a unanimous court, ruled that the patent was invalid because the patent effectively claimed ownership of a fact about human biology. The only "invention" consisted of "well-understood, routine, conventional activity" to measure the patient's blood chemistry.
The ACLU argues the same point applies to Myriad's gene patent. Myriad acknowledges that it can't patent genes while they're in the human body. But it argues that the BRCA genes become eligible for patent protection once they are "isolated" from the human body. But the ACLU counters that the differences between "natural" and "isolated" genes are not significant enough to make the latter a human invention rather than a mere discovery.
"Gold does not become patentable once taken out of a stream because it can be used in jewelry," the ACLU argues in its brief. "Kidneys do not become patentable once taken out of a body because they can be transplanted."
Myriad's genes were originally invalidated by a trial court judge in 2010. But his ruling was overturned on appeal in a 2-1 vote. The appeals court majority held that the process of removing DNA from the body and isolating a BRCA gene from the rest of a patient's genetic material effectively creates a new "composition of matter" that is eligible for patent protection.
Last year, the Supreme Court ordered the appeals court to give the case another look in light of its ruling on the diagnostic testing issue in Mayo v. Prometheus. But the appeals court again ruled that the patents were valid.
"Although isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body," wrote Judge Alan Lourie for the court's majority. In his view, that difference was sufficient to merit a patent for Myriad.
But his colleague, Judge William Bryson, disagreed. "The informational content of the nucleotide sequences is the critical aspect of these molecules," he wrote. He noted that the chemical differences between the "natural" and "isolated" version of the BRCA genes were not even mentioned in Myriad's patent claim.
The ACLU's view enjoys broad support from the medical profession. "Genetic information is integral to health care professionals’ determination of which diseases a patient might be suffering from and which treatments might benefit or harm that patient," the American Medical Association argued in an amicus brief. "Patents on human genes interfere with health care professionals’ ability to provide appropriate care to their patients. These patents inhibit, rather than encourage, scientific research and technological innovation."
Stay tuned Monday for our coverage of Monday's oral arguments before the Supreme Court.
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