Sixty years ago, scientists first discovered DNA, the structure in which a person’s genes are encoded. Since then, our knowledge of the genome has revolutionized medicine. But when it comes to the U.S. legal system, important questions about what a gene is remain unsolved.
Here's one question: If a gene is patentable, does that mean a company can claim the rights to the gene's offspring?
The U.S. patent law was written in 1793, and it certainly didn’t take into consideration a biological invention that could make endless copies of itself. So when Vernon Bowman, a 75-year-old farmer, decided to save some cash and buy seeds from a bulk grain distributor (seeds that were arguably protected by a patent), did he break intellectual property law?
Here's another: Do law enforcement need a search warrant to take a sample of a person's DNA? When the state of Maryland swabbed the cheek cells of Alonzo King when he was booked for assault, were they violating his Fourth Amendment right to privacy, since those cells would be crucial in convicting him of a crime committed six years earlier? To what extent is DNA protected private information?
As is often the case, U.S. law has still not caught up to the science. Three cases coming before the Supreme Court this term will have a significant impact on the future of genetics and the law. Each contains its own powerful question about genetics and what it means to criminal justice and industry.
1. Can You Patent a Piece of the Human Genome?
The first precedent for the patenting of genetic code can be found in the 1980 case Diamond v. Chakrabarty. Ananda Mohan Charkrabarty, a microbiologist, had engineered a strain of bacteria that could break down crude oil. The idea was that these bacteria could be unleashed at the site of an oil spill and clean it up through biological action. When Charkrabarty went to patent his creation, the examiner rejected his claim on the grounds that bacteria are products of nature, and you can’t patent nature.
“Defining a gene can be difficult, but in the broadest sense it’s easy—it’s a packet of information,” says Dr. James P. Evan, a professor of genetics and medicine at the University of North Carolina. “And if you have not really changed the content of that, the informational content, you don’t deserve a patent.”
Because Chakrabarty had actually created something novel, he won the case. But he was dealing in bacterial genetics. The question gets a little more confusing when it comes to human DNA, as we’ll find in the upcoming case Association for Molecular Pathology v. Myriad Genetics.
Here’s the background. If you’re a woman, you really don’t want to have a mutated version of the genes BRCA1 or BRCA2. That because 60 percent of female carriers of those genes develop breast cancer during their lifetime (compared with 12 percent of women in the population at large).
Myriad Genetics found a way to isolate the BRCA genes for testing, and have patented that technology. But they took the patent a step further. Claiming that they altered the BRCA genes to a degree not found in nature—that is, took them outside of a strand of DNA—they also filed a patent on the genes themselves.
What this means is that every diagnostic test for BRCA has to be run through Myriad, and any lab that wants to run experiments on the gene must go through the company as well. The test for the BRCA genes costs $3,000, and opponents of Myriad say such a monopoly on the human genetic code is unfair and it inhibits cancer research.
The question that has to be answered by the Court is this: In isolating the gene, did Myriad invent it?
Evan (who thinks the Court should side against Myriad) offered an analogy to explain what Myriad’s opponents are angry about. It was as if Myriad went into a public library and took Moby Dick (a book in the public domain), cut it up and changed some words around, and declared it to be something new. A lower court shot down the patent on the grounds that Myriad unfairly took ownership of a force of nature. The Supreme Court will also decide whether human genes are eligible, in any circumstance, for patenting.
2. Does Collecting Genetic Information Without a Warrant Constitute an Unreasonable Search and Seizure?
AP Photo/Winfried Rothermel
In Maryland, if you’re booked for a crime, the police will take a sample of your DNA. This serves two purposes: One is to ensure identity as you proceed through the justice system; the other is for solving crimes. In 2009, Alonzo King was arrested for assault. The swab of cheek cells they took from him were matched a few months later to those in an unsolved rape case from six years earlier. And King was convicted.
The King legal team argues that the cheek swab amounts to an unreasonable search and seizure, which is forbidden under the Fourth Amendment. Usually, to investigate a cold case, police would need to get a search warrant to go digging around in a person’s belongings.
Just to be clear, Maryland and the other 26 states that collect DNA samples aren’t storing the whole genome of a person. They just take 13 benign “markers,” which are thought to have no association with an identifiable trait, but are still significant enough to match a person or relatives of that person. These 13 markers are a national standard.
“The nuance regarding DNA in the Maryland case,” says Sara Katsanis, a genetics and legal policy researcher at Duke University, “is whether there’s anything regarding those markers that would be more subject to privacy, or is a simply like a fingerprint.”
Science only becomes more sophisticated over time. What worries opponents of DNA swabbing is what these supposedly benign markers may be able to tell investigators in the future. “We selected the markers because they were believed to be benign,” Katsanis says. “But as we understand more and more about the genome, those markers become more and more related to traits that we are uncovering as we learn more about the genome. There’s an unpredictability of whether or not these are actually benign or not.”
There are huge consequences for justice here. "I think this is perhaps the most important criminal procedure case that this Court has heard in decades," Justice Samuel Alito said during a hearing this week. On the technological horizon are rapid DNA analyzers that can process these 13 genetic sites in 90 minutes or less. What if, in the future, instead of asking for a driver's license when a person is pulled over, police ask for a cheek swab? That's an extreme possibility, but this case could set the precedent or boundaries to that scenario.
Maryland says that the cheek swab is not all that invasive, and should be considered to be like a fingerprint. Plus, it helps get criminals off the streets. But as Scalia said during the hearing earlier this week, the Fourth Amendment by design slows down the justice system. “I'll bet you if you conducted a lot of unreasonable searches and seizures, you'd get more convictions too," he said.
3. You Can Patent a Gene, but Do You Retain the Rights to Its Progeny?
AP Photo/Dan Gil
Never before the age of genetic engineering did inventions have the ability to make copies of themselves.
Seed giant Monsanto owns the patent for a soybean that won’t die when the weed killer Roundup is sprayed on it. This is very useful. A farmer can rid his crop of weeds without fearing damage to the money-making plants. In creating a new strand of soybean that did not exist in nature, Monsanto made a patentable invention. But that is not the question in Monsanto v. Bowman. It’s this: At what point does Monsanto’s patent to the genetically modified piece of code expire?
In its contract with farmers, Monsanto stipulates that farmers are not allowed to use the offspring of Monsanto seeds for further planting. To supplement expensive Monsanto seeds in his fields, Vernon Bowman bought commodity seeds (meant for animal feed, not planting). Some of these commodity seeds had Monsanto’s patented technology in them. In planting them, he had created a crop of Roundup-resistant plants without buying them from Monsanto. That’s when Monsanto sued.
Monsanto’s lawyers say Bowman infringed on their patent because the farmer, in essence, re-created their patented technology without their approval. Bowman’s lawyers say that like any other invention you can buy, the patent is exhausted at the point of sale (i.e., no one will sue you for selling a second-hand piece of patented technology). The stakes here are actually larger than realm of farming. The ruling can hold meaning over the copying of computer software, for instance.
As Andrew Cohen quips in The Atlantic, “The essence of Monsanto's argument reads rather like a philosophy exam question.” Monsanto’s lawyers argue that “the patent exhaustion doctrine never grants the purchaser the right to ‘make’ new copies of the invention.” But the nature of genetic muddles all of this. Plants create pollen, which hold genetic material and don’t care about silly things such as contracts. Does Monsanto own the intellectual rights to this too? In the past, they’ve argued yes.
Genes complicate the courts because they have something of a dual nature. For one, genes are strands of information—they are bits of data like plots on a blueprint or the swirls on a fingerprint. But genes are also life, capable of replicating, mutating, and holding vast amounts of private information. Would it be contradictory for the Supreme Court to rule in the Monsanto case in favor of the seed company, and in doing so bolster the idea that genes and their progeny are intellectual property; but at the same time, rule in the King case in favor of Maryland, against the idea that DNA is a piece of personal property protected by the Fourth Amendment?
That’s a rhetorical question. The Court doesn’t dwell in philosophy, and will settle these legal matters on a case-by-case basis. But it’s only certain that as our technology becomes more complex, so too will our legal proceedings.
CORRECTION: This article was updated to clarify that the BRCA1 and BRCA2 genes are only associated with cancer if they are mutated.