On June 2, 2016, scientists announced a controversial plan to create synthetic human genomes from scratch. The paper — which they published following reports about a private, off-the-record meeting — outlined an ambitious plan to build human genomes with various, medically relevant properties, like ones that are immune to cancer. But the overall description of the project, called HGP-write, was vague, leaving many with questions about the project’s aims. Chief among them: would the project make it possible to patent a human genome for the first time? And are the scientists involved in the project contemplating this?
A PATENT ON THE GENETIC BLUEPRINT FOR A HUMAN BEING
The short answers to both those questions are “probably” and “yes, they definitely are.” But the longer version — the one that involves a Supreme Court case — is worth paying attention to as well. If the project is successful, it won’t just affect how genetics research is conducted, or how scientists look at humans and their health. It would mean also that the world could end up with a patent on the genetic blueprint for a human being.
For many researchers, that’s a distressing thought. Patents aren’t necessarily bad for science, but in at least one instance, patents on two human genes held by Myriad Genetics, a molecular diagnostics company, impeded research and made testing for an important cause of illness impossible outside of the company’s own test. Both genes have been linked to breast cancer, and the patents meant that Myriad was the only company that could perform genetic test to determine if a woman is at a higher risk for the disease. So, a challenge filed by the Association for Molecular Pathology sought to change that. Its main argument? Human genes aren’t patentable.
The Supreme Court issued its opinion in June 2013 — and it was unanimous. Myriad’s patents were invalid. But in a strange twist, that ruling is now also one of the main reasons that patenting a synthetic human genome might be possible.
To file or not to file?
Two of the prominent scientists involved in the project said patents were a possibility. “I think that if you made a virus-resistant mammalian cell line that could be used for manufacturing orphan drugs, and so forth, that would make a lot of sense to patent that,” George Church, a geneticist at Harvard University who’s tied to the project, told The Verge. Jef Boeke, a geneticist at New York University, confirmed that the subject has come up within the group, but he was more measured in his response. “We’ve certainly talked about the general topic, but we haven’t made any decisions on it as a group,” he said.
“WE’VE CERTAINLY TALKED ABOUT THE GENERAL TOPIC”
Much of the patent discussion will take place later — a synthetic genome could take years to accomplish — and it’ll depend on who funds various portions of the project, Boeke says. The private company Autodesk has already committed $250,000, but researchers hope to gather $100 million in pledged support from public, private, and academic sources within the year. So if the money comes from public sources, it’s possible that at least some of the researchers will try to avoid patenting their inventions. “If we can convince government agencies to publicly fund the project, I would certainly push for a no-patent policy on the cell line and the DNA sequence, but I can’t guarantee that I’ll carry the day,” Boeke told The Verge.
There’s a big difference between filing a patent and actually winning a claim, however. So, we asked a few experts to tell us if they thought a claim on a synthetic human genome would pass muster. In the end, they all told us pretty much the same thing: to understand how this might go down, understanding the Myriad case is key. That’s because when the Supreme Court made its decision, it drew a line between two different types of DNA. The first kind is isolated DNA that does the same job you’d see it do in a person; it doesn’t qualify as “patentable subject matter.” The second kind, though — synthetic DNA that’s markedly different from what you’d find in nature — is something you can legally patent. And that’s the bit that lawyers say matters for HGP-write. Under that rule, a synthetic human genome like the one Church described — one that resists all viruses and pathogens — would probably eligible for patenting, too.
“THAT LIKELY COULD BE ELIGIBLE FOR PATENTING”
“If we read that decision onto Church’s plans, at least as we understand them, then that would say a synthetic genome — in fact any segment of synthetic DNA — is patentable subject matter,” says John Conley, a law professor at the University of North Carolina and a lawyer for Robinson Bradshaw, a firm that assisted Church in getting the Personal Genome Project off the ground a few years ago. Courtenay Brinckerhoff, an intellectual property lawyer at Foley and Lardner who works on life science cases, agrees. “If they’re changing the DNA sequences, then that likely could be eligible for patenting.” And that’s pretty much the argument that Church made on the phone. “You obviously can’t patent things that are natural, but here we are talking about something decidedly unnatural,” he said.
As for a cell line patent, that would likely be doable as well. Scientists already hold patents for cell lines, even human ones, so cells that are produced by HGP-write would probably be eligible. In fact, patenting a cell line instead of the synthetic genome itself might actually be easier to do, in part because the filing is more specific, says Robert Cook-Deegan, a genomics and intellectual property expert at Duke University. “One would guess that [lawyers] would build out from the precedent of many other human cell lines,” he told The Verge.
Eligibility is just the start
There’s a lot more to a patent filing then determining if something’s eligible. To hold a patent, lawyers will also have to show that a cell line or genome is novel and “non-obvious,” rather than a development that just follows the general progression of the field.
And so, making that determination means looking not only at an invention, but also at the field as a whole, Conley says. Recently, the federal circuit, the appellate court below the Supreme Court that hears patent appeals, has been fairly liberal when it comes to designating a life sciences invention as “obvious,” and that could play against HGP-write, he says. But until the group releases more information about what it plans to patent, it’s hard to know for sure how this will play out.
“One of the rules about patent law is that you don’t actually know how to figure it out unless you get down into the nitty gritty details,” Cook-Deegan says. “Whether they obtain the patents will depend very crucially on the decision that the people trying to get the patents make.”
“THERE WILL BE SIGNIFICANT UPROAR, BACKLASH”
Because of the Myriad case, the mere mention of patents can be uncomfortable for researchers who aren’t involved in HGP-write. “If it’s a product that has such global implications, there will be significant uproar, backlash,” says Charles Rotimi, director of the Center for Research on Genomics and Global Health at the National Institutes of Health. “From a societal point of view, it may be difficult to say, ‘I’m just going to be the roadblock to everyone else.’” Lawrence Brody, director of the Division of Genomics and Society at the NIH, is more open to the idea, but only slightly. A patent could be a positive development for research, because filing one forces scientists to share their methods with others, he says — just “as long as it won’t prevent anyone from doing anything else.”
If Brody and Rotimi’s reactions are any indication, the patent discussions surrounding HGP-write are bound to be controversial. And in many ways, that’s a sign of the project’s potential. Few would worry about this if it there wasn’t at least a slim chance that building a useful synthetic human genome was possible. But until we know more what the researchers are planning there’s little to do but speculate.