The Supreme Court's Myriad Genetics case has been argued back and forth all year, but the justices finally reached a decision this Wednesday. In the end, they came to something of a compromise: Human DNA cannot be patented, but synthetic DNA can. It's the same solution suggested by the president's solicitor general earlier this year, and is seen by the court as the least painful way forward for everyone involved. Scientists can progress with research, and companies will still have some protection over early discoveries. Still, the decision has left many observers puzzled. Is this a victory for patents? A triumph of science? An early blow to genetic patent trolling before it starts? The answer seems to be all of the above.
Is this a victory for patents? A triumph of science?
So far, both sides of the debate are declaring victory. The narrow issue is Myriad Genetics' claim on the BRCA genes, rare mutations that dramatically increase the risk of breast cancer. And while Myriad doesn't have claim on the genes anymore, their proprietary test has survived unscathed. The "synthetic DNA" clause in the ruling includes cDNA, the synthesized nucleotides used to check for the BRCA gene, so a crucial stage in the process is still under patent. In a statement after the ruling, Myriad reminded investors that the company has "more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test." None of those are for DNA (some of them don’t involve genetics at all), but it’s enough to make sure that no one can copy Myriad’s DNA test outright. That said, the ruling will also make it easier for researchers to develop competing tests, since they can study the gene without risk of infringing on any patents.
At the same time, the coalition of plaintiffs, which included the Association of Molecular Biologists with legal help from the American Civil Liberties Union, is already celebrating. When we spoke to Dr. Haig Kazazian, a Johns Hopkins geneticists and one of the plaintiffs in the case, he could hardly contain himself. "I'm overjoyed that this came through," Kazazian told The Verge. "Losing on the cDNA is, to me, not a big deal. I would oppose it, but I don't think it's that big a deal."
"I'm overjoyed this came through."
Much of the confusion surrounding the results comes from the specifics of Myriad’s test, which works by synthesizing cDNA to test for a specific gene. That’s a good way to test for genes, but it’s not the only way, and more accurate options like small-scale sequencing may already be on the way. This new batch of tests would totally avoid cDNA and, more importantly, Myriad’s patents. It’s good news for breast cancer advocates, who worried that Myriad’s monopoly on the BRCA gene was driving prices up and stifling research on potentially life-saving tests.
That particular test is a hot-button issue, especially after Angelina Jolie's high-profile mastectomy earlier this year, the result of a positive BRCA test result. Still, some doctors are still worried that Myriad's head start in the field might stunt research on the genes. Dr. Kazazian believes Myriad still has a head start thanks to their immense private database of testing information. It's the best tool doctors have for discovering new variants of the gene and stopping more breast cancer cases early — and despite the ruling, it's still proprietary to Myriad.
"Most human gene sequence patents will be expired in the next five years anyway."
Beyond BRCA, the effects of the Supreme Court's decision are more nebulous. Michele Wales, a lawyer specializing in biotech patents, expects the broader implications to be fairly limited. "Most human gene sequence patents will be expired in the next five years anyway, so these monopolies are going away," Wales told The Verge. "Diagnostic companies often rely on method claims, so this decision won’t affect them much either." (Method patents give a company claim to a particular testing procedure, but leave the door open for other tests to be developed.) A broader ruling might have changed the sector more deeply, but the court chose a way forward that leaves most biotech patents the way they are.
And in many ways, the BRCA gene is an exception in modern science: a powerful mutation that's easy to test for, an anomaly among an otherwise cluttered and mysterious genome. Most genes aren’t as well understood, and they’re considerably more difficult to patent thanks to a legal standard called "non-obviousness." To get any patent, a company needs to show its invention is a step beyond the current state of the art. But because of recent advances in whole-genome sequencing, most recent gene patents haven’t been able to clear that standard, and the result is that very few patents like Myriad’s are granted in modern courts. In other words, the business of stockpiling gene patents is just an expensive sideshow — one that's thankfully drawing to a close.
The biggest surprise out of the ruling is the slight precedent the court has set for human genetics going forward. By making a distinction between natural genes and synthetic genetic products, the court has set the stage for a host of future technologies, from GMO organs to man-made gene transplants. None of those technologies exist yet, but this week saw the first glimpses of how the law might treat them: patenting synthetic genes but leaving naturally occurring sequences untouched. If the ruling wasn't as definitive as advocates might have hoped, it's because the justices know this won't be the last time they're asked to litigate the building blocks of life.