The U.S. Supreme Court finally ruled today on patenting breast-cancer genes. The ruling found that naturally occurring genes aren't patentable. If you make a synthetic version, however, that is your own work.
"The Court's decision strikes a middle ground that likely will not be particularly disruptive," Tom Goldstein, a Harvard Law School professor and publisher of SCOTUSblog, wrote in his publication's liveblog about the ruling.
Scientists from Myriad Genetics in Utah were the first to find and isolate BRCA1 and BRCA2, two major genes that affect people's chances of getting hereditary breast, ovarian and other cancers. The company holds numerous patents relating to those discoveries, which opponents say is unreasonable, because genes are products of nature, not patentable inventions. The case made its way to the Supreme Court because one group—including doctors, researchers and patient advocacy organizations—has been challenging Myriad Genetics' BRCA1 and BRCA2 patents since 2009.
Among Myriad's patents are ones that say the company has the rights to any isolated BRCA1 and BRCA2 genes. That means it has the exclusive right to offer testing for those genes, since you gotta isolate 'em to test for 'em. Yes, those are the same tests that, for example, Angelina Jolie took before deciding to get a preventative double mastectomy.
The new ruling says that even when isolated, naturally occurring genes aren't patentable because they're a product of nature, just like Myriad Genetics' opponents originally claimed. It doesn't matter that Myriad Genetics invested a lot of money, time and talent into finding BRCA1 and BRCA2. "Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry," Justice Clarence Thomas wrote in the court's opinion. §101 distinguishes between patentable inventions and un-patentable abstractions.
Nevertheless, some products from Myriad Genetics' research into BRCA1 and BRCA2 received protection from the Supreme Court ruling. When the company builds synthetic versions of the genes that are different from how they appear in nature, then those genes are patentable. The Supreme Court opinion talks about Myriad scientists making synthetic breast-cancer genes that have everything removed except for the portions responsible for coding proteins. It wasn't immediately clear from the opinion what Myriad plans to do with those synthetic genes.
Gene patenting is a legally contested area in a variety of genetic sciences, not just cancer genetics. Thomas concluded the court opinion with an eye for other interested parties that are watching. The Myriad Genetics ruling doesn't apply to genes that have been altered from their natural state, he wrote. That should include many genetically engineered crops, for example.
The ruling also doesn't preclude Myriad from patenting uses of the knowledge it gained from BRCA1 and BRCA2, Thomas wrote.
If ANY gene is in a position where it can reproduce itself into and show up in a totally different organism, it should not be patentable! The origin just plain doesn't matter! Monsanto has already been taking advantage of patented genes to produce GM crops that produce GM pollen which spreads to other farms, then suing those farms for stealing their GM BS. This ruling is nonsense!
Kage, there is not a simple solution to this.
Are the millions of genes in your DNA all natural and pre-existing? Yes. Did the companies in question invent the gene? Nope. But they did isolate it. They decoded what it meant, and correlated it to something important. Before it was just 1000 random base-pairs. Now it is a reliable signal for breast-cancer that will save lives. And it cost them a lot of money to make it do that.
And if the company can't be entitled to exclusive rights to make money from that discovery, they don't have much incentive to invest resources discover a new one. A ruling like this means present-day gene informatics will be cheaper, but development of new ones will be slow. Short-term benefit, long-term detriment.
I applaud the court for going half-way - that means they understood the problem, and tried to find a balanced solution.
But My main concern is that progress will be slowed. Companies won't patent discovered genes; they'll just isolate them, discover their effect, develop tests for it, and then keep that information hidden. They'll develop reliable tests and sell the results, but the rest of the scientific community and industry won't be able to integrate their discoveries into their own developments and treatments. It's encouraging keeping medical scientific information secret rather than sharing it openly in exchange for temporary legal intellectual property rights.
Time will tell if its a beneficial trade-off or not.
Brian 144 I disagree that you say if they can't patent these genes they can't make money. Its just that they won't be the only ones who can make money on it. This is the same as discovering oil and saying that the person that discovered oil is the only one who can use oil for profit. If anything progress will be quickened because mroe people will have access to this data.
I agree with ianredneck
Better/faster scientific progress through open access. Also I HIGHLY doubt that a scientific team, lab, or company as a whole would choose to keep information they discover about a gene secret. If they did it would only be for a short while. The reason for this is that scientists need to publish their data for credibility, to keep their jobs, and to advance their careers and funding opportunities. Holding onto info/newly discovered data about a gene for too long raises the possibility of another team to publish the same material. This is particularly the case for any highly original discovery. There are so many highly competitive companies and institutions these days, it just wouldn't be worth the risk to keep it on the hush for too long.
Scientists working for coorperations don't rely on publications and grant money.
@Lanredneck, your analogy is flawed. They haven't produced a product. They've discovered information in a product - they've discovered something unique in a large pile of what looks the same.
The issue is analogous to another part of the medical industry - FDA clinical trials for safety. With a new product, someone has to run extremely expensive clinical trails to prove that it is safe in humans. But once this has been proven, any company can sell a similar product with minimal testing. So without a patent, a product strait up will-not-get-made because the company can't be certain of a good return on their investment, due to competition. And anyone that works in the medical industry will tell you about a miracle-product that doesn't exist precisely because of that. My story is an ideal anti-coagulant coating for catheters. Guy talked about it at a conference over a year before his patent application. Denied. Product doesn't exist.
Same thing is here. One company spends the tens or hundreds of millions of dollars trying to cess out properties of a gene. But once that is discovered, anyone can search for that gene in the sequence, and tell somebody with equal confidence. Think of a math test. The first guy has to go through and solve all the problems, write down the answers, and then offer his grading services to the test-takers. But with this ruling, anybody can copy his answer key, and offer an identical service without any investment.
I figured you would say that, except you are disregarding the fact that we are talking about "genes." With the magnitude of gene screening technologies out there, you would expect multiple corporations to make similar (if not the same) findings given enough time.
I agree that it would make investment more difficult, and profit uncertain AT FIRST, but it also opens the possibilities for new findings through open access, thus making more opportunities for investment.
Well, there is another article in PopSci about the question whether the government should fund research for "unpopular science" (read "unprofitable science"). Genetic research should become one of those fields then. The profit in the long run would be a healthier society in general and lower health-care cost.