U.S. Court Upholds Status Quo on Gene Patents
Is a gene more like a tree trunk or more like a baseball bat? A federal court Thursday took a stand on the question, ruling that isolated DNA molecules are “not found in nature”, and are therefore more like inventions, such as baseball bats, than natural phenomenon, such as tree trunks.
Using language steeped in metaphor in a packed U.S. federal courtroom, attorneys in July debated the question in a closely-watched case on the right to patent genes that has been working its way through the courts.
At stake: the right of one company – Myriad Genetics – to patent a gene as a human invention under U.S. patent law, which allows patents on inventions but not on products of nature.
In a ruling that largely upheld the status quo in a biotech industry that has been patenting genes for decades, the U.S. Court of Appeals for the Federal Circuit ruled Thursday that “isolated” human genes are patentable. Methods of “comparing” or “analyzing” DNA sequences are, however, not patent eligible, it ruled.
In a two-to-one decision, the court affirmed Myriad’s right to claim intellectual property rights on the BRCA-1 BRCA-2 genes, genes where mutations indicate a woman has an 82 percent increased risk of developing breast cancer.
The company’s patents on the genes are the basis of a breast cancer indicator test that has been a profitable asset in the company’s portfolio of intellectual property.
The American Civil Liberties Union (ACLU), representing a group of about 20 plaintiffs, including the breast cancer patient advocates and geneticists, several years ago launched a legal challenge to Myriad’s right to patent the genes.
The plaintiffs, including patient advocacy group Breast Cancer Action, have argued that Myriad’s IP rights to the genes allow it to block others from testing for – or even looking at – the BRCA-1 and BRCA-2 genes, a right they say Myriad has exercised in the past with legal threats.
Plaintiffs have also argued the patents raise prices for testing and essentially create a market monopoly which blocks the poorest from getting tested and stifles scientists who want to look at the genes. Yale geneticist Ellen Matloff, a plaintiff in the case, told IPS last year the situation was “horrifying.”
Matloff told IPS that 95 percent of patients she recommended for Myriad’s 700-dollar supplementary BART test, which looks for mutations on the BRCA-1 and BRCA-2 genes, opted not to get it because of its high cost.
Furthermore, those who question gene patents have pointed out that patenting individual genes might even be myopic, especially in a world of whole genome sequencing where the scientific community is increasingly interested in gene interactions, the influence of the environment on genetics (called epigenetics), and other big-picture indicators to understand patient health.
The case has been working its way through the courts. A New York district court judge sided with the ACLU in 2010, but the Federal Circuit Court of Appeals overturned the ruling in July 2011.
The ACLU appealed to the Supreme Court last year, but the Court declined to issue a ruling in the case. Instead, it sent the case back to the Federal Circuit to re-examine in light of its unanimous spring decision that Prometheus Laboratories Inc. did not have a right to patent a certain blood test because the patent was based on observations about natural phenomena.
But Thursday, the Federal Circuit again ruled that genes are patentable. The court wrote, “The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity.”
In its majority opinion the court also highlighted that gene patenting had been standard practice for the U.S. Patent and Trademark Office (PTO) for years.
“Why hasn’t this come up in 30 years,” Circuit Judge Kimberly Moore, who sided with the majority, asked during oral arguments in the courtroom July.
Moore hinted at the biotech sector’s financial stake in gene patents, often key components of diagnostic test IP at the centre of a much-hyped personalized medicine industry. “What about the biotech sector and all the money?” Moore asked.
In his dissenting opinion, Circuit Judge William Bryson wrote, “my colleagues assign significant weight to the fact that since 2001 the PTO has had guidelines in place that have allowed patents on entire human genes… I think the PTO’s practice and guidelines are not entitled to significant weight…”
Sandra Park, an attorney with the ACLU, told IPS her team was disappointed in the Federal Circuit court’s decision, which she said she believed did not take the Supreme Court’s ruling in Prometheus adequately into consideration.
“We think that the Supreme Court’s recent decision is very clear that the Court is very concerned about how patents interfere with scientific work,” Park told IPS. “The Supreme Court has said that the interests of industry in relying on patent protection is not a factor in determining that something is patentable.”
Park said the mere fact that Prometheus argued that it needed its patents to advance its interests, in the Supreme Court’s ruling, was insufficient reason to justify patents.
If the ACLU decides, with the other plaintiffs, to appeal the Federal Circuit court’s decision, it is possible the Supreme Court might decide to hear the case. Such a scenario is not unheard of. In fact, Park said, the Supreme Court decision to overturn Prometheus’s right to its diagnostic patent came after the Federal Circuit twice upheld it.
Park said the ACLU was still deciding its next step. “We are reviewing our options, but we haven’t made any decisions yet.”
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11 comments on "U.S. Court Upholds Status Quo on Gene Patents"
August 20, 2012 7:56pm
The best for society is to increase government funding for research and grant no patent monopolies here.
But some folks want us to believe they have a right to deny other folks the ability to research so as to keep each other from dying.
While a patent on a drug, for all its ills, at least secures that the particular medicine exists, denying research and the creation of new medicines prevents an arbitrary number of future inventions/medicines from coming about.
To drag politics into this... The very wealthy cut the government size and pay few to no taxes and then people like Folta try to use that as an excuse for government super subsidized liberty restricting patents. No dice.
If justice gets served, it will be no such patents and higher taxes on the privileged elite who are exploiting all of that government power as leverage in the private sector without paying a fee for all of that value and costs to our government.
The owners of Boardwalk and Park Place are going to have to give up their properties or pay much higher taxes or the field of play will continue to remain extremely biased, keeping the already wealthy safe and everyone else going up against a huge barrier.
Every asset held is a restriction on all 300 million Americans, so if people want to leave the country to pay no taxes, you won't be missed.
Everyone has a responsibility to society. And these patents abridge people's free will, stifle the progress, and abridge independent creation and thought and even speech.
If you only get a few bucks, you are no business person and likely would do much better with government support of a tax base. That is no excuse to have the rest of the world handcuffed and die without people being able to help each other.
August 20, 2012 3:23am
OBVIOUSLY !!! These genes, MUTATED or NOT, occur in nature. In both forms they naturally occur in humans. This is essentially the same as normal and deseased hearts occuring in humans naturally. Does this mean that they cannot be observed or treated without paying a royalty? Either idea is crazy and inhumane. However, if the genetics company wants to keep their discovery secret until they can develop a drug and thereby get a headstart over other companies, then that should be allowed and their specific drug should be patentable. Should the inventor of a specific surgical method be allowed to patent it to prevent other physicians from using the same method? Of course NOT. Otherwise, we would all have to go to the same surgeon or pay an extra patent fee to get the surgery. Money does not trump humanity and common sense.
August 19, 2012 5:55pm
These patents seem premature, considering the limited knowledge on the rapidly developing field.
August 19, 2012 3:11pm
You still here, Mr. Folta? Did you take my advice yesterday?(for those of you who didn't read my comment, I advised mr. Folta to inspect his gut flora after consuming frankenfoods with built in pesticides) Are you even a real person, or just another corporation posing as one? Oh, sorry, I forgot, corporations are people nowadays, aren't they? Yeah, right!
August 19, 2012 2:43pm
@kevinfolta
So what happens when those genes must be investigated in order to cure cancer (or multiple sclerosis, or ALS)? Since no other scientists can even look at them, what them?
August 19, 2012 2:01pm
Seems to me they got it exactly backwards. As Some1_Else said, everybody's got an asshole (and an opinion) and it doesn't exit by itself. But the innovation was that these scientists created a test to detect a DNA fragment. I agree that they should get paid for the use of their discovery, but how can they patent something that every human body has the ability to make? Isn't that what's called prior art?
This federal court doesn't seem to have much in the way of common sense, but I don't think the conservatives on the Supreme Court will do much better... Wanna bet that it will be a 5-4 split on affirming the lower court's ruling?
August 19, 2012 12:48pm
@KevinFolta
As a Ph.D. scientist with several patents, I can tell you that you've missed the point. New genes are not being invented, their roles are being discovered. The genes themselves have existed and are not new creations, nor are the genes' observed functions new or new creations. The invention is not the gene, the invention is the means of analyzing for it, the means of isolating it, the tests for its function, mutation, etc. The logic you have espoused suggests the first person with a microscope might have patented red blood cells because s/he was the first person to discover them and figure out what they did. In that case, it might well have been the invention of the microscope that was patentable -- observing red blood cells would have supported its utility. If the person who invented the microscope hadn't bothered to look at blood, and someone else did, that next person wouldn't have done anything unique to allow patenting of a red blood cell just by using a microscope to observe it -- using a microcope to look at things is a pretty obvious use of an existing technique. If a unique test has been invented, or unique methods for isolating and identifying a gene's function, then you might have something patentable (unique, non-obvious, useful, etc.). The problem here is that the science, and the lawyers and companies profiting from it, got way out in front of the judicial branch (and is still leading, though by less), and enough established case law and PTO rulings are in place that judges (big fans of using existing case law, i.e., the status quo, rather than creating new law) are reluctant to overturn them. It just happens that a lot of the judicial and PTO history on genes to this point if based on flawed reasoning (judges didn't understand the science).
August 19, 2012 12:29pm
"... isolated DNA molecules are 'not found in nature', and are therefore more like inventions, such as baseball bats..."
please be advised that i have submitted patent requests on various male reproductive organs, eyes, index fingers and various sphincters. as i fully expect to show that these do not appear in nature as isolated entities, i expect to receive patents for these "baseball bat-like" items.
hereby understand that if you desire to use any of these, you will be required to agree to pay royalties based on "pay per play" licensing. discounts may be made based on size...
August 19, 2012 11:50am
Once again kevinfolta you are so obviously working for 'the man'...................
Gainesville, FL
August 19, 2012 11:25am
Bravo on helping scientists recoup some of their investments in cutting edge research. We discover new genes that control important traits. It costs tens to hundreds of thousands of dollars per gene. Once we understand what it does we can patent it, then license the technology to companies that use it. We get a few bucks, enough to usually cover the original research and maybe seed some new research.
Research costs money and gets more expensive every day. Everyone wants improved medical tests, medicines and food, but they want it for free. Keep in mind that NIH, NSF, USDA, DOE funding are being cut dramatically soon, so the costs of discovery need to be recovered through licensing of inventions.
August 19, 2012 12:14pm
Are you serious? You think they spend hundreds of thousands of dollars and only get "a few bucks" in return? They make huge, huge profits by selling the drugs at high prices. So you think it's better if they profit and only the rich people can afford to get tested and use the drugs they invented? Do you realize how much we lose if these genes are patented and only that one company can research them? Collaboration is a huge part of research, sharing the information and ideas so we can use all our knowledge to fight diseases. With these patents so many people lose, so much research collaboration is lost and so many people will not benefit because of price. I don't think you have to feel sad for drug companies, their profits would be less without patents but they'd still be raking in the money like the do.