In a victory for biotechnology companies, a federal appeals court ruled Friday that human genes can be patented. Odds are pretty good the case will make its way to the Supreme Court, and it's possible the justices will rule the other way, so this is not a done deal — but until then, it seems companies can own the exclusive right to use human genes.
The case involved patents on two human genes that are used to predict breast cancer, BRCA1 and BRCA2. To study these genes, patients and scientists will again have to pay a fee — up to $3,000 — to the company that owns the patent, Myriad Genetics.
In a 2-1 ruling, the Court of Appeals for the Federal Circuit, which specializes in patent law, overturned an earlier decision that invalidated the patents. The decision is still somewhat unclear, however, with three separate opinions and a half-dozen points of law under debate. The lack of clarity, and the complex and controversial nature of the case, makes a hearing by the high court seem likely.
The court did rule against Myriad in one aspect, involving the process they use to analyze a patient's genes. This requires "abstract mental steps," the court said. So the court said the genes themselves could be patented, but a specific method of studying them could not.
"We strongly support the Court's decision that isolated DNA and cDNA are patent-eligible material as both are new chemical matter with important utilities which can only exist as the product of human ingenuity," said Peter Meldrum, president and CEO of Myriad Genetics. Scientists were not as pleased: "Genes or a sequence of the genome is a product of nature and should not be patentable," said Dr. Timothy J. O'Leary, president of the Association for Molecular Pathology, which brought the lawsuit.
The U.S. Trademark and Patent Office has already issued patents on more than 4,000 human genes, so a ruling that would invalidate gene patents would have major implications for the biotech industry. Companies like Myriad argue patents are necessary to protect product development and encourage innovation; opponents argue the ruling will stifle competitive research and jeopardize patient health, and that it's unethical to patent something that comes from nature. The Obama administration had filed a brief arguing that isolated genes should not be patented.
Patents on plant and even animal genes have not risen to this level of controversy. Genetically altered plants and animals are big business for biotech firms, which license their gene patents to other companies that produce seeds, additives and other products. About 20 percent of the human genome is also patented, including genes associated with diseases like Alzheimer's. Other companies and researchers must pay fees to license the patent.
The court ruled that patents are allowed because once pieces of DNA are isolated from the body, their chemical structures differ from the DNA that exists inside the body — so they're not actually products of nature. Two of the judges on the three-judge appellate panel are scientists, and brought their own analysis to the debate. Judge Alan D. Lourie, who as the Atlantic points out holds a PhD in chemistry, concluded thusly:
Judge Kimberly A. Moore, who has a degree in electrical engineering, also discussed the chemical makeup of the isolated DNA, but also said the new sequences have a utility that whole gene sequences do not — in this case, predicting breast cancer risk.
Judge William C. Bryson, who does not list any scientific background on his bio, was the sole dissenter, arguing that most people would argue patents are intended to protect inventions, and "a human gene is not an invention."
Much legal wrangling remains to be done before this question is finally settled.
It's not a victory for biotechnology companies, it's a victory for some biotechnology companies, at best. I don't see why they should be allowed to patent something found in nature. It's akin to patenting a stick, something found, not invented.
I agree with @jd929. Why can't they just patent their final product? For example, I may have a patent on a recipe for cornbread, that doesn't mean people have to pay me to grow corn. Maybe not the best analogy but that's how I see it. This just hinders genetic research. Lame.
I don't agree with this court decision. I don't think that people should be allowed to patent genes because it could hinder progress. Some scientists may not be able to pay that fee for studying a certain gene. Maybe those scientists have an idea that could lead to new treatments and require that gene. And like JD929 said, it seems ridiculous to patent something found in nature.
"Absence of evidence is not evidence of absence."
~ Carl Sagan
Does this mean that I could sell my mutations as an invention? Cause I,ve got a pretty useful one, double platelet count. I can see people borrowing genes from their favorite celebraties for their kids. Gene brokers, heh.
So, what if they patent a gene, but it turns out that I naturally possess that gene?
This is just a bad idea, plain and simple.
Patents are starting to kill off technology. The big players are suing each other and every small company just trying to survive and research is being held back in all fields. Worse, medical patents are stopping lives from being saved.
Seriously when does the insanity stop? Patent laws are completely outdated, and now mega wealthy corporations are using them to kill off their smaller competitors. The sad thing is most genius takes place with small firms lacking the massive and slow political forces present in corporations.
In effect they are slowing down the human race, causing people to die because cancer detection that could have been matured was held back by a patent. What is the price of humanity really, does some guy with millions really need to worry about money to the point people are dying?
At the very least science should have a blanket protection from patent infringement, to be reclaimed once their research present some value to production or profitability. We should not slow down progress over a few rich cry babies that want their cuts before any real fruit comes out.
Are they trying to say the owner of the gene patent owns part of my body? Are they going to charge me for the use of their gene? If the company owns patents on more than half of the genes in my body does that company own controlling interest in me and do I have to do whatever that company says? What a dumb decision.
This decision is completely irresponsible. I sense the abuse coming miles away.
Monsanto has already managed to sue independant farmers by air-dropping its patented seeds on their fields and then send inspectors to check. Of course the farmers didn't have the license, so they were condamned because the court assumed they stole Monsanto seeds.
Just wait until we can engineer babies, or just pets, with specific genes, some of which have been patented. Can you imagine being sued because you happen to have a specific mutation that makes your eyes a trendy shade of blue ?
Do you think I'm taking it too far ? What, you've never been surprised by the insanity of some business' actions ?
I'm really concerned that all the reactions so far have been about hindering progress. We're not only allowing people to toy with life here, we're giving them rights over undiscutably sentient life.
Over our own lives.
Seriously, this decision means a company can own part of people.
I don't want to sound catastrophist or melodramatic, even though I realize I ended up doing just that, but I am REALLY concerned about the implications.
Two things to say.
First of all, I'm glad to see no one here is attempting to defend the insanity of patenting natural genetic sequences.
Second of all, I hope to God the Supreme court shares our views.
Patenting things like this has always seemed stupid to me.. It's like patenting immortal cell lines. You could patent your production methods, but the cell line itself is not something you created.
Now, if you make a custom creature (ie flame throwing hamsters), in my opinion, you should be able to patent that. They most certainly do not exist in nature. A more realistic version would be the oil munching bacteria that were made a while back. Or, if you created your own gene from scratch to make some novel protein, that's fine with me.
I just can't see why you should be able to copy a gene as they do... It just seems wrong... If you make it from scratch, sure. Isolating things doesn't make them unique. By that logic, I could say that trees don't grow in the air, so I could patent non-planeted trees so those tree-moving companies would have to pay me. It is just completely nonsensical...
This is a loss for everyone who does not own part of those Biotech firms.
So, if I read correctly, the patenting system isn't made for such specific cases.
The lack of legislation concerning DNA does allow companies to patent these discoveries.
But there's nothing more to do than wait for the final decision, then we'll argue if it's a wise decision...
Here's an interesting doc about the U.S patent office and someone who is able to cure 30% of incurable cancer patients. And the FDA fight to shut down this Dr/s practice, and the big pharma's quest to steal said patents.
Natural sequences should not be patentable, but man made sequences, why not?
This is silly. You can't own something that is a part of everyone on earth. If you can, then I'm submitting my patent application for the hand soon...
Aldrons Last Hope...more conspiracy stuff, his work was never peer reviewed and he didn't follow the normal channels to get approval, the film about Dr. Burzynski is full of half truths and misinformation, the FDA does not always do the right thing but neither did he; back on topic please
This is on topic seeing how big pharma wants to own your genome.
Did you watch the whole doc.? Dr.Burzynski is a Phd. that graduated at the top of his class. He runs a successful practice that has made him millions.
He has developed and patented a cancer treatment that cures 30% of his patients....patients that the medical industry told to go home and wait for death.
What exactly was misinformation? How did he "not do the right thing". I guess saving the lives of all of those children wasn't the right thing?
What about the FDA bringing false charge upon false charge? How about big pharma trying to steal his ideas and trying to throw him in jail?
Stop being a sheep and wake up.
you won't believe any evidence i show you, you are a conspiracy theorist nut who should patent the word sheep, you use it enough, the movie everyone watches and goes "oh the evil FDA" forget they are watching a movie, his work has never been peer reviewed and this promotional video passed off as science and evidence he is being persecuted is mostly all bullsh#t
You have no evidence. LMAO "bulsh#t"?
His evidence is all the people he has cured. Remember these same cancer patients were told to go home and die. The cancer they have (brain cancer) has had a survival rate of .09%. This increased to 30% survival rate with his patients...can you crunch numbers? Those stats indicate that his treatment is working.
You keep saying "peer reviewed". The peer review process is important in fields like astronomy when deciding how a black hole formed, or in anthropology when deciding when humans started to walk. Because there is NO PROOF. Some one comes up with a theory and if a majority of his peers agree with it it is taken as truth. This is a completely different situation. His ability to cure cancer patients is proof enough. Cancer disappearing from MRI brain scans is proof enough.
That's like 100 years ago the Wright brothers flying around your house and you say "Hey you can't do that, it's not peer reviewed!" That's how ridiculous your argument is.
Stop being a simpleton.
Here is another video on topic.
How about patenting cancer? Then, all of you who got some, must pay ME royalties!