Supreme Court Rules Isolated Human Genes Can't Be Patented

[TimothyC]

The Supreme Court unanimously ruled Thursday that human genes isolated from the body can't be patented, a victory for doctors and patients who argued that such patents interfere with scientific research and the practice of medicine.

The court was handing down one of its most significant rulings in the age of molecular medicine, deciding who may own the fundamental building blocks of life.

The case involved Myriad Genetics Inc. (MYGN), which holds patents related to two genes, known as BRCA1 and BRCA2, that can indicate whether a woman has a heightened risk of developing breast cancer or ovarian cancer.

Justice Clarence Thomas, writing for the court, said the genes Myriad isolated are products of nature, which aren't eligible for patents.

The high court's ruling was a win for a coalition of cancer patients, medical groups and geneticists who filed a lawsuit in 2009 challenging Myriad's patents. Thanks to those patents, the Salt Lake City company has been the exclusive U.S. commercial provider of genetic tests for breast cancer and ovarian cancer.

The challengers argued the patents have allowed Myriad to dictate the type and terms of genetic screening available for the diseases, while also dissuading research by other laboratories.

Humans have roughly 25,000 genes, which are DNA segments that represent basic units of heredity.

Myriad said its patents were the result of significant financial investments that allowed the company to make breakthroughs in diagnosing a woman's hereditary cancer risk. The company and its backers, including trade groups for the pharmaceutical and biotech industries, warned that disallowing patents like Myriad's could deter financial investments for future medical innovations.

But many companies in the medical industry took a more sanguine view of the case, saying an end to gene patents could open up new opportunities to develop diagnostic services, including tests that analyze large numbers of genes at once.

The Supreme Court's ruling overturned a divided appeals court opinion that broadly allowed gene-related patents. Lower court judges noted the U.S. Patent and Trademark Office had been granting patents on DNA sequences for 30 years.

At arguments in April, Supreme Court justices were skeptical that human DNA extracted from the body could be patented like a mechanical invention. The debate highlighted how some discoveries may not be patentable, even if they unlock important medical mysteries.

"Patent law is filled with uneasy compromises," Justice Stephen Breyer said during the arguments. "On the one hand, we do want people to invent; on the other hand, we're very worried about them tying up some kind of whatever it is, particularly a thing that itself could be used for further advance."

The court in recent years has sought to constrict the scope of patent protections, concerned that patents were being issued too easily and so broadly as to squelch competition and impede innovation. Justice Elena Kagan at one point alluded to such concerns, describing the Patent and Trademark Office as "patent-happy."

The arguments featured a battle of analogies.

"A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat," Myriad lawyer Gregory Castanias told the court.

Chief Justice John Roberts, who compared the gene-isolating technique to simply "snipping" one element from a longer strand, disagreed.

"The baseball bat is quite different," he said. "You don't look at a tree and say, well, I've cut the branch here and cut it here and all of a sudden I've got a baseball bat. You have to invent it."

A ruling that should be at least somewhat liked around here. To patent a DNA sequence you have to the the one to make it, you can't get a patent for something that is occurring in nature.

[UnderAGreySky]

"A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat," Myriad lawyer Gregory Castanias told the court.

I can't believe they actually tried this argument, and that too in the Supreme Court. If this was part of their case, I suspect it wasn't that strong in the first place. A 9-0 decision in the USSC isn't easy.

[Simon_Jester]

It seems to me- well, by analogy, you can patent a radon detector, you can't patent radon itself. But if all you can patent is the detector, it's only a matter of time until someone builds a better one than yours... which is good for progress.

Does Myriad's monopoly on BRCA1/2 testing hinge entirely on a patent on the gene, or do they also have patents on the testing techniques without which the gene couldn't be spotted in the first place?

[Mr. Tickle]

Good win for common sense I guess.

It does potentially throw a bit of spanner into medical research however, while I don't like the idea of big medical tech companies "owning" the rights to genes etc, you have to admit they would be able to throw a shit ton of money at it if they could, the benefits of it would be likely out the reach of the common guy for a long time true but patents do end.

Overall it's win, but it does have it's downsides.

[bilateralrope]

Good win for common sense I guess.

It does potentially throw a bit of spanner into medical research however, while I don't like the idea of big medical tech companies "owning" the rights to genes etc, you have to admit they would be able to throw a shit ton of money at it if they could, the benefits of it would be likely out the reach of the common guy for a long time true but patents do end.

Overall it's win, but it does have it's downsides.

That just means that governments need to step up and fund medical research in areas that for-profit research will not touch.

[Sea Skimmer]

It seems to me- well, by analogy, you can patent a radon detector, you can't patent radon itself. But if all you can patent is the detector, it's only a matter of time until someone builds a better one than yours... which is good for progress.

Does Myriad's monopoly on BRCA1/2 testing hinge entirely on a patent on the gene, or do they also have patents on the testing techniques without which the gene couldn't be spotted in the first place?

They have loads of other patents on the testing method, which IIRC hinges on identifying specific mutations of the gene, and it appears the court ruled that patents on specific gene tests can still be allowed the way I'm reading it anyway. The problem with patents on genes was they precluded other companies or individuals from researching the gene for any purpose, and the way the patents were filed Myriad had the rights to all mutations of the genes too. Very insane, and thankfully very dead.

It does potentially throw a bit of spanner into medical research however, while I don't like the idea of big medical tech companies "owning" the rights to genes etc, you have to admit they would be able to throw a shit ton of money at it if they could, the benefits of it would be likely out the reach of the common guy for a long time true but patents do end.

That logic would work, except allowing such sweeping patents actually precludes throwing shitloads of money at the genes by limiting them to a single company. Even the largest company has very finite research funds compared to the entire world which might like to be able to do business in the US marketplace, and some 20% of all human genes were already patented. Think about how massively constricting that is, and how much worse it could have gotten.

[mr friendly guy]

It seems to me- well, by analogy, you can patent a radon detector, you can't patent radon itself. But if all you can patent is the detector, it's only a matter of time until someone builds a better one than yours... which is good for progress.

Does Myriad's monopoly on BRCA1/2 testing hinge entirely on a patent on the gene, or do they also have patents on the testing techniques without which the gene couldn't be spotted in the first place?

That was my thought as well. Which of course leads me to a fun thought. A few years ago there was a case of the French government being taken to court because patients acquired HIV via a blood transfusion. The French government was alleged to have deliberately not utilise existing American detection methods, choosing to not have one until such time as French biomedical companies could develop their own. Which leads me to my present train of thought. Under the old system it was possible to patent the "disease" as well as the method for detecting it. In the case of the BRCA1/2 genes. What was stopping a company patenting the disease as well? Was the old patent ruling allowing only patents on genetically inheritable diseases, and not ones which are acquired such as infectious diseases for example?