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A U.S. Federal Court ruled this week that unaltered human genes are products of nature and not patentable. It revoked the patents on breast cancer genes held by Myriad Genetics.  (Source: K Science)

Until now, Myriad Genetics "owned" the human breast cancer genes. It blocked competitors from developing tests for commonly occurring variants of the genes, essentially preventing patients from getting a second opinion.  (Source: Think Gene)
ACLU triumphs over Myriad Genetics, but future legal challenges are likely forthcoming

A court decision this week may at last spell the end to companies' rights to claim ownership of your genes.  However, the story started long ago in the biotechnology industry's nascent days in the year 1980.

The 1980 U.S. Supreme Court Decision Diamond v. Chakrabarty was among the most important legal precedents of the last two decades of the previous millennia.  While it will never enjoy the instant recognition of a case like 
Roe v Wade or Brown v Board of Education, the case was among the most important commercial and medical decisions in modern history.

It ruled that "organisms" made from human DNA were patentable if they were "man-made" -- produced by human processes.  This was interpreted, over time, to mean that genes of organisms could be patented, granting the holder exclusive ownership of that gene.

That may sound incredible, given that most patent systems worldwide, including that of the U.S., disallow patents based on nature, and genes were developed by nature, not man.  Still, the U.S. Patent and Trademark Office has received over 3 million patent applications to date on genomes, according to the Human Genome Project.  Many of those patents were granted.

Today, according to experts speaking with 
National Public Radio, over 20 percent of the genes in the human genome are patented.  Companies that own these patents can block other companies or research institutions from developing tests for these genes or developing certain medical treatments.  The criteria to receive a genome patent today has become slightly stricter, but they today are granted if the inventors can:

  1. Identify a novel gene

  2. Specify the gene's sequence

  3. Explain how the gene functions in nature

  4. Extract the gene using bioengineering techniques

  5. Enable its use in medicine

By that definition, companies are perfectly entitled to "own" rights to genes that your body likely contains, and own the rights to genetic tests on those genes.

However, that may be coming to an end, with what may come to be considered one of the most important federal court rulings of the new century.

In the case Association for Molecular Pathology v. United States Patent and Trademark Office, better known as ACLU v. Myriad Genetics, ACLU lawyers challenged a big biotech firm's ownership of two breast cancer genes, BRCA1 and BRCA2.  Myriad Genetics had extracted the genes, unaltered, using standard techniques, then patented them.  It proceeded to sell expensive test kits for breast cancer.  It blocked competitors from using the genes, essentially disallowing patients the chance at a second opinion.  It also blocked university cancer researchers from studying the gene in some cases.

On Monday, Judge Robert W. Sweet of the United States District Court for the Southern District of New York ruled against Myriad Genetics in a precedent setting case.

He writes in his decision [PDF]:

In sum, the clear line of Supreme Court precedent and accompanying lower court authorities, stretching from American Wood-Paper through to Chakrabarty, establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess “markedly different characteristics” in order to satisfy the requirements of § 101.

That decision essentially rules patents on unaltered genes of humans and other organisms dead, unless the decision is appealed or overturned in this case or another by another federal court or the Supreme Court.  There will be ample opportunity for that to occur -- the ruling is expected to lead to many genome patent holders to be taken to court in an effort to revoke their ownership of genes of humans and other creatures.

Advocates of reform are cheering the decision.  Despite being heralded by critics as a "liberal" ruling, among the strongest opponents of gene patents was conservative late science-fiction author Michael Crichton.  Crichton published an op-ed in 
The New York Times in 2007 attacking the BRCA patents, writing:

YOU, or someone you love, may die because of a gene patent that should never have been granted in the first place. Sound far-fetched? Unfortunately, it’s only too real.

Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000. 

For critics, though, the decision is infuriating.  Gene Quinn, Patent Attorney and founder of the IPWatchdog blog calls Judge Sweet a "88 year old liberal jurist" and comments:

Our founding fathers seemed to have done quite well with this “American experiment” and one thing is certain, they knew a thing or two about incentivizing people in the face of long odds. They also felt it necessary to mention intellectual property, specifically patents, in the Constitution, which is an almost unbelievably short document that does little more than announce fundamental principles. For those who have trouble keeping up, this means the US patent system was considered of FUNDAMENTAL IMPORTANCE by the likes of Jefferson, Madison, Washington and all the others in the starting a thriving and sustaining democracy Hall of Fame!
...
It isn’t just a passing craze. Hakuna matada, its just a matter of time before the United States Court of Appeals for the Federal Circuit reverses Judge Sweet, because word on the street is Myriad WILL appeal (surprise surprise). 

Like it or not, the claim that a company can "own" a human gene has been dealt a serious body blow by the U.S. federal court system and stands a few more blows away from a knockout.  The U.S. leads the world in biotechnology and genetics research -- so whatever legal precedent is set in the U.S. will likely have a profound affect on the law in Japan, China, India, the EU, and elsewhere.



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This article is over a month old, voting and posting comments is disabled

This is NOT a liberal ruling.
By rika13 on 4/1/2010 1:06:53 PM , Rating: 0
1. Human DNA is not "new". It has been around since humans have.

2. It is not novel or nonobvious. The idea that cancer is caused by defective genes can be summed up in one word, duh!




RE: This is NOT a liberal ruling.
By porkpie on 4/1/2010 1:25:12 PM , Rating: 2
"Human DNA is not "new""

Neither is electricity. We still have patents on ways electricity may be used, however.

The invention here is not the gene. It is about a potential use for a gene. And while admittedly many such patents are being improperly granted for obvious usages, the basic concept here is not in error.


RE: This is NOT a liberal ruling.
By rdhood on 4/1/2010 4:05:12 PM , Rating: 3
"We still have patents on ways electricity may be used, however."

Exactly. You can't (or shouldn't be able to) patent a gene. You can, however, take that gene and insert it into a plant genome to confer some property of the gene to the plant... and patent the plant, or a method to splice the gene into the plant, etc. That is NOT what they have done here. What they have done is to locate a gene that performs a function in the body and then patent it. So there is a race to identify all of the genes that a company might be able to exploit (disease genes, genes that confer a property, etc) and patent them. I'll call it "gene squatting".

It is kind of like cybersquatting. Buy all the domain names of the fortune 500, or popular people, etc., in order to exploit that domain name at some point in the future.

So we have all of these companies "gene squatting" on 20% of the human genome due to our patent system, and the idiots who issue patents.


RE: This is NOT a liberal ruling.
By porkpie on 4/1/10, Rating: 0
RE: This is NOT a liberal ruling.
By banthracis on 4/2/10, Rating: 0
RE: This is NOT a liberal ruling.
By porkpie on 4/2/2010 1:38:35 PM , Rating: 2
Good lord, is English too complex for you? They haven't patented the gene, they've patented a particular method of finding a USE for that gene.

They don't "own" the gene. If someone else finds another use for that gene tomorrow, they're free to go and file their own patent on that method and procedure.


By banthracis on 4/2/2010 12:44:03 PM , Rating: 2
The issue here is that the patent office lacks qualififed individuals to review patents. To truly understand and be qualified to review genetics patents, one would need to have both a PhD in genetics and extensive knowledge of law, likely a law degree.

How many people have both degrees? How many of these are willing to work for $60,000 a year in the patent office, when a law or genetics PhD by itself can earn you $100,000 + in the corporate world?

This is why all these silly patents get approved. There's no one qualified to get past the technical jargon reviewing them.


RE: This is NOT a liberal ruling.
By Shatbot on 4/2/2010 1:37:52 PM , Rating: 2
This is awesome!!! I cant believe this wasn't on the news, as someone said the precedent is incredibly important.

Apparently there are 7 million biotech patents that everyone has to try and tip toe round.


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