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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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RE: Genes Are Natural, Tests are Unique
By Dragen on 4/1/2010 4:39:10 PM , Rating: -1
Finally, an intelligent, articulate, well thought comment regarding this issue. Thank you Scubascott29 for posting this. I work for a Biotechnology company like Myriad that has discovered very specific markers related to disease which took millions of venture capital to hire the right people, equipment, laboratory, pay salaries, and develop working procedure and tests for use in the medical industry. Nothing is more infuriating than those running around yelling, "OMGz U don't PWN my DNA, that is ILLeGAL111!!one"

The ACLU has approached this entire issue with complete ignorance and has only shot all of humanity in the foot. How so? Imagine people who desperately need and benefit from this research through lab tests released to the medical field after a Biotechnology company has discovered major break-throughs and patented the sequences and markers to SECURE their Intellectual Property which allows them to recoup investment costs and overhead, along with a comfortable overhead to further FUTURE research. Now existing Biotechnology companies, especially startups will have absolutely no incentive (or even the financial means) to continue research and develop medical solutions. Who suffers? You, me, your family... anybody who is sick.

Who is going to continue the research now? Colleges? Ok, and do they have the financial resources to produce medical products for the healthcare industry? And if at the very least, colleges discover new and important genetic data relating to disease, what company (existing or new) is going to have the investor support to create any kind of product for society, when there is no way to secure it through the patent system, which is THE de-facto standard for securing intellectual property in this age?

Nobody is saying, anybody has some kind of exclusive right to your DNA. This isn't what this is about, nor what Myriad was doing. The ACLU and this judge just shot the very companies who offered hope in to a cure for cancer among a plethora of other diseases, straight in the face.

I want somebody to tell me how this ruling can even remotely be considered a "Victory".


By porkpie on 4/1/2010 5:17:20 PM , Rating: 2
Of course, the upholding of this decision will mean an immediate drying-up of capital funding for such firms to study the genome, and develop new tests and treatments based on their research.

Humanity, shot in the foot indeed. Hopefully, the appeals court will take a more reasonable point of view.


By Mitch101 on 4/2/2010 12:19:27 PM , Rating: 1
To keep a-hole companies like Myriad from preventing others from fiding cures then being sued for thier solutions because your company believes they own the marker.

Pfeizer pulls the same crap with trying to patent viruses so I didnt single just the company you work for for being a-holes.


By JediJeb on 4/2/2010 6:04:08 PM , Rating: 3
You may put in the work to discover what a certain gene does, but I don't think you should be able to patent that gene to the point you can block anyone else from researching that gene. You CAN however patent any process based on that gene. So if you discover how to test for it, then anyone else would have to discover a different way to test for it, but they should still be allowed to use the gene to try to discover that different test procedure.

One example would be something like testing for Aflatoxin. You can use an Immunoassay test to detect it, or you can use an analytical chemistry test using High Performance Liquid Chromatography/Mass Spectrometry to detect it. Two totally different ways to look for a naturally occurring toxin from mold. If the person who discovered Aflatoxin had been allowed to patent Aflatoxin and never allowed anyone else to do research on it, then how many test for it would have been found? You might as well patent the North Star and tell everyone they have to pay you to look at it.

Patients should cover something you invent not something you discover that was always there. If someone had patented "Beer" instead of their recipe, then beer would be limited to only one flavor. The idea of fermented grain is a natural process, the mixing of several different ingredients to obtain a unique taste is the invention.


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