It is Illegal to Patent Unaltered Human Genes

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)

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)

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:
Identify a novel gene
Specify the gene's sequence
Explain how the gene functions in nature
Extract the gene using bioengineering techniques
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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