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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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Genes Are Natural, Tests are Unique
By scubascott29 on 4/1/2010 3:44:39 PM , Rating: 5
This is my first time posting on an article, but I had to weigh in here. I am a PhD student in biochemical engineering and so am very familiar with this debate. On the one hand, researchers are trying to protect all of the time and hard work that went into their discoveries, and on the other the general public is at the mercy of these researchers when it comes to break through discoveries such as the BRCA1 gene. The problem is that it takes years to discover what a gene does, and even then you may only have a piece of the puzzle.

Take the BRCA1 and BRCA2 genes, the presence of mutations to the genes only indicate an increased risk of breast cancer. Therefore, it would be beneficial for a woman to know if she has these mutations, and if so, be more proactive is checking herself for possible cancer development. These tests are where the money is for the researches, and to develop these tests, they have to have a very thorough working knowledge of the gene sequence.

Now back to the problem at hand, millions of dollars of research are put forward to discover not only the sequence of genes, but also there purpose in the living organism. However, once this is discovered, just that knowledge is not enough to recoup the money spent. They now need a practical application for the gene in question. With the BRCA1 and BRCA1 genes, they developed a test to help identify mutations in said genes. I don't think anyone would debate the fact that the company should be allowed to patent and benefit from this invention.

The problem then becomes, should an individual, or corporation, be allowed to patent a gene so that they will have the time to develop a financially beneficial application of that gene? I think the answer is yes, but it should be a new special type of patent with a much more limiting scope than traditional patents. I don't think anyone should be able to possess a patent on genes in general, but there should be some type of grace period for the original gene discovers. Otherwise, if I were to spend 3 years discovering a gene, I would then be forced to share that knowledge with everyone, who could then reap all of the benefits without any of the initial risk and hard work.

As for the patent holders of BRCA1 and BRCA2, they have had exclusive rights for long enough, and it should now be opne to everyone.




RE: Genes Are Natural, Tests are Unique
By Dragen on 4/1/10, Rating: -1
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.


RE: Genes Are Natural, Tests are Unique
By croc on 4/1/2010 9:32:41 PM , Rating: 2
Hmmm... This borders on a very sticky ethics issue. Now, I have no issue with a company developing and patenting a test for a specific gene mutation that might cause an issue with humans (or plants, animals for that matter) BUT I do have an issue with them claiming that because they 'discovered' a naturally occurring gene that they then 'own' that gene. Now, if they had genetically altered that gene, for what ever reason, then I suppose they should be allowed a patent on their alteration of said gene, but not the underlying gene itself!

Where this becomes an ethical issue, in my opinion, is when a company developes 'a' test for one particular gene and is then given a patent for that gene. This, in effect bars any other company from even researching that gene, let alone developing further tests for various aspects of that gene. As in the case in hand... The company in effect blocked any, and all, further research and development of the BCA1 and 2 genes. Who knows what other useful information / tests could have come from this gene if the underlying gene were left un-patented?

There was a case some time ago where a person was found with a very specific rare gene. The company doing the research claimed that since they had patented the gene, and there was only the one subject that carried that gene, that in essence they owned that person.


RE: Genes Are Natural, Tests are Unique
By mcnabney on 4/2/2010 9:50:55 AM , Rating: 2
The problem is that they are giving patents to the entire gene and not just the specific process of testing for it. This would be like granting Coca-Cola a patent to a carbonated beverage using cola flavoring - preventing competition from other manufactures that would also like to make their own cola-flavored soft drinks.

And I really wouldn't call what these firms have done 'research'. My brother does this type of work at Johns Hopkins and all it really is doing is performing broad genetic tests of targeted groups of people, loading the data into a database, and pulling out the trends. They are giving the perception that actual research is going on here. Guess what, the human genome is mapped. We already know what all the genes are. They are just running targeted DNA tests on patients (who receive nothing). Then they develop a single or dual gene test kit and sell it for a ton of money. No one else can compete with this model - capitalism indeed. Oh, also, they receive free money from the government and not-for-profits to do a lot of this research. So think back to when you wrote those checks back in the 90's for breast cancer research. You helped these jerks get rich.


RE: Genes Are Natural, Tests are Unique
By porkpie on 4/2/2010 10:26:36 AM , Rating: 4
"The problem is that they are giving patents to the entire gene and not just the specific process of testing for it."

No they are not. It takes all of 30 seconds to look up any of these patents. Why not read one for yourself, instead of relying on sensationalistic, biased journalist accounts?


RE: Genes Are Natural, Tests are Unique
By croc on 4/2/2010 8:11:48 PM , Rating: 2
OK, I have looked at all of the patents involved. In essence, all of them were for a method of isolating the particular gene sequence from the entire genome, and the methods used to do so. Thus, they claim rights over that particular gene sequence.

I also went over the entire case PDF that was the main thesis of this article, and it seems that the preponderance of the previous cases, including judgements from the US supreme court, seem on the whole to weigh against Myriad's claims to gene patenting. So, my original argument stands... One should be able to patent a process for using a gene sequence for relevant tests, but not the underlying gene sequence. I have to agree with the judge in this case. Myriad has stifled research, hindered further developments for other tests on this particular gene sequence, and in effect giving Myriad the patents to this particular gene sequence.


By porkpie on 4/2/2010 9:23:14 PM , Rating: 2
"Thus, they claim rights over that particular gene sequence."

They do not. I've already posted the text from one of the patents in question. If you think they're somehow claming "ownership" of a gene, you've misread the patent sadly.

This isn't rocket science. You cannot patent data -- be it a gene, a bit pattern, a piece of computer code, or anything else. You can patent a new, novel use for a genetic sequence.

You can copyright data. But genes, being preexisting, cannot be copyrighted. Patents require a method and procedure for establishing some particular usage.

Furthermore, one thing that is rarely mentioned in these arguments is that patents are limited to a 20 year life. Some of the first patents on genetic sequences are already expiring. This fantasy that companies can somehow "lock up" ownership of the human genome is really ridiculous. But then, people believed in a flat earth once, too.


RE: Genes Are Natural, Tests are Unique
By banthracis on 4/2/2010 12:19:44 PM , Rating: 2
You might be thinking about the novel "Next" by Michael Crichton. The scenario in that novel is fiction and obviously exaggerated.
While the company can't own a person, in reality if a person had a gene that resulted in him getting "cured" of leukemia (think that was the case in the novel) he could theoretical be sued by the company who's patented the gene for copyright violation. The company of course would have to prove that that gene they patented did cure the individual using the method they described.

This would not occur on a 1 person basis since it's simply not cost effective. However, if you take the case of say the BRCA 1/2 genes, which affect millions, it might be more cost viable, but no less stunningly stupid.


By porkpie on 4/2/2010 2:30:25 PM , Rating: 2
quote:
if a person had a gene that resulted in him getting "cured" of leukemia he could theoretical be sued by the company who's patented the gene for copyright violation.
Ignorance truly does know no bounds. Not only is your statement wholly false, but you've also managed to confuse patents with copyrights.

Say it one more time. You cannot patent a gene. You can only patent a method which finds a new use for a gene.


RE: Genes Are Natural, Tests are Unique
By redbone75 on 4/2/2010 1:00:02 AM , Rating: 3
quote:
The problem then becomes, should an individual, or corporation, be allowed to patent a gene so that they will have the time to develop a financially beneficial application of that gene? I think the answer is yes, but it should be a new special type of patent with a much more limiting scope than traditional patents.

Unfortunately for you, and quite thankfully imho, the courts do not agree with you. You should be no more able to patent a newly discovered gene than you can a newly discovered species of frog. The frog already existed before you found it, and so did the gene.
quote:
Now back to the problem at hand, millions of dollars of research are put forward to discover not only the sequence of genes, but also there purpose in the living organism.

Again, back to the frog: You couldn't possibly expect to patent the mating habits of said frog, now would you? Sounds absurd even saying it. Why, then, would any individual or company expect to be granted a patent on the precise purpose of a particular gene? The gene has been doing it's thing before man even knew to call it a gene!
quote:
Otherwise, if I were to spend 3 years discovering a gene, I would then be forced to share that knowledge with everyone, who could then reap all of the benefits without any of the initial risk and hard work.

I'm sorry, but that's just a dilemma you're going to have to deal with. My question to you and others like you is this: what are you in it for? Is it research for research's sake, or is it profit? If research, then there is no dilemma. If profit, then let me be unapologetic and blunt with two words: risk management. Actually, that's coupled with two more: free enterprise. No one is forcing you or any company to spend loads of money and time on research. You are driven by the prospect of making a profit, so you have to accept the risks involved in doing so. Don't ask the courts to hold your competition at bay while you figure out a way to profit from something that already existed. Recognition is the reward of discovery. Profit is the reward for the successful marriage of supply and demand and marketing. If private funds allowed you to discover a particular gene, then simply don't release the information if you want to get a leg up on the competition.


RE: Genes Are Natural, Tests are Unique
By porkpie on 4/2/2010 10:29:08 AM , Rating: 4
"The frog already existed before you found it, and so did the gene."

Electricity and radio waves existed before we found them. Why do we have patents on their usages?

For the last time -- you cannot patent a gene. You can only patent a new usage for a gene.

I feel like I'm in the middle of some Salem witch trial mass hysteria here. Will you people put down your pitchforks, and take 30 seconds and learn the actual facts of the case?


RE: Genes Are Natural, Tests are Unique
By banthracis on 4/2/10, Rating: 0
RE: Genes Are Natural, Tests are Unique
By banthracis on 4/2/2010 12:30:08 PM , Rating: 2
As an elaboration, you can't patent a naturally occurring phenomenon. What companies like Myriad Genetics do is take the segment of the genome they want, excise the non coding segments (something a college bio major can do), and then patent the construct as something they invented.

Yes it's no longer the gene in the manner that's it's found in nature, however, all parts of the gene that are actually coded are unchanged and identical to their natural counterpart.


By WW102 on 4/2/2010 4:09:30 PM , Rating: 2
I think everyone on this forum is now dumber for having read your post. I award you no points and my god have mercy on your soul.


RE: Genes Are Natural, Tests are Unique
By porkpie on 4/2/2010 1:28:07 PM , Rating: 2
"You're wrong porkpie. Myriad Genetics OWNs the GENES themselves, NOT the test. See US patent # 6514713."

God, the reality distortion field is operating in full force today. Why didn't you take 30 seconds and actually read the patent?
quote:

Methods for detecting BRCA1 mutations are provided. The methods include the steps of determining the amount of the BRCA1 polypeptide contained in a sample of the subject, and correlating the amount of BRCA1 to the presence of the BRCA1 gene mutation in the subject, wherein the amount below a predetermined cutoff value is an indication of the presence of the mutation in the BRCA1 gene of the subject. The methods of the present invention are well suited for use to determine a condition associated with BRCA1 mutation, such as a predisposition to breast cancer, ovarian cancer, colorectal, and prostate cancers, and the presence or prognosis of breast cancer, ovarian cancer, colorectal, and prostate cancers.
No one can patent a gene. Stop spreading disinformation.


By karielash on 4/3/2010 5:31:58 PM , Rating: 2

Arguing with the pie... futility personified. Don't you know he is always right... at least in his own little mind.


By banthracis on 4/2/2010 11:57:25 AM , Rating: 1
Glad that the government is taking steps to halt the copyrighting of genes. I'd love to see a company sue every person in America because they copyrighted a gene for a naturally occurring process in every human.

Before anyone complains, this would be a perfectly viable claim. The current patent on the BRCA1/2 genes for breast cancer is a patent on the mutation of said genes in a manner that results in breast cancer. IE, nearly everyone with breast cancer is technically violating Myriad Genetics patent on this process, simply by getting breast cancer.

To Scubascott, you remind me a lot of many of the arrogant youth applying to both my institution and my lab, who come into the field purely to make a big discovery and get rich.

Science is BASED on the FREE distribution of knowledge acquired over years. Countless individuals over millenia have contributed their life work to the advancement of science, not for personal gain, but for the betterment of mankind. Not for profit, but purely to advance the knowledge of mankind.

Think about your education. What kind of world would we be in if EVERY bit of knowledge you earned, ie every lab technique/process had been patented and as a result required royalties to even learn about or use.

What would your own work be like if western blotting or even PCR was a patented process subject to high costs and royalty fees to use? or worse, forbidden to be used except by a singular company. How would future students even be able to afford the cost of a thesis project? (already a major issue)


By Laereom on 4/4/2010 12:46:14 PM , Rating: 2
You know, I wrong a fancy-long post, but it really boils down to this:

Genes are, in fact, natural, as you put it. As such they may not be patented. Blocking other people from R&D ON A GENE is ridiculously egregious.

Tests are, in fact, unique -- and as such they can be patented. So, if they want to recoup their costs, they can keep quiet until they have a test, or are close to having a test -- assuming their working knowledge doesn't already give them a head start.


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