Company that makes test for breast, ovarian cancers can patent BRCA1 and BRCA2
Article Source: msnbc.com
from:msnbc.comA patent on breast cancer genes? Yes, says court
Seeded on Fri Jul 29, 2011 3:09 PM EDT (msnbc.com)
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So can I patent a boob size then?
Does this mean they created the genes? How can you patent something you found existing in people for thousands of years already?
So does this mean since they own the patent to breast cancer we can sue them for having it?
Sometimes the US Courts are so ridiculously stupid.
Rogers this is not stupid at all...patenting is how any innovative company protects their intellectual property, be they Microsoft or Myriad.
No, it does not mean they created the genes. It means the process they use to isolate those genes for cancer screening is patented. This is also not new, Myriad's test has been around years. They can patent something found in nature because A)they are the ones who found it and more importantly B)they are the ones who have demonstrated clinical utility to those findings. Look at penicillin as a case study...it is a naturally occurring compound that existed in fruit for thousands of years already. It was "discovered" by Alexander Flemming in 1928. BUT, it wasn't until Andrew Moyer patented the synthesis process in 1941 that penicillin became a widely-used antibiotic. Had that patent not been granted, people the past 60 years would still be dying of easily treatable infection.
The Biotech industry is relatively new, and there are many legal (and perhaps ethical) questions still out there to be answered...but bottom line is that these companies research and develop new diagnostics, treatments, and procedures which help millions of people globally. All that innovation doesn't come cheap, and patent protection is one incentive for companies to invest in R&D. After all Mr. Rogers, I do not see you in the lab coming up with novel breast cancer diagnostics!
I don't that is what is going on here Beer. I believe that patent filed is for working with the gene itself and prevents other companies from using it. If it was a simple case of patenting a method for detecting it, this would never have gone to court. But they are actually preventing other firms to do any work on those two genes.
At least that's my interpretation of the articles I've read regarding this cose.
Mitchell
I have to disagree. I've been doing research on this subject since 2008 as a grad student. When the patent was first granted and the test first came out, the backlash was that Myriad did not demonstrate clinical utility and was using shock tactics to scare patients into using the diagnostic. That was in the mid-90's I believe and has since changed. There has not been any backlash from other firms being barred from research/development. Something important to consider...legally things have been quiet for more than a decade....and it was the ACLU, not another biotech company, who brought about this suit!
What is going on here is the mutation of the gene has been patented. Those mutations make detection is possible, and why the diagnostic has clinical utility. Just like any other patent on the face of the earth, that does bar another company from reproducing that method. HOWEVER, to date Myriad has not once enforced patent rights over BRCA research!
In addition, something else to consider is that other companies can invest their own dollars to discover their own biomarkers for breast cancer, nobody is stopping them from doing that. But when it comes to the specific mutations that Myriad discovered in BRCA1 and 2, that is their intellectual property and, rightly so, is off limits to other companies if Myraid wishes to enforce their rights, which they have not done. To be honest, I believe this whole suit is over ACLU whining, clearly it is not about preventing other firms from working on these genes (because many do, including the federal government/NIH) that is the sole reason this went to court
That's good to hear. I'm fine with methodologies and synthetics being patented. But to patent naturally occurring sequences (even mutations) and preventing others from working on them I am against.
I know the ACLU was all over this, but I thought I remember reading once that Myriad actually did leverage that patent against another biotech for using a different method of detecting the mutation. Hmm...I guess I could have been wrong about that.
Mitchell
No backlash? When other companies cannot research and compete it drives the costs of the drugs and tests up, and then medical costs go up (and in this case for every woman who is suspected of having breast cancer). So basically if a woman needs a test for breast cancer, she is in effect going to have to pay this company whatever they ask because they have taken detection hostage by way of a patent.
This one of the many reasons healthcare costs are so high.
It is a disgusting practice and needs to stop.
Patenting any form of genetic research is contrary to the science behind it. Patenting methodologies is especially sinister, because it denies the right of scientists outside the company owning the patent to perform review on those methods.
Science does not end with a clinical trial. It is a process that is vital to our understanding of ourselves and the world. What happened here is a company patented part of that process, preventing further research on that specific mutation by independent scientists.
MmmMmmBeer is completely wrong. Myriad IS suing people for even reserching the two genes. He is misinformed. Watch the 60 minutes special and stop repeating the misinformation MmmMmmBeers is spreading.
I'm filing a patent on Monday for O-negative blood.
You could file a patent for the detecting the gene that produces the antigen for o-negative blood provided you have clinical data linking that to a hereditary disease, which is exactly what happened here. However, that will likely take you lots of time and lots of money. Soooo if you do that, then you deserve the patent!
This is insane. Patent the technology for detecting the genes or the method for doing the test but NOT THE GENES THEMSELVES.
Patents are WAY out of hand. It is impossible to start a tech business these days. Or rather, it is impossible to make any money. As soon as you start making money, some JERK that is NOT USING the patent (and the entire purpose of a patent is to protect the inventor so he can enjoy a monopoly on the patented product) comes after you.
USE IT OR LOSE IT. If you are only sitting on a patent to protect your crappy products, YOU SHOULD LOSE THE PATENT.
I agree SRS, Patents used to be for the invention, not the discovery. But now if one can patent the discovery there is only a stunted amount of invention that can occur. Pharmaceutical companies need to back off of the naturally occurring things in our body and the government needs to re-examine laws, maybe that may start to fix what's wrong in our economy, because a lot of innovation in the US is held back by laws and patents.
The patent system has gone TOTALLY INSANE. You cannot start a business anymore because some jerk has EVERYTHING patented. And everything is patented MULTIPLE TIMES. There was just a patent on TOAST. That is not a joke, it is for real.
I say USE IT OR LOSE IT. If you are not using a patent, it goes INVALID. I am sick an tired of all these firms buying up patents just to SUE.
Are you tired of jackpot lawsuits? You want tort reform? START WITH PATENTS!!!
This is so wrong. It will limit research and delay innovation and treatment for breast cancer. The genes are naturally occurring so there is absolutely no reason that a company should be able to patent them! I recommend that you read the "Immortal Life of Henrietta Lacks" for some insight on this.
So greed and business triumph over common sense and the little guy yet again. I am human enough to hope everyone involved in this injustice and insanity finds themselves diagnosed with cancer.
Time for change.
The world cannot go on this way.
Patents on body parts and food is totally insane!!
@ElectricPimp
Don't bother with the patents on monday, I already filed for the patent on friday.....
But I will consider selling you the patent for a couple million dollars. LOL
All judges are lawyers....and as such, they need to keep "rainmaking" for their profession....the whole "legal system" is disgusting.
This will end badly, very badly. Remember what Monsanto did to farmers when the courts said they could patent lifeforms, this is going to be even worse.
This practice needs to be outlawed.
Another win for big pharma.
Diagnosing breast cancer is now going to be even more ridiculously expensive.
Every person on earth, men and women, carry the BRCA1 and BRCA2 gene. It is only a problem when one or both of those genes mutate, thus causing the higher risk of breast and ovarian cancers. (Yes, it can affect men, too, regarding breast cancer and prostate cancer susceptability-obviously not ovarian) I'm guessing that they patented the MUTATED BRCA1 and BRCA2 genes. The article didn't explain the difference, though I don't know why they would patent those genes. They should have just patented the test for that. When those genes mutate, the "instructions" for cell repair are corrupted and cancer can occur. A simplistic explanation.
The court is wrong, this kind of decision goes against the good of the people.
Both men and women carry the BRCA1 and BRCA2 gene. It becomes a problem when it mutates and I believe the mutated gene is what was patented, though I don't know why they would even do that. The mutated genes cause a higher risk of cancer in both men and women because the "instructions" for repairing a cell become corrupted and cancer may occur. (Breast and ovarian for women; breast and prostate for men). It isn't a test to diagnose breast cancer, only a test for the mutated gene in cases where there is a considerable family history of breast and ovarian cancers. It can give the carrier of the mutated gene the opportunity to choose a course of action, whether it be a prophylactic mastectomy or fallopian tube/ovarian removal, to start a family sooner than later, etc.
This is insane. I wonder how much money went into the courts 'pocket' for them to allow a company to patent a naturally occurring part of the body. Yet again the little people lose to the larger corporations who want to suck more money out of sick people. Eventually though we will not take it anymore and I can only hope that occurs in my lifetime. There needs to be a HUGE change in how things are patented, right now the systems is broken.
So we can sue them if we carry "their" patented genes?
Now wouldn't that be interesting. hmmm....................
This is a stunning example of how much financial control and influence these corporations have. unfortunately, morality and ethics have gone by the wayside all in the name of the almighty dollar. the us government will go bankrupt and these corporate entities will continue to make their millions. shame, shame on us all for allowing this to continue.
Myriad has been the only lab in the country to detect/identify the BRAC1 and 2 genes. I'm only guessing here but hopefully their research has assisted in developing the fix. The fix is in the form of a pill that replaces the protein that the BRAC mutations lack. It is in clinical trials for people now and I for one am grateful.
One question: who educated the people that come up with these patents?
Present patent laws are solely used to prevent competition and inhibit any innovation. As a small company you are wasting your time and money on innovation, because if you come up with something new, the big companies will use their lawyers to not only invalidate your patent, but also claim it to be theirs, as part of one of their own often unrelated patents.
The lack of comprehension of patent law and just plain high school economics here is astonishing.
Patents are a time- and subject matter-limited monopoly over an invention. The public policy purpose of patents is to encourage PUBLICATION of inventions (rather than keeping things a trade secret, for example) to "promote the progress of science and the useful arts" - in other words, to GIVE to the public the information about how to make and use the invention, so they can in turn make new inventions based on this information while the patent is in force, as well as to use the invention freely when the patent expires, IN EXCHANGE FOR the limited monopoly to the inventor a limited time to exclusivly explot their invention, to make a profit from their own invention, and to repay the investors who risked their capital to invest in the making and commercialization of the invention.
The grant of a patent gives the inventor the right for a limited time to exclude others from making and using their invention, further limited by the requirements of fully disclosing, enabling and effectively claiming that invention. This is the quid pro quo of the patent grant.
The term of patent protection is now 20 years from filing of the patent application (until 1995, it was 17 years from issue) - given how long it takes to get a patent issued (3-5 years on average), the effective patent term is often much less. In particular, in the biotechnology and pharmaceutical arts, it can take 10-15 years to get a product commercialized, leaving a far more limited effective patent life, and thus opportunity to recoup the money invested (upwards of a BILLION dollars to bring a drug to market now). After the patent expires, anyone can make and use the invention.
Patents on genes do NOT cover the genes as they exist in the body. They cover ISOLATED and/or PURIFIED genes, as they would be used in a laboratory. If the patents covered genes as they exist in the body, they would be invalid for anticipation - patents have to cover NOVEL inventions. It sure would be nice if the press and the public would understand this before they make ridiculous accusations about the morality of gene patents.
And by the way, the foundational clause in the Constitution, Article I, Section 8 describes Congress's enumerated powers - and the recitation enabling the power to grant patents references DISCOVERIES, not inventions:
“
The Congress shall have power To lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common defence and general Welfare of the United States; but all Duties, Imposts and Excises shall be uniform throughout the United States; ....
To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries; ....
And yes, I'm a biotech patent attorney. And the Myriad decision was correct, pretty much across the board. I can even live with the rationale behind the claims that were found not patent-eligible, because they could easily have been fixed by proper claim drafting, to explicitly include the transformative steps (obtaining a sample, doing the sequencing) that were inherently required to do the tests.
What you're saying is that they don't own the red marbles while they are in the jar full of other colored marbles, but if anybody pulls the red ones from the jar, they do. Nice. Clearly you are a lawyer if you think there is a difference.
I agree that the procedure for separating the red marbles from the jar should be patentable (if it's not overly vague and simply "pull from jar"), but not the red marbles themselves. Doing so keeps others from finding a better way of extracting them.
Allowing them to patent the genes themselves stifles anyone else from coming up with a different way of detecting them.
You give me the DNA sequences from 500,000 people, and a list of their maladies, and I'll write you a program that differences out the likely gene sequences responsible for those maladies. Does that mean I should be able to patent all the individual genes for every disease? No. Knowing which genes are responsible is only the first step, and me having complete control over the first step stops anyone else from moving on to any step beyond it. This seems to be what they have done, only they stopped progress at step two, isolation. They didn't patent how to isolate them, they patented that act of them being isolated. In doing so, they have locked everyone else out of any steps beyond.
When did medicine become about money instead of improving the human condition?
Thanks DianaCox, I believe most people are more concerned with patents and copyrights stifling of progress and innovation, as this article reveals
People are concerned, but not rationally so, because the reporters who sensationalize stories like this apparently don't understand and thus misrepresent the truth to make the story "interesting."
Intellectual property law is a balance between public and private rights. The Constitutional mandate is to provide a way for inventors and other creative people to share the fruits of their creations with the public, without completely losing the right to profit from them, at least for a limited time. Gene patents are consistent with 200+ years of patent law, including many many patents on purified natural products, ISOLATED from their natural condition. These products are generally not useful until they are put into a different condition by "the hand of man" - i.e., isolated and purified, or are made MORE useful. And 20 years later, they enter the public domain, free of any claims.
Without the financial motivation to make these inventions/discoveries, many wouldn't be made, or would take much longer to be made, and FAR fewer would ever be commercialized, e.g., as new drugs or clinical tests. For example, until the Human Genome Project was challenged by the private companies racing to complete the sequencing of the human genome, the 15 year plan was to finish the sequence under the government project by about 2005 - instead, it was finished 5 years earlier. Patenting important drug targets was a driving force in this race.
People might think this is wrong. However, if anyone in your family has had breast and/or ovarian cancers, these tests are often recommended to see if other cancers are possible in the patient or closely related female relatives. It might be better if all women were able to be screened to see if they could possibly avoid or stop the development or advancement of these horrible diseases. I'm speaking from the experience of losing a sister to a rare breast cancer and a mother who had a pre-cancerous condition. These are terrible diseases and knowing the results of these tests could save many lives.
i wonder how much a federal judge costs...no doubt not as much as a representative or senator would cost..
The right to seek a patent for a specific gene or set of genes isn't what worries me. What worries me is that like in some science fiction movies, health becomes even more of a commodity than it is currently, where people who get healthy but don't pay their medical bills have things "repossessed." Imagine someone inserts a special gene "marker" in your body to suppress the mechanism that causes cancer. Imagine you're having a tough time paying your "subscription." Now imagine them not giving you the supplemental treatments and the gene "turning off" and you get Stage 3 or 4 cancer... Not pretty to think about.
If we all have different DNA (Isolated or not) and different fingerprints can we patent them also? The quote below seems to make the patent okay because the DNA was different. Patents now are for different instead of created? If I capture a different animal can I patent it?
"The appeals court has now held that isolated DNA is patent eligible, and it recognized that isolated DNA has a different molecular structure than DNA as it exists in the body. That is a very significant result that is very important to the biotech industry," said Bruce Wexler, a partner in the law firm Paul Hastings which was not involved in the lawsuit but represents biotech clients.