“Who owns the patent on this vaccine?” Salk replied, “Well, the people, I would say. There is no patent. Could you patent the sun?”
Parijata Mackey
Deadly Medical Monopolies
Gene patents stifle research, inflate prices, and prevent people from getting treatment.
22 Jul 2009 / David Bollier
Topics Filed Under: Science and Health
Tags: ACLU; breast cancer; genes; patents
There is something ethically distasteful about anyone “owning” our DNA, yet that’s exactly what the U.S. Patent and Trademark Office does. It grants patents in genes (among other things). With the sanction of the U.S. Supreme Court, which recognized patents in lifeforms in 1981, one-fifth of the human genome is now privately owned.
The implications of this trend, which has been accelerating for the past few decades, are sobering. Pharmaceutical and biotech companies can legally assert exclusive control over who may study, test or look at a gene, lest such activities interfere with the profit potential of their patent.
Granting property rights in genes is supposed to be a necessary incentive to spur medical innovation and treat disease better. In practice, it is now clear that exclusive patents on genetic knowledge are an arcane form of monopoly. Not surprisingly, this means that patent holders have the ability to thwart competitive research, squelch innovative products and charge exorbitant prices. The end result, as some women are discovering, is dangerous to their health.
Myriad Genetics, a private company in Salt Lake City, owns a patent on breast cancer genes known as BCA1 and BCA2. Women who have these genes have a significantly higher risk of contracting breast and ovarian cancer. But because of its patent, Myriad is the only source of diagnostic testing for the genes.
Myriad is also the only research center that is allowed to study the BCA genes. Everyone else needs formal permission, which may require a license fee. If you happen to be a medical researcher at Harvard or UCLA or an illustrious European medical center, don’t bother trying to study these genes. It would violate Myriad Genetics’ patent.
And if you want to get a diagnostic test to see if you have BRCA gene mutations, again, you can only go to Myriad Genetics. Its BRCAnalysis® test costs $3,000.
The problems of patenting genes are not confined to breast cancer. Across the board, gene patents have gummed up scientific research and diagnostic testing by erecting artificial fences on knowledge and what can be done with it. The result: delays, restrictions and outright bans on certain forms of research. Certain forms of medical innovation are simply off-limits. The harm may sound abstract, but in fact, it hurts real people who are suffering from certain cancers or illnesses that researchers might be able to treat — if only they could share their knowledge and collaborate.
Now, finally, a significant legal challenge is being mounted to the whole notion of patenting genes. On May 12, 2009, the ACLU and the Public Patent Foundation, a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law, filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.
The lawsuit has been brought on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals (the lead plaintiff is Association for Molecular Pathology). The case also represents individual researchers, breast cancer and women’s health groups, genetic counselors and individual women. The defendants in the case are the U.S. Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes.
The ACLU explained the reason for its lawsuit:
The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad. According to the lawsuit, such monopolistic control over these genes hampers clinical diagnosis and serves as a disincentive for research because Myriad not only has the right to enforce its patents against other entities but also has the rights to future mutations discovered on the BRCA2 gene. The gene patents are also illegal under patent law because genes are “products of nature.”
“Patents are meant to protect inventions, not things that exist in nature like genes in the human body,” said Chris Hansen, a staff attorney with the ACLU. “Genes isolated from the human body are no more patentable than gold extracted from a mountain.”
The role of Myriad Genetics in stifling breast cancer research received some exposure recently on the PBS POV series. A film called In the Family, (http://www.pbs.org/pov/inthefamily/film_description.php) profiled woman who had a family history of breast cancer but could not afford the BRCAnalysis® diagnostic test.
In trying to deal with her own hereditary cancer risks, filmmaker Joanna Rudnick said:
“Over the last eight years, I have pleaded with doctors and scientists to tell me more about my odds of developing cancer. Their answers are always the same: ‘One day, we will understand how other genes, so called ‘modifier’ genes, increase or decrease your risk.’ Genes don’t act in isolation. How can we find out how BRCA works with other genes if Myriad’s patent limits this essential research?”
When the filmmaker went to Myriad’s headquarters, she interviewed the founder and chief scientific officer of the company, Dr. Mark Skolnick. “The lab was beautiful and state of the art,” she reported, “but Skolnick’s answers surrounding the fixed pricing, ethics and detrimental consequences of gene patenting were unsatisfying and dubious (“People don’t complain about having patents for the iPods,” he told me), leaving more questions than answers and leading to where we are now with the ACLU challenge.”
Things weren’t always this way. In a famous incident in the 1950s, journalist Edward R. Murrow asked Dr. Jonas Salk, inventor of the polio vaccine, “Who owns the patent on this vaccine?” Salk replied, “Well, the people, I would say. There is no patent. Could you patent the sun?”
In a way, lawyers have found a way to patent something else as elemental as the sun – and our courts and legislatures now sanction this ethical offense against the commons. Here’s hoping the ACLU prevails. You can sign a message of support for the ACLU lawsuit here.
University of Chicago
pari...@gmail.com
www.parijata.com
--
"Have patience with all yet unsolved in your heart. Try to love the questions themselves, like locked rooms and foreign scripts. Do not now seek the answers. They cannot yet be given because you could not yet live them -- and the point is to live everything. At the present, you need to live the question. Perhaps you will gradually, without even noticing it, find yourself experiencing the answer, some distant day."
- Rainer Maria Rilke
Parijata Mackey
I have no desire to use the listhost as a way to pressure people into
advocacy, but this is interesting from an academic's as well as an
activist's standpoint.
An article entitled "Deadly Medical Monopolies" [1] was sent out
earlier tonight, and at the bottom, there was a link to an ACLU
petition [2] in support of their case against Myriad Genetics [3].
Myriad is a private company in Salt Lake City that owns patents on
breast cancer genes BCA1 and BCA2. Myriad is the only group legally
allowed to study these genes; other institutions require a license,
which can involve paying a fee to Myriad Genetics. The ACLU is going
to court to overturn the patent on these genes, which could create an
interesting precedent.
The text of the petition is as follows:
Knowledge about our own bodies and the ability to make decisions about
our health care are some of our most personal and fundamental rights.
Genes are not inventions. They are products of nature and part of our
common heritage. The government should not be granting private
entities control over something as personal and basic to the human
body as our genes. Moreover, granting patents that limit scientific
research, learning and the free flow of information violates the First
Amendment. We cannot afford to let gene patents stand in the way of
scientific innovation and patient care. That’s why I support the ACLU
and PUBPAT’s lawsuit challenging the patenting of human genes.
Signed,
[Your Name]
Does anyone have the legal background to describe what, if any,
effects this case could have (successful or not)?
Links:
[1] http://onthecommons.org/content.php?id=2481
[2] https://secure.aclu.org/site/SPageServer?pagename=Nat_BRCA_Support_Statement
[3] http://www.myriad.com/
Josh Perfetto
very novel arguments in here. I'm all for patents on genuine inventions
that encourage innovation, but these gene patents are neither inventions nor
encouraging innovation. This would be huge if they prevail.
-Josh
Andrew Hessel
I am not a lawyer. I am a bio type. Most bio folks would argue about the definition of the gene. Even if the sequence was not patented, there would be process and purification patents. And so on.
You're either willing to share it freely or you're not.
I support open biology so that better therapies or ideas have another ecosystem to develop in. Who cares about a particular gene sequence anymore, when just redundancy in the code (let alone a few amino acid substitutions) expands the possibilities?
Links:
[1] http://onthecommons.org/content.php?id=2481
[2] https://secure.aclu.org/site/SPageServer?pagename=Nat_BRCA_Support_Statement
[3] http://www.myriad.com/
--
Parijata Mackey
University of Chicago
pari...@gmail.com
www.parijata.com
--
"Have patience with all yet unsolved in your heart. Try to love the
questions themselves, like locked rooms and foreign scripts. Do not
now seek the answers. They cannot yet be given because you could not
yet live them -- and the point is to live everything. At the present,
you need to live the question. Perhaps you will gradually, without
even noticing it, find yourself experiencing the answer, some distant
day."
- Rainer Maria Rilke
--
***************************************
Andrew Hessel
Q2 Consulting Inc.
Open innovation solutions
780.868.3169
ahe...@gmail.com
Jason Bobe
On Jul 24, 5:39 am, Parijata Mackey <parij...@gmail.com> wrote:
> Does anyone have the legal background to describe what, if any,
> effects this case could have (successful or not)?
>
Patent Docs blog:
http://www.patentdocs.org/2009/06/falsehoods-distortions-and-outright-lies-in-the-gene-patenting-debate.html
In particular, see the comment threads.
Thanks,
Jason Bobe
Rajagopal V
As long as soverignty remain as a concept with rigid borders people won't trust despite discussions and dialogues.The diybiologists and all diyers wont reveal their positons and activities.If succesful they may contribute knowledge to prosperity or monetize them for thei faily benefit.Entire law system favours few selfish soverign nations as if they are superior to others.Even racism is such a force which evades all law.
Raj
Ty
corporation loses its patent on a snip of DNA, a biologist gets its
wings. Fact of the matter is that they are trying to prosecute this on
the constitutional level. If the ACLU wins, it will be BIG. It will
establish important legal precedent here. Here hoping the ACLU wins