New York, NY – Patents on two human genes linked to breast and ovarian cancers are being challenged in court by the American Civil Liberties Union, which argues that patenting pure genes is unconstitutional and hinders research for a cancer cure.
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A lawyer in the case says patenting genes would be like patenting an eyeball removed from someone.
“Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights,” said ACLU Executive Director Anthony D. Romero. “The government should not be granting private entities control over something as personal and basic to who we are as our genes.”
The ACLU, joined by the Public Patent Foundation, an organization affiliated with Benjamin N. Cardozo School of Law of Yeshiva University, filed the lawsuit today.
Myriad and the research foundation hold patents on the pair of genes — known as BRCA1 and BRCA2 — that are responsible for many cases of hereditary breast and ovarian cancers.
The ACLU contends that patenting the genes limits research and the free flow of information, and as a result violates the First Amendment. The lawsuit also challenges genetic patenting in general, noting that about 20 percent of all human genes are patented — including genes associated with Alzheimer’s disease, muscular dystrophy and asthma.
“It is absolutely our intent that upon victory this will rend invalid patents on many other genes,” said Dan Ravisher, executive director of the Public Patent Foundation and a patent law professor at Yeshiva University’s Benjamin N. Cardozo School of Law. “We just had to pick one case as our case.”
Ravisher offered an analogy to describe the plaintiffs’ argument, saying, “It’s like saying if someone removes your eyeball … just because you remove the eyeball and wash it off, that doesn’t make the eyeball patentable.
“Now if they create another eyeball out of plastic or metal, then you can patent that.”
Officials at Myriad declined to comment. Tom Parks, the president of the University of Utah foundation, said he was not aware of the lawsuit.
More than 192,000 U.S. women are diagnosed with breast cancer each year — about 5 to 10 percent of those cases have a hereditary form of the disease, according to the National Cancer Institute. Mutation in the genes called BRCA1 and BRCA2 — short for breast cancer 1 and breast cancer 2 — are involved in many cases of hereditary breast and ovarian cancers, the institute said.
“A woman’s lifetime chance of developing breast and/or ovarian cancer is greatly increased if she inherits an altered BRCA1 or BRCA2 gene,” according to the institute.
Myriad’s patents give it exclusive right to perform diagnostic tests on the genes — forcing other researchers to request permission from the company before they can take a look at BRCA1 and BRCA2, the ACLU said. The patents also give the company the rights to future mutations on the BRCA2 gene and the power to exclude others from providing genetic testing.
The company also charged $3,000 a test, possibly keeping some women from seeking preventive genetic testing, the ACLU says.
“Women whose doctors recommend genetic testing should be able to find out whether they have the gene mutations linked to breast and ovarian cancer so that they are able to make choices that could save their lives, and these patents interfere with their ability to do so,” said Lenora Lapidus, director of ACLU’s Women’s Rights Project.
The plaintiffs in the lawsuit include several patients and more than a dozen universities, genetic specialists and medical associations, such as the Association for Molecular Pathology and the American College of Medical Genetics.
At least one expert said the ACLU should focus more on getting the patents reversed than arguing whether they are constitutional.
“I doubt they’re going to get far with argument that the patent is unconstitutional,” said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
“A better argument would be that they were wrong when they granted the patent,” he added referring to the patent office.
Caplan said patents are privileges, not “carved in stone.” He noted that the defendants may have identified the genes, but didn’t actually work on them. So, the government could reverse the patents on the genes.
“It’s like trying to patent the moon,” he said. “You didn’t do anything to create it, just discovered something that already existed. You can’t patent things that are publicly available, that anyone can find. You have to create something, make something, do something with the thing.”
an interesting topic: I hear the issue why the patent shouldn’t be allowed. however there is another side of the coin, if a company gets the rights to themselfs for one thing, then they also have the power and confidence to invest a lot of money since they know no one will come and grab away from them, because they own this issue on there own. so we must look at both sides.
They may be right on the moral ground, but you want to encourage people to invent and discover knowledge, than that’s the worst move.
Both sides have good, strong arguments.
If we remove the financial incentive, research will slow down, and it will be many years until these type of breakthroughs will develop.
If we grant standard patent rights, it gives private firms long-term control over the products of their research, instead of giving it to the public.
But, if the research did not happen, the public would not have it either.
Why not compromise. Allow the patent, but make it for a shorter term. Long enough to allow profit taking, but half the time than the “guestimated” time the research would have taken otherwise.
This way, the public gets the results in “half the time” and the research firms still have the financial motivation to continue development.
Or, maybe after the first time period expires, allow the patend-holding company to still get a small fee for the use of its “early-expired” patents. Maybe only 20% of what they would have received before.
i would say a ‘yeshsivah’ university would have a patent argument on a original torah thought etc, looks like its not the kind of yeshivah. wonder why yeshivas like ponovitch. mir, viznitz dont have such problems
I absolutely hope they win! In this case, nobody except the patent holder is even allowed to conduct research on that gene sequence (unless they pay for permission), so nobody else can try to use the gene to find a cure or treatment for these cancers. Outrageous! It should never be allowed to patent the human body, or any part thereof.
I have always wondered how such stupid patents could be granted, and used an anlogy to the sun, like the author above used to the moon. Maybe if I patent the sun, I can make money off anybody who saves money on lights during the day, since he is using my sun to light his house.
why is it different then canavan or famil dys?? all because of money? same basic concept if it will help the world? let them patent and give SMALL royalties but let the reseaarch continue!
Genae Girard received a diagnosis of breast cancer in 2006, she knew she would be facing medical challenges and high expenses. But she did not expect to run into patent problems.
Ms. Girard took a genetic test to see if her genes also put her at increased risk for ovarian cancer, which might require the removal of her ovaries. The test came back positive, so she wanted a second opinion from another test. But there can be no second opinion. The decision by the government more than 10 years ago allowed the single company, Myriad Genetics, to own the patent on two genes that are closely associated with increased risk for breast cancer and ovarian cancer, and on the testing that measures that risk.
Ms. Girard, 39, who lives in the Austin, Tex., area, also filed a lawsuit against Myriad and the Patent Office, challenging the decision to grant a patent on a gene to Myriad and companies like it. She was joined by four other cancer patients, by professional organizations of pathologists with more than 100,000 members and by several individual pathologists and genetic researchers.
Lets say you undertake an expensive expedition to discover the North Pole. It costs millions and you finally reach your goal and discover it. Does that make it yours? While you are there you discover that Inuits/Eskimos have been living there for centuries. Can you take their land away from them becuause you spent money to find it? No. Same here. THe drug companies/universities spent millions to discover this gene. But it belongs to the person in whose body it was found. And the millions of pther people in whose body it is found. They can exploit their first discoverer advantage by tinkering with it and finding cures but it doesnt belong to them. They cannot prevent other scientists from tinkering with it. This was a mistake by the patent office or someone was paid off to grant it. It must be reversed. The patent has also made mistakes in granting patents to “ideas” such as a technique to avoid taxes legally. THese should not be patentable.
I can’t believe that on this supposedly frum site there has been no mention of the halachic issues regarding intellectual property, and whether I have a right under Torah law or Rabbinic law to control the use of one of my scientific discoveries.
People are missing the point. No one is arguing that you can’t patent the TEST. If the company develops a process to test for a gene, of course they can patent the process. But patenting the gene itself is like patenting the arm or the leg, and shouldn’t be allowed.
The value of the Patent system, and the main reason it was instituted is that patent applicants must publish their discoveries. The new invention or process then becomes public knowledge. The period of exclusivity encourages inventors to produce new ideas, after which they become are available to others to use, modify or improve. Note that many companies choose not to patent some of their discoveries specifically to keep them secret.
If a guy needs a guarantee of ownership over your genes to study and discover them, maybe we would rather have someone else studying them. Most of this research goes on in universities with government and non-profit grant money anyway.
#1 . These genes & their variants were discovered with government grants, not just private funds.
#2. These genes & their variants are products of nature, according to laws of nature. Should Newton have been able to patent the law of gravity? Would undergraduate physics students have to pay royalties every time they used gravitational equations?