[Corp. Watch] Ending corporate control over human life -- and death

[Corporation Watch]

ACLU Sues Over Patents on Breast Cancer Genes

(CNN, May 13) -- Myriad Genetics, a Utah-based company, vowed  
Wednesday to "vigorously defend" itself against a legal challenge to  
its patents on two human genes linked to breast and ovarian cancers,  
its attorney told CNN.

	"Myriad strongly believes its patents are valid and enforceable and  
will be upheld by the courts," said Richard Marsh, the company's  
general counsel.

	The American Civil Liberties Union (ACLU) is suing Myriad, arguing  
that patenting pure genes is unconstitutional, and hinders research  
for a cancer cure.

	Marsh said the company is aware the lawsuit has been filed but has  
not yet been served any legal documents. "We do intend to vigorously  
defend our intellectual property rights," he said.

	He noted a 1980 U.S. Supreme Court decision related to gene patenting  
that he said cleared the way for "tens of thousands of genetic and  
genetic-related patents" to be granted by the U.S. Patent and  
Trademark Office.

	The ACLU, joined by Yeshiva University's law school, filed the  
lawsuit Tuesday in U.S. District Court in southern New York against  
the Patent and Trademark Office, Myriad Genetics, and the University  
of Utah Research Foundation.

	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 says that patenting the genes limits research and the free  
flow of information, and as a result violates the First Amendment.

	"Knowledge about our own bodies and the ability to make decisions  
about our healthcare are some of our most personal and fundamental  
rights," said ACLU Executive Director Anthony Romero. "The government  
should not be granting private entities control over something as  
personal and basic to who we are as our genes."

	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 Ravicher, executive director of  
the Public Patent Foundation and a patent law professor at Yeshiva  
University's Benjamin Cardozo School of Law. "We just had to pick one  
case as our case."

	Ravicher offered an analogy to describe the plaintiffs' argument  
[against genetic patents based on identifying a given gene], saying,  
"It's like saying if someone removes your eyeball ... just because  
[they] 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 [they] can patent that."

	More than 192,000 U.S. women get breast cancer diagnoses each year,  
and about 5 to 10 percent of those cases are a hereditary form of the  
disease, according to the National Cancer Institute.

	Mutations in 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 of  
the BRCA2 gene, and the power to exclude others from providing genetic  
testing. The company charged $3,000 a test, which could keep some  
women from seeking preventative 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 the 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 an 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, and are not "carved in stone." He  
said 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."