MONDAY, April 15 (HealthDay News) -- The question of whether
human genes can be patented is at the center of a case to be heard
Monday by the U.S. Supreme Court.
The court's decision could have a profound effect on medical
research in the country, efforts to fight diseases such as breast
and ovarian cancer, and the multi-billion dollar medical and
biotechnology industry, experts say.
The U.S. Patent and Trademark Office has been granting patents
on human genes for more than 30 years, according to the
Associated Press. The current case stems from a 2009 lawsuit
filed by the American Civil Liberties Union on behalf of breast
cancer patients and health professionals challenging the validity
of Myriad Genetics' patents on two genes associated with breast and
ovarian cancer risk.
BRCA1 and BRCA2 gene mutations are linked to increased risk of
breast and ovarian cancer, and Myriad sells the only BRCA gene
test, which gives them a monopoly on a highly profitable business,
Opponents also say that allowing companies to patent human genes
or parts of human genes will hinder potentially lifesaving research
to fight diseases such as breast cancer.
"What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes," Karuna Jagger, executive director of Breast Cancer Action, told the AP.
Myriad has the patent on a specific method of isolation and
identification of specific BRCA mutations, explained Dr. Iuliana
Shapira, director of cancer genetics at North Shore-LIJ Cancer
Institute in Lake Success, N.Y.
The way Shapira sees it, patents allow a temporary legal
monopoly over the use of an invention, but genes are "not invented"
by human intelligence and therefore cannot be patented.
On the other hand, if scientists "edit" the gene, for example
removing parts of it or introducing some parts and thus creating "a
synthetic gene" -- something that does not exist in nature and has
specific functions -- that type of "synthetic gene" is patentable,
"Some synthetic genes are used by the biotechnology industry to make therapeutic antibodies, such as Rituxan (used to treat lymphoma) or Herceptin (used to treat breast cancer)," Shapira said. "These synthetic genes have patents that nobody disputes."
Some of the opposition's concerns are overblown and some are
simply incorrect, according to Mark Capone, president of Myriad
Genetics Laboratories, Inc., a subsidiary of Myriad.
"Myriad cannot, should not and has not patented genes as they exist in the human body on DNA," Capone told the AP. "This case is truly about isolated DNA molecules, which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent."
However, the ACLU contends that isolating the DNA molecules
doesn't stop them from being DNA molecules, and that these
molecules are not patentable. That position appears to have the
support of the Obama administration, the
APreported. In court papers, Solicitor General Donald
Verrilli said artificially created DNA can be patented, while
"isolated but otherwise unmodified genomic DNA is not
Whatever the ruling, the implications will be significant in
terms of shaping laws governing biotechnology and medical
innovations, one expert said.
"The intellectual framework that comes out of the decision could have a significant impact on other patents -- for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature," Robert Cook-Deegan, director for genome ethics, law and policy at Duke University, said in a statement, the APreported.
"This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications," he explained.
Current research would come to a halt, others contend.
Biotechnology Industry Organization said in a friend of the court
brief that invalidating the current patent law "would chill a wide
range of important activities that benefit society," according to
The New York Times.
Others are less convinced that the ruling will have an enormous
impact, especially since the Myriad patents will expire over the
next two years. Dr. James Evans, a professor of genetics and
medicine at the University of North Carolina, told the
Timesthat the significance of the nine justices' decision
"will be much more ideological than it will be practical."
The U.S. National Cancer Institute has more on
genes and breast cancer.
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