Navigation Links
Human Gene Patent Case Goes to Supreme Court
Date:4/15/2013

By Margaret Steele
HealthDay Reporter

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, critics say.

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, Shapira said.

"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 AP reported. In court papers, Solicitor General Donald Verrilli said artificially created DNA can be patented, while "isolated but otherwise unmodified genomic DNA is not patent-eligible."

Dr. Barbara Pober, a professor of medical sciences at Quinnipiac University's Frank H. Netter MD School of Medicine, agreed that the Myriad genes should not have been patented. "Genetic sequencing in the laboratory, as performed by Myriad Genetics, does not involve sufficient alteration or modification of the gene to warrant the protections afforded to a patented product," she said.

"In fact, patenting genes inhibits dissemination of genetic information to patients, as well as innovation and technology by eliminating the ability of both small and large laboratories to develop genetic tests," she added. As a result, consumers and hospitals pay more for tests and wait longer for the results, she said.

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 AP reported.

"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, Chapel Hill, told the Times that the significance of the nine justices' decision "will be much more ideological than it will be practical."

More information

The U.S. National Cancer Institute has more on genes and breast cancer.

SOURCES: Iuliana Shapira, M.D., director, cancer genetics, North Shore-LIJ Cancer Institute, Lake Success, N.Y., and investigator, Feinstein Institute for Medical Research in Manhasset, N.Y.; Barbara R. Pober, M.D., professor, medical sciences, Frank H. Netter M.D. School of Medicine, Quinnipiac University, Hamden, Conn.; April 15, 2013, New York Times and Associated Press


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. 10 Years On, Still Much To Be Learned From Human Genome Map
2. Transparent Mouse Brain Could Shed Light on Human Brain Health
3. The beat goes on: Modeling the human heart
4. Dr. Oz Misses Key Point On Mercury Amalgam’s Impact On Human Health
5. Penn State to Offer Human Development and Family Studies Degree Online
6. Skin deep: Fruit flies reveal clues to wound healing in humans
7. For the first time, researchers isolate adult stem cells from human intestinal tissue
8. Ability to think about thinking not limited to humans
9. Joan Keddell, International Tour Management Institute (ITMI) Educator to Provide Human Trafficking Awareness Training at the Trafficking in America Conference in Nashville, TN, May 23 – 25, 2013
10. Center for Emotional Restructuring Announces a Published Article Suggesting the Brain Code for Learning and Memory Prior to Human Brain and Brain Activity Map Projects
11. Research suggests popular diabetes drugs can cause abnormal pancreatic growth in humans
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Human Gene Patent Case Goes to Supreme Court
(Date:5/24/2016)... ... May 24, 2016 , ... American Gene Technologies ... to its board of directors. Otterstatter is co-founder, president and CEO of ... technological innovations that lead to broad-based healthcare solutions. , “Jon knows how to ...
(Date:5/24/2016)... ... 24, 2016 , ... WaterAid launched the #perioddrama campaign to mark Menstrual Hygiene Day ... women around the world who do not have access to a toilet, even when they’re ... their dread of #perioddrama. The (sometimes hilarious) results help shine a light on the awkwardness ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... patient Services To Begin In June , Aloria Health, specializing in a re-imagined, ... opening of Aloria Milwaukee, its first treatment facility for outpatient, day treatment and ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... ... and tick-borne disease research and education, today announced that it has named Scott ... of the Bonnie J. Addario Lung Cancer Foundation (ALCF) in San Francisco, where ...
(Date:5/24/2016)... ... 24, 2016 , ... Dignity Health has announced it will be opening a ... licensed under Dignity Health Arizona General Hospital, which opened last year in the West ... that the new facility will complement Dignity Health’s existing hospitals’ emergency departments. “We ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... , May 24, 2016 Open ... in Clinical Neurophysiology  Elsevier , a ... and services, today announced the launch of ... access journal that focuses on clinical practice issues in ... reports, clinical series, normal values and didactic reviews. It ...
(Date:5/23/2016)... PUNE, India , May 23, 2016 /PRNewswire/ ... research report "Patient Handling Equipment Market by Product ... Type of Care (Bariatric Care, Critical Care, Wound), ... Hospital) - Forecast to 2021", published by MarketsandMarkets, ... reach USD 17.18 Billion by 2021 at a ...
(Date:5/23/2016)... ALBANY, New York , May 23, 2016 /PRNewswire/ ... new market report titled, " Exocrine Pancreatic Insufficiency Market ... Forecast 2013 - 2023 ." According to the report, ... at a CAGR of 8.3% from 2015 to 2023 ... pancreatic insufficiency (EPI) is a condition characterized by the ...
Breaking Medicine Technology: