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Supreme Court to decide if human genes can be patented

Published time: April 11, 2013 19:40
Edited time: April 15, 2013 07:47
RIA Novosti / S. Solovjev

RIA Novosti / S. Solovjev

The US Supreme Court is about to hear arguments in a case challenging patents on breast and ovarian cancer genes. If the court upholds the company’s right to patent human genes, the course of US medical research could forever be altered.

The case involves the Utah biotech firm Myriad Genetics, which for years has been facing a lawsuit for placing patents on human genes and restricting cancer patients’ treatment options.

The molecular diagnostic company, which is based in Salt Lake City, holds a number of patents on genes related to breast cancer and ovarian cancer, two of which US District Court Judge Robert W. Sweet ruled invalid in 2010, the decision that Myriad appealed. The genes in question, BRCA1 an BRCA2, often appear in cancer patients, sometimes before the cancer has even developed. With methods to diagnose these genes patented by Myriad Genetics, patients are unable to go to any other doctors for a second opinion before seeking treatment.

“Myriad is gate-keeping who can do what research on these genes and they are uniquely aggressive in how they control a patent,” Karuna Jagger, executive director of Breast Cancer Action, told The Guardian. As a result of Myriad’s gene-ownership, other doctors and researchers are unable to develop alternate tests or treatment options, thereby giving cancer patients very few options.

Women with the BRCA1 or BRCA2 genes have no other options aside from taking the Myriad test, which is expensive and not always covered by insurance. Breast cancer survivors are expected to speak before the Supreme Court next week, where they will talk about the costs of the $3,000 tests that their health insurances did not cover.

“The Supreme Court has the opportunity to right this wrong, to correct a problem that could free up human genomics to develop new diagnostic tests,” Jagger said.

A coalition of cancer survivors, scientists, cancer patients, medical associations and support groups have expressed their outrage at the biotech firm for patenting parts of the human body, which they say are “products of nature” and should not be financially exploited. The group claims that the patents violate the First Amendment by restricting the free exchange of ideas on human body parts.

Runi Limary, a 36-year-old breast cancer survivor, told USA TODAY that one of the patented genes showed up in her body when she was 28. Suspecting ovarian cancer, she debated having her ovaries removed, but couldn’t get a second opinion because Myriad held a patent on the mutated gene that she developed.

“It’s so frustrating,” she said. “I’m really trying to buy time until I’m 40.”

Limary has not yet had her ovaries removed, since doing so would diminish her ability to have children. She claims that if Myriad didn’t have a patent on the mutated gene, she could seek better treatment options and medical advice.

In its defense, Myriad argues that without the ability to have such patents, which financially sustain the industry, research and development would dry up. But patent-opponents claim that the resulting competition would cause medical bills to go down in price and lead to greater scientific discoveries.

“It’s about the future of personalized medicine for every single human being on this planet, and actually animals too,” Ellen Matloff, director of cancer genetic counseling at Yale School of Medicine, told USA TODAY.

Currently, about 20 percent of the 4,000 genes found in the human body are already covered by a patent, including some linked to colon cancer and Alzheimer’s disease. Some patents are owned by research institutions that try to prevent large corporations from using them for profit.

The Supreme Court ruling on Myriad’s patents could affect the entire medical industry. The court will ultimately decide whether or not human genes can be ‘owned’ by corporations, which continues to encourage a race towards discovering them, while also limiting research after their discovery.

“You have to ask, how is it possible that my doctor cannot look at my DNA without being concerned about patent infringement?” Christopher Mason, assistant professor at Weill Medical College, told The Guardian.

But in order to strike down Myriad’s patents, the Supreme Court would likely have to rule against a law that has already allowed about a thousand human genes to become patented – a landmark decision that would overhaul the US medical research system.