Breast Cancer Gene Test


human-dna

Image Credit: CBC News

Hooray!

The U.S. Supreme Court’s unanimous judgment is in: Companies cannot patent parts of naturally-occurring human genes. This decision has the potential to profoundly affect the emerging and lucrative medical and biotechnology industries. (National Human Genome Research Institute/Reuters)

Myriad Genetics Inc. is the only lab in America where testing for mutations of BRCA genes 1 and 2 are sent. The test costs between $3,000 and $6,000 and not is not covered by all health insurance. The test consists of a tube of blood. That tube is then packed in a padded box, then placed inside another padded box. The package is kept refrigerated, and shipped overnight to the Utah lab. They look to see if the DNA code is broken. If it is broken, it means the woman has a mutant gene. If that’s the case, the woman has a higher risk (three to seven times higher) than the normal population for breast or ovarian cancer.  BRCA1 is more common, and points to risks of breast or ovarian cancer. BRCA2 is less common, and points to risks of other cancers forming.

The U.S. Supreme Court ruling reverses three decades of patent awards by government officials. It throws out patents held by Myriad Genetics Inc. on the BRCA 1 and 2 test.

Justice Clarence Thomas, who wrote the court’s decision, said that Myriad’s assertion — that the DNA it isolated from the body for its proprietary breast and ovarian cancer tests were patentable — had to be dismissed because it violates patent rules. The court has said that laws of nature, natural phenomena and abstract ideas are not patentable.

“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Thomas said.

For thirty years, the U.S. Patent and Trademark Office has been awarding patents on human genes. Patents provide legal protection to inventors to prevent others from making, using or selling a novel device, process or application. Opponents of Myriad Genetics Inc’s patents on BRCA genes 1 and 2 say patent protection shouldn’t be given to something that can be found in the human body.

I’m not up on Hollywood names. Before Angelina Jolie’s story hit the news, I didn’t know a thing about her. For those of you who also live under a rock, she’s an actress. Last month, she shared that bother her mother and maternal grandmother died of ovarian cancer. By having the BRCA gene test, Jolie learned she carries a mutated BRCA1 gene that puts her at high risk of developing breast and ovarian cancers.This led Jolie to have both of her healthy breasts removed to try to avoid the same fate.

When her story went public, I had several thoughts:

  • Why does everyone need to know this woman’s private decision? 
  • Oh, great. Now a superstar makes a bilateral mastectomy and implants look quick, easy, and foolproof. —But, perhaps that’s the media’s doing, not hers.
  • What good timing to bring light to the debate about patenting DNA. I see her decision as a tough, private one that has become a very public discussion. Maybe she’s become the face to this BRCA gene test, and the importance of the test being accessible to those with questionable family cancer history. Maybe without the DNA patent ruling, the mainstream media and gossip magazines would be asking the question, “Do you agree with Jolie’s decision?” —As if it’s ours to decide.

How the sides see this case:

Opponents of its patents say Myriad can use the patents to keep other researchers from working with the BRCA gene to develop other tests.

Companies have billions of dollars of investment and years of research on the line in this case. Their advocates argue that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries to combat all kinds of medical maladies wouldn’t happen.

“Genes and the information they encode area not patent eligible… simply because they have been isolated from the surrounding genetic material,” Thomas said.

Justice Antonin Scalia concurred, “the portion of the DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state.”

The court did rule that synthetically created DNA, known as cDNA, can be patented “because it is not naturally occurring,” Thomas said.

Thomas noted there were still ways for Myriad to make money off its discovery. “Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent,” he said. And he noted that the case before the court did not include patents on the application of knowledge about the two genes.

Source: The Associated Press Posted: Jun 13, 2013 12:11 PM ET

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