Supreme Court Gene Ruling Benefits Biotech, Breast Cancer Research

FILE - A technician loads patient samples into a machine for testing 

at Myriad Genetics, May 31, 2002.

Megan McGrath - Everyone has BRCA genes in their cells. If you are a woman and one of your BRCA gene copies has a mutation, your risk of developing breast cancer is very high - up to 87 percent in some cases.

A biotechnology company called Myriad Genetics Inc. was the first to discover the healthy, normal code of BRCA. Because a mutation is an error in that code, the normal sequence can be used to test for the breast cancer-causing BRCA mutation. Myriad developed the test, and won patent protection for it and the original BRCA gene.

Thursday, in a case against Myriad by the ACLU, the Supreme Court decreed that genes can no longer be patented, invalidating Myriad’s intellectual claim to the BRCA code. Yet both sides came away claiming victory.

So what happened, and what does this decision mean for cancer patients, medical researchers and biotechnology?

A patent is issued to give an inventor or developer intellectual and property rights to whatever has been made. The patent on the BRCA gene initially was granted for isolated DNA: the gene removed from the human body so that it may be worked with in the lab.

But the federal Patent Act states that an inventor may not claim intellectual property rights for “laws of nature” or “natural phenomena.”

The question was whether the isolated BRCA gene constituted a new invention, having been removed from the body. The Supreme Court unanimously decided that isolated DNA, though isolated, is still natural, and not a human invention.

According to Dr. Marisa Weiss, founder and president of Breastcancer.org,this could mean new research, cures and testing for women with BRCA mutations, and for cancer patients. Until now, researchers have had to pay for the isolated BRCA genetic code, which they need to have to understand how BRCA functions both on its own and in concert with other genes.

BRCA repairs errors in the DNA of breast tissue cells, and prevents unrestrained growth. So, if BRCA is damaged, breast tissue growth can go haywire, leading to cancer.

Five to 10 percent of all breast cancers are caused by BRCA mutation, and it also leads to a greatly increased risk of ovarian cancer. Freeing the isolated BRCA gene from its patent could allow researchers to develop more, cheaper tests for BRCA mutation, which could give more women at increased risk of developing cancer a chance to know their status earlier.

Women with BRCA mutations are advised to monitor their health with frequent breast MRIs, according to Dr. Weiss. They also may choose to undergo preventive mastectomies and removal of the ovaries and fallopian tubes to avoid cancer.

With the early awareness provided by BRCA mutation testing, women may even choose to have children earlier to prepare for these surgeries.

American actress Angelina Jolie's recent decision to undergo a preventive double mastectomy was a result of having discovered a mutation in one of her BRCA genes.

Myriad Genetics Inc. is not deprived by this decision, however, said Jennifer L. Swize, a lawyer who represented the biotech company. In fact, she said, “to Myriad, this decision is a win.” While the court overturned patents on isolated DNA, it made a point to uphold patents on cDNA (complementary DNA), or synthetic copies of the genetic sequence with useless “junk” segments removed.

CDNA is what Myriad uses in most of its BRCA research anyway, not unmodified isolated DNA. Patents on research and designs like the BRCA mutation test also were upheld. Myriad’s stock rose following the decision.