U.S. Supreme Court to Review Patents on Genes

AARP Foundation Litigation attorneys have filed a total of five amicus briefs (two in the Federal Circuit, three in the Supreme Court) urging the court to reject patents on human genes. The case is before the U.S. Supreme Court for the second time for review.

Background

Myriad Genetics holds an exclusive patent on BRCA1 and BRCA2 genes, which are fragments of DNA that relate to a person's predisposition to develop breast and ovarian cancer. Because of its patents, Myriad is the only provider of BRAC genetic testing in the United States.

Approximately 5 to 10 percent of individuals diagnosed with breast cancer have mutations in their BRCA1 or BRCA2 genes. Those with mutations have as much as an 85 percent chance of developing breast cancer and a 50 percent chance of developing ovarian cancer. But early preventive action (including lifestyle changes, chemoprevention or surgery) can make the odds of survival more favorable.

Because of its exclusive license, Myriad is the only provider of BRCA genetic testing in the United States. Myriad thus provides the only option for BRCA testing in the U.S., hindering the ability to seek a second opinion. Moreover, Myriad charges in excess of $3,400 for its BRCA genetic test.

Various nonprofit organizations, scientists, professors, counselors and individuals potentially at high risk for hereditary breast and/or ovarian cancer filed a lawsuit alleging that seven patents on genes violate the constitution. They argued that human genes and DNA molecules are natural phenomena that are not the kind of "discovery" anticipated by U.S. Patent laws.

AARP's brief pointed out that patent law did not envision patenting natural phenomena; patents stifle competition in the marketplace (leading to reduced availability and increased costs, as here); and that the effect of the high costs of genetic testing limit access to the tests, which can be life-saving.

A federal district court in New York invalidated the patents on BRCA genes, and Myriad appealed. A federal appeals court upheld in part and reversed in part. Most damaging, it held that isolated human genetic sequences can be patented. However, in a small victory, the court overturned some patents on certain diagnostics tests, as AARP and others had urged, but unfortunately upheld other diagnostic tests.

What's at Stake

The cost and availability of diagnostic tests is what is at stake here. The outcome of this case left open the question of what additional diagnostic methods are patentable. Genetic diagnostic tests can determine how a patient will respond to a specific drug or a patient's risk for developing a number of illnesses including Alzheimer's, hearing loss, heart disease and a variety of cancers.

Case Status

Ass’n for Molecular Pathology v. Myriad Genetics is now in the Supreme Court for the second time with oral arguments scheduled for April 15, 2013.