Breast cancer: Gene patents get court approval

Really? A company can patent a human gene?

Yes, an appeals court decided Friday, in a closely watched case pitting a coalition that includes the American Civil Liberties Union, physicians and health advocates against Salt Lake City-based biotech firm Myriad Genetics Inc.

For the Record, 4:14 p.m. July 29: An earlier version of this post implied that the BRCA1 and BRCA2 genes increase the risk of developing breast and ovarian cancer, and that only some women have them. In fact, everybody has both of these genes, though women with certain versions of them face the increased cancer risk.

Myriad holds 23 patents related to the BRCA1 and BRCA2 genes. When a woman has certain versions of these genes, it greatly increases her risk of developing breast and ovarian cancer. Myriad manufactures and markets a test for the gene variants called BRACAnalysis.

The plaintiffs in the case challenged the company’s patents on the grounds that they discouraged scientific research and development of new tests for ovarian and breast cancer and therefore threatened women’s health. They argued that the patents were illegal because BRCA1 and BRCA2 occur in nature -- that is, in the DNA of every person. More than 30 years ago, the Supreme Court found that patents apply only when an object is “a product of human ingenuity” and not naturally occurring.

In March 2010, a district court agreed with the plaintiffs, striking down seven of the patents on the genes.

But the appeals court found that “the molecules as claimed” -- the “isolated DNA” -- in fact “do not exist in nature.” Because the genes are separated from surrounding biological materials, the DNA is patentable, Judge Alan Lourie wrote.

The court’s decision didn’t completely fall in the company’s favor; some patents associated with analyzing DNA were found ineligible for protection. But the ruling is considered a victory for biotechnology companies.

“The fact that genes will be considered patentable subject matter is a good decision and the Court based the decision in part on the intent of Congress and under the patent laws in the U.S,” wrote Lisa A. Haile, co-chair of the Global Life Sciences Sector at DLA Piper, a law firm in San Diego. “Patents will continue to be granted to applicants who ‘isolate’ nucleic acid sequences from their natural environment, sequence them and identify functions and uses for those sequences, and existing patents will remain enforceable.”

The ACLU may decide to appeal the case to the Supreme Court.