The case for and against the patenting of genes

In 1998, Penn geneticists Arupa Ganguly and Haig Kazazian were ordered to stop offering women a test for genetic mutations that carry a dire risk of breast cancer.

Myriad Genetics Inc. accused the researchers of patent infringement and threatened them with a lawsuit. They weren't even using a test patented by Myriad. Ganguly had pioneered a new way to read these genes and devised her own test.

But Myriad held a patent on the genes themselves.

Now both University of Pennsylvania scientists have been pulled into a lawsuit that could not only strip Myriad of its patents but end the 30-year-old practice of patenting human genes.

The lawsuit was filed in New York by the American Civil Liberties Union along with several medical associations and breast cancer activists.

The ACLU won the first round in March when federal Judge Robert Sweet ruled that Myriad's patents on genes called BRCA1 and BRCA2 were improperly granted. Myriad lawyer Richard Marsh said they filed for appeal on Wednesday. The case now looks likely to reach the U.S. Supreme Court.

A decision could invalidate several thousand patents on genes as well as thousands of other patents on diagnostic tests and natural products, say lawyers following the case.

Those in favor of DNA patents say if the ACLU gets its wish, it could devastate the biotechnology industry - especially if the ruling fans out to cover more than DNA.

Opponents say Myriad's aggression toward potential competitors has deprived women of the chance to independently confirm Myriad's test, which cost around $3,120 and is covered by most health insurance.

Women with mutations in these so-called breast cancer genes, BRCA1 and BRCA2, live with a 60 percent to 80 percent chance of getting the disease over their lives. BRCA2 mutations also lead to a high risk of ovarian cancer.

Doctors often advise these women to undergo a double mastectomy before they get cancer. For those with BRCA2 mutations, doctors sometimes recommend they have their ovaries removed as well.

Opponents are also troubled by gene patents on principle, since genes are not inventions, nor in most cases are they natural products used as a medicine.

Some scientists have long resented the Utah-based company holding the patents, Myriad Genetics Inc., and its founder, Mark Skolnick.

He was not favored to win the race for the breast cancer genes. The first person to realize that such a gene existed was a revered geneticist, Mary Claire King, now at the University of Washington.