Cancer Gene Patents

After being diagnosed with breast cancer 3 years ago, Genae Girard knew she faced medical travails and steep costs, but she didn’t necessarily expect to encounter a patent problem.

Still, that’s what happened after the 39 year-old Austin, Texas native underwent BRCA gene testing to determine whether she was at increased risk for ovarian cancer, perhaps necessitating that her ovaries be removed as well.

The test was positive.

She requested confirmation using another test, but was stoned by a decade-old Patent Office ruling that granted Myriad Genetics a patent on BRCA genes and the related testing procedures that determine ovarian cancer risk.

Now Girard is suing Myriad and the Patent Office. She has been joined by other cancer patients, professional organizations representing 100,000 pathologists, and a raft of genetic researchers. The ACLU organized the case and filed it in a federal court in New York. 

The coalition does not plan to accuse Myriad of being a poor steward of the information concerning the BRCA genes, but rather that BRCA testing could improve and costs could be reduced in the absence the monopoly held by Myriad as a result of the Patent Office’s decision.

“With a sole provider, there’s mediocrity,” Wendy Chung told the New York Times. Chung is a plaintiff in the case and directs clinical genetics at Columbia.

Companies like Myriad have contended in similar cases that the patent system fosters innovation by rewarding risky investments in research and development.

The Patent Office has already granted patents to single companies for genetic testing on long QT syndrome, a condition associated with cardiac arrhythmias and sudden death, and testing for the gene that causes hemochromatosis, a rare condition characterized by excessive iron accumulation.

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