by Jake Meyer

Earlier this week, a lawsuit organized by the American Civil Liberties Union was filed challenging the validity and constitutionality of patents on the BRCA1 and BRCA2 breast cancer genes owned by Myriad Genetics.  The plaintiffs in this case include: women who wish to have testing for the BRCA1 and BRCA2 genes; researchers who have the capabilities to offer testing for these genes but are unable to because of Myriad’s patents on the BRCA1 and BRCA2 genes; medical organizations; and women’s health organizations.

The presence of the certain mutations in the BRCA1 or BRCA2 genes is associated with a predisposition to breast or ovarian cancer.  Women who have these mutations are much more likely to develop these cancers and men who have the mutation can pass the mutation to their daughter.  Women who learn they have these mutations will often opt for drastic surgeries, such as a mastectomy or oopherectomy (removal of the ovaries) to avoid a battle with breast or ovarian cancer.  However, Myriad Genetics owns patents that cover both the BRCA1 and BRCA2 gene sequences and mutations of the genes, which grant Myriad a monopoly over the gene sequences (for an example of one of Myriad’s patents click here). Myriad is the only company that offers genetic testing for BRCA1 and BRCA2 in the U.S. and therefore women cannot get second opinions before making decisions about major surgery.  Also, since Myriad has a monopoly on testing, it can charge whatever it wishes for the testing – currently the test costs over $3,000.  Many insurance plans don’t cover this testing and many people can’t afford the out of pocket cost of the test – so testing isn’t available to them.  Further, according to a 2006 study, Myriad’s test can miss certain mutations that help cause the disease.

The plaintiffs in this case include researchers who would engage in research on and offer testing for BRCA1 and BRCA2 but are unable to because of Myriad’s patents.  Dr. Arupa Ganguly, Associate Professor of Genetics at the Hospital of the University of Pennsylvania, received a cease-and-desist letter from Myriad that forced her to abandon her research and clinical practice on breast cancer.  If the BRCA1 and BRCA2 patents were invalidated, researchers would be free to offer testing and engage in further research.  Competition from other researchers and labs offering testing would also make the test more affordable, available for women.  For example, plaintiff Dr. Harry Osterer is the Director of the Molecular Genetics Laboratory of NYU Medical Center, one of the largest academic genetic testing laboratories in the U.S., and the lab has the ability to evaluate BRCA1 and BRCA2 genes using custom-designed tests that may be more cost-effective than Myriad’s tests.  With multiple labs offering BRCA1 and BRCA2 testing, women could get second opinions, and the competition among the labs would lower the cost and improve the quality of the testing.

The plaintiffs in this case also include medical organizations and women’s health organizations.  The medical organizations are suing on behalf of their members, who include researchers that would engage in medical research and clinical practice on the BRCA1 and BRCA2 genes if the Myriad’s patents are found invalid.  For example, the American Society for Clinical Pathology is a not-for-profit entity that represents 130,000 members who work as pathologists and laboratory professionals.  Members of the ASCP design and interpret tests that detect disease, predict outcomes, and determine the proper treatment.  If Myriad’s patents are invalidated members of the ASCP would be able engage in research and provide testing for BRCA1 and BRCA2.  Breast Cancer Action is a not-for-profit breast cancer advocacy and educational organization.  Members of Breast Cancer Action have had their BRCA1 and BRCA2 genes analyzed and also provide information to the public about genetic testing.  Breast Cancer Action would be able to provide this information to the public without fear of infringement in Myriad’s patents are found invalid.