Forum on ACLU Patent Challenge

This May, the American Civil Liberties Union filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer stifle research that could lead to cures and limit women’s options regarding their medical care. Mutations along the genes, known as BRCA1 and BRCA2, are responsible for most cases of hereditary breast and ovarian cancers. The lawsuit argues that the patents on these genes are unconstitutional and invalid.

The ACLU and the Center for Ethics in Science & Technology present a forum to discuss the scientific, ethical, and civil liberties comepeting interests raised by the practice of patenting specific genes.

Patents, Scientific Freedom, and the First Amendment

Wednesday, August 5, 2009
5:30 – 7 pm
Featured speakers:
– Leonard Deftos, UC San Diego
– Kevin Keenan, Executive Director, ACLU
– Stacy Taylor, DLA Piper LLP
Reuben H. Fleet Science Center [Venue information]

This is a free event.

Click here for details on the event.
Click here to RSVP.

The lawsuit by the ACLU and the Public Patent Foundation, a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law (PUBPAT) was filed in U.S. District Court for the Southern District of New York on May 12, 2009, on behalf of breast cancer and women’s health groups, individual women and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals against the U.S. Patent and Trademark Office (PTO), as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. It is the first to apply the First Amendment to a gene patent challenge.

The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad. According to the lawsuit, such monopolistic control over these genes hampers clinical diagnosis and serves as a disincentive for research because Myriad not only has the right to enforce its patents against other entities but also has the rights to future mutations discovered on the BRCA2 gene. The gene patents are also illegal under patent law because genes are “products of nature.”

Many women with a history of breast and ovarian cancer in their families opt to undergo genetic testing to determine if they have the mutations on their BRCA genes that put them at increased risk for these diseases. This information is critical in helping these women decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal. However, the fact that Myriad can exclude others from providing this testing has several negative consequences for patients: many women cannot afford the more than $3,000 Myriad charges for the test; patients cannot get second opinions on their test results; and patients whose tests come back with inconclusive results do not have the option to seek additional testing elsewhere.

Because the ACLU’s lawsuit challenges the whole notion of gene patenting, it could have far reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, asthma and many other illnesses.