The BRCA Gene Patent Fight Rears Its Ugly Head Again

By: Allison McCowan *

Breast cancer ribbonOn September 25, 2012, the American Civil Liberties Union (the “ACLU”) along with the Public Patent Foundation requested the U.S. Supreme Court to reconsider the patents for BRCA1 and BRCA2, genes which are associated with hereditary breast and ovarian cancer. The ACLU’s lawsuit names Myriad Genetics, Inc. (“Myriad”) and the University of Utah Research Foundation as defendants and requests the Supreme Court invalidate the two gene patents on grounds that they are illegal and restrict scientific research and patients’ access to medical care. Previously, the U.S. Supreme Court has unanimously held that companies are not permitted to patent observations of natural phenomena.

In 1998 Myriad Genetics, Inc. patented the genes BRCA1 and BRCA2. These two genes are used by Myriad to detect the risk of breast and ovarian cancers and to help inform patients of their treatment options. Patients who test positive for the “breast cancer gene” using Myriad’s gene test have an 82 percent higher risk of developing breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes. By patenting these two genes, Myriad has the exclusive rights to perform tests on the two genes. Critics, including the ACLU, argue that this level of exclusivity allows Myriad to set the costs for the tests and makes it completely impossible for women to get a second opinion about their results. Additionally, the ACLU contends that the exclusivity prevents other researchers from additional testing or even looking at the genes without prior permission from Myriad.

ACLU logoThis case originated in 2009 when the ACLU and the Public Patent Foundation brought a suit against the U.S. Patent and Trademark Office, Myriad, and the University of Utah Research Foundation. In 2010 a New York federal district court invalidated all of the challenged patents. On appeal, the U.S. Court of Appeals for the Federal Circuit ruled that companies could obtain patents on the genes but could not patent methods to compare the gene sequences. Following this decision, the U.S. Supreme Court vacated the court of appeals decision and instructed the court to reconsider the facts in light of Mayo Collaborative Services v. Promethus Laboratories, where the U.S. Supreme Court invalidated patents on methods for evaluating a patient’s response to a drug dosage.

In its most recent pleading, the ACLU argues that “the court of appeals did not fully consider or correctly apply the Supreme Court’s most recent and relevant patent law decisions.” Jeffrey Kahn, a bioethics and public policy professor at the Johns Hopkins University, suggested that “there’s a real crying need for clarification about patent law and intellectual property related to genomics” and that research is suffering because of the uncertainty surrounding this case.

Myriad logoThis issue highlights a major source of concern for women and women’s rights advocates and showcases the struggle between protecting someone’s creation via patents and the ability for women to receive life-saving preventative tests. What makes this even more sensitive is the current politically charged atmosphere and whether either presidential candidate will take a position for either the ACLU or Myriad. Obama or Romney would garner strong support from the women’s rights advocates if they endorse the ACLU’s quest to expand BRCA1 and BRCA2 access for researchers, drug companies, and most of all, women.

* Allison McCowan is a third-year student at Wake Forest University School of Law and is President of the Domestic Violence Advocacy Committee. She holds a Bachelor of Arts in Psychology from Norwich University. Upon graduation in May 2013, Ms. McCowan intends to practice corporate law, commercial law, or alternative entity law in either Delaware or Washington D.C.