Appeals Court Unanimously Invalidates Patents on Human Gene Analysis, Divides of Whether Genes Themselves May Be PatentedNEW YORK -- July 29, 2011 -- A federal appeals court today upheld the right of patients and geneticists to challenge patents relatig to genetic testing. The court also unanimously upheld a lower court's decision to invalidate claims on analyzing gene sequences. In another portion of the decision today, the three court of appeals judges split on whether two human genes associated with hereditary breast cancer and ovarian cancer can themselves be patented, with two voting they can, and one voting they cannot.
The ruling follows a lawsuit brought by a group of patients and scientists represented by the Public Patent Foundation (PUBPAT) and the American Civil Liberties Union (ACLU) and calls into question the validity of patents now held on approximately 4,000 human genes.
“As all the judges today agreed that our clients had standing to bring this case and that analyzing gene sequences for alterations is not patentable,” said Daniel B. Ravicher, executive director of PUBPAT and counsel for plaintiffs in the lawsuit. “The judges disagreed with each other on whether pieces of the human genome are patentable, and we agree with Judge Bryson who explained they are not because no one ‘invents’ genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves.”
The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, charged that the challenged patents are illegal and restrict both scientific research and patients’ access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are "products of nature."
“Today’s ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research,” said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. “Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.”
The specific patents the lawsuit challenged are on the BRCA1 and BRCA2 genes. Mutations along those genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of those cancers 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, preventive mastectomies or ovary removal.
One of the judges on the panel dissented in part with the decision, writing that patents on the genes should be invalid. “…[E]xtracting a gene is akin to snapping a leaf from a tree,” Judge William C. Bryson of the U.S. Court of Appeals for the Federal Circuit wrote. “Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.”
The lawsuit, Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., was filed on behalf of breast cancer and women’s health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. Because the PUBPAT/ACLU lawsuit challenges the whole notion of gene patenting, its outcome 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.
The patents granted to Myriad gave 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. Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to charge a high price for its tests.
“The court has made the wrong decision for a woman’s health,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “No corporation should be able to claim ownership of women’s own genetic information.”
Several major organizations, including the American Medical Association, the March of Dimes and the American Society for Human Genetics, filed friend-of-the-court briefs in support of the challenge to the patents on the BRCA genes. In addition, the United States Department of Justice filed a brief arguing that many of the gene patents issued by the Patent Office are invalid.
Attorneys on the case include Ravicher and Sabrina Hassan of PUBPAT; Hansen and Aden Fine of the ACLU Speech, Privacy and Technology Project; and, Sandra Park and Lenora Lapidus of the ACLU Women's Rights Project.
Today's Court of Appeals decision is available here.
More information about the case is available online at www.pubpat.org/brca.
Daniel B. Ravicher, (212) 796-0570; email@example.com