Motion To Declare Gene Patents Unconstitutional

[Guest ACLU]

The American Civil Liberties Union and the Public Patent Foundation (PUBPAT), a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law, filed a motion asking a federal court to rule that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. Several major organizations, including the American Medical Association (AMA), the March of Dimes and the American Society for Human Genetics (ASHG), are filing friend-of-the-court briefs in support of the motion for summary judgment. The groups charge that the patents stifle diagnostic testing and research that could lead to cures and that they limit women's options regarding their medical care.

 

"When you patent genes, you are really patenting knowledge," said Chris Hansen, an attorney with the ACLU. "Granting patents on human genes limits scientific research, learning and the free flow of information. We hope the court rules soon that patents are meant to protect inventions, not things that exist in nature like genes in the human body."

 

The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was originally filed on May 12 in the U.S. District Court for the Southern District of New York on behalf of breast cancer and women's health groups, individual women and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. The lawsuit was filed against the U.S. Patent and Trademark Office, as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The lawsuit charges that patents on human genes violate the First Amendment and patent law because genes are "products of nature."

 

"Human genes are products of nature and patents on them should never have been granted in the first place," said Daniel B. Ravicher, Executive Director of PUBPAT and co-counsel in the lawsuit. "There is something fundamentally wrong with companies being able to own the rights to a piece of the human genome. Genes are not inventions, and patenting genetic sequences is like patenting blood, air or water."

 

Mutations along the genes, known as BRCA1 and BRCA2, are responsible for most cases of hereditary breast and ovarian cancers. 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.

 

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. Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a second opinion about their results and allows Myriad to charge a high rate for their tests.

 

"The AMA is concerned that medical patents on genes could harm patients' access to care," said Rebecca Patchin, M.D, AMA Board Chair. "Physicians should not be stifled in what care they can provide because someone has patented a part of human biology. These patents are too broad and should be reined in so that no patient is denied care."

 

Dr. Edward McCabe of UCLA, President of ASHG, said, "The American Society of Human Genetics includes thousands of members who do basic research as well as those who are involved in clinical and patient care. The deterrents presented by the patenting and exclusive licensing of BRCA genes continue to cause problems in many laboratories. ASHG is therefore a party to the amicus brief with other large and representative medical and research organizations."

 

Because the ACLU's 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.

 

"Every baby deserves a healthy start in life and patenting genes stifles research and will slow, or may even prevent, the March of Dimes from realizing that goal," said Alan R. Fleischman, M.D., March of Dimes Medical Director. "The 540,000 American babies who face life long health challenges such as learning disabilities, cerebral palsy, blindness and many other diseases because they were born too soon are relying on genetic research to find a way to prevent preterm birth and birth defects."

 

Nobel Prize winner Sir John Sulston, Chair of the Institute for Science, Ethics and Innovation at the University of Manchester, who supports the ACLU's lawsuit, said, "Patents on human genes are harmful to the practice of science and a disincentive to further research on those genes. Patents on genes inhibit access to the most basic information and discourage scientific communication and data sharing. Free sharing of this information is vital to understanding the role of genetic variations in human disease."

 

Attorneys on the case include Hansen and Aden Fine of the ACLU First Amendment Working Group; Lenora Lapidus and Sandra Park of the ACLU Women's Rights Project; and Ravicher of PUBPAT. Tania Simoncelli, the ACLU's science advisor, provides expert guidance on the case.