Washington, DC – May 13, 2009 – The Association for Molecular Pathology (AMP) announced today that it is working with the American Civil Liberties Union (ACLU) and the Public Patent Foundation to bring a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and should be invalidated. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers.

The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed May 12 in U.S. District Court for the Southern District of New York against the U.S. Patent and Trademark Office (PTO) and Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The plaintiffs include organizations representing over 150,000 researchers and pathologists, breast cancer and women’s health groups, and individual women.

“After careful deliberation, AMP decided to join this suit as a plaintiff and was the first professional association to do so,” said Jan A. Nowak, MD, PhD, the president of AMP. “We have done this for a number of reasons, the most compelling of which is that the principle being argued in the case is consistent with our desire to support public policies that we believe are in the best interests of our profession and the patients we serve.”

In 2008, AMP adopted a revised Policy Statement on gene patenting and the licensing of intellectual property that urged an end to the practice of granting patents on single genes, sequences of the genome or correlations between genetic variations and biological states. AMP also encouraged groups that currently hold gene patents, including higher educational and research institutions, not to grant exclusive licenses to access those patents.

“This suit is not intended to allege that Myriad is an unethical company. Rather the intent with both the revised Policy Statement and the lawsuit is to address the larger implications of gene patents. We want to prompt changes to the patent system that will resolve what we see as increasingly narrowing options for manufacturers and laboratories to access gene sequence data to develop the tests needed to make molecular medicine a reality,” said Dr. Nowak.

The lawsuit charges that gene patents interfere with the free flow of information and knowledge (among researchers, doctors, patients) in violation of the First Amendment, and that patents on human genes are illegal under patent law because genes are "products of nature” and the PTO never should have granted patents on them.

The PTO has granted thousands of patents on human genes – in fact, estimates are that about 20 percent of the human genome is under patent. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene or to greatly limit those who can access the gene through the use of exclusive licensing agreement. As a result, scientific research has been delayed, limited or even shut down due to concerns about gene patents. In the case of the BRCA genes, Myriad’s lab is the only place in the country that performs full sequencing of the genes for diagnostic purposes.

“AMP believes gene patents can serve as a disincentive to innovation in molecular testing because they deny access to a vital baseline of genomic information that cannot be invented around,” said Dr. Nowak. “Moreover, threat of enforcement from a patent holder and ensuing litigation costs lead to a chilling effect as clinical laboratories and manufacturers are reluctant to develop new tests that could directly benefit patients. That’s why this suit is so important.”
 

05/21/2009