The Association for Molecular Pathology (AMP) is an international medical and professional association representing approximately 1,800 physicians, doctoral scientists, and medical laboratory scientists who perform laboratory testing based on knowledge derived from molecular biology, genetics, and genomics. AMP applauds US District Judge Robert Sweet’s ruling in favor of the plaintiffs in the lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.
“This is a landmark decision that has the potential to dramatically improve patient access to genetic testing. It is a boon to personalized medicine in the purest sense as nothing is more personal than one’s genetic makeup. This judgment removes numerous barriers and impediments to clinical research, testing, and innovation since patented genes cannot be invented around, and has implications for how we evaluate each and every patient’s genetic information” said Dr. Karen Mann, AMP President.
In 2008, AMP adopted a Policy Statement (http://www.amp.org/Gov/Positions.htm) 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.
The case was originally filed on May 12, 2009 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.
“DNA patents have delayed, limited, or even shut down clinical testing and scientific research,” added Dr. Mann, “and 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. Patients can’t get a second opinion before they make major, irreversible health decisions.”
The summary judgment released on March 31, 2010 is a significant step forward to eliminating future DNA patents and calls into question the appropriateness of those already in existence. This ruling will most definitely advance the development of personalized, molecular medicine and the practice of molecular pathology.
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