Win for personalised medicine in US DNA patent case

In the US, the District Judge Robert Sweet has ruled in favour of the plaintiffs in the lawsuit Association for Molecular Pathology (AMP), et al. v. U.S. Patent and Trademark Office, et al.

The case was originally filed on 12 May 2009 in US District Court for the Southern District of New York against the US 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 organisations representing over 150,000 researchers and pathologists, breast cancer and women’s health groups, and individual women.

The summary judgment 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 personalised, molecular medicine and the practice of molecular pathology.

The AMP is an international medical and professional association representing approximately 1800 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 favour of the plaintiffs in the lawsuit.

“This is a landmark decision that has the potential to dramatically improve patient access to genetic testing. It is a boon to personalised medicine in the purest sense as nothing is more personal than one’s genetic make-up. 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.

“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.”

In 2008, AMP adopted a 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 licences to access those patents.