Stifling Scientific Progress: The District Court’s Decision in Myriad
The human genome contains approximately 23,000 protein-coding genes. Approximately twenty percent of these human genes are patented, with some genes being patented as many as twenty times. On May 12, 2009, the Association for Molecular Pathology (“AMP”) and nineteen other plaintiffs, including healthcare associations and individual doctors, researchers, and patients, filed a lawsuit against the United States Patent Office (“USPTO”), Myriad Genetics (“Myriad”) and ten other individual defendants in their capacity as Directors of the University of Utah Research Foundation challenging the validity of Myriad’s gene patents. Myriad holds, through either assignment or exclusive license, a number of domestic and international patents covering isolated DNA molecules encoding the BRCA1 and BRCA2 (“BRCA1/2”) mutations that cause an increased risk for the development of breast and ovarian cancer and diagnostic methods using these isolated DNA molecules to identify a patient’s predisposition to the development of familial breast cancer.
Although the district court’s decision’s applicability is limited to the patents in the instant case, if upheld by the Federal Circuit, the decision would have far-reaching implications for human gene patents currently in force and the future of the biotechnology industry, both domestically and abroad. Therefore, this paper seeks to address the legal and policy issues concerning human gene patents in view of the current decision in Association for Molecular Pathology v. United States Patent & Trademark Office (hereinafter “Myriad”) with a view to related cases involving Myriad’s patenting of isolated DNA molecules encoding BRCA1/2 in the United States and European forums