Facilitating Patient Access to Patent-Protected Genetic Testing

Abstract:     
In March 2010, a New York federal district court granted summary judgment invalidating a number of biotechnology patents directed to the BRCA1 and BRCA2 human breast cancer genes. One of the most highly publicized patent disputes in recent memory, Association for Molecular Pathology (AMP) v. United States Patent and Trademark Office (USPTO) and Myriad Genetics, Inc. pits patient care advocates against the patent-owning biotechnology industry. The Myriad decision is now under review by the U.S. Court of Appeals for the Federal Circuit. Neither the Federal Circuit (nor the U.S. Supreme Court, if it were to grant review) should prohibit the patenting of genetic material through judicial decision; such a drastic change in patent law requires due deliberation by Congress. Despite the critical importance to society of facilitating patient access to genetic testing, dismantling patent protection for this important technology is not the right approach; instead, modifying approaches to licensing gene patents is. This essay concludes that the district court’s decision in Myriad should not stand. The essay also evaluates the recommendations of a Department of Health and Human Services Advisory Committee for facilitating access to patented genetic testing and offers a modification of the committee’s proposed framework.

Number of Pages in PDF File: 19

Keywords: Patent law, gene patents, biotechnology, Myriad, ACLU, AMP, breast cancer, BRCA1, BRCA2, patent infringement, patent licensing, patient access, genetic testing

Accepted Paper Series