"Genetic testing is often heralded as a cornerstone in an imminent and exciting new age of personalized medicine, in which our health care is customized based on our individual genetic profiles. But let's not get carried away by the fantasy and promise; progress has lagged while persistent medical, ethical and scientific issues associated with genetic testing abound.
Last week, we witnessed a major step toward reigning in what has, until last year, been a veritable Wild West of genetic testing. On Monday, a U.S. District Court Judge in Utah decided that Myriad Genetics could not stop a competitor (Ambry Genetics) from offering commercial BRCA ("breast cancer gene") testing as their current legal suit winds through the courts. (Full disclosure: Breast Cancer Action filed an amicus brief in opposition to Myriad's request for an injunction, along with the American Civil Liberties Union (ACLU), Public Patent Foundation (PUBPAT), Association for Molecular Pathology (AMP), and the AARP, each of which was also involved in a multi-year lawsuit cited below which challenged Myriad's patent claims on the two BRCA genes.)
This somewhat esoteric legal battle between two biotech companies is instructive about what is at stake in the multi-million dollar genetic testing business as well as the broader issue of corporate influence in science and medicine. Last June, the Supreme Court unanimously ruled that patents on human genes are illegal and ended Myriad's longstanding monopoly on the BRCA1 and BRCA2 genes, often called simply the "breast cancer" genes. Women's health advocates rejoiced that the ruling opened the door to newer, better and cheaper BRCA tests. Indeed, the very day the Court ruled, half a dozen labs, including Ambry Genetics, announced they would begin offering BRCA testing at a fraction of the cost of Myriad's BRCA Analysis Test (a staggering $4,000).
Many people rightly wonder how Myriad can sue other companies for patent infringement after the highest court in the land rescinded the company's monopoly rights on the BRCA genes. The short answer is that Myriad's ultimate goal may be less about winning these latest lawsuits and more about the lawsuits to stall the financial implications of the Supreme Courts' ruling, allowing them to hold onto their BRCA testing monopoly for as long as possible.
For many companies, particularly smaller biotechs, the threat of legal action means a choice between going under completely or giving in to a corporate giant with virtually unlimited resources. Just last month, another company that began providing BRCA testing after the Supreme Court's ruling settled with Myriad to end a lawsuit; Gene by Gene agreed in February not to market or sell clinical BRCA diagnostic tests in North America after Myriad's legal onslaught."