The thousands of gene patents that have been issued in the United States could be affected by the Supreme Court's decision this summer.
At this week's Biotechnology Industry Organization show in Chicago, a panel of law experts bemoaned the recent Supreme Court hearings on whether individual genes can be patented, saying there was no sign that anyone involved in the case truly understood the technology or the business implications of their arguments. That's disturbing, because the decision could have important effects on industries including the developing field of molecular diagnostics.
BIO attendees, mostly executives in a variety of biotech fields, crowded into meeting rooms to stand through overfilled sessions on the promises and challenges of personalized medicine and diagnostics. In some cases, these tests can help doctors diagnose disease or predict whether a particular drug will work in a patient or cause unwanted side effects. Other tests can determine how quickly a patient metabolizes drugs, information that can help doctors decide how big a dose to prescribe. At the convention, panelists described the many challenges facing companies that develop these tests. Among others, they are still working out how much to charge for diagnostics and how to partner with drug companies, and the industry is still not governed by clear regulatory rules. In this context, the turmoil over gene and biomarker patents is disconcerting.
Association for Molecular Pathology v. Myriad Genetics, the case in which the Supreme Court heard arguments last week, turns on the question of whether an isolated human gene is patentable. Myriad, a company based in Salt Lake City, Utah, currently has exclusive rights to perform diagnostic tests that screen two genes for variants linked to breast and ovarian cancer. A decision is expected this summer.
One expert at BIO's session on the patent case said she was surprised by how poorly the lawyers arguing the case seemed to understand the biotechnology involved. Another was concerned that the arguments failed to consider the consequences the decision could have for issues such as genetic sequences that might be used for vaccine development.
Last summer, the Supreme Court overturned a patent claim on a process for monitoring levels of a metabolite in a patient's blood to determine the correct dosage of certain drugs. Some say that this earlier case is likely to affect their industry more than the Myriad case will.