The USPTO held a hearing on February 16 to collect testimony from interested parties to discuss factors affecting the availability of confirmatory, or second opinion, genetic testing. However, the hearing quickly devolved into testimonies addressing so called ‘gene patents’ and genetic testing more broadly.
Dr. Hans Sauer testified on behalf of BIO and first raised the question whether there is in fact patient demand for an ‘independent second opinion genetic test.’ While doctors would likely agree that patients sometimes ask for a second opinion on a doctor’s treatment recommendations, how many patients desire a genetic test (or any other test) to be run again without any indication that there was something wrong with the initial test? Insurance companies likely would not cover a confirmatory test, further limiting the desirability of seeking such confirmation as the patient would have to pay the full cost of a repeat genetic test out of pocket. More generally, it must also be asked whether just offering a re-test really translates into a true patient benefit. A repeat test does not necessarily provide peace of mind. It can create doubts in the patient’s mind about the reliability of the doctor’s treatment recommendation. It can prolong uncertainty, give rise to unrealistic hopes, cause significant unnecessary out-of-pocket cost, and create indecision where treatment decisions are urgently needed. These potential negatives must be considered too.
On the broader question of access to genetic tests in the first instance, Dr. Sauer highlighted that available data indicates that a patent premium for genetic tests does not seem to exist. One study compares similar genetic tests with one test based on exclusively licensed ‘gene patents’ and the other nonexclusively licensed finding no “obvious price premium attributable to exclusive patent rights.”
Finally, Dr. Sauer showed a map of Medicaid coverage by State of a particular type of genetic test for breast cancer, highlighting the differences in coverage. As Dr. Sauer points out,
“If a poor patient in Nevada doesn’t have access to an advanced molecular diagnostic test, and right across the border in California a similar patient has access to the same test, there’s obviously something wrong with that, but how can that be a patent problem? How can it be a patent problem in Nevada and not a patent problem in California? That’s not how we understand patents to operate – inescapably, there’s something else at work here. “