Diagnostic Kits/Diagnostic testing fails the test
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Merz, J.F. et al., 2002. Diagnostic testing fails the test. Nature, 415(6872), 577-579.(Garcia & Shimizu 1997) Available at: http://repository.upenn.edu/bioethics_papers/48/ [Accessed August 5, 2009].
- Merz, J.F. et al., 2002 - This article generally considers gene patents which cover clinical diagnosis of mutations or use of the gene sequence in potential therapies but specifically investigates Hemochromatosis (HFE) testing in detail. The HFE genetic test patent history is developed and used to show how patent ownership and licensing complexities can have measurable effect on the development and performance of genetic testing. The patent ownership of HFE testing begins with Mercator Genetics in 1998. Next, Progenitor, Inc. merged with Mercator and was assigned its patents. SmithKline Beecham Clinical Laboratories then became the exclusive license of Progenitor’s HFE patents. Following the licensing deal, SmithKline Beecham Clinical Laboratories was sold to Quest Diagnostics. Finally, Bio-Rad Laboratories, Inc., acquired the HFE patents from Progenitor.
- A comprehensive telephone survey was conducted to increase the empirical evidence available about diagnostic genetic test patents. The survey measured the effects of patents and licensing strategy on the laboratory practice related to HFE. The study reached the conclusion that the patents and licensing behavior had a measurable effect on the development and performance of HFE laboratory studies. This conclusion is qualified with the statement that they cannot “say whether the decrease in the rate of laboratory adoption after the time the patents issued was due to the perception by laboratory staff of inadequate demand to justify their development of the test or due to concerns about patent enforcement” (Merz, J.F. et al., 2002). On the other hand, there is evidence that patents were not necessary for the quick transformation of the genetic markers of HFE and the development of a clinical test. If this is the case, it weakens the case that patents are created a necessary incentive.
- Additional patenting concerns raised by the paper included possible delay in publication, the cost and availability of clinical diagnostic testing, and the scope of protection that is possible. The scope of protection for HFE is broad with the “two most common mutant alleles covered by the US patents account for up to 85% of hemochromatosis in the northern European population” (Merz, J.F. et al., 2002).