Originally Published IVD Technology
July 2004
EDITOR'S PAGE
The battle over licensing
A recent presentation by Jack Spiegel, PhD, a senior advisor for technology transfer operations in the
Office of Technology Transfer at the National Institutes of Health (NIH; Bethesda, MD) has raised once again the long-standing debate over the granting of licenses for genomic intellectual properties. In this ongoing debate, which is in part a turf battle between manufacturers and laboratorians, two sharply opposing viewpoints have emerged.
Clinical reference laboratories argue that granting exclusive licenses to IVD manufacturers is detrimental to the public health. Laboratories believe that the public is harmed when a single company becomes the only source for a genetic test. In addition, they say, having only a single provider for an assay discourages peer review and proficiency testing, which are essential elements of quality assurance.
Although reference laboratories have placed their arguments in the context of public health, they also have a vested interest in securing exclusive licenses for themselves. On the basis of such licenses, some laboratories offer genetic testing services that make use of their own, exclusive home-brew tests. Under FDA’s analyte specific reagent (ASR) regulations, such labs have an easy and low-cost way to conduct genomic testing without having to obtain FDA approval for their tests.
Meanwhile, IVD manufacturers typically seek out exclusive licenses for genomic properties that can be developed into commercialized products. Manufacturers encounter high costs and risks when developing such diagnostics. Since the market for new genetic tests can be small, manufacturers can afford to produce such tests only by capturing the entire market.
IVD manufacturers argue that such exclusive licenses are necessary for advancing the field of molecular diagnostics. Manufacturers have shown they are capable of developing genomic inventions into effective IVDs. In addition, manufacturers can streamline the development process, explore ways to multiplex genetic tests, and ultimately reduce the cost of genetic testing.
Moreover, contrary to what reference laboratories claim, granting exclusive licenses to IVD manufacturers can benefit the public health. With exclusive licenses, manufacturers can offer to all labs genetic tests that have undergone FDA’s rigorous approval process, and have a proven level of quality and consistency. If individual laboratories are allowed to develop their own home-brew tests, however, consistency and comparability of results are less certain.
Despite arguments to the contrary, products developed by the IVD industry contribute to the public health. Agencies such as NIH and FDA should implement policies and procedures that stimulate, rather than hinder, the growth of commercial genetic diagnostics.
Richard Park
Copyright ©2004 IVD Technology
