Originally Published March 2000
These days, one doesn't need to look far to realize that there's trouble brewing in the molecular cauldron.
To be sure, there's plenty of good news on the technological front. For instance, Celera Genomics (Rockville, MD) predicts that it will complete the sequencing of the entire human genome later this year—more than two years ahead of the international, government-funded Human Genome Project. Nucleic acid analyzers that incorporate automated sample preparation modules have begun to appear on the market, thereby eliminating a major stumbling block to the acceptance of such testing by laboratorians. And FDA's Office of Device Evaluation appears to be gearing up for the scientific challenge of reviewing product submissions for molecular diagnostics by forming a new panel on molecular and clinical genetics.
Unfortunately, much of the good technological news in the field is being sullied by intellectual property and licensing disputes. For example, the inspector general's office of the U.S. Department of Health and Human Services is investigating whether federal funds were used in the 1980s to support invention of the automated DNA sequencer, a technology whose patent is held by the California Institute of Technology (Pasadena, CA) and licensed to PE Biosystems (Norwalk CT). If federal funds were used, government researchers would gain the right to use DNA sequencing technologies without paying royalties. Perhaps not so coincidentally, a primary beneficiary of PE's sequencer license is Celera Genomics, which is a PE subsidiary.
Celera is also at the center of a controversy over patent rights for human genome sequencing discoveries. At last November's AACC San Diego Conference, Celera president and CSO Craig Venter assured attendees that the company had no interest in asserting exclusive ownership rights that would enable it to capitalize on its discoveries. But since then Celera has filed thousands of provisional patents on its genetic discoveries, leading industry analysts to speculate about the availability of the sequences for future medical research.
In response, the Association for Molecular Pathology (AMP) is leading a charge "to define in-house molecular diagnostic tests as medical procedures rather than devices, so that qualified practitioners and patients should not be barred from their use by exclusive licenses or unreasonable sublicensing fees."
It would not be surprising if the developers of automated molecular diagnostic systems found AMP's recommendations slightly disconcerting. As described in the association's February newsletter, the AMP approach would lower the regulatory bar for in-house tests, but would do nothing to reduce the regulatory burdens or licensing costs incurred in the development of advanced molecular diagnostic devices.
In the context of an industry that is already showing a predilection toward combative patent disputes, such issues are matters for considerable concern. Left unresolved, they could have a chilling effect on the future development of commercial technologies for molecular diagnostics.
At present, amidst the din of courtroom squabbling, it is difficult to detect a unified industry viewpoint on these issues. If manufacturers intend to be heard, they may need to set aside proprietary interests and, for a time, consider what is best for the advancement of the field.