Commercialization of Biomarkers
High-throughput genomics and proteomics technologies have led to the emergence and rapid proliferation of clinical use and commercial demand for biomarkers —
molecular indicators directly and highly predictive of a biological process or that have
utility as theranostics to guide therapeutic decision making. These are a common
product of research and can be valuable intellectual property. For example, a specific
gene expression profile may indicate or contraindicate treatment with a particular drug,
or allow a physician to monitor how a patient responds to a particular drug.
Pharmaceutical companies are very interested in markers and assays useful for
selecting and enrolling patients who will respond favorably to a drug in clinical trials. Patent considerations in
What exactly are biomarkers?
CU-Boulder and CU-Colorado
panel may not necessarily cover all uses
biomarkers and their uses is complex ⇒Metabolites (drugs; endogenous)
UC Denver inventors:
against prior literature and patents to ⇒Altered cellular distributions
confirm novelty; the commercial value of
Analytical methods that may generate
Information about licensing to
it does not cover other equally predictive biomarkers:
designed studies, comprehensive ⇒Mass Spec
evaluation of all potential markers, and
General information and CU
format can all enhance the probability of
General address for
arrays of biomarker probes, coupled with
many underlying informatics subroutines Commercial applications of
CU System Technology
that convert raw marker information into
4740 Walnut St., Suite 100
multiplex in silico
diagnostic assays. ⇒Drug Screening
Boulder, CO 80309-0588
Thus, in addition to the biomarkers, the
Tips for realizing the full value of your discoveries:
Reach of patent rights depends on the data sets and study design.
A panel of biomarkers for Lipitor® toxicity
may not necessarily create a patent position covering an assay for Crestor® toxicity. Careful planning before studies are conducted can expand data applications.
Commercial utility of biomarkers is as much about the scientific question as about the results.
commercial utility of a biomarker assay is tied to its validity. Prospective validation of a clinical diagnostic biomarker against the gold-standard moves more rapidly toward a commercial assay and enhances the value of the underlying intellectual property.
Envision the commercial assay format and ponder synergy with your research objectives.
exercise can sometimes shed light on potential new research questions and lead to a stronger IP position, a more valid marker panel and a commercially compelling research outcome.
The IP is the assay, not the reagents.
Inclusion of your markers in a product does not constitute an infringement
on your patent. Only the use of the assay or the use of the biomarkers to detect a biological process you have claimed encroaches upon your IP.
Downstream and derivative discoveries often occur.
Having identified the markers, many researchers opt to
understand the underlying biological mechanism from which the markers are derived. These mechanisms lead to the discovery of novel targets and therapeutic modalities.
Validation enhances the value of your biomarker IP.
Mechanistic data generates new IP. Commercialization
and follow-on research begin to diverge. Validation work tends to interest clinical researchers, mechanistic studies interest fundamental researchers. Companies tend to value validated products over cutting edge information.
Commercial considerations in biomarker exploitation
The regulatory environment for diagnostic assays utilizing high-throughput biomarker analysis is still emerging.
The FDA is experiencing much consternation as it attempts to establish clear guidelines for policing the analytical
outcomes and regulating the clinical interpretation of assay data. Interpretation of these new data is not intuitive,
and the clinician often does not have the requisite expertise in statistical analysis and molecular biology.
Consequently, informatics is required to transform assay results into useful clinical tools — the solution to the
challenges of utilizing and regulating biomarker discoveries lies in validated informatics and algorithms.
In most clinical settings, there will be a need for more than just a single biomarker for a definitive clinical
decision. The diagnostic lab will likely use a broader array containing a variety of markers indicative of common
misdiagnoses, secondary disease, and complications to gather a full complement of relevant clinical information
from a single assay. This commercial format will require many patents, many assays, and many algorithms to be
applied to a single product resulting in a complex mesh of intellectual property within a single product. The
paradigm of one patent, one assay, one product is fading. Synergizing the commercial potential with your academic aims
Participation in the technology commercialization process can expand and advance your academic aspirations in
many ways. Consideration of the legal and commercial implications of your biomarker discovery efforts in the
context of your research aims can add many dimensions of value and impact to your work — commercial
relevance is one of the best ways to ensure the impact of your biomarkers.
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