product manufacturers that use a
widely adopted standard. In such circumstances, the patent holder could
arguably extract a royalty in excess of
the technical contribution made by
the patent.
How applicable are the approaches
adopted by SSOs in the ICT industries
to biological standards? To a significant extent, the answer depends on
the type of standard.
Currently, some of the most advanced standardization efforts involve
specifications for the development
and presentation of biological data.
The Microarray Gene Expression Data
Society (MGED) was an early leader
in the field. MGED’s “Minimum Information About a Microarray Experiment” (MIAME) standard has inspired
similar efforts in many other biological fields, including proteomics, me-tabolomics, and RNA interference.
4
The Minimum Information for Biological and Biomedical Investigations
(MIBBI) project takes standardization
one step further by attempting to rationalize the varying data standards that
have developed in different biological
fields. MIBBI’s goal is interoperability
across data sets from different biological communities.
5
These data standardization efforts,
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which emerged from academic institutions, do not appear to have adopted
formal policies on patents. But in the
case of data standards, the administrative costs associated with establishing
an SSO-type apparatus may exceed any
challenges that patents pose. At least
at this stage, the numbers of patents
that could be asserted may not be particularly large.
Biomarker standards
Another important category of biological standardization efforts involves
biomarkers. Biomarkers are biological
signs of drug toxicity and efficacy, and
the pharmaceutical industry has high
hopes that improved biomarkers will
yield expedited preclinical drug safety
evaluation as well as early indicators of
clinical safety and efficacy. With such
indicators, firms should be able to reduce the costly drug trial failures that
are currently a major contributing factor to diminished biopharmaceutical
innovation.
Pharmaceutical companies have
formed a number of consortia that
pool information and conduct collaborative research to identify consensus
biomarker standards. Prominent consortia include the Predictive Safety
Testing Consortium (PSTC), which
comprises 17 major multinational
pharmaceutical firms. The PSTC has
already been successful in securing
U.S. Food and Drug Administration
and European Medicines Evaluation
Agency approval for seven new biomarkers that signal kidney injury at
the preclinical stage.
The various biomarker standards
consortia set up by pharmaceutical
firms deal very explicitly with patent
rights. To some extent, these consortia
adopt policies similar to those of SSOs
in the ICT industries. For example, although the PSTC policy does not address the licensing of “background”
patents that firms may bring to the collaborative research, it addresses with
great care future patents on biomarker
standards that may emerge. Specifically, PSTC members assign any future
patent rights to a non-profit trusted intermediary, Critical Path. Critical Path,
in turn, is obliged to license the rights
on “fair, neutral, and commercially
reasonable” terms to members of the
Consortium as well as third parties.
Described another way, in the PSTC,
future patents are addressed in terms
somewhat similar to those used by ICT
SSOs for background patents.
The emerging discipline of synthetic biology aims for what is arguably
the most comprehensive form of standardization. It hopes to make all of
biotechnology a science that relies on
standardized, well-characterized DNA
“parts.” These parts could then be assembled into composite devices and
systems with similarly well-defined behavior. When transplanted into suitable model organism “chassis” (which
had themselves been standardized),
the composite systems could yield
outputs ranging from drug therapies
to environmentally friendly fuels.
Standards would cover not only parts
and chassis but, perhaps even more
importantly, the interfaces used to assemble parts and the interactions between parts and host cells.
standardization in
synthetic Biology
The synthetic biology community is
still debating precisely how much
information about a biological standard is necessary before full standardization can be said to have been
achieved.
1 Even so, some progress has
been made. The Registry of Standard
Biological Parts ( http://www.partsreg-
istry.org), an academic effort that
receives significant federal funding,
now contains about 3,200 parts. Each
of these parts adheres to the so-called
BioBricks protocol for cloning and
physical linking and has specific as-
some of the
most advanced
standardization
efforts involve
specifications for
the development
and presentation
of biological data.