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.