Vviewpoints
DOI: 10.1145/1629175.1629191
Law and technology
Unstandard standardization:
the Case of Biology
How applicable are the approaches adopted by information and communication
technology standards-setting organizations to biological standards?
Most enGineeRinG-BAseD in- dustries construct prod- ucts from standard, well- understoodcomponents. By contrast, despite the
early attachment of the moniker “
genetic engineering” to biotechnology,
standardization in the biological sciences has been relatively rare. In 2004,
MI T computer scientist Tom Knight offered this colorful characterization of
the difference between a biologist and
an engineer: “A biologist goes into the
lab, studies a system, and finds that it
is far more complex than anyone suspected. He’s delighted; he can spend
a lot of time exploring that complexity
and writing papers. An engineer goes
into the lab and makes the same finding. His response is ‘How can I get rid
of this?’”
2
IMaGe sourCe: MarK d. leVIn , J. ClIn. InVest. 119: 11 doI: 10.1172/JCI39109
standard-setting organizations
The area of engineering where standard setting has been most discussed
is information and communication
technology (IC T). In the ICT industries,
standards often have the potential to
read on dozens if not hundreds of patents. Thus standard-setting organizations (SSOs) that make choices among
potential standards generally have policies concerning patent disclosure and
licensing. The most elaborate policies
Knight’s insightful observation notwithstanding, efforts are currently being made to standardize biology. What
lessons (if any) can biology learn from
engineering?
require disclosure of patents not only
by those entities that actually submit
technology to the standard but also
by other members of the standards
organization. As for licensing, patent
owners may be required to license
royalty-free or, more frequently, on
“reasonable and nondiscriminatory
terms.” At least in theory, such delib-
erate decision making should lead to
the adoption of standards that balance
payment of patent licensing royalties
with technological superiority.
Through rigorous disclosure and
licensing policies, SSOs also hope to
avoid future lawsuits in which previously unknown patent owners make
assertions of infringement against
