sociated inputs and outputs.
The Registry of Standard Biological
Parts presents what may be the most
interesting, and difficult, challenge
for patents on biological standards. As
currently constituted, the Registry may
well read on a large number of patents.
Tens of thousands of U.S. patents have
been granted on DNA sequences. Although these patents are not specific
to synthetic biology, they could certainly read on various standardized parts.
Preliminary patent mapping also reveals a significant number of patents
highly relevant to synthetic biology in
Thus far the Registry essentially
puts results in the public domain, albeit with a hortatory suggestion that
users should contribute back information and data, so as to improve the
“community resource.” As for background patents that the Registry may
infringe, the academic scientists involved appear to be proceeding under
the assumption that they will be not
be sued because potential plaintiffs
will not foresee significant monetary
payoffs from such suits. As for potential industry defendants, at this stage it
does not appear that Registry parts are
being used by industry to make commercially valuable products.
At some point, however, Registry
parts may begin to be used by industry.
In addition, use of such standardized
parts may be difficult to conceal. Thus
one apparently common biopharmaceutical industry strategy for avoiding
patents on research inputs—secret
infringement—may not be possible.
Industry users that are contemplating
using Registry parts might therefore
consider organizing patent mapping
efforts to determine whether patents
do in fact read on key standards.
The situation the Registry faces arguably bears some similarity to that
faced by standards developers for the
Web in its early days. For example,
in the case of the XML standard for
structured data presentation, the critical early work was done by developers from academic and commercial
organizations, as well as independent
contributors, without any significant
thought being given to patents.
As the Web matured, however,
the issue of background patents on
core technical standards had to be
aims for what is
arguably the most
addressed. By 1999, the World Wide
Web Consortium had created a patent
policy working group. Participants in
that group included representatives
from the major software, hardware,
and telecommunications firms (Apple,
AT&T, Hewlett-Packard, IBM, Intel,
Motorola, Nokia, Nortel, Sun Micro-systems, and Xerox).
At this stage in the evolution of synthetic biology, it is probably too early
to determine whether any of the work
done thus far has yielded key standards upon which the community will
eventually converge. But as synthetic
biologists and other biologists continue work on standardization, they
should carefully examine mechanisms
(both successful and unsuccessful)
for addressing patent issues that have
been invoked in the ICT industries.
1. arkin, a. setting the standard in synthetic biology.
Nature Biotechnology 26 (2008), 771–774.
2. brown, C. biobricks to help reverse-engineer life. EE
Times (nov. 6, 2004).
3. Kumar, s. and rai, a. synthetic biology: the
intellectual property puzzle. Texas Law Review 85
4. standard operating procedures. Nature
Biotechnology 24 (2006), 1299.
5. taylor et al. Promoting coherent minimum
reporting guidelines for biological and biomedical
investigations: the MIbbI project. Nature
Biotechnology 26 (2008), 889–896.
6. Walsh, J., arora, a., and Cohen, W. Working through
the patent problem. Science 299 (2003), 1021.
Arti Rai ( raI@law.duke.edu) is elvin r. latty Professor
of law at duke university and the chair of the
Intellectual Property Committee of the administrative
law section of the american bar association.
this column was written before the author entered u.s.
government service and does not represent the views of
the u.s. government.
Copyright held by author.
popL ’10: the 37th Annual
symposium on principles
of programming Lanuguages
Contact: Manuel V. Hermenegildo,
pepM ’10: partial evaluation
and program Manipulation
(co-located with popL 2010)
Contact: John p. Gallagher,
phone: 45 46742196,
the twelfth Australasian
Contact: tony G. Clear,
on Biomedical engineering
Contact: Joaquim B. Filipe,
international Conference on
Agents and Artificial
Contact: Joaquim B. Filipe,
Fourth international Conference
on tangible, embedded, and
Contact: Jamie Zigelbaum,
Multimedia systems Conference
Contact: wu-Chi Feng,