To a reformer, the suggestion that the enablement
doctrine be allowed to operate as a standard, and that it be left to evolve
incrementally through case law may seem too passive. But this is deceptive. It
is quite possible to fashion policy initiatives proactively in a
standards-driven environment. For example, there are several ways in which the
enablement standard, as applied to plant sciences inventions, might be enriched
without converting it into a bright-line rule:
1.
Develop a better understanding of the qualities of the
‘person of ordinary skill’ in the plant biotechnology art.
2.
Develop a better fact base for assessing whether
particular endeavours within the plant sciences are ‘predictable’.
3.
Continue to develop a fact base for assessing undue
experimentation.
One mechanism that might be considered for implementing
these suggestions is the process of developing examination guidelines at the
PTO. The process of formulating examination guidelines for enablement in plant
biotechnology might yield benefits even apart from the substantive content of
any such guidelines. The guidelines drafting exercise could serve as a forum in
which researchers can inform the PTO about relevant facts within the plant
sciences industry. In addition, because guidelines are less formal than
legislation or even regulations, guidelines may in theory be formulated more
rapidly, and may thus prove to be a good mechanism by which the PTO can respond
to rapid shifts in the technological landscape.
Similarly, because guidelines need not be permanent,
they can provide a good forum for policy experimentation. Mistakes can be more
readily addressed, and hypothetical illustrations can be explored and analysed.
There is some evidence that examination guidelines can operate constructively
in the patent system, and can inform judicial decisions as well as PTO practice
(e.g.
in
re Brana, Enzo Biochem, Inc. v Gen-Probe, Inc
.;
Utility Examination Guidelines
, 2001).
Examination guidelines also present significant
potential downsides. Because they do not have the force of law, they are
inherently less capable of reducing uncertainty costs than would a binding set
of legal commands. In addition, a guideline drafting exercise always carries
the risk of devolving into an exercise in formalism (e.g. Pila, 2003). An
effort to develop bright-line rules in the guise of guidelines would be as
counterproductive as an effort to develop bright-line legislation for
enablement.