KRS July Final Jour.09. - Association of Biotechnology and Pharmacy

Current Trends in Biotechnology and Pharmacy
Vol. 3 (3) 225 - 240, July 2009. ISSN 0973-8916
passing specific laws, can what can or cannot be
patented. If an invention is considered by various
special interest groups to have a potentially
negative impact on an existing agricultural
practice, for example, then it is quite possible that
a law preventing the implementation of the new
technology could be passed
Experimental use exemption
In some cases, the courts have
recognized what has come to be known as an
experimental use exemption, or research
exemption, from infringement liability. On its
face, the patent statute does not appear to permit
any unlicensed use of a patented invention, in
research or otherwise, but language in some
judicial opinions nonetheless suggests that use
of a patented invention solely for research or
experimentation is, in principle, exempt from
infringement liability. The experimental-use
doctrine was first expounded in 1813 by Justice
Story in dictum in the case of Whittemore v.
Cutter16. Here the legal term dictum refers to
something said in a judicial opinion that was not
necessary to resolve the case before the court,
and therefore does not create binding precedent
in subsequent cases.
He observed “that it could never have
been the intention of the legislature to punish a
man who constructed [a patented] machine
merely for philosophical experiments or for the
purpose of ascertaining the sufficiency of the
machine to produce its described effects”. It is
difficult to discern the scope of this exception
with any precision, inasmuch as experimental use
becomes an issue only in patent infringement
actions, and patent holders are unlikely to file a
lawsuit against an academic researcher whose use
of the invention is commercially insignificant.
Judicial pronouncements on the scope of the
experimental use exemption address situations
in which a patent holder has found a defendant’s
activities sufficiently annoying to be worth the
234
trouble of pursuing a lawsuit; this factor has
undoubtedly skewed the distribution of cases in
which the defense arises toward cases with high
commercial stakes. Within this universe, the
experimental use defense has been frequently
raised, but almost never sustained. Nonetheless,
courts have consistently recognized the existence
of an experimental use defense in theory, although
the defense has almost never succeeded in
practice.
Recent case law suggests that the
experimental use defense may be available only
for pure research with no commercial
implications, if such a thing exists. In Roche
Products v. Bolar Pharmaceutical Company (17),
1984 decision of the US Court of Appeals for the
Federal Circuit,the court rejected the arguments
of a generic drug manufacturer that the
experimental use defense should apply to its use
of a patented drug to conduct clinical trials during
the patent term. The purpose of the trials was to
gather data necessary to obtain FDA approval to
market a generic version of the drug as soon as
the patent expired. The court characterized the
defense as “truly narrow”, noting that the
defendant’s use of the drug was “no dilettante
affair such as Justice Story envisioned”.
“The court held that the defense does not
permit unlicensed experiments conducted with a
view to the adoption of a patented invention for
use in an experimenter’s business, as opposed to
experiments conducted for amusement, to satisfy
idle curiosity, or for strictly philosophical inquiry.
Although it is not entirely clear what sort of
research the court would exclude from
infringement liability as a mere “dilettante affair”,
the language of the decision offers little hope of
an exemption for research scientists who use
patented inventions with an aim to discover
something of potential usefulness. It certainly
suggests that the defense would be unavailable
whenever the defendant’s research is motivated
Firoz et al