Synthetic Life Forms – The New Patent Frontier

In May of 2007 scientists at J. Craig Venter Institute filed a U.S.
patent application on the world’s first synthetic living organism
(U.S. Patent application number 20070122826). The patent application
claims include a set of essential genes required to provide the bare
essentials of life as well as a “free-living organism that can grow
and replicate” constructed using those genes.

Examining the application from legal perspective, what is the likely
outcome for patentability of synthetic life forms? More importantly,
what should the outcome be?

One of the theories underlying patent law is that people should be
granted time-limited monopolies in order to encourage them to produce
results that contribute to the well-being of the society. These
socially beneficial results for which society rewards inventors are
called inventions.

Furthermore, invention is a legal term of art. It is shaped by
policies behind parliamentary legislation and judicial attitudes of
those interpreting the said legislation. The interpretation is not
made in vacuum; it evolves over time and can differ between

For instance, while Canadian and U.S. Patent Acts define “invention”
in almost exactly the same terms, the interpretation of what socially
beneficial results deserve a reward has been rather different.

US perspective

In the United States the courts have taken very liberal approach to
interpretation of “invention” and held that “‘anything under the sun
that is made by man” is patentable.

According to the USSC in Diamond v Chakrabarty, 447 U.S. 303 (1980)
“the relevant distinction is not between living and inanimate things,
but between products of nature, whether living or not, and human-made
inventions.” The Court noted the “gruesome parade of horribles” that
could potentially result from biotechnology patents, but held itself
helpless to weigh the potential hazards.

The only limit to patentability is claims directed to a human being
since “[t]he grant of a limited, but exclusive property right in a
human being is prohibited by the Constitution.”

It seems that in the United States almost any technological advance is
deemed to be worthy of reward. Based on this reasoning U.S. patenting
of Harvard’s genetically engineered onco-mouse was treated as a
relatively routine matter. Similarly, a new, non-obvious and useful
synthetic living organism described by Dr. Venter’s team will also
qualify for U.S. patent protection.

Canadian perspective

In Canada, however, the majority of the Supreme Court refused to
follow expansive U.S. approach. In Harvard College v. Canada
(Commissioner of Patents), 2002 SCC 76 the majority held that higher
life forms are not patentable within the meaning of s.2 of the Patent
Act. The distinction was drawn between lower and higher life forms,
though the court did not clearly define what constitutes a “lower” or
a “higher” life form.

According to the majority, “Parliament did not intend to include
higher life forms within the definition of invention found in the
Patent Act… This is a policy issue that raises questions of great
significance and importance and that would appear to require a
dramatic expansion of the traditional patent regime. Absent explicit
legislative direction, the Court should not order the Commissioner to
grant a patent on a higher life form.”

Under this premise it would appear that even though a synthetic
organism could be new, useful and novel, it will not qualify as
patentable subject matter if it is classified as a “higher life form”.

Unlike the U.S. Supreme Court, the Canadian Supreme Court took a more
cautious approach and deferred the decision with respect to
patentability of higher life forms to where it belongs, Parliament. It
is not the role of the patent office or the judiciary to expand
patentability to new and morally controversial areas via expansive
interpretation of the Patent Act.

Given that by definition “invention” cannot be defined in advance, it
is impossible to make a definite statement about legislative intent
with respect to something that we know legislature did not and could
not think about. Also, since statutory language of the Patent Act
could plausibly be given either broad or narrow construction, in words
of the Chakrabarty’s minority, “the courts should leave to Congress
the decisions whether and how far to extend the patent privilege into
areas where the common understanding has been that patents are not

If the patent system is designed to reward inventors for results that
benefit the society, it is the society itself, via its elected
representatives, who must decide what those results are.

Meanwhile, unlike under American sun, under Canadian sun patents are
not as easy to come by.

One Comment
  1. Dr Craig Venter’s US patent application for a synthetic life form should raise flags for the Canadian legislature. It is not too long before such applications are made here – but is Canada ready for them?

    Courts are increasingly being required to deal with cases that demand greater knowledge of complex technologies and scientific concepts, than of the law. However, the current Patent Act is ill-equipped to deal with advanced biotechnology claims, and as Anna Sosis mentions above, interpretation of the Act is also difficult, given the time it was drafted and the evolving nature of the subject matter.

    The Harvard Mouse case highlights the Act’s inability to tackle complex claims. The SCC categorized mice as being un-patentable because they were higher, as opposed to lower, life forms, but could not provide the basis for such a distinction. It reasoned that the line between the two categories was arbitrary [yet failed to divulge where this arbitrary line should be drawn]; that it was easier to analogize a micro-organism to an inanimate object; and that distinction between the life forms was based on “common sense” differences. This reasoning is grossly subjective and arbitrary, and it is questionable how useful it will be in future situations concerning even more complex organisms.

    Having only unsound case-law and a silent Act to rely on should be incentive enough for quick reform in this area. Venter-like cases will be in Canada before we know it, but as of now, we simply are not ready for them.

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