Patent sought on ’synthetic life’

Upon discovery of the J. Craig Venter Institute’s
(Institute) application for patent protection on a
synthetic life form, called “Mycoplasma laboratorium”,
the ETC Group promptly announced its intention to
challenge the patent and urged the relevant
authorities to reject the application as contrary to
public morality and safety.  The ETC Group does not
contend that the invention fails to meet the
definitions of novelty, non-obviousness and utility.
Instead, the primary objections are based on ethical,
social and environmental concerns, in addition to
criticisms over the broad scope of the claims and the
potential restrictions on future innovations.  This
uproar is a timely reminder that technological
advancements are outpacing society’s ability to fully
evaluate and debate the consequences of such
technology.  Also, this latest controversy highlights
the inadequacy of Canada’s Patent Act to deal with
these emerging and controversial technologies and the
need for Parliament to revise the current system of
granting patents.

Dubbed “Synthia” by the ETC Group, the synthetic life
form is being trumpeted by the Institute as a solution
to problems like pollution, climate change and fossil
fuel dependency.  Nonetheless, the dangers associated
with the technology are equally compelling.  For
instance, it is conceivable that this knowledge might
be used to create a self-replicating synthetic
pathogen.  Moreover, the ramifications of introducing
a synthetic organism into nature have not been fully
explored.  While the concerns raised by the ETC Group
are undoubtedly valid, they should not obfuscate the
potential benefits of this technology, especially
since there are inherent risks to any notable
scientific endeavor.  Given these considerations, the
proper approach is to balance the full costs and
benefits of any new technology and construct a
regulatory structure to manage the risks.

This task is best achieved by acts of Parliament.  In
Harvard College v. Canada (Commissioner of Patents),
2002 SCC 76, [2002] 4 S.C.R. 45, the majority
correctly pointed out that courts are ill-equipped to
address the complex ethical and social issues
associated with patenting higher life forms.  This
argument is equally compelling with respect to
synthetic life forms.  Besides the scientific
complexity of the issue, there are various social
ramifications that are best addressed by an elected
and publicly accountable institution.  After all, the
morality of society is more likely to be reflected in
the decisions of an elected legislature than it is in
the courts.  Moreover, courts lack the broad
fact-finding capability of the legislature.  The
narrow mandate of the courts when adjudicating cases
prevents them from considering facts and evidence not
related to the case at hand.  In contrast, Parliament
has the unrestricted ability to solicit evidence and
engage in wide-ranging debates on the legal, moral,
social and environmental impact of a new technology.
More importantly, given the controversial nature of
creating artificial life, solutions developed by a
democratically elected legislature will engender more
public acceptance than any judicial decisions. 

Currently, the Patent Act does not give the
Commissioner of Patents discretion to deny a patent
based on public morality and ethics once the statutory
requirements are met.  This is a sensible approach as
it prevents the Commissioner’s subjective value
judgments from influencing patentability.  However,
while this approach might be suitable for relatively
uncontroversial inventions, biotechnology and genetic
engineering advancements can have substantially more
profound implications for society that justifies the
introduction of additional considerations besides the
strict technical ones contained in the Patent Act. 

Instead of expanding the mandate of the Commissioner,
Parliament can permanently create an administrative
body or committee to scrutinize patent applications in
specified controversial and risky technological areas.
 Before any patent is granted, the government
committee is convened to solicit public feedback and
evaluate the broader social implications as well as
scientific merits of the application.  The members of
the committee can consist of interested parties from
the scientific community, special interests group and
the legislature.  The Commissioner of Patents will
then issue patents based on the recommendations of
this committee.  This approach has the benefit of
retaining the current patent system for conventional
applications while being flexible enough to handle
controversial patent applications.  Furthermore, the
open and systematic process of evaluating
controversial patent applications can reduce personal
bias in assessing patentability and engender wider
acceptance of the results.  Admittedly, the
requirement that patents be granted only upon a
comprehensive and open review can impede the pace of
progress by delaying the economic exploitation of new
technologies and hence discourage innovation.
Nonetheless, the ramifications of such technologies
justify this cautious approach and the benefit of such
an approach outweighs the cost.

One Comment
  1. Venter’s invention is patentable under Harvard as a lower life form. Even if a distinction is drawn between synthetic and lower life forms, its genetic sequence would nevertheless be patentable. All synthetic life forms being developed are merely genes injected into empty bacterial shells and a patent on the genetic sequence would effectively protect the entire organism. That paradox, in addition to the health, security, environmental and ethical implications of synthetic life forms, mandates a sui generis piece of legislation dealing with inventions involving genetic material. Such legislation should regulate patentability as well as exploitation and should reflect the efforts of the global community to preclude unintended or pernicious applications of genetic material. Minimizing the risk of bio-terrorism and bio-piracy by screening of requests to genetic sequence databases such as Genbank and restricting the sale of substances and equipment for synthesizing DNA should be a priority. Preventing ecological repercussions of synthetic and genetically-modified life forms and curbing the economic impact on communities dependent on production of commodities which will be displaced by a biosynthetic equivalent also require parliament’s attention.

    Failure to provide a stable legislative framework in Canada where the interests of inventors are protected and balanced against the interest of all stakeholders would result in brain and invention drain to the US and Canadians paying for fuel, medications and substances produced by life forms patented and exploited in the US. Indeed, fifteen out of the sixteen companies with synthetic biologic activity are situated there. Wake up, Parliament, wake up!

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