Anything Under the Sun Made by Man

In June 2007, the BBC reported, that scientists from the J. Craig Venter
Institute had applied to patent the method they plan to use to create
their synthetic organism. According to the article, the Institute is
claiming exclusive ownership of a set of 381 essential genes believed
necessary to keep an organism alive and the synthetic free-living organism
that has the ability to grow and replicate made using those genes.

According to the US Supreme Court in Diamond v. Chakrabarty, the above
title accurately represents the US’s approach to patent applications.
Writing for the majority in Harvard College v. Canada (Commissioner of
Patents), Justice Bastarache stated that the broad approach to patents
articulated in US courts, is not one Canadian courts have chosen to
follow. The court held that, a mouse is not a manufacture, as manufacture
denotes a non-living, mechanistic product or process, nor should it be
considered a composition of matter, as that phrase is best interpreted as
not including higher life forms.

However, in light of the BBC article, Canadian courts may once again find
themselves grappling with the 133 year old Patent Act (Act) described by
the SCC in Harvard as being inadequate to address the complex ethical and
legal questions that arise with respect to genetic engineering. The court
firmly stated that since patenting higher life forms involves a radical
departure from the traditional regime, clear and unequivocal legislation
is required for a future request to be successful.

Higher vs. Lower Life Forms:
The difficulty in determining the delineation between higher and lower
life forms is that neither the courts nor the legislature have clearly
articulated the division. At best, Abitibi Co. is the authority defining
lower life forms, stating that they include all micro-organisms including
yeasts, moulds, fungi, bacteria, cell lines and all new life forms
produced en masse and are formed in such large numbers that any measurable
quantity will possess uniform properties and characteristics.

It is not surprising that it is difficult to determine where exactly a
synthetic-free living organism belongs on the spectrum or if the 1982
definition in Abitibi still remains relevant in this area of rapidly
changing technological development.

Is Life, Synthetic or Otherwise Patentable?
In the media, Dr. Venter has toted his synthetic life form as being an
environmental solution, stating it has the potential to make biofuels and
absorb harmful greenhouse gases. The importance of their environmental
solution arguably aligns this scientific breakthrough with the exception
disallowing patent protection for medical/surgical procedures. The policy
rationale behind the exception is that saving lives and alleviating
suffering is a more important concern for society, than an individual’s
patent rights. I argue that those concerns are somewhat analogous with
respect to the Institute’s synthetic life patent application. The
potential significant environmental impact and health related benefits
should trump an individual’s patent rights.

Another common and well grounded concern is that a patent could
potentially halt research. By granting a 20 year monopoly, a patent
holder has complete ownership and could strategically prevent their
products use by imposing significant user costs. This could result in
deterred innovation, as investors may direct capital into other,
potentially less fruitful areas to avoid the appearance of infringement.
Moreover, the resources, time and money, involved in negotiating licencing
agreements could instead be directed at furthering innovation.

Lastly, the basis for minimal genome research, biology’s bottom line, is
nature; research that is often financed by the public or completed at
public institutions. While the final product may be developed in a
private lab, does the public not have an ownership right in the newest
improvement?

The other side to the argument is if researchers and investors are unable
to patent the fruits of their labour, what would be the incentive to
finance or complete the expensive, labour intensive research? Could
biotechnical research be stifled in Canada? Harvard University contends
that, Canadian scientists are at risk of being left behind by their
colleagues around the world. This sentiment was echoed by the president of
BIOTECanada who stated, the Harvard decision stops our pursuit of
knowledge and innovation. The inability to receive life patents could
create a chilling effect on scientists doing research in Canada.

Solutions:
One option is to leave the Act intact, clarify the categories of higher
and lower life forms and impose a regulatory system mandating compulsory
licencing, reasonable prices and obligatory sharing. However, another
solution is to create specific legislation focused at the patentability of
life and not force the Act to accommodate technological advances that were
not contemplated in its construction. An working example of this type of
solution is the Plant Breeders’ Right Act created to fill a gap with
respect to plant life. This could enable both the public and private
industry to provide input into the future of IP laws in this area.

Citations: I referenced the Institute of Science in Society website,
specifically the article entitled, “Canada Rejects Patents on Higher Life
Forms” by Lim Li Ching, http://www.i-sis.org.uk/crpohlf.php