The Monsanto decision: The edge or the wedge
Nature Biotechnology, June 2001 Volume 19 Number 6 p 587
E. Richard Gold & Wendy A. Adams
E. Richard Gold and Wendy A. Adams are assistant professors on the faculty of law at the University of Western Ontario, London, ON, Canada N6A 3K7 (e-mail: ergold@uwo.ca).
Date accessed: 6 June 2001
Left out of almost all reporting on the Canadian Federal
Court's recent ruling in Monsanto v. Schmeiser were the
implications of the decision on patenting
plants—something that Canada has not permitted.
The Federal Court of Canada's decision in Monsanto
Company v. Percy Schmeiser (reported last month1) has
potentially far-reaching and disturbing implications. Intellectual
property protection for biotechnological innovation has been
granted with the tacit understanding that whereas corporations
may acquire patents for genes and processes using genes—for
example, genetic testing for breast cancer—the scope of
protection does not extend to the plants and animals in which
patented genes are inserted. The Federal Court's decision
allows Monsanto to do indirectly what Canadian patent law has
not allowed them to do directly: namely, to acquire patent
protection over whole plants.
Canola seed being loaded for delivery to a farm east of
Winnipeg, Manitoba.
Canola Council of Canada
Monsanto, through genetic engineering, has produced a strain
of canola resistant to Monsanto's herbicide marketed under the
name Roundup. The purported advantage to herbicide-resistant
"Roundup Ready" canola is that Roundup herbicide can be
sprayed liberally after the crop has emerged, killing off all other
plant life but leaving the canola untouched. Monsanto claims
that this procedure offers significant cost savings over more
traditional methods of cultivation.
In 1993, Monsanto was issued a Canadian patent for the
genetically engineered gene and cells containing those genes.
Monsanto does not sell its genetically modified seeds. Instead,
it has developed licensing arrangements whereby farmers, in
exchange for a licensing fee and other commitments, are
permitted to use the seed for planting one crop only. Seeds
resulting from this crop, however, cannot be used for replanting
in subsequent years.
As the well-known adage would have it, build a better
mousetrap and the world will beat a path to your door. Without
patent protection, however, the deserving inventor would not
necessarily receive a steady flow of traffic. The first customer to
buy the better mousetrap would be free to duplicate the process
in his own workshop. He would probably be able to turn around
and offer the product at a lower cost, given that he would not
have to recoup any investment in research and development.
With patent protection, the inventor is given the exclusive right to
build the better mousetrap. Customers may indeed sell the
mousetraps they have purchased, but unless they receive
permission from the inventor, they are not allowed to start up
rival production facilities.
In relation to inventions resulting from genetic modifications, it is
important to note the difference between an inventor's exclusive
right to the blueprint for a better mousetrap, and building a
better mouse. The principal distinction between traditional
patented technologies and the products of biotechnological
innovation is the capacity for progeny. A mousetrap cannot
replicate itself, but a canola plant can. Any plant containing
Monsanto's genetic modification, regardless of whether
generated through insertion directly into the DNA of canola cells
or through natural means, is now subject to Monsanto's
intellectual property rights. Had Monsanto attempted from the
outset, however, to acquire patent protection for the genetically
modified whole plant itself, instead of merely the modified gene
and cells, Canadian patent office policy would not have
permitted this.
The implications of this decision go far beyond agriculture.
Although Canada has been liberal in granting patents over
genes and cells whether of plant, animal, or human origin, the
Canadian patent system is only now coming to grips with the
issue of whether whole plants and animals are subject to patent
law. The issue may soon reach the Supreme Court of Canada if
leave to appeal is granted from the decision of the Federal
Court of Appeal of August 2000, with respect the so-called
Harvard oncomouse, which was genetically engineered to be
susceptible to cancer.
The distinction between genes and cells on the one hand and
whole plants, animals, and humans on the other has been the
subject of fierce debate among biotechnology companies,
environmental groups, academics, researchers, and
government representatives. In fact, the Canadian
Biotechnology Advisory Committee has recently held
roundtable discussions across Canada with representatives
from industry, nongovernmental agencies, and governments on
the patenting of higher life forms. The committee is seeking
input from stakeholders and members of the public in order to
formulate recommendations to be delivered to the federal
government this summer. The Monsanto decision preempts
this debate, because it effectively grants a patent holder rights
in not only a gene, but in the whole life form. Other legal tools
were available to protect Monsanto's commercial interests
without needing to push patent law in this direction.
Following the reasoning of the decision to its logical conclusion,
we believe that we have reason to be concerned. Read literally,
the decision means that by the simple act of reproduction,
patients treated with germline gene therapy could be liable for
patent infringement. The fact that germline gene therapy is very
much fraught with ethical problems and echoes of eugenics at
the moment suggests that this is unlikely to occur in practice any
time soon; however, the possibilities signal that the decision in
the Monsanto case leaves much to be desired.
REFERENCES
1.Fox, J.L. Nat. Biotechnol. 19, 396-397 (2001). | Article | PubMed |
Category: 2. Patent Law, 24.Monsanto