biotechnology patents, Monsanto v Schmeiser, Trans-Pacific Strategic Economic Partnership (TPP)
As the frontiers of science are constantly redefined by the emergence of new technology, patent law often has to struggle to keep pace with the changing conception of what constitutes a protectable “invention”. A key challenge facing patent law in the age of biotechnology lies in ascertaining the extent to which genetically engineered life forms should be protected. A major concern relates to whether such life forms should be excluded from patentability on grounds of ordre public, ethics and morality.
This article critically explores the extent to which patent law in Canada protects this “forbidden fruit” of biotechnological innovation, and compares the position in Canada with that of the United States and the European Union. The author argues that recent Canadian jurisprudence in the field of biotechnology law has brought the Canadian position more in line with patent developments in other industrialized nations, although there continue to be differences in the formal definition of “patentable subject matter”. The groundbreaking decision by the Supreme Court of Canada in Monsanto v Schmeiser marks the emergence of a more permissive approach toward the patentability of genetically modified inventions — an approach that is more compatible with patent practices in the United States and the European Union than the position taken earlier by the same court in Harvard College v Canada. However, while genetically modified cells and genes are now eligible for patent protection in Canada, entire organisms remain unpatentable under existing Canadian law. Practically speaking, the distinction drawn by the Schmeiser court between genetically modified “components” and genetically modified “life forms” is artificial, because a patent over a genetically modified cell effectively gives a patentee de facto control over the commercial exploitation of the entire organism.
This article proposes that Canada should jettison this artificial distinction and explicitly recognize life forms as patentable subject matter if it wishes to play a more influential role in trade agreements such as the Trans-Pacific Strategic Economic Partnership (TPP). Embracing “life forms” as a category of patentable subject matter would also make Canada a more attractive destination for biotechnology investment.
Eugene C. Lim, "Harvesting the "Forbidden Fruit" of Biotechnology Research: Genetic Engineering, International Law and the Patentability of Higher Life Forms in Canada" (2012) 10:2 CJLT.