Growing up, I would wander through pet stores and become drawn to the tanks of neon-coloured fish, unaware that they (known by their trade name GloFish) are not marvels of nature but instead patented, genetically engineered organisms. The existence of GloFish is just one of many organisms at the heart of a current debate over the patentability of higher life forms and the legal and ethical boundaries of genetic engineering.
There is a clear disconnect in North America regarding the patentability of higher life forms: Canada has taken a much more restrictive approach than U.S. patent law. In the landmark ruling of Diamond v. Chakrabarty in 1980, the United States Supreme Court held that a genetically modified bacterium was patentable, thereby paving the way for patenting living organisms that are sufficiently “human-made.” Conversely, the Supreme Court of Canada in Harvard College v. Canada (Commissioner of Patents) in 2002 refused to adopt the broad interpretation used in U.S. patent law and Diamond. Regarding the patentability of the “oncomouse,” a genetically modified mouse predisposed to cancer, the majority in Harvard College held that Canada’s Patent Act was intended to limit the scope of patentable inventions and refused to extend eligibility to higher life forms. Yet even as Canada maintains its cautious stance, emerging U.S. ventures are ambitiously reshaping the legal and ethical boundaries of patent law, resurrecting extinct species like the woolly mammoth and the dodo bird.
In my view, companies such as Colossal Biosciences, a startup backed with multimillion-dollar funding and revolutionary CRISPR-gene editing, illustrate the benefits of U.S. patent law’s flexible interpretation of patent eligibility. The framework of U.S. patent law not only encourages but incentivizes such visionary projects which can rapidly advance the fields of synthetic biology and genetic engineering. If enacted properly, the incentive for commercialization can help promote genetic engineering with societal benefits, including modifying animals to become climate-adapted to preserve biodiversity or enhancing key traits like growth rate or nutritional value to bolster food production and alleviate global food shortages. With the prohibitively high costs of cutting-edge genetic research, the broad interpretation of patent eligibility in U.S. patent law provides the necessary financial incentive for investors to bring innovations in genetic engineering from the laboratory to the real world.
Of course, a bleaker outlook on the commercialization of these emerging technologies is the potential for its misuse, specifically regarding the commercialization, enhancement and/or creation of human lifeforms. Fortunately, there are safeguards to bar this dystopian outcome: the Weldon Amendment prohibits the commercialization of human organisms, in addition to multiple constitutional barriers. Ultimately, I maintain a positive outlook that if maintained responsibly, the broader U.S. stance on patent eligibility is beneficial because it fosters a forward-thinking ideology that catalyzes breakthrough innovations in genetic engineering that can meaningfully benefit society.
