HARVARD COLLEGE V. CANADA (COMMISSIONER OF PATENTS) 2002 4 S.C.R 45
FACTS
- The respondent applied for a patent on an invention titled “transgenic animals” which they claimed to be suitable for animal carcinogenic studies. They injected oncogene which is a cancer-promoting gene into fertilized mouse eggs as close as possible to one cell stage which were further implanted into a female host mouse.
- They tested for the presence of oncogene upon the development and delivery of the offspring which are further mated with the ones who are not genetically altered. This whole process led to a mice (founder mice) genetically altered and named as oncomouse.
- This has susceptibility to cancer and hence was a useful means to bring out a cure for cancer. Respondents claimed patent protection for both the process by which oncomice are produced and the end product of the process.
- Patent examiner granted patent only for the process and not for the product which was further confirmed by the appellant commissioner.
ISSUE
- Whether higher forms of life are inventions as ‘manufacture’ or ‘composition of matter’ within the meaning of inventions under The Patent Act?
RULE
- Section 2 of the present Patent Act (Canadian Law) now provides as follows: “Invention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.”
HOLDING
- The Court noted that biological inventions were living and self-replicating, incredibly complex, incapable of full description and contained important characteristics that had nothing to do with the invention. These issues clearly show that patenting higher life forms raise serious concerns which are not covered by the scheme of the Patent Act. The Court acknowledged that the two central objects of the Patent Act were to advance research and development and to encourage broader economic activity. However, these objects do not imply that “anything under the sun that is made by man” is patentable.
- Instead, he found that the language and scheme of the Act is not well suited to higher life forms and as such he surmised that Parliament did not intend for patent rights to extend to higher life forms.
- ‘Manufacture’ (considered in context of the act) is a non-living mechanistic product or process, and not a higher life form and neither is the composition of matter. While fertilized eggs are injected and may constitute to be a mixture of ingredients, the oncomouse itself doesn’t consist of ingredients that have been combined or mixed together by a person, as it is biologically grown and doesn’t require any human intervention.
- Further denying the contention that inventions which precede patent laws are unanticipated and hence should be considered a patentable subject matter the court said that not all of them to be necessarily patentable as may be parliament didn’t intend them to be covered under patentable subject matter or they regarded these to be mere discoveries. Further referring to the Plant breeder’s Rights Act, the court said that these higher life forms (plants) have been covered under a special legislation specifically for the rights of plant breeders which demonstrates that higher life forms were never intended by the parliament to be covered under the Patents act and hence suggested that that until Parliament creates an applicable legislation it is appropriate to let the patent commissioner forbid this kind of patent of higher life forms.
- Higher life forms are not inventions under the meaning of S.2 of the Patent act as it does not qualify as a “composition of matter” or a “manufacture” and hence does not meet the subject matter criteria of the patent act. Hence patent cannot be given to the product oncomouse.
DISSENT
- The decision of the majority was opposed by a strong dissent. Justice Binnie argued that it is an extraordinary scientific achievement to permanently genetically alter the genes of an animal where that alteration did not arise in nature. He rationalized that just as other forms of invention such as moon rockets, antibiotics, telephones, e-mail or hand-held computers, which would not have been anticipated at the time the Patent Act was drafted, would be considered inventions, so too should genetic engineering of higher life forms.