International Law

Patent Rights and ?Public Order?

By Randy Ai

In Harvard College v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45, the Supreme Court, in a 5-4 decision, ruled that a genetically modified mouse was not a patentable invention under the Patent Act. Harvard College had created a genetically modified mouse, known as the ?oncomouse,? that was particularly susceptible to developing cancer, and thus ideal for oncology research. The technique of creating the oncomouse involves inserting a special cancer-promoting gene into fertilized mouse eggs, which are then implanted into female mice; subsequently, cancer-susceptible mice offspring are born and used for scientific research. Harvard College requested a patent for both the procedure through which the oncomouse is created, and also the oncomouse itself. The latter request was rejected by the Commissioner of Patents, and this rejection resulted in subsequent litigation at the Supreme Court.

The Supreme Court ruled that the oncomouse was not an ?invention? within the meaning of the Patent Act, as an ?invention? must be an ?art, process, machine, manufacture or composition of matter.?2 The Court concluded that it was not the intent of Parliament to allow higher life forms to be patented, as they do not fall into any of the enumerated categories. The dissent advanced a spirited argument, arguing that the difference between lower life forms (which are patentable, according to Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193) and higher life forms was arbitrary, and absent legislation explicitly excluding higher life forms, the oncomouse should be considered a ?composition of matter.?

What is curious about this decision is that public policy concerns were not a serious factor in the Court?s analysis of salient issues. Both the majority and the dissent focused on a battle of semantics, most notably disagreeing on the intent of Parliament in crafting the definition of invention. The dissent concluded that Parliament had intended to protect inventions not in existence at the time of enactment of the Patent Act and thus a liberal reading of the Act is to be called for. The majority disagreed, arguing that Parliament crafted the definition of invention in a specific way with the intent of limiting the scope of what could be considered an invention. However, both majority and dissent side-stepped the issue of public policy, morality, and ethics in the patenting of a higher life form.

The Patent Act prior to its 1993 amendment had a provision under s. 27(3) outlawing the patenting of inventions that had ?an illicit object in view.? This clause is no longer in the current Patent Act, which makes no mention of any public policy considerations. The absence of such consideration is contrasted by many international conventions on intellectual property. For example, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an international agreement administered by the WTO, states:

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

Furthermore, the European Patent Convention (link leads to .PDF file) has a similar provision, stating:

European patents shall not be granted in respect of:

(a) Inventions the publication or exploitation of which would be contrary to “ordre public” or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States.

The Canadian Patent Act does not have a similar provision. As a result, the Court seems content on shifting the responsibility onto Parliament to make the policy decisions and regulations in the area of genetically engineering and the patenting of higher life forms. The Court specifically indicated its reluctance to consider policy implications in its assessment of whether something is a patentable invention. It is curious that the Court would actively avoid engaging in policy discourse in this context, when it so readily and enthusiastically does so in other types of cases and in other contexts. The Court?s decision in Harvard College v. Canada (Commissioner of Patents) appears to indicate an unwillingness to look beyond the semantics of a statute. This is surprising given that the patenting of an entire animal merits, on the face of it, at least some judicial analysis into its public policy implications. The Court?s focus on semantics at the expense of other considerations limits the scope of the analysis in intellectual property cases ? especially where the subject of the patent is a highly controversial item that is an ideal candidate for policy discourse.

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Full post as published by The Court on September 24, 2008 (boomark / email).