"They have created a method to inject eggs with a myc gene but they have not invented the mouse."
- Judge Marc Nadon, Federal Court of Canada
Canada is holding the line on life patenting. Bucking patent trends in the USA and Europe, Canada's Federal Court ruled last week that Harvard's "oncomouse" is not patentable under Canadian law.
On August 4, 1995 Canada's Commissioner of Patents ruled that Harvard University's genetically altered mice were not patentable in Canada. The President and Fellows of Harvard appealed that decision to Canada's Federal Court. On April 21, 1998, the Federal Court ruled against Harvard, and dismissed the appeal.
Harvard's "oncomouse" was genetically engineered to be susceptible to cancers. In 1984 its "inventors" received a US patent on both the biotech process used to "create" the oncomouse, and on the mouse itself (and all other mammals genetically altered by the technology). At that time Harvard also applied for a Canadian patent - the first ever sought in Canada for a mammal. The Canadian Patent office accepted the genetic engineering process claims, but rejected claims on the mammals themselves.
Citing Canadian and US legal precedents covering patents on microorganisms and plants, as well as mammals, Judge Nadon's decision focused on whether the oncomouse was an invention as defined by the Patent Act, and on the extent to which the inventors could control the end product of their invention. He reasoned that the Harvard inventors had invented a process (for which a patent had already been granted) but not a mouse. In ruling the mouse unpatentable, he also argued:
On even the broadest interpretation I cannot find that a mouse is "raw material" which was given new qualities from the inventor. Certainly the presence of the myc gene is new, but the mouse is not new nor is it a "raw material" in the ordinary sense of that phrase. (pp. 15)
The inherent genetic makeup of the mouse itself controls a myriad of characteristicsä. (T)here is no way to separate the transgene from the rest of the mouse once it is introduced and everything else about the mouse is present completely independent of human intervention. (pp. 16)
The creation of the oncomouse is a marriage between nature and human intervention. (pp. 17)
(T)he appellant has not made any claims to even minor control over any aspect of the mammal except the presence of the transgene ä.(T)he appellant can make no claim to being able to reproduce the mammal at will by doing anything other than ordinary breeding. In my view this is insufficient. (pp. 20)
A complex life form does not fit within the current parameters of the Patent Act without stretching the meaning of the words to the breaking point, which I am not prepared to do. However, if Parliament so wishes, it clearly can alter legislation so that mammals can be patented. (pp. 22)
This ruling sends a strong and timely message to the European Parliament, which is still debating the issue of life patenting. It strengthens the hand of those in Europe who are preparing to oppose life patenting in national referendums this summer. For Canadian opponents to life patenting, it buys some time.
"This decision gives us some breathing space", says Michelle Swenarchuk, Counsel and Director of International Programs at the Canadian Environmental Law Association (CELA). CELA has followed this patent closely, but was denied intervenor status in the appeal. Swenarchuk feared that the environmental and social implications of this case would be overlooked. "We have our work cut out for us" she said. "Justice Nadon has correctly placed this matter at the door of elected officials. Now we must ensure that the public understands the significance of life patenting, and that politicians are also well briefed. Public interest groups must move this debate into the parliamentary arena, where it belongs."
Harvard is expected to appeal this decision to the Federal Court of Appeal, and if unsuccessful there, to the Supreme Court of Canada.
Look soon for CELA's legal analysis of this decision, at CELA's website.
Source: Federal Court of Canada Docket T-275-96; President and Fellows of Harvard College and Commissioner of Patents, Judgment