In a landmark decision that opens the door for genetically engineered organisms to be patented in Canada, an Ottawa court ruled last week that Harvard is eligible for a patent on a trailblazing class of genetically altered mice.

"Oncomice," which have genes that make them prone to cancer, won the first ever American patent for an animal in 1988, but the University has been fighting for fifteen years to gain similar protection in Canada.

Genetically engineered single-celled organisms and processes used to create modified higher life forms were previously eligible for patents in Canada, but transgenic plants and animals themselves were not.

The 2-1 ruling by the Canadian Federal Court of Appeal reversed the decisions of Canada's patent commissioner and a lower court, requiring the commissioner to apply the same criteria to living and inanimate inventions. The decision was confined to interpretation of the patent code and did not address broader ethical objections some raised to the patenting of life forms.

The ruling will allow for renewal of patent review for more than 250 biotechnology applications that have been on hold awaiting the decision.

But the government may still appeal the case to the Canadian Supreme Court, a possibility that Justice Department lawyer Rick Woyiwada said this week is under consideration.

A. David Morrow, the Ottawa attorney who argued the case for Harvard, predicts that the case will be heard in the Court's 2001 session if the government goes forward with an appeal.

Limited Impact in Cambridge

Though the ruling was front-page news in Canada, its implications for Harvard are limited.

"I don't think this will have any major impact on our portfolio," said Dr. Jeff Labovitz, director of the Medical School Office of Technology Licensing, which handles the oncomouse technology.

The University claims as intellectual property any mammal genetically altered to express oncogenes, the genes that cause cancer. Harvard has licensed this technology to Delaware chemical giant DuPont, Inc. which sublicenses the rights around the world. As part of the license agreement, DuPont pays the massive legal bills that have been generated by years of litigation.

Though Harvard will not reveal the license fee paid by DuPont, it is small in corporate terms: the University takes in a total of $15 million per year from all technology licensing, a small fraction of its budget.

David Einhorn, counsel at the Jackson Laboratory, a major supplier of laboratory mice that distributes animals covered by the oncomouse patent, said the mice typically sell for about $50 to $60 each.

But Harvard's yield is small because academic researchers are allowed to use the technology free of license fees, according Medical School Genetics Department Chair Phillip Leder, the co-creator of the mouse.

Industry officials said that the impact of the ruling will not be large as Canada is a small market and even in the United States, the demand for the oncomouse is limited.

"There are a number of strains that fit within the definition of the patent but we don't distribute large numbers of these mice," Einhorn said. "I can't imagine Canada's that big a market."

The Law of the North

But while the mouse means little to Harvard financially, the case it created, Harvard v. Commissioner of Patents, will be a landmark in Canadian patent law.

The case deals directly with the heart of the patent code: the definition of the word invention itself.

The Canadian Patent Act of 1869 defines an invention as "any art, process, machine, manufacture or composition of matter" that is new, useful and isn't obvious. Over the years the oncomouse case has revolved around whether animals should be considered "compositions of matter," "manufactures" or both.

The majority opinion, written by Justice Marshall Rothstein and joined by Justice A. M. Linden, takes a sweeping view of inventions that includes transgenic organisms under the category of compositions of matter.

"The language of patent law is broad and general and is to be given wide scope because inventions are, necessarily, unanticipated and unforeseeable," Rothstein wrote. "Nothing in the term composition of matter suggests that living things are excluded from the definition."

The court rejected the government's argument that the oncomouse is not an invention because scientists do not have control over some of its features, like tail length and eye color, arguing that those characteristics are irrelevant to the animal's usefulness and novelty.

The Justices also made a key distinction between the laws of nature, which were used to create the mouse and cannot be patented, and the mouse itself, the creative product of scientists.

The Dissent

The dissenter, Justice Julius Isaac, argued that higher life forms simply did not fit the Canadian Parliament's intended definition of inventions. He also said that more deference should have been given to the patent commissioner's expert judgement of the application.

Critics of biotechnology in Canada echoed his judgements this week and called the court's opinion hasty and irresponsible.

"There are environmental, health and ethical issues associated with the patenting of biotechnology," said Michelle Swenarchuck, Director of International Programmes at the Canadian Environmental Law Association. "The court never had a full discussion of these issues."

The Environmental Law Association, which argued against Harvard in court as an interested party, is lobbying the government to appeal.

But the association also argues that Parliament, not the courts, is the place where the issue should be considered.

"Courts are the wrong place to decide whether we should be patenting higher life forms," Swenarchuck said. "Our legislatures need to look at the Patent Act and the idea of invention and whether they intend it to cover living creatures."

Until that time, the ruling's critics say, Parliament's original intentions must stand--and in writing the 1869 Patent Act it did not intend that life would be patented.

"Parliament never intended an invention to be something that you look in the eye," said Julie Delahanty, Researcher and Programme Manager for the Rural Advancement Foundation International, a Winnipeg-based advocacy group.