December 6, 2002

Canada High Court Forbids Patents of Harvard's Mice

By JOEL BAGLOLE
Staff Reporter of THE WALL STREET JOURNAL


OTTAWA -- In a decision that could affect scientific research north of the
border, the Supreme Court of Canada ruled that higher life forms such as
mice can't be patented.

In a 5-4 decision, Canada's Supreme Court judges ruled that Harvard
University can't patent in Canada a mouse genetically altered to develop
cancer. The judges said the mouse failed to meet the definition of an
invention under Canada's Patent Act, which was written in 1869. However,
the judges conceded the 133-year-old act was not designed to deal with
living mammals such as mice and urged Canada's government to address the
issue in Parliament.

Lower Canadian courts ruled Harvard can patent the process by which it
genetically alters the mouse, but cannot patent the entire mouse. Canada's
Supreme Court upheld this ruling.

The mouse was patented in the U.S. in 1988, and has patent protection in
Australia, Japan and several European countries. The decision makes Canada
the only industrialized country to ban patents on any kind of higher life
form. Canadian law does allow patents on certain bacteria, single-celled
organisms, plants and agricultural crops.

The "oconomouse," named for oncology, the study of cancer, was developed by
Harvard's medical school in 1984. The modified mice are used by
universities and commercial labs to study cancer and its various
treatments. The patents give Harvard exclusive rights to create the mice
and charge licensing fees to scientists who use them for research. In
Canada, others could obtain the altered mice and breed them for research
purposes without paying Harvard a fee.

The inability to receive life-form patents "could create a chilling effect
on scientists doing research here," said Janet Lambert, president of
Biotecanada, which represents Canada's biotechnology companies. She added,
"Without revenues, many emerging companies' key assets are their patents."

Harvard's medical school, in a prepared statement, said: "Canadian
scientists are at risk of being left behind their colleagues around the
world as a result of this decision."

Environmental and religious groups that oppose the patenting of higher life
forms for ethical reasons applauded the decision.

Jerry DeMarco, managing lawyer for the Sierra Legal Defense Fund, a
Toronto-based nonprofit environmental law group that argued against Harvard
in the case, said the court made the right decision. "Mammals are the
product of evolution, not invention. Harvard isn't inventing the whole
mouse. They're just tinkering with the genes, and that doesn't constitute
an invention." Mr. DeMarco added that the ruling kills "hundreds" of
Canadian patent applications regarding higher life forms that were on hold
pending a ruling in the Harvard mouse case.

There are 403 registered biotechnology companies in Canada with 58,000
employees and 5 billion Canadian dollars (US$3.21 billion) in annual revenue.