[petnews]

Harvard mouse doesn't qualify as an invention under Patent Act

Janice Tibbetts
The Ottawa Citizen
Friday, December 06, 2002

Canadian law prohibits animals from being patented, a deeply divided Supreme Court said yesterday in a ruling that rejected Harvard Medical School's 17-year quest to claim ownership of a genetically altered mouse.

The court was philosophically split in its first foray into the burgeoning legal field of bioethics, but the majority concluded that the rodent does not fit the definition of an invention in Canada's 133-year-old Patent Act.

"Patenting higher life forms would involve a radical departure from the traditional patent regime," Justice Michel Bastarache wrote in the 5-4 decision.

"Moreover, the patentability of such life forms is a highly contentious matter that raises a number of extremely complex issues. If higher life forms are to be patentable, it must be under the clear and unequivocal direction of Parliament."

The mouse has already been patented in the U.S., many European countries, Japan and Australia. Harvard first applied for a Canadian patent 17 years ago.

Some critics said the ruling could hinder biotechnological research in Canada by depriving researchers of legal protection for their inventions.

Industry Minister Allan Rock said he will accept the court's invitation to embark on a thorny debate on how the government should deal with higher life forms, including humans.

"We have to decide how to balance, on the one hand, how to encourage research and innovation and, on the other, to reflect the values of Canadians," Mr. Rock said.

"Whether you can patent a higher life form raises issues about how we regard life. We have to come to grips with those issues. We can't be afraid of them."

The Supreme Court overturned the Federal Court of Appeal, which ruled two years ago that the Harvard mouse, genetically engineered to be susceptible to cancer, is patentable in Canada, but that human beings are not.

Judge Bastarache said that the Federal Court oversimplified the issue and that lawmakers should deal with the "increasingly blurred line between human beings and other higher life forms."

Among other things, the court did not consider how to define a human, and whether its ban would include human fetuses and human organs, Judge Bastarache said.

He also warned that he could not overlook concerns that allowing patents on higher life forms could eventually lead to patenting human beings.

In a dissenting opinion, Justice Ian Binnie dismissed the prospect, saying that the Charter of Rights would prohibit ownership of human beings for commercial purposes.

Judge Binnie pointed out that it's ludicrous that Canada should stand alone in refusing to grant patent protection to Harvard.

The mouse, which is known in the medical research community as the onco-mouse, is used to test treatments for breast, prostate and other forms of cancer.

The Patent Office said that as many as 1,500 applications for plant and animal patents have been on hold pending the Supreme Court's verdict.

They include applications to patent a salmon that is genetically engineered to grow quickly and a goat that is altered to produce milk with proteins used by drug manufacturers. There are also applications involving patents for cats, rabbits, dogs and cows.

At issue in the case was whether the mouse is a "composition of matter" under the Patent Act.

Since 1982, the Patent Office has accepted that lower life forms are patentable, such as yeasts and moulds.

But animals' capacity to display emotion separates them from lower life forms and shows they are more than a composition of matter, said the Supreme Court.

"Higher life forms are generally regarded as possessing qualities and characteristics that transcend the particular genetic material of which they are composed," wrote Judge Bastarache.

"A person whose genetic makeup is modified by radiation does not cease to be him or herself. Likewise, the same mouse would exist absent the injection of the oncogene."

Harvard University denounced the decision, saying, in a statement, that "Canadian scientists are at risk of being left behind their colleagues around the world."

David Morrow, Harvard's Ottawa-based lawyer, also warned that the ruling could hinder biotechnological research in Canada. The Canadian Biotechnology Advisory Committee, a panel of experts that advises the federal government on biotechnology issues, renewed calls for Mr. Rock to revamp the Patent Act so that it permits patents for all higher life forms except humans and fetuses.

But the prospect was rejected by religious, environmental, and animal-rights groups, who applauded yesterday's ruling.

"Life is not a human invention and living beings should not be treated as commercial commodities," said Paul Muldoon, a lawyer for the Canadian Environmental Law Association.

A patent protects an invention for 17 years for inventions filed before October 1989 and for 20 years after that date as a result of strengthened protection given by the federal government.

The grace period allows an inventor to exploit the invention free from competition to permit the recovery of research and development money that went into the invention.

Source: The Ottawa Citizen