The Cross-Border Controversy Over the Patentability of Living Organisms

March 2004

In 1980, the U.S. Supreme Court held in Diamond v. Chakrabarty that living organisms are patentable if they are the result of human effort or ingenuity, in other words, if they are genetically engineered. Chakrabarty, a microbiologist, had developed a genetically engineered bacterium that was capable of breaking down multiple components of crude oil. General Electric filed a patent on the invention in 1972. The patent included three types of claims - process claims covering the method of producing the bacteria, composition claims covering a carrier material (like straw) inoculated with the bacteria, and claims covering the bacteria themselves. The patent examiner allowed the process and composition claims but took the position that the bacteria could not be patented.

Article I, Section 8, of the U.S. Constitution directs Congress to promote "the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." According to the U.S. Supreme Court, this clause was intended to have a positive impact on society through the introduction of new products and the associated increase in employment. In implementing this provision of the Constitution, Congress stated in Section 101 of the Patent Act that any new and useful "process, machine, manufacture, or composition of matter" could be patented. The issue in the Chakrabarty case was whether the genetically engineered bacterium was a "manufacture" or a "composition of matter" under the statute. In addressing this issue, the Court noted that our patent laws should be given wide scope. The Court also quoted Thomas Jefferson, the country's first patent examiner, for the proposition that "ingenuity should receive a liberal encouragement."

According to the U.S. Supreme Court, Chakrabarty had developed a nonnaturally occurring manufacture or composition of matter with the potential for significant commercial utility. In terms of patentability, said the Court, the distinction is between products of nature, whether living or not, and human-made inventions. The latter are patentable, but the former are not.

As a result of the Supreme Court's decision in Chakrabarty, Harvard College patented in 1988 the so-called oncomouse. More specifically, Harvard patented a transgenic non-human eukaryotic animal whose germ and somatic cells contained an activated oncogene sequence that had been introduced into the animal (or the animal's ancestors) at the embryonic stage. This transgenic animal had an increased propensity to develop tumors, which made the animal useful for testing materials suspected of being carcinogens.

After patenting the oncomouse in the U.S., Harvard succeeded in obtaining patent protection for the oncomouse in Japan, New Zealand and several European countries. Canada, however, proved to be a stumbling block. The Canadian patent office rejected Harvard's application to patent the oncomouse, and the case made its way to the Canadian Supreme Court in 2002.

In the case of Harvard College v. Canada, the Canadian Supreme Court held that higher life forms are not patentable because they are not a "manufacture" or "composition of matter." According to the Canadian Supreme Court, the term "manufacture" means a non-living mechanistic product or process, and the term "composition of matter" means ingredients or substances that have been combined or mixed together by a person. Because a mouse body is not made by humans, it cannot be considered a composition of matter. The justices who joined in the majority opinion were concerned about drawing the line between human and animal life, and in particular, whether the patenting of the oncomouse would lead to the patenting of human body parts. The Court acknowledged that the distinction it was drawing between higher and lower life forms was not based on any express language in the Patent Act but rather was defensible on the basis of common sense.

The dissenting justices in Harvard College faulted the majority for allowing religious overtones to permeate its opinion. According to the dissent, the extraordinary scientific achievement of altering every single cell in the body of an animal by human modification of genetic material is a "composition of matter" within the meaning of the Patent Act. In reaching its conclusion, the dissent emphasized the importance of furthering the mobility of capital and technology by maintaining patent laws consistent with those of other jurisdictions. The dissent answered objections of animal rights supporters that patenting the oncomouse would lead to animal cruelty by noting that the failure to patent the oncomouse would simply allow anyone to make an oncomouse.

Canada remains in the minority on the issue of the patentability of the oncomouse, but the Harvard College decision raises an important question: at what point does patenting a living organism become unacceptable for ethical, if not legal, reasons? According to the U.S. Supreme Court, we have not yet reached that point, but with the continuing advance of genetic engineering, this issue will inevitably arise again.


Amicable photo of Toni

Antoinette M. Tease, P.L.L.C.