Issue 183

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New 'Lease on Life' for Patents
RH #183
by Brewster Kneen

Corporations were created as a way to limit the personal responsibility and liability of their owners/shareholders. No matter how much money a shareholder may take out of a corporation in the form of dividends, if the corporation goes bankrupt the shareholder stands to lose only as much as they have actually invested. If a corporation is sued, the personal assets of the directors and shareholders of the corporation remain beyond reach. This is all backed up by the government authority under which corporations have to be registered and licensed.

The purpose of a corporation is, of course, to make money for its shareholders. This is its fiduciary responsibility under law. As western societies have become satiated with goods and services, the production and trading of which have been the traditional means to corporate wealth, corporations have had to look to new mechanisms of wealth appropriation. An instrument that has been around for some time, but is taking a new lease on life (yes, thats a pun), is the industrial patent. This new lease on life was initiated with the granting of a patent on a purported oil-eating bacteria by the U.S. patent office in 1980, although there was no mad rush to patent life forms for another decade.

Now, however, we hear the corporations and the universities almost daily pleading for increased patent protection on the products and process of biotechnology. We are unremittingly scolded that without the mechanism of patent royalties and licenses to recoup their investments, the corporations and universities will be unable to invest in Progress. (Never mind that an awful lot of this Progress, or of what the corporations want to patent, shouldnt be created or on the market in the first place.)

The obscene race to patent so-called novel life forms seems to be clear proof that we have allowed corporate profit to take priority over everything else, including life itself. And of course it must be protected against the immense risks involved in messing around with living organisms. Limited liability is not enough.

The corporate sector is now engaged in a pernicious strategy to absolve themselves of all responsibility and to require the public to prove social and personal harm if any attempt is made to limit corporate freedom to profit. Common sense says that a corporation should be responsible for proving safety in order to get product approval. In the regulation of products and processes of genetic engineering, however, their aim is to make the regulatory agencies such as the Canadian Food Inspection Agency (CFIA) esponsible for proving harm before a product can be kept off the market.

The same approach is being taken with patent infringement: the corporations are arguing that it is up to those accused of infringing patents to prove their innocence, rather than the patent holder having to prove guilt. Given that this is most likely to pit the individual farmer, for example, against the giant corporation, there is little chance that the accused could fight the accusation and prove their innocence. The mere threat of a lawsuit is sufficient to intimidate even the most innocent unless they have access to substantial financial resources. (Saskatchewan farmer Percy Schmeiser is the exception to the rule.)

As for the law, the Globe & Mail pointed out in a curious editorial (8/8/00), "biotechnology is both different and new. Canadian legislators enacting the first Patent Act in the middle of the 19th century couldnt have imagined our emerging ability to control biology." In other words, patent law was not written with the intent of covering life forms.

Oncomouse Verdict: Guilty until proven innocent

Alluring Minie

Almost two decades ago Harvard University scientists genetically engineered a mouse to be susceptible to cancers for use in cancer research. Dubbed the oncomouse or cancer-mouse, this animal was created specifically in order to suffer the pain of cancer breast cancer in particular. In 1985 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 Canadian Patent Office accepted the genetic engineering process claims, but rejected claims on the mammals themselves.

Harvard appealed that judgement and in 1995 the trial division of the Federal Court rejected Harvards appeal. Judge Nadons decision focussed 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 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. . .

"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. . ."

Harvard appealed again, and on August 3rd the Federal Court of Appeal, in a 2-1 decision, reversed the earlier decision of Judge Nadon and ordered the Patent Office to issue Canadas first patent on a living animal. In a stunning inversion of the argument of the earlier judgement, the court ruled there may be good reasons that living animals should not be patented, but that is for elected officials, not courts, to decide, saying there is nothing in the Patent Act that outlaws the patenting of animals.

Judge Isaacs, in his dissenting opinion, wrote,

In all the circumstances of this case, including the limited role that our jurisprudence has assigned to the Courts in this area and the serious moral and ethical implications of this subject matter, it seems to me that Parliament is the most appropriate forum for the resolution of the issues in dispute here.
Minnie Masectomy

Canada's commissioner of patents can appeal this latest decision to the Supreme Court of Canada, if there is the bureaucratic and political will to do so. The issue before us, the public, is how to force parliament to consideration appropriate new legislation to guard against the patenting of life forms.

The Mouse that Roared on Animal Pharm
thanks to RAFI, Rural Advancement Foundation International

The decision to grant a patent for this multicellular, higher life form opens the door to patenting any non-human life form. To date, Canada has granted patents for single-cell life forms, including human cell lines, but not for multi-cellular ones. Harvard modified the mouse by inserting a gene to cause it to develop cancer for use in research. However, the patent that was granted extends to all non-human mammals.

The Canadian government has been noticeably silent on the political implications of the case. They have used the courts to sidestep their responsibility to consider the ethics and impact of the patenting of life forms, says Julie Delahanty of RAFI. The court rulings on this case have twice agreed that the issue of life patenting is more rightly decided by Parliament, yet the government continues to avoid the democratic process and is instead hiding beneath the judges robes.

Through other official documents such as the Canadian Biotechnology Strategy, the present government has made it clear that they support the biotechnology industrys desire for patenting anything that moves. The decision in this case leaves them free to avoid broad public debate on the question of patenting life forms in Canada.

The Canadian Environmental Law Association (CELA) intervened in the case, arguing that the Federal Court decision should be upheld and that the patent should not be granted. Michelle Swenarchuk, Counsel and Director of International Programs for CELA, argued that the Court is not the appropriate body to determine this question, since it was not in the position of having before it all the information required for a full examination of the implications of life form patenting. Rather, the decision should be made by legislative review, after a full public debate of all the implications. . . Only Parliament, not the Courts, can ensure that such safeguards are in place for the public interest.

Like the other copyrighted mouse, Mickey, the oncomouse also serves corporate interests. Although the patent is owned by Harvard Medical School, an earlier commercialization arrangement leaves Du-Pont, not Harvard, entitled to exclusive license of the patent. DuPont has claimed patent protection on any anticancer product ever derived from the mice.

There are currently approximately 250 applications pending in the Canadian Intellectual Property Office dealing with animal patents that have been on hold awaiting this decision. When asked to divulge the nature of these patents, Murray Wilson, a spokesman for the Patent Commissioner, stated: Let your mind run wild what people could dream up for getting the body of an animal to do.

The Canadian lawyers representing Harvard argued that it is in the interest of the Canadian public to allow patents for higher life forms. The Federal Court of Appeal majority decision agreed that without patent protection the creation of inventions would be discouraged.

The court did attempt to draw the line at people and warned that the decision does not endorse patents of human life. The potential extension to human beings is an obvious concern, stated Judge Rothstein The answer is clearly that the Patent Act cannot be extended to cover human beings. Patenting is a form of ownership of property. Ownership concepts cannot be extended to human beings. Critics are not so confident.

The Canadian and other patent offices already allow patents on human genes and cell lines. In 1997, a patent was granted by the World Intellectual Property Organization (WIPO) on a sheep named Dolly, the world s first cloned mammal. The patents held by the Roslin Institute, responsible for the Dolly experiment, cover the use of the technology in all animals, including humans. The Institute claim-ed that they included humans simply to ensure that nobody else could lay claim to human cloning. Such good intentions are dubious given the rate of corporate takeover of small operations and the knowledge that once the legal precedent has been set for the patenting of humans, turning the clocks back is almost impossible. The line between what is human and what is not and therefore what multicellular organisms can be patented is becoming fuzzier everyday. Were only a few genes ahead of being a salamander anyway, says Pat Mooney, Executive Director of RAFI. Human genes and cells have already been patented. With the rapid advances in biotechnology and other technologies, its hard to be overly confident that human beings will not eventually, also be the subject of a patent. Once you accept the patenting of life, there is virtually no way to keep the doors shut on the patenting of organs and any other parts of the human body that have a commercial application.

Geno-Types, 10/8/00 (edited)

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