Wednesday, April 13, 2005

'Product of the Year' : Patenting Higher Life Forms

Patents play a huge part of today’s society, in terms of science, innovation, technology and the economy. Usually inanimate objects, such as toasters, radios, and clocks are being patented. This is common practice, yet in the United States and other countries animals or higher life forms are being submitted in this category. In the United States, private companies, universities and individual bioentrepereneurs, have granted over 470 patents on animals such as monkeys, pigs, mice, dogs and cats. The traditional role of the patent is to give inventors incentives to develop new technologies that in turn create jobs and economic vitality for society. This new trend is alarming for some, yet seen as an inevitable advance in science research for others.

There are two main concerns with this issue. The first being animal cruelty. Many times animals are being subject to inhumane chemicals and drugs because of the ability to patent them. For instance, a recent patent in the States was approved for beagles who were severely sickened and whose lungs were purposefully infected with a mold in order to test new human drugs on them. Secondly, with this trend of approving microorganisms, to mice and then to domestic pets for patenting, the inevitable future is humans, which creates a huge moral dilemma. These concerns are counterbalanced with three other outcomes of patenting higher life forms which are the desire to learn more about diseases. With the outset of innovated testing, scientists may be able to cure epidemics that threatened humans. Also with continue patenting, it will give the economy a boost and therefore create a more thriving employment field therefore increasing the welfare of the public. All of these arguments are valid and true for both sides of the issue. The problem is not deciding whether or not to allow the patenting of animals, but rather the enforcement of it. Currently in Canada this is seen as a judicial decision, rather than a political issue. Therefore the government is not taking any action. In order to protect both sides of the argument, the Canadian government needs to address this as a political issue and create a public forum in order to implement regulations which set out guidelines to patenting higher life forms.

Where patenting animals is concerned there is a tremendous movement against such an act. People who do not agree with the patenting of higher life forms are also in effect opposed to genetic research. The fear here is mostly moral or ethical, they believe that the natural order should not be changed or altered in any way. It raises ethical questions. The government currently does not treat this as a socio-logical political legal issue. They just treat it as ‘black letter’ law, which is the main source of resolving the issue. With morality comes into effect the ideal in the law which is, in which decision will the public benefit more from, patenting animals or not patenting animals. The answer to the question should be done in a case by case synopsis meaning every case should be looked at in an individual context. The advocates against patenting life forms reflect two different moral philosophies. The first, being the ‘deontological approach’, which is that “certain acts are intrinsically right or wrong regardless of their consequences.” This basically means that tampering with nature is wrong. Secondly the other approach is the ‘consequentialist’ or utilitarian approach, which judges the morality of an action by weighing its beneficial and harmful consequences. For instance, using a mouse in order to research the fight in cancer and potentially find a cure may outweigh the concerns over suffering animals or possible risks to the environment. The law should reflect the “basic interest of mankind.” Yet also there should be an interest to protect animals from cruelty. Both interests need to be combined in order to better meet society’s needs. Concerns about the environment, and societal effects fall under this category. Most arguments combine both approaches in order to disapprove of patenting of higher life forms. The main objective to advocates is that patenting animals is the process of playing God. Genetic engineering is seen as morally wrong because it interferes with natural evolution. After the Onco-mouse patent was introduced there began concerns about potential for human cloning following the sheep Dolly. This fear created uneasiness throughout the public over the power of humans and science to manipulate nature. One argument under the idea of playing God is that it makes animals into commodities and uses them as a means to an end degrades the sanctity of life. It makes the creator seem unnecessary to the process of live. Yet on the other hand those who do support animal patenting make a clear point that animals have been considered property for thousands of years, and are used for food, clothing and other consumer products , so the idea of placing a patent on animal life forms is nothing new. The whole playing God argument is not a very concrete, seeing how it can be said that God wants humans to use there God-given powers to use nature to its full potential. The point of countering the ethical argument is to prove that there is a moral issue that is related to genetic engineering, but it is not about God or philosophy but rather if the technology of patenting animals applied responsibly. That is the most significant aspect of the whole ethical argument. There is no doubt many different links to morals and patenting higher life forms, but in order to meet the standards of society and the public good, there must be technology in place which is responsible and done under a set of governmental guidelines.

The emergence of biotechnology has created a new way of looking at patent law. In Diamond v. Chakrabarty, the United States Supreme Court broadened the concept of patent protection to include inventions derived from biological advances, holding that genetically altered living microorganisms constituted patentable matter. On the economic front of the argument for patentability of animals, there are many reasons to follow the United States’ lead. Advocates of the patentability side of the argument state that patent rights are critical if Canadian biotechnology companies are to “attract and hold the investment necessary to develop their inventions in Canada.” It is known that transgenic animals can serve as models to study humans in order to find cures for disease and to test drugs and also being developed to donate organs for transplants in humans. Besides the social interests of medical advancement in humans, there are also many economic interests involved. For instance, there is evidence to show that animal patenting has resulted in a huge increase in stock values of corporations who are involved in the industry. Therefore patents help to advance the industry of drug testing and scientific technology, therefore patent protection is needed in order to continue the increased research. The general manager of the Industrial Biotechnology Association of Canadian, Jason Flint, estimates that “the core industry is capitalized at about one billion dollars already and it is growing by about 26 percent a year.” This is a thriving marketplace and is needed in our economy. Along with it comes worldwide recognition with other companies and many new job opportunities. The advocates in favour of patenting higher life forms address both economic and social issues.

It is evident that the issue of patenting animals is simply not one of judicial response but rather a political issue. There are various factors such as ethical, economic and social, that must be addressed through the Canadian public and acted upon by the government. It is clear that Canada must articulate an unambiguous policy when it comes to patents in order to keep up with the biotechnology industry. There are many benefits involved in patenting animals, such as finding cures for diseases, creating jobs and a matured economy. However, there are many issues which seem to be forgotten about. This is not an issue of debating which side has more pros to it, but rather one of figuring out how to combine both sides of the issue through creating clear policies. This should be done in order to prevent animal cruelty and to draw the line somewhere so the inevitability of patenting humans does not occur. Both sides agree that the advancement in technology will eventually lead to testing on human beings and therefore patenting on humans. It is argued that the view of looking at animals as commodities in regards to patenting will soon become the same for humans. Another concern that goes along with this is cloning. After “Dolly” the sheep was cloned, there was concern about humans being cloned. The scientists agreed that doing such would be highly offensive, yet human cloning is not illegal in all countries leaving the door open to manipulate the human race.

The Patent Act in Canada provides criteria which must be met in order for a patent to be imposed. The criteria are newness or novelty, utility and non-obviousness. The Canadian courts and the general public need to be aware that the Patent Act does not regulate, nor does it attempt to regulate, the subject matter that it considers to be patentable. Section 2 defines an invention as “any new and useful improvement in any art, process, machine, manufacture or composition of matter.” Therefore in order to receive a patent it must be an invention and it must be both new and useful. The problem here is the scope of the legislation because it is left to the interpretation of the courts to decide whether or not a higher life form is an invention, or whether it fits the terms of new and useful. This ambiguous piece of legislation creates confusion and does not even attempt to take into account the socio-political issues related to patenting higher life forms.
The Patent Act is just enforced in order to flourish research and attempts to do that by creating incentives for financial reward. The inventor is granted a monopoly over the patented invention. The question remains whether or not this should be granted over a mammal. Since legislation does not dictate any solutions, the decisions should therefore be based on the views and beliefs of popular society. The answer is how society views a genetically altered animal and where it chooses to draw the fine line between proper subjects. The Patent Act simply acts a legal administrative framework that lacks the reality of societal issues.

The case of the ‘Harvard mouse’ involves the respondent, making an application on an invention concerning genetically altered mice, induced with a cancer gene. Harvard College is looking to protect the process to which the animals are produced and the outcome of that process. The question of this appeal is the meaning of the words in the Patent Act. The Supreme Court of Canada held that a transgenic mouse was not a patentable subject matter under section 2 of the Act, yet the cancer prone gene was patentable. Justice Bastarache concluded that the patenting of higher life forms raises serious practical, ethical and environmental concerns, which are highly complex and go beyond the scope of the judiciary. The idea of the interpretation of the words being so significant in deciding the case shows that legislature alone is not important but the interpretation and application is what matters. This case raises the reality that Parliament is inactive in a controversial subject, leaving the court as the default system. This demonstrates a paternalistic relationship the Canadian public has with the court system. Meanwhile, the Onco-mouse in the States received tremendous attention and honour from the public because it was a massive step to figuring out cancer. The excitement was so tremendous that the mouse was named the ‘product of the year’ by a popular economic magazine. Therefore there was public support for the court’s decision to make the animal patentable and mouse was seen as a commodity or as a product. Meanwhile the Canadian courts show that Canada did not agree completely with the American courts’ decision to see this as a purely economic investment.

The Canadian approach is in direct contrast to that of the U.S. decision which has eventually advocated the patenting “everything under the sun made by man.” Usually in the law, Canadian courts refuse to use U.S. precedents and look at Great Britain for a model, yet in the area of patents, the jurisprudence is closely related in the two jurisdictions. For instance Section 2 of the Canadian Patent Act is very similar to 35 U.S.C. 101. They both protect “anyone who invents or discovers a process, machine, manufacture, composition of matter, or improvement thereof.” In this appeal, both the appellants and the respondents advocate that we should define “manufacture” and “composition of matter” according to the U.S. court’s definition in Diamond. Which is the pioneer case that set out human made; genetically engineered bacteria were patentable subject matter and were able to receive patent protection. Along with that is the idea that biotechnology is a new field which is quickly advancing and in order to meet this trend of ‘international globalization’ the Canada Patent Office needs to look beyond federal legislation and create a new way of deciding to issue patents on higher life forms. This is vital to the Canadian economy because lots of patents that are granted in Canada are for foreign technology that is usually developed in the United States. Therefore these may be reasons why Canada has slowly adopted the view similar of the United States in a small yet significant way. According to Joyce Groote, President of BIOTECanada, this decision “means that innovators of new, multi-cell plant and animal products obtained using biotechnology now have patent protection.” This decision will nonetheless help to flourish the economy. It will increase the number of companies doing research which may result in lower drug prices. Steven Holtzman, chief operating officer of the Ohio-based Embryogen Corp. states, “Patent protection is the lifeblood of the pharmaceutical and biotechnology industries.” Yet even those who approve of this small step in the Canadian legislation regarding patents, there is still concern about how it is to be done properly. Groote states that, “you must still go through an extensive regulatory approval process that is also subject to research ethical boards. This judgment does not change one iota of that.” The government is trying to avoid public discussions over the ethical and political repercussions of genetic engineering in order to remain sitting on the fence. That is the major problem that needs to be addressed in order to help mend the two sides of biotechnology and animal protection in the law. There is a need for Canada to follow the lead of other countries, such as the U.S., but in a way that looks to protect the civil rights and the public opinion about such a controversial matter.

In order to help solve the issue there needs to be reform in the Patent Act, by defining and clearly stating whether or not higher life forms can be patented and what constitutes a higher life form. Along with any restrictions that might help to control the innovations that will inevitably occur.

The biotechnology industry, in Canada, is regulated by numerous federal departments, such as Health Canada, Environment Canada and Agriculture Food Canada. They regulate to make sure that the products are safe and effective, yet they do not distinguish among products based on the techniques that are used in the process. The Standing Committee on Environment and Sustainable Development looked at the issue of biotechnology and decided that there must be an advisory on the biotechnology that is independent from both government and industry, yet with representatives from both disciplines. The committee would look at the potential risks and ethical aspects of the technology and would advice whether or not a patent should be enforced. Similarly, one recommendation made to the Government of Canada was from the Canadian Biotechnology Advisory Committee (CBAC) in 2002, proposed that the government make the legislation more clear in order to help counter the political issues that have evolved. The committee states that they took into account issues and concerns of social and ethical overtures. They address three possible approaches for addressing the social and ethical concerns. The first solution being that of ‘Status Quo’ which suggest that a variety of mechanisms other than the patent system should be created in order to help deal with political issues. Secondly, is ‘Alignment: Limited Role for the Patent System’ which under this approach, the rights associated with patents would be suspended or withdrawn only if the invention is related to any activity which had already been prohibited in Canada. Finally is the ‘Open-ended: Broad Role for Patent System’ where patents would be issued except in cases of serious ethical or social concern arising from the commercialization of the invention, then a different body would be the deciding factor of suspending the patent until the issue is addressed. Basically the committee is suggesting that in order to tackle such political issues, there needs to be a separate governing body, which is set apart from the Patent Act. This will introduce a new mechanism in terms of determining patents and will help to solve many socio issues, instead of just ‘black letter’ law. If the current government refuses to deal with the issues themselves then such a plan should be implemented in order to create a separate body to collect public opinion and control such controversial matters. Also the CBAC proposed that higher life forms should be patentable but under certain controlled conditions, in order to address the concerns raised in the Supreme Court Harvard mouse case, which are the rights of animals, protection of the environment and the role of patents in an innovative economy. It is not important whether or not to decide whether technology is good or bad, but rather how the technology is applied needs to be closely monitored and done in a way that is parallel to the views of society.

Biotechnology is a rapidly advancing field which offers many benefits to society. It is seen as an important part of “maintaining the momentum, and stimulating further advances, is to protect biotechnology, where appropriate with a patent.” Biotechnology is a market which helps to build the Canadian economy and without implementing it, our economy would be left in a depressive state. Therefore it is essentially a part of our marketplace, and also a part of our law. There is a problem though, all this technology often attacks our ethical and societal beliefs when it comes to animal cruelty and where to the draw the line before humans are involved. The concerns are very real and need to be addressed in order to create a balanced patent system. Currently the Canadian government is just seeing the issue of patenting higher life forms as a judicial problem, they are refusing to take into account all the underlying factors involved such as economic, political, social and ethical concerns. In order to come to a proportional legal system these issues need to be regulated because patenting higher life forms is a reality that is more political than judicial in nature. The public needs to become involved through the mechanism of the government and legislation.

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