Good or Bad Invention?
--Morality Problems arising from EU patent law
作者:何放 (伦敦政治经济学院)       本站发布时间:2003-5-17 20:01:06

“好发明”还是”坏发明”-从欧盟法律浅谈专利的道德性问题

By He Fang 何放,London School of Economics and Political Science, University of London

Licensed PRC Attorney-at-law and trademark agent

The EU patent legislation traditionally has a role in promoting “good” rather than “bad” inventions. Morality problem has been considered in the UK and EU patent law systems. For example, Article 53(a) of EPC stipulates that “European patents shall not be granted in respect of: (a) inventions the publication or exploitation of which would be contrary to “ordre public” or morality…” [1] Similar words were implemented by the UK national law in Section 1 (3)(a) of its Patent Act 1977, “A patent shall not be granted for an invention the commercial exploitation of which could be contrary to public policy or morality.” [2] Besides, nearly all of the EU states are members of TRIPs. According to Article 27.2 of TRIPs, “Members may exclude from patentability invention, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality…” [3] It can be seen that “morality” clauses have already adopted in patent laws both at the national and the international levels.

Although theoretically the patent law should have a role in ensuring that there are incentive to produce good/moral rather than bad/immoral inventions, traditionally the morality problems had not attracted much limelight in the history of patent system. Actually the above “morality” clauses had been rarely put into practical enforcement except such cases as gambling machine until recently. Nevertheless, it has been long debated on the standard of “immorality” for the patent law. Apparently nearly all important “participants” to the patent systems including the inventors, the patent practitioners, the patent examiners and most judges are scientific-background. Few of them have been specifically trained in philosophy and morality issues before they face some real “immorality” problems in true cases.

Recently there have been interesting EPC decisions dealing with such morality problems. Two biotechnology patent applications considered by the European Patent Office have involved Harvard University’s "Oncomouse" and Upjohn’s hairless mouse. The Oncomouse patent application covered a process for producing a genetically engineered mouse that would develop cancer. The Oncomouse produced from the method could be used as a tool to study the effects of anticancer treatments and products. The hairless mouse covered technology whereby a hairless or bald mouse was genetically engineered and bred for the primary purposes of testing hair restorative products and wool production techniques.

The European Patent Office considered oppositions to the grant of patents for both of these inventions on the grounds of morality. The Oncomouse patent was finally granted to Harvard University by the European Patent Office. However, Upjohn’s hairless mouse application was refused.

In considering these oppositions, the European Patent Office adopted a morality test requiring a weighing of the benefits to humans against any other negative ethical issues, such as pain and suffering to the mouse and the risk to future gene pools of the genetic engineering.

It was argued throughout the opposition proceedings that the Oncomouse was a "moral" invention because it provided a powerful tool or aid in the fight against cancer. Additionally, it was argued that there was no alternative to animal testing for cancer. Experts in the biotechnology industry produced substantial evidences in support of these arguments. Against the utilitarian aspect to the Oncomouse was balanced the negative consequences. These included the risk of damage to the environment by uncontrolled dissemination of unwanted genes, should the mice escape. The European Patent Office did not consider this a significant matter, as the mice would be strictly controlled. The European Patent Office therefore concluded that overall the positive consequences outweighed the negative consequences and granted the patent for the Oncomouse. They concluded that the Oncomouse was a moral invention.

On the other hand, when a similar test was applied to the hairless mouse, the European Patent Office considered that the positive effects arising from the production of this mouse were outweighed by the negative consequences. The European Patent Office considered that the benefit to humans, namely the aid in studying hair growth and wool production, did not outweigh the ethical issues of the risk of pain and suffering to the mouse.

The author is very happy to see a utilization approach was adopted by the EPO in the Oncomouse decision in practice. It is a wise method to weigh the advantage and potential disadvantage of a “controversial” invention. However, although similar method was adopted in the hairless mouse application, the author strongly disagreed with the decision of hairless mouse application by EPO. In another case involving an opposition by Greenpeace to a patent application filed by Plant Genetics it was considered that questions of morality should only be looked at in extreme cases. The question here lies in what is “extreme”. Where can the line be drawn? It is argued that the hairless mouse application was not “extreme” enough in view of morality to be rejected. Although it might be the case that the benefit to humans of this invention did not outweigh the ethical issues of the risk of pain and suffering to the mouse, it should not take it for granted to conclude that the invention is immoral. The most questions are: what is the standard of morality? What is the borderline of “immorality” which should be excluded from the patent systems?

It is argued that EPO’s decision on hairless mouse unnecessarily raised the standard of morality of the invention. It should be admitted that different people and groups will have different morality standard: Religious people of course will think differently as do antitheists while the guild of butchers will oppose many declarations of Greenpeace. The standard of morality in the field of patent law should not be raised manually from the concern of morality standard of one group or one kind of people. The EU patent law shall only adopted commonly accepted morality standard to avoid the legal uncertainty of different patent applications if different morality standards are considered.

It is believed that the standard of morality should confirm to the generally accepted international conventions concerning human rights, such as, UN Declaration of Human Rights and European Human Rights Conventions. The immorality borderline in the field of patent law should only be narrowly interpreted through such human rights conventions. As long as an invention is not opposite to the general human rights regulations, it should be prima facie patentable. In reality, only a very few of extreme scientists will try to invent something opposite to the requirement of human rights on purpose. It is argued that the “morality clauses” should be aimed at those extreme scientists only. Such “morality clauses” should have function in discouraging those extreme scientists from making immoral invention by denying them from any profit from the patent systems.

However, it cannot be denied that the influence of patent law to prevent “un-intentional” immoral invention is very limited. It can be known from the above two EPO cases that both of the inventors of the above two applications did not thought their inventions were immoral. Finally these applications experienced the opposition process after publication in the patent gazette. Supposed these applications were “immoral”, however, the “immoral” information had already been disclosed and spread via the Patent Gazette and it was just such disclosure that attracted the oppositions from opposing parties and groups. It can be inferred that the influence of  “morality clause” of patent law was only limited to the economic aspect, thus, it is recommended that such limited-functioned clause should not be an obstacle of most patent applications which are well above generally accepted morality standard. With the development of bioscience, many newly developed technologies have a kind of “dual effects” on human beings. Such inventions are just tools, which can be beneficial by positive utilizing or contrarily, they can be hazard if utilized with immoral purpose. The role of morality clause in patent law should not have a function in strangling all these applications at an simple excuse that they “may be” immoral. That they “may also be” moral should not be overlooked.

Conclusion:

It appears that some changes may need to be introduced into patent legislation in EU to clarify some of these morality issues which are beginning to arise. However, such clarification should not be a legal ground to reject all of the controversial inventions which may be immorally exploited. It is recommended that the morality standard should confirm to the basic human right conventions. In case of morality problem arises, the case should be interpreted according to such human right conventions rather than “pure” technology consequences.

It is further recommended that the “immoral prohibition” of the grant of inventions should be narrowly applied in only extreme cases. The morality clause should act as a kind of final “safeguard” of the patent system. However, limitation of exploitation of those “dual effects” patent shall be considered after they are publicized. While the patent law can give guidelines on in what circumstances the exploitation of “dual effects” patent shall be limited or even prohibited, it shall not simply “block” such applications at the very beginning.  



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[1] EPC A 53(a)

[2] Patent Act 1977 S1(3)(a)

[3] TRIPs A27.2

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