Biotechnological Inventions – A Comparison between the Patent Systems of Europe and the United States

Reaching everything from medicine to the food industry, biotechnology’s impact on society has become a major economic factor and is ever-increasing. In addition to its impressive potential benefits, biotechnology carries serious risks, especially regarding security and ethics. The European Patent Convention includes statutory restrictions regarding morality and public policy, while today’s U.S. laws in contrast, try to avoid morality restrictions in patenting biotechnology and U.S. agencies generally grant patents without regard to moral concerns. Not long ago, the U.S. Patent Act included a morality doctrine which had a restrictive effect on biotechnology.

The new U.S. approach applies to micro-organisms, plants, and animals where moral concerns were not considered at all before the United States Patent and Trademark Office. It is not clear, if the moral questions re-emerged referring to the Newman/Rifkin patent application, claiming an animal-human chimera, since the application was finally rejected on the grounds that human beings do not constitute statutory subject matter under 35 U.S.C. § 101. This line of argumentation was a break from the developed case law concerning living matter. The attempt to keep ethical concerns out of the U.S. patent laws stands on very shaky grounds.

Another problem arises from the fact that both patent systems, in Europe and the U.S., are relying on the term “human” as a borderline for patentability but none of them define the term “human” which leads to ambiguities. An interesting approach came up, defining a human being not by its biological criteria but rather by its intellectual capabilities. However, this approach is still in its infancy.

The project is co-sponsored by the Stanford-Vienna Transatlantic Technology Law Forum (TTLF, a joint initiative of Stanford Law School and the University of Vienna School of Law) and by Stanford University’s Forum on Contemporary Europe at the Freeman Spogli Institute for International Studies.