A Study of Issues Relating to the Patentability of Biotechnological Subject Matter: Executive Summary

Biotechnology is an important area of research, development and commercial activity. The prospects for commercial development in this area are considerable especially considering that so many sectors of the economy are affected by it. Chapter 1 of the Report provides an overview of this situation and discusses the fact that Canada is currently well positioned to be a leader in Biotechnology. It goes on to suggest that the Patent system which helped to fuel the growth of the field may not be the best means by which to sustain the growth. This is explained as being due to a number of fundamental aspects of biotechnological subject matter which make it different from all other fields of technology. Consequently, the Report queries whether the patent system is the appropriate vehicle for securing intellectual property rights. A summary of objectives for the Report is provided which serve to focus the scope of the Report to the issues of "invention", "non-obviousness" and "novelty" as they relate to the patentability of biotechnological subject matter.

In order to set the stage for subsequent discussion, in Chapter 2 "biotechnology" is broken down into three basic categories of subject matter which are encompassed by the term. These are the bio-matter itself which includes parts of biotechnology; methods and processes for making bio-matter; and, the uses of bio-matter of biotechnology. The chapter provides a brief review of basic biology and genetics in respect of the broad divisions of biotechnology in order to assist the reader in understanding the nature of the subject matter which is at the heart of the issue of invention in biotechnology.

Chapter 3 of the Report provides a discussion of the "concept" of invention from a somewhat philosophical perspective with a view to considering whether the subject matter of biotechnology can, at any level, be considered an invention. The discussion provided in the chapter is based on the perceptions and perspectives of the author drawing on a background in the medical sciences and patent law to analyze the issue. A discussion in relation to creation and discovery as those concepts relate to invention is provided with a conclusion that invention is a sub-set or separate class which shares features of both creation and discovery. One of the key elements proposed as a distinguishing feature of invention over creations and discoveries is the element of utility or applicability. It is concluded that invention is very much a subjective assessment and that there is nothing unusual or different about the subject matter of biotechnology which would result in a finding that there could not be biotechnological invention.

A more pragmatic and substantive analysis of the question of invention in biotechnology is presented in Chapter 4 where the Report provides discussion on the elements of patentable invention as this concept is understood in Canadian practice. An overview of the philosophical basis for the patent system is first provided with the preliminary recitation of the current definition of "invention" as found in the Canadian Patent Act. The Report then considers wh ether biotechnology subject matter fits within the scope of the legislative definition highlighting in particular, exceptions to proper subject matter including methods of medical treatment, human beings and higher life forms.

In respect of higher life forms, the enumerated categories which describe the "proper subject matter" of statutory invention are discussed with particular attention to the terms "manufacture" and "composition of matter." In this part, discussion is provided with respect to the scope of patent protection which may be available in respect of biotechnological subject matter with an example of a higher life form highlighted. Related issues such as the problem of progeny are discussed with specific reference to the potential for infringement by progeny and the problems of infringement analysis under the doctrine of equivalents.

The Report then turns to the questions of statutory invention which necessarily flow once proper subject matter has been found. These questions are contained in the elements of "novelty", "utility" and "obviousness." Each of these elements is discussed briefly with an overview of the current Canadian position or standards in respect of their evaluation or assessment. The Report then examines whether biotechnological invention fits within those standards, with an emphasis on those aspects which are of particular concern in biotechnology. The Report concludes that there is nothing about biotechnology that requires a review of the standard of utility as applied in Canada. Further the Report concludes that the only unusual aspect of biotechnology in respect of analysis of the element of novelty is in respect of products of nature. Consequently, issues relating to the "product of nature" doctrine are discussed in greater detail.

Arising from the determination of non-obviousness, the chapter provides consideration of the "worth a try" doctrine and desideratum inventions are considered as they are stated to be intermingled with the analysis of the "worth a try" doctrine. Following this is a consideration of the "technicians skilled in the art." The discussion under this heading quickly focuses on the expertise of Examiners in the Patent Office as it is these individuals who are called upon daily to assess this element of the test for non-obviousness.

The Report concludes in this chapter that with respect to invention in biotechnology the "skilled technician" is likely to be a Ph.D. researcher and may more likely be a composite research team. This is a direct result of the complexity of the subject matter of biotechnology. The Report also concludes that the mere complexity of biotechnological subject matter should not be the basis upon which a change is sought or brought to the standard of non-obviousness.

Chapter 5 is the final chapter and it presents the recommendations of the Report. In this chapter the Report indicates that there are three outstanding issues which, arguably, are preventing Canada from being a world leader with respect to providing rights to innovators in biotechnology. Namely, the question of patentability of higher life forms; the patentability of products of nature; and the problems with progeny.

The Report recommends that higher life forms be patentable and recommends amendments to the Patent Act, in order to achieve this result. As a consequence of this recommendation, the Report provides a farmer's exemption with respect to the potential problems with progeny. Also introduced is a proposal to limit patentability of higher life forms to non-human subject matter.

The Report also recommends that the current Canadian standards applied in the assessment of novelty and non-obviousness are acceptable and need not be changed in order to accommodate biotechnological innovation.

Finally, the Report recommends that in order to further encourage the biotechnology industry in Canada, a separate piece of legislation should be enacted in order to encourage research and development with respect to "products of nature."