INTRODUCTION

The Patent Appeal Board (C.D. 1290) recently rejected the Amazon "One-Click" patent application (Canadian application No. 2,246,933) based on non-statutory subject matter.[i] The Amazon patent application relates to software and business methods.

The position taken by the Patent Appeal Board on non-statutory subject matter may have a direct impact on other types of patents, such as those related to BIO-IT, which is a discipline that has emerged from the sharing of complex biomedical data and collaboration among multidisciplinary teams, particularly from the fields of bio-technology and information technologies. Personalized medicine and other types of diagnostic and theranostic methods are examples of BIO-IT.

APPROACH TO ASSESSING SUBJECT MATTER

The Board assessed patentable subject matter as follows:

  1. The form of the claim: The claim on its face must relate to one of five patentable categories of invention (art, process, machine, manufacture or composition of matter).
  2. The substance of the claimed invention: The contribution to human knowledge must fit under one of five patentable categories of invention.
  3. Excluded subject matter: What has been added to human knowledge by the claim must not be directed towards either excluded subject matter or non-technological subject matter.

EXCLUDED SUBJECT MATTER

The interpretation of "excluded subject matter" may have an impact on BIO-IT patents in Canada. With the development of new approaches and modern techniques, new horizons are opening up for biotechnology industries. Many of the innovations in the field of BIO-IT, while relating to more traditional aspects of science such as genetics, microbiology, and molecular biology, involve computers and software to improve the quality of products and increase the productivity of systems.

The Board has stated that certain types of subject matter are not patentable. For example, some computer programs (if the discovery involved is a method of calculation), methods of medical treatment, higher life forms, business systems and professional skills have been excluded by judicial interpretation of sections 2 and 27(8) of the Patent Act.[ii]

Bioinformatics, which addresses biological problems using computational techniques and makes the rapid organization and analysis of biological data possible, is at risk of being classified as excluded subject matter. Pharmacogenomics, the study of how the genetic inheritance of an individual affects the body's response to drugs, is another area where computer programs are used that could be at risk. Yet another area is genetic testing, whereby a scientist scans a patient's DNA sample and uses software to interpret the data obtained and identify the presence of mutated sequences. In each of these fields, it will be important to thoroughly disclose, and claim, tangible machine aspects of innovations. For example, input, output, and control functions performed by processors should be emphasized and claimed.

MEETING THE CRITERIA TO FALL INTO THE "ART" CATEGORY

In the Amazon decision, the Board emphasized that if the substance of the claimed invention is not "an act or series of acts performed by some physical agent upon some physical object and producing in such object some change either of character or of condition," it is not an art under section 2 of the Canadian Patent Act. To an extent, the Board's decision is consistent with a trend recently observed in the United States.

In the Amazon claims, products or goods are offered for sale, and what was considered to be added to human knowledge is a change in the character or condition of how the order for a product is actually placed and processed. The products or goods are not changed. That is, the Board found no change either of character or of condition in any physical object itself by the act of ordering the product in one way or another. Consequently, the substance of the claims was not found to be an art under section 2 of the Canadian Patent Act.

One question that remains is whether a computer processor performing a series of steps to produce a change in a set of data will be considered as meeting the criteria to be classified as patentable in Canada. BIO-IT claims often rely on the processing of input data to produce a meaningful result. The processing aspect usually constitutes the substance of the claim and therefore, what is to be added to human knowledge. It is possible that a change in the character or condition of a physical object produced by a physical agent will only be deemed to result if the computer processor is accepted as a physical agent and the data being processed is accepted as a physical object.

CONCLUSION

The Amazon decision, while intended to address the patentability of business methods, may affect Canadian applications in other fields such as BIO-IT. BIO-IT is a young discipline that has not yet matured in terms of its patent potential. Applicants should carefully craft their patent applications to avoid, as much as possible, falling into the category of non-patentable subject matter.