Intellectual Property Policy

A Study of Issues Relating to the Patentability of Biotechnological Subject Matter

Dr. John R. Rudolph: Gowling, Strathy & Henderson

This study was funded by the Intellectual Property Policy Directorate, Industry Canada. The study represents the opinions of the author who is solely responsible for its contents. It does not necessarily represent government policy.

Executive Summary
Chapter 1: Introduction and Overview
Chapter 2: Subject Matter of Biotechnology
1. Bio-matter Itself
  - Non-living Bio-matter Living Bio-matter
2. Methods and Processes of Making Products of Biotechnology
3. Methods of Use or Uses
Chapter 3: On the Nature of Invention
1. Introduction
2. Invention
3. Invention as a Result
4. Invention as a Process
5. Avenues to Invention
6. Creation and Invention
7. Discovery and Invention
8. What Does "Invention" Mean - A Synthesis
Chapter 4: Patentable Invention
- The Quid Pro Quo of a Patent
  - Statutory Invention
- Does Biotechnology Fit?: Proper Subject-matter
  1. Methods of Medical Treatment
  2. Human Beings
  3. Enumerated Categories of Statutory Invention
    - Manufacture and Composition of Matter
  4. Scope of Patents for Higher Life Forms
    - Essence of Invention
    - Mere Aggregation?
    - Sound Prediction?
    - The Problem of Progeny
    - Infringement and the Doctrine of Equivalents
- New, Ueful and Unobvious - Does Biotechnology Fit?: Specific Issues of Patentability
  1. Utility
  2. Novelty
    - Availability to the Public
    - Product of Nature Doctrine
    - Standard of Novelty Assessment in CIPO
  3. Non-obviousness
    - The Worth A Try Doctrine
    - Desideratum Inventions
    - Examiners Expertise - The Technician Skilled in the Art
Chapter 5: Conclusions and Directions
1. Introduction
2. Summary
3. The Patentability of Higher Life forms
  - "Manufacture or Composition of Matter"
  - Human Beings are Not Patentable
  - Problems with Progeny
4. Novelty and Invention in Biotechnology
  - Amending the Act and Dilution of the Standard of Novelty
  - The Products of Biotechnology Act
5. Non-obviousness in Biotechnology
6. Conclusions
Appendix "A"
Bibliography
Footnotes

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