1. Canada and the World J. Sheldon Hamilton, Smart & Biggar Tony Creber, Gowlings Donald Cameron, Bereskin & Parr Norman Siebrasse, UNB (moderator)

2. Outline Introduction False promise Sound prediction The disclosure requirement in sound prediction Conclusion

3. INTRODUCTION

4. Introduction What is utility? What is utility? “It works.” “It works.” It already works. It already works. (demonstrated utility) (demonstrated utility) It ought to work. It ought to work. (sound prediction) (sound prediction) Why do we care? Why do we care? Mischief: You could stop others from using improvements. Mischief: You could stop others from using improvements.

5. Statutory Basis “invention” means any new and useful art, process, machine, manufacture or composition of matter “invention” means any new and useful art, process, machine, manufacture or composition of matter Patent Act s 2 Patent Act s 2 Each party shall make patents available … provided that such inventions are … capable of industrial application. Each party shall make patents available … provided that such inventions are … capable of industrial application. A party may deem the term…“capable of industrial application” to be synonymous with … “useful”. A party may deem the term…“capable of industrial application” to be synonymous with … “useful”. NAFTA Article 1709 (1) NAFTA Article 1709 (1)

6. Demonstrated Utility and Sound Prediction [T]he utility required for patentability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction based on the information and expertise then available. [T]he utility required for patentability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction based on the information and expertise then available. The doctrine of "sound prediction" balances the public interest in early disclosure of new and useful inventions, even before their utility has been verified by tests... and granting monopoly rights in exchange for misinformation. The doctrine of "sound prediction" balances the public interest in early disclosure of new and useful inventions, even before their utility has been verified by tests... and granting monopoly rights in exchange for misinformation. Wellcome / AZT 2002 SCC 77, [56], [69] Wellcome / AZT 2002 SCC 77, [56], [69]

7. FALSE PROMISE

8. False Promise Where the specification does not promise a specific result, no particular level of utility is required; a "mere scintilla" of utility will suffice. However, where the specification sets out an explicit "promise", utility will be measured against that promise. The promise of the patent is fundamental to the utility analysis. Lilly / olanzapine 2010 FCA 197 [76], [93]

9. False Promise [A patent may be revoked on the ground] that the invention is not useful; that the patent was obtained on a false suggestion or representation; UK Patent Act (1932) s 25(2) A patent shall be void if the specification … contains more or less than is necessary… such omission or addition being wilfully made for the purpose of misleading. Canadian Patent Act (1869) s 27

10. History The Federal Courts cite English case law going back 100 years as authority for this approach. Why is this an issue now? What has changed?

11. Construction of the Promise Construction of the promise is a crucial issue in many cases; it is often as important as claim construction. How do the courts construe the promise of the patent?

12. Litigation Perspective What challenges does the false promise doctrine present in litigation?

13. Litigation Perspective Is the promise of the patent a matter of law? What is the role of expert witnesses? Is the promise of the patent a matter of law? What is the role of expert witnesses?

14. SOUND PREDICTION

15. Sound prediction The doctrine of sound prediction has three components. Firstly... there must be a factual basis for the prediction. Secondly, the inventor must have...an articulable and "sound" line of reasoning from which the desired result can be inferred from the factual basis. Thirdly, there must be proper disclosure. Wellcome / AZT 2002 SCC 77 [70] Wellcome / AZT 2002 SCC 77 [70]

16. Impact How has the doctrine of sound prediction changed the law and practice?

17. Predictability [T]he soundness of a prediction is a question of fact Sanofi-Aventis / ramipril 2011 FCA 300 [A] sound prediction requires a prima facie reasonable inference of utility Lilly / olanzapine 2010 FCA 197 [85] How easy is it to predict whether a prediction of utility will be held to be sound?

18. THE DISCLOSURE REQUIREMENT IN SOUND PREDICTION

19. The Disclosure Requirement It seems to me that it is beyond debate in Canada that where a patentee asserts that the utility of its invention has been demonstrated, it need not assert its supporting evidence in the patent. In a case involving a claimed sound prediction of utility, it is equally beyond debate that an additional disclosure obligation arises [which] is met by disclosing in the patent both the factual data on which the prediction is based and the line of reasoning followed to enable the prediction to be made. Lilly / atomoxetine 2010 FC 915 aff’d 2011 FCA 220

20. History Are any of you aware of any cases, prior to Justice Binnie’s remarks in Wellcome / AZT where a patent was held to lack utility because the supporting evidence or line of reasoning was not disclosed in the patent itself?

21. Two Kinds of Utility What is the justification for applying different disclosure requirements to demonstrated utility and sound prediction?

22. Impact In practice, how significant is the requirement to disclose the factual basis and line of reasoning supporting sound prediction in the patent itself?

23. Litigation Perspective What litigation strategies can respond to this disclosure requirement?

24. CONCLUSIONS

25. Conclusions Can anything be done in patent drafting and prosecution to respond to the peculiarities of Canadian utility law? How does the utility requirement interact with other requirements, such as obviousness? Other comments?