Canada and the Canada and the WorldWorld

J. Sheldon Hamilton, Smart & J. Sheldon Hamilton, Smart & BiggarBiggar

Tony Creber, GowlingsTony Creber, Gowlings

Donald Cameron, Bereskin & ParrDonald Cameron, Bereskin & Parr

Norman Siebrasse, UNB Norman Siebrasse, UNB (moderator)(moderator)

OutlineOutline

IntroductionIntroduction

False promiseFalse promise

Sound predictionSound prediction

The disclosure requirement in sound The disclosure requirement in sound predictionprediction

ConclusionConclusion

INTRODUCTIONINTRODUCTION

IntroductionIntroduction What is utility?What is utility?

““It works.”It works.” It already works.It already works.

(demonstrated (demonstrated utility)utility)

It ought to work.It ought to work. (sound prediction)(sound prediction)

Why do we care?Why do we care? Mischief: You could Mischief: You could

stop others from stop others from using improvements.using improvements.

Statutory BasisStatutory Basis ““invention” means invention” means any new and any new and usefuluseful art, art,

process, machine, manufacture or process, machine, manufacture or composition of mattercomposition of matter Patent Act s 2Patent Act s 2

Each party shall make patents available … Each party shall make patents available … provided that such inventions are … provided that such inventions are … capable of industrial applicationcapable of industrial application..

A party may deem the termA party may deem the term…“capable of …“capable of industrial application” to be synonymous industrial application” to be synonymous with … “useful”with … “useful”.. NAFTA Article 1709 (1)NAFTA Article 1709 (1)

Demonstrated Utility and Demonstrated Utility and

Sound PredictionSound Prediction [T]he [T]he utilityutility required for patentability (s. 2) required for patentability (s. 2) must, as of the priority date, must, as of the priority date, eithereither be be demonstrated demonstrated oror be be a sound predictiona sound prediction based on the information and expertise then based on the information and expertise then available. available.

The doctrine of "sound prediction" The doctrine of "sound prediction" balancesbalances the public interest in the public interest in early disclosure of early disclosure of new and useful inventionsnew and useful inventions, even before , even before their utility has been verified by tests . . . their utility has been verified by tests . . . and granting monopoly rights in exchange and granting monopoly rights in exchange for misinformation.for misinformation. Wellcome / AZTWellcome / AZT 2002 SCC 77, [56], [69]2002 SCC 77, [56], [69]

FALSE PROMISEFALSE PROMISE

False PromiseFalse Promise

Where the specification does not Where the specification does not promise a specific result, no promise a specific result, no particular level of utility is required; a particular level of utility is required; a "mere scintilla" of utility will suffice. "mere scintilla" of utility will suffice. However, However, where the specification sets where the specification sets out an explicit "promise", utility will out an explicit "promise", utility will be measured against that promisebe measured against that promise..

The promise of the patent is The promise of the patent is fundamental to the utility analysis.fundamental to the utility analysis.Lilly / olanzapine Lilly / olanzapine 2010 FCA 197 [76], [93]2010 FCA 197 [76], [93]

False PromiseFalse Promise

[A patent may be revoked on the ground][A patent may be revoked on the ground]that the invention is that the invention is not usefulnot useful;;that the patent was that the patent was obtained on a false obtained on a false suggestion suggestion or representation;or representation;UK Patent Act (1932) s 25(2)UK Patent Act (1932) s 25(2)

A patent shall be void if the specification A patent shall be void if the specification … contains more or less than is … contains more or less than is necessary… necessary… such omission or addition such omission or addition being wilfully made for the purpose of being wilfully made for the purpose of misleadingmisleading..Canadian Patent Act (1869) s 27 Canadian Patent Act (1869) s 27

HistoryHistory

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

Construction of the Construction of the PromisePromise

Construction of the promise is a Construction of the promise is a crucial issue in many cases; it is crucial issue in many cases; it is often as important as claim often as important as claim construction. construction.

How do the courts construe the How do the courts construe the promise of the patent?promise of the patent?

Litigation PerspectiveLitigation Perspective

What challenges does the false What challenges does the false promise doctrine present in promise doctrine present in litigation?litigation?

Litigation PerspectiveLitigation Perspective

Is the promise of the patent a matter Is the promise of the patent a matter of law? What is the role of expert of law? What is the role of expert witnesses?witnesses?

SOUND PREDICTIONSOUND PREDICTION

Sound predictionSound prediction

The doctrine of sound prediction has The doctrine of sound prediction has three components. three components. Firstly. . . there must be a Firstly. . . there must be a factual basis factual basis for for

the prediction.the prediction.

Secondly, the inventor must have . . .an Secondly, the inventor must have . . .an articulable and articulable and "sound" line of reasoning "sound" line of reasoning from which the desired result can be from which the desired result can be inferred from the factual basis.inferred from the factual basis.

Thirdly, there must be Thirdly, there must be proper disclosureproper disclosure.. Wellcome / AZT Wellcome / AZT 2002 SCC 772002 SCC 77 [70] [70]

ImpactImpact

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

PredictabilityPredictability

[T]he soundness of a prediction is a [T]he soundness of a prediction is a question of factquestion of factSanofi-Aventis / ramiprilSanofi-Aventis / ramipril 2011 FCA 300 2011 FCA 300

[A] sound prediction requires [A] sound prediction requires a prima a prima facie reasonable inferencefacie reasonable inference of utility of utilityLilly / olanzapine Lilly / olanzapine 2010 FCA 197 [85]2010 FCA 197 [85]

How easy is it to predict whether a How easy is it to predict whether a prediction of utility will be held to be prediction of utility will be held to be sound?sound?

THE DISCLOSURE THE DISCLOSURE REQUIREMENT IN REQUIREMENT IN SOUND PREDICTIONSOUND PREDICTION

The Disclosure The Disclosure RequirementRequirement

It seems to me that it is beyond debate in Canada It seems to me that it is beyond debate in Canada that that wherewhere a patentee asserts that the a patentee asserts that the utilityutility of of its invention has been its invention has been demonstrateddemonstrated, , it need not it need not assert its supporting evidence in the patentassert its supporting evidence in the patent..

In a case involving a claimed In a case involving a claimed sound prediction of sound prediction of utilityutility, it is equally beyond debate that an , it is equally beyond debate that an additional disclosure additional disclosure obligation arises [which] is obligation arises [which] is met by disclosingmet by disclosing in the patentin the patent both the factual both the factual data on which the prediction is based data on which the prediction is based and the and the line of reasoning followed to enable the line of reasoning followed to enable the prediction to be made.prediction to be made.

Lilly / atomoxetine Lilly / atomoxetine 2010 FC 915 aff’d 2011 FCA 2202010 FC 915 aff’d 2011 FCA 220

HistoryHistory

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

Two Kinds of UtilityTwo Kinds of Utility

What is the justification for applying What is the justification for applying different disclosure requirements to different disclosure requirements to demonstrated utility and sound demonstrated utility and sound prediction?prediction?

ImpactImpact

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

Litigation PerspectiveLitigation Perspective

What litigation strategies can respond What litigation strategies can respond to this disclosure requirementto this disclosure requirement??

CONCLUSIONSCONCLUSIONS

ConclusionsConclusions

Can anything be done in patent Can anything be done in patent drafting and prosecution to respond drafting and prosecution to respond to the peculiarities of Canadian to the peculiarities of Canadian utility law?utility law?

How does the utility requirement How does the utility requirement interact with other requirements, interact with other requirements, such as obviousness?such as obviousness?

Other comments?Other comments?