Anticipation and

Obviousness in Canada

since Sanofi

February 15, 2012

Donald M. Cameron

2

What’s a patentable invention need to be?

•New

•Useful

• Inventive

• An invention of the court:

• 1890: it’s an “invention”, so it must be “inventive”

• 1936: SCC required “a degree of ingenuity” to be present

• Now in the New Patent Act, s. 28.3

New – Novelty/Anticipation

Current Patent Act

• 28.2 (1) The subject-matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed

• (a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere;

• (b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere;

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What Sanofi said

•Enabling disclosure

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What Sanofi said

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What Sanofi said

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Enablement: The “IKEA” threshold

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Cases since Sanofi

Merck v. Apotex (2010)

•Prior art: fermentation

process with yeast – did it

produce lovostatin?

•No disclosure:

• Not inevitable that claimed

product would be produced

• No evidence process was

actually used before key

date

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disclose enable

Cases since Sanofi

Sloan Kettering (P.A.B.)

•Claim was for an antibody

•No disclosure:

•BTW: No enablement:

• starting material: you

couldn’t buy it, you’d have

to make it

• To make it would take:

• “hopeful yet prolonged and

arduous experimentation”

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disclose enable

Cases since Sanofi

AstraZeneca v. Apotex

• esomeprazole, a

stereoisomer of enalapril

•Prior art said it separated

optically pure compounds

•Apotex: slight change in

process produced

esmeprazole

•AstraZeneca: no it didn’t

•Court: result not consistent

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disclose enable

Cases since Sanofi

Easton v. Bauer

•Hockey skate boot: a one-

piece rear quarter

•Used in test league, but in

public rink

•Disclosed but not enabled

• You’d have to dismantle the

skate to reproduce it

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disclose enable

Conclusions since Sanofi

Mechanical:

• “The Caramilk bar test”

• If you can see it, you can

figure it out

•Observing isn’t

“experimenting”

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disclose enable

Conclusions since Sanofi

Chem/Pharma:

• “The Coca-cola test”

• Can’t figure out how they

made it.

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disclose enable

Inventive - Obviousness

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Hard to express a test

for obviousness/inventiveness

• What it is

• Obvious, very plain, plain as day, crystal clear

• Quantum: need an inventive step, a scintilla of invention

• How to get to it

• Directly and without difficulty

• but lack of difficulty doesn’t mean it’s obvious

• Out of track with what was known at the time

• The mind it comes from, or doesn’t

• Inventive, if the product of an inventive mind

• Obvious, if the product of a non-inventive mind

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Hugesson J.A. in Beloit – Would any idiot have

come up with it, directly and without difficulty?

"The test for obviousness is not to ask what competent inventors did or would have done to solve the problem. Inventors are by definition inventive.”

"The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent.”

Obvious – New Act

• “28.3 The subject-matter defined by a claim in an application for a patent in

Canada must be subject-matter that would not have been obvious on the

claim date to a person skilled in the art or science to which it pertains,

having regard to

• (a) information disclosed more than one year before the filing date by the

applicant, or by a person who obtained knowledge, directly or indirectly,

from the applicant in such a manner that the information became available

to the public in Canada or elsewhere; and

• (b) information disclosed before the claim date by a person not mentioned

in paragraph (a) in such a manner that the information became available to

the public in Canada or elsewhere.”

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What Sanofi said

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Obviousness – the Sanofi approach

(Windsurfing redux)

(1) (a) Identify the notional “person skilled in the art”;

(b) Identify the relevant common general knowledge of that

person;

(2) Identify the inventive concept of the claim in question or, if that

cannot readily be done, construe it;

(3) Identify what, if any, differences exist between the matter cited

as forming part of the “state of the art” and the inventive

concept of the claim or the claim as construed;

(4) Viewed without any knowledge of the alleged invention as

claimed, do those differences constitute steps which would

have been obvious to the person skilled in the art or do they

require any degree of invention?

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“Obvious to try” test

– for cases involving experimentation

• “Obvious to try” test

• Could be part of step #4 in cases “where advances are won by experimentation”

• Rothstein’s Questions:

• (1) Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art?

• (2) What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine? The path followed by the inventor(s) is worth examining.

• (3) Is there a motive provided in the prior art to find the solution the patent addresses?

“Obvious to try” – an unfortunate misnomer

•Did he really mean it?

“For a finding that an invention was “obvious to try”, there

must be evidence to convince a judge on a balance of

probabilities that it was more or less self-evident to try to

obtain the invention.” [emphasis added]

• and then, in addressing the evidence:

“I conclude that the prior art and common general

knowledge of persons skilled in the art at the relevant time

were not sufficient for it to be more or less self-evident to try

to find the dextro-rotatory isomer.”

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Then clarified 7 I think

“The invention must be self-evident from the prior art and

common general knowledge in order to satisfy the

“obvious to try” test.”

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Lessons since Sanofi

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Applying the Windsurfing

approach

Don’t trip on the “inventive step”

•UK “Windsurfing/Pozzoli” approach was based on UK

statute

•Our “New Act” has specific language:

• “28.3 The subject-matter defined by a claim in an application for a patent in

Canada must be subject-matter that would not have been obvious on the claim

date to a person skilled in the art or science to which it pertains, having regard to

• (a) information disclosed more than one year before the filing date by the applicant, or by

a person who obtained knowledge, directly or indirectly, from the applicant in such a

manner that the information became available to the public in Canada or elsewhere; and

• (b in such a manner that the i) information disclosed before the claim date by a person

not mentioned in paragraph (a) became available to the public in Canada or elsewhere.”

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Windsurfing approach redux for New Act

2. Identify the invention of the claim in question or, if

that cannot readily be done, construe it;

3. Identify what, if any, differences exist between the

matter cited as forming part of the “state of the art” and

the invention of the claim as construed;

4. Viewed without any knowledge of the alleged

invention as claimed, would the invention as claimed

have been obvious on the claim date to a person skilled

in the art or science to which it pertains, having regard to

the information referred to in s. 28.3(a) and (b)?

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First application to New Act patent

Apotex v. Pfizer (PMNOC for VIAGRA’s sildenafil citrate)

• “Although there was a significant amount of evidence indicating that cGMP

PDE inhibitors should be further explored with regards to the treatment of

ED in the months leading up to the Pfizer discovery, the evidence does not

in my view establish that the solution taught by the patent was obvious at

the time. At best there was speculation, which in hindsight proved to be

correct, that PDE5 inhibitors might treat impotence. Experiments with

zaprinast, a cGMP PDE inhibitor, had been performed but in an effort to

understand how the erectile process works, not how to treat ED.”

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What’s the invention/inventive concept?

•Servier (FCA)

• Approved what Snider did: look to the claims

• Adopted Angiotech v. Conor:

• “O the invention is the product specified in a claim and the

patentee is entitled to have the question of obviousness

determined by reference to his claim and not to some vague

paraphrase based upon the extent of his disclosure in the

description.”

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What’s the invention/inventive concept?

•Corlac v. Weatherford (FCA)

• For a combination, look to the whole of the claim:

• “Although they maintain that the judge did not specifically identify the inventive concept of

the patent (as contemplated at Pozzoli step two), they acknowledge that he did refer to

the patent’s three “key concepts” in his reasons. In any event, the second step indicates

that it will be sufficient to construe the patent if the inventive concept is not readily

discernible from its claims. As indicated earlier in these reasons, the judge properly

construed the patent’s claims. Moreover, the '937 Patent is a combination patent.

Therefore, its essence lies in the unique combination claimed even though individual

elements of the invention, considered in isolation, may not have been inventive. As

recently explained by this Court, “[i]t is not fair to a person claiming to have invented a

combination invention to break the combination down into its parts and find that, because

each part is well known, the combination is necessarily obvious”: Bridgeview

Manufacturing Inc. v. 931409 Alberta Ltd., 2010 FCA 188, 87 C.P.R. (4th) 195, para. 51

(Bridgeview), leave to appeal dismissed, [2010] S.C.C.A. No. 346.”

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Applying “Obvious to try”

“Obvious to try” open to mis-application?

•Abbott Laboratories v. Canada, 2009 per Hughes J.

•Held, the patent at issue was anticipated.

•Obiter re obviousness:

• it would have been self-evident to a person skilled in the art to try the

solubility of the crystalline form to see if it would work.

• testing for solubility was routine.

• it was self-evident that a person skilled in the art would test the

solubility of any newly identified crystal to determine if it was soluble at

a rate sufficient to give therapeutic utility and concluded that the

invention was obvious.

• He did not ask, however, whether it was more or less self-evident

that what was being tested ought to work

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“Obvious to try” – when applicable

•Sanofi, at para 68:

• “In areas of endeavour where advances are often won by

experimentation, an “obvious to try” test might be

appropriate. In such areas, there may be numerous

interrelated variables with which to experiment. For

example, some inventions in the pharmaceutical industry

might warrant an “obvious to try” test since there may be

many chemically similar structures that can elicit different

biological responses and offer the potential for significant

therapeutic advances.”

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“Obvious to try” – when not applicable

•Mechanical devices: not

really that kind of case

• UView Ultraviolet Systems

Inc. v. Brasscorp Ltd.

• charging a closed,

pressurized air

conditioning system.

• Bridgeview Manufacturing

Inc. et al v. 931409 Alberta

Ltd.

• A hay bale buster

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Not self-evident

•Abbott Laboratories v. Canada (Health) and Sandoz

• clarithromycin extended-release 500 mg tablets

•Heneghan J. did it all right:

• dealt sequentially with each of the differences between the prior art and

the alleged invention

• factors why the chosen polymer would not have been a likely choice

• nothing in the prior art that would suggest that this formulation would be

suitable

• other prior art that taught away from the invention

• failure of other prior users to make the invention

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Just finding a salt: obvious

•Ratiopharm Inc. v. Pfizer

Limited (amlodipine

maleate)

•Start with amlodipine

maleate

•Find a suitable salt

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Nature & Amount of effort required: routine

trials

• the prior art provided:

•means of creating acid addition salts; and

• predicted the results, which Pfizer merely had to verify

through routine testing; and

•The type of experiments used by Pfizer’s scientists to

verify the physicochemical characteristics of each salt

were held not to be equivalent to the trial and error

procedures often employed to discover a new compound

where the prior art gave no motivation or suggestion to

make the new compound nor a reasonable expectation of

success.

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Old considerations still apply

Sharlow J.A. in levofloxacin infringement case:

1. The invention

2. The hypothetical skilled person referred to in the Beloit quotation

3. The body of knowledge of the person of ordinary skill in the art

4. The climate in the relevant field at the time the alleged invention was

made

5. The motivation in existence at the time the alleged invention to solve a

recognized problem

6. The time and effort involved in the invention:

Secondary factors:

1. Commercial success

2. Meritorious awards

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Corlac v. Weatherford (FCA)

•Sanofi said that an “expansive and flexible approach that

would include ‘any secondary considerations that [will]

prove instructive’ will be useful”.

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Conclusions

•An obvious truth:

• a predictable solution may be obvious; but

• an unpredictable outcome cannot be an obvious solution.

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Anticipation and

Obviousness in Canada

since Sanofi

February 15, 2012

Donald M. Cameron