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;
4
What Sanofi said
•Enabling disclosure
5
What Sanofi said
6
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”
10
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
11
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
12
disclose enable
Conclusions since Sanofi
Mechanical:
• “The Caramilk bar test”
• If you can see it, you can
figure it out
•Observing isn’t
“experimenting”
13
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
17
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.”
22
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.”
23
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)?
27
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.”
33
“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
34
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
36
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.
37
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
38
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”.
39
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
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