Transcript The “Immediately Possible”

Obviousness
April 17, 2014
Don Cameron
Donald M. Cameron
What’s a patentable invention need to
be?
• New
• Useful
• Inventive
– Judge made
• An 1890 judge-made addition to patentability
• 1936: SCC required “a degree of ingenuity” to be present
– Now in the Patent Act
– “plain as day”, “crystal clear”
2
Hard to express a test
for obviousness/inventiveness
What it is
– “proper subject matter” – an “invention”, inventive
– Obvious, very plain, plain as day, crystal clear
The Quantum
– an inventive step
– a “scintilla” of invention
The Path to get it/there
– 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: the product of an inventive mind
– Obvious: the product of a non-inventive mind
3
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.”
4
Beware of formulae: obvious just
means obvious
• House of Lords in General Tire:
• “We agree, however, with what was said by Diplock, L.J.
(as he then was) and Willmer, L.J. in the JohnsManville case [1967] R.P.C. 478 at 493 and 496
deprecating “coining” phrases which may later be suggested to
be of general application. “Obvious” is, after all, a much-
used word and it does not seem to us that there is
any need to go beyond the primary dictionary
meaning of “very plain”.”
5
The “Immediately Possible”
• What’s immediately possible?
• What an obvious improvement over what’s
known?
what’s
known
6
The sunspot analogy, cont’d
• Key:
– Black “umbra”: what’s
old
– Dark aura “penumbra”:
what’s obvious
– Yellow: what’s inventive
– Outside the picture:
what’s not “adjacently
possible” (what’s
impossible: can’t be
done, yet)
7
The “Inventive Step”
8
New
Inventive
• It’s been done/taught before,
in one place
• Hasn’t been done before but
anyone could have done it
• Can mosiac
Explaining the difference – How many coins?
9
The Scientific Method & Experiments
10
Windsurfing/Pozzoli
THE RIGHT APPROACH (ACCORDING TO
SANOFI)
Windsurfing case, as updated in Pozzoli
(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?
12
Obviousness
13
WHEN EXPERIMENTS DRIVE
INNOVATION
Plodders get patents too
“Very few inventions are unexpected discoveries. Practically all research work is
done by looking in directions where the “state of the art” points. On that basis
and with hindsight, it could be said in most cases that there was no inventive
ingenuity in the new development because everyone would then see how the
previous accomplishments pointed the way. The discovery of penicillin was, of
course, a major development, a great invention. After that, a number of workers
went looking for other antibiotics methodically testing whole families of various
microorganisms other than penicillum noatum. This research work was rewarded
by the discoveries a number of antibiotics such as chloromycetin obtained from
streptomyces venezuelae as mentioned in Laboratoire Pentagone v. Parke, Davis &
Co. [1968] R.C.S. 307, tetracycline as mentioned in American Cyanamid Co. v. Berk
Pharmaceuticals Ltd. [1976] R.P.C. 231 where Whitford J. said (at p. 257):
“A patient searcher is as much entitled to the benefits of a monopoly as someone who
hits upon an invention by some lucky chance or inspiration.”
Farbwerke Hoechst v. Halocarbon (Ontario) Limited et al (1979), 42 C.P.R. (2d) 145 (S.C.C. per
Pigeon J.), at paras. 33-35.
15
Iterative drug design
• If this works, tweak it a
little and try that
• and so on
• and so on
• and so on
16
So when do experiments result in
obvious results?
• On the one hand:
“It is enough that the
person versed in the art
would assess the
likelihood of success as
sufficient to warrant
actual trial”.
Johns-Manville Corporation’s Patent
[1967] RPC 479 (per Lord Diplock) at
495 – the UK “worth a try” test
17
• On the other hand:
“Practically all research
work is done by looking
in directions where the
“state of the art”
points.”
Farbwerke Hoechst
Experiments
• Two kinds of experiments:
– Ones where you already know the answer
– Ones where you don’t know the answer
18
Experiments where you already know
the answer
• It’s been done before
– You’ve done it before
• good experiments are repeatable
– You’ve learned from others
• good experiments are repeatable
AND
• It’s highly likely to happen again
– The sun will rise tomorrow
– Apples fall from trees
19
Experiments where you already know
the answer
= confirmatory experiments
• Should not be entitled to a patent.
• You haven’t really contributed anything new
• The solution is obvious.
20
Experiments where you don’t know
the answer
• If you don’t know, you do research to find out the
answer.
• Trial and error
– If you have errors, you went the wrong way
– Therefore the right way wasn’t obvious or you would
have done that first
– Long recognized to be a legitimate route to a
patentable invention
• Hoescht: once penicillin discovered, try other
microorganisms. That begat chloromycetin and tetracyclin –
patentable
• American Cyanamid: “a patient searcher is as much entitled
to the benefits of a monopoly as someone who hits upon an
invention by some lucky chance or inspriation”
21
Experiments where you don’t know
the answer
• How well can you predict the outcome?
Guessing…………………….Likely…………….Highly Certain
Coin Toss…………Pen at Reception Desk…Sunrise tomorrow
– They’ll tend to polarize to either end of the spectrum
22
Obvious to Try or Worth a Try
• Obvious to try
– The microorganisms after penicillin discovered
– Not determinative: May be obvious, but may not.
• Worth a try … but if uncertain of result, it can’t
be obvious
23
Experiments when you know an
answer’s there
• Question: Where are my glasses?
• Usual Answer: Look in the obvious places
– Where did you last see them?
– Where were you last?
24
An expected result
• Which is the sharpest knife in the drawer?
– One is.
– Measure by routine testing
– Should the identification of the sharpest knife be
patentable?
• Probably not – you’re confirming what’s is a given
• What if it’s really sharp? Surprisingly sharper
than the rest?
25
An expected result
• What is it’s melting point?
– Merely measuring a physical characteristic
– You’re just observing – that’s science
• Find me an application and that might be
patentable.
26
A BUMP IN THE ROAD
Would require “undue
experimentation”
• IKEA furniture
– It can be done, but it’s not always easy
• To implement an invention after reading a patent,
you may have to play around with it a bit
• Patent is supposed to be “enabling’ – disclose
what you need to know to make it work
• If it took “undue experimentation” to implement,
the disclosure is lacking
• Converse adopted: if there wasn’t undue
experimentation to make it, it’s obvious.
28
THE EASY ONES
An unexpected result
• “Surprise, surprise”
30
Going the wrong way
• Doing things backwards resulted in a patented
process.
31
Led Directly and Without Difficulty
• Reality check: How hard was it for the
inventor?
– If circuitous, it wasn’t obvious to the inventor
– If easy, may or may not be inventive
32
“a mere application of mechanical skill
does not make you an inventor”
• Corn flakes case:
– Q.: Is the first person to do it an inventor?
– A.: Not if he was just the technician working the
machine.
• Over-transmogrified into: If its merely an
exercise of mechanical skills, there’s no
invention.
33
Other indicia of inventiveness
• If it’s “wow” – it’s probably an invention
• If creative people say, “I was there and I never
thought of it” – it’s probably inventive
34
Summary
• If you can put 2 and 2 together and come up
with 4, it’s obvious
• If you don’t know the answer/solution and
have to do research (even if by pedestrian
means), it’s not obvious
35
NEWS FROM THE SOUTH: KSR
KSR – US Supreme Court
• Adjustable car pedal for drivers of different
heights
• Sensor that controlled throttle, etc.
• Sensor attached to a fixed pivot point
• Prior art:
– A+B
– A+C
– B+C
• Invention A+B+C
37
KSR
• TSM:
– Teaching
– Suggestion
– Motivation
• “a patent claim is only proved obvious if ‘some
motivation or suggestion to combine the prior art
teachings’ can be found in the prior art, the
nature of the problem, or the knowledge of a
person having ordinary skill in the art.”
38
KSR
• TSM is not a rigid rule – your don’t have to have it
in every case in order to find obviousness
• Instead, you start with where things were and ask
if it was obvious to go to the invention:
– “The Court of Appeals considered the issue too
narrowly by, in effect, asking whether a pedal designer
writing on a blank slate would have chosen …”
– “The consequent legal question, then, is whether a
pedal designer of ordinary skill starting with Asano
would have found it obvious to put the sensor on a
fixed pivot point.”
39
KSR – “Predictable results”
• “The combination of familiar elements according
to known methods is likely to be obvious when it
does no more than yield predictable results.”
• “… when a patent claims a structure already
known in the prior art that is altered by the mere
substitution of one element for another known in
the field, the combination must do more than
yield a predictable result.”
• “If a person of ordinary skill can implement a
predictable variation, § 103 likely bars its
patentability.”
40
KSR – “Predictable solutions”
• “… a court must ask whether the improvement is more
than the predictable use of prior art elements
according to their established functions.”
• “Where there is a design need or market pressure to
solve a problem and there are a finite number of
identified, predictable solutions, a person of ordinary
skill has good reason to pursue the known options
within his or her technical grasp. If this leads to the
anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense.”
41
KSR – some weird stuff
• “A person of ordinary skill is also a person of
ordinary creativity.”
• “And as progress beginning from higher levels of
achievement is expected in the normal course,
the result of ordinary innovation are not the
subject of exclusive rights under the patent law.”
• What the heck is “ordinary creativity” or
“ordinary innovation”?
– OK if: Creating something new but non-inventive?
42
KSR – weird stuff
• “The proper question to have asked was whether a
pedal designer of ordinary skill, facing the wide range
of needs created by developments in the field of
endeavor, would have seen a benefit to upgrading
Asano with a sensor.”
• What triggers the vision?
• Surely doesn’t mean you ask the notional person,
“Would you see a benefit doing this upgrade?
• That’s a leading question inventors are never asked.
• OK if: Where were we? Where was obvious to go from
there?
43
KSR – weird stuff
• Synergy: the whole is greater than the sum of its
parts.
• THERE’S NO SUCH THING!!!!!
• a “patent for a combination which only unites old
elements with no change in their respective
functions … obviously withdraws what is already
known into the fiield of its monopoly and
dimishes the resources available to skillful men”
• Stuff just does what it does … but you can have a
new result – example – the sailboard
44
Predictability from UK
ST. GOBAIN (2005)
45
“Worth a try” test gets buried
• “Mere possible inclusion of something within a
research programme on the basis you will find out
more and something might turn up is not enough. If it
were otherwise there would be few inventions that
were patentable. The only research which would be
worthwhile (because of the prospect of protection)
would be into areas totally devoid of prospect. The
“obvious to try” test really only works where it is
more or less self-evident that what is being tested
ought to work.”
Saint-Gobain PAM SA v. Fusion Provida Ltd., [2005] EWCA Civ 177 at
para. 35 (per Lord Jacob).
46
SANOFI
If something is worth trying, is it
obvious?
• UK Johns-Manville 1967 Diplock L.J.:
– It’s obvious if it is:
• “obvious to try” and
• “It is enough that the person versed in the art would assess
the likelihood of success as sufficient to warrant actual
trial...”
• 1972 Technograph case Sach L.J.:
– “He would be expected to try out all obvious
modifications or combinations of these methods
which seemed to him worth trying."
48
1974 Hoechst F.C.T.D. – obvious if you
could predict success
• Collier J.:
– "Mr. Sim sparred at some length with Dr. Schmutzler, pressing and
exploring the hypothesis that the liquid phase process was, to a skilled
person, "worth a try". Using the magnifying spectacles of hind-sight
(a half borrowed phrase), it is easy to say that any experiment, if
time and expense are unlimited … is or was worth a try."
– “Using a paraphrase of the “Cripps question”: Was it for all practical
purposes obvious to any skilled chemist in the state of chemical
knowledge existing at the date of the invention, which consists of the
chemical literature available and his general knowledge, particularly in
the filed of fluorine chemistry, that he would successfully produce
isohalothane (assuming the monomer used here and the hydrogen
bromide) in the liquid phase? …
49
Hoescht FCA: success doesn’t have to
be predicted
• Federal Court of Appeal, Jackett C.J.:
– “The learned trial judge appears to have proceeded upon the
assumption that the requirement of “inventive ingenuity”, is satisfied
unless the “state of the art” at the time of the alleged invention was
such that it would have been obvious to any skilled chemist “that he
would successfully produce isohalothane (assuming the monomer
used here and hydrogen bromide) in the ‘liquid phase’.” (The italics
are mine.) I do not think that the learned trial judge’s assumption is
correct as a universal rule. I would not hazard a definition of what is
involved in the requirement of “inventive ingenuity: but, as it seems to
me, the requirement of “inventive ingenuity”, is not met in a the
circumstances of the claim in question where the “state of the art”
points to a process and all the alleged inventor has done is ascertain
whether or not the process will work successfully.”
50
1979 Hoechst SCC
• In my view this statement of the requirement of inventive ingenuity puts
it much too high. Very few inventions are unexpected discoveries.
Practically all research work is done by looking in directions where the
“state of the art” points. On that basis and with hindsight, it could be said
in most cases that there was no inventive ingenuity in the new
development because everyone would then see how the previous
accomplishments pointed the way. The discovery of penicillin was, of
course, a major development, a great invention. After that, a number of
workers went looking for other antibiotics methodically testing whole
families of various microorganisms other than penicillum noatum. This
research work was rewarded by the discoveries a number of antibiotics
such as chloromycetin obtained from streptomyces venezuelae as
mentioned in Laboratoire Pentagone v. Parke, Davis & Co. [1968] R.C.S.
307, tetracycline as mentioned in American Cyanamid Co. v. Berk
Pharmaceuticals Ltd. [1976] R.P.C. 231 where Whitford J. said (at p. 257):
“A patient searcher is as much entitled to the benefits of a monopoly as
someone who hits upon an invention by some lucky chance or
inspiration.”
51
Predictability of success
USA
1977: UK
JohnsManville
“obvious to try”
obvious if worth
trying
%
“reasonable
expectation
of success”
1979
Hoechst
obvious if
can predict
success
100%
52
Canadian case law develops
• If any research (learning something new) is
needed, the invention is not obvious
• “Undue experimentation”
– renders a discovery non-obvious
– less than undue experimentation makes it obvious
• If the result of the experimental is highly
predictable or the result expected (the
experiment is confirmatory rather than
exploratory), then the result is obvious.
53
2005 UK “obvious to try” test moves
• Saint-Gobain PAM SA v. Fusion Provida Ltd. per
Jacob:
– “Mere possible inclusion of something within a
research programme on the basis you will find out
more and something might turn up is not enough. If it
were otherwise there would be few inventions that
were patentable. The only research which would be
worthwhile (because of the prospect of protection)
would be into areas totally devoid of prospect. The
“obvious to try” test really only works where it is
more or less self-evident that what is being tested
ought to work.”
54
Predictability of success
USA
1977: UK
JohnsManville
“obvious to try” =
enough to try a trial
%
“reasonable
expectation
of success”
2005: SaintGobain
“ought to
work”
1979
Hoechst
success
100%
55
2007 USA KSR decision
• Rejected CAFC’s restrictive TSM test
– Teaching
– Suggestion
– Motivation
• “Consider everything” approach, including “obvious to try”:
“The same constricted analysis led the Court of Appeals to conclude, in error,
that a patent claim cannot be proved obvious merely by showing that the
combination of elements was “obvious to try”. ... When there is a design
need or market pressure to solve a problem and there are a finite number
of identified, predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of innovation but
of ordinary skill and common sense. In that instance the fact that a
combination was obvious to try might show that it was obvious under
§103.”
56
Rothstein in Sanofi
“It is now clear that both jurisdictions accept
that an “obvious to try” test can be relevant in
an obviousness inquiry. The United States
Supreme Court has now stated so explicitly in
KSR. The convergence of the United Kingdom
and the United States law on this issue
suggests that the restrictiveness with which
the Beloit test has been interpreted in Canada
should be re-examined.”
57
Obviousness – the Sanofi test
(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?
58
“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?
59
Obviousness
• Rothstein’s Questions (redux):
– (3) What was the motive?
• To try? To combine those references?
– (2) How easy was it for the inventor(s)?
• Prolonged and arduous (inventive) vs. “routine” (obvious)
– (1) Was it predictably successful?
• Was it“ more or less self-evident” that it “ought to work”?
• Were there a finite number of identified predictable
solutions?
60
(3) What was the motive?
• Marketplace was searching for an effective,
non-toxic product
– [How does that make it obvious?
– [More likely to make it non-obvious if everyone
was looking and nobody found it]
• The genus patent did not provide a specific
motivation to pursue the right handed
enantiomer.
61
(2) How easy was it for the
inventor(s)?
• What was known:
– Separation methods
– Methods of testing properties
– Finite number of salts
• But the inventor took 5 months
– That’s prolonged and arduous (inventive) vs.
“routine” (obvious)?
– [That’s a new definition for “routine”.]
62
(1) Was it predictably successful?
• Was it “more or less self-evident” that it “ought to work”?
• (Were there a finite number of identified predictable solutions)
• Skilled person would not have known:
– before separating the racemate into the two isomers and testing
them, that the properties of the right-handed isomer would be
different than the properties of the racemate or the left-handed
isomer;
– the relative advantage of the right-handed isomer;
– what to select or omit from the genus patent was not self-evident;
– before trying the salts in combination with the right-handed isomer,
what the bisulfate salt’s beneficial properties would be;
– the right-handed isomer ought to work.
Therefore, the right-handed enantiomer salt was not obvious.
63
OBVIOUSNESS SINCE SANOFI
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.”
65
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)?
66
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.”
67
What’s the invention/inventive
concept?
• Servier (FCA)
– Approved what Snider did: look to the claims
– Adopted Angiotech v. Conor:
• “… 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.”
68
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.”
69
APPLYING “OBVIOUS TO TRY”
“Obvious to try” open to misapplication?
• 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
71
“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.”
72
“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
73
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
74
Just finding a salt: obvious
• Ratiopharm Inc. v. Pfizer
Limited (amlodipine
maleate)
• Start with amlodipine
maleate
• Find a suitable salt
75
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”.
78
Conclusions
• An obvious truth:
– a predictable solution may be obvious; but
– an unpredictable outcome cannot be an obvious
solution.
79
Thank You
Don Cameron
[email protected]
Bereskin & Parr LLP