Transcript Strict Liability & Vicarious Liability

Obviousness
The Legal Meaning of Ingenuity
Obviousness
• Patent law requires that for an invention to be
patentable, it must embody ingenuity, that is,
the subject-matter of the invention should not
have been obvious to a person skilled in the
relevant art.
• Prior to Oct. 1, 1996, Canadian patent law
presumed the application of the criterion
without specific statutory basis of support.
• Amendments to the Patent Act effective Oct.
1, 1996 include, for the first time, provisions
that specifically address the criterion of nonobviousness. See s. 28 (3) of the Patent Act.
s. 28(3) of the Patent Act
• “the subject-matter defined by a claim in an application
for a patent in Canada must be a 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 as 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.”
Meaning of Ingenuity
• From the provisions of s. 28 (3) certain
elements are crucial to meet the test of nonobviousness.
• First, beyond the temporal aspects which will
be examined anon, the critical quality is that
the “ingenuity” embodied in the invention as
CLAIMED must not be OBVIOUS to a person
skilled in the relevant art or science.
• What is the legal definition or test for
identifying this unspecified quality of
“ingenuity”.
Claim in the Patent, Filing
Date & Ingenuity
• In determining the existence or otherwise of
inventiveness or ingenuity in the alleged
invention, the CLAIM in the patent application
and FILING DATE are both crucial.
• Obviousness MUST be assessed in relation to
both THE CLAIM and the FILING DATE.
• Similarly, the word “public” as used in s. 28
(3), pertains to the specialized group of
persons SKILLED in the RELEVANT ART or
SCIENCE, and not the ordinary public.
Defining “Obviousness”
• The word “obvious” is not defined in the Act.
• Judicial attempts at a definition include
Farbewerke Hoescht, where the court defined
it as “finding out something which has not
been found out by other people.”
• The case of Beloit v. Valmet Oy describes it
as “substantial exercise of inventive power or
inventive genius, which could be slight if
important results are achieved.”
• These are attempts to capture in words, an
elusive manifest criterion.
Tests of Obviousness
• Case law and scholarly authorities are agreed
that an invention must ipso facto, embody an
element of “inventiveness” or “inventive
genius.”
• Once a patent has been issued, however, the
onus is on the person asserting that an
invention lacks inventiveness to plead and
prove same.
• The test for inventiveness or non-obviousness
(both terms are often used interchangeably)
has produced a welter of “approaches”.
Tests for Obviousness
• First, the courts have consistently asserted
that obviousness is a question of fact. In
effect, obviousness is a matter of evidence.
• The courts have however grappled with an allencompassing test for determining the
existence or lack thereof of the “inventive”
quality in an invention.
• Viscount Dunedin articulated it as “finding out
something which has not been found out by
other people.” See Pope Alliance case, [1929]
AC 269.
The “Cripps” Test
• Sir Stafford Cripps as counsel in the Sharpe
case, [1928] 45 RPC 153 at 163 formulated
the test thus, “was it obvious to any skilled
chemist in the state of chemical knowledge
existing at the date of the patent that he could
manufacture valuable therapeutic agents by
making the higher resorcinols by the use of
the condensation and reduction processes
described? If the answer is NO the patent is
valid, if YES the patent is invalid.”
• This is known as the Cripps test.
Objectivity of Obviousness
• The existence of otherwise of inventive
genius in the invention must be
evaluated from the perspective of A
PERSON SKILLED IN THE ART. The
context of the relevant skill of this
person must satisfy s. 28 (3) (a) (b)
Substantial Exercise of Genius?
• In the Fada Radio case, the P.C. held,
“there must be substantial exercise of
the inventive power or inventive genius,
though in cases it may be very slight.
Slight alterations or improvements may
produce important results, and may
disclose great ingenuity…”
The Beloit Test
• The most widely adopted, albeit romanticized test of
obviousness in Canadian patent law was proposed by
Hugessen J, in the Beloit v. Valmet Oy case. According
to Judge Hugessen,
• “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 (patent law’s
version of the average “Joe”), ..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
to the solution taught by the patent. It is a very difficult
test to satisfy.” (Underlining mine)
Beecham case
• Urie, J. continued with Hugessen JA’s test
when he proposed in the Beecham case that
the test to be applied “is whether at the date
of the invention…an unimaginative skilled
technician, in the light of his general
knowledge and the literature and information
on the subject available to him on that date,
would have been led directly and without
difficulty to the invention.”
Testing or No Testing at All?
• Cases such as Beloit and Beecham constitute a long
line of judicial dicta, if not jurisprudence, supportive of
the idea that testing is not allowed for the purposes of
obviousness.
• In other words, cases such as Beloit v. Valmet purport
that to determine whether the invention is obvious, the
solution to the problem taught by the patent must be
“plain as day” or “crystal clear”.
• The court must determine whether a person skilled in
the art would be led “based on the state of the art, to
the claimed invention without conducting further
experiments, serious thought, or research”. See Abbott
v. Ratiopharm [2006]; Procter & Gamble v. Canada
[2004]
Testing or no Testing?
• From these cases, once it is in evidence that testing
would be required to arrive at the invention, the
argument on obviousness would fail. See AB Hassle .
Genpharm Inc., [2003]
• In Dimplex v. CFM (2006)
• The import of cases purporting to hold onto the “no
testing” line is that the threshold on inventiveness or
ingenuity is reduced to a level that arguably elevates all
miniscule changes to the level of ingenuity.
• Any and every kind of change or alteration to the state
of the art would rise to the level of “inventive genius”
even if the change, improvement, or alteration was a
routine and trivial change.
Ingenuity and NOC Regulations
• Patented Medicines Notice of Compliance
Regulations (NOC Regulations) is a type of
linkage regulation which tie patent protection
for marketed pharmaceuticals to the domestic
drug approval process.
• NOC Regulations control the entry into market
of generic drugs. It seems that the threshold
for allowable testing is inversely related to the
concept of inventiveness, that is, the more
stringent the test for obviousness, the higher
likelihood of failure in impugning a patent for
obviousness.
Ingenuity & NOC Regulations
• A recent review of the case law in Canada by one
author reveals the existence of uncertainty in the
jurisprudence pertaining to whether testing is
permissible when dealing with the issue of obviousness
in NOC Regulation matters.
• A litany of cases such as Procter & Gamble v. Canada;
Abbott v. Ratiopharm; Pfizer v. Canada; AB Hassle v.
Genpharm; etc support the NO TESTING approach.
• On the other hand, there are several cases and judicial
dicta supportive of the idea that some degree of testing
or experimentation is permissible in determining
whether the subject-matter of the invention embodies
substantial exercise of ingenuity.
Ingenuity and NOC Regulations
• On the other hand, there is a long line of
cases where the courts have held that some
degree of testing/experimentation is
permissible in obviousness analysis.
• The cases include Janssen v. Novopharm;
BMS v. Novopharm; Aventis v. Apotex, etc
• Other line of cases purport to uphold the NO
TESTING approach while in fact, applying the
ROUTINE TEST doctrine. This third line of
cases include Apotex v. Wellcome; Burns &
Russell, Novartis v. Apotex.
Ingenuity & NOC Regulations
• Cases that purport that patent law does not permit
testing or experimentation in obviousness analysis fly in
the face of decades of judicial reasoning that mere
workshop improvements do not rise to the level of
ingenuity sufficient for obviousness test.
• It is a well-established canon of patent law that in
determining the presence or otherwise of inventive
genius in an alleged invention, a distinction must be
drawn between (a) mere workshop improvements such
as could be made by the exercise of a constructional
ability or the expected knowledge of the hypothetical
person skilled in the art and science and (b) changes
which rise “to the dignity of invention”.
Workshop Improvements
• In the US case of Johnson v. Pennsylvania, the court
held that the “line to be marked is that which separates
mere constructive ability from inventive capacity and as
the lowest order of invention is something more than
mechanical skill, so the highest degree of mechanical
skill is something less than invention.”
• Cases that support the NO TESTING doctrine ignore
this accepted doctrine of patent law.
• Another major problem with the NO TESTING
approach is that it gives short shrift to the purposive
construction of claims, in particular, when the issue of
infringement is in point.
Ingenuity & Workshop
Improvement
• It is often said that the distinction between an invention
and a workshop improvement is that the former
contains a ‘scintilla’ of inventive ingenuity. But as Tomlin
J, observed in the Samuel Parkes case, the search for
a “scintilla” of inventive ingenuity is a difficult, if not
frustrating exercise.
• “Nobody, however, has told me, and I do not suppose
anybody ever will tell me, what is the precise
characteristic or quality the presence of which
distinguishes invention from a mere workshop
improvement. Day is day and night is night, but who
shall tell where day ends and night. It is, I think,
practically impossible to say there is not that scintilla of
invention to support the patent.” [1929] 46 RPC 248.
The Valuation of Genius
• Scholars like Graham Potts have posited that a scintilla
is an incipient or merely perceptible spark. But the
questions that follow are: spark of what? Perceptible to
whom? Ultimately, it would seem that obviousness
involves what the German legal writers term a
Wertuitel, a judgment of value.
• Pott’s argument seems compelling. In his view, “the
judge is called upon to evaluate the quantum of
difference from the prior art, by making a subjective
estimate of its effect on the mind of a hypothetical
skilled technician. There is nothing to be absolute here,
the judge is to make an estimate of more or less.”
• It is submitted that in NOC cases, obviousness cannot
be ascertained without the benefit of some testing.
Hindsight and Ingenuity
• The problem with obviousness is that many
inventions lose their claims to “inventiveness”
once their working or operating mechanisms
or principles have been disclosed to the
public. As Lord Russell warned, “nothing is
easier than to say, after the event, that the
thing was obvious and involved no invention”
Non-Drip, [1934] 60 RPC 135
• For this reason, the courts warn against the
inherent dangers of hindsight analysis in
determining whether an alleged invention
possesses inventive genius or not.
Indicators of Ingenuity
• Indicators for ingenuity in inventions may include:
• Does the invention introduce a new “technical effect”?
• Does the result of the invention “surprise” the skilled
but unimaginative technician?
• Is the alleged invention NOVEL and SUPERIOR to
what was available until then?
• Has it been widely used in preference to alternative
devices?
• Have competitors or experts in the field ever thought of
anything like it?
• Did amazement follow its public disclosure?
• Is the invention a commercial success?
Test for Ingenuity
• In sum, the popular definition or test of
obviousness is whether a skilled but
unimaginative technician would “have
come WITHOUT DIFFICULTY to the
solution taught by the patent.”
Farbwerke Hoescht v.
Halocarbon
•
•
Patentee relied upon two patents in a patent infringement
action. The first patent related to a process of producing
isohalothane by reacting in the liquid phase a monomer with
hydrogen bromide under radical forming conditions. The
novelty resided in carrying out the process in the liquid phase.
The second patent related to a process to convert
isohalothane into halothane. The inventive step over the prior
art was that the process was carried out at about 50
degree(s)C.
The trial Judge held the first patent to be valid and infringed
and the second patent to be invalid. The CA held both patents
invalid. On further appeal to the SC, the plurality of the court
held that CA put the test for inventive ingenuity too high in
respect of its consideration of the first patent in stating that
"the requirement of 'inventive ingenuity' is not met in the
circumstances of the claim in question where the 'state of the
art' points to a process and all
Farbwerke Hoescht v.
Halocarbon
• that the alleged inventor has done is ascertain whether
or not the process will work successfully." Practically all
research work is done by looking at directions where
the "state of the art" points.
• As to the second patent, the SC held that the trial
Judge misapprehended the evidence of the expert in
relation to the significance of carrying out the process
at 50 degree(s)C, the point in respect of which the
invention was said to reside.
• The evidence was that the reaction could be obtained
more readily and economically at temperatures around
50 degree(s)C instead of having it done at 0
degree(s)C as taught by the prior art.
Examples of Non-Obviousness
• An inventor of a new chemical is entitled to a patent on
that chemical as well as its specific uses. However, if
the chemical is prepared by a chemical process only
the chemical when produced by that process as
disclosed is eligible for a patent. See Marzone
Chemicals, [1978], 37 C.P.R. 37.
• When a compound is mixed with a carrier, there is no
inventive ingenuity involved.
• The isolation of a virus that does not exist in nature
may be patentable.
• The discovery of a new use of old compounds would
meet the criterion of non-obviousness.
• However, where a combination of old compounds is
indicated in the literature as being potentially useful for
a stated purpose,
Examples of Non-Obviousness
• there is no invention in experimenting with the
combination and demonstrating a commercial utility for
that purpose.
• If a new use is discovered, the patent does not give a
complete monopoly to the old compound.
• Invention may arise where one material is substituted
for another in such a manner that a better product is
created.
• Similarly, the simplification of an apparatus such as the
elimination of some parts which results in greater
economy or efficiency may possess the requisite
degree of inventive genius.