Introduction to Patents
7
I. Definitions
7
III. Some History
7
Kemp’s British “Patent,” 1331
7
Brunelleschi and Badalone, A.D. 1421
7
Venetian Patent Statute, 1472
7
The Statute of Monopolies, 1623
7
IV. Is the Patent System Necessary?
8
Professor Fritz Machlup’s study
8
Historical Necessity of Patents
8
Varied Impacts on Industries
8
V. Theories of Patent Law
What Is An Invention?
8
10
I. Definitions
10
II. Elements of a Patentable Invention
11
Is there a Fourth Criterion?
11
III. The Steps
11
IV. Patentable Categories
11
V. Non-Patentable Categories/Inventions
12
VI. Summary
13
Criteria for Patentability
I. Novelty
13
13
Anticipation Distinguished from Obviousness
13
Legal Characteristics of Anticipation
13
The Current Test for Anticipation (Free World Trust)
13
1
Test for Anticipation
Step One: Methods of Anticipation
14
14
A. Verbal/Oral Disclosure
14
B. Disclosure by Prior Use, Sale or Display
14
C. Publication
14
Step Two: Enabling Disclosure
15
Common Critical Dates of Prior Art for Novelty and Non-Obviousness
15
Novelty Under the Post-1989 Patent Act
15
A. Statutory Provisions
Prior Disclosure
II. Obviousness
15
16
16
Definitions
16
Tests for Obviousness Under the Pre-1989 Patent Act
17
The Current Test for Obviousness - Sanofi
17
Examples of Non-Obviousness
18
Farbwerke Hoescht v Halocarbon
18
KSR v Teleflex
18
Apotex v Synthelabo
19
Double Patenting
19
IIIA. Utility
Utility in Early Patent Law
19
20
Venetian Patent Act, 1474
20
Statute of Monopolies, 1624
20
Judicial Construction of Utility
21
Proof of Utility
22
IIIB. Doctrine of Sound Prediction
22
Apotex v Wellcome, [2002] SCC
22
2
Pharmacological Prediction
23
Farbwerke Hoescht v Comm of Patents
23
Apotex v Wellcome
23
Genetic Inventions and Sound Prediction
23
Homology and Sound Prediction
23
ESTs, cDNAs, and SNPs
23
Death Ray Case
24
Novopharm v Pfizer
24
Selection Patents
24
Sanofi-Synthelabo Canada Inc v Apotex Inc
The Limits on Patentability
I. Non-Patentable Subject Matter
24
25
26
The Prohibition of Patents on Natural Products
26
Chemical Compounds & Patents
26
Shift from Stare Decisis: The New Rule
27
Patents on Products of Nature
27
Problems with the New Rule
27
GE Co v Deforest Radio: Purifying
27
The Patent on Aspirin
27
Kuehmsted v Farbenfabriken
28
Parke-Davis v Mulford, [1912] 196 F 496
28
II. Computer Related Subject Matter
28
Schlumberger Case
28
Amazon Case
28
Aftermath of Schlumberger
29
The “Technical Effect” Test
29
3
Specification and Disclosure
29
I. Introduction
29
II. Parts of the Specification and Requirements as to Form
31
III. Legal Requirements of the Specification
32
Sufficiency of the Specification and Freedom from Ambiguity
32
Best Mode
33
Good Faith
33
Interpretation of Disclosure
33
A. Extrinsic Evidence
33
B. Construction
34
Ownership
34
I. The Inventor
34
II. Inventorship
34
III. Joint Inventors & Co-Inventors
34
Apotex v Wellcome
IV. Employer-Owned Inventions
35
35
Hired to Invent
35
Not Hired to Invent: Inventive Employee
36
Spiroll Corp v Putti, BCSC
36
Public Servants
36
Inventions of War Munitions
36
Infringement
37
I. Introduction
37
II. Infringement Analysis
37
III. Claim Construction
37
The Doctrine of Equivalents
37
4
Triple Identity Test: Function-Way-Result
38
McPhar Case, 1960
38
Purposive Approach
38
IV. Who Can Sue for Patent Infringement?
38
V. What Constitutes Infringement?
39
Making and Constructing
39
Manufacture for Export
39
Manufacture of Kits
39
Manufacture of Parts
40
Partially Filled and Unfilled Contracts Involving Infringing Articles
40
Use of a Patented Invention
40
Sale of a Patented Invention
40
Goods Not Yet Made
40
Sale and Delivery Taking Place Outside of Canada
40
Sale or Use of Product Made Using a Patented Invention
40
Importing a Patented Invention
40
VI. Inducement to Infringement
40
VII. When Does Infringement Occur?
41
A. Time Limits in the Patent Act
41
B. Other Limitation Periods
42
C. Limitation Periods Do Not Apply to Defences
42
Exceptions to Infringement
42
I. Statutory Exceptions
42
Private Use
42
Information Required by the Government
42
Experimental Use
43
5
Research Exemption in the US
Merck v Integra Lifesciences
Experimental Use in Canada
Rationes of Micro-Chemicals
43
43
44
44
Trials on Generic Medical Products
44
Visiting Ships and Aircrafts
44
Use Prior to Patent
44
Farmer’s Rights
44
Doha Exceptions
45
II. Mens Rea in Infringement
Biotechnology and Mens Rea in Infringement
Monsanto v Schmeiser
Mens Rea Continued
Approaches of Other Jurisdictions
Defences and Remedies
I. Defences
45
45
45
45
46
46
46
Denial of Infringement
46
Leave and License of the Patentee
46
Denial of the Plaintiff’s Title
46
Estoppel
47
Lapse of the Patent Sued Upon
47
Dutch Industries v Commissioner for Patents
Invalidity of the Patent Sued Upon
II. Remedies
47
47
47
Calgon v North Bay
48
Quantification of Damages
48
6
Exemplary Damages
48
Prescriptions and Limitations
48
Jurisdiction of Courts
48
Introduction to Patents
I. Definitions
Patent - derives from the Latin verb patere which means “open”. In the adjectival form, a letter of patent is an open
letter addressed to the public, declaring that the person(s) named therein (the inventor) has the exclusive right to
exploit and use the named invention in the letter for a fixed duration of time. A Patent may also be defined as a
“governmental grant of the exclusive rights to make, use, and sell the substance of a recent invention. The life of a
patent is limited and starts when a patent document is issued by the government.”
Patent Holders obtain the right to exclude others, for a limited period of time, from making use of the invention
without the consent of the patentee. A patent is therefore a Negative Right as opposed to a Positive Right.
There is no indication that patents propel inventiveness, despite several well-reasoned studies; there is a link
between patent regimes and the commercialization of inventions, however.
II. Elements of a Valid Patent System
There must be an exclusive and enforceable property right;
1. over an invention;
2. for a delimited period of time;
3. the exclusive right must be the predictable and transparent outcome of a set of legal rules, prescriptions, and
process rather than an ad hoc, discretionary exercise of state or royal prerogative.
III. Some History
Kemp’s British “Patent,” 1331
This ‘patent’ was a royal discretion granted to J. Kemp in 1331, with the intent to promote British local industry
(connection to commercialization). Kemp was regarded for importing foreign technology into Britain. In
contemporary times, such a ‘patent’ would constitute an infringement of a patent. More importantly, Kemp’s
‘patent’ is emblematic of the discredited regime of “invention by importation” rather than by inspiration (illustrates
the lack of connection re: inventiveness).
Brunelleschi and Badalone, A.D. 1421
The Florentine, Brunelleschi, invested the sea craft, el Badalone, in 1421. He demanded for exclusive use of the
invention; Florence yielded to his demands. A “patent letter” was issued to Brunelleschi on June 19, 1421.
Brunelleschi’s letter in isolation seems patent-like; however, it fails to qualify as legitimate because it was an ad
hoc, one time grant.
Venetian Patent Statute, 1472
Predated the Stuart Statute of Monopolies by over 150 years; arguably, the first real patent system, it was based on
legislation enacted by the Parliament of Venice. The law delimited the duration of patents (10 years); defined the
scope of patentable subject matter; provided for a system of examination of patent applications; and imposed a
remedy for infringement of patents.
The Statute of Monopolies, 1623
Enacted in response to British Royalty’s egregious abuses of European Patents.
It banned patents on discoveries, laws of nature, and other dubious ‘discoveries’ (?).
7
IV. Is the Patent System Necessary?
An overwhelming majority of reputable studies tepidly endorse the patent system.
Professor Fritz Machlup’s study
Sponsored by the US congress, which remains the most authoritative finding concluded that “none of the theoretical
arguments either confirms or confutes the belief that the patent system has promoted the progress of the technical
arts and the productivity of the economy.” No economist, on the basis of present knowledge, could possibly state
with certainty that the patent system, as it now operates, confers a net benefit or a net loss upon society.
Professor Frederick Abbott, “There is a serious gap in economic data and analysis which might demonstrate the
positive impact of patent protection as claimed by patent holders. This gap is well known and accepted among
intellectual property rights economists and public policy specialists.”
Historical Necessity of Patents
Inventiveness can occur without a patent system. Holland, Switzerland, and Japan once abolished their patent
systems. The US nearly did. The British Patent Act was instituted in 1624 but the Industrial Revolution took 150
more years to arrive. Venetian creativity flourished for centuries before its patent law was instituted.
Varied Impacts on Industries
Some industries are far less reliant on patents for their success. These include pottery, wine-making, automobiles,
and brewing. Other industries are far more reliant on the patent system, such as the pharmaceutical industry,
agriculture, and chemicals.
John Jewkes, D. Sawers, & Stillerman: “The Patent system lacks logic. It postulates something called ‘invention’
but in fact no satisfactory definition of ‘invention’ has ever appeared ... the system, too, is wasteful. It gives
protection for 20 years whilst in fact over nine-tenths of the patents do not remain active for the whole of this
period ... it is almost impossible for conceive of any existing social institution so faulty in so many ways. It
survives only because there seems to be nothing better.” The Sources of Invention, 25.
Professor Vaver: “The claim that patents are necessary to encourage individual creativity and inventiveness and
that society would be worse off without such laws rests on myth and paradox rather than proof.”
Myths have a kernel of truth and in respect of patents, the little truth there is that patents arguably help to
commercialize inventions.
The Last Word
“The patent system is more essential to getting together the risk capital which is required to exploit and to develop
and to apply the contributions of the genius inventor than to provide a stimulus for the actual mental contribution.”
Judge Simon Rikind, Co-Chair, US President’s Commission on the Patent System.
V. Theories of Patent Law
Theory
Natural Rights
No Patent system
anywhere in the
world is premised
on this theory; the
theory is too
romanticized. It
attained its greatest
heights in the
French Revolution.
Beliefs/Elements
Patents are representations of property.
Property is a subject of exclusive ownership.
Patents are not governmental privileges, but an
inherent right of the inventor, independent of state
laws.
Limitations on patents rights are infringements of
human rights.
They do not point to any specific section of the
Constitution/Charter, but maintain that it is
included in the language therein.
Limitations
Patents are granted subject to the
Patent Law (s 27(1) of the Patent
Act); they are the subjects of
statutory law (not God).
Patent law places limitations on the
patent grant, incl. duration (s 44),
patentable subject matter (s 22,
20(17)), and terms of use (s 19(2)).
Governmental use and takings (s
19(1)).
8
Theory
Beliefs/Elements
Limitations
Reward
Has more vitality in
academic circles,
unlike the Natural
Rights theory
(which is dead
there).
**This theory has
been adopted by the
SCC in several
cases** Apotex v
Wellcome
An inventor has a natural right to receive a reward
for adding value to society (the invention), and that
reward should be in the form of a monopoly
commensurate with the usefulness of the valueadded.
It is justice-based in the sense that society is
considered to be morally obligated under natural
law to grant the reward.
Also based on an economic premise that the
monopoly should be or is proportional to the
benefit received by society.
Suffers from the necessity of
presuming that property is a natural
right rather than a creation of
society.
This presumption is extended to
intangible property in the form of
exclusivity granted by a patent.
However, an invention is an
inexhaustible form of property
AND artificial exclusivity creates
scarcity.
Reward to the inventor depends
upon commercial success and the
ability to restrict output by
monopoly pricing (Frivolous but
popular inventions may create
excessive reward for their
inventors, ie fax machine inv. 1842
but first worked in 1980).
Intention to reward inventor vs
Reality.
Patent-Induced,
“Inducement”
(But For)
The SCC spoke
“glowingly” of this
theory in
Consolboard.
Patents are an incentive for inventors and that
absent patents, there will be no inventions (...).
The disclosure theory derives a measure of validity
from the specification requirement of patents,
introduced by the British Calico Printers Act of
1787. Shortly after that enactment, Lord Mansfield
imported the requirement of specification into
patent law in Liardet v Johnson.
History is replete with serendipity
and simultaneous inventions by
different inventors (Watt and
Polzunov simultaneously invented
the steam engine in England and
Russia).
Fails to account for inventions
induced by the market, or by
scientific curiosity, or accident.
Many inventors do not work for the
sake of obtaining patents.
Evidence suggests that most
inventors who apply for patents do
so out of fear that their rivals or
competitors would get to the patent
office before them.
The limited monopoly granted to
the inventor may not represent the
true worth of the invention.
9
Theory
Beliefs/Elements
Limitations
Contract
Flip side of the
disclosure/inducem
ent theory. It is the
most dominant
theory of patent
systems.
Freeworld v Electro
Sante.
A patent is a form of contract between the state and
the inventor.
By this conception, the specification is the
consideration offered by the inventor in return for
the limited monopoly plus the obligation of the
state to use its coercive powers to protect the rights
of the inventor (s 27(3), Free World v Electro
Sante).
It is a half-truth that a disclosure is
all that a person skilled in the art
requires to work an invention; there
is no legal obligation on an
applicant for a patent to include the
“know-how” in the disclosure.
The alleged bargain between the
inventor and society is often
skewed in favour of the inventor;
most disclosures are crafted to
disclose as little as possible (Teva
Canada Limited v Pfizer Canada
Inc., et al).
The increase in the number of
Corporate owned patents undercuts
the argument that a patenet is a
contract between the inventor and
society; most patents are
automatically assigned to the
employers of the inventor.
Prospect
Articulated by
Professor Edmund
Kitch.
Patents perform the function of prospecting
licenses.
There is a difference between the claim and the
actual invention; while the latter may be limited,
the former is often open-ended to perform the role
of a prospecting license.
Justices expansive claims and “spirit of the
invention” type of patents.
Virtually all patent systems require
only that the application disclose a
version of the invention that will
work; it does not require a finished,
commercially relevant invention.
Based on economic assumptions
which are not verifiable.
Empirical evidence does not
support the theory.
Reliance of the theory on
commercial success of the
invention for patentability is not
supported by patent law.
It is not predictive of whether a
particular application will be
approved by the Patent Office and
if so, whether the patent will
redeem its promises.
What Is An Invention?
I. Definitions
Invention:
Section 2 of the Patent Act provides that an ““invention” is “any new and useful art, process, machine, manufacture
or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or
composition of matter.”
Further, ss 2 and 27 effectively mean that the concept of what constitutes an invention is left in the hands of the
Patent Office and the courts to work out, with the proviso that certain categories of technological pursuits may not
be proper subject-matter for patent protection. *Bouncer Analogy*
10
II. Elements of a Patentable Invention
Section 2 of the Patent Act holds that a patent may only be granted for an invention which meets the following
conditions:
(a) the invention is new;
(b) the invention involves an inventive step; (by virtue of TRIPS, s 27)
(c) the invention is useful (works as predicted by the inventor).
Is there a Fourth Criterion?
There is an ongoing debate as to whether there is a fourth criterion, namely whether the alleged invention is
otherwise excluded by the statutory exceptions to grant (Biogen v Medeva).
Patent applications also require a high degree of detail and specificity.
III. The Steps
Step
Test
Other Considerations
New (Novelty)
It is the knowledge notionally
possessed by the proverbial person
skilled in the art at the date of
invention that proves novelty.
Before applying the test, the court
must first:
(a) determine the state of the art as
of the date of the invention.
(b) the date of the invention.
Inventive (Ingenuity)
The test is whether a person skilled
in the art at the date of the invention
could not have found the invention
to be obvious.
The alleged invention must possess
sufficient skill and ingenuity. This
is perhaps a subjective test, which
the Germans refer to as
“werturteil.”
Utility (Industrial Applicability)
Whether the invention performs as
described or predicted by the
inventor.
It is irrelevant that the invention is a
nuisance, immoral, or a burden to
society.
IV. Patentable Categories
The statutorily permissible categories include:
Category
Art
Lawson v Commissioner
of Patents
Re Dixon Application.
Definition
The word “art” in the
Patent Act must be given
its general connotation of
learning or knowledge as
commonly used in
expressions such as “state
of the art” or “the prior
art.”
Test
An addition to the
cumulative wisdom in a
field whereby a desired
result is effected having
commercial value is a
“new and useful” art.
Obiter
Lawson: “process ... must
be one that offers some
advantage which is
material (a useful art, not
a fine art)”
“there must be some
manual, chemical, or
physical effect to
transform or reduce
something to a different
state or thing.”
11
Category
Definition
Process
Machine
Any instrument or
assemblage of parts for
the transmission of force,
energy, or power in a
predetermined manner. It
may be simple or
complex.
Manufacture
A mechanistic process or
product. It connotes the
making of something,
even though living
organisms may be part of
the manufacturing
process, e.g. brewing.
Composition of Matter
Harvard Oncomouse.
Polansky Electronics v
AGT Ltd.
Chemical Compounds and
mechanical mixtures are
typically protected by this
-> pharmas often apply
for chemical compound
patent.
Test
Obiter
Whether the process
confers some advantage
which is material, in the
sense that the process
belongs to a useful art as
distinct from a fine art.
The word ‘process’ is
used interchangeably with
‘method.’
Must be limited in some
way so as not to include a
“machine” or
“manufacture.”
The combination or
mixture does not include
higher life forms whose
genetic code has been
altered by scientific
manipulation (Harvard
Oncomouse).
Patents may be granted
for the new use of an old
compound as there is
inventive ingenuity in
such discovery; however,
Patent Act requires that
the claim must be directed
to such new use. Claims
directed to the compound
itself or the old use are not
patentable. The new
patent does not grant any
rights to the inventor over
the claims covered by old
invention (Polansky).
V. Non-Patentable Categories/Inventions
(1) Methods of treatment of the human or animal body by surgery or therapy or of diagnosis practiced on the human
or animal body;
(2) A discovery, scientific theory, or mathematical method;
(3) A literary, dramatic, musical, or artistic work, or any other aesthetic creation whatsoever;
(4) The presentation of information;
(5) Any invention the exploitation of which would be generally expected to encourage offensive, immoral, or antisocial behaviour;
(6) Any variety of animal or plan or any essentially biological process for the production of animals or plants, not
being a microbiological process or the product of such a process;
(7) A scheme or method for performing a mental act.
12
VI. Summary
In Harvard Oncomouse, the majority of the SCC held that “while the definition of “invention” is broad, Parliament
did not define invention as ‘anything new and useful made by man ... just because all inventions are unanticipated
and unforeseeable, it does not necessarily follow that they are all patentable.’”
The combined effect of all the provisions stated above is that an invention is not necessarily a juridical fact or a legal
fact unless it meets the requirements of the Patent Act and falls within the scope of patentable subject matter.
An innovation or technological improvisation may thus meet all the technical requirements for patentability and yet
fail the test of patentability on the ground that it is not a patentable subject matter.
Criteria for Patentability
I. Novelty
The requirement of novelty as a precondition to the grant of a patent derives from the requirement in section 2 of the
Patent Act that an invention be new. Assessment of novelty is in accordance with the granting provisions of the Act.
An invention is said to have been anticipated if prior to the filing of the application, another patent, document,
and/or reliable oral information had previously described, embodied, or put in public use the alleged invention
(Pfizer v Apotex, AstraZeneca AB v Apotex).
The SCC has recognized on numerous occasions that novelty resides at the core of the “patent bargain” between the
inventor and the public. If the public has been put into possession of the claimed invention by whatever means, it
does not have to pay the price of a monopoly to get it again (Shire Biochem Inc v Canada (Minister of Health),
2008).
Anticipation Distinguished from Obviousness
Novelty and inventiveness are similar: both contribute to the consideration that must be paid by the inventor in the
patent bargain. Their antonyms, anticipation and obviousness, denote conditions in which the consideration is
inadequate.
While anticipation and obviousness are both fatal to the patentability of an invention, they have different causes.
When assessing novelty, the question is whether the alleged invention has been disclosed before, in which case the
public cannot thereafter be deprived of it. When assessing obviousness, the question is the nature and extent of the
difference between the invention and what has been disclosed before; it is one of degree.
Legal Characteristics of Anticipation
In Reeves Bros, the Court held that a valid anticipation must comprise the following elements:
1. Give an exact description;
2. Give directions which will inevitably result in something within the claims;
3. Give clear and unmistakable directions;
4. Give information which for the purpose of practical utility is equal to that given by the subject patent;
5. Convey information so that a person grappling with the same problem must be able to say “Ah! That gives me
what I wish”
6. If documented, be contained in one SINGLE document. The information given by the purported PRIOR ART
“must for the purpose of practical utility be EQUAL to that given in the patent in suit” (Dickson J in
Consolboard).
The Current Test for Anticipation (Free World Trust)
The issue when assessing novelty is whether the alleged invention has been disclosed before, in which case the
public cannot thereafter be deprived of it. It is said to be a two-step inquiry (Apotex v Sanofi):
1. Whether the publication or earlier patent discloses the special advantage allegedly conferred by the “invention”;
and
2. Whether a person skilled in the art, without access to the invention, could understand the nature of the invention
and carry it into practical use without the aid of inventive genius but purely by mechanical skill.
13
Test for Anticipation
Step One: Methods of Anticipation
A. Verbal/Oral Disclosure
In Tenneco Chemicals [1967], Jackett P opined that the patent examiner was bound to consider oral sources of
disclosure as sufficient to invalidate a patent on the grounds of anticipation. However, considering some of the
remarks of Justice Binnie in the Electro Sante case, the law on the relevance of oral anticipation seems unsettled.
B. Disclosure by Prior Use, Sale or Display
The disclosure of the invention to ONE person without an obligation of confidence puts the invention in the public
domain and out of the reach of valid patentability. No patent may issue for an invention that was in public use or on
sale in Canada for more than one year before the filing of the application in Canada (s 28(2)(1) of the Patent Act).
Note that there is an exemption for experimental uses in which public display is unavoidable (Gibney).
Croysdale v Fisher
Pollock: “When it is said that a process has been disclosed or an invention has been disclosed by means of a “use,” it
is not necessary that such “user” should be a use by the public proper, provided only there is a use in public, that is
to say, in such a way as contra-distinguished from a mere experimental user with a view of patenting a thing which
may or may not be existing.”
Gibney v Ford Motors
Plaintiff instituted action for infringement of a patent relating to a protector for a generator; the Plaintiff put a
protector makeshift cover on the generator of an unidentified customer. No precautions as to secrecy or confidence
were taken in respect of the use. The Defendant argued, and the court agreed, that the subject matter of the patent
had been used in public in Canada for more than two years before the application for patent was filed.
Ratio: As soon as the unidentified customer drove out without any injunction or restriction placed upon him, the
invention then became available to anyone who wanted to lift up the hood of the car and look at it.
Birtwhistle v Sumner engineering Co. Ltd, (1928)
One unit only of a timing device for book-makers was not even sold but merely carried around by a book-maker
when he went on his rounds for the purpose of trying it out and yet this was held to be prior public use.
Re Stahlwerk Becker Aktiengesellscheft
The House of Lords decided that if an invention were available to even one member of the public, that was sufficient
for the purposes of defeating the patent on the basis of public display.
1. Lord Finlay, “The law as to prior user seems to be this, that, if the article has been manufactured and sold, that
gives the means of knowledge to the purchaser, and that that is enough to establish prior user.”
2. Lord Shaw of Dunfernline: “When an article is manufactured and sold, and from an inspection of it is possible
for the vendee to ascertain its component elements, or the main principles of its construction, then, in my
opinion, there has been publication by prior user.”
C. Publication
In order for a document to qualify as a printed publication, it must:
1. have become generally available without restriction to members of the public;
2. the person or persons receiving the document, to be categorized as members of the public, must have no special
relationship with the author;
3. the onus is on the person asserting publication to prove the fact of publication.
Mosaicing is not permissible under Canadian patent law during the novelty inquiry; it may be relevant during the
obviousness inquiry.
J M Voith GmbH
The Court held that the distribution of a brochure at a trade convention to customers and others constituted
publication.
Koehring Canada
14
Placement of a document in a restricted area of a library kept by a trade association and thereby treated as
confidential was held not to constitute publication.
Step Two: Enabling Disclosure
“Enabling disclosure” refers to the requirement that the disclosure provided by the inventor must be sufficient to
enable a person skilled in the art to reduce the invention to practice, or at least be sufficient to be a basis of sound
prediction (VISX v Nidek). This disclosure is used in the preparation of the specification, and is required by section
27(3) of the Patent Act.
If the patent deals with a device or method of manufacture which method or mechanisms of the device can only be
disclosed by dissecting the device or method of manufacture, it is not necessary to prove that the device or method
was in fact dissected. Mere sale or public use of the device or method is enough to invalidate the patent (Risi Stone).
Exception: A prior use that is experimental does not invalidate a patent. A fortiori, where public experimentation is
the only means by which an inventor could test the device, a court may hold that such use was not “public” and
hence, not fatal to the patent.
Common Critical Dates of Prior Art for Novelty and Non-Obviousness
The Canadian filing date is the critical date for applicability of prior art when assessing novelty and non-obviousness
under sections 28.2(1)(a) and 28.3(a) of the Act. Section 28.2(1)(a) requires that the invention must not have been
disclosed more than one year before the filing date by the applicant, or by a person who obtained knowledge,
directly or indirectly, form the applicant, in such a manner that the subject matter became available to the public in
Canada or elsewhere.
Section 28.3(a) provides that 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 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.
Thus, both sections provide a one-year “grace period” within which to file a Canadian patent application following
disclosure by the applicant, without that disclosure being citable as prior art. Implicit in the establishment of grace
periods is an understanding that a fundamental objective of inventors and scientists, especially at universities and
public research organizations, is to disseminate scientific knowledge through publication of research.
It is important to note that the filing date referred to in sections 28.2(1)(a) and 28.3(a) of the Patent Act is the actual
Canadian filing date, and not any claim date to which the applicant may be entitled by virtue of treaty or convention.
Thus, if an invention has been disclosed to the public, it is not enough to file a patent application in a foreign
country within the one-year grace period and after the one-year grace period file an application in Canada claiming
convention priority from the foreign application (Baker Petrolite Corp v Canwell Enviro-Industries Ltd, 2002 FCA).
Disclosures by persons hired by an applicant to invest have been deemed to be disclosures by the applicant named in
a patent application, even if the invention is invented by and names different inventors (GD Searle & Co v
Novopharm Ltd, 2007 SCC).
The claim date is the critical date for applicability of prior art when assessing novelty and non-obviousness.
Novelty Under the Post-1989 Patent Act
A. Statutory Provisions
The granting provisions of section 28.2(1) of the present Act stipulate four requirements for novelty:
1. The invention must not have been 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 subject
matter became available to the public in Canada or elsewhere (section 28.2(1)(a)).
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2. The invention must not have been disclosed before the claim date by any person other than the applicant, or 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 (section 28.2(1)(b)).
3. The invention must not have been disclosed in an application for a patent that is filed in Canada by a person
other than the applicant, and has a filing date that is before the claim date (section 28.2(1)(c)).
4. The invention must not have been disclosed in a co-pending application filed in Canada by a person other than
the applicant that has a filing date that is on or after the claim date but has an earlier priority claim date (section
28.2(1)(d)).
Prior Disclosure
For a finding of anticipation the prior art must disclose the claimed subject matter such that, if performed after grant
of the patent, it would necessarily result in an infringement (Synthon).
II. Obviousness
Definitions
Available to the Public
Sections 28(3)(a) and (b) of the Patent Act stipulate that an invention must not be obvious having regard to
information disclosed in such a manner that the subject matter became available to the public in Canada or
elsewhere.
In the case of prior sale to the public or use of a chemical product, disclosure will be established if the composition
can be discovered through analysis of the product in accordance with known analytical techniques available at the
relevant time. The same is true of mixed materials, such as steel alloys. It does not matter whether any such analysis
is carried out.
The receipt of information in circumstances of confidentiality by a person who shares a “common cause” with the
applicant establishes a duty not to disclose that information for any purposes other than that for which it was
conveyed, and such information cannot be considered to have been disclosed for purposes of the Patent Act.
Claim Date
The “Claim Date” is the earlier of the filing date and the date of any patent application filed with the previous 12
months in Canada, or in any country with which Canada share convention priority rights, from which priority is
claimed and which disclosures the subject matter defined by the claim.
Divisional Patents
Where a patent specification discloses and claims more than one invention, divisional patents may be granted for the
additional inventions on the basis that the disclosure of each invention in the common specification represents
adequate consideration of the grant of the respective patent.
Doctrine of Double Patenting
Under this doctrine, a second patent that issues for an invention that has already been patented will be invalid, since
no additional consideration has been paid. Also known as “evergreening.”
Filing Date
The “Filing Date” is the date that an application for patent is filed with the Canadian Intellectual Property Office.
The Patent Act stipulates that 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.
Statutory Basis
The current statutory requirement that an invention must not be obvious is set forth in section 28(3) of the Patent
Act. Section 28(3) requires that
(a) the invention must not be obvious having regard to information disclosed more than one year before the “filing
date” by the applicant, or be a person who obtained knowledge from the applicant in such a manner that the
information became available to the public; and
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(b) the invention must not be obvious having regard to information disclosed before the “claim date” by any person
other than the applicant, or a person who obtained knowledge, directly or indirectly, from the applicant, in such
a manner that the subject matter became available to the public.
Tests for Obviousness Under the Pre-1989 Patent Act
Cripps Question
Modified Cripps Question from
Xerox v IBM
Beloit Test
Was it obvious to any skilled
chemist in the state of chemical
knowledge existing at [the relevant
date] that he could manufacture [the
invention]?
Would an ordinary skilled workman
[at the relevant date] have been led
directly and without difficulty to
[the invention]?
The question to be asked is whether
the mythical creature (the man in
the Clapham omnibus of patent
law) would, in light of the state of
the art and of common general
knowledge as at the [relevant date]
have come directly and without
difficulty to the [invention]?
However, the Court subsequently observed that the Beloit test does not appear in the Patent Act, and therefore it is
within the jurisdiction of the trial judge to make a factual conclusion on obviousness, irrespective of whether or not
the conclusion is cast in terms of the Beloit test (this found full expression in Janssen-Ortho Inc v Novopharm Ltd
and Sanofi-Sythelabo Canada Inc v Apotex Inc).
The Current Test for Obviousness - Sanofi
In Sanofi-Synthelabo Canada Inc v Apotex Inc, the SCC adopted a flexible, expansive, and contextual approach to
determining obviousness.
Janssen-Ortho Test
Is the invention obvious having regard to:
Non-Exhaustive List
Principle Factors:
(1) The claimed invention as construed by the Court.
(2) The hypothetical person of ordinary skill in the art
and the skills possessed thereby.
(3) The body of knowledge of the person of ordinary
skill in the art.
(4) The climate in the relevant field at the time of the
alleged invention.
(5) The motivation in existence at the time of the
alleged invention to solve a recognized problem.
(6) The time and effort involved in the invention.
Secondary Factors:
(7) Commercial success.
(8) Meritorious awards.
Sanofi Test
(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 be readily 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? - subject to a non-exhaustive list of
factors that should be considered if an “obvious to
try” test is warranted, namely: (a) 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? (b)
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? (c) Is there a motive provided
in the prior art to find the solution the patent
addresses?
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The decision of the SCC in Sanofi-Synthelabo Canada Inc v Apotex Inc, [2008] continues the trend from the
decisions in Janssen-Ortho Inc v Novopharm Ltd toward a more contextual approach to the obviousness inquiry in
Canada, with evidentiary factors being selected and weight in importance on the basis of the facts of each case.
In Pfizer Canada Inc v Apotex Inc, [2009] the Federal Court of Appeal, providing more guidance on the “obvious to
try” notion, noted that an invention is not obvious merely because the prior art would have alerted the person skilled
in the art to the possibility that something might be worth trying. Rather, in the event that an “obvious to try” test is
warranted, the invention must be more or less self-evident for a finding of obviousness to be established.
In Merck & Co v Pharmascience Inc, Hughes J observed that if the person skilled in the art would put expectations
of success respecting the invention so low that one would never start inquiries in that area, that can result in a loss of
“motivation,” with the result that pursuing the invention against conventional wisdom would be inventive.
Examples of Non-Obviousness
(1) An inventor of a new chemical is entitled to a patent on that chemical as well as its specific uses, if the test of
ingenuity is met. However, if the chemical is prepared by a chemical process only the chemical when produced
by the process as disclosed is eligible for a patent (Marzone Chemicals, [1978]).
(2) When a compound is mixed with a carrier, there is no inventive ingenuity involved. If you substitute a known
thing to carry out the process, it is not patentable. However, if it requires a high degree of re-jigging to make it
work or “sit well,” then ingenuity may be found. Substituting chemical batteries in a watch, vs substituting a
chemical battery for a solar-powered battery in a watch. Gas-powered cars vs solar-powered cars.
(3) The isolation of a virus that does not exist in nature may be patentable.
(4) The discovery of a new use of old compounds would meet the criterion of non-obviousness.
(5) However, where a combination of old compounds is indicated in the literature as being potentially useful for a
stated purpose, there is no invention in experimenting with the combination and demonstrating a commercial
utility for that purpose.
(6) If a new use is discovered, the patent does not give a complete monopoly to the old compound.
(7) Invention may arise where one material is substituted for another in such a manner that a better product is
created.
(8) 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. Example: cell phones.
Farbwerke Hoescht v Halocarbon
Facts: The 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 (ingenuity) 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 degrees Celsius.
Held: The trial Judge held the first patent was valid and infringed, and held the second patent to be invalid. The
Court of Appeal held both patents invalid.
Applicable Rules/Reasons:
The SCC held that the Court of Appeal had put the test of 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 that the alleged inventor has done is ascertain
whether or not the process will work successfully.” It had been suggested in writings, but it had not been carried out.
As to the second patent, the SCC held that the trial judge misapprehended the evidence of the expert in relation to
the significance of carrying out the process at 50C, 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 50C
instead of at 0C as taught by the prior art. The prior art had never previously specified that 50C was the temperature
at which the process should be carried out. The previous approaches by the trial judge and CA were too rigid and
formulaic.
KSR v Teleflex
Facts: Teleflex, Inc sued KSR International, claiming that one of KSR’s products infringed Teleflex’s patent on
connecting an adjustable vehicle control pedal to an electronic throttle control; essentially, the issue was whether the
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use of a censor to control the gas pedal was ingenius. KSR argued that the combination of the two elements was
obvious, and the claim was invalid.
Rulings: The disctrict court ruled in favour of KSR, but the Court of Appeals for the Federal Circuit reserved the
decision in January 2005.
Applicable Rules/Reasons:
The US Supreme Court unanimously reversed the judgement of the Federal Circuit, holding that the disputed claim
of the patent was obvious under the requirements of 35 USC 103 and that in “rejecting the District Court’s rulings,
the Court of Appeals analyzed the issue in a narrow, rigid manner inconsistent with s 103 and our precedents,”
referring to the Federal Circuit’s application of the “teaching-suggestion-motivation” (TSM) test. If there is
something that teaches, suggests, motivates a person to arrive at that conclusion, then most likely there is no
ingenuity involved.
Apotex v Synthelabo
“Obviousness is largely concerned with how a skilled worker would have acted in the light of the prior art. An
obviousness inquiry should follow a four-step approach.
The notional “person skilled in the art” and that person’s relevant common general knowledge must be identified;
The inventive concept of the claim in question must be determined or construed;
The differences, if any, that exist between the matters cited as forming part of the “state of the art” and the inventive
concept of the claim or the claim as construed must be identified.
A court must consider whether, viewed without any knowledge of the alleged invention as claimed, those
differences constitute steps which would have been obvious to the person skilled in the art or whether they require
any degree of inventiveness. It is at this final step that the issue of “obvious to try” will arise and the nature of the
invention in this case is such as to warrant this test.”
“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. Mere possibility that something
might turn up is not enough.”
Double Patenting
Under the doctrine of double patenting, a second patent that issues for an invention that has already been patented
will be invalid, since no additional consideration has been paid. The offence is double patenting is sometimes
referred to as “evergreening,” since the result is an extension of the term of the exclusive right, which is contrary to
the fundamental patent bargain.
Double patenting only applies where the patentee is the same for both patents. If some other person has received an
earlier patent claiming the same invention, then the second patent is to be considered in the context of anticipation
and obviousness.
Where a patent specification discloses and claims more than one invention, divisional patents may be granted for the
additional inventions on the basis that the disclosure of each invention in the common specification represents
adequate consideration of the grant of the respective patent.
IIIA. Utility
Patent law requires that in addition to novelty and inventive ingenuity (non-obviousness), for an invention to be
patentable, it must also be useful. This has been characterized as the criterion of utility. The criterion of utility is
interchangeable with the US concept of industrial application.
An invention has utility if someone skilled in the art could take the specification and construct the apparatus or
process, etc as described by the inventor. In this context, there is a nexus between specification and utility.
Utility is therefore not a matter of general operability of an invention per se, rather it deals with the specific
operability and pertinence of the invention or its conformity with what has been claimed in the disclosure. It is
immaterial that the invention may be a failure in the market. An invention must satisfy the test of utility even when
the invention offers no real benefit to the public.
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As the SCC observed in Consolboard, it suffices that “... the invention gives either a new article, or a better article,
or a cheaper article, or affords the public a useful choice.” Further, the court stated that there is no obligation on the
patentee to establish general utility in the patent.
If a person files an application for a Patent claiming for X, Y, and Z as the results, and only Z works, the patent will
stand on Z. It will not be struck out entirely; X, and Y will merely be unpatentable claims. Where a patent is filed for
X, but the outcome is Y, then the entire claim will fail where the applicant has not claimed for Y.
All that the law requires is that when a person skilled in the art seeks to produce or re-produce the alleged invention
from the specification, s/he must attain the results predicted by the inventor (Owens-Illinois v Keohring Waterous
Ltd, [1980]).
Utility in Early Patent Law
Early patent law construed and understood “utility” to mean a socially beneficial and useful invention.
Venetian Patent Act, 1474
Stated that it is clear on the need for patents to be issued only to inventions that possessed social and economic
utility.
Statute of Monopolies, 1624
Provided that patents were not to be granted to inventions that were “mischievous to the State, by raising prices of
commodities at home, or hurt or trade, or generally inconvenient” to society.
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Judicial Construction of Utility
First Era
Basic Test
Ethical/Mora
l Concerns
In-Depth
Second Era
Third Era
Utility of inventions was
construed literally.
Utility was construed
pragmatically.
Contemporary patent law. Utility
was understood to deal with
whether an invention could perform
or be worked as predicted by an
invention as per disclosure.
Patents were only to be
issued for inventions that
“performed some function
of positive benefit to
society,” provided that
such inventions scaled the
ethical hurdle.
Judges adopted a tripodal
test:
1. Does the invention work?
2. Does the invention serve
human needs?
3. Even if the invention was
immoral, was there a
redeeming quality?
Yes. Puritanical bias.
Little regard.
Rarely invoked; reserved by article
27(2) of TRIPS:
“Members may
exclude from patentability
inventions ... which is necessary to
protect ordre public or morality,
including to protect human, animal
or plant life or health or to avoid
serious prejudice to the
environment ...”
Inventions which served
the purpose of
impeding/preventing
subsequent improvements
were invalidated for lack
of utility.
To pass this test, the
invention must have the
capacity to be used for
something that is not
exclusively “immoral” or
“anti-social.”
It demands that an invention
perform whatever it claims or
purports as per its specification;
however, article 27(2) of TRIPS
has, for exceptional cases, reserved
moral and policy consideration in
determining utility of inventions.
Sex toy example.
A doctrine emerged that
unless an invention was
only useful for criminal or
fraudulent activities, it was
useful if it worked as
predicted by the inventor.
The test of utility does not speak to
the question of whether the
invention is socially or
economically useful; the test is tied
to what the applicant claims in the
specification (Doctrine of Sound
Prediction).
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Case Law
First Era
Second Era
Third Era
Morgan v Seaward,
(1837) invalidated
invention that was said to
be a device for “immoral”
and “mischievous”
purposes.
Ex Parte Murphy (“OneArmed Bandit” case) held
that while gambling may be
injurious to public morals
and society, the court could
not find any basis to justify
a conclusion that inventions
which are useful only for
gambling are void of
patentable utility.
*this was one of the
inventions that helped
establish Las Vegas*
Consolboard v MacMillan Bloedel,
[1981] the SCC held that the
requirement of utility does not
impose a duty on the applicant to
extol the virtues of the invention or
dwell on what makes the invention
superior to prior art.
Lowell v Lewis, Justice
Story advised the USSC
that “all that the law
requires is that the
invention should not be
frivolous or injurious to
the well-being, good
policy, or sound morals.”
Proof of Utility
In determining whether an invention has utility, examiners are required to look at the totality of the specification and
not limit themselves to the claims. The entire specification must be read and construed with a view to determining
“what the whole of the patent would have meant to a skilled workperson as of the date the claims were filed.”
Subject to the operation of the Doctrine of Sound Predication, the claim, however, must not exceed the invention.
In some cases, the utility of an invention can be proven by the public reception showered on the invention. This may
be inferred from commercial success of the invention. It is wrong, however, to treat evidence of commercial success
of the invention as dispositive of the question of utility, especially where some extra step had to be taken to make
the invention workable.
The Courts have held that the mere fact that some parts of the invention have to be repaired, modified, or replaced
does not make the invention lack utility. Hughes and Woodley point out, “an invention will have utility if it worked
as of the date of the invention even when, subsequently, improvements were made to make it work better.”
IIIB. Doctrine of Sound Prediction
The leading case in Canada was Monsanto v Commissioner of Patents, [1979] 2 SCR 1108. The Commissioner and
Federal Court of Appeal denied Monsanto a patent for 126 chemicals, given that only three of them had been tested.
The SCC reversed this decision, holding that the “architecture of chemical compounds was no longer a mystery but,
within limits, soundly predictable.”
Apotex v Wellcome, [2002] SCC
This is the current leading case in Canada on the doctrine of sound prediction. Wellcome identified AZT as a drug
that would work in humans against the HIV retrovirus. The SCC held that “[t]he evidence accepted by the trial judge
showed that by the date the UK patent was applied for, Glaxo/Wellcome had sufficient information about ACT and
its activity against HIV in human cells to make a sound prediction that AZT would be useful in the treatment and
prophylaxis of HIV/AIDS in human beings.”
The Court stated that the utility of an invention can be established by sound prediction where “utility can be
predicted in advance of complete testing.” “Mere speculation” is insufficient to qualify as sound prediction.
The Court devised a three prong approach to the doctrine:
1. There must be a factual basis for the prediction;
2. The inventor must have an articulable and sound line of reasoning from which the desired result can be inferred
from the factual basis; and
3. There must be proper disclosure.
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For there to be proper disclosure, “it is sufficient if the specification provides a full, clear and exact description of
the nature of the invention and the manner in which it can be practised. ... It is generally not necessary for an
inventor to provide a theory of why the invention works.” (Apotex v Wellcome)
Olin Mathieson involved a patent claim for the substitution of the -CF3 radical in the place of the -C1 radical in
chlorpromazine and a number of drugs, of which a small number had been tested. The patent was found to be valid.
Graham J stated, “normally in chemical reactions, and ... presumably also in physical interactions, it is the
functional, as it is called, or characteristic groups which are of importance.”
“The soundness of a prediction is a question of fact and is to be assessed based upon information and expertise
available at the relevant time.” (Aventis Pharma Inc v Apotex Inc, [2006] FC). The relevant time is the Canadian
filing date of an application for patent, rather than the priority date.
Purpose of the Doctrine of Sound Prediction
“The doctrine ... seeks to balance the public interest in early disclosure of new and useful inventions, even before
their utility has been verified by tests ... and the public interest in avoiding cluttering the public domain with useless
patents, and granting monopoly rights in exchange for misinformation.”
Professor’s Opinion
This is a dangerous doctrine; it results in people racing to the patent office with speculative claims.
My thoughts: these claims occupy the grey area between science and pseudoscience?
Pharmacological Prediction
The application of the Doctrine of Sound Prediction to drugs with pharmacological effects that are unknown is
problematic.
Farbwerke Hoescht v Comm of Patents
In Farbwerke Hoescht v Comm of Patents, (1966) SCC the Supreme Court warned that the “pharmacological effects
of new and untried substances are not generally predictable or, if predictable at all, are not predictable to any great
extent.”
Apotex v Wellcome
The SCC also warned in Apotex that “the predictability of chemical reactions should not be confused with the
predictability of the pharmacological effects and thus of the pharmacological utility of new substances.”
Genetic Inventions and Sound Prediction
Genes or genetic sequences as they exist in vivo, are not patentable per se. However, to the extent that fragments are
chemicals, patent protection is available if the utility is known and specifically identified by whoever isolates and
purifies them. The problem, however, is that some gene sequences have been patented simply on the basis of
homology rather than ascertained utility.
Homology and Sound Prediction
Patents on homologous genes stretch the limits of sound prediction. As the NIH and AAMC recently warned, “a
difference in a single base pair in a gene sequence can have important functional implications.”
Patents on gene sequences with unknown functions is speculative and presumptuous.
ESTs, cDNAs, and SNPs
Patents have also been granted in Canada and the US for Expressed Sequence Tags (ESTs), complementary DNA
(cDNA), and Single Nucleotide Polymorphisms (SNPs).
ESTs are short fragments of larger genes that have a variety of uses in molecular biology, including the
identification of complementary full length genes and similar homologous gene sequences within and among
species.
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cDNAs are widely used research tool for methods such as gene mapping.
SNPs constitute single nucleotide variations within genes between and among organisms. Single nucleotide
variation within a gene can result in disease development. SNPs are use frequently to locate chromosome markers to
identify genes implicated in diseases.
Death Ray Case
In the Death Ray case (X v Canada [1981] FC), X presented an application, the specification of which covered 43
pages and contained 10 claims. The crucial fact in this case that the entire alleged invention was merely speculative.
There was no certainty that the device, if ever constructed, would work or redeem the promises it made as per the
claims.
The irreducible or minimum requirement is that the invention must be reducible to a workable artifice, or product,
process, or composition of matter.
In the opinion of the board, “the test of utility of an alleged invention depends on whether, by following the
directions of the specification, the effects which the patentee professed to produce can be, in fact, produced. In the
application we are satisfied that which is described lacks utility because it is inoperable for the purpose for which it
is designed.” The reasoning was affirmed by the Federal Court of Appeal.
Novopharm v Pfizer
Pfizer owned the so-called “446 patent.” The patent claims the use of sildenafil citrate for the treatment of ED.
Sildenafil was initially developed to treat angina and hypertension; however, when testing the drug on patients
suffering from angina, Pfizer scientists noticed that patients had experienced “prolonged and spontaneous erections.”
Until that time, no oral treatment for ED had been available and existing treatment generally required drugs to be
injected directly into the penis. The patent disclosure states that “the present invention concerns the use of a
compound of Formula 1.” Formula 1 gives rise to approximately 260 quintillion chemical compounds.
The appellant (Novopharm, now Teva) argued that as of the filing date, Pfizer had not demonstrated the utility of
sildenafil; it argued the patent itself did not disclose the utility of sildenafil. Further, the appellant argued that the
study conducted by Pfizer was flawed in three ways:
1. It used erections as an end point, rather than sexual intercourse;
2. The diary data of patients were not statistically significant; and
3. RigiScan results did not necessarily indicate an ability to engage in sexual intercourse.
The Court of Appeal held that utility need not be demonstrated in the patent disclosure. There is nothing in the Act
which leads one to conclude that such a demonstration is necessary. Second, there is no a priori reason to think that
the patent disclosure should contain proof of all the elements required to obtain the patent.
The decision was appealed to the SC. See Teva v Pfizer, wherein the SC decided on the issue of sufficiency and
disclosure.
Selection Patents
Selection patents are entirely creatures of jurisprudence; the term “selection patent” does not appear in the Patent
Act. Although not restricted to chemical patents, selection patents more commonly arise in that context.
The originating (genus) patent typically refers to a group of products or processes from all of which a particular
result (or results) may be obtained or predicted. If a property, quality, or use is subsequently discovered, that
discovery may be an invention giving rise to a valid selection patent.
Sanofi-Synthelabo Canada Inc v Apotex Inc
In Sanofi-Synthelabo Canada Inc v Apotex Inc, the SCC considered the question of whether the fact that a patent had
issued for a genus of compounds necessarily means that a patent could not be issued for any compound falling
within the genus. It answered in the affirmative and described the characteristics of a valid selection patent as
follows:
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1.
2.
3.
There must be a substantial advantage to be secured or disadvantage to be avoided by the use of the selected
members;
The whole of the selected members possess the advantage in question;
The selection must be in respect of a quality of a special character peculiar to the selected group. If further
research revealed a small number of unselected compounds possessing the same advantage, that would not
invalidate the selection patent. However, if research showed that a larger number of unselected compounds
possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a
special character.
To qualify as a selection patent, the selection of known elements of another patent must be “novel,” and the
compound must possess a “special property of an unexpected character.”
Professor’s Thoughts
This, in combination with the doctrine of sound prediction, some would argue, results in the cluttering of speculative
patents.
My Opinion
Patents should consist of stages. Where one is achieved through sound prediction, it should be demonstrated to
maintain that patent.
The Limits on Patentability
Subject matter may be denied patent protection where:
it falls within a class that is specifically excluded by statute; or
it is excluded by the common law interpretation of statutory definition.
The SCC stated in Monsanto Canada Inc v Schmeiser:
“Subject matters that are specifically precluded by statute from patent protection are natural
phenomena, laws of nature, and scientific principles: s 27(8). Other subject matter has been
excluded by judicial interpretation of s 2 definitions of “invention” and “process” and s
27(8).”
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I. Non-Patentable Subject Matter
Scientific
Principles and
Abstract
Theorems
Methods of
Medical
Treatment
Section 27(8) of the Patent Act: “[n]o patent shall
be granted for any mere scientific principle or
abstract theorem.”
Includes: mathematical formulae, natural
phenomena, laws of nature, schemes,
plans, rules, and mental processes.
While patents may not be granted these theorems
or principles, patents can be granted for practical
applications in inventions (CIPO).
However, a
scientific idea with a method for its practical
application is patentable (Shell Oil v
Commissioner of Patents).
It does not include business methods.
The SCC has held that “methods of medical
treatment are not contemplated in the definition of
‘invention’ as a kind of ‘process,’ the same must
... be true of a method of surgical treatment.”
However, methods of diagnosis, treating
non-pathological conditions (aging,
pregnancy), and treating animals solely
to derive economic benefits are
patentable.
CIPO is of the opinion that surgical, medical,
dental, and physiotherapeutic methods are nonstatutory subject matter and are therefore
unpatentable.
Higher Life
Forms
Microorganisms were found to be patentable in
Application of Abitibi Co (Re), 1982.
Mammalian lifeforms have been found to be
unpatentable (President and Fellows of Harvard
College v Canada, 2002).
The SCC refused to consider patent protection for
plants in Pioneer Hi-Bred; the Plant Breeders’
Rights Act has been enacted which offers
protections short of what a patent would.
Forms of
Energy
No Canadian court has considered whether or not
signals constitute statutory subject matter within
the meaning of s 2 of the Patent Act.
CIPO policy is at odds with the
Amazon.com decision regarding
computer programs.
This does not exclude pharmaceuticals or
products including medical devices from
patentability.
The issue is where to draw the line
between lower lifeforms and higher
lifeforms, in order to determine patent
eligibility.
In Harvard College, the SCC noted that a
fertilized, genetically altered oncomouse
egg would be patentable subject matter,
regardless of its anticipated development
into a mouse.
CIPO, however, has indicated that forms
of energy are not patentable subject
matter. These include: electromagnetic
and acoustic signals, regions of the
electromagnetic spectrum, electric
currents, and explosions.
The Prohibition of Patents on Natural Products
It is arguable that the first category of patentable subject matter was machines. With the advent of the industrial age,
processes of machinery, automation, and other manufacturing processes became part of the permissible category of
patentable subject matter.The discovery of a wide array of organic compounds derived from burnt coal offered a
new world of useful products, such as medicinal agents, sweetening materials, and anti-toxins. These new products
helped to redefine the scope of patentable subject matter.
Chemical Compounds & Patents
The pharmaceutical industry is the first major offshoot of the coal tar industry. As organic chemistry blossomed, the
most important development within the context of patent law was the extraction and purification of the active
compounds of plant-based drugs. Plant-based alkaloid substances such as morphine, codeine, quinine, and cocaine
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necessitated the reconsideration of patent laws prohibition of the ban on patents of products of nature. Bayer became
the world’s first pharmaceutical company. Its first drugs were Phenactin and acetylsalicylic acid.
Shift from Stare Decisis: The New Rule
Judicial reasoning began to suggest that what was prohibited was the discovery of the properties inherent in
materials (see Sharp & Dohme v Boots, [1928]).
Thus, the new rule was that “if there was ingenuity and novelty in the preparation or extraction of a substance, and
that substance was useful, its origin in nature would not debar patentability.”
A Conundrum:
Arguably, proteins and DNA sequences are naturally-occurring polymers. Insulin occurs in nature but a patent was
granted to Dr. Frederick Banting for the method of producing the hormone secreted by the insulae of the pancreas.
Are these inventions, discoveries of natural substances?
Patents on Products of Nature
On the new theory, “purified” and “raw” forms of natural substances were distinguished. The general rule thus
emerged that the former is patentable, while the latter is not.
The process of extracting, purifying, or manufacturing many substances from their natural source is often laborious
and expensive. EG, HGH is harvested from cadaverous tissues. The tissue is not plentiful and there is the extant
danger of transmitting diseases, hence the additional cost in expense and ingenuity.
Problems with the New Rule
Arguments that justify granting patents on products derived from nature on the inventiveness of the process seem to
conflate process patents with product patents.
First, products of nature are discoveries of what already exists in nature. If a sailor who by remarkable ingenuity,
expense, and privations discovers an island, they are not entitled to a patent on the island. Thus, Dr. Banting who
discovered insulin in the islets of the pancreas should not be entitled to a patent on insulin.
Second, there is a disturbing degree of inconsistency in the jurisprudence. For example, although the new rule
permits patenting of purified compounds, purified metals (isotopes) remain debarred.
What is the difference between purified chemical compounds such as proteins, hormones, and vitamins, and purified
lead or tungsten?
GE Co v Deforest Radio: Purifying
William Coolidge of GE developed a process of purifying tungsten to high levels of purity. He brought an
infringement suit as Deforest Radio. The issue turned on whether the patent itself was valid.
According to the Court, Coolidge took Tungsten as it “existed” (WO3) or as it is found in the earth, its native abode,
and by his process converted it into pure tungsten or tungsten that is substantially pure, and, doubtless, was first to
discover that when pure it has characteristics, notably those of ductility and high tensile strength, which are wholly
different from the characteristics of impure tungsten.
What Coolidge produced was the process; through this process he purified natural tungsten, and discovered the
natural qualities of pure tungsten. It is clear that he did not create tungsten.
The Court rejected the claims relating to the product (tungsten). It upheld the claims relating to the new process of
purifying tungsten.
The Patent on Aspirin
While courts have firmly and consistently rejected patents on metallic elements, a completely different, indeed
contradictory, approach has been exhibited in respect of chemical compounds derived from nature.
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The first major breach of the rule against the patentability of biomolecules occurred in Kuehmsted v Farbenfabriken.
Kuehmsted v Farbenfabriken
The issue in this case was whether purified acetyl salicylic acid (aspirin) could be patented.
Writing for the court, Judge Grosscup reasoned that “where the one is therapeutically available and the others were
therapeutically unavailable, patentability will follow.” Effectively, the pure form of ASA was useful as a therapeutic
agent; it contributed to the arts. The Defendants did not; it was impure and unavailable, and therefore of no use.
Thus, a compound purified from a mixture was held to be patentable, even if that compound was previously known
to exist as part of a mixture, as long as the purified compound was useful in a manner that the original mixture was
not.
Parke-Davis v Mulford, [1912] 196 F 496
In this case, Judge Learned Hand based his reasoning on that of Kuehmsted.
II. Computer Related Subject Matter
The patentability of computer-related subject matter is a somewhat unsettled aspect of patent law. Generally
speaking, inventions relating to computer hardware fit into the category of “machines” which are clearly patentable
subject matter within the meaning of section 2 of the Act. The patentability of computer software programs and
processes employing computer programs is much less clear.
The reason why Bilski turned out why it did, is because the applicants claims were directed to the software; it was
not part and parcel of any machine. In contrast, Amazon the claim wasn’t just directed to the software, it was part
and parcel of a computer.
Schlumberger Case
The reasoning of the Court rested on the premise that computer programs are essentially mathematical processes or
formula which could be applied mentally. In other words, the fact that such mathematical processes are performed
by computers, and not by human beings, does not change the essential character of the subject. The calculations and
formulae were equated with “mere scientific principles or abstract theorems” for which s 27(8) prescribed that no
patent shall issue.
The Court applied a two step approach for determining whether computer-related subject matter is patentable. The
Court must ask:
“What has been discovered?”
“Is that discovery patentable regardless of whether a computer is or should be used to implement the discovery?”
This approach seems to ensure that unpatentable computer programs are not made patentable merely because they
have been integrated in a computer.
Amazon Case
The leading case in Canada on patentability of software; previously it was Schlumberger.
The Federal Court ruled that a computer system implementing the Amazon.com “one-click” ordering method
constitutes patentable subject matter. The Court stated:
“The Court finds that a purposive construction of the “system claims” clearly discloses a
machine which is used to implement Amazon.com’s one-click ordering system. The
described components (e.g., a computer) are essential elements in implementing an online
ordering process. This is not merely “a mathematical formula” which could be carried on
without a machine or simply a computer program.”
Once a computer-related subject matter is integrated as part and parcel of a machine (machines including laptops,
phones, etc) then you have a patentable subject matter. It is a matter of a nexus between the software and the
machine.
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Aftermath of Schlumberger
1. Unapplied mathematical formulae are considered equivalent to mere scientific principles or abstract theorems
which are not patentable under s 27(8) of the Patent Act;
2. The presence of a programmed general purpose computer or a program for such computer does not lend
patentability to, nor subtract patentability from, an apparatus or process;
3. It follows from 2 that new and useful processes incorporating a computer program, and apparatus incorporating a
programmed computer, are directed to patentable subject matter if the computer related subject matter has been
integrated with another practical system that falls within an area which is traditionally patentable.
The “Technical Effect” Test
A test for determining when an algorithm has entered the realm of “part and parcel” of the machine, and therefore
has become patentable.
If an invention solves a technical problem or exhibits a technical character, it would be deemed to be patentable.
Bilski v Kappos.
Specification and Disclosure
I. Introduction
There is no inherent common law right to a patent. At the heart of the bargain required by the Patent Act between
the public and the inventor, is the requirement for a specification. The object of the specification is to provide full
disclosure of the invention and to furnish a statement of the inventor’s claim upon the public.
A specification consists of two parts:
A description of the invention (disclosure); and
One or more claims.
The Public Policy Rationale for the patent bargain is that the disclosure of inventions through publication of the
specification urges the state of the art forward, promotes advances in science and technology, and encourages
broader economic activity. Amendments to the Patent Act in October 1989 resulted in automatic publication of
patent applications 18 months after the claim date, whether or not the inventor’s patent issues.
The claims proscribe the metes and bounds or the extent of the exclusive right granted by the patent (Gillette Safety
Razor Co of Canada v Pal Blade Corp, 1933 SCC). A specification may disclose several novel, inventive and useful
aspects of an invention, yet claim only a few.
In order to obtain patent protection for a subordinate element of a combination, the subordinate element must be
claimed separately (Baldwin International Radio Co of Canada v Western Electric Co, 1933 SCC).
The rule is generally that what is not claimed is considered disclaimed (Consolidated Pneumatic Tool Company Ltd
v Clark, 1906; Whirlpool Corp v Camco Inc, 2000 SCC; Monsanto Canada v Schmeiser, 2004 SCC).
Canadian courts have emphasized the primacy of the language of the claims for defining the legal boundary of the
state-conferred monopoly, on the basis that the public policy objectives of the patent system are undermined if the
scope of the patent lacks a reasonable measure of precision and certainty (Free World Trust v Electro Sante Inc,
[2000] SCC).
The requirements of the specification are set forth in ss 27(3) and 27(4) of the Patent Act. Section 27(3) requires that
the description or disclosure:
(a) correctly and fully describe the invention and its operation or use as contemplated by the inventor;
(b) set out clearly the various steps in the process, or the method of constructing, making,
compounding or using a machine, manufacture or composition of matter, in such full, clear,
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concise and exact terms as to enable any person skilled in the art or science to which it pertains, or
with which it is most closely connected, to make, construct, compound or use it;
(c) in the case of a machine, explain the principle of the machine and the best mode in which the
inventor has contemplated the application of that principle; and
(d) in the case of a process, explain the necessary sequence, if any, of the various steps, so as to
distinguish the invention from other inventions.
Section 27(4) requires that the specification
“... must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the
invention for which an exclusive privilege or property is claimed.”
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II. Parts of the Specification and Requirements as to Form
Legislation/Regulations
Description
Section 80(1) of the Patent Rules prescribes that the description must:
(a) state the title of the invention, which shall be short and precise and shall not include a
trade-mark, coined word or personal name;
(b) specify the technical field to which the invention relates;
(c) describe the background art that, as far as is known to the applicant, can be regarded as
important for the understanding, searching and examination of the invention;
(d) describe the invention in terms that allow the understanding of the technical problem,
even if not expressly stated as such, and its solution;
(e) briefly describe the figures in the drawings, if any;
(f) set forth at least one mode contemplated by the inventor for carrying out the invention
in terms of examples, where appropriate, and with references to the drawings, if any;
and
(g) contain a sequence listing where required by the Rules.
Claims
The Patent Rules contain regulatory requirements relating to claims. Claims:
(a) must commence on a new page, and the pages must be numbered consecutively. If
there are several claims, they must be numbered consecutively in Arabic numerals
beginning with the number “1” (ss 73, 85, 135(5), 171(5)).
(b) must not contain drawings, but may contain chemical or mathematical formulae or the
like (ss 74(1), 74(2)).
(c) must be clear and concise and shall be fully supported by the description
independently of any document referred to in the description (ss 84, 138, 174(1)).
(d) may be either independent or dependent. A dependent claim may only refer to a
preceding claim or claims (s 87(2)). The first claim is always independent.
(e) shall not, except where necessary, rely, in respect of the features of the invention, on
references to the description or drawings and, in particular, they shall not rely on such
references as: “as described in Part ... of the description” or “as illustrated in figure ...
of the drawings” (s 86(1)).
The Manual of Patent Office Practice stipulates that each claim must be restricted to a
single sentence (MOPOP at 11.01). Critics have argued that there is no legal basis for this
and has a negative impact on clarity.
The CIPO will object to a claim as failing to meet the requirements of s 27(4) if it recites
an element using a definite article (eg. “the,” “said”) without previously introducing the
element in the claim.
A claim will generally include a preamble, a transitional word or phrase, and a body. The
preamble generally indicates the category of the claim and may include the purpose of the
invention. The body lists the elements for which protection is being sought.
Drawings and
Photographs
Section 37 of the Patent Act makes drawings a statutory requirement where the invention
is a machine, or in any other case in which the invention admits of illustration.
Each drawing must include references that correspond to references used in the
specification (s 37), and must conform to the general rules on presentation of documents
set forth in the Patent Rules (ss 69(2-4), 72).
In any case where an invention does not readily admit of illustration by means of
drawings, photographs may be included as part of the application (s 83).
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Legislation/Regulations
Biological Deposits
and Sequence
Listings
Section 38.1 of the Patent Act requires that any reference in the patent specification to a
deposit of biological material will be taken into consideration in determining whether the
specification complies with section 27(3) of the Patent Act, but does not in and of itself
create a presumption of compliance.
Section 104 of the Patent Rules require that the deposit of biological material be made
with an international depository authority on or before the filing date of the Canadian
patent application, and that the applicant include in the description the name of the
international depository authority to the deposit, before the application is open to public
inspection.
Section 111 of the Patent Rules requires that where the description or disclosure portion
of the specification describes a new nucleotide or amino acid sequence, the description
must contain a sequence listing. A copy of the sequence listing must also be filed with the
patent application, in computer-readable form along with a statement that the content of
the computer-readable copy is the same as the sequence listing contained in the
description.
III. Legal Requirements of the Specification
Novelty, non-obviousness and utility are pre-conditions for the grant of a patent, and the application must also be in
compliance with “all other requirements” of the Patent Act, including ss 27(3) and 27(4). Thus, an invention that is
possessed of novelty, inventiveness, and utility will not benefit from patent protection if the specification is
insufficient or ambiguous. The description must explain the nature of the invention and how the invention is put into
operation. Failing either of these, the patent is ambiguous or insufficient, respectively, and the patent is invalid.
The description must enable a person skilled in the art or the field of the invention to produce it using only the
instructions contained in the disclosure (Burton Parsons Chemicals Inc v Hewlett-Packard (Canada) Ltd, 1974
SCC) and once the monopoly period is over, to use the invention as successfully as the inventor could at the time the
application was filed (Consolboard Inc v MacMillan Bloedel (Saskatchewan) Ltd, 1981 SCC).
In 1981, the SCC generalized the requirements of specification in Consolboard: “Section 36(1) seeks an answer to
the questions: ‘what is your invention? how does it work?’ With respect to each question the description must be
correct and full.” The court went on to characterize the requirements of specification using the bargain theory.
The SCC has since revisited the theme of characterizing the requirement of specification in terms of bargain theory.
In Pioneer Hi-Bred Ltd v Canada (Commissioner of Patents), Whirlpool Corp v Camco Inc, and Free World Trust v
Electro Sante Inc.
Sufficiency of the Specification and Freedom from Ambiguity
The test for ambiguity and sufficiency of specifications was stated in Pioneer Hi-Bred Ltd v Canada (Commissioner
of Patents):
“The applicant must define the nature of the invention and describe how it is put into operation.
A failure to meet the first condition would invalidate the application for ambiguity, while a
failure to meet the second invalidates for insufficiency. The description must be such as to
enable a person skilled in the art or the field of the invention to produce it using only the
instructions contained in the disclosure ... and once the monopoly period is over, to use the
invention as successfully as the inventor could at the time of his application.”
In considering ambiguity:
1. The specification must be read by a mind willing to understand and should not be defeated on a mere technicality
(Apotex Inc v Wellcome Foundation Ltd, 2002 SCC);
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2. Where a claim can, with some effort, be construed in a meaningful way, then that construction is to be preferred
over an ambiguous construction (Lubrizol Corp v Imperial Oil Ltd, 1992 FCA); and
3. If the patentee uses language which, when fairly read, is avoidably obscure or ambiguous, the patent is invalid,
whether the defect be due to design, or to carelessness, or to want of skill (Unilever PLC v Procter & Gamble
Inc, 1995 FCJ); allowance will be made, however, were there is difficulty in the language of the specification
simply because the invention itself is difficult to explain.
In considering sufficiency:
1. The question is whether sufficient information has been disclosed so as to enable a person skilled in the art to
make use of the invention (Pfizer Canada Inc v Canada (Minister of Health), 2008 FCJ);
2. There is no requirement that the inventor actually understand why the invention works in a certain way (Merck &
Co v Apotex Inc, 1995 FCJ);
3. There is no need to explain the utility of the invention (Pfizer Canada Inc v Canada (Minister of Health), 2008
FCJ); and
4. There is no need to enumerate the advantages or extol the effects of the invention in the specification
(Consolboard Inc v MacMillan Bloedel (Saskatchewan) Ltd, 1981 SCC).
Jansen-Ortho v Novopharm (2006) is instructive on the issue of sufficiency of disclosure. The case dealt with an
allegation that the patent was invalid for insufficiency on the basis that the toxicity and solubility data in the patent
failed to provide a correct, full and clear description as required by s 34(1) of the old patent act. The court held that
although the data provided was scant, the patent should not be invalidated on that basis.
Pfizer v Ratiopharm: the court held that sufficiency of disclosure should be adjudged from the perspective of a
person skilled in the relevant art.
Consolboard v Macmillan: The appellant alleged that the respondent infringed their patent of a process for the
manufacture of molded products, particularly fibre board. The issue turned on whether the appellant’s invention met
the tests of sufficient disclosure. In interpreting s 36 (now 27(3)), the court laid down the rule that in interpreting
specifications, courts must be fair to both the inventor and the public.
Best Mode
Contained in section 27(3)(c). In Canada, the best mode requirement is limited to machines; this was clarified in
Apotex v Sanofi-Synthelabo. The inventor is required, has a duty, to explain the best mode, not merely a known
mode (TRW Inc v Walbar of Canada Inc, 1991 FCA). The relevant date for assessing best mode is the filing date, or,
if convention priority has been claimed, the claim date (Teledyne Industries Inc v Lido Industrial Products Ltd, 1981
FCA).
Good Faith
The inventor must act uberrima fide in his disclosure and must give all information known to him that will enable
the invention to be carried out to its best effect as contemplated by him (Minerals Separation North American Corp
v Noranda Mines Ltd).
Failure to meet the obligations of good faith in the specification can give rise to a patent being invalidated by
operation of section 53(1) of the Patent Act, which states that a patent is void if the specification and drawings
contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or
addition is wilfully made for the purpose of misleading.
Interpretation of Disclosure
A. Extrinsic Evidence
In interpreting or construing a disclosure, only the specification itself is to be consulted; extrinsic evidence is not
permissible under Canadian patent law (Free World Trust). However, the US does permit “file wrapper” evidence or
“prosecution history” to be considered when construing the scope of a patent claim. Thus, a Canadian file wrapper
may be admissible in US patent litigation involving a counterpart US patent.
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B. Construction
The construction or interpretation of disclosures is a task solely left in the hands of the court and in interpreting the
disclosures; the court views it from the optical and intellectual perspective of the proverbial “person skilled in the
art.” This principle is borne out of the doctrine that a patent disclosure is not addressed to the court or to the public,
but to the person skilled in the art who has special knowledge (Free World v Electro Sante).
Ownership
I. The Inventor
In Apotex v Wellcome, the SCC reiterated that an inventor must meet two requirements:
1. S/he must conceive of a new idea; and
2. reduce the conception into a practical or workable device, method, process, composition of matter, or substance.
The invention must have originated from the inventor’s own mind and must not have been borrowed from anyone
else; otherwise, the patent may be invalid as the named inventor was not entitled to apply (Gerrard Wire Trying
Machines Co Ltd v Cary Mfg Co, 1928 Ex CJ).
More than one inventor may independently conceive of the same invention. Although both inventors may qualify to
file a patent application, only one patent may issue and according to Canadian law it will be awarded to the inventor
having the earliest claim date (ss 28.2(1)(c) and (d)). All inventors/joint inventors must be named in the application,
or else the application will be contrary to section 53(1) as a an untrue material allegation, and the patent will be void.
Ownership of an invention may be established by virtue of employment, assignment, agreement, or other legal
mechanism, such as inheritance. In the case of assignment, the Patent Act specifically states that every patent is
assignable (section 50(1)) and therefore may be bought and sold like any other form of property.
Where the inventor is a Public Servant, the Public Servants Inventions Act governs ownership rights and the patent
process.
II. Inventorship
Section 27(1) of the Patent Act gives inventors or assignees the right to obtain a patent. Since patents are granted to
the inventor or the inventor’s legal representative, it is vitally important to correctly identify the inventor or
inventors. This legal presumption that the inventor is entitled to the patent grant may be rebutted under certain
circumstances.
Although the Patent Act contains no definition of the term “inventor,” the SCC stated in Apotex v Wellcome that the
term can be inferred from other sections of the act, and that invention therefore involves two steps:
conception of the invention, and
its reduction to practice.
It is occasionally difficult to distinguish inventive contributions from other important but non-inventive
contributions. One who merely puts forward an idea, or suggestion, in terms of an objective or an end result has not
thereby invented anything that is necessarily patentable (Comstock Canada v Electec Ltd, 1991 FC). A person
whose only contributed is verification of the idea rather than conception is not an inventor (Apotex).
If inventors are incorrectly identified and the incorrect identification is done wilfully and for the purpose of
misleading, the pay may be held to be invalid (section 53(1)). The Courts, however, have been somewhat reluctant
to impose this unusually harsh penalty. The focus when considering an allegation of invalidity based on section
53(1) is on the materiality of the misstatement and “even an untrue statement made with something less than a
purpose to mislead, will void a patent if it is something material” (Weatherford Canada Ltd v Corlac Inc, 2010 FC).
III. Joint Inventors & Co-Inventors
There are cases where two or more persons contribute ideas and work together to reduce an innovative idea into a
working invention (the contribution is part and parcel of the invention). In such cases, the contributors are treated as
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co-inventors or joint inventors for the purposes of obtaining a patent on the invention. If any of such joint-inventors
is omitted from the patent application contrary to s 53(1), the patent is void.
The proper test is to interpret the claim so as to ascertain the essential inventive concept and then determine who
contributed that idea. It is inappropriate to divide the elements of a claim and then ask who devised each.
Thus, in order to determine whether two or more persons are joint/co-inventors, the court must first ascertain what
has been invented. When you are determining what the invention is, regard must be had to the claims in the
application. It is commonly accepted that where a person has done something that helps to solve a particular
problem, this will be regarded as inventive contribution.
In Apotex v Wellcome, the SCC clarified the dictum in Gerald Wire Tying, to the effect that, “to the extent this
suggests that an individual who contributes to the inventor concept may be a co-inventor without being the prime
originator, I agree with it. To the extent, however, that it can be read to include as inventors those who help with the
invention to completion, but whose ingenuity is directed to verification rather than the original inventive concept, I
respectfully disagree.”
Apotex v Wellcome
Background: Glaxo-Wellcome conceived of the idea that AZT, an old compound, would work in humans against the
HIV retrovirus. Glaxo-Wellcome was not equipped to undertake the required clinical testing and thus turned the
concept to other laboratories including the National Institutes of Health (NIH) for verification. NIH scientists
performed the requisite tests and in February 1985 confirmed that AZT inhibited the replication of HIV in vitro.
They advised Glaxo-Wellcome accordingly. In March 1985, Glaxo-Wellcome filed in the UK the patent application
from which the Canadian patent claims priority.
In a suit for infringement of the Canadian patent, Apotex countered, inter alia, that the Canadian patent was invalid
for the misleading nature of the disclosure in that the specification did not name NIH scientists who had performed
the verification as ‘co-inventor’ alongside Glaxo/Wellcome.
Issue: The question on this point was whether the NIH scientists were co-inventors, and if so, whether the omission
of their names was a misleading non-disclosure contrary to s 53(1) of the Patent Act.
Held: The SCC held that in the steps leading from conception to inventorship, the inventor may utilize the services
of others, who may be highly skilled, but those other persons may not be construed or regarded as co-inventors
unless they participated in the inventive concept as opposed to its verification.
IV. Employer-Owned Inventions
The rules detailed above only apply in relations devoid of the legal incidents of employee-employer relationship.
The law on ownership of inventions in cases where there are no compulsory assignment of patent rights has
developed into two categories:
Where the inventor is specifically hired to invent; and
Where the employee is generally inventive but has no specific responsibility or obligation imposed by the employer
to invent.
Hired to Invent
In cases where the employee is specifically hired to invent, whatever invention that comes from such employee
belongs to the employer (Devoe-Holbein Inc v Yam, 1984 CIPR). As long as the invention was made during the
duration and in furtherance of the contractual engagement, ownership rights will vest in the employer (Seanix
Technology Inc v Vladislav Ircha, 1998 WWR).
The law suggests that there is an implied contract to assign employee inventions to the employer, but every case will
depend on its facts. This implied term of contractual relationships may, however, be displaced by a contrary legal
agreement (Seanix Technology Inc v Ircha, 1998 CPR).
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The employee is often deemed to be the trustee of any invention made by him/her in the course of his/her
employment. The employer may thus act as the legal representative of the employee.
Where, in spite of a contract of employment, the employee develops an invention outside of the work assigned to
him/her, and in his/her spare time, ownership rights on the invention may, in the absence of an agreement to the
contrary, vest in the employee. The question of whether an implied agreement to assign exists between the employer
and the employee is one of fact.
Not Hired to Invent: Inventive Employee
This second category covers those cases where an employee is hired for a general purpose without expectations that
s/he would invent things, but because s/he is inventive, some inventions are developed by him/her in the course of
employment.The law suggests that where such employee uses the tools or resources of the employer, or makes the
invention in the course of work, there may be a deemed assignment of the invention and rights thereto to the
employer.
In cases where there is considerable doubt as to whether the employee used the resources of the employer, the courts
may approve the equitable remedy of creating a “shop right” for the employer. This is a defense; it functions as a
kind of shield. “Shop right” authorizes the employer to make use of the invention and shields him/her from any
action in infringement. Thus, the employee gets the legal title, but the employer enjoys some equitable benefits such
as non-infringing use.
Spiroll Corp v Putti, BCSC
Background: The Plaintiff employed the Defendant to operate a machine for manufacturing pre-cast, pre-stressed,
hollow-core concrete slabs used for flooring. The Defendant was hired as a mechanic and by remarkable talent
became the mechanical superintendent in charge of all machines at the plant operated by the Plaintiff. The
Defendant greatly improved on the performance of the machine in issue by identifying the problem with breakages
of hollowed concrete slabs manufactured by the employer. The Defendant thus applied for and obtained patents on
the improvement made to the machine.
Issue: Whether the patents on the improved machine belonged to the employer. To determine this, the Court needed
to consider: but-for his employment at Spiroll, would the Plaintiff have been able to create this invention?
Held: The Court concluded that upon case law, there is no principle of law that supports the notion that mere
employment, ipso facto, obligates the employee to deliver up his/her invention to his/her employer.
Obiter: “I take this to mean that a court must first find what the employee is engaged to do and, if he invents
something while performing that function, it belongs to the employer. If he is employed to design then it would be a
“normal incident” of his contract of employment that he should do so and that the result of his ingenuity should
belong to his employer.”
Public Servants
Inventions made by persons employed by the federal public service must be disclosed to the appropriate Minister
and the patent rights thereto belong to Her Majesty in Right of Canada IF:
The person made the invention while acting within the scope of his/her duties;
Used government facilities.
The Public Servant affected by this law may be given an award (Public Servants Inventions Act, s 10; Patent Act, s
20).
Inventions of War Munitions
Section 20 of the Patent Act prescribes that any public officer or employee, acting within the scope of his/her duties
who invents munitions of war, must, if required by the Minister of Defence, assign the same to the Minister of
Defence. These require some degree of privacy and secrecy. Compensation would, however, be paid.
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Infringement
I. Introduction
The Canadian Patent Act does not define infringement per se. Instead, it grants to the patentee and the patentee’s
legal representatives “ ... the exclusive right, privilege and liberty of making, constructing and using the invention
and selling it to others to be used ...”
The key phrase here is “from the granting of the patent” - the rights commence upon the grant of the patent. Until
the patent actually issues, the applicant has no legal rights or recourse.
II. Infringement Analysis
The patentee in a patent infringement action is interested in achieving a claim construction that is broad enough to
readily find infringement by an infringing article at the infringement analysis, but at the same time achieving a claim
construction that is narrow enough to avoid a finding of invalidity during the validity analysis.
The correct question to ask at the beginning of an infringement analysis is: does the alleged infringing article fall
within the scope of the claims?
Construction of the claims is generally considered a matter of law, and is typically a larger task than determining
infringement. The infringement analysis is a matter of fact (Western Electric Co v Baldwin International Radio Co
of Canada, 1934 SCC).
III. Claim Construction
Infringement is an issue of law and fact (Free World, 2004). This is because the construction of the claim is a
question of law; you are determining whether a set of rights exists. The issue of whether the defendant’s actions fall
within the scope of the rights covered by the claims conferred on the patentee is a question of fact.
In the United States, the “pith and marrow” approach posits that an infringement occurs when a defendant
unlawfully takes, makes and uses the pith and marrow of an invention. The Courts are effectively purporting to
distinguish between the pith of an invention and its “bells and whistles.” This is known as the doctrine of
equivalents.
In Canada, however, it is settled law that the correct approach is the purposive approach (Free World).
The Doctrine of Equivalents
The doctrine of equivalents is founded on the theory that, if two devices do the same work in substantially the same
way, and accomplish substantially the same result, they are the same, even if they differ in name, form or shape.
In determining equivalents, consideration must be given to the purpose for which an ingredient is used in a patent,
the qualities it has when combined with other ingredients, the functions which it is intended to perform, and whether
persons reasonably skilled in the art would have known of the interchangeability of an ingredient not contained in
the patent with one that was.
In applying this doctrine, the court determines what constitutes the essential components of a device. If the invention
is a mechanical device, for example, the test is one of mechanical equivalence. The test looks for the equivalent of
what was allegedly taken by the infringer (Warner-Jenkinson v Hilton Davis, 1997).
In making a factual determination of infringement, the test would have to determine whether the alleged infringer’s
device interfered with the monopoly enjoyed by the original patented mechanical device. Similarly, if the invention
if the invention is a chemical compound, the issue would be whether the patented substance differs from similar
compounds of the same class (Warner-Jenkinson v Hilton Davis, 1997).
A defendant is liable for infringement even where the alleged infringing device or product does not appropriate the
express description of the invention as articulated in the disclosure and claim. The substance of the claim would be
infringed where the offending article is the equivalent of the original.
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The current state of the law on the Doctrine of Equivalents is that quite apart from the Triple Identity Test, an
important factor to be considered is “whether persons reasonably skilled in the art would have known of the
interchangeability of an ingredient not contained in the patent with one that was.”
Triple Identity Test: Function-Way-Result
The US Doctrine of Equivalents is effectively a triple identity test. The doctrine of equivalents requires proof of the
fact that the alleged infringing invention offers substantially the same:
Function;
Way; and
Result.
The test looks at whether the alleged infringing article performs the same function, in the same way, and produces
the same result as the patented subject matter. The purpose is the protection of the alleged ‘substance’ of the
invention by rejecting “colorable” differences and slight improvements as patentable subjects.
This test offers little protection when the alleged infringement pertains to inventions of great sophistication and
subtlety, where the slightest difference or nuance could make radical differences between the allegedly infringing
product and patented product. Moreover, as technology becomes more sophisticated, and the innovative process
more complex, the function-way-result test may not invariably suffice to show the substantiality or even profoundly
nuanced differences. The Triple Identity Test seems inadequate in contemporary times.
The Triple Identity Test found its way into Canadian patent law in the 1960s and 1980s (McPhar), but it seems to
have been eclipsed by what is referred to as the “purposive approach.”
McPhar Case, 1960
Facts: The Plaintiff obtained a patent for an apparatus for detecting subterranean ore bodies. A crucial unit of the
device was a suspended transmitting coil. The Defendant achieved the same result by supporting the transmitting
coil on a mast erected on a tripod.
Issue: Whether the Defendant infringed the Plaintiff’s patent.
Held: The Defendant took the “substance” of the Plaintiff’s invention; yes, infringed.
Purposive Approach
Section 12 of the Interpretation Act justifies the purposive approach to the interpretation of claims.
In Whirlpool v Camco, 2000 the SSC revisited the issue of whether a claim must be construed literally or
purposively. In the opinion of the court, the key to purposive construction is identification by the court of the
particular words or phrases in the claim that describe what the inventor considered to be essential elements of the
invention.
The purposive approach seeks to understand what the purpose of the original invention is, having regard to the
claims in the patent (Whirlpool). Since the SCC decision in Free World v Electro Sante, it is settled law that courts
in Canada construe the claims in a purposive manner to determine whether the defendant’s conduct infringed on the
rights of the patent holder.
By using such an approach, the inventor is not necessarily tied to the letters of the claims, but to the intended
meanings of the words and phrases used in the claims. Although it is apparently slanted in favour of the patentee, it
can be “cut either way” (Justice Binnie, Whirlpool). Thus, a purposive construction is capable of expanding or
limiting a literal test, and it is not necessarily a broader construction than a purely literal one. A purposive approach
looks at the context of the claims.
IV. Who Can Sue for Patent Infringement?
A person who makes a claim for patent infringement must be able to show the link between their use of the patent
and the patentee or they may not have a valid cause of action. This requirement is made explicit in at least two
places in the Patent Act. Section 42 provides that:
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“Every patent granted under this Act shall contain the title or name of the invention, with a
reference to the specification, and shall, subject to this Act, grant to the patentee and the
patentee’s legal representatives for the term of the patent, from the granting of the patent,
the exclusive right, privilege and liberty of making, constructing and using the invention
and selling it to others to be used, subject to adjudication in respect thereof before any court
of competent jurisdiction.”
Section 55(1) provides:
“A person who infringes a patent is liable to the patentee and to all persons claiming under
the patentee for all damage sustained by the patentee or by any such person, after the grant
of the patent, by reason of the infringement.”
A person who is “claiming under the patentee” may include exclusive and non-exclusive licensees, as well as
purchasers of patented articles. This list is non-exhaustive. The Patent Act further requires that the patentee “shall be
or be made a party” to any action for patent infringement.
V. What Constitutes Infringement?
In general, infringing activities are those that interfere with the rights granted exclusively to the patent holder.
Reference to bargain theory is helpful when considering what activities may be infringing - in that if a given activity
effectively deprives the patentee of its rights under the “bargain,” then the activity should be deemed an infringing
activity.
When it comes to patented improvements and infringing, section 32 provides:
“Any person who has invented any improvement on any patented invention may obtain
a patent for the improvement, but he does not thereby obtain the right of making,
vending or using the original invention, nor does the patent for the original invention
confer the right of making, vending, or using the patented improvement.”
This is to say that each patent is independent. It is possible that more than one party may own the patent rights to
different, but equally essential, pieces of a given technology. Legally, neither can force the other to share, although it
is typically in both parties’ best interests to arrive at some kind of agreement; perhaps a sale or cross-licensing
agreement.
Making and Constructing
Someone who assembles or builds the invention, as claimed in a patent, is potentially liable for infringement of that
patent.
Manufacture for Export
In addition to straightforward manufacturing for sale locally, infringement can be found where the components of a
machine destined for sale outside of Canada are made locally and temporarily assembled for testing purposes only.
This activity was held to constitute infringement of the entire assembled machine, even though the machine was
later disassembled without being used and exported from Canada in a disassembled condition (JM Voith GmbH v
Beloit Corp, 1993 FC).
Manufacture of Kits
The manufacture and sale of a series of components in the form of a kit, including instructions, that when
assembled, result in an infringing product, is an act of infringement. In Windsurfing International Inc v Bic Sports
Inc, the court held that a kit sold by Bic Sports resulted in a sailboard that infringed Windsurfing’s patent; this is
inducement to infringe the patent, itself an act of infringement.
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Manufacture of Parts
Repairing a lawfully acquired patented article does not constitute infringement, but reconstruction of the same
article is an infringing act (Rucker Co v Gavel’s Vulcanizing Ltd, 1985 FC).
Partially Filled and Unfilled Contracts Involving Infringing Articles
A party will be liable for infringement where that party has irrevocably committed to pay for wares that were in
existence at the relevant date, even though those wares were not actually in possession of that party and the funds
had not been remitted (Teledyne Industries, Inc v Lido Industrial Products Ltd, 1981 FC).
Use of a Patented Invention
Generally, “use” connotes “utilization with a view to production or advantage” (Monsanto Canada Inc v Schmeiser,
2004 SCC).
Sale of a Patented Invention
Fairly obvious.
Goods Not Yet Made
Liability for infringement may still exist where there is a contract to sell infringing goods in Canada even if those
goods have not yet been made.
Sale and Delivery Taking Place Outside of Canada
It has been held that where delivery or possession of patented goods takes place outside of Canada, and where there
is no proven contract for sale of the goods in Canada, then the bending has not occurred for the purpose of
establishing infringement, even though the patented goods are offered to Canadian customers who would be using
the goods in Canada (Domco Industries Ltd v Mannington Mills Inc, 1988 FC).
Sale or Use of Product Made Using a Patented Invention
It is infringement of a process patent to sell a product made by a patented process without permission from the
patentee. Additionally, section 55.1 provides that:
“In an action for infringement of a patent granted for a process for obtaining a new
product, any product that is the same as the new product shall, in the absence of proof to
the contrary, be considered to have been produced by the patented process.”
This has the effect of shifting the burden of proof from a patentee who would normally have to demonstrate
infringement to the alleged infringer who must show that the product was, in fact, not made using the patented
process.
Importing a Patented Invention
The Act of importation of an infringing article is an act of infringement (Farbwerke Hoechst v Halocarbon
(Ontario) Ltd, 1979; Eli Lilly & Co v Apotex, 1998). Sale or importation for sale of a product made in a foreign
jurisdiction using a patented process, alone or in combination with other process steps, can infringe a process claim,
even if that patent has no claims to the product itself (American Cyanamid v Charles E Frosst & Co, 1965).
VI. Inducement to Infringement
Another way to find liability for patent infringement is through inducement to infringe. This occurs where one party
induces another to infringe a patent. In 2002, the modern version of the test for inducement to infringe was outlined
as having three components:
“A patentee wishing to rely on the doctrine of induced infringement must allege and
prove each of the following elements:
(a) that the act of infringement was completed by the direct infringer;
(b) the completed act of infringement was influenced by the seller, to the point where
without said influence, infringement by the buyer would not otherwise take place;
and
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(c) the influence must knowingly be exercised by the seller, such that the seller knows
that his influence will result in the completion of the act of infringement.”
One area where inducement to infringe can have expensive consequences is the area of off-label use of
pharmaceutical products. This is the kind of scenario that occurred in the case of Sanofi-Aventis Canada Inc v
Novopharm Ltd, 2006 FC.
“Infringement of a use claim by a person other than a generic drug manufacturer may
occur because of the “off label” use of drug products. [...] A generic drug manufacturer
may be implicated in the infringement by others of a claim for a new use of a medicine
if the generic drug manufacturer induces that infringement. Infringement by inducement
may be established, for example, by inferences reasonably drawn from the contents of
the product monograph for the generic drug product, or evidence relating to the dosage
form of the generic product, or its labelling or marketing. However, an inducement to
infringe generally cannot be inferred from a mere reference to the new use in the
product monograph, for example, in the course of explaining contraindications or drug
interactions, or as part of a list of scientific references.”
VII. When Does Infringement Occur?
What, if any, time limits exist on a patentee’s allegations of infringement? The answer depends on which version of
the Patent Act applies, as well as provincial legislation regarding limitation periods. Where a patent is governed
exclusively by the most recent version of the Act, then acts are subject to an express limitation period of six years. In
versions of the Act were no period is specified, the laws of the province in which the infringement occurred will
govern.
A. Time Limits in the Patent Act
There are several time constraints on infringement set out in the Act. Sections 55(1) and 55(2) of the Act set out the
basic rules of liability for two time periods: the period after the patent is granted and the period between publication
and the grant of a patent:
(1) A person who infringes a patent is liable to the patentee and to all persons claiming under the
patentee for all damage sustained by the patentee or by any such person, after the grant of the
patent, by reason of the infringement.
(2) A person is liable to pay reasonable compensation to a patentee and to all persons claiming under
the patentee for any damage sustained by the patentee or by any of those persons by reason of any
act on the part of that person, after the application for the patent became open to public inspection
under section 10 and before the grant of the patent, that would have constituted an infringement of
the patent if the patent had been granted on the day the application became open to public
inspection under that section.
These general rules are subject to two additional constraints imposed by the Act. First, there is a six-year limitation
period on any claim for infringement. Second, anyone who acquires the patented article before the claim date may
continue to use or sell the patented article without infringing the patent.
This means that to determine whether a claim for a patent infringement may be brought one must consider the date
of the alleged infringing activities in comparison with:
1. the claim date of the claims alleged to be infringed;
2. the publication date of the patent application;
3. the issue date of the patent; and
4. the date that the court action is filed.
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B. Other Limitation Periods
Earlier versions of the Act where no limitation period is specified are governed by the laws of province in which the
infringement occurred. Limitation periods typically run from the time that person with the claim knew, or ought to
have known, that there was a recoverable injury.
Section 39(2) of the Federal Courts Act provides another potential limitation period: “A proceeding in the Federal
Court of Appeal or the Federal Court in respect of a cause of action arising otherwise than in a province shall be
taken within six years after the cause of action arose.”
The Limitation period in Ontario is two years; in NS it is 6 years.
C. Limitation Periods Do Not Apply to Defences
Merck & Co v Apotex (2006) is the only case which deals with this issue. In that case, the Federal Court of Appeal
overturned the trial courts decision that limitations periods applied to defences.
“In my view on a plan reading of both subsection 39(2) of the [Federal Courts Act] and
section 55.01 of the [Patent] Act, neither is applicable to limit the Apotex defences of
infringement. [...] Clearly, these limitation periods apply only to a plaintiff alleging
infringement and not to a defendant.”
Exceptions to Infringement
I. Statutory Exceptions
There are certain acts which may interfere with the property rights of patentees, but are statutory exemptions,
removed from censure under law. The main exceptions to infringement are found in the Patent Act. The categories
of infringing acts exempted from damnation include:
Private use;
Information required by the government;
Experimental purposes;
Exemptions for trials on generic medicinal products;
Medical preparations;
Public safety use under the WTO/TRIPS;
Visiting aircrafts, ships, and other vehicles;
Farmers’ privileges; and
Use before priority date.
Private Use
Generally speaking, the use of a patented device in private and for a non-commercial purpose is not actionable. The
crucial elements are the “private use” and “non-commercial” purpose.
Privacy in this context is not coterminous with “secrecy.” A private use been judicially defined as that type of use
carried out solely for the individual’s personal use, or possibly for “friends or family but not for the benefit of the
public at large.”
Non-commercial use is defined as use devoid of economic benefit for the user. The non-commercial purpose must
be the only purpose.
Information Required by the Government
Section 55.2(1) of the Patent Act provides that:
“it is not an infringement of a patent for any person to make, construct, use or sell the
patented invention solely for uses reasonably related to the development and submission of
information required under any law of Canada, a province or a country other than Canada
that regulates the manufacture, construction, use or sale of any product.”
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See also section 55(2)(4).
Experimental Use
The Patent Act does not contain any provisions which specifically exempt general experimentation and research
from infringement. As already noted, section 55.2(1) is limited to those cases where the would-be infringer is
required to submit the information for purposes of regulatory approval.
Section 55.2(6) of the Patent Act raises a measure of uncertainty as to the existence or otherwise of a statutory basis
for a defence in experimentation with patented subject-matter. The provision reads:
“for greater certainty, subsection (1) does not affect any exception to the exclusive property
or privilege granted by a patent that exists at law in respect of acts done privately or in
respect of any use, manufacture, construction, or sale of the patented invention solely for
the purpose of experiments that related to the subject-matter of the patent.”
It has been argued by Stephen Ferance that if there is a defence of experimentation at common law, the effect of
section 55.2(6) is to leave matters the way they are.
The defence of experimental use is well-established in case law on section 55 of the Patent Act and at common law
(Micro Chemicals Ltd v Smith Kline; Cochlear Corp v Cosem; Dableh v Ontario Hydro).
At common law, the experimental use exemption was available where “a man makes things merely by way of a
bona fide experiment, and not with the intention of selling and making use of the thing so made for the purpose of
which a patent has been granted, but with the view of improving upon the invention the subject of the patent or with
the view of seeing whether the improvement can be made or not, that is not an invasion of the exclusive rights
granted by a patent” (Frearson v Loe, 1878).
Effectively, the law allows for some kinds of inquiries for the purposes of improving upon a patented subject matter.
To that extent, the person can interfere with the property rights of the patentee. However, this line is drawn at the
point of imminent profit.
Section 32 of the Patent Act allows a researcher to apply for a patent on the improvement,
“Any person who has invented any improvement on any patented invention may obtain
a patent for the improvement, but he does not thereby obtain the right of making,
vending or using the original invention, nor does the patent for the original invention
confer the right of making, vending or using the patented improvement.”
Research Exemption in the US
The US has one of the most liberal regimes, and the case law is also much more liberal when it comes to
experimentation. For example, Justice Scalia penned the majority decision in Merck v Integra Lifesciences, in which
the USSC held that the use of a patented compound in preclinical studies is exempt from patent infringement where
there is a reasonable basis for believing that the compound could be the subject of a regulatory filing to the USFDA,
or where the experiment may produce information for use in a USFDA submission.
Merck v Integra Lifesciences
In a unanimous decision, the USSC set aside the Federal Circuit’s holding that narrowly interpreted the statutory
safe harbour of section 271(e)(1). Writing for the Court, Justice Scalia found that “[a]s an initial matter, we think it
apparent from the statutory text that section 271(e)(1)’s exemption from infringement extends to all uses of patented
inventions that are reasonably related to the development and submission of any information under the FCDA.”
This includes:
Clinical and Preclinical studies of patented compounds that are appropriate for submission to the FDA;
Studies intended to generate pharmacological, toxicological, pharmacokinetic, and biological qualities of the drug in
animals;
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Studies intended to generate information regarding a “risk-benefit assessment of the appropriateness of [a proposed
clinical] trial”; and
Safety related tests even if not compliant with FDA regulations.
The Court recognized that “scientific testing is a process of trial and error.” As such, section 271(e)(1) must also
protect research for which an IND (Investigational New Drug) is not ultimately filed.
Experimental Use in Canada
In Micro Chemicals v Smith Kline & French, the SCC expanded the experimental use defence by holding that the
defence was not limited merely to improvements. The SCC held that activities which were for the purpose of
enabling the defendant the determine whether it could produce the invention commercially were held to be bona fide
experimentation because it was “not for profit.” In other words, the making of a patented substance to ensure that a
quality product could be produced using the specifications in the patent was held to constitute experimental use and
thus exempt from infringement clauses.
Rationes of Micro-Chemicals
It seems that the rationes decidendi of the Micro Chemicals case is that the law does not regard testing or
preparation to be an infringing use. On its face, activities in the testing phase are “not for profit” and therefore are
exempted use of patented subject-matter.
In Cochlear Corp, it was held that the experimental use defence will apply until the defendant “at some stage of its
product development takes steps to manufacture, promote, and sell it.” This stage, where it becomes “for profit,” is
effectively the Rubicon Line for infringement.
The defence was applied in Micro Chemicals because the experimentation was geared towards determining how the
active ingredient in the drug would be produced and whether production would be economical. It was rejected in
Wellcome v Apotex because Apotex and Novopharm were importing the active ingredient, rather than attempting to
produce it.
Trials on Generic Medical Products
Under NOC (Notice of Compliance) regulations, allowance is made in Canada for certain trials and tests for the
regulation of generic drugs. The regulatory approval is largely designed to obtain information about tests, clinical
trials, etc (see section 55(1)).
There are also cases where the products are not “generic” but are similar/derivatives. In such cases, appropriate
regulatory agencies may require test results showing that they are safe and efficacious.
Visiting Ships and Aircrafts
Section 23 of the Patent Act provides that:
“no patent shall extend to prevent the use of any invention in any ship, vessel, aircraft or
land vehicle of any country entering Canada temporarily or accidentally if the invention is
employed exclusively for the needs of the ship, vessel, aircraft, or land vehicle, and not so
used for the manufacture of any goods to be sold or exported from Canada.”
Use Prior to Patent
Persons who have prior to the priority date done an act or purchased patented inventions are at liberty to continue
the use of such inventions. Questions may arise whether such a person is permitted to expand his/her operation. It
would seem to follow that as long as the production is continued by the same person for the same business, s/he can
do so.
Farmer’s Rights
It is now settled that farmer’s in many jurisdictions retain traditional “farmer’s right” over patented seeds. This is a
fairly contentious issues.
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A Farmer’s Right in the “right” to replant or use second-generation seeds for subsequent farming seasons. Note that
this right is increasingly being curtailed by the use of different types of licensing agreements. Farmer’s rights have
effectively disappeared today.
Doha Exceptions
Pursuant to the DOHA regulations, section 21 of the Patent Act was amended to permit the Minister of Health to
authorize the manufacture and distribution of generic drugs to HIV/AIDS stricken areas of the world.
II. Mens Rea in Infringement
Patent law does not countenance “intent” as an element of the legal test in determining whether infringement has
occurred; it was a strict liability regime. However, the emergence of genetic patents challenges the implicit
assumptions of patent law on the factual characteristics of actions which infringe patented inventions. For example,
the dispersal of patented genes by forces of nature does not quite fit with the imagery of an infringer as a methodical
thief of intellectual property.
In particular, is a person who by no individual fault comes into possession of adventitious patented genetic material
liable to the patentee for infringement?
This question arises because of the unique ability of certain biotechnological inventions to escape the control of their
lawful owners. Biotechnological products, particularly transgenic products, are unique at least in one respect: they
can and do replicate themselves in a manner outside the control of either the patent holder or the alleged infringer.
Prof: IMO, in such cases, damages should be minimal, an injunction.
Biotechnology and Mens Rea in Infringement
Although the element of intent in infringement of patents has largely been dealt with by the courts for decades,
primarily in relation to the assessment of damages, traditional patent law doctrine has long been of the view that in
most cases, intent is irrelevant when considering the issue of infringement. However, none of the old cases have
dealt with the issue in relation to the specific question of whether the old doctrine sits well with new technologies.
Two recent cases, Monsanto Canada Inc v Schmeiser and Hoffman v Monsanto Canada Inc, have somewhat
broached the issue.
Monsanto v Schmeiser
Facts/Background: In this case, Monsanto successfully argued that ownership of a patent for a molecularly
engineered plant patent gene and transgenic plant seed entitled it to full control over stray plants and progeny
containing the gene. The suit alleged that Schmeiser planted glyphosate-resistant canola for harvest, without a
license from Monsanto.
Issue: Whether a person can be said to have infringed the patented invention without as much as intentionally
planting the patented crop in question.
Held: Mackay J held that a person may be liable for infringing a genetic patent even in cases where genetic pollution
or promiscuity was in fact an act of forces or factors beyond the control of the alleged infringer.
Mens Rea Continued
A recent survey of court decisions in the US and Canada on infringement yields the impression that infringement is
unquestionably a strict liability tort. This can cause people to wonder whether it is really necessary in cases of
infringement of genetic patents that a court should consider the element of intent.
It appears that ignorance of the law is an ambiguous point of law in infringement cases. To resolve the ambiguity, a
distinction must be drawn between ignorance of the legal consequences of the act in question on the one hand, and
the absence of intent on the part of the alleged infringer on the other hand. Ignorance of the law, and thus of the legal
consequences of an act, is no excuse.
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Thus, a person who consciously conducts certain activities incompatible with the rights of a patentee, although she
or he was oblivious of the legal consequences of such an act, cannot escape liability on infringement by pleading his
ignorance of the legal consequences of acts of infringement.
Generally speaking, liability in patent infringement is strict. However, this characterization is only partially correct.
To the extent that a defendant may be held liable without having any notice, prior to the filing of an infringement
action, that his/her conduct was infringing, the tort of infringement may be described as one of strict liability. Thus,
on its face, unintentional or inadvertent infringement is not a defense to a patent infringement.
Approaches of Other Jurisdictions
In some cases, however, there are both statutory and judicial bases in some jurisdictions such as the US and England
for the view that infringement is an objective as opposed to an unforgiving regime of strict liability.
First, in the US, while assessing damages for infringement, courts take into account the element of intent. Indeed, in
such cases, courts subscribe to the test of “whether the infringer, acting in good faith and upon due inquiry, has
sound reason to believe that it had the right to act in the manner found to be infringing” (SRI Int v Advanced
Technology Lab, 1997).
Second, and with specific regard to the finding of liability in infringement, courts in England have held that in cases
pertaining to the use of a process, intent is required to show that the putative infringer knows or it is obvious to a
reasonable person in the circumstances that the use of the process is infringing.
Third, in cases pertaining to supplying means of putting a patented invention into practice, intent is equally required
to prove that the putative infringer knows or it is obvious to a reasonable person in the circumstances that the supply
of the means in question is suitable for putting the invention into use and thus infringing.
Fourth, in English patent law, intent is a crucial element in infringement cases where the patent at bar claims a
product of which is to be used in a particular way.
Defences and Remedies
I. Defences
1.
2.
3.
4.
5.
6.
A denial of infringement;
Leave and license of the patentee;
A denial of the Plaintiff’s Title;
Estoppel;
Lapse of the letters patent prior to the acts complained of; and
Invalidity of the letters patent sued upon.
Denial of Infringement
Generally speaking, a denial of infringement is used as one of the defences where the alleged infringing device or
process differs (even slightly) from that disclosed in the patentee’s specification. The Defendant must prove that the
acts complained of did not infringe on the Plaintiff’s patent, or that the scope of the Plaintiff’s claims does not
capture the alleged infringing device.
Where there is infringement, the five other defences may be invoked.
Leave and License of the Patentee
A Defendant may plead that the acts complained of were done under the leave and license of the Plaintiff or of his
predecessor in title. The onus here rests on the Defendant.
Where the terms of the license have not been complied with by the Defendant, the Plaintiff is not estopped. A plea
of leave and license of the Plaintiff cannot be joined with a denial of infringement. Similarly, such a plea cannot b
joined with that of invalidity of the patent.
Denial of the Plaintiff’s Title
This defence is very narrow and relies solely on the abstract of title obtained from the Patent Office. The kernel of
the Defendant’s contention is that the Plaintiff is not the person named on the abstract of title as the patentee.
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Estoppel
Where, in a prior action, the validity of a patent has been unsuccessfully attacked, such a decision does not stop a
different Defendant in a subsequent suit from pleading the invalidity of the same patent. Discontinuance of the old
action does not operate as res judicata.
However, estoppel may arise where the court feels itself bound by a construction put upon the specification by
another court in a prior suit. The proviso is that the prior construction must pertain directly to the same document
without any new consideration of other factors such as novelty, utility, or proper subject-matter.
For the Doctrine of Estoppel to apply, the facts and the issues before the Court should be substantially the same as
those considered in the previous action. A court will usually feel free to disregard a prior construction only when
new facts are presented; new arguments will not suffice. However, where the new attack on the Patent is on new
grounds, estoppel will not apply.
In construing estoppel, parties must ascertain:
1. Whether the issues alleged estopped were interlocutory or final orders;
2. the particulars of the pleadings in the original trial;
3. the particulars of the breaches as specified in the pleadings;
4. the parties; and
5. particulars of the objections in the previous action.
Lapse of the Patent Sued Upon
It is a good defence to the action if the Defendant can assert and prove that the letters patent on which the Plaintiff
bases his action have lapsed prior to the acts complained of. The patent must have lapsed prior to the acts
complained of, and not merely prior to the action brought.
A patent may lapse for non-payment of statutory maintenance fees. See Dutch Industries v Commissioner for
Patents.
Dutch Industries v Commissioner for Patents
Facts: The Patentee paid lesser fees (as a small entity) for some time. Within the period when the lesser were paid,
acts of infringement were performed by the Plaintiff. It was later discovered that the Patentee was not a “small
entity” and as such was not entitled to pay the lesser fees. The Commissioner unilaterally allowed the patentee to
“top up” the fees so as to re-validate the patent.
Issue(s): Whether the Commissioner had discretion under section 27(1) of the Act to top up the fees. Whether the
Plaintiff infringed the Defendant’s patent.
Held: The Federal Court sided with the Plaintiff in holding that the Commissioner had no discretion under section
27(1) to top up the fees. Thus, the patent had lapsed before the acts complained of occurred, and there was no
infringement.
Invalidity of the Patent Sued Upon
This is the most important defence. Although a patent is presumed valid once issued, the presumption is rebuttable.
The defence of invalidity divides itself into several independent sub-defences, each of which, where applicable,
must be specifically pleaded. The sub-defences are as follows:
1. A denial that the patent upon contains proper subject-matter;
2. A denial that the alleged invention embodies inventive skill or genius, ie that the alleged invention was obvious;
3. A denial that the alleged invention is novel;
4. A denial that the alleged invention is useful;
5. A denial that the patentee is the true and first inventor; and
6. An allegation that the specification is insufficient.
II. Remedies
Section 55 provides that the infringer of a patent is liable to the patentee for “all damage sustained by the patentee,
by reason of the infringement.”
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In addition to obtaining a permanent injunction, a successful Plaintiff is entitled to have, at his election, either an
account of profits made by the Defendant for the use or sale of the patented invention, or the payment of such
damages as the Plaintiff may have suffered by reason of the wrongful acts of the Defendant.
The Plaintiff cannot have both accounts and damages against one Defendant; s/he must elect one. However, s/he
may have both against several defendants.
A successful Plaintiff may be entitled to an order for the delivery and destruction of the infringing articles.
Calgon v North Bay
In Calgon v North Bay (2006), the court found that the patent was invalid but observed that if the patent was invalid,
the issue of quantum of damages would have been referred for subsequent determination.
Quantification of Damages
Patent law is bedeviled by unresolved issue on the legal principles applicable to quantification of damage claims.
The main difficulty stems from the valuation of patents; how do you value patents? Is a compensatory approach
preferable to a market-based approach? Does an account for profits take into consideration the expenditures and
marketing assets of the infringer?
Exemplary Damages
Exemplary damages are only awarded in cases of egregious, high-handed, and oppressive infringement of a patent.
The Defendant’s behaviour must depart substantially from ordinary standards of decent behaviour.
In addition, the Plaintiff must plead and prove the relevant facts that justify such weighty punishment (see Merck v
Apotex, 2006).
Prescriptions and Limitations
A right of action in damages for infringement of a patent does not lie in perpetuity; it is limited by time. Under
section 55.01, “no remedy may be awarded for an act of infringement committed more than six years before the
commencement of the action for infringement.” It is not when the Plaintiff knew, but when the act occurred that
matters.
Jurisdiction of Courts
For the purposes of adjudicating suits or actions in respect of infringement of patents, section 54 provides that an
action would have to be brought in that “court of record” ... “with jurisdiction” in which the “infringement is said to
have occurred.”
Under section 54(2), the Federal Court has exclusive original jurisdiction to adjudicate over claims arising from
Patents. Also see section 20 of the Federal Courts Act.
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