Exceptions to Infringement
Intentional & Non-Intentional Acts
Statutory Exceptions
• There are certain acts which may interfere
with the property rights of patentees but are
for statutory exemptions, removed from
censure under law.
• The main exceptions to infringement are
found in the patent act.
• However, it must be noted at the outset that
case law from other jurisdictions are of limited
assistance as most states have different
legislative provisions on exemptions from
infringement.
• The category of infringing acts exempted from
damnation include:
Category of Exempted Acts
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1. Private Use;
2. Information required by government;
3. Experimental Purposes;
4. Exemptions for Trials on Generic Medicinal
Products;
5. Medical Preparations;
6. Public Safety Use under the WTO/TRIPS;
7. Visiting Aircrafts, Ships, and other vehicles
8. Farmer’s Privileges
9. Use begun before priority date.
Private Use
• Generally speaking, the use of a patented device in
private and for non-commercial purposes is not
actionable.
• The crucial elements are:
• 1. “private” use and;
• 2. “non-commercial” purpose.
• Privacy in this context is not coterminous with
“secrecy”. A private use has been judicially defined as
that type of use carried out solely for the individual’s
personal or use or possibly for “friends or family but not
for the benefit of the public at large.” Ashely Roughton,
et al, at 41.
• 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 Govt
• S. 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”.
• See also s. 55 (2) (4)
Experimental Use
• The Canadian Patent Act does not contain
any provisions which specifically exempt
general experimentation and research from
infringement.
• As already noted, s. 55.2(1) is limited to those
cases where the would-be infringer is required
to submit the information for purposes of
regulatory approval.
• S. 55. 2(1) cannot be a basis for shielding
activities that have the additional purpose of
experimentation of new uses or to make
improvements.
Experimental Use
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S. 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 thus:
“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 s.
55.2 (6) is to leave matters the way they are. See S.
Ferrance, “The Experimental Use Defence to Patent
Infringement.” (2003) 20 C.I.P.R. 1.
Experimental Use
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The defence of experimental use is well-established in
common law. Micro Chemicals Ltd v. Smith Kline; Cochlear
Copr v. Cosem; Dableh . Ontario Hydro.
At common law, the experimental use exemption was
available where,
“a man makes things merely by way of 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 the patent.” Frearson v. Loe
(1878) 9 Ch. D 48.
The common law position suggests that experimental use
defence applies where is no COMMERCIAL intent.
Experimental Use
• However, in Micro Chemicals v, Smith Kilne & French,
the Supreme Court of Canada expanded the
experimental use defence by holding that the defence
was not limited merely to improvements.
• In the opinion of the SC, activities which were for the
purpose of enabling the defendant to 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.
Rationes of Micro Chemicals
• It seems that the rationes decidendi of the
Micro Chemicals case is that the law does not
regard testing to be an infringing use. See
Dableh v. Ontario Hydro.
• In Cochlear Corp, it was held that the
experimental use defence will apply until the
defendant “at some stage of its product
development decides to give a fic to the
particular model and take steps to
manufacture, promote and sell it.”
• On its face, activities in the testing phase are
“not for profit” and therefore are exempted use
of patented subject-matter.
Crossing the Line: For Profit
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It seems from decided cases that whether a particular experimental
use is bona fide testing or for profit would depend on the technical
complexity of the experimentation at hand and the predictability of the
results.
For example, in Micro Chemicals, the defence applied because the
experimentation was geared towards determining how the active
ingredient in the drug would be produced and whether production
would be economical.
On the other hand, in Wellcome v. Apotex, because Apotex and
Novopharm were importing the active ingredient rather than
attempting to produce it, the court rejected the defendant’s argument
that the purpose of creating the imported tablets from the imported
bulk was to experiment with the safety and stability of the tablets.
Where a patented product is relatively simple, the defence of
experimentation would likely fail.
In sum, as the SCC warned in Harvard College, the status of the
common law experimental use defence is currently unclear.
Experimental Use
• Despite the absence of or ambiguity in the
existence of the defence of experimental use
in Canadian patent law, all members of the
EU, except Austria have introduced
experimental use provision to exempt
experiments with the patented subject-matter.
• The limits of this right vary from one state to
the other.
• In the US, there is a relatively broad right to
experimental use anchored on the US Patent
law. The US applies a test of whether the
experiment is geared towards gaining
information.
Bolar and Bolar-type Exceptions
• In the Bolar case, the US Federal Circuit
limited the experimental use exception,
implying that it does not apply to commercial
uses and is restricted to uses “for amusement,
to satisfy idle curiosity, or for strictly
philosophical inquiry.”
• Under the TRIPs Agreement and Doha
Declarations, experimental use exemption
has been significantly relaxed.
Trials on Generic Medicinal
Products
• Under NOC 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
infromation about tests, clinical trials, etc. see
s. 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
• S. 23 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 a farmer’s in many
jurisdictions retain the farmer’s right
over patented seeds. This is a fairly
contentious issue.
• A Farmer’s right is the “right” to replant
or use second-generation seeds for
subsequent farming seasons.
• Note that this “right” is increasingly
been curtailed by the use of different
types of licensing agreements.
Doha Exceptions
• Pursuant to the Declaration of
Doha, s. 21 of the Patent Act was
amended to permit the Minister of
Health to authorize the
manufacture and export of generic
drugs to HIV-AIDS stricken parts
of the world.
• Note the detailed provisions of s.
21.02 of the Patent Act.
Use by Government
• See s. 19 of the Patent Act.
Mens Rea
• Patent law does not countenance intent in
ascertaining determining infringement.
• 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.
Mens Rea in Infringement
• In particular, is a person who by no individual fault
comes into possession of adventitious patented genetic
material (e.g, through the accidental, or adventitious
appearance of a genetically modified organism) be
liable to the patentee in 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
Biotechnology and Mens Rea in
Infringement
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Although the element of intent in infringement of patents has
largely been dealt with by the courts for decades largely 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 from Canada--Monsanto Canada Inc. v.
Schmeiser; Hoffman v. Monsanto Canada Inc. (currently
under appeal)- somewhat broached the issue.
In Monsanto v. Schmeiser, 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.
Schmeiser
• The suit alleged that Schmeiser planted
glyphosate-resistant canola for harvest,
without a license from Monsanto.
• This is the first suit anywhere in the world on
the question of (innocent?) infringement of a
genetic patent.
• The central question for determination is
whether a person can be said to have
infringed the patented invention without as
much as intentionally planting the patented
crop in question?
Schmeiser
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Schmeiser’s farm was not licensed to plant the patented
canola seeds but such plants were found to be growing on his
farm. Evidence from a witness, Dr. Downey clearly
demonstrated that “the canola plants growing there (on
Schmeiser’s farm) were not the result of pollen movement
into those fields…[but] from commercial Roundup Ready
canola seed” [pg. 11-14 of law report]
Query: Whodunit?
An astonishing legal proposition made by Mackay J., is 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. Given the novelty of the issue, this is a problematic
proposition of law.
Mens Rea
• One may also wonder whether it is really necessary in
cases of infringement of genetic patents that a court
should consider the element of intent.
• This doubt arises because a general survey of court
decisions in either the US or Canada on infringement
yields the impression that infringement is
unquestionably a strict liability tort.
• Indeed, ignorance of the law is an ambiguous point of
law in infringement cases.
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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. Like in most
cases, ignorance of the law, and thus of the legal
consequences of an act is no excuse.
Mens Rea
• Thus a person who consciously conducts certain
activities incompatible with the rights of a patentee,
although s/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.
• It is therefore natural that in the reasoning of both
Canadian and American courts in cases of infringement
of patents, little or scant regard has been paid to the
ignorance of the infringer of the legal consequences of
the infringing.
• Generally speaking, liability in patent infringement is
strict.
Mens Rea
• 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.
• On the face of it thus, unintentional or inadvertent
infringement is not a defense to a patent infringement.
• Thus, generally speaking, a court may enjoin a
defendant even if the only notice the defendant had
about the patent in issue was the actual writ
commencing the infringement action.
Mens Rea
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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.
Mens Rea
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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.
Thus, with respect to acts of infringement consisting of the
unauthorized importation, use, sale, or offer to sell of
unpatented products of a patented process, a defendant in
jurisdictions such as the UK may be liable for damages if s/he
has actual knowledge or constructive notice prior to the
infringement.
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.
Generally known to UK patent lawyers as “Swiss-type
claims”, such claims are of the form of “compound XYZ for
use as ABC”.
Summary
• Therefore, where the nature and
characteristics of the invention are such as to
raise grave questions on the intent of the
alleged infringer, it is submitted that a court
should adopt and apply the totality of
circumstances test.
• This approach, already applied with respect to
the issue of assessment of damages in “wilful
infringement” cases is already well developed
in United States patent law.