I OVERVIEW

As a result of recent developments in patent legislation, jurisprudence and improved court procedures designed to facilitate fast and effective litigation, Canada has been receiving positive international attention from patent owners and practitioners.

Canadian courts have recognised the need to create an environment for timely and efficient disposition of civil litigation. Over the past several years, the Federal Court, where most patent proceedings are commenced, has implemented a number of procedures to permit litigants to achieve quick and cost-effective results. This has included implementing court procedures that assist in having matters progress to trial in an economical and expeditious manner, including proactive case management and imposing limitations on the discovery process. Additionally, the Court has also adopted summary trial provisions to facilitate the summary disposition of proceedings on issues that do not require a full trial on the merits.

There are also several other features of the legal system in Canada that make it an attractive jurisdiction for patent litigation, including:

  1. the availability of flexible remedies, including damages, disgorgement of a defendant's profits and injunctive relief;
  2. costs of the proceeding, namely a percentage of lawyers' fees and reimbursement of all reasonable disbursements (e.g., expert fees), are typically awarded to the successful party;
  3. because the Federal Court has national jurisdiction, issues such as forum shopping typically do not arise in Canada; and
  4. in the Federal Court, jury trials are not available and as such patent actions are decided by the trial judge alone.

II TYPES OF PATENT

The Canadian Patent Act provides the ability to obtain a patent, which provides protection for an invention across Canada.2 Canada does not have other forms of protection, such as regional patents, utility models or short-term patents.

A patent is obtained by filing a patent application with the Canadian Intellectual Property Office (CIPO). The patent application is examined by CIPO, and if it is determined that the requirements of the Act have been met, the application issues to patent.

A Canadian patent has a term of 20 years from the filing date.3 Historically, Canada did not have a patent term extension regime. However, as discussed in greater detail below, Canada has recently implemented a certificate of supplementary protection (CSP) regime for new pharmaceutical products that provides a sui generis term of protection for up to two years beyond the expiry of relevant patent.4

III PROCEDURE IN PATENT ENFORCEMENT AND INVALIDITY ACTIONS

i Patent proceedings before Canadian courts

Canadian court systems

There are two separate court systems in Canada: a Federal Court system with national jurisdiction and a provincial court system in each of the country's 13 provinces and territories. A patentee can commence an action for patent infringement in either the Federal Court or the appropriate provincial or territorial court.5 However, most patent infringement actions are brought in the Federal Court because it has national jurisdiction and is more experienced with patent matters. Additionally, the Federal Court has exclusive jurisdiction to expunge a patent (invalidate a patent in rem).6 Thus, a patent expungement proceeding can only be brought in the Federal Court.7

Court procedure in Canada

Pleadings

An action is commenced by the plaintiff filing a statement of claim, setting out the material facts that support the action and the relief claimed. In response, the defendant must file a statement of defence. A reply may be filed by the plaintiff in response to the statement of defence. In the statement of defence and reply, the party must admit or deny the allegations set out by the other party and plead any additional relevant material facts upon which the party intends to rely.

The pleadings also typically include a counterclaim by the defendant (e.g., a claim seeking to expunge the patent), and may also include a cross-claim between defendants or a third-party claim by the defendant against a party not previously named in the proceeding.

Discovery

Evidence relevant to patent proceeding is obtained through the discovery process. The first step is documentary discovery, wherein each party must list all relevant documents in its possession, power or control. All non-privileged documents must be produced to all adverse parties.

After documentary discovery, each party is permitted to conduct an oral examination of a representative of each adverse party. The representative must answer any relevant and proper question based upon the information of the party. In the Federal Court, a party that is adverse to the patentee is also permitted to examine the inventors of the patent.

Trial

All patent actions in Canada are heard and decided by a judge alone.

The plaintiff bears the onus of proving infringement. However, a patent is prima facie valid so the defendant bears the onus of demonstrating invalidity. The standard of proof in patent proceedings in Canada is a balance of probabilities.

Evidence is submitted at trial by testimony of witnesses, by the admission of documents or by reading in the testimony of an adverse party on oral discovery. Expert evidence is admissible in a patent proceeding in Canada provided that the party who calls the expert produces an expert report setting out the expert's evidence in advance of trial.

Interim and interlocutory injunctions and stays

In Canada, interim or interlocutory injunctions are available.8 A tripartite test must be satisfied to obtain such an injunction, namely:

  1. Is there a serious question to be tried on a preliminary assessment of the merits of the case?
  2. Will the plaintiff suffer irreparable harm if the injunction is refused?
  3. Considering all of the circumstances, does the balance of convenience favour the granting of an injunction?9

The second element of the test, namely irreparable harm, can be difficult to establish in patent proceedings given that 'irreparable' harm is harm that cannot be quantified in monetary terms or which cannot be cured.10

Stays of proceedings are also available in Canada, and are subject to the same tripartite test as applicable to interim or interlocutory injunctions.11

Standing
Patent infringement proceeding

In Canada, a patent infringement action can be commenced by the patentee or any person 'claiming under the patentee'.12 This has been interpreted broadly to include anyone that can trace an express or implied interest under the patent to the patentee,13 which includes exclusive, non-exclusive and implied licensees as well as distributors.14

Patent invalidity proceedings

In a patent infringement action, a defendant will typically attack the validity of the patent as part of its defence, and if the action is in the Federal Court, the defendant will also typically counterclaim seeking to expunge the patent.

The Patent Act also provides the ability for any interested party to commence an action to expunge a patent in the Federal Court.15 The threshold to qualify as an interested party is low as the term has been held to have a broad definition, including anyone in competition with the patentee or who has received a cease-and-desist letter from the patentee.16

Limitation periods

In Canada, remedies are only available for infringing activities that occur within a six-year limitation period prior to the commencement of the action.17

Timing and costs of patent proceedings

Patent proceedings in Canadian courts typically take between two and four years from the commencement of the proceeding to judgment, and cost C$700,000 million to C$1 million or more depending on the complexity and number of issues in the proceeding.

Summary disposition

The Federal Courts Rules include summary trial and summary judgment motion provisions that aim to facilitate the summary disposition of proceedings on issues that do not require a full trial on the merits.18 These may be particularly appropriate in cases where the cost in taking the matter to trial as a regular action could well exceed any monetary award that would have accrued, and where the parties have worked together to narrow the issues in dispute.19 There are also summary default proceedings that are available should a defendant not respond to the commencement of an action within the time limits provided.

ii Threats of patent proceedings

The Patent Act does not include any provisions that limit how a patentee may enforce its patent (other than the abuse provisions discussed in Section III.iii, 'Abuse Proceedings' ). That said, provisions contained in the Competition Act20 and the unfair competition provisions in the Trademarks Act21 can be used to protect against unfair competition-type behaviour by a patent owner, including making unjustified allegations of patent infringement to the public or third parties, such as to customers of a competitor.22

iii Post-grant proceedings before the Canadian Patent Office

Re-examination

Pursuant to the Patent Act, any person, including the patentee, may request a re-examination of an issued patent based upon prior art consisting of patents, published applications and printed publications. A re-examination has two stages.23 First, the re-examination board determines whether a substantial new question of patentability affecting any claim of the patent in issue has been raised in the re-examination request. If it is decided that a substantial new question has not been raised, the board will notify the requesting party, and the board's decision is final and is not subject to appeal or review by a court.24

If the board decides that the re-examination request raises a substantial new question of patentability, the patentee is notified and has an opportunity to make submissions, including proposing amendments to the claims or new claims for the patent (provided the proposed amendment or new claim does not enlarge the scope of the patent).25

The re-examination board then renders a decision as to patentability of the claims in issue.26 The board has the power to cancel any unpatentable claim or incorporate in the patent any proposed amended or new claim submitted by the patentee.27 The board's decision can be appealed by the patentee to the Federal Court.28 A third party requesting re-examination has no right to be part of the second stage of the re-examination process or to appeal the re-examination board's decision.29

Abuse proceedings

At any time three years after the grant of the patent, any person interested may apply to the Commissioner of Patents alleging that there has been abuse of the exclusive rights granted by the patent, and request relief.30 The remedies available in such a proceeding include the grant of a compulsory licence or revocation of the patent.31 The exclusive rights under a patent are deemed to be abused in certain circumstances enumerated in the Patent Act, although abuse may not be restricted to only those grounds.32 The abuse provisions have not been extensively used in Canada.

IV SUBSTANTIVE LAW

i Patent construction

In Canada, the scope of the exclusive rights granted by a patent is defined by the claims.33 The claims of a Canadian patent are construed purposively, not in a purely literal fashion.34 Purposive construction involves identification of the particular words or phrases in the claims that describe what the inventor considered to be the essential elements of the invention.35

A Canadian patent is construed based upon a review of the whole patent specification through the eyes of a 'person skilled in the art'.36 The person skilled in the art may include a combination of the collective expertise of a number of skilled workers, scientists and technicians.37

The doctrine of file wrapper estoppel formerly did not apply in Canada as the Supreme Court of Canada had expressly stated that that Canadian or foreign file wrappers are inadmissible to construe a Canadian patent.38 However, recent amendments to the Patent Act have set out that written communications between the applicant for a patent or a patentee and the Patent Office or member of a patent re-examination board, which are prepared in respect of the prosecution of the application for the patent, a disclaimer made in respect of the patent, or a request for re-examination or a re-examination proceeding, are admissible into evidence to rebut any representation made by the patentee in an action or proceeding as to the construction of a claim in the patent. This provision has not yet been judicially construed so its full scope and effect is yet to be determined. Additionally, these amendments do not appear to pertain to foreign file wrappers.

ii Infringement

Direct infringement

The Patent Act does not define infringement, but does provide the patentee with 'the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used'.39 Canadian courts have held that any act, direct or indirect, that interferes in whole or in part with the full enjoyment of the exclusive rights granted to the patentee during the term of the patent constitutes an infringement.40

There is no infringement in Canada if an essential element of the patent claim is different or omitted. However, there may be infringement if non-essential claim elements are substituted or omitted. For infringement to be established in circumstances where a variant from the claimed invention is incorporated, it must be shown that:

  1. the variant has no material effect upon the way the invention works, namely, the variant performs substantially the same function, in substantially the same way, to obtain substantially the same result;
  2. at the date of publication of the patent, it would have been obvious to a person skilled in the art that such a variant would have no material effect on the way the invention worked; and
  3. a person skilled in the art would have understood from the language of the claim that the patentee did not intend that strict compliance was an essential requirement of the invention such that the immaterial variant of interest was not intended to be excluded from the claim.41

Inducing infringement (indirect infringement)

Although Canada does not have a doctrine of contributory infringement per se,42 a person may be liable for infringement for inducing or procuring another person to infringe the patent. Three elements are required to establish liability, namely:

  1. an actual act of infringement was completed by a direct infringer;
  2. the completed act of infringement was influenced by the alleged inducer, to the point where without such influence, infringement by the direct infringer would not otherwise have taken place; and
  3. the alleged inducer knowingly exercised the influence, such that the alleged inducer knew that the influence would result in the completion of the act of infringement.43

Director and officer liability

In Canada, officers and directors of a company are typically not personally liable for the company's infringing activities. That said, personal liability can be established if a director or an officer engages in activities that constituted a deliberate, wilful and knowing pursuit of a course of conduct that was likely to constitute infringement or reflected an indifference to the risk of it.44 Canadian courts have stated that personal liability can be established when the behaviour of the officer or director is itself tortious or when the actions serve a personal interest rather than that of the corporation.45

iii Invalidity and other defences

Invalidity

Subject matter

Pursuant to the Patent Act, a patent may be granted for any invention, defined as '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'.46 Mere scientific principles or abstract theorems are not patentable.47 Although a mere discovery, for example a scientific observation, is not patentable, a new and useful application of a discovery is an invention.48

Novelty

As referenced above, the definition of 'invention' in the Patent Act requires the subject matter to be new (referred to as 'novelty'). When the scope of a patent claim encompasses subject matter within the relevant prior art, the claim is invalid as being anticipated. Pursuant to the Patent Act, a claimed invention is new unless:

  1. the invention is disclosed in a Canadian patent application that has an earlier effective filing date (either the actual Canadian filing date49 or the convention priority date, if applicable);
  2. the invention was, more than one year before the Canadian filing date, disclosed by the applicant, or a person who obtained knowledge directly or indirectly from the applicant, in such a manner that it became available to the public in Canada or elsewhere; or
  3. the invention was, before the Canadian filing date (or the convention priority date, if applicable), disclosed by any third party in such a manner that it became available to the public in Canada or elsewhere.50

Anticipation can be based upon a prior publication, including a prior patent or patent application, as well as a prior public use or sale of the claimed invention. It is impermissible to rely upon multiple pieces of prior art (referred to as 'mosaicing') to establish lack of novelty.51

The legal test for lack of novelty is a rigorous one.52 Two requirements must be satisfied for a patent claim to be invalidated on the basis of anticipation, namely prior disclosure and enablement.53 For the prior disclosure'requirement, the prior art must disclose subject matter that, if performed, would necessarily result in the infringement of the patent. For the enablement'requirement, a person skilled in the art must be able to perform the invention, which may include trial and error experimentation.54

Obviousness

In Canada, a patent cannot be granted for subject matter that lacks inventive ingenuity (inventive step) or is obvious. In assessing obviousness, the Supreme Court of Canada has adopted the four-step approach of the House of Lords in the Windsurfing case,55 namely:

  1. identify the notional person skilled in the art and the relevant common general knowledge of that person;
  2. identify the inventive concept of the claim in question or, if that cannot readily be done, construe it;
  3. identify what, if any, differences exist between the matter cited as forming part of the state of the art and the inventive concept of the claim or the claim as construed; and
  4. viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps that would have been obvious to the person skilled in the art or do they require any degree of invention?56

The Supreme Court of Canada has also stated that in the fourth step of the analysis for obviousness, an 'obvious to try' test may be appropriate, for example, in fields where advances are often won by experimentation.57 The Federal Court of Appeal has clarified that the mere possibility that something might turn up or is 'worth a try' is not sufficient to satisfy the 'obvious to try' test.58

Utility

The definition of 'invention' includes the requirement that the invention be 'useful', and thus it must have utility.59 The Patent Act does not prescribe the degree of usefulness required but Canadian courts have held that a scintilla of utility will suffice.

The Supreme Court of Canada has recently held that a single use related to the nature of the subject matter as claimed is sufficient to satisfy the utility requirement.60 The Court also set out a two-step approach for assessing whether a patent discloses an invention with sufficient utility. First, the court must identify the subject matter of the invention as claimed in the patent. Second, the court must ask whether that subject matter is useful? is it capable of a practical purpose (i.e., an actual result)?61Additionally, utility of an invention must, as of the Canadian filing date, either be demonstrated or be soundly predicted based on the information and expertise available at that time.62 The doctrine of sound prediction is typically used when a class of compounds are covered by the patent claims but only a few members within the class are shown to work in the patent disclosure or as of the Canadian filing date. To be able to rely upon a sound prediction of utility, a three-part test applies, namely:

  1. there must be a factual basis for the prediction;
  2. the inventor must have at the date of the patent application 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.63

There is some uncertainty in the Canadian jurisprudence at the moment as to what the proper disclosure requirement entails, and whether it requires the factual basis and sound line of reasoning to be disclosed in the patent specification.64 Recent cases have held that when the sound prediction relies on data outside the common general knowledge of the skilled person, disclosure of this factual basis in the specification may be required to support the utility of the invention.65

The Federal Court had developed a promise doctrine for the measure of utility where, in the specification of the patent set out an explicit 'promise' of a specific result, utility was measured against that promise.66 However, the Supreme Court of Canada has recently stated that the 'promise of the patent' doctrine is not appropriate under Canadian law.67

Double patenting

Double patenting is not contained in the Patent Act but is a common law doctrine to prevent the improper extension or 'evergreening' of the term of a patent by a series of patents for the same invention.68 The doctrine is used in situations where the earlier patent is not citable as prior art for anticipation or obviousness.

The Canadian jurisprudence has recognised two categories of double patenting. The first category encompasses two patents that have identical or conterminous claims. The second category relates to where the claims are not identical or conterminous, but where the claims of the second patent are not patentably distinct from the first (commonly referred to as 'obviousness double patenting').69

Other validity attacks

In addition to novelty, obviousness, utility and double patenting, there are a number of other grounds upon which a Canadian patent can be invalidated, including insufficiency of the specification,70 ambiguity of the disclosure or of the claims,71 and claims broader than the invention made or disclosed.72 A patent may also be invalidated if a material allegation in the petition is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, provided the omission or addition is wilfully made for the purpose of misleading.73

Other defences

Experimentation

It has been held in Canada that use of a patented invention for non-commercial experiments to determine if the patented article can be manufactured in accordance with the patent or improved upon does not constitute infringement.74

In addition, Section 55.2(1) of the Patent Act provides that it is not an infringement to make, construct, use or sell a patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada or any other country that regulates the manufacture, construction, use or sale of the product.75 Section 55.3(1) of the Patent Act further provides that an act committed for the purpose of experimentation relating to the subject-matter of a patent is not an infringement of the patent.76

Prior acquisition or prior user rights

Section 56 of the Patent Act77 was recently amended to provide that any person who, before the 'relevant date',78 has, in good faith, committed an act that would otherwise constitute an infringement of the patent in respect of that claim, or made serious and effective preparations to commit such an act is permitted to commit that act, without being liable to the patentee. Previously Section 56 more narrowly stated that any person who, before the 'relevant date' has purchased, constructed or acquired the subject matter defined by the claim of a patent, is permitted to use and sell to others the specific article, machine, manufacture or composition of matter so purchased, constructed or acquired, without being liable to the patentee. The previous exception applied only to the 'specific article, machine, manufacture or composition of matter' previously purchased, constructed or acquired, although the right of 'use' extended to any form of the invention, including the right to use and sell things produced using the article. Additional amendments to Section 56 are discussed in further detail in Section VIII.i below.

Licence or exhaustion

A valid licence granted by the patentee to the defendant to engage in the acts alleged to infringe the patent is a complete defence to a patent infringement claim.79 However, a licence will not provide a defence for any activities that extend beyond the terms of the agreement.80

The sale of a patented article to a purchaser gives the purchaser an implied licence to use, sell or deal with the patented article as he or she pleases. Any restrictions that a patentee wishes to impose upon a purchaser must be brought to the attention of the purchaser when the patented article is acquired.81

Unfair competition

In Canada, the Competition Act82 regulates anticompetitive behaviour and has provisions that may impose limitations on the exercise of certain patent rights. The Federal Court has allowed allegations relating to violations of the Competition Act to be raised as a defence in patent infringement actions, provided there is a direct link or nexus between the alleged unlawful conduct and the patent right at issue in the action.83 A defendant or third party may also be able to assert causes of action against a patentee on the basis of alleged anticompetitive behaviour. To date, there have not been any cases in Canada where such a defence or cause of action has been successful at trial.84

V FINAL REMEDIES FOR INFRINGEMENT

i Monetary remedies

In Canada, an infringer of a patent is liable for any damages sustained by the patentee by reason of the infringement.85 Alternatively, a patentee may be permitted to elect an accounting of the defendant's profits made as a result the infringing activity.86

Damages are calculated based on the principle of restoration, namely to restore the patentee to the position it would have been in but for the infringement.87 The jurisprudence has established two measures of damages, namely damages based on the plaintiff's lost profits or a reasonable royalty.88 In contrast, an accounting of the defendant's profits is to be a measure of the value of the invention through a disgorgement of the profits made by the infringer in using the patent invention.89 However, an accounting of profits is a discretionary remedy and therefore is not granted as of right.90

A patentee is also entitled to 'reasonable compensation' for any damages sustained as a result of acts between the date the patent application became open to the inspection of the public until the grant of the patent that would have constituted an infringement if the patent had been granted.91 'Reasonable compensation is not the equivalent of damages, and thus does not include lost profits. Reasonable compensation is typically calculated as a reasonable royalty.92

Generally speaking, both pre- and post-judgment interest is awarded on monetary awards by Canadian courts.

ii Punitive or exemplary damages

Punitive or exemplary damages are available in Canada but are only awarded in exceptional circumstances, namely for high-handed, malicious, arbitrary or highly reprehensible conduct that departs to a marked degree from ordinary standards of decent behaviour.93 Knowingly infringing a patent by itself is typically insufficient for entitlement to punitive or exemplary damages.94

iii Permanent injunction and delivery up or destruction of infringing articles

Although a successful patentee is typically awarded a permanent injunction restraining the defendant from future infringing activities,95 as an equitable remedy it is subject to the discretion of the Court.96

In addition, an order that all infringing articles in the possession of the defendant be either delivered up or destroyed is typically granted in a successful patent infringement action.97

iv Costs

The successful litigant (plaintiff or defendant) is typically awarded its 'costs', which consists of a portion of its attorney's fees and all reasonable disbursements including expert fees. In respect of proceedings before the Federal Court, the Court may fix the costs based on Tariff B of the Federal Courts Rules and may award a lump sum as a percentage of total fees in lieu of, or in addition to, any assessed costs. In exceptional circumstances, full or substantial indemnity for actual attorney's fees may be awarded.

VI OTHER TYPES OF PATENT PROCEEDING

i Declaration of non-infringement

The Patent Act provides any person who has reasonable cause to believe that its activities in Canada might be alleged by a patentee to infringe a patent with the ability to commence an action in the Federal Court for a declaration of non-infringement.98

ii Notice of compliance regulations for patented medicines99

In Canada, regulatory approval in the form of a Notice of Compliance (NOC) must be obtained before a drug can be marketed.100 Pursuant to the Patented Medicines Notice of Compliance (PMNOC) Regulations,101 a drug manufacturer who files a new drug submission or supplement thereto (a 'first person') may also submit to the Minister of Health a list of patents for inclusion on the Patent Register.102 To be eligible for listing on the Register, the patent must contain a claim for the medicinal ingredient, the formulation, the dosage form or the use of the medicinal ingredient.103 The list may include an expired patent but for which a CSP has taken effect.104 For each patent or CSP on the list, the first person must include a statement of entitlement to list: namely that the first person either owns the patent, has an exclusive licence to the patent or has obtained the consent of the owner to include the patent on the list.105

A 'second person' (typically a generic drug or biosimilar manufacturer) may file an abbreviated new drug submission that compares the new drug with a drug already marketed in Canada under an NOC ('reference drug'). If the reference drug has patents listed on the Patent Register, the second person must, in its submission, indicate it has the consent of the first person, acknowledge that the NOC will not issue until the listed patent expires or assert in a 'notice of allegation' that:

  1. the statement of entitlement to list of the first person is false;
  2. the patent or CSP is invalid or void;
  3. the patent or CSP is ineligible for inclusion on the register;
  4. the patent or CSP would not be infringed by the second person;
  5. the patent or CSP has expired; or
  6. in the case of a CSP, the CSP cannot take effect.106

The first person has 45 days after being served with the notice of allegation to bring a proceeding in the Federal Court in relation to the notice of allegation. Historically, the proceeding was a summary application in the Federal Court for an order prohibiting the Minister from issuing a NOC to the second person until after the expiration of the listed patent or patents. However, the PMNOC Regulations were recently amended107 to provide that the first person can bring a full action in the Federal Court for a declaration that the second person would infringe the patent or CSP.108 In response to the first person's action, the second person may counterclaim for expungement of the patent or CSP, or for a declaration of non-infringement.109

The commencement of an action by a first person results in a statutory stay of up to 24 months preventing the Minister of Health from issuing the NOC to the second person until the resolution of the action.110 However, the first person may be liable to the second person for any loss suffered as a result of the delay in NOC issuance if the action is discontinued or dismissed, or a declaration of infringement is overturned on appeal.111 That said, the first person may renounce the statutory stay and thereby avoid such damages.112

iii Criminal provisions

There are no criminal provisions in Canada that pertain to infringement of a patent. The only criminal provisions contained in the Patent Act relate to:

  1. falsely marking or selling an article as patented;113
  2. making a false representation or tendering a false document for the purposes of the Patent Act;114 and
  3. failing to comply with certain provisions under the Patent Act relating to patented medicines.115

VII APPEAL

The Federal Court and each provincial or territorial court system have their own appellate courts. An appeal to the Federal Court of Appeal is available as of right from any interlocutory or final order of the Federal Court. In some provincial court systems, leave is required to appeal interlocutory orders.

The Supreme Court of Canada hears appeals from the Federal Court of Appeal and provincial appellate courts. For patent proceedings, leave to appeal to the Supreme Court of Canada is required.

VIII THE YEAR IN REVIEW

i Prior user rights

Section 56 of the Patent Act concerning the rights of prior users of patented technologies, was amended and came into force on 13 December 2018. 116

Section 56 now protects any acts 'that would otherwise constitute an infringement' if the act had been completed before the claim date (i.e., the priority date for a particular claim), or if 'serious and effective preparations to commit such an act' were made before the claim date. The previous Section 56 limited prior user rights to the right to 'use and sell to others the specific article, machine, manufacture or composition of matter patented and so purchased, constructed or acquired' before the claim date. This change is significant as it appears to broaden the protection, including to indicate that prior user rights can be invoked for patented processes. Previously, courts had provided differing conclusions on prior user rights to patented processes.

Right to transform or sell

While it was previously protected, it is unclear if prior users will have the ability to transform or sell articles produced prior to the relevant date after the relevant date if they have not done so in the past. This may depend on how courts construe the phrase 'serious and effective preparations to commit such an act.'

Good faith requirements

The amended section includes a good faith requirement and provides that users cannot invoke the prior use defence if they obtain knowledge of the subject matter defined by the claim, either directly or indirectly, from the applicant of the application on the basis of which the patent was granted and they knew that the applicant was the source of the knowledge.117 Prior jurisprudence under the previous section suggests that the good faith requirement may be limited to breach of confidence or secrecy between the parties.118

Purchasing from a prior user

Section 56 now provides rights to purchasers of an article from a prior user, including the rights to use and sell the article which extends to the use of 'an article that is substantially the same as the one used, for that use.'119 There is some concern with the extension of these rights to articles that are 'substantially the same.'

Substantially similar services

New subsections 56(4) and 56(9) introduce exemptions for the use of a service or a service that is substantially the same as one previously used, respectively. However, the term 'service' has not been used in previous provisions and it remains to be seen how 'service' will be interpreted.

Transferee of a business

Subsections 56(2), (7) and (10) provide that a transferee of a business or a part of a business may acquire the prior user rights of the transferor. The permitted activities are not limited to the same locations or sites as the original prior use.

ii Canadian Competition Bureau updates Intellectual Property Enforcement Guidelines

In 2019, the Canadian Competition Bureau updated its Intellectual Property Enforcement Guidelines (IPEGs), which help to explain how the Bureau addresses matters relating to competition policy and intellectual property (IP) rights and conduct involving IP that may raise an issue under the Competition Act.120 The overall approach of the Bureau in circumstances involving IP is first broken into two broad categories: conduct involving the mere exercise of IP rights; and conduct involving 'something more' than the mere exercise of IP rights. The Bureau will generally not presume a violation of the Competition Act when there is a mere exercise of IP rights, and views its approach to non-IP forms of property as sufficiently flexible to apply to IP.

The updated Guidelines provide several examples of activities where the Bureau might investigate or pursue enforcement as follows:

  1. Price fixing: where a price-fixing agreement between parties with patented technologies relating to a particular product tends to limit competition between them, the Bureau may investigate.
  2. Abuse of dominance: the Bureau may investigate conduct under Section 79 of the Competition Act, which would include conduct such as a large firm using its market dominance to obtain exclusive licences in order to shut competitors out of the market.
  3. Patent pools: when a number of firms cross-license patents relating to one product, they may be subject to investigation if there is evidence that the patent pool is an agreement between competitors.
  4. Refusal to licence: generally, refusing to license an IP right is not subject to review by the Bureau. However, the Bureau may investigate where the refusal created an undue restraint of trade or unduly lessened competition, which requires first that the refusal adversely affected competition in a market that is different or larger than the subject matter of the IP, and second that the refusal would alter other firms' incentives to invest in research and development.
  5. Product switching: abuse of dominance provisions may be applied where a party removes Product A from the marketplace and replaces it with a similar Product B whose patent protection extends later than the previous product ('hard' switching). However, a party that merely stops promoting Product A in favour of Product B would not raise concerns.

The Guidelines also discuss the Bureau's treatment of patent assertion entities (PAEs), also known as non-practising entities (NPEs) or, colloquially, patent trolls. In the Guidelines, the Bureau acknowledges that there is an increasing roll of competition law enforcement relating to PAEs and provides some examples of its approach to PAEs. For example, if a PAE sends out a notice of patent infringement threatening legal action and includes false statements, these statements may be reviewable under the misleading advertising and deceptive marketing provisions of the Competition Act. On the other hand, the mere assignment of patent rights to a PAE for more effective enforcement will not likely raise issues.

iii Implementation of Canada-European Union Comprehensive Economic and Trade Agreement

As a result of its obligations under the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada made amendments to the Patent Act and implemented new regulations. Below are some notable updates regarding these new regulations.

Patented Medicines Notice of Compliance Regulations (PMNOC Regulations)

Almost two years have passed since substantial amendments to the PMNOC Regulations came into force on 21 September 2017,121 including a significant procedural change where there is no longer the possibility of dual litigation122 and all matters wherein an innovative drug company seeks to prevent Health Canada from issuing market approval to a generic (via an NOC) must be brought by an action for patent infringement. As of 30 June 2019, 78 actions (relating to 26 drugs) under the new regime had been commenced in the Federal Court and 56 of the actions (relating to 17 drugs) were ongoing. The first trial is scheduled to start on November 4, 2019: Bristol-Myers Squibb v. Apotex (Eliquis).123

To date, several procedural decisions in respect of the new enforcement regime have been issued by the Court which are of interest, including: (1) common invalidity issues raised by different generic manufacturers were ordered to be heard concurrently;124 (2) only second persons125 can be named as defendants (although this could include a person other than the regulatory submission filer);126 and (3) an infringement claim based on making or selling under a notice of compliance for one strength was struck from an action triggered by a notice of allegation based on a different strength.127

Certificate of Supplementary Protection regime

Following Canada's commitments under CETA, the Patent Act was amended to add a new Certificate of Supplementary Protection (CSP) regime that provides additional protection for a new drug after the expiry of the relevant patent.128 The term of the CSP is calculated by subtracting five years from the difference between the filing date of the application for the patent and the day on which the NOC is issued, up to a maximum of two years. Regulations for the new CSP regime came into force together with the Patent Act amendments, on 21 September 2017. As of 11 July 2019 Health Canada had issued 29 CSPs for drugs for human use and two veterinary drugs, and four applications for CSPs were pending.

CSPs have been refused for seven drugs, for a variety of reasons pursuant to the regulations.

In addition to patent protection and CSPs, small molecule (human and veterinary) and human biologic drugs approved in Canada that meet the definition of an 'innovative drug' are also protected by data protection. An innovative drug is 'a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.'129 A subsequent manufacturer seeking approval on the basis of a direct or indirect comparison to the innovative drug cannot file its submission until six years after the innovator drug's first approval and cannot receive approval until eight years after such approval, or eight-and-a-half years if a pediatric extension is granted. In assessing the value of any potential CSP, its expiry relative to data protection expiry is important.

iv Changes to the Patent Act

There have been several notable amendments to the Canadian Patent Act in the past year.

Licensing

Section 52.1 of the Patent Act requires that a licensing commitment made by a patentee regarding a standard-essential patent is also binding upon any subsequent patentee.130 In other words, if the patent is assigned, the assignee is also bound by the licensing commitment made by the assignor. This provision extends to CSPs. As of yet, the terms 'licensing commitment' and 'standard-essential patent' have not been further defined by regulation.

Prosecution history as evidence

Pursuant to previous Canadian jurisprudence, the prosecution history of a patent was inadmissible to determine the scope of patent protection. However, the Patent Act was amended to include new Section 53.1, which provides that written communications made between an applicant for a patent or patentee and the Patent Office may be admissible in any action or proceeding that has not been finally disposed of as of 13 December 2018.131 This form of evidence is only admissible when it is used to rebut a representation made by a patentee in an action or proceeding as to the construction of a claim. It has not yet been judicially considered such that the full scope and application of the section remains to be determined.

Research exemption

In Canada, there is a common law exemption to patent infringement for non-commercial experimental use of an invention. This exception has now been codified in Section 55.3(1) of the Patent Act.132 It is often difficult to determine what constitutes 'experimental use', and Section 55.3(2) provides the government with authority to make regulations regarding the factors the court may consider, must consider or is not permitted to consider in determining whether an act is committed for the purpose of experimentation, and the circumstances in which an act is, or is not, committed for the purpose of experimentation.133 It remains to be seen what factors will be included in the eventual regulations.

Written demand letters

Section 76.2 of the Patent Act has been added to address written demands (e.g., cease-and-desist letters) related to patented inventions. In particular, written demands received by a person in Canada, relating to an invention patented in Canada or elsewhere must comply with 'prescribed requirements'.134 If such requirements are not met then the section gives the receiver of a demand letter the ability to commence a proceeding in the Federal Court upon which the Federal Court may, if the note does not meet the requirements, grant relief that it considers appropriate including recovery of damages, punitive damages, an injunction, a declaration or an award of costs. To date, the government has not published regulations setting out the requirements. This Section appears to apply to any cease-and-desist letter, so long as the recipient is located in Canada. For example, it does not matter that the patent is a foreign patent, that the alleged infringement occurs elsewhere or that the complainant sending the letter is located in another country.

v Interlocutory injunctions

For many years, interlocutory injunctions relating to patents have only been granted in exceptional circumstances in the Canadian Federal Court. Typically, it has been difficult for the plaintiff meet the requirement of demonstrating that it will suffer irreparable harm. However, there have been signals from the Court in recent times that it would be more open to granting injunctions in appropriate circumstances, and a plaintiff was recently granted an interlocutory injunction in a patent case.135 The Court found that there was irreparable harm based on the loss of goodwill, a risk of losing distributors of the patented product, a risk of loss of distributors for other products as a result, and in view of the patented product comprising 30 per cent of the sales of the plaintiff while comprising only 5 per cent of the defendant's sales.136

IX OUTLOOK

i International agreements

Canada has become party to a number of significant international agreements over the past few years, many of which have led to legislative changes that impact on patent litigation in Canada. In particular, changes resulting from the CETA agreement between Canada and the European Union have already had an impact on patent litigation and further changes are coming as a result of the NAFTA 2.0 agreement between Canada, the United States and Mexico.

CETA

Continued development of jurisprudence is expected, particularly in the following areas in view of Canada's commitments to CETA:

  1. the new PMNOC Regulations; and
  2. the CSP regime.

NAFTA 2.0

Canada, the United States, and Mexico signed the Canada-U.S.-Mexico Agreement (CUSMA), dubbed at the time as 'NAFTO 2.0', on 30 November 2018. In a step towards ratifying the CUSMA, the Canadian government introduced Bill C-100 on 29 May 2019.137 The Bill passed second reading and has been referred to committee for review. If ratified, CUSMA would replace the North American Free Trade Agreement (NAFTA) and would require a number of changes to Canada's IP laws, including:

  1. increase of the data protection term for biologics from eight years to 10 years; and
  2. introduction of a patent term adjustment procedure to compensate for the Patent Office delay in issuing a patent.

ii Prior user rights

It is expected that there will be development of jurisprudence regarding the scope of prior user rights under amended Section 56 of the Patent Act.

iii Demand letter requirements

Although legislation has been passed which allows the creation of requirements for written demand letters relating to patented inventions, regulations setting out the requirements have not yet been enacted. Once regulations are in place, the practice of sending demand letters is likely to adapt, and demand letters may ultimately result in litigation before the Federal Court initiated by recipients of alleged non-compliant letters.


Footnotes

1 Steven B Garland and Jeremy E Want are partners, and Daniel J Hnatchuk is an associate at Smart & Biggar. The assistance Bram Schwartz, Erin Stuart and Brendan Peters, articling students, Smart & Biggar, in the preparation of this article is acknowledged with appreciation.

2 Patent Act, RSC 1985, c P-4, Section 42.

3 ibid, Section 44.

4 ibid, Sections 115 and 116.

5 ibid, Sections 54(1) and 54(2).

6 ibid, Section 60.

7 Federal Courts Act, RSC 1985, c F-7, Section 20.

8 Federal Courts Rules, SOR/98-106, r. 373, 374.

9 RJR-Macdonald Inc v. Canada (Attorney General), [1994] 1 SCR 311 at 334–347.

10 ibid at 340–342; and Cutter Ltd v. Baxter Travenol Laboratories of Canada Ltd (1980), 47 CPR (2d) 53 at 55–56 (FCA), leave to appeal to SCC refused (1980), 47 CPR (2d) 249.

11 RJR-Macdonald Inc v. Canada (Attorney General), [1994] 1 SCR 311 at 334–347.

12 Patent Act, RSC 1985, c P-4, Sections 55(1), 55(2).

13 Jay-Lor International Inc v. Penta Farm Systems Ltd, 2007 FC 358 at Paragraph 36.

14 Armstrong Cork Canada v. Domco Industries Ltd, [1982] 1 SCR 907; Signalisation de Montréal Inc v. Services de Béton Universels Ltée (1992), 46 CPR (3d) 199 (FCA), leave to appeal to SCC refused (1993), 48 CPR (3d) vi (note).

15 Patent Act, RSC 1985, c P-4, Section 60(1).

16 EI Du Pont de Nemours & Co v. Montecatini-Societa Generale Per L'Industria Mineraria E Chimica (1966), 49 CPR 209 at 212–218 (Ex Ct), aff'd (1967), 52 CPR 18 (SCC); Wakefield Properties Corp v. Teknion Furniture Systems Inc (1992), 44 CPR (3d) 474 at 476–477 (FCTD).

17 Patent Act, RSC 1985, c P-4, Sections 55.01 and 78.2. For patents issued from applications filed prior to 1 October 1989, the limitation period may be governed by the relevant legislation in the province in which the infringing activities take place. These limitation periods range from two to six years depending upon the province. If the infringing activities take place in more than one province, a six-year federal limitation period applies (Federal Courts Act, RSC 1985, c F-7, Section 39).

18 Federal Courts Rules, SOR/98-106, Rule 216.

19 Cascade Corporation v. Kinshofer GmbH, 2016 FC 1117.

20 Competition Act, RSC 1985, c C-34, Sections 52, 74.01(1).

21 Trade-marks Act, RSC 1985, c T-13, Section 7; S&S Industries Inc v. Rowell, [1966] SCR 419.

22 See, for example, E Mishan & Sons v. Supertek, 2016 FC 986 and Excalibre Oil Tools Ltd v. Advantage Products Inc, 2016 FC 1279.

23 Genencor International Inc v. Canada (Commissioner of Patents), 2007 FCA 129 at Paragraphs 6–8, 55 CPR (4th) 378, leave to appeal to SCC refused, [2007] SCCA No 272.

24 Patent Act, RSC 1985, c P-4, Section 48.2.

25 ibid, Sections 48.2 and 48.3(2).

26 ibid, Section 48.3.

27 ibid, Section 48.4.

28 ibid, Section 48.5; Genencor International Inc v. Canada (Commissioner of Patents), 2008 FC 608 at Paragraph 48; Newco Tank Corp v. Canada (Attorney General), 2015 FCA 47 at Paragraph 12.

29 Genencor International Inc v. Canada (Commissioner of Patents), 2006 FC 1021, aff'd 2007 FCA 129, leave to appeal to SCC refused, [2007] SCCA No 272.

30 Patent Act, RSC 1985, c P-4, Section 65.

31 ibid, Section 66.

32 ibid, s. 65(2); and Torpharm Inc v. Canada (Commissioner of Patents), 2004 FC 673 at Paragraph 38; but see Torpharm Inc v. Merck & Co (2000), 9 CPR (4th) 520 at 539 (Pat App Bd).

33 Free World Trust v. Électro Santé Inc, 2000 SCC 66 at Paragraph 33.

34 Whirlpool Corp v. Camco Inc, 2000 SCC 67 at Paragraphs 42–50.

35 ibid at Paragraphs 45–48.

36 ibid at Paragraphs 48–49.

37 Mobil Oil Corp v. Hercules Canada Inc (1994), 57 CPR (3d) 488 at 494 (FCTD), rev'd in part (1995), 63 CPR (3d) 473 (FCA), leave to appeal SCC refused (1996), 66 CPR (3d) vi.

38 Free World Trust v. Électro Santé Inc, 2000 SCC 66 at Paragraphs 64 and 66. However, recently several Federal Court decisions have drawn a distinction between statements or admissions made in the course of patent prosecution and a change to a claim as a result of an objection from CIPO, which was characterised as an objective fact that can be properly considered when construing a claim. See: Distrimedic v. Dispill, 2013 FC 1043 at Paragraphs 209–210; Eli Lilly Canada Inc v. Mylan Pharmaceuticals ULC, 2015 FC 125 at Paragraph 154. It remains to be seen whether this approach will be approved by the Federal Court of Appeal or Supreme Court of Canada.

39 Patent Act, RSC 1985, c P-4, Section 42.

40 HG Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions 349 (4th ed The Carswell Co. Ltd. 1969); Monsanto Canada Inc v. Schmeiser, 2004 SCC 34 at Paragraphs 30–58.

41 Free World Trust v. Électro Santé Inc, 2000 SCC 66 at Paragraphs 55–56; Halford v. Seed Hawk Inc, 2006 FCA 275 at Paragraphs 12–15.

42 Apotex Inc v. Nycomed Canada Inc, 2011 FC 1441 at Paragraphs 18–27, aff'd 2012 FCA 195.

43 AB Hassle v. Canada (Minister of National Health and Welfare), 2002 FCA 421 at Paragraph 17, leave to appeal to SCC refused [2002] SCCA No 531; MacLennan v. Gilbert Inc, 2008 FCA 35 at Paragraph 13; Weatherford Canada Ltd v. Corlac Inc, 2011 FCA 228 at Paragraph 162, leave to appeal to SCC refused, 34459 (29 March 2012). However, the inducer is not required to have knowledge of the patent to be liable for inducing infringement, see Bauer Hockey Corp v. Easton Sports Canada Inc, 2010 FC 361 at Paragraphs 197–203, aff'd without comment on this issue 2011 FCA 83.

44 Mentmore Manufacturing Co v. National Merchandise Manufacturing Co Inc (1978), 40 CPR (2d) 164 at 174 (FCA); Monsanto Canada Inc v. Schmeiser, 2001 FCT 256 at 248 (FCTD), aff'd 2002 FCA 309, appeal allowed in part 2004 SCC 34.

45 Halford v. Seed Hawk Inc, 2004 FC 88 at Paragraphs 324–332, rev'd 2006 FCA 275 (but aff'd on this issue at Paragraphs 54–55).

46 Patent Act, RSC 1985, c P-4, Section 2.

47 ibid, Section 27(8); Riello Canadian Inc v. Lambert (1986), 9 CPR (3d) 324 at 338 (FCTD).

48 Calgon Carbon Corp v. North Bay (City), 2005 FCA 410 at Paragraphs 9–19, leave to appeal to SCC refused, 31306 (30 March 2006).

49 'Canadian filing date' is the date a Canadian patent application was filed with the Canadian Patent Office or the date of filing a PCT patent application.

50 Patent Act, RSC 1985, c P-4, Section 28.2.

51 671905 Alberta Inc v. Q'Max Solutions Inc, 2003 FCA 241 at Paragraph 43.

52 Almecon Industries Ltd v. Nutron Manufacturing Ltd (1996), 65 CPR (3d) 417 at 429–430 (FCTD), aff'd (1997), 72 CPR (3d) 397 (FCA); Hi-Qual Manufacturing Ltd v. Rea's Welding & Steel Supplies Ltd (1994), 55 CPR (3d) 224 at 237 (FCTD), aff'd (1995), 61 CPR (3d) 270 (FCA); Free World Trust v. Électro Santé Inc, 2000 SCC 66 at Paragraph 25.

53 Sanofi-Synthelabo Canada Inc v. Apotex Inc, 2008 SCC 61 at Paragraphs 23–30; Abbott Laboratories v. Canada (Minister of Health), 2008 FC 1359 at Paragraph 75, aff'd 2009 FCA 94.

54 Sanofi-Synthelabo Canada Inc v. Apotex Inc, 2008 SCC 61 at Paragraphs 26–27.

55 Windsurfing International Inc v. Tabur Marine (Great Britain) Ltd (1984), [1985] RPC 59 (Eng CA).

56 Sanofi-Synthelabo Canada Inc v. Apotex Inc, 2008 SCC 61 at Paragraph 67.

57 ibid at Paragraphs 67–68.

58 Pfizer Canada Inc v. Apotex Inc, 2009 FCA 8 at Paragraphs 22–29; Eli Lilly Canada Inc v. Mylan Pharmaceuticals ULC, 2015 FCA 286 at Paragraph 4.

59 Patent Act, RSC 1985, c P-4, Section 2 (invention); Apotex v. Wellcome Foundation Ltd, 2002 SCC 77 at Paragraph 56.

60 AstraZeneca Canada Inc v. Apotex Inc, 2017 SCC 36 at Paragraph 55.

61 ibid. at Paragraph 54.

62 Apotex v. Wellcome Foundation Ltd, 2002 SCC 77 at Paragraphs 51–56; Aventis Pharma v. Apotex Inc, 2005 FC 1283 at Paragraphs 82–83, aff'd 2006 FCA 64 at Paragraphs 26–35, leave to appeal to SCC refused, [2006] SCCA No. 136; GD Searle & Co v. Novopharm Limited, 2007 FC 81 at Paragraph 102, rev'd on other grounds 2007 FCA 173, leave to appeal to SCC refused, [2007] SCCA No. 340.

63 Apotex Inc v. Wellcome Foundation Ltd, 2002 SCC 77 (SCC) at Paragraph 70.

64 Pfizer Canada Inc v. Novopharm Ltd, 2012 SCC 60 at Paragraphs 36–44; AstraZeneca Canada Inc v. Apotex Inc, 2014 FC 638 at Paragraphs 141–160; AstraZeneca Canada Inc v. Apotex Inc, 2017 SCC 36 at Paragraph 58; Eli Lilly Canada Inc v. Hospira Healthcare Corp, 2016 FC 47 at Paragraphs 46–49.

65 Safe Gaming System v. Atlantic Lottery Corporation, 2018 FC 542 at Paragraph 132, citing Eli Lilly Canada Inc v. Hospira Health Care Corporation, 2016 FC 47 at Paragraphs 46-49, and Eurocopter v. Bell Helicopter Textron Canada Ltée, 2013 FCA 219 at Paragraphs 152-154.

66 Laboratoires Servier v. Apotex Inc, 2008 FC 825 at Paragraph 270, aff'd 2009 FCA 222, leave to appeal to SCC refused, [2009] SCCA No 403; Consolboard Inc v. MacMillan Bloedel (Saskatchewan) Ltd, [1981] 1 SCR 504 at 160–161; Sanofi-Aventis v. Apotex Inc, 2013 FCA 186 at Paragraphs 47–49.

67 AstraZeneca Canada Inc v. Apotex Inc, 2017 SCC 36; Bristol-Myers Squibb Canada Co v Apotex Inc, 2017 FCA 190.

68 Pharmascience Inc v. Sanofi-Aventis Canada Inc, 2006 FCA 229 at Paragraphs 67–73, leave to appeal to SCC refused.

69 Commissioner of Patents v. Farbwerke Hoechst A/G, [1964] SCR 49 at Paragraph 13; Whirlpool Corp v. Camco Inc, 2000 SCC 67 at Paragraphs 63–75; Pharmascience Inc v. Sanofi-Aventis Canada Inc, 2006 FCA 229 at Paragraph 68, leave to appeal to SCC refused, [2006] SCCA No. 362; Mylan Pharmaceuticals ULC v. Eli Lilly Canada Inc, 2016 FCA 119 at Paragraphs 27 to 29.

70 Consolboard Inc v. MacMillian Bloedel (Saskatchewan) Ltd, [1981] 1 SCR 504; Pioneer Hi-Bred Ltd v. Canada (Commissioner of Patents), [1989] 1 SCR 1623; Mobil Oil Corp v. Hercules Canada Inc (1995), 63 CPR (3d) 473 at 484–486 (FCA); Teva Canada Ltd v. Pfizer Canada Inc, 2012 SCC 60.

71 Mobil Oil Corp v. Hercules Canada Inc (1995), 63 CPR (3d) 473 at 483–484 (FCA).

72 Farbwerke Hoechst A/G v. Commissioner of Patents, [1966] Ex CR 91 at 106, aff'd [1966] SCR 604; Pfizer Canada Inc v. Apotex Inc, 2007 FCA 209 at Paragraph 115, leave to appeal to SCC refused [2007] SCCA No. 377.

73 Patent Act, RSC 1985, c P-4, Section 53(1).

74 Micro Chemicals Ltd v. Smith, Kline & French Inter-American Corp (1971), [1972] SCR 506 at 520; Merck & Co v. Apotex Inc, 2006 FC 524 at Paragraphs 159–163, rev'd on other grounds, but aff'd on this issue 2006 FCA 323 at Paragraphs 105–113, leave to appeal to SCC refused, [2006] SCCA No. 507.

75 Patent Act, RSC 1985, c P-4, Section 55.2(1). It is uncertain as to whether this provision would be limited to the pharmaceutical patents in view of the related Patented Medicines Notice of Compliance Regulations that were introduced at the same time as Section 55.2(1).

76 Patent Act, RSC 1985, c P-4, Section 55.3(1). It is left open for future regulations what circumstances and factors the court may consider, must consider or is not permitted to consider in determining whether an act is, or is not, committed for the purpose set out in this section.

77 Patent Act, RSC 1985, c P-4, Section 56.

78 ibid, Sections 56(2), (3), (4): The 'relevant date' depends on the filing date of the patent application, namely:

if filed before 1 October 1989: the relevant date = date the patent was granted;

if filed on or after 1 October 1989 but before 1 October 1996: the relevant date = the date the application was laid open; and

if filed on or after 1 October 1996: the relevant date = Canadian filing date (or the convention priority date, if applicable).

79 An expired licence will not provide a defence: Lubrizol Corp v. Imperial Oil Ltd (1990), 33 CPR (3d) 1 (FCTD) at 10, rev'd on other grounds, but aff'd on this issue (1992), 45 CPR (3d) 1 at 3 (FCA).

80 Canadian Marconi Co v. Nordmende Pheonix Ltd (1962), 39 CPR 185 at 201; Micro Chemicals Ltd v. Rhone-Poulenc SA, (1964) 44 CPR 193 at 208, aff'd [1965] SCR 284.

81 Eli Lilly and Co v. Novopharm Ltd, [1998] 2 SCR 129 at 363–364.

82 Competition Act, RSC 1985, c C-34.

83 Eli Lilly & Co v. Apotex Inc, 2005 FCA 361 at Paragraphs 14, 36; Eli Lilly & Co v. Marzone Chemicals Ltd (1976), 29 CPR (2d) 253 at 255 (FCTD), aff'd (1976), 29 CPR (2d) 255 (FCA); Volkswagen Canada Inc v. Access International Automotive Ltd, 2001 FCA 79 at Paragraphs 21, 26; j2 Global Communications Inc v. Protus IP Solutions Inc, 2008 FC 759 at Paragraphs 29–36, aff'd 2009 FCA 41; Eli Lilly & Co v. Apotex Inc, 2002 FCT 1007 at 371–372 (FCTD).

84 Eli Lilly & Co v. Apotex Inc, 2009 FC 991, 80 CPR (4th) 1, aff'd without comment on this issue 2010 FCA 240, leave to appeal to SCC refused, [2010] SCCA No 434; Laboratoires Servier v. Apotex Inc, 2008 FC 825 at Paragraphs 463–478, aff'd 2009 FCA 222 at Paragraphs 48–50, leave to appeal to SCC refused, [2009] SCCA No. 403.

85 Patent Act, RSC 1985, c P-4, Section 55.

86 ibid, Section 57.

87 JM Voith GmbH v. Beloit Corp (1993), 47 CPR (3d) 448 at 474–478 (FCTD), rev'd on other grounds (1997), 73 CPR (3d) 321 (FCA).

88 ConsolBoard Inc v. MacMillian Bloedel (Saskatchewan) Ltd (1982), 63 CPR (2d) 1 at 7 (FCTD), var'd (1983), 74 CPR (2d) 199 (FCA).

89 Monsanto Canada Inc v. Schmeiser, 2004 SCC 34 at Paragraph 100; Teledyne Industries Inc v. Lido Industrial Products Ltd (1982), 68 CPR (2d) 204 at 208 (FCTD).

90 Beloit Canada Ltée v. Valmet Oy (1994), 55 CPR (3d) 433 at 453–55 (FCTD) rev'd on other grounds (1995), 61 CPR (3d) 271, leave to appeal to SCC refused (1996), 64 CPR (3d) vi; Merck & Co v. Apotex Inc, 2006 FC 524 at Paragraph 229, rev'd on other grounds, but aff'd on this issue 2006 FCA 323 at Paragraphs 127–1331, leave to appeal to SCC refused, [2006] SCCA No. 507.

91 Patent Act, RSC 1985, c P-4, Sections 10, 55(1), 55(2).

92 Jay-Lor International Inc v. Penta Farm Systems Ltd, 2007 FC 358 at Paragraphs 120–123; Dow Chemical Company v. Nova Chemicals Corporation, 2017 FC 350 at Paragraphs 63-65.

93 Whiten v. Pilot Insurance Co, 2002 SCC 18 at Paragraph 94; Dimplex North America Ltd v. CFM Corp, 2006 FC 586 at Paragraph 121, aff'd 2007 FCA 278; Eurocopter v. Bell Helicopter Textron Canada Limitée, 2013 FCA 219 at Paragraph 163.

94 Dimplex North America Ltd v. CFM Corp, 2006 FC 586 at Paragraph 132, aff'd 2007 FCA 278.

95 Merck & Co v. Apotex Inc (2000), 5 CPR (4th) 1 at 22 (FCTD), rev'd on other grounds 2003 FCA 234, leave to appeal to SCC refused, [2003] SCCA No 366; Patent Act, RSC 1985, c P-4, Section 57.

96 Eurocopter v. Bell Helicopter Textron Canada Ltd, 2012 FC 113 at Paragraph 397, 100 CPR (4th) 87, aff'd on other grounds 2013 FCA 219.

97 Baxter Travenol Laboratories of Canada Ltd v. Cutter (Canada) Ltd (1983), 68 CPR (2d) 179 at 200 (FCA) leave to appeal to SCC refused (1983), 72 CPR (2d) 287; Merck & Co v. Apotex Inc, 2006 FCA 323 at Paragraphs 117–124, leave to appeal to SCC refused [2006] SCCA No. 507.

98 Patent Act, RSC 1985, c P-4, Section 60(2).

99 The contribution of Nancy Pei, partner, and Urszula Wojtyra, associate, at Smart & Biggar/Fetherstonhaugh in co-authoring this section is acknowledged with appreciation.

100 Food and Drugs Act, RSC 1985, c F-27 and Food and Drug Regulations, CRC, c 870.

101 Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended.

102 ibid, Section 4(1).

103 ibid, Section 4(2).

104 ibid, Section 4(1.1).

105 ibid, Section 4(4)(d).

106 ibid, Section 5.

107 The amendments to the PMNOC Regulations came into force on 21 September 2017. The new PMNOC Regulations apply to any matter relating to a notice of allegation served on a first person on or after that day. Any matter relating to a notice of allegation served prior to 21 September 2017 is governed by the former regulations.

108 Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended, Section 6.

109 ibid.

110 ibid, Section 7.

111 ibid, Section 8.

112 ibid, Sections 7(5)(b), 7(6) and 8(4).

113 Patent Act, RSC 1985, c P-4, Section 75.

114 ibid, Section 76.

115 ibid, Section 76.1.

116 Budget Implementation Act, 2018, No.2, SC 2018, c 27, Section 194.

117 Patent Act, RSC 1985, c P-4, Sections 56(5), 56(8).

118 Libbey-Owens-Ford Glass Co. v Ford Motor Co (1969), 57 CPR 155 at 182 (Ex Ct), aff'd [1970] SCR 833 (SCC); Victor Sporting Goods v. Harold Wilson Company (1904), 7 OLR 570 (ONCA), aff'd 1904 CarswellOnt 786 (SCC); Stephenson v. Babiy Motors Ltd (1978), 40 CPR (2d) 187 at 191 (BCSC); Merck & Co v. Apotex Inc (1994), 59 CPR (3d) 133 at 160-162 (FCTD), rev'd on other grounds (1995), 60 CPR (3d) 356 (FCA).

119 Patent Act, RSC 1985, c P-4, Sections 56(4), 56(9).

120 Competition Act, RSC, c C-34.

121 For a detailed review of the amendments, see 'Publication of Final Regulations on Patent Linkage and Term Restoration related to CETA' by Urszula Wojtyra, Nancy Pei and Daphne Lainson, 7 September 2017 (www.smart-biggar.ca/en/articles_detail.cfm?news_id=1298).

122 Under the previous version of the regulations, proceedings under the PMNOC Regulations had to be brought as an application separate from an action under the Patent Act. Under the updated regulations, litigation may be advanced by way of a single action relating to remedies sought under the PMNOC Regulations and in respect of patent infringement and related remedies pursuant to the Patent Act.

123 Bristol-Myers Squibb et al. v. Apotex Inc., No T-350-18 and T-351-18 (FC, October 17, 2019).

124 Bayer Inc v. Apotex Inc, 2019 FC 191, 164 C.P.R. (4th) 318.

125 Second persons are persons who file a submission or supplement for a notice of compliance in respect of a drug.

126 Genentech, Inc v. Celltrion Healthcare Co, Ltd, 2019 FC 293, 303 ACWS (3d) 850.

127 Teva Canada v. Pharmascience Inc, 2019 FC 595, 306 ACWS (3d) 154.

128 Patent Act, RSC 1985, c P-4, Sections 104-134.

129 Health Canada, Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations (Ottawa: Health Canada, 2019), (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-data-protection-under-08-004-1-food-drug-regulations.html).

130 Patent Act, RSC 1985, c P-4, Section 52.1.

131 ibid, Section 53.1.

132 ibid, Section 55.3(1).

133 Patent Act, RSC 1985, c P-4, Section 55.3(2).

134 ibid, Section 76.2.

135 Thermolec ltée c. Stelpro Design Inc., 2018 QCCS 901.

136 ibid, at Paragraphs 78-84.

137 Bill C-100, An Act to implement the Agreement between Canada, the United States of America and the United Mexican States, 1st Sess, 42nd Parl, 2019.