2020 FC 1180, 2020 FC 1180

2020 FC 1180 T-670-20 Merck Sharp & Dohme Corp. and Merck Canada Inc. ( Plaintiffs ) v. Sandoz Canada Inc. ( Defendant ) T-673-20 Merck Sharp & Dohme Corp. and Merck Canada Inc. ( Plaintiffs ) v . Pharmascience Inc. ( Defendant ) Indexed as: Merck Sharp & Dohme Corp. v. Sandoz Canada Inc. Federal Court, Southcott J.—Ottawa, November 23 and December 22, 2020. Patents — Infringement — Motions by defendants seeking order for

summary judgment under Federal Courts Rules , r. 215 or, alternatively, order striking out statement of claim in patent action under r. 221 — Plaintiffs opposing motions, requesting

summary judgment dismissing defendants’ defence — Each of Sandoz Canada Inc., Pharmascience Inc. defendant in patent action brought by plaintiffs Merck Sharp & Dohme Corp., Merck Canada Inc. — Motions based on defendants’ position that Patented Medicines (Notice of Compliance) Regulations , s. 8.2 , made under Patent Act , imposing limitation period, that within actions commenced after expiry of this period — Plaintiffs in both actions submitted that motions should be dismissed, sought

summary judgment, dismissing defendants’ limitation period defence — Plaintiff, Merck Canada Inc., authorized by Health Canada to sell drug sitagliptin (brand name JANUVIA) in Canada — Plaintiff, Merck Sharp & Dohme Corp., owning three patents listed in patent register for sitagliptin — On February 13, 2020, defendants serving Merck Canada Inc. with notice of allegation (NOA) respecting those three listed patents in which indicating that regulatory approval sought to market, sell generic sitagliptin tablet in Canada — Less than 45 days later, plaintiffs issued statements of claim under Regulations, s. 6(1) against each defendant relating to three patents subject of NOAs — As result, Regulations, s. 7(1)(d), automatic 24​-month stay applying to issuance of notice of compliance (NOC) relating to generic products subject of defendants’ submissions to Health Canada — In addition to listed patents, Merck Sharp & Dohme Corp. owning Canadian Patent No. 2518435 (′435 Patent), which not listed on patent register — On June 24, 2020, plaintiffs filing statements of claim commencing actions underlying these motions, alleging that making, constructing, using or selling of sitagliptin tablets by defendants would infringe certain claims in ′435 Patent — On July 17, 2020, defendants filing original versions of present motions to strike plaintiffs’ Regulations, s. 8.2 actions — Plaintiffs opposing motions arguing that no 45-day limitation period as defendants asserting; that Court should consider whether to grant

summary judgment in their favour, dismissing defendants’ limitation period defence as raising no genuine issue for trial — Whether Regulations imposing any timing requirements for s. 8.2 actions; whether plaintiffs’ claim in each action should be dismissed or struck as time-barred; whether

summary judgment should be granted in favour of plaintiffs — Commencement of Regulations, s. 6(1) action automatically triggers 24-month stay of grant of NOC (s. 7(1)(d)) — Plaintiffs right in arguing that 45-day limitation period linked to this statutory stay, overall need to bring litigation to conclusion expeditiously — 45-day limitation period is function of intention that stay, if to be invoked through commencing s. 6(1) action, be invoked promptly so that it will conclude promptly — Regulatory stay applying only to s. 6(1) actions, not to those under s. 8.2 — Legislative purpose of s. 8.2 is removal of previously existing barriers to quia timet actions to facilitate legal consideration of unlisted patents, thereby address uncertainty resulting from risks associated with such patents — However, such purpose not requiring elimination of such uncertainty within any particular timeframe as no

interpretation of s. 8.2 can eliminate uncertainty that potential for post-launch litigation of unlisted patents will continue to present — Rather, elimination of common law barrier achieved by s. 8.2 permitting earlier access to legal consideration; thus, earlier resolution of unlisted patent infringement claims — Therefore, no basis to conclude that relevant legislative purpose required reading down s. 8.2 to include 45-day limitation period — In conclusion, no genuine issue for trial with respect to defendants’ limitation period defence — Defence as to limitation period failing — Motions by defendants dismissed; request by plaintiffs granted.

These were two motions by the defendants seeking an order for

summary judgment under rule 215 of the Federal Courts Rules or, in the alternative, an order striking out the statement of claim in a patent action under rule 221 . Each of Sandoz Canada Inc. and Pharmascience Inc. is a defendant in a patent action brought by the plaintiffs Merck Sharp & Dohme Corp. and Merck Canada Inc. These motions were based on the defendants’ position that

section 8.2 of the Patented Medicines (Notice of Compliance) Regulations , made under the Patent Act , imposes a limitation period and that the within actions were commenced after expiry of this period. The plaintiffs in both actions submitted that these motions should be dismissed but also sought

summary judgment, dismissing the defendants’ limitation period defence. The motions were heard together. The plaintiff, Merck Canada Inc., is authorized by Health Canada to sell the drug sitagliptin (sold under the brand name JANUVIA) in Canada. The other plaintiff, Merck Sharp & Dohme Corp., owns three patents listed in the patent register for sitagliptin. On February 13, 2020, each of the defendants served Merck Canada Inc. with a notice of allegation (NOA) in respect of those three listed patents. Each NOA indicated that regulatory approval was being sought to market and sell a generic sitagliptin tablet in Canada. Less than 45 days

later, the plaintiffs issued statements of claim under subsection 6(1) of the Regulations against each of the defendants related to the threepatents that were the subject of the NOAs. As a result, pursuant to paragraph 7(1)(

d) of the Regulations, an automatic 24​-month stayapplied to the issuance of a notice of compliance (NOC) relating to the generic products that were the subject of the defendants’submissions to Health Canada. In addition to the listed patents, Merck Sharp & Dohme Corp. owns Canadian Patent No. 2518435 (′435Patent), which is not listed on the patent register. On June 24, 2020, the plaintiffs filed statements of claim commencing the actionsunderlying these motions, pursuant to

section 8.2 of the Regulations, alleging that the making, constructing, using or selling of sitagliptintablets by the defendants would infringe certain claims in the ′435 Patent. On July 17, 2020, the defendants filed the original versions ofthe present motions to strike the

section 8.2 actions under rule 221. The basis of these motions was that

section 8.2, properly interpreted,includes a 45-day limitation period, which began running upon service of the NOAs, and the plaintiffs served their statements of claimfor the

section 8.2 actions 132 days after they received the NOAs. The plaintiffs opposed the motions arguing that there is no 45-daylimitation period as the defendants asserted. They also submitted that the Court should consider whether to grant

summary judgment intheir favour, dismissing the defendants’ limitation period defence as raising no genuine issue for trial. The issues were whether the Regulations impose any timing requirements for

section 8.2 actions; whether the plaintiffs’ claim in eachaction should be dismissed or struck as time-barred; and whether

summary judgment should be granted in favour of the plaintiffs. Held, the defendants’ motions should be dismissed and the plaintiffs’ request for

summary judgment should be granted. The parties’ submissions on the

interpretation of

section 8.2 focussed on the text of that provision and the context of other sections in theRegulations but with significant reliance on their respective positions surrounding the legislative purpose. The plaintiffs’ principalsubmissions emphasized that

section 8.2 contains no express reference to a 45-day limitation period and stands in stark contrast tosubsection 6(1), which does expressly set out such a limitation. The defendants submitted that the language of

section 8.2 must be readdown to include a 45-day limitation period (or at least some limitation period), to facilitate the adjudication of unlisted patentinfringement claims before expiry of the 24-month statutory stay applicable to subsection 6(1) infringement claims brought within the45-day period. The divergence in the parties’ proposed

interpretations of

section 8.2 did not turn on reliance on different authorities orthe interpretive principles found therein. Rather, it was the parties’ different positions on the legislative purpose surrounding

section 8.2that drove different results through the application of those principles. Paragraph 55.2(4)(

e) of the Act, which has an interpretive influence, enables the enactment of regulations with respect to not only theprevention but also the resolution, of disputes respecting the infringement of a patent. Commencement of a subsection 6(1) actionautomatically triggers a 24-month stay of the grant of the NOC (paragraph 7(1)(d)). The plaintiffs were right in arguing that the 45-daylimitation period is linked to this statutory stay and the overall need to bring the litigation to conclusion expeditiously.

The 45-daylimitation period is a function of the intention that the stay, if it is to be invoked through commencing a subsection 6(1) action, beinvoked promptly so that it will conclude promptly. This is part of the balance, intended to be achieved by the Regulations, between theprotection of patent rights and the early availability of generic products. However, the regulatory stay applies only to subsection 6(1)actions, not to actions under

section 8.2. This point favoured the plaintiffs’ argument that the purpose for the 45-day period, applicable tothe former, does not apply to the latter. It would be an odd result if, through the statutory

interpretation advocated by the defendants,section 8.2 actions were subject to an absolute 45-day limitation period when subsection 6(1) actions are not. There would be no logic tosubjecting

section 8.2 claims to an absolute bar following the expiry of 45 days when the same does not apply to claims under subsection6(1). The plaintiffs advanced a number of points, which focussed on the specific features of the regulatory regime applicable tosubsection 6(1) actions, and inapplicable to

section 8.2 actions, to make a compelling case for their position. As the

section 8.2 actionproceeds outside the regulatory regime, the legislative purpose underlying the Regulations does not require, or indeed favour, readingdown

section 8.2 to include a limitation period, either the same as or comparable to that of subsection 6(1). The legislative purpose ofsection 8.2 is the removal of previously existing barriers to quia timet actions so as to facilitate legal consideration of unlisted patents andthereby address uncertainty resulting from the risks associated with such patents. However, this purpose does not require the eliminationof such uncertainty within any particular timeframe, as no

interpretation of

section 8.2 can eliminate the uncertainty that the potential forpost-launch litigation of unlisted patents will continue to present. Rather, the elimination of the common law barrier achieved by section8.2 permits earlier access to legal consideration and, therefore, earlier resolution of unlisted patent infringement claims. This result is inkeeping with the overall objective of striking a balance between effective patent enforcement and timely generic market entry. As such,there was no basis to conclude that the relevant legislative purpose required reading down

section 8.2 to include a 45-day limitationperiod. In conclusion, there was no genuine issue for trial with respect to the defendants’ limitation period defence. As there was no suchlimitation period applicable to the within actions, that defence had to fail. STATUTES AND REGULATIONS CITED Federal Courts Act, R.S.C., 1985, c. F-7, s. 20. Federal Courts Rules, SOR/98-106, rr. 215, 221, Tariff B, Column III. Food and Drugs Act, R.S.C., 1985, c. F-27. Patent Act, R.S.C., 1985, c. P-4, ss. 54(1),(2), 55.2(4)(e), 124(1).

Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 3(7), 4(1), 5, 6(1), 6.01, 6.02, 6.09, 6.1, 6.12, 7(1)(d), 8(6),8.1, 8.2. CASES CITED APPLIED: Milano Pizza Ltd. v. 6034799 Canada Inc., 2018 FC 1112, 159 C.P.R. (4th) 275; Rodriguez v. Canada, 2018 FC 1125; Apotex Inc. v.Pfizer Canada Inc., 2016 FC 136, [2017] 1 F.C.R. 3; Rizzo & Rizzo Shoes Ltd. (Re), (SCC), [1998] 1 S.C.R. 27,

(1998), 36 O.R. (3d) 418; Apotex Inc. v. Merck & Co. Inc., 2009 FCA 187, [2010] 2 F.C.R. 389, affg in part Apotex Inc. v. Merck & CoInc, 2008 FC 1185, [2009] 3 F.C.R. 234; AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] 2 S.C.R. 560. CONSIDERED: Genentech, Inc. v. Celltrion Healthcare Co., Ltd., 2019 FC 293, 165 C.P.R. (4th) 323; Connaught Laboratories Ltd. v. SmithklineBeecham Pharma Inc. (1998), (FC), 86 C.P.R. (3d) 36, [1998] F.C.J. No. 1851 (QL) (T.D.); Syndicat de la fonctionpublique du Québec v. Quebec (Attorney General), 2010 SCC 28, [2010] 2 S.C.R. 61; Friesen v.

Canada, (SCC), [1995]3 S.C.R. 103, (1995), 127 D.L.R. (4th) 193; R. v. Zeolkowski, (SCC), [1989] 1 S.C.R. 1378, (1989), 58 Man. R. (2d) 63;Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329, [1993] F.C.J. No. 1106 (QL) (C.A.); ABHassle v. Canada (Minister of National Health & Welfare) (2000), (FCA), 7 C.P.R. (4th) 272, [2000] F.C.J. No. 855(QL) (C.A.); Apotex Inc. v. Bayer Inc., 2020 FCA 86, [2021] 2 F.C.R. 184. REFERRED TO: Lepage v. Canada, 2017 FC 1136; Celgene Corp. v. Canada (Attorney General), 2011 SCC 1, [2011] 1 S.C.R. 3; 65302 BritishColumbia Ltd. v.

Canada, (SCC), [1999] 3 S.C.R. 804, (1999), 179 D.L.R. (4th) 577; Apotex Inc. v. Pfizer Inc., 2017FCA 201, [2019] 2 F.C.R. 263; Canada (Information Commissioner) v. Canada (Minister of National Defence), 2011 SCC 25, [2011] 2S.C.R. 306. AUTHORS CITED Regulatory Impact Analysis Statement, SOR/2017-166, C. Gaz. 2017.II.16. Sullivan, Ruth. Sullivan on the Construction of Statutes, 6th ed. Markham, Ont.: LexisNexis, 2014. MOTIONS by defendants seeking an order for

summary judgment under rule 215 of the Federal Courts Rules or, in the alternative, anorder striking out the statement of claim in that patent action under rule 221; REQUEST by plaintiffs for

summary judgment dismissingthe defendants’ limitation period defence. Motions by defendants dismissed; request by plaintiffs granted. APPEARANCES David Tait and Bohdana Tkachuk for plaintiffs. Neil Fineberg for defendant Sandoz Canada Inc. Kavita Ramamoorthy for defendant Pharmascience Inc. SOLICITORS OF RECORD McCarthy Tétrault LLP, Toronto, for plaintiffs. Fineberg Ramamoorthy LLP, Toronto, for defendants Sandoz Canada Inc. and Pharmascience Inc. The following are the reasons for judgment and judgment rendered in English by Southcott J.: I.

Overview [1] Each of Sandoz Canada Inc. and Pharmascience Inc. is a defendant in a patent action brought by Merck Sharp & Dohme Corp.and Merck Canada Inc. (Court File Nos. T-670-20 and T-673-20, respectively). Each defendant has brought a motion in the action towhich it is a party, seeking an order for

summary judgment under rule 215 of the Federal Courts Rules, SOR/98-106 (the Rules) or, inthe alternative, an order striking out the statement of claim in that action under rule 221. [2] These motions are based on the defendants’ position that

section 8.2 of the Patented Medicines (Notice of Compliance)Regulations, SOR/93-133 (the PM(NOC) Regulations or Regulations), made under the Patent Act, R.S.C., 1985, c. P-4 (the Act),imposes a limitation period and that the within actions were commenced after expiry of this period. [3] Merck Sharp & Dohme Corp. and Merck Canada Inc., the plaintiffs in both actions, submit that these motions should bedismissed but also seek

summary judgment, dismissing the defendants’ limitation period defence. [4] The defendants initiated the motions in both actions by filing notices of motion on July 17, 2020. The defendants subsequentlyamended their notices of motion on September 4, 2020. The motions were heard together on November 23, 2020. As the parties’arguments in both matters are identical, these reasons apply to the motions in both actions. [5] For the reasons explained in more detail below, the defendants’ motions are dismissed, and the plaintiffs’ request for

summaryjudgment is granted. This case presents circumstances where it is appropriate to grant

summary judgment on the issue of statutoryinterpretation raised by the parties. I agree with the plaintiffs’ argument, that

section 8.2 of the Regulations does not impose a limitationperiod applicable to actions commenced thereunder. My judgment will therefore dismiss the defendants’ limitation period defence ineach action. A. Legislative and Regulatory Background [6] The following is a general description of the regulatory regime that represents the context for the issue in these motions. The

statutory and regulatory provisions relevant to this issue will be addressed in more detail in the Analysis portion of these reasons. [ 7 ] In order to sell a drug in Canada, pharmaceutical manufacturers must obtain authorization from Health Canada in the form of a notice of compliance (NOC) issued pursuant to regulations made under the Food and Drugs Act , R.S.C., 1985, c. F-27 .

A “first person” who files a submission for an NOC for a drug may submit to the Minister of Health a list of patents related to the drug and, if it receives an NOC, may have that list placed on the patent register under the PM(NOC) Regulations (subsections 4(1) and 3(7)).

When a “second person” subsequently files a submission for an NOC that references a drug in respect of which a patent is listed on the patent register, the Regulations require that second person to serve upon the first person a notice of allegation (NOA) in relation to the drug including any allegation that the listed patent is invalid (section 5 of the Regulations). [ 8 ] Under subsection 6(1) of the Regulations , the first person or an owner of a patent who receives an NOA may, within 45 days of service of the NOA, bring an action in the Federal Court against the second person who served the NOA, seeking a declaration that the making, constructing, using, or selling of the drug in accordance with the second person’s submission would infringe the patent.

The subsection 6(1) right of action applies only to listed patent(

s) that are referenced in the NOA. An action brought under subsection 6(1) triggers an automatic statutory stay preventing the Minister of Health from issuing an NOC to the second person for 24 months (paragraph 7(1)(

d) of the Regulations). The language of subsection 6(1) is as follows: 6

(1) The first person or an owner of a patent who receives a notice of allegation referred to in paragraph 5(3)(

a) may, within 45 days after the day on which the first person is served with the notice, bring an action against the second person in the Federal Court for a declaration that the making, constructing, using or selling of a drug in accordance with the submission or supplement referred to in subsection 5(1) or (2) would infringe any patent or certificate of supplementary protection that is the subject of an allegation set out in that notice. [ 9 ]

Section 8.2 of Regulations, the

interpretation of which is at issue in these motions, provides a first person or patent owner the right, on receipt of an NOA, to commence an action for patent infringement that could result from the making, constructing, using, or selling of the drug that is the subject of the second person’s submission. The

section 8.2 right of action applies to patents other than the listed patent(

s) referenced in the NOA. The language of

section 8.2 is as follows: 8.2 On receipt of a notice of allegation relating to a submission or supplement, a first person or owner of a patent may, under subsection 54(1) or 124(1) of the Patent Act , bring an action for infringement of a patent or certificate of supplementary protection — other than one that is the subject of an allegation set out in that notice — that could result from the making, constructing, using or selling of the drug in accordance with the submission or supplement. B.

Factual Background [ 10 ] The plaintiff, Merck Canada Inc., is authorized by Health Canada to sell the drug sitagliptin (sold under the brand name JANUVIA) in Canada. The other plaintiff, Merck Sharp & Dohme Corp., owns three patents listed in the patent register for sitagliptin. On February 13, 2020, each of the defendants served Merck Canada Inc. with an NOA in respect of those three listed patents.

Each NOA indicated that regulatory approval was being sought to market and sell a generic sitagliptin tablet in Canada. [ 11 ] Less than 45 days later, the plaintiffs issued statements of claim under subsection 6(1) of the PM(NOC) Regulations (in Court File Nos. T-418-20 and T-419-20) against each of the defendants related to the three patents that were the subject of the NOAs. As a result, pursuant to paragraph 7(1)(

d) of the Regulations, an automatic 24-month stay applies to the issuance of an NOC relating to the generic products that are the subject of the defendants’ submissions to Health Canada. [ 12 ] In addition to the listed patents, Merck Sharp & Dohme Corp. owns Canadian Patent No. 2518435 (′435 Patent), which is not listed on the patent register. On June 24, 2020, the plaintiffs filed statements of claim commencing the actions underlying these motions (in Court File Nos. T-670-02 and T-673-20), pursuant to

section 8.2 of the Regulations, alleging that the making, constructing, using or selling of sitagliptin tablets by the defendants will infringe certain claims in the ′435 Patent. [ 13 ] On July 17, 2020, the defendants filed the original versions of the present motions to strike the

section 8.2 actions under rule 221. The basis of these motions was that

section 8.2, properly interpreted, includes a 45-day limitation period, which began running upon service of the NOAs, and the plaintiffs served their statements of claim for the

section 8.2 actions 132 days after they received the NOAs. [ 14 ] The hearing of the motions was originally scheduled for September 3, 2020. However, the defendants advised the Court in late August 2020 that they intended to amend their motions to add a request for

summary judgment. After hearing submissions from the parties, Prothonotary Furlanetto issued an order dated September 11, 2020, directing that the defendants’ amended motions for

summary judgment and to strike would be heard on November 23, 2020, and that the plaintiffs would maintain the right to raise the rescheduling and amendments relating to these motions as an argument relevant to costs. II. Issues [ 15 ] The defendants submit that the issues to be decided in this motion are: A. Whether the PM(NOC) Regulations impose any timing requirements for

section 8.2 actions? B. Whether the plaintiffs’ claim in each action should be dismissed or struck as time-barred? [ 16 ] The plaintiffs oppose the motions. They also submit that the Court should consider whether to grant

summary judgment in favour of the plaintiffs, dismissing the defendants’ limitation period defence as raising no genuine issue for trial. III. Analysis

A. Suitability of Limitation Period Issue for

Summary Judgment [17] While this motion was originally framed as a motion to strike under rule 221, the amended motion materials and the parties’arguments at the hearing focused upon the availability of

summary judgment to address the legal issue of whether a 45-day limitationperiod applies to actions commenced under

section 8.2 of the Regulations. [18] Subsection 215(1) [of the Rules] provides that, if on a motion for

summary judgment the Court is satisfied that there is nogenuine issue for trial with respect to a claim or defence, the Court shall grant

summary judgment accordingly. In Milano Pizza Ltd. v.6034799 Canada Inc., 2018 FC 1112, 159 C.P.R. (4th) 275 (Milano Pizza), at paragraphs 24 to 41, Justice Mactavish summarized thelaw governing motions for

summary judgment in the Federal Court, including explaining that the purpose of

summary judgment is toallow the Court to summarily dispense with actions that ought not to proceed to trial because they do not raise a genuine issue to be tried,thereby conserving scarce judicial resources and improving access to justice (at paragraph 25). [19] As the defendants note, Justice Norris observed in Rodriguez v. Canada, 2018 FC 1125 that where there is no real dispute aboutthe evidence, and the only dispute is about how to apply relevant legal principles, the case is something that can be readily and fairlydetermined in the context of a motion for

summary judgment (at paragraph 24). Addressing whether a limitation period has expired is thesort of circumstance in which

summary judgment may be appropriate (see, e.g., Lepage v. Canada, 2017 FC 1136, at paragraph 53). [20] I need not canvass in any further detail the principles governing the availability of

summary judgment, as the parties to thesemotions agree that the limitation period issue raised by the defendants’ motions is suitable for adjudication in this manner. The plaintiffsoppose the motions, as they argue that there is no 45-day limitation period as the defendants assert. However, the plaintiffs urge theCourt to find in their favour through

summary judgment on this issue. In other words, while the parties dispute whether there is anapplicable limitation period, they agree the Court should decide that issue, one way or the other, on these motions and enter

summaryjudgment on that issue accordingly. [21] Of course, if the plaintiffs prevail on this issue,

summary judgment in their favour will serve only to remove one defence fromthe issues in these actions. However, as the defendants note in their written submissions, subsections 215(2) and (3) [of the Rules] permitthe Court to grant motions for

summary judgment in part. The plaintiffs also rely on Apotex Inc. v. Pfizer Canada Inc., 2016 FC 136,[2017] 1 F.C.R. 3, at paragraphs 33 to 36, in which Justice Diner held that, on a motion involving the

interpretation of a law, the Courtcould grant

summary judgment in favour of ether party, regardless of whether a cross-motion had been filed. (See also Milano Pizza, atparagraph 111.) [22] The present motions raise an issue of statutory

interpretation. There is little dispute between the parties as to the surrounding factsand, in any event, the determination of the statutory

interpretation issue does not require any factual determinations. I concur with theparties that this issue is suitable for adjudication through

summary judgment in the present motions. B. Principles of Statutory

Interpretation [23] The parties also agree on the fundamental principles governing statutory

interpretation although, as will be explained later in thisAnalysis, they do part ways on some of the nuances of the interpretive principles identified in the authorities, and they disagree on theoutcome resulting from application of these principles to the particular issue at hand. [24] The parties agree that Rizzo & Rizzo Shoes Ltd. (Re), (SCC), [1998] 1 S.C.R. 27, (1998), 36 O.R. (3d) 418(Rizzo Shoes) is the leading authority on the so-called “modern approach” to statutory

interpretation, requiring that statutory language beread in its entire context and in its grammatical and ordinary sense, harmoniously with the scheme of the legislation, the object of thelegislation, and the intention of Parliament (at paragraph 21). The

interpretation of a statutory provision involves a textual, contextualand purposive analysis to find a meaning that is harmonious with the statute as a whole (see, e.g., Celgene Corp. v. Canada (AttorneyGeneral), 2011 SCC 1, [2011] 1 S.C.R. 3, at paragraph 21). [25] The defendants also emphasize that the legislative purpose ought to be considered at every stage of a statutory analysis, includingwhen conducting the textual analysis. To the extent the language of the text permits,

interpretations that are consistent with or promotethe legislative purpose should be adopted, while

interpretations that defeat or undermine that purpose should be avoided (see RuthSullivan, Sullivan on the Construction of Statutes, 6th ed. (Markham, Ont.: LexisNexis, 2014) (Sullivan), at page 260). [26] The defendants also rely substantially on the ability, in conducting the statutory

interpretation exercise, to “read down” aprovision when a contextual analysis indicates that a narrow scope was intended, so as to ensure the provision aligns with the statutorypurpose. In Apotex Inc. v. Merck & Co. Inc., 2009 FCA 187, [2010] 2 F.C.R. 389, at paragraphs 87–91, the Federal Court of Appealendorsed this approach followed by the Federal Court, distinguishing “reading down” from “reading in”. In the decision under appeal,Apotex Inc. v.

Merck & Co Inc, 2008 FC 1185, [2009] 3 F.C.R. 234, at paragraphs 98 to 102, Justice Hughes relied on Sullivan’sexplanation of the difference between “reading down” and “reading in”. The former is described as a legitimate interpretative technique,involving adding restrictions or qualifications to give effect to the intended scope of legislation. The latter is described as expanding thereach of legislation and not a legitimate interpretative technique, other than perhaps as a constitutional remedy.

Justice Hughes alsoexplained that, while legislation is presumed to be well drafted (the so-called “presumption of perfection”), this presumption can bereadily rebutted, because drafting mistakes inevitably occur. [27] The defendants also emphasize that, when the statutory language being interpreted appears in regulations, the interpretiveprocess must be conducted in the context of the enabling legislation and its constraints (see AstraZeneca Canada Inc. v.

Canada(Minister of Health), 2006 SCC 49, [2006] 2 S.C.R. 560 (AstraZeneca), at paragraphs 15–16). [28] Finally, the defendants note that the history and evolution of a statute is an extrinsic aid that can be used to assist in determininglegislative intent (see, e.g., Rizzo Shoes, at paragraph 31). Both parties rely on the Regulatory Impact Analysis Statement (RIAS), whichaccompanied the most recent amendments to the Regulations in 2017 [SOR/2017-166, C. Gaz. 2017.II.16], as well as RIASs applicableto previous sets of amendments, as instructive in understanding the legislative intent.

[29] I have no difficulty accepting the principles described above as relevant to the process of statutory

interpretation. I will applythese principles to the

interpretation of the provision at issue in these motions. C. Sources of Legislative Purpose [30] Conscious of the defendants’ point that legislative purpose permeates all aspects of the legislative

interpretation process, I beginby identifying their submissions as to the sources from which that purpose can be derived and, briefly, their respective positions on thelegislative purpose. [31] The defendants’ amended written representations describe the Regulations’ broad legislative purpose as follows: 29. The Regulations are intended to balance the interests in making safe and effective drugs available to the public while preventingabuse of the “early working” exception from patent infringement under s 55.2(1) of the Patent Act.

The Regulations seek to achieve thisbalance by enabling legal proceedings to address patent concerns without unduly delaying access to generic medicines. This objectiveremained unchanged with the 2017 amendments to the Regulations. [32] While the defendants’ description relies in part on AstraZeneca (at paragraphs 15–16), which considered an earlier version of theRegulations, the defendants also note that Genentech, Inc. v. Celltrion Healthcare Co., Ltd., 2019 FC 293, 165 C.P.R. (4th) 323(Genentech) described the legislative purpose of the current Regulations in similar terms.

Specifically, Genentech (at paragraph 23) reliedon AstraZeneca in describing subsection 6(1) of the Regulations as enacted for the limited purpose of preventing infringement by aperson who takes advantage of the early working and stockpiling exemptions to patent infringement. [33] Consistent with the defendants’ above characterization of the broad legislative purpose of the Regulations, they also referencethe following paragraph from the “Background”

section of the RIAS covering the 2017 amendments [at page 33]: The Government’s pharmaceutical patent policy seeks to balance effective patent enforcement over new and innovative drugs with thetimely market entry of their lower-priced generic competitors. The Regulations were intended to reflect this balance by enablingsummary legal proceedings that would address patent concerns without unduly delaying access to generic medicines. Over time, theRegulations became less effective, in part because litigants commenced further litigation under the Patent Act (the Act) when unsatisfiedwith

summary proceeding rulings. [34] Against that background, the 2017 amendments incorporated into the Regulations a right of action for infringement of listedpatents (see subsection 6(1)). However, the amendments also provided for rights of action related to non-listed patents (see sections 8.1and 8.2).

In relation thereto, the defendants emphasize the following paragraphs of the RIAS [at pages 48 and 49]: Related rights of action Not all patents are eligible for listing on the patent register (e.g. patents claiming chemical intermediates, patents claiming processes formaking a drug) and not all eligible patents are necessarily listed on the register. Such patents can create legal uncertainty if there is riskthat they could be infringed by the generic product.

To facilitate legal consideration of such patents without expanding the scope ofproceedings under the proposed Regulations, related rights of action are proposed. … Innovator Right of Action The proposed Regulations would enable a first person or owner of a patent, upon receiving an NOA, to bring an action for infringementof a patent that is not the subject of an allegation in the NOA that could arise from making, constructing, using or selling a drug inaccordance with the second person’s submission or supplement. This would not establish a standalone patent infringement processunder the Regulations.

The purpose is effectively to permit the first person or patent owner to bring an action prior to actualinfringement occurring (essentially, an action quia timet). [Defendants’ emphasis.] [35] Noting the above reference to quia timet actions, it is useful to explain at this juncture that, prior to the 2017 regulatoryamendments, the common law prohibited such actions (i.e., actions seeking to restrain an activity that was threatened but had not yetviolated the plaintiff’s rights) except in exceptional circumstances. Connaught Laboratories Ltd. v.

Smithkline Beecham Pharma Inc.(1998), (FC), 86 C.P.R. (3d) 36, [1998] F.C.J. No. 1851 (QL) (T.D.), at paragraph 20, explained that a statement ofclaim initiating a quia timet proceeding alleging patent infringement required: (

a) allegations of a deliberate expressed intention toengage in activity the result of which would raise a strong possibility of infringement; (

b) that the activity be alleged to be imminent andthe resulting damage be alleged to be very substantial if not irreparable; and (

c) that the facts pleaded be cogent, precise and material. [36] As an aid to the

interpretation of

section 8.2 of the Regulations, the defendants also point to the enabling legislation pursuant towhich

section 8.2 was enacted. The parties appear to agree that the relevant subsection of the Act is paragraph 55.2(4)(e), whichprovides as follows: 55.2 … Regulations

(4) The Governor in Council may make regulations respecting the infringement of any patent that, directly or indirectly, could result orresults from the making, construction, use or sale of a patented invention in accordance with subsection (1), including regulations … (

e) respecting the prevention and resolution of disputes with respect to the infringement of a patent that could result directly or indirectly

from the manufacture, construction, use or sale of a product referred to in paragraph (a). [37] I do not understand the plaintiffs to take any particular issue with the defendants’ reliance on the above sources to inform anunderstanding of the legislative purpose. The plaintiffs also rely on the following paragraph in the “Objectives”

section of the RIAS forthe 2017 amendments: … the Government believes these amendments would achieve a number of objectives: … ● Fifthly, the proposed amendments remove barriers that may prevent innovators and generics from litigating certain patents outside theRegulations prior to generic market entry. [38] Later in this Analysis, I will return in more detail to the parties’ respective positions on the legislative purpose underlying section8.2 of the Regulations, and their arguments in support of, and derived from, those positions.

However, in brief, the defendants’ positionis that the purpose is the pursuit of legal certainty, surrounding the risks associated with unlisted patents, before a generic product islaunched. In contrast, the plaintiffs’ position is that the purpose is the removal of previously existing barriers to addressing theuncertainty arising from such risks, but not necessarily the elimination of such uncertainty or risks prior to generic product launch. D. Consideration of Text and Context [39] I now turn to the issue in dispute, whether

section 8.2 imposes a limitation period as argued by the defendants. Consistent withthe applicable jurisprudence, the parties’ submissions on the

interpretation of

section 8.2 focus on the text of that provision and thecontext of other sections in the Regulations, but with significant reliance on their respective positions surrounding the legislativepurpose. [40] For ease of reference, the text of

section 8.2 is as follows: 8.2 On receipt of a notice of allegation relating to a submission or supplement, a first person or owner of a patent may, under subsection54(1) or 124(1) of the Patent Act, bring an action for infringement of a patent or certificate of supplementary protection—other than onethat is the subject of an allegation set out in that notice—that could result from the making, constructing, using or selling of the drug inaccordance with the submission or supplement. [41] Focusing upon both text and context, the plaintiffs’ principal submissions emphasize that

section 8.2 contains no expressreference to a 45-day limitation period and stands in stark contrast to subsection 6(1), which does expressly set out such a limitation. Theplaintiffs argue subsection 6(1) demonstrates that those who drafted the Regulations clearly knew how to include a limitation period, andthe fact they failed to do so in

section 8.2 demonstrates that no limitation period was intended to apply to actions under that section. Theplaintiffs rely on similar reasoning in 65302 British Columbia Ltd. v. Canada, (SCC), [1999] 3 S.C.R. 804, (1999), 179D.L.R. (4th) 577, at paragraphs 63 to 65. They also note the point expressed by the Supreme Court of Canada in Syndicat de la fonctionpublique du Québec v.

Quebec (Attorney General), 2010 SCC 28, [2010] 2 S.C.R. 61, at paragraph 37, that there is no reason to thinkthat a legislature would choose to use two different drafting techniques to achieve the same result in the same statute. [42] While these arguments are simple, they are compelling. However, I remain conscious of the defendants’ submission that theauthorities caution against taking a purely literal approach to statutory

interpretation. Even if the words of a legislative provision appearclear, it is necessary to go beyond the text and consider both the context and the legislative purpose (see Apotex Inc. v. Pfizer Inc., 2017FCA 201, [2019] 2 F.C.R. 263, at paragraphs 50–51). Before considering other arguments by the plaintiffs, I will explain those advancedby the defendants to support their position that a limitation period applies to

section 8.2, notwithstanding the absence of express words tothat effect in the section. [43] Focusing upon the text of

section 8.2, the defendants note that it affords the right of action “[o]n receipt of a notice of allegation”.They observe that the provision does not use the language, “[o]n or after receipt of a notice of allegation”. Rather, the words chosenimply an immediacy, and they argue that meaning must be given to those words that achieves the intended legislative purpose of thesection and the regime overall. [44] Like the plaintiffs, the defendants also rely on subsection 6(1) as context, but they argue that the express 45-day limitation periodin subsection 6(1) supports their

interpretation, as they submit that consistency in the timing of commencement and therefore resolutionof infringement actions, related to listed and unlisted patents, is necessary in order to achieve the legislative intent. As previously noted,the defendants rely on the ability to “read down” a statutory provision, to limit or qualify express language in order to achieve that intent. [45] The defendants submit that, to achieve the legislative purpose of

section 8.2 and address the legal uncertainty associated with therisk that unlisted patents could be infringed by the generic product that is the subject of an NOA, such uncertainly must be addressed in atimely manner. The defendants argue that, to allow a first person to bring a

section 8.2 action whenever it wishes after being served withan NOA would fail to address that uncertainty, as

section 8.2 litigation (along with the possibility of the first person seeking injunctiverelief) could continue beyond the period when subsection 6(1) litigation on listed patents is resolved. [46] Indeed, the defendants raise the spectre of a first person commencing multiple and serial

section 8.2 actions. They argue thiswould frustrate the broad legislative purpose of facilitating timely entry of generic products to market and the specific legislative purposeunderlying

section 8.2 of addressing legal uncertainty surrounding the effect of unlisted patents upon such market entry. The defendantsnote the issue of “evergreening,” the concern about late-appearing patents frustrating generic market entry (see, e.g., AstraZeneca, atparagraph 39, for a discussion of the issue) that existed prior to 2006 amendments to the Regulations. Those amendments addressed thatconcern through a patent register that is “frozen” at the time a generic files a submission for an NOC. The defendants argue that, withouta limitation period applicable to

section 8.2 actions, the potential for evergreening will reappear, as first persons can file serial lawsuitsrelated to unlisted patents and thereby frustrate generic market entry.

[47] The defendants therefore argue that the language “[o]n receipt of a notice of allegation” in

section 8.2 must be interpreted tomean that a

section 8.2 action must be brought immediately upon receipt of an NOA and, at latest, within 45 days of such receipt.

Whilesection 8.2 does not include a reference to a 45-day limitation period, the defendants contend that reading down the language to includesuch a limitation is necessary to facilitate the adjudication of unlisted patent infringement claims within the pendency of the 24-monthstatutory stay that results from subsection 6(1) infringement claims brought within the 45-day period. [48] In response to these arguments, the plaintiffs submit that the Court cannot disregard the actual words chosen by the legislator andrewrite the legislation (see Canada (Information Commissioner) v.

Canada (Minister of National Defence), 2011 SCC 25, [2011] 2S.C.R. 306, at paragraph 40). They also rely on Friesen v. Canada, (SCC), [1995] 3 S.C.R. 103, (1995), 127 D.L.R.(4th) 193 (Friesen), for the proposition that the Court should not accept an

interpretation which requires the insertion of extra wordingwhen there is another acceptable

interpretation that does not require that extra wording (at paragraph 41). Also, in R. v. Zeolkowski, (SCC), [1989] 1 S.C.R. 1378, at page 1387, (1989), 58 Man. R. (2d) 63 (Zeolkowski), the Supreme Court referred to givingthe same words the same meaning throughout a statute as a basic principle of statutory

interpretation. [49] The defendants question the currency of the principles expressed in Friesen and Zeolkowski, noting that both pre-date RizzoShoes. I accept that there may be circumstances where a previous judicial expression of an interpretive principle may have to give way tothe governing principles of the modern approach. However, in the absence of any compelling submissions identifying inconsistenciesbetween the principles in those authorities and those explained in Rizzo Shoes, I see no reason to reject the guidance contained in theolder authorities.

Nor do I regard the application of the older authorities to guide the Court to a different result in the present matters thando the principles articulated in Rizzo Shoes and subsequent jurisprudence. [50] The plaintiffs point out that subsection 6(1) and

section 8.2 employ similar language in referring to the effect of receipt of anNOA. Subsection 6(1) states that, “[t]he first person or owner of a patent who receives a notice of allegation … may … bring an action”.Section 8.2 states that “[o]n receipt of a notice of allegation … a first person or owner of a patent may … bring an action”.

The plaintiffsacknowledge that this language is not identical in the two provisions, but they argue it is sufficiently alike that the principle expressed inZeolkowski applies. [51] While accepting the value of the guidance in Zeolkowski, I am not convinced it assists the plaintiffs in these particular matters.The defendants rely on the use of the words “[o]n receipt” in

section 8.2. These words are not reproduced identically in subsection 6(1). Itherefore do not consider Zeolkowski to necessarily guide the Court to the result advocated by the plaintiffs. [52] Turning to Friesen, considering whether there is an acceptable

interpretation of the provision at issue that does not require extrawording strikes me as similar to the interpretive exercise of considering whether or not respect for legislative purpose requires readingdown through the insertion of qualifying wording. I therefore do not consider Friesen to conflict with the interpretive process that thedefendants argue must be conducted. [53] In my view, the divergence in the parties’ proposed

interpretations of

section 8.2 does not turn on reliance on different authoritiesor the interpretive principles found therein. Rather, it is the parties’ different positions on the legislative purpose surrounding

section 8.2which drives different results through the application of those principles. I will now consider the parties’ arguments in support of thosepositions. E. Consideration of Legislative Purpose [54] As previously explained, the defendants submit that the language of

section 8.2 must be read down to include a 45-day limitationperiod (or at least some limitation period), to facilitate the adjudication of unlisted patent infringement claims before expiry of the 24-month statutory stay applicable to subsection 6(1) infringement claims brought within the 45-day period. Otherwise, outstanding section8.2 claims may frustrate the market entry of generics, even though all subsection 6(1) claims have been resolved. The defendants arguethis

interpretation of

section 8.2 is necessary to achieve the legislative purpose of that section, the pursuit of legal certainty in respect ofunlisted patents before a generic product is launched. [55] In support of this articulation of the purpose of

section 8.2, the defendants rely on the statements in the 2017 RIAS cited earlier inthese reasons. In

summary, the RIAS states that rights of action are proposed to facilitate legal consideration of unlisted patents that cancreate legal uncertainty, and (apparently in relation to

section 8.2) it expressly refers to the “purpose” as permitting a first person to bringan action prior to actual infringement occurring. [56] The defendants also rely on the enabling paragraph 55.2(4)(

e) of the Act, noting in particular the reference in that

section to theprevention of disputes with respect to the infringement of a patent. They argue that the prevention of infringement by a generic productfor which an NOC is sought is possible only if the action under the enabled

section of the Regulations is brought immediately uponservice of the NOA, so that resulting litigation can be concluded prior to the product entering the market. [57] The defendants’ arguments are not without merit, as I accept that the legal uncertainty associated with unlisted patents is reducedsooner if litigation surrounding those patents is commenced, and therefore resolved, promptly. I also accept the argument that theprevention of disputes with respect to the infringement of a patent is achieved by adjudication of potential infringement concerns beforethe potentially infringing product is launched. However, I am not convinced that the purpose of the Regulations, or

section 8.2 inparticular, should be understood exactly as the defendants advocate, or that the purpose drives the

interpretation that the defendants urgethe Court to adopt. [58] Examining first the interpretive influence of paragraph 55.2(4)(

e) of the Act, I note that it enables the enactment of regulationswith respect to not only the prevention, but also the resolution, of disputes with respect to the infringement of a patent. This point detractsfrom the defendants’ argument that

section 8.2 has a strictly preventative mandate that requires it be interpreted to permit only actionsthat are commenced quickly, and therefore capable of completion, prior to potential infringement. Even if one were to construe“prevention” as relating solely to litigation that concludes before generic product launch and “resolution” as relating to litigation thatconcludes after such launch, paragraph 55.2(4)(

e) enables the enactment of regulations with respect to both. Moreover, the plaintiffsmake the valid point that even litigation which does not conclude until after product launch serves to prevent infringement (if the first

person is successful) following judgment. [59] Turning to the 2017 RIAS, in addition to the paragraphs upon which the defendants rely, the plaintiffs note the paragraph thatdescribes the 2017 amendments as removing barriers that may prevent innovators and generics from litigating certain patents outside theRegulations prior to generic market entry. The plaintiffs argue that the legislative intention is that actions brought under

section 8.2 notform part of the regulatory regime created by the Regulations. While the Regulations govern subsection 6(1) actions,

section 8.2 actionsare brought outside that regime, with the sole impact of Regulations on such actions being the elimination of the common law barriers toquia timet actions. [60] I agree that such a purpose can be inferred from the language of the RIAS. I also agree with the plaintiffs’ submission that theintention that

section 8.2 actions proceed independently of the regulatory regime applicable to subsection 6(1) actions can be inferredfrom other provisions of the Regulations. As previously noted, commencement of a subsection 6(1) action automatically triggers a 24-month stay of the grant of the NOC (paragraph 7(1)(d)). The plaintiffs refer to Bayer AG v. Canada (Minister of National Health andWelfare) (1993), 51 C.P.R. (3d) 329, [1993] F.C.J.

No. 1106 (QL) (C.A.), at paragraphs 12 to 14, as linking the 45-day limitation periodto the statutory stay and the overall need to bring the litigation to conclusion expeditiously. [61] I accept the plaintiffs’ submission that these features of the subsection 6(1) action are linked. The 45-day limitation period is afunction of the intention that the stay, if it is to be invoked through commencing a subsection 6(1) action, be invoked promptly so that itwill conclude promptly.

This is part of the balance, intended to be achieved by the Regulations, between the protection of patent rightsand the early availability of generic products. However, the regulatory stay applies only to subsection 6(1) actions, not to actions undersection 8.2. This point favours the plaintiffs’ argument that the purpose for the 45-day period, applicable to the former, does not apply tothe latter. [62] Of course, a first person may seek a judicial stay in the context of a

section 8.2 action. However, such a stay is discretionary, andwhether it will be available will depend upon on assessment of the particular circumstances of the matter in which it is sought. It is theautomatic nature of the 24-month stay triggered by subsection 6(1) actions that creates the need for the 45-day limitation period. In myview, the potential availability of the discretionary remedy of a judicial stay does not suggest a need for a similar limitation periodapplicable to claims under

section 8.2. [63] The plaintiffs note that there are other provisions of the Regulations, which are also designed to achieve the expeditiousadvancement of subsection 6(1) actions. Such an action is automatically a specially managed proceeding under the Rules (section 6.1 ofthe Regulations), and there are provisions which require, or are designed to incentivize, diligence by the parties in conducting theproceeding (sections 6.09, 6.12, and subsection 8(6)). These provisions do not apply to

section 8.2 actions. Again, this difference favoursthe plaintiffs’ position that the 45-day limitation period, which is linked to the need for expeditious advancement of subsection 6(1)proceedings, is not intended to apply to

section 8.2. [64] The plaintiffs emphasize in particular the effect of

section 6.01 of the Regulations, which expressly prohibits any patent actionagainst the second person for infringement of a patent that is the subject of an NOA, other than an action under subsection 6(1), unlessthe first person did not within the 45-day limitation period have a reasonable basis for bringing the action. The effect is to makesubsection 6(1) actions brought within the limitation period an exclusive remedy, unless the “reasonable basis” exception applies. Thepotential availability of the exception militates against the defendants’ position. The plaintiffs argue, and I agree, that it would be an oddresult if, through the statutory

interpretation advocated by the defendants,

section 8.2 actions were subject to an absolute 45-daylimitation period when subsection 6(1) actions are not. [65] In so concluding, I am conscious of the submission by the defendants that its proposed

interpretation would not mean that, if the45-day limitation period was missed, a claim for infringement of an unlisted patent would be forever barred. The defendantsacknowledge that, while under their

interpretation of

section 8.2 the quia timet action permitted by

section 8.2 would be barred if out oftime, the first person could still commence an action under the Act once the generic product is launched and infringement occurs.However, that point does not dissuade me from the conclusion that there would be no logic to subjecting

section 8.2 claims to an absolutebar following the expiry of 45 days, when the same does not apply to claims under subsection 6(1). [66] The plaintiffs also rely on the purpose of the NOA, in the regulatory regime surrounding subsection 6(1) actions, to support theirposition on the

interpretation issue in dispute. As explained in AB Hassle v. Canada (Minister of National Health & Welfare) (2000), (FCA), 7 C.P.R. (4th) 272, [2000] F.C.J. No. 855 (QL) (C.A.), at paragraph 19, that purpose is to enable the firstperson to confidently decide within the 45-day time limit whether to resist the issuance of the NOC by commencing a subsection 6(1)action.

The plaintiffs submit that the NOA and information provided therewith, much of which is focused upon the listed patentsreferenced in the NOA, provide the first person with sufficient information to be able to prepare its claim quickly enough to meet the 45-day deadline. However, as the NOA is not directed to unlisted patents, the first person would not be similarly equipped to commence asection 8.2 action within the same 45 days. [67] Finally, the plaintiffs note the

section 6.02 prohibition against joinder of any other action to a subsection 6(1) action, while the24-month stay is in place. In its recent decision in Apotex Inc. v. Bayer Inc., 2020 FCA 86, [2021] 2 F.C.R. 184 (Bayer), the FederalCourt of Appeal explained that the purpose of this prohibition is to facilitate the expeditious resolution of subsection 6(1) actions withinthe 24-month stay period (at paragraphs 96 and 122). In contrast,

section 8.2 actions are not subject to such a prohibition. Indeed, theplaintiffs argue that it would be inconsistent with the legislative purpose identified in Bayer to require

section 8.2 actions to becommenced on the same timeline as subsection 6(1) actions, as this would increase the litigation burden on the parties and the difficultyin concluding the subsection 6(1) litigation within the 24 months. [68] I find that the above points advanced by the plaintiffs, which focus on the specific features of the regulatory regime applicable tosubsection 6(1) actions, and inapplicable to

section 8.2 actions, to make a compelling case for their position. As the

section 8.2 actionproceeds outside the regulatory regime, the legislative purpose underlying the Regulations does not require, or indeed favour, readingdown

section 8.2 to include a limitation period, either the same as or comparable to that of subsection 6(1).

[ 69 ] The plaintiffs also respond directly to the defendants’ argument that the legislative purpose of facilitating generic market entry following conclusion of subsection 6(1) litigation requires that

section 8.2 actions be commenced and concluded on the same timeline, so as to avoid serial ligation. As the plaintiffs observe,

section 8.2 merely provides a first person with the option of commencing an action for infringement of an unlisted patent prior to generic market entry. The plaintiffs note the defendants’ acknowledgement that, even if their

interpretation of

section 8.2 is accepted, a first person would still be free to sue on an unlisted patent following market entry, when the common law restrictions upon quia timet actions would no longer apply and the first person would no longer require recourse to

section 8.2. As such, the plaintiffs submit that it is not possible to conclude that the legislative purpose is to eliminate any further risk of patent litigation by the time the generic enters the market. [ 70 ] In response to the defendants’ argument that, without a limitation period,

section 8.2 will give rise to a resurrection of the pre- 2006 evergreening concern, the plaintiffs submit that the evergreening problem was a function of the automatic stay resulting from commencing an action for infringement of a listed patent. Under the pre-2006 regime, a series of such actions would trigger successive stays, continuing to delay generic market entry. However, commencing a

section 8.2 action does not invoke an automatic stay. As previously noted, there is a possibility of a first person seeking a judicial stay in the context of a

section 8.2 action. But this is discretionary relief and therefore does not raise the same concern as the potential for successive automatic stays of the pre-2006 era. Again, I agree with the plaintiffs’ submissions. [ 71 ] I accept that the legislative purpose of

section 8.2 is the removal of previously existing barriers to quia timet actions, so as to facilitate legal consideration of unlisted patents and thereby address uncertainty resulting from the risks associated with such patents. However, this purpose does not require the elimination of such uncertainty within any particular timeframe, as no

interpretation of

section 8.2 can eliminate the uncertainty that the potential for post-launch litigation of unlisted patents will continue to present. Rather, the elimination of the common law barrier achieved by

section 8.2 permits earlier access to legal consideration, and therefore earlier resolution, of unlisted patent infringement claims. This result is in keeping with the overall objective of striking a balance between effective patent enforcement and timely generic market entry. [ 72 ] As such, there is no basis to conclude that the relevant legislative purpose requires reading down

section 8.2 to include a 45-day limitation period. F. Argument on Jurisdiction [ 73 ] Before concluding my analysis, I must address a jurisdictional point raised by the defendants. They note that

section 8.2 permits a first person to bring an action for infringement of an unlisted patent under subsection 54(1) (or, although irrelevant for present purposes, subsection 124(1)) of the Act .

Section 54 of the Act provides as follows: Jurisdiction of courts 54

(1) An action for the infringement of a patent may be brought in that court of record that, in the province in which the infringement is said to have occurred, has jurisdiction, pecuniarily, to the amount of the damages claimed and that, with relation to the other courts of the province, holds its sittings nearest to the place of residence or of business of the defendant, and that court shall decide the case and determine the costs, and assumption of jurisdiction by the court is of itself sufficient proof of jurisdiction. Jurisdiction of Federal Court

(2) Nothing in this

section impairs the jurisdiction of the Federal Court under

section 20 of the Federal Courts Act or otherwise. [ 74 ] On its face, subsection 54(1) invokes the jurisdiction of the provincial superior courts, not the Federal Court. Of course, subsection 54(2) provides that subsection 54(1) does not impair the Federal Court’s jurisdiction under

section 20 of the Federal Courts Act , R.S.C., 1985, c. F-7 , which in turn states: Industrial property, exclusive jurisdiction 20

(1) The Federal Court has exclusive original jurisdiction, between subject and subject as well as otherwise, (

a) in all cases of conflicting applications for any patent of invention or for any certificate of supplementary protection under the Patent Act , or for the registration of any copyright, trademark, industrial design or topography within the meaning of the Integrated Circuit Topography Act ; and (

b) in all cases in which it is sought to impeach or annul any patent of invention or any certificate of supplementary protection issued under the Patent Act , or to have any entry in any register of copyrights, trademarks, industrial designs or topographies referred to in paragraph (

a) made, expunged, varied or rectified. Industrial property, concurrent jurisdiction

(2) The Federal Court has concurrent jurisdiction in all cases, other than those mentioned in subsection (1), in which a remedy is sought under the authority of

an Act of Parliament or at law or in equity respecting any patent of invention, certificate of supplementary protection issued under the Patent Act , copyright, trademark, industrial design or topography referred to in paragraph (1)(a). [ 75 ] The defendants’ point is that the legislative language provides no express linkage between the

section 8.2 right of action and the jurisdiction of the Federal Court. I do not understand the defendants to be directly challenging the jurisdiction of this Court over the within actions, at least not on this motion. Rather, the defendants submit that, if the legislative intent behind

section 8.2 is to afford concurrent jurisdiction to the provincial superior courts and the Federal Court, the legislative drafting is less than elegant. The defendants raise this point to illustrate the difficulty with taking a literal approach to statutory

interpretation. They argue that, if the Court is inclined to find no limitation period applicable to

section 8.2, because no express words to that effect appear in that section, the Court must then contend with a literal

interpretation of the section’s reference solely to subsection 54(1), raising concern that the Federal Court has no

jurisdiction over

section 8.2 actions. Put otherwise, if the “presumption of perfection” has not been rebutted in relation to

section 8.2, that presumption applies to the entirety of that

section including its reference solely to subsection 54(1) . [ 76 ] I do not intend to engage in a detailed analysis of this jurisdictional point. I do not read the defendants’ notice of motion as seeking relief based on this Court having no jurisdiction over the within actions. Nor would I be prepared to reach a conclusion on this issue without it being raised more squarely, and argued more comprehensively, than was the case on the present motions. [ 77 ] However, I have considered the defendants’ argument in the context of the statutory

interpretation exercise in which it is raised. In my view, this argument does not assist the defendants, as my conclusion that

section 8.2 does not include a limitation period is not based on an analysis confined to a literal reading of that section. To be clear, the text of the

section is an important component of the analysis and, as I have observed earlier in these reasons, the absence of limitation period language in the

section militates significantly against the defendants’ proposed

interpretation. However, I have conducted the broader analysis advocated by the defendants and supported by the authorities, taking into account not only the text but also the context and legislative purpose of

section 8.2 and the Regulations overall and, with the benefit of that full analysis, have rejected the defendants’ proposed

interpretation. IV. Conclusion [ 78 ] Based on the above exercise in statutory

interpretation, I am satisfied that there is no genuine issue for trial with respect to the defendants’ limitation period defence. As there is no such limitation period applicable to the within actions, that defence must fail. My judgment will therefore dismiss the defendants’ motion but will grant

summary judgment in favour of the plaintiffs, dismissing the limitation period defence in both actions. V. Costs [ 79 ] Each of the parties seeks costs. The plaintiffs seek costs of these motions, payable forthwith, in any event of the cause. They also argue that elevated costs are appropriate, to compensate them for the effect of the defendants’ decision to postpone their motions to strike, shortly before they were scheduled to be heard, to add the request for

summary judgment. [ 80 ] The defendants suggest that costs should be in the cause and disagree that the adjournment of their motions should result in elevated costs. [ 81 ] I agree with the plaintiffs that costs should follow their success in these motions, payable forthwith, in any event of the cause. If the defendants had prevailed, that result would have brought the actions to an end, and costs would necessarily have followed.

The plaintiffs should similarly receive their costs based on their success. [ 82 ] However, I do not consider the circumstances leading to the hearing of these motions to warrant costs on an elevated scale. I can identify little additional effort on the plaintiffs’ part required to respond to the motions as a result of their adjournment or the addition of the defendants’ request for

summary judgment. The statutory

interpretation arguments associated with the

summary judgment motions are the same as those related to the motions to strike. Moreover, the defendants’ addition of the request for

summary judgment opened the door for the plaintiffs also to seek

summary judgment in the event their position on the statutory

interpretation question prevailed. To the plaintiffs’ benefit, this had resulted in the elimination of an issue that would otherwise have remained to be resolved at trial. [ 83 ] Despite the Court’s request that the parties attempt to agree on the quantification of a costs award, they have not been able to do so. I will therefore award costs based on Column III of Tariff B [ Federal Courts Rules ], plus reasonable provable disbursements. If, with the benefit of that direction, the parties remain unable to agree on quantification, costs will be assessed. JUDGMENT IN T-670-20 AND T-673-20 THIS COURT’S JUDGMENT is that: 1. The defendant’s motion to strike and for

summary judgment is dismissed. 2.

Summary judgment is granted, on a partial basis, in favour of the plaintiffs, dismissing the defendant’s defence that the plaintiffs’ action is time-barred. 3. The plaintiffs are awarded costs of these motions, payable forthwith by the defendant, in any event of the cause. Costs shall be calculated based on Column III of Tariff B, plus reasonable provable disbursements, to be assessed if the parties cannot agree on their quantification.