2021 FCA 52, 2021 FCA 52

2021 FCA 52 A-282-18 Apotex Inc. ( Appellant ) v. Shire LLC and Shire Pharma Canada ULC ( Respondents ) A-283-18 Apotex Inc. ( Appellant ) v. Shire Pharma Canada ULC, Shire LLC and the Minister of Health ( Respondents ) Indexed as: Apotex Inc. v. Shire LLC Federal Court of Appeal, Rennie, de Montigny and Gleason JJ.A.—By videoconference, December 15 and 16, 2020; Ottawa, March 11, 2021.

Patents — Appeal from Federal Court decision concluding that asserted claims of Canadian Patent No. 2527646 ( ′646 patent) valid, prohibiting respondent Minister of Health from issuing notice of compliance (NOC) for Lisdexamfetamine (LDX) to appellant — LDX designed to treat attention deficit and hyperactivity disorder — Appellant filing abbreviated new drug submission, seeking NOC to manufacture, sell Apo-Lisdexamfetamine — Seeking declaration that ′646 patent invalid or that Apo-Lisdexamfetamine non-infringing — Federal Court adopting test in Apotex Inc. v.

Sanofi-Synthelabo Canada Inc. (Sanofi) — Appellant claiming Australian Patent No. 1965054168 (′168 patent) disclosing asserted claims of ′646 patent — Federal Court concluding that: appellant not meeting its burden with respect to disclosure requirement; claims’ inventive concept grasped without difficulty; differences between inventive concept, prior art not obvious to try — Finding claims of ′646 patent specific, valid — Granting Shire’s request for prohibition order — Appellant arguing, inter alia, that: Federal Court’s approach inconsistent with changes to Patent Act following Sanofi; Federal Court erring in considering advantages of LDX in anticipation analysis; Federal Court departing from claim-by-claim approach mandated by Patent Act , s. 28.3 in analysis of inventive concept; Federal Court erring in stage 4 of Sanofi analysis — Main issue whether Federal Court erring in adopting Sanofi test or in its application to the facts herein — Federal Court committing no reviewable error in legal framework nor in its application to facts as found — Validity analysis not changing depending on whether patent classified as selection patent or not — Core of appellant’s argument being that Federal Court erring by not conducting anticipation analysis by comparing ′168, ′646 patents — This amounting to assertion that genus patents necessarily anticipating chemical composition claims in species patents — “Necessarily infringe” test, [1] requirements of Patent Act , s. 28.2 applying to all patents — But anticipation still having role in context of genus disclosures — Federal Court finding specific asserted claims within ′646 patent not anticipated — Obviousness also assessed on claim-by-claim basis — Federal Court determining inventive concept based on reading of claims informed by specification — Patent Act , s . 28.3 not displacing longstanding case law indicating how obviousness determined — Sanofi not changing substantive law of obviousness by implication — Term “inventive concept” not materially different than previously used term “solution taught by the patent” — In sum, single inventive concept flowing through patent, but each claim’s specific inventive concept may be different — Federal Court not erring in having regard to properties, beneficial features of LDX — Inventive concept cannot be used as vehicle to construe or read inventive concept of claims more narrowly or broadly than their text will allow — Redundancy only permitted where purposive analysis showing that claims duplicated — Ciba Specialty Chemicals Water Treatments Limited v.

SNF Inc. not contradicting Sanofi — If identification about inventive concept not readily apparent, court should “simply work on the features of the claim” — With respect to last stage of obviousness inquiry, Federal Court making determinations of fact related directly to other two “obvious to try” factors, cementing Federal Court’s position, rather than detracting from it — Appeal dismissed.

This was an appeal from a Federal Court decision concluding that the asserted claims of Canadian Patent No. 2527646 (′646 patent) were valid, and that the respondent Minister of Health should be prohibited from issuing a notice of compliance (NOC) for Lisdexamfetamine (LDX) to the appellant. LDX is a chemical compound sold by the respondents Shire LLC and Shire Pharma Canada ULC (Shire). It is designed to treat attention deficit and hyperactivity disorder.

The appellant filed an abbreviated new drug submission with Health Canada seeking a NOC to manufacture and sell Apo-Lisdexamfetamine and served Shire with a notice of allegation under the Patented Medicines (Notice of Compliance) Regulations , SOR/93-113 (Regulations). Shire sought to prohibit the Minister from granting the appellant the NOC until the expiry of the ′646 patent. The appellant subsequently sought a declaration that the ′646 patent was invalid, or, alternatively, that Apo- Lisdexamfetamine would not infringe any valid claim of the ′646 patent.

In addressing the anticipation requirement, the Federal Court adopted as the starting point the test articulated in Apotex Inc. v. Sanofi-Synthelabo Canada Inc. ( Sanofi ). On this issue, the appellant claimed Australian Patent No. 1965054168 (′168 patent) discloses the asserted claims of the ′646 patent. The Federal Court disagreed and concluded that the appellant had not met its burden with respect to the disclosure requirement. On the issue of obviousness, the Federal Court concluded that the claims’ inventive concept was grasped without difficulty.

The Federal Court rejected the appellant’s argument that, based on the guidance of Ciba Specialty Chemicals Water Treatments Limited v. SNF Inc. ( Ciba ), claims construction was

dispositive and the Court would err in searching for an inventive concept. On the issue of the differences between the prior art and the inventive concept, the Federal Court concluded that as of the relevant date, May 2003, there were numerous differences between the state of the art and the inventive concept.

The Federal Court concluded that the overall difference between the inventive concept and the prior art was the compound LDX and its advantageous properties, that the differences were not obvious to try (the fourth Sanofi factor), largely as it was not more or less self-evident that LDX ought to work as an abuse resistant and sustained release formulation using only routine tests. The Federal Court found the claims of the ′646 patent sufficiently specific, not overbroad and therefore valid, and granted Shire’s request for a prohibition order pursuant to subsection 6(1) of the Regulations.

The thrust of the appellant’s argument here was that the tests for anticipation and obviousness are claim-by-claim analyses that focus on the subject matter of the claims alone. It argued, inter alia , that the Federal Court’s approach was inconsistent with the changes to the Patent Act following Sanofi , with the Supreme Court decision in AstraZeneca Canada Inc. v. Apotex Inc. , and with recent Federal Court of Appeal decisions in Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research ( Hospira ) and Ciba .

Turning to anticipation, the appellant argued that only the claimed bare chemical formula itself should be compared to the genus disclosed in the prior art. It is only in a selection patent [2] that the advantageous qualities of a compound are also examined against the prior art. As the ′646 patent was not categorised by the Federal Court as a selection patent, the appellant further argued it was an error to consider the advantages of LDX in the anticipation analysis.

The appellant also challenged the Federal Court’s analysis of the ′646 patent’s inventive concept, arguing that its departure from the claim-by-claim approach mandated by

section 28.3 of the Patent Act was an egregious error in light of criticism, both judicial and academic, of the “inventive concept” as a circular, illogical, and redundant inquiry. The appellant also said that the Federal Court erred in stage 4 of the Sanofi analysis by considering whether the properties of LDX were predictable without experimentation in the obvious and “obvious to try” analyses. The main issue was whether the Federal Court erred in adopting the Sanofi test or in its application to the facts herein. Held , the appeal should be dismissed.

The Federal Court committed no reviewable error in the legal framework nor in its application to the facts as found. The Federal Court did not decide whether the ′646 patent was a selection patent, and the arguments herein pivoted on the consequences of that. Although the failure of a court to characterize a patent one way or another may reflect a lack of understanding of the patent and its factual context, the failure to do so, in and of itself, is not an error of law. The validity analysis does not change depending on whether the patent was formally classified as a selection patent or not.

Anticipation requires proof of both disclosure and enablement. A prior art reference discloses the claimed invention when, if performed, the prior art reference would necessarily result in the infringement of the patent claim. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee. If the flag is planted, the claim has been disclosed.

The core of the appellant’s argument was that the Federal Court erred by failing to conduct the anticipation analysis by comparing the ′168 patent to the subject matter defined by each of the individual claims asserted by the ′646 patent. The appellant’s argument, distilled, amounted to no more than an assertion that genus patents necessarily anticipate the chemical composition claims in species patents. To accede to this proposition would be, in these circumstances, a marked departure from established precedent, including the decision in Hospira .

The “necessarily infringe” test [3] applies to all patents, as do the requirements of

section 28.2 of the Patent Act . This is not to say that anticipation has no role in the context of genus disclosures—to the contrary, it is very much alive. Therefore, the ultimate answer to the question of whether the inventor “planted a flag” at the compound is driven by the specific evidence in each case. Here, the Federal Court identified differences that relate to the specific asserted claims within the ′646 patent. In doing so, it found that those specific claims were not anticipated. The Federal Court undertook the exercise required of it by Sanofi .

As with anticipation, obviousness is assessed on a claim-by-claim basis. Each claim is evaluated against the four-part Sanofi test. [4] The present dispute was the end point of the obviousness inquiry—both how it is determined and whether the Federal Court erred in its application of the concept. The Federal Court did not determine the inventive concept based on some “generalized concept”; rather it was based on a reading of the claims informed by the specification. The effect of

section 28.3 of the Patent Act is not to narrow the inventive concept to the essential elements of the claim itself.

Section 28.3 , in codifying the common law requirement that an invention not be obvious, did not displace the longstanding case law that indicates how obviousness is determined. The purpose of the inventive concept is to help determine what, if anything, makes the claim, as constructed, inventive. This is the very inquiry

section 28.3 requires. Sanofi did not change the substantive law of obviousness by implication, and the term “inventive concept” is not materially different than the previously used term of “solution taught by the patent”. This is the lens that the Court should keep in mind when determining the inventive concept. This lens becomes particularly important if recourse to the specification is required. In sum, a single inventive concept must flow through a patent, but each claim’s specific inventive concept may be different.

The Federal Court committed no error in having regard to the properties and beneficial features of LDX in determining the inventive concept of the claims in issue. The description was sufficient to allow the Federal Court to construe these properties as features of the compound as claimed in the independent claims, such that they should form part of the inventive concept.

Although a certain degree of redundancy is often inherent at the inventive concept stage, an inventive concept cannot be used as a vehicle to construe or read the inventive concept of claims more narrowly or broadly than their text, or plain language, will allow. As such, redundancy is only permitted where a purposive analysis shows that claims are in effect duplicated. The Federal Court was aware of this limitation on the use of the inventive concept.

None of the claims of the ′646 patent contained wording that conflicted with the inventive concept as identified by the Federal Court, although it did render some of the later claims redundant. The inventive concept as determined by the Federal Court was not affected by any impermissible redundancy or duplication in its application. Ciba does not, however, contradict Sanofi . Ciba recognises that an inventive concept must be based on a claim, and not some vague paraphrase in the disclosure.

Thus, if the identification about an inventive concept is not readily apparent, the court should “simply work on the features of the claim”. This ensures that obviousness is grounded in the claims themselves, a requirement discussed in both Sanofi and the Patent Act . Finally, with respect to the last stage of the obviousness inquiry, the Federal Court made determinations of fact that related directly to the other two “obvious to try” factors, both of which cemented the Federal Court’s position, rather than detracted from it.

In sum, on the issue of obviousness, the Federal Court applied the Sanofi test and identified the single inventive concept linking each claim of the ′646 patent. It then considered the state of the art, the gap between the state of the art and the inventive concept, and finally considered whether the differences were obvious based on the enumerated and contextual factors of the “obvious to try” analysis.

STATUTES AND REGULATIONS CITED Patent Act, R.S.C., 1985, c. P-4, ss. 28.2, 28.3, 43(2), 58, 60. Patented Medicines (Notice of Compliance) Regulations, SOR/93-113, s. 6(1). CASES CITED APPLIED: Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265; Hospira Healthcare Corporation v. Kennedy Trust forRheumatology Research, 2020 FCA 30; Ranbaxy Laboratories Limited v. AstraZeneca AB, [2013] FCA 368 (Aus.); Unilever PLC. v.Chefaro Proprietaries Ltd., [1994] R.P.C. 567 (Eng. C.A.). CONSIDERED: Ciba Specialty Chemicals Water Treatments Limited v.

SNF Inc., 2017 FCA 225, 152 C.P.R. (4th) 239; AstraZeneca Canada Inc. v.Apotex Inc., 2017 SCC 36, [2017] 1 S.C.R. 943; Bristol-Myers Squibb Canada Co. v. Teva Canada Limited, 2017 FCA 76, [2018] 3F.C.R. 380; Tetra Tech EBA Inc. v. Georgetown Rail Equipment Company, 2019 FCA 203, 166 C.P.R. (4th) 1; Tearlab Corporation v. I-MED Pharma Inc., 2019 FCA 179, 166 C.P.R. (4th) 367; Apotex Inc. v. Pfizer Canada Inc., 2019 FCA 16, 163 C.P.R. (4th) 191; Eli LillyCanada Inc. v. Novopharm Limited, 2010 FCA 197, [2012] 1 F.C.R. 349; General Tire & Rubber Co. v. Firestone Tyre & Rubber Co.,[1972] R.P.C. 457; Halford v.

Seed Hawk Inc., 2004 FC 88, 31 C.P.R. (4th) 434, revd in part on other grounds, 2006 FCA 275, 54 C.P.R.(4th) 130; Ratiopharm Inc. v. Canada (Health), 2007 FCA 83, 58 C.P.R. (4th) 97. REFERRED TO: Hoffman-La Roche Limited v. Apotex Inc., 2013 FC 718, 436 F.T.R. 198; Apotex Inc. v. Allergan Inc., 2012 FCA 308, 105 C.P.R. (4th)371; Bell Helicopter Textron Canada Limitée v. Eurocopter, société par actions simplifiée, 2013 FCA 219, 449 N.R. 111; Free WorldTrust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024; Consolboard Inc. v.

MacMillan Bloedel (Sask.) Ltd., (SCC), [1981] 1 S.C.R. 504, (1981), 122 D.L.R. (3d) 203; Zero Spill Systems (Int’

l) Inc. v. Heide, 2015 FCA 115, 130 C.P.R. (4th) 291;Safe Gaming System v. Atlantic Lottery Corporation, 2018 FC 542, 155 C.P.R. (4th) 1; Seedlings Life Science Ventures, LLC v. PfizerCanada ULC, 2020 FC 1; Aux Sable Liquid Products LP v. JL Energy Transportation Inc., 2019 FC 581, [2020] 1 F.C.R. 547; ValenceTechnology Inc. v. Phostech Lithium Inc., 2011 FC 174, 92 C.P.R. (4th) 123, affd 2011 FCA 237, 96 C.P.R. (4th) 207; MillenniumPharmaceuticals Inc. v. Teva Canada Limited, 2019 FCA 273, 174 C.P.R. (4th) 96, leave to appeal to S.C.C. refused May 7, 2020(39007); Whirlpool Corp. v.

Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067; Bauer Hockey Corp. v. Easton Sports Canada Inc., 2010FC 361, 83 C.P.R. (4th) 315, affd 2011 FCA 83, 92 C.P.R. (4th) 103; Pfizer Canada Inc. v. Apotex Inc., 2017 FC 774, 150 C.P.R. (4th) 1,affd 2019 FCA 16, 163 C.P.R. (4th) 191; Apotex Inc. v. ADIR, 2009 FCA 222, 75 C.P.R. (4th) 443; Eli Lilly Canada Inc. v. MylanPharmaceuticals ULC, 2016 FCA 119, [2017] 2 F.C.R. 280; Teva Canada Limited v. Pfizer Canada Inc., 2019 FCA 15, 163 C.P.R. (4th)265; Pozzoli SPA v. BDMO SA, [2007] EWCA Civ. 588 (BAILII), [2007] F.S.R. 37; Teva Canada Limited v.

Janssen Inc., 2018 FC 754,157 C.P.R. (4th) 391, affd sub nom. Millenium Pharmaceuticals Inc. v. Teva Canada Limited, 2019 FCA 273, 174 C.P.R. (4th) 96, leaveto appeal to S.C.C. refused May 7, 2020 (39007); Regents of the University of California v. I-MED Pharma Inc., 2018 FC 164, affd 2019FCA 179, 166 C.P.R. (4th) 367. AUTHORS CITED Sealy-Harrington, Joshua. “The Inventive Concept in Patent Law: Not So Obvious” (2015), 27 I.P.J. 385. Vaver, David. Intellectual Property Law, 2nd ed. Toronto: Irwin Law, 2011.

APPEAL from a Federal Court decision (2018 FC 637) concluding that the asserted claims of Canadian Patent No. 2527646 were valid,and that the respondent Minister of Health should be prohibited from issuing a notice of compliance for Lisdexamfetamine to theappellant. Appeal dismissed. APPEARANCES Harry Radomski, Richard Naiberg and Jenene Roberts for appellant. Jay Zakaïb, Adam Heckman and Alex Gloor for respondents Shire LLC and Shire Pharma Canada ULC. No one appearing for respondent Minister of Health. SOLICITORS OF RECORD Goodmans LLP, Toronto, for appellant.

Gowlings WLG (Canada) LLP, Ottawa, for respondents Shire LLC and Shire Pharma Canada ULC. Deputy Attorney General of Canada for respondent Minister of Health. The following are the reasons for judgment rendered in English by Rennie J.A.: I. Overview

[ 1 ] Lisdexamfetamine, or L-lysine-d-amphetamine (LDX), is a chemical compound. It is sold as a prescription medication under the trade name Vyvanse by the respondents Shire LLC and Shire Pharma Canada ULC (Shire) and is designed to treat attention deficit and hyperactivity disorder (ADHD).

The respondents hold the Canadian patent for LDX. [ 2 ] In February 2016 Apotex Inc. filed an abbreviated new drug submission with Health Canada seeking a notice of compliance (NOC) to manufacture and sell Apo-Lisdexamfetamine and served Shire with a notice of allegation under the Patented Medicines (Notice of Compliance) Regulations , SOR/93-113 (PM(NOC) Regulations).

In response, Shire sought an order from the Federal Court prohibiting the Minister from granting Apotex the NOC until the expiry of Canadian Patent No. 2527646 (CA ′646) pursuant to subsection 6(1) of the PM(NOC) Regulations . [ 3 ] Apotex subsequently commenced an action against Shire pursuant to

section 60 of the Patent Act , R.S.C., 1985, c. P-4 ( Patent Act ) seeking a declaration that CA ′646 was invalid, or, alternatively, that Apo-Lisdexamfetamine would not infringe any valid claim of CA ′646. The prohibition and invalidity proceedings were consolidated prior to trial in the Federal Court. [ 4 ] The claims of CA ′646 fall into various subject matter categories: some are bare chemical formulae, others describe a reduced potential for abuse of LDX, others describe some of LDX’s pharmacokinetic properties, others describe its use, others describe dosing amounts and frequencies.

Shire asserted that some, but not all of the claims of CA ′646 would be infringed by Apotex. Claims 1 to 5, 8, 10 to 12, 22, 24 to 30, 33 to 36, and 43, the claims in issue, are reproduced in Annex A to these reasons. [ 5 ] In reasons reported at 2018 FC 637 (Decision), Fothergill J. concluded that the asserted claims of CA ′646 were valid and that the Minister should be prohibited from issuing an NOC for LDX to Apotex. [ 6 ] Apotex appeals both judgments.

It contends that the Judge erred in not finding the asserted claims of CA ′ 646 both obvious and anticipated. [ 7 ] For the reasons that follow, I would dismiss the appeals with costs. II. Facts [ 8 ] Amphetamine is an established treatment for ADHD, obesity and narcolepsy due to its stimulating effects on the central nervous system. In its bare form, amphetamine is an immediate release compound: it is absorbed immediately upon entering the body. This rapid assimilation requires patients to take doses more frequently throughout the day in order to maintain therapeutic blood plasma levels.

In contrast, a sustained release compound slowly absorbs into the bloodstream. The slower release allows patients to take less frequent doses while still maintaining consistent, therapeutic blood plasma levels of the compound. [ 9 ] LDX is a type of sustained release compound known as a “prodrug”—a molecule that is metabolically converted into its active form. It is formed when amphetamine attaches to the amino acid L-lysine via an amide bond.

Upon entering the body, the amphetamine cleaves from the amino acid, liberating the active moiety of d-amphetamine. [ 10 ] The immediate and sustained released formulations of amphetamine were susceptible to abuse. LDX reduced that abuse potential; the amphetamine is covalently modified in a manner that decreases its pharmacological activity compared to unmodified amphetamine whether taken at doses above those considered therapeutic or using methods other than those prescribed. III. Decision of the Federal Court [ 11 ] In addressing the anticipation requirement pursuant to

section 28.2 of the Patent Act , the Judge adopted as the starting point the test articulated in Apotex Inc. v. Sanofi-Synthelabo Canada Inc. , 2008 SCC 61 , [2008] 3 S.C.R. 265 ( Sanofi ), at paragraph 25 : “the prior patent must disclose subject matter which, if performed, would necessarily result in infringement of the patent” (Decision, at paragraph 99). [ 12 ] On this issue, Apotex claimed Australian Patent No. 1965054168 (AU ′168) discloses the asserted claims of CA ′646.

After reviewing the expert testimony and the two patents, the Judge disagreed, concluding Apotex had not met its burden with respect to the disclosure requirement. [ 13 ] Turning to the issue of obviousness, the Judge followed the four-part test specified in Sanofi (at paragraph 67). Upon ascertaining the person skilled in the art (PSIA) and their common general knowledge, the Judge concluded that the claims’ inventive concept was grasped without difficulty.

The Judge defined CA ′646’s inventive concept as “a sustained release formulation of a therapeutically useful dose of amphetamine that is resistant to abuse” (Decision, at paragraph 122). [ 14 ] In reaching this decision, the Judge rejected Apotex’s argument that, based on the guidance of Ciba Specialty Chemicals Water Treatments Limited v. SNF Inc. , 2017 FCA 225 , 152 C.P.R. (4th) 239 ( Ciba ), claims construction was dispositive and the judge would err in searching for an inventive concept.

In rejecting this proposition, the Judge commented that, as a matter of stare decisis , Ciba could not be understood as departing from Sanofi , and in any event, Ciba pertained to a process patent, while Sanofi concerned a patent for a bare chemical and was more applicable to the facts of the case before the Court. [ 15 ] On the issue of the differences between the prior art and the inventive concept, the Judge concluded that as of the relevant date, May 2003, there were numerous differences between the state of the art and the inventive concept.

He found those to include that in the state of the art no prodrug had yet been developed as a means of reducing the potential for abuse, that the development of LDX was expensive and time-consuming and that even minor changes to covalent bonds required potential prodrugs to undergo extensive testing in order to ascertain their properties. [ 16 ] In light of these specific differences, the Judge concluded that the overall difference between the inventive concept and the prior art was the compound LDX and its advantageous properties, as none of the prior art indicated LDX would provide a sustained release treatment of amphetamine with a reduced potential for oral, intranasal, and intravenous abuse.

He concluded that these differences were

not obvious to try, the fourth Sanofi factor, largely as it was not more or less self-evident that LDX ought to work as an abuse resistantand sustained release formulation using only routine tests. Additionally, the Judge found that the received teaching taught away from theuse of prodrugs, that the inventors of LDX conducted extensive work prior to the discovery of LDX, and including failed attempts to finda prodrug version of amphetamine. [17] After concluding the asserted claims of CA ′646 were neither anticipated nor obvious, the Judge also found them sufficientlyspecific, not overbroad and therefore valid.

As no exceptional circumstances existed that would warrant departing from the generalguidance that the prohibition action follows the result of the impeachment action, the Judge granted Shire’s request for a prohibitionorder pursuant to subsection 6(1) of the PM(NOC) Regulations. IV. Arguments in Brief [18] The thrust of Apotex’s argument before us is that the tests for anticipation and obviousness are claim-by-claim analyses thatfocus on the subject matter of the claims alone.

By examining the patent as a whole and working from the notion of “inventive concept”as opposed to the precise language of the claims, the Judge did not do what sections 28.2 and 28.3 of the Patent Act mandate—assessingvalidity on the basis of each individual claim. It argues that the Judge’s approach was inconsistent with the changes to the Patent Actfollowing Sanofi, with the Supreme Court decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, [2017] 1 S.C.R. 943(AstraZeneca Canada Inc.), at paragraph 31, and with recent decisions of this Court in Hospira Healthcare Corporation v.

KennedyTrust for Rheumatology Research, 2020 FCA 30 (Hospira) and, as noted, Ciba. [19] Turning to anticipation, Apotex argues only the claimed bare chemical formula itself should be compared to the genus disclosedin the prior art. It is only in a selection patent that the advantageous qualities of a compound are also examined against the prior art(Hoffman-La Roche Limited v. Apotex Inc., 2013 FC 718, 436 F.T.R. 198, at paragraphs 177, 196 and 237–241).

As CA ′646 was notcategorized by the Judge as a selection patent, it was an error to consider the advantages of LDX in the anticipation analysis, particularlyas these properties were not essential elements of the asserted claims in question. Since LDX would fit into the “advantageous” categoryof compounds described in AU ′168, it disclosed CA ′646’s claims 1-5, 8, 10–12, 22, 24–30, 33–36, and 43, as LDX is created when AU′168 is performed across the scope of its genus. [20] On the issue of obviousness, Apotex challenges the Judge’s analysis of CA ′646’s inventive concept.

In concluding there wasonly one inventive concept for the entire patent, the Judge departed from the claim-by-claim approach mandated by

section 28.3 of thePatent Act. This, according to Apotex, was an egregious error in light of criticism, both judicial and academic, of the “inventive concept”as a circular, illogical, and redundant inquiry (Bristol-Myers Squibb Canada Co. v. Teva Canada Limited, 2017 FCA 76, [2018] 3 F.C.R.380 (Bristol-Myers), at paragraph 69; Ciba, at paragraphs 72–77). Additionally, the inventive concept identified by the Judge createdredundancies within some of CA ′646’s enumerated claims, which, as discussed in Tetra Tech EBA Inc. v.

Georgetown Rail EquipmentCompany, 2019 FCA 203, 166 C.P.R. (4th) 1 (Tetra Tech EBA Inc.) and Tearlab Corporation v.

I-MED Pharma Inc., 2019 FCA 179,166 C.P.R. (4th) 367 (Tearlab), suggests a fundamental problem in the analysis. [21] Apotex also says that the Judge erred in stage 4 of the Sanofi analysis by considering whether the properties of LDX werepredictable without experimentation in the obvious and “obvious to try” analyses, failing to examine each factor in the “obvious to try”framework (Hospira, at paragraphs 90 and 95), and failing to recognize that secondary factors (in this case, evidence of experimentationbeyond the experimentation necessary to reach that claim) were not determinative and were to be applied narrowly to the subject matterof each claim. [22] Shire, on anticipation, responds that AU ′168 does not disclose any claim of CA ′646.

Shire rests its case on Sanofi, at paragraph25 and the requirement that performing the subject matter of a piece of prior art must necessarily infringe the subject matter of a claim ofa patent to disclose it. Further, if the PSIA must make a choice in order to infringe the subject matter of the claim, the claim is notdisclosed. Here, because LDX is not a specifically enumerated example of AU ′168, and is instead only one member of a described classof “advantageous compounds”, the PSIA would have to make a choice to make LDX.

Because choice is necessary to land on LDX, LDXis not disclosed by AU ′168. [23] On obviousness, Shire contends that Sanofi, Apotex Inc. v. Allergan Inc., 2012 FCA 308, 105 C.P.R. (4th) 371 (Apotex Inc. v.Allergan), and Bell Helicopter Textron Canada Limitée v. Eurocopter, société par actions simplifiée, 2013 FCA 219, 449 N.R. 111 (BellHelicopter), at paragraphs 122–126, support the identification of a singular inventive concept for the entire patent.

Further, in a flexible,contextual and fact-driven inquiry it is open to the judge to consider the properties of the subject matter of the claim when ascertaining asingular inventive concept (Apotex Inc. v. Pfizer Canada Inc., 2019 FCA 16, 163 C.P.R. (4th) 191 (Apotex Inc. v. Pfizer), at paragraphs32 and 37–38). This is because the subject matter of the claim describes its scope of protection, not why the subject matter is patentable(Free World Trust v.

Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 (Free World), at paragraph 14; Consolboard Inc. v.MacMillan Bloedel (Sask.) Ltd., (SCC), [1981] 1 S.C.R. 504, at pages 525–526 and 531–533, (1981), 122 D.L.R. (3d)203). [24] With respect to the argument that the Judge erred in the Sanofi stage 4 analysis, Shire claims that stage 4 is a contextual analysisaimed at addressing the problem the invention was created to solve.

Thus, in the case of a bare chemical claim, the focus should not belimited to the experimentation required to create the compound but rather on the experimentation and motivation required to reach aparticular compound as a solution to the problem at hand. That the process could have been easy to carry out or the result of routinetesting is an insufficient basis for concluding the invention was obvious to try (Sanofi, at paragraph 85). V. Analysis [25] I begin with a review of a few basic principles governing patent infringement. [26] In a patent dispute, the emphasis is on the claims as worded.

While the assessment of a patent’s subject matter or utility mayrequire a more holistic appreciation of the patent and its claims, the tests for obviousness and anticipation require a claim-by-claimanalysis (AstraZeneca Canada Inc., at paragraph 54; Hospira, at paragraph 71).

[ 27 ] Only if every claim in a patent is invalid will the entire patent be invalid. If an independent claim is declared invalid,

section 58 of the Patent Act allows for the examination of dependent claims in order to determine if their additional elements rectify the deficiencies in the independent claim. If so, the dependent claim remains valid despite the independent claim’s invalidity ( AstraZeneca Canada Inc. , at paragraph 46 ; Zero Spill Systems (Int’

l) Inc. v. Heide , 2015 FCA 115 , 130 C.P.R. (4th) 291 ( Zero Spill Systems ), at paragraph 94 ; Safe Gaming System v. Atlantic Lottery Corporation , 2018 FC 542 , 155 C.P.R. (4th) 1, at paragraph 159 ; Seedlings Life Science Ventures, LLC v. Pfizer Canada ULC , 2020 FC 1 , at paragraph 71 ). [ 28 ] Much of the argument before us focused on whether, and if so how, these principles of claim construction vary or apply at all depending on whether the patent is a selection patent.

A selection patent is a patent whose subject matter is a fraction of a larger known class which was the subject matter of a previous disclosure ( Sanofi , at paragraph 1). [ 29 ] The Judge did not decide whether CA ′646 was a selection patent, and the arguments before us pivot on the consequences of that. The Judge did not find CA ′646 to be a selection patent on the basis that CA ′646 did not explicitly reference or discuss the advantages of LDX in relation to the compounds claimed in AU ′168 (Decision, at paragraphs 93 and 98).

Apotex says because of this, the patent is not a selection patent and that this had consequences for the correctness of the Judge’s analysis—the Judge erred in having regard to the specification. [ 30 ] Shire, in turn, claims the Judge’s analysis was correct, regardless of whether CA ′646 was a selection patent or not. As this conversation occurs throughout the arguments on both anticipation and obviousness, I will address the substance of the matter here. [ 31 ] There is no magic to the term “selection patent”.

A selection patent is simply a patent devoted to a selection of a particular compound, or compounds, from a larger grouping of compounds previously disclosed in general terms and claimed in a pre-existing genus patent.

The Patent Act does not refer to selection patents and the jurisprudence is clear that a selection patent does not differ in substance or form from other patents ( Sanofi , at paragraph 9). [ 32 ] A selection patent is subject to the same requirements and vulnerable to the same attacks as any other patent, including attacks based on anticipation and obviousness ( Sanofi , at paragraphs 9 and 108; Eli Lilly Canada Inc. v. Novopharm Limited , 2010 FCA 197 , [2012] 1 F.C.R. 349 ( Eli Lilly ) , at paragraph 33 ).

Although the failure of a judge to characterize a patent one way or another may reflect a lack of understanding of the patent and its factual context, the failure to do so, in and of itself, is not an error of law. Put otherwise, a finding that the characteristics of a selection patent have, or have not, been met, “does not constitute an independent basis upon which to attack the validity of a patent” ( Eli Lilly , at paragraphs 27–28, 33 and 48).

I note, parenthetically, that I am not suggesting that the Judge in this case did not have that understanding of the patent or its context. [ 33 ] The exercise of classification of a patent as a “selection” or “process” patent is to assist the Court in understanding “the nature of the beast” it is dealing with ( Eli Lilly , at paragraph 28). Essentially, classification contextualizes what specific claims profess to do while also making it easier to compare the facts of the particular case before the Court to other previous fact scenarios ( Eli Lilly , at paragraphs 27–28).

For example, selection patents commonly attest that their inventiveness lies in “the making of the selected compound, coupled with its advantage or advantages” ( Eli Lilly , at paragraph 78). [ 34 ] As noted, the validity analysis does not change depending on whether the patent was formally classified as a selection patent or not. The focus of an anticipation or obviousness inquiry is, as always, on what the patent actually claims in comparison to what is disclosed in the prior art.

Each validity analysis should be entered into with open eyes as to the application of the specific facts against the panoply of tests utility, novelty, anticipation, and obviousness, etc. [ 35 ] These principles, I suggest, frame the approach to this appeal. There is no divergence between the requirements for a valid patent claim depending on whether it is found in a selection patent or not. A. Anticipation [ 36 ] The law on anticipation is clear. “[A]nticipation requires proof of both disclosure and enablement” ( Sanofi , at paragraph 42).

If a published reference fails to either disclose or enable the essential elements of a claim, the patent claim is novel, or not anticipated ( Hospira , at paragraph 71; Sanofi , at paragraphs 25–28). [ 37 ] A prior art reference discloses the claimed invention when, if performed, the prior art reference would necessarily result in the infringement of the patent claim. Phrased another way: …. To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented ….

A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee. ( General Tire & Rubber Co. v. Firestone Tyre & Rubber Co. , [1972] R.P.C. 457 ( General Tire ), at page 486, cited in Sanofi , at paragraph 21). [ 38 ] If the flag is planted, the claim has been disclosed ( Sanofi , at paragraph 21). [ 39 ] The second requirement is enablement.

The reference in the prior art must be sufficiently detailed as to enable a PSIA to perform the claimed invention without the exercise of inventive ingenuity or undue experimentation ( Sanofi , at paragraphs 25 and 33–37). In this instance, both parties concede there is no enablement issue (Decision, at paragraph 100). [ 40 ] The language of the Sanofi test is important: if the performance of a published reference does not necessarily result in infringement of the claim, then the published reference does not disclose that claim.

This test takes on particular meaning in the context of patents such as AU ′168 and CA ′646. [ 41 ] The core of Apotex’s argument is that the Judge erred by failing to conduct the anticipation analysis by comparing AU ′168 to

the subject matter defined by each of the individual claims asserted by the ′646 patent, as required by

section 28.2 of the Patent Act . The Judge, instead, asked whether AU ′168 disclosed both the subject matter of the claim and the advantages and properties of that subject matter. Apotex says that to be anticipatory, the patent need not disclose the properties of, or the advantages in using, the claimed invention.

The Judge’s methodology was therefore, according to Apotex, inconsistent with this court’s guidance in Hospira . [ 42 ] Viewed in this light, the Judge’s factual findings are irrelevant, as, according to Apotex, the wrong approach was applied to the test of anticipation (appellant’s factum, at paragraph 46).

It asserts that AU ′168 necessarily encompasses the compound LDX because, if AU ′168 was practied “across its scope” it would necessarily infringe CA ′646 (appellant’s factum, at paragraph 38). [ 43 ] Apotex’s argument, distilled, amounts to no more than an assertion that genus patents necessarily anticipate the chemical composition claims in species patents. [ 44 ] To accede to this proposition would, in these circumstances, be a marked departure from established precedent, including, most recently, the decision of this court in Hospira , at paragraph 66 that “[t]he prior art reference must disclose the claimed invention such that, if performed, it would necessarily result in infringement”.

The necessarily infringe test, most recently endorsed in Hospira , applies to all patents, as do the requirements of

section 28.2 of the Patent Act . [ 45 ] It would also be inconsistent with the principle articulated, and noted earlier, in General Tire , that “[t]he prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee” (at page 486). The point was also made succinctly in Ranbaxy Laboratories Limited v.

AstraZeneca AB , [2013] FCA 368 (Aus.) at paragraph 170: .… it is not sufficient for a prior publication to merely “include” or “encompass” the claimed invention—a broad disclosure will not necessarily anticipate a later, more specific claim: see eg Eli Lilly [2013] FCA 214 at [272] to [293] and the authorities cited therein. [ 46 ] This is not to say that anticipation has no role in the context of genus disclosures—to the contrary, it is very much alive.

A genus may, depending on its size, the language of the claims, context and included examples, anticipate the individual species (see, e.g., Aux Sable Liquid Products LP v. JL Energy Transportation Inc. , 2019 FC 581 , [2020] 1 F.C.R. 547 , at paragraphs 90 and 98 ; Valence Technology Inc. v. Phostech Lithium Inc. , 2011 FC 174 , 92 C.P.R. (4th) 123, at paragraphs 228–230 , affd 2011 FCA 237 , 96 C.P.R. (4th) 207). [ 47 ] Therefore, the ultimate answer to the question of whether the inventor “planted a flag” at the compound is driven by the specific evidence in each case.

Here, the Judge identified differences that relate to the specific asserted claims within CA ′646. In doing so, he found that those specific claims were not anticipated. The Judge undertook the exercise required of him by Sanofi .

The Judge identified the correct test for anticipation (Decision, at paragraphs 99–100) and his conclusion that CA ′646 was not anticipated by AU ′168 was amply supported by the evidence. [ 48 ] The reasoning in Ranbaxy is directly on point and, as the following review of the facts as found by the Judge show, dispositive of Apotex’s argument. [ 49 ] The Judge identified the various ways CA ′646 and AU ′168 are different. While AU ′168 refers to a class of advantageous compounds, LDX is not specifically mentioned in any of its 30 examples.

None of the compounds in AU ′168 were said to be for the treatment of ADHD and none related to the reduction in abuse potential. AU ′168 does not mention prodrugs, any of LDX’s pharmacokinetic data, such as its equivalent area under curve (AUC) and lowered maximum amphetamine concentration (C max ), nor was the intended functionality explained. (Decision, at paragraphs 106–108 and 137). [ 50 ] Claims 1 to 5 and claim 8 of CA ′646 describe various compositions and examples of LDX, the linkage of LDX and a therapeutically acceptable salt, potentially with an additive.

For these claims, the wording of the “necessarily infringe” test becomes particularly relevant. As found by the Judge, LDX was not an example described in AU ′168, it was merely one of a large class of “advantageous” compounds (Decision, at paragraphs 104–105). As such, the PSIA would have to adopt a specific way forward in order to make LDX. Phrased another way, there are numerous other ways to “perform” AU ′168 without necessarily infringing CA ′646.

Therefore, LDX, as claimed in claims 1–5 and 8, was not specifically disclosed by AU ′168 ( Eli Lilly , at paragraph 52; Sanofi , at paragraph 39). [ 51 ] Although this finding is dispositive of the issue for each of its dependant claims, the Judge also found claims 10–12 to be novel. Claim 10 discusses the release of amphetamine. Claim 11 discusses the provision of a therapeutically effective amount of amphetamine.

Claim 12 discusses the reduction in C max associated with the use of LDX, which, as discussed in the patent disclosure, is one aspect of the compound that makes it abuse resistant. [ 52 ] Asserted claims 22 and 24–30 are dependent on claims 11–15. Since the essential elements of claims 11–15 include the therapeutic benefits, prolonged release, and abuse-resistant properties of LDX, so do their dependent claims, 22 and 24–30, which stand or fall accordingly.

Apotex did not contest the validity of claims 13–15 and the onus was on it to show how the dependent claims were invalid notwithstanding the presumed validity of the un-asserted claims in the 11–15 claim range ( Patent Act , at subsection 43(2) ). [ 53 ] Claims 33–36 relate to the use of LDX for the treatment of ADHD.

Since the subject matter of these claims had not previously been disclosed, dependent claim 43 was also not disclosed. [ 54 ] Apotex is correct that the Judge’s comment specifying, “[t]he process of making LDX is not disclosed by AU 168” (Decision, at paragraph 108) was irrelevant to the disclosure analysis as it speaks to the enablement requirement, which both parties admitted was not in issue. Whether this error has any consequence on the integrity of the anticipation analysis is another matter.

When read in light of the list of enumerated differences, the error is akin to an “imperfection” ( Millennium Pharmaceuticals Inc. v. Teva Canada Limited , 2019 FCA 273 , 174 C.P.R. (4th) 96, at paragraphs 8–12 , leave to appeal to S.C.C. refused May 7, 2020 (39007)). It does not rise to the level of a reversible error. B. Obviousness

[ 55 ] As with anticipation, obviousness is assessed on a claim-by-claim basis ( Zero Spill Systems , at paragraphs 83 and 85). Each claim is evaluated against the four-part Sanofi test (at paragraph 67): (1) (

a) Identify the notional “person skilled in the art”; (

b) Identify the relevant common general knowledge of that person;

(2) Identify the inventive concept of the claim in question or if that cannot 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;

(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention? [ 56 ] As I indicated earlier, the issues on appeal relate to stages 2–4. However, as these stages build upon each other, I will briefly revisit the Judge’s conclusions in relation to stage 1.

Stage 1: The Person Ordinarily Skilled in the Art and their Common General Knowledge [ 57 ] The Judge defined the PSIA as (Decision , at paragraph 60): … a drug development team with expertise in medicinal chemistry, pharmacology, pharmaceutical formulation and medicine. Shire described the members of the team as having “knowledge of (

a) medicinal chemistry; (

b) pharmaceutical formulation; (

c) pharmacology; and (

d) the treatment of ADHD.” Each of the team members would have an advanced degree such as a PhD or MD, and would have approximately three to five years of work experience. [ 58 ] The Judge then determined that the PSIA’s relevant common general knowledge comprised the following elements (Decision, at paragraphs 66 and 70): (

a) ADHD is a common neurobehavioural disorder in both children and adults that is characterized by a persistent pattern of hyperactivity, impulsivity and inattention. (

b) Physicians could treat the symptoms of ADHD with stimulants, including amphetamine. (

c) Amphetamine products were available as immediate and sustained release formulations, each of which produced different durations of action. (

d) In sustained release formulations, the dosage form was designed to release the drug at a continuous and controlled rate for a longer period than would normally be achieved using an immediate release formulation. (

e) One significant drawback of both immediate and sustained release formulations of amphetamine was their potential for abuse. Those who abused amphetamine wished to attain the euphoria that results from exposure to a rapid and elevated dose. In pharmacokinetic terms, abusers were seeking a short time to maximum plasma concentration [T max ] and a high peak plasma concentration [C max ] of amphetamine. (

f) As of May 2003, the PSIA would have recognized the need for an amphetamine product that could not be abused by crushing and snorting, dissolving and injecting, or taking an oral overdose. (

g) The PSIA would have understood that one of the known strategies to reduce the abuse of amphetamine was to reduce its C max and extend its T max . (

h) As of May 2003, no known formulation could address all principal routes of abuse of amphetamine ( i.e. , crushing and snorting, dissolving and injection, oral overdose). Adderall XR was an extended release formulation which reduced C max and extended T max , but did not provide a means to prevent abusers from circumventing the extended release mechanism, either by crushing or dissolution. (

i) Concerta was a known methylphenidate composition that was designed to form a paste when crushed so it could not be snorted. However, Concerta would dissolve in water and release its active ingredient for injection or swallowing, and thus its abuse protection was limited. Further, the extended release mechanism in Concerta could be undone by crushing or chewing the tablet. (

j) An irritant could be added to a formulation that was intended to sting if snorted or injected. However, the irritant would do nothing to alter the pharmacokinetics of amphetamine, or stop someone from dissolving the drug and ingesting it orally. No formulation containing an irritant to discourage abuse had ever reached the market. … … the PSIA’s common general knowledge would include an awareness of the development of prodrugs to overcome barriers to a drug’s usefulness, including its pharmacokinetic limitations.

Stage 2: The Inventive Concept [ 59 ] It is at stage 2, where the Court is to “identify the inventive concept of the claim in question or if that cannot readily be done, construe it”, that the parties join issue. Distilled, the dispute before us is the end point of the obviousness inquiry—both how it is determined and whether the Judge erred in his application of the concept.

[ 60 ] The Judge held that the inventive concept could “be grasped without difficulty”, finding that “the inventive concept of the ′646 Patent is a sustained release formulation of a therapeutically useful dose of amphetamine that is resistant to abuse” (Decision, at paragraphs 117, 122 and 132). He characterized the inventive concept following a review of the claims and the problem that CA ′646 was intended to solve (Decision, at paragraphs 117, 120 and 132). [ 61 ] Apotex contends the Judge erred in doing so as

section 28.3 mandates a narrow, claim-based end point, focussed solely on the “subject matter of the claim”. Recourse to the specification or disclosure is not allowed. The consequence of this is that the claims in issue are limited to their bare formulae and the process of their making, excluding their beneficial properties or anything that is not an “essential element” of the claim.

The essential element of the claim in issue was LDX—the bare chemical compound, without its features or advantages, as those can only be found in the specification. [ 62 ] Apotex further argues the Judge erred in declaring the inventive concept “could be grasped without difficulty” in the absence of agreement of the parties or an analysis of whether any of the claims’ inventive concepts could be readily identified from the wording of the claim itself, as was done in Sanofi and is now required by both

section 28.3 of the Patent Act and AstraZeneca Canada Inc . Instead, according to Apotex, the Judge focussed on the “amorphous and ill-defined” inventive concept that could be derived from the specification as a whole rather than the claims themselves, contrary to established jurisprudence ( Tearlab , at paragraph 49; Ciba , at paragraphs 72 and 74). [ 63 ] Further, the Judge adopted the inventive concept without explaining why it was readily apparent (Decision , at paragraph 122). Apotex argues that none of the asserted claims related to sustained release or abuse resistance.

Those concepts were present in claims 16– 21 (sustained release profile) and 45 (abuse resistance) of CA ′646, which were not asserted. As a consequence, the specific inventive concept(

s) of some of the claims were rendered redundant, giving rise to a palpable and overriding error. [ 64 ] Apotex’s arguments cannot succeed. I say this for two reasons. [ 65 ]

Section 28.3 of the Patent Act does not displace the common law test for obviousness. The inventive concept, properly construed and applied, remains the end point for the obviousness inquiry. Second, I do not see an error in the Judge’s analysis of the inventive concept, nor in its application. Further, the arguments raised by Apotex, interesting as they may be, are of no consequence in light of the Judge’s factual findings. I will elaborate on this later. [ 66 ] I begin with three basic principles. [ 67 ] First, on occasion, the inventive concept may be “readily apparent” where there is agreement on it.

If not, the inventive concept needs to be construed. To do that, the judge is to first determine whether it can be identified from the previously completed claims construction exercise ( Ciba , at paragraphs 76–77). Second, where it is not possible to fully grasp the nature of the inventive concept solely from those claims, the judge may have regard to the patent specification to determine if it provides any insight or clarification into the inventive concept of the claim(

s) in issue ( Sanofi , at paragraph 77; AstraZeneca Canada Inc. , at paragraph 31 ). If this step is necessary, “it is not permissible to read the specification in order to construe the [inventive concept of the] claims more narrowly or widely than the text will allow” ( Sanofi , at paragraph 77). [ 68 ] Second, insight from Sanofi shows that while an inventive concept is an attribute of the claims, it differs from claims construction (Joshua Sealy-Harrington, “The Inventive Concept in Patent Law: Not so Obvious” (2015) 27 I.P.J. 385).

As such, though the process for the identification of an inventive concept bears a striking resemblance to that of claims construction, as seen in longstanding Supreme Court of Canada rulings (see, e.g., Free World , at paragraphs 33–50; Whirlpool Corp. v. Camco Inc. , 2000 SCC 67 , [2000] 2 S.C.R. 1067, at paragraphs 43 and 49 ), it is nonetheless a distinct, separate exercise. [ 69 ] Third, the caution expressed in Unilever PLC. v. Chefaro Proprietaries Ltd. , [1994] R.P.C. 567 (Eng.

C.A.) ( Unilever PLC ), at page 580 remains a governing legal principle: “[i]t is the ‘inventive concept’ of the claim in question which must be considered, not some generalised concept to be derived from the specification as a whole.” Thus, as required by

section 28.3 as well as the wording of Sanofi , it is the inventive concept(

s) of the claim(

s) in issue that must be the focus of an obviousness inquiry, not the inventive concept of the patent ( Ciba , at paragraph 72; Bauer Hockey Corp. v. Easton Sports Canada Inc. , 2010 FC 361 , 83 C.P.R. (4th) 315, at paragraph 250 , affd 2011 FCA 83 , 92 C.P.R. (4th) 103; Pfizer Canada Inc. v.

Apotex Inc. , 2017 FC 774 , 150 C.P.R. (4th) 1 ( Pfizer Canada Inc. ), at paragraph 247 , affd 2019 FCA 16 , 163 C.P.R. (4th) 191). [ 70 ] The Judge did not determine the inventive concept based on some “generalized concept”; rather it was based on a reading of the claims informed by the specification. [ 71 ] A reading of the Decision as a whole shows that the finding that the inventive concept could “be grasped without difficulty” was based on an analysis of the claims as informed by the specification (see, e.g., the Decision, at paragraphs 119–122).

This aligns with the process applied by the Supreme Court in Sanofi and described above. I cannot agree with the conclusion that the inventive concept was faulty by reason of a failure of the Judge to explain its origins in copious detail. As will be explained, it was, in fact, easily deciphered from the claims and specification. [ 72 ] As in Sanofi , claims 1–5 of the patent in suit in this appeal are to bare chemical compounds. The essential element of each of these claims is simply the chemical formula itself which, standing alone, says nothing as to the “inventiveness” of the patent claims.

As such, it is necessary to turn to the specification for amplification. The language of Sanofi is directly applicable [at paragraphs 77–78]: The inventive concept of the claims is not readily discernable from the claims themselves. A bare chemical formula in a patent claim may not be sufficient to determine its inventiveness. In such cases, I think it must be acceptable to read the specification in the patent to determine the inventive concept of the claims. Of course, it is not permissible to read the specification in order to construe the claims more narrowly or widely than the text will allow.

In the present case, it is apparent that the inventive concept of the claims in the ′777 patent is a compound useful in inhibiting platelet aggregation which has greater therapeutic effect and less toxicity than the other compounds of the ‘875 patent and the methods for

obtaining that compound. [ 73 ] It should be recalled that in Sanofi the Supreme Court found that the inventive concept was “not readily discernable from the claims themselves” (paragraph 77). What Rothstein J. did next is, however, very instructive; the beneficial properties of the bare formulae were examined (paragraph 78). [ 74 ] I cannot agree that the effect of

section 28.3 of the Patent Act is to narrow the inventive concept to the essential elements of the claim itself. This conflates the claims construction exercise with the identification of the inventive concept, and would alter, in a very significant manner, the inquiry into “inventiveness”, which is the sole purpose of the obviousness inquiry. Beyond Sanofi , there are many cases in which this Court has upheld the use of a specification to determine the inventive concept where it was not readily discernable from the claims themselves ( Apotex Inc. v. Allergan , at paragraph 72, citing Apotex Inc. v.

ADIR , 2009 FCA 222 , 75 C.P.R. (4th) 443, at paragraph 58 ; see also Apotex Inc . v. Pfizer , at paragraph 39). [ 75 ] Although identification of the inventive concept follows from claims construction and is necessarily informed by it, they are nonetheless discrete exercises, with discrete purposes ( Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC , 2016 FCA 119 , [2017] 2 F.C.R. 280 , at paragraphs 40–41 ; Bell Helicopter , at paragraphs 122–126). As noted earlier, the purpose of claims construction is to determine the scope of the claim by looking at the “subject matter of the claim”.

It does not, on its own, determine a claim’s validity.

Section 28.3 , in codifying the common law requirement that an invention not be obvious, did not displace the longstanding jurisprudence that tells us how obviousness is determined. [ 76 ] The inventive concept is an element of that determination. Its purpose is to help determine what, if anything, makes the claim, as constructed, inventive. This is the very inquiry

section 28.3 asks of us. As noted in Bristol-Myers , Sanofi did not change the substantive law of obviousness by implication, and the term “inventive concept” is not materially different than the previously used term of “solution taught by the patent” ( Bristol-Myers , at paragraphs 65–68 and 75). This is the lens that we should keep in mind when determining the inventive concept. This lens becomes particularly important if recourse to the specification is required.

For example, in the case of a bare chemical formula claim, not all the chemical’s properties will inform its inventive concept ( Bristol-Myers , at paragraph 74; Teva Canada Limited v. Pfizer Canada Inc. , 2019 FCA 15 , 163 C.P.R. (4th) 265, at paragraph 34 ). [ 77 ] In sum, a single inventive concept must flow through a patent, but each claim’s specific inventive concept may be different.

I will return to this point later when I consider Apotex’s argument that the Judge erred in adopting an inventive concept that was redundant with some of the claims. [ 78 ] I turn to Apotex’s second argument that, in any event, the Judge erred in construing the inventive concept. [ 79 ] As previously explained, similar to Sanofi , the independent claims in issue were bare chemical formula claims. Thus, an examination of the essential elements of the claims did not reveal their inventive concept(s).

Recourse to the specification was required ( Sanofi , at paragraph 77). [ 80 ] In this case, as is typically seen in many patents, including the patent at issue in Sanofi , the description of CA ′646 contains a background statement describing the beneficial properties of the invention. Here, this occurs in paragraph 003 of the description. Also similar to Sanofi , CA ′646 contains a study comparing the performance of several chemicals to amphetamine, as summarised in Table 46. Some of these chemicals are examples of chemicals encompassed by AU ′168.

Though the Judge was correct in finding that “[t]he claimed advantages of LDX are principally in comparison to the parent compound amphetamine, not to other conjugates of d- amphetamine” (Decision, at paragraph 93), by comparing all the chemicals against the same standard, Table 46 also demonstrates how the chemicals perform in relation to each other. [ 81 ] Beyond comparing LDX to some other compounds encompassed by AU ′168, the study and

summary statement also lends itself to an inventive concept of “a sustained release formulation of a therapeutically useful dose of amphetamine that is resistant to abuse” (Decision , at paragraph 122). This is because the study, by demonstrating that LDX has both a lower absorption rate and lower C max when taken either intranasally or intravenously, demonstrates LDX’s property of abuse resistance upon introduction into the body. [ 82 ] Other elements of the inventive concept are rooted in the specification.

As the Judge found, abuse resistance upon oral administration and a sustained release formulation arise from the demonstration of how LDX has a combination of a lower C max with a similar percent AUC. As discussed by Dr. Eldon in his report, the same amount of amphetamine is being released, but with a lower maximum concentration. This flattens, or extends, the curve. Indeed, both these aspects are described in the

summary statement as a property of the compound, at paragraph 003 of the description: Additionally, release of amphetamine following oral administration [of the compound] occurs gradually over an extended period of time thereby eliminating spiking of drug levels. When taken at doses above the intended prescription, the bioavailability of amphetamine, including peak levels and total amount of drug absorbed, is substantially decreased. This decreases the potential for amphetamine abuse which often entails the use of extreme doses (1g or more a day).

The compositions are also resistant to abuse by parenteral routes of administration, such as intravenous - “shooting”, intranasal “snorting”, or inhalation “smoking”, that are often employed in illicit use. [ 83 ] Further, the

summary statement at paragraph 003 of the description refers to “a therapeutically useful dose”. The supporting study, as summarised in Table 46, validates this statement by comparing the percent AUC’s of the various compounds. Particularly, it demonstrates how LDX provides a therapeutically effective release of amphetamine that is both roughly equivalent to straight amphetamine’s release and superior to the other compounds. [ 84 ] In sum, the Judge committed no error in having regard to these properties and beneficial features of LDX in determining the inventive concept of the claims in issue.

I am also satisfied that the description was sufficient to allow the Judge to construe these properties as features of the compound as claimed in the independent claims, such that they should form part of the inventive concept. Unlike the situation seen in Bristol-Myers , these beneficial properties were the “solution taught by the patent” claim. They explain the source of the motivation to pursue the solution ( Bristol-Myers , at paragraph 75).

[ 85 ] I now turn to Apotex’s argument that the inventive concept was faulty because it made the inventive concept of some of the claims “necessarily redundant”. Here again, it is useful to revisit a few basic principles. [ 86 ] Although a claim by claim analysis of each claim’s inventive concept is to be conducted, it is important to remember that a single, overarching inventive concept connects every claim of a patent, with its genesis usually in the independent claim(s). As seen in AstraZeneca Canada Inc. , the “subject matter” of an invention can be multi-faceted (at paragraph 49).

There, Rowe J., quoting David Vaver, Intellectual Property Law , 2nd ed. (Toronto: Irwin Law, 2011), at page 275, noted: For simplicity’s sake, the rule is “one invention, one application, one patent.” But inventions are like a many-faceted prism: multiple claims (sometimes running into the hundreds) covering all facets are allowed in the same patent if a “single general inventive concept” links them. [ 87 ] Despite the singular common inventive concept, “[d]ifferent claims can, and generally will, have different inventive concepts” ( Unilever PLC , at page 580 as quoted in Ciba , at paragraph 72).

These are, in effect, inventive concepts that are stitched on, or bound to, the single, common concept ( Ciba , at paragraph 72, quoting Unilever PLC , at page 580; Pozzoli SPA v. BDMO SA, [2007] EWCA Civ. 588 (BAILII), [2007] F.S.R. 37, at paragraph 17; Pfizer Canada Inc. , at paragraph 247; Teva Canada Limited v. Janssen Inc. , 2018 FC 754 , 157 C.P.R. (4th) 391, at paragraph 176 , affd sub nom. Millenium Pharmaceuticals Inc. v. Teva Canada Limited , 2019 FCA 273 , 174 C.P.R. (4th) 96, leave to appeal to S.C.C. refused May 7, 2020 (39007)).

Practically speaking, however, so long as the single common inventive concept is found to be non-obvious, the Court will typically not need to explicitly consider any amendments to it made by later claims. [ 88 ] I have spent some time elaborating the principles pertaining to the definition and role of the inventive concept of a claim or claims. At the risk of repetition (see paragraphs 72–77, above), each claim can give rise to its own inventive concept, and the inventive concepts of the various claims may overlap or replicate each other.

This is permissible, provided they are joined or unified by an over- arching, single inventive concept. Put otherwise, the potential for redundancy is inherent in the inventive concept exercise. [ 89 ] Despite this, a claim’s limitation should not be read into a more generally worded claim to avoid either infringement or invalidity; “Where some claims are broad and others narrow, the narrow claim limitations cannot be read into the broad whether to avoid invalidity or to escape infringement” (cited in Halford v.

Seed Hawk Inc. , 2004 FC 88 , 31 C.P.R. (4th) 434, at paragraphs 91–97 , revd in part on other grounds, 2006 FCA 275 , 54 C.P.R. (4th) 130, as approved by our Court in Tetra Tech EBA Inc. , at paragraphs 113–115 ). These principles also apply at the inventive concept stage. [ 90 ] As in the claims construction exercise, a redundancy should only be permitted at the inventive concept stage where “a purposive analysis shows that claims are in effect duplicated” ( Ratiopharm Inc. v. Canada (Health) , 2007 FCA 83 , 58 C.P.R. (4th) 97 ( Ratiopharm Inc. ), at paragraph 33 ).

Generally, it would make little sense to specifically read away from a redundancy at the claims construction stage ( Tetra Tech EBA Inc. , at paragraphs 113–115, 123 and 128–130 ; Ratiopharm Inc. , at paragraph 33 ), only to read it back in at stage 2 of the obviousness analysis. [ 91 ] Tetra Tech EBA Inc. and Tearlab are instructive in this respect. [ 92 ] Tetra Tech EBA Inc. read away from a redundancy at the claims construction stage, then selected an inventive concept based on the essential elements of the claims alone.

Tearlab also read away from redundancy at the construction stage, then refused to read it back in at the inventive concept stage. In both situations, the redundancy was inappropriate at both the claims construction and inventive concept stages as the proposed addition(s), explicitly stated in the dependent claims, amounted to a limitation on the independent claims. The wording of the independent claims indicated that the invention described by that claim could work without that limitation ( Regents of the University of California v.

I-MED Pharma Inc. , 2018 FC 164 , at paragraph 192 , affd 2019 FCA 179 , 166 C.P.R. (4th) 367, at paragraph 49 ; Tetra Tech EBA Inc. , at paragraphs 113–115 ). The redundancy, caused by the proposed limitation, was inappropriate at both the claims construction and inventive concept stages, despite their separate purposes. [ 93 ] To recapitulate, although a certain degree of redundancy is often inherent at the inventive concept stage, an inventive concept cannot be used as a vehicle to construe or read the inventive concept of claims more narrowly or broadly than their text, or plain language, will allow.

As such, redundancy is only permitted where a purposive analysis shows that claims are in effect duplicated.

This purposive analysis is necessarily informed by the purpose behind an identification of the inventive concept, which is different than the purpose behind a claims construction. [ 94 ] Turning to the specifics of the case before us, the Judge was aware of this limitation on the use of the inventive concept, noting, for example, that it would be inappropriate to include “a ‘once daily’ administration to treat ADHD within the inventive concept” underlying every claim as certain claims relate to the administration of LDX more than once a day, while others reference using LDX to treat narcolepsy and obesity (Decision, at paragraphe 121). [ 95 ] None of the claims of CA ′646 contains wording that conflicts with the inventive concept as identified by the Judge, although it does render some of the later claims redundant.

Examples of these dependent claims include claims 11, 12, 14, 15, 16, etc. However, a purposive analysis shows that these claims are a permissible duplication of, or merely dependent upon, the specific inherent properties of LDX that inform the single common inventive concept. [ 96 ] LDX cannot exist without these inherent properties: every molecule of LDX necessarily has these properties. For example, the study in paragraphs 228–231 of the description, and summarised in Table 46, discusses these pharmacokinetic properties.

These properties, at the claims construction stage, import a limitation into the essential element(

s) of the independent claims—the chemical LDX. At the inventive concept stage, these properties do not limit the chemical in any way; the narrow claim is not importing a limitation onto the more general claim, but merely highlighting one inherent aspect of it. Further, these properties, in turn, describe the problem taught by the solution, the chemical LDX. [ 97 ] Although these pharmacokinetic properties are the subject of later claims, such as claim 11, which reads as, “the pharmaceutical composition according to any one of claims 6–9, wherein the L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof

provides a therapeutically effective amount of amphetamine”, these claims merely reiterate these properties, emphasising that the chemical is the solution to the problem. This, in effect, duplicates the inventive concepts. [ 98 ] The inventive concept as determined by the Judge is therefore not affected by any impermissible redundancy or duplication in its application. [ 99 ] As I will explain next, when considering stages 3 and 4 of the Sanofi test, I do not see any error in the Judge’s analysis. Therefore, I need not turn my attention to any arguments relating to the dependent claims.

However, before leaving this analysis of stage 2, there are two points arising from the reasons that merit brief comment. [ 100 ] The Judge was of the view that Ciba stood for the proposition that a judge should only consider the claims construction of each claim to reduce the uncertainty associated with the search for an inventive concept (Decision, at paragraphs 116–117). The Judge concluded this commentary was inconsistent with Sanofi . Ciba does not, however, contradict Sanofi . Ciba recognises that an inventive concept must be based on a claim, and not some vague paraphrase in the disclosure.

Thus, if the identification about an inventive concept is not readily apparent, the judge should “simply work on the features of the claim” ( Ciba , at paragraphs 74–76). This ensures that obviousness is grounded in the claims themselves, a requirement discussed in both Sanofi and the Patent Act . Ciba does not address what should happen when, after examination of the claims construction, the inventive concept is still not “readily discernible”.

Pursuant to Sanofi , that is when recourse to the specification is allowed ( Sanofi , at paragraph 77). [ 101 ] Nor is the Judge’s distinction between Ciba and Sanofi on the basis that Ciba was a process patent and Sanofi a bare chemical patent relevant. The legal principles surrounding the obviousness analysis do not pertain solely to process patents, just as the comments in Sanofi were not solely geared to selection patents or bare chemical formula claims. Sanofi makes this clear.

At paragraph 29 Rothstein J. wrote: Subject to any limitations expressed in the Patent Act , I see no reason why the discussion of anticipation should not apply to other prior art than merely genus patents. Again, subject to limitations in the Patent Act , the discussion of anticipation and obviousness would seem applicable to patents generally.

Stage 3: Difference between the Prior Art and the Inventive Concept [ 102 ] As I conclude the Judge’s inventive concept of “a sustained release formulation of a therapeutically useful dose of amphetamine that is resistant to abuse” applies to the independent claims and the appellant has pointed to no specific error, I agree with the Judge’s finding that: … the key difference between the state of the art and the inventive concept is the compound LDX and its advantageous properties.

Nothing in the prior art indicated or suggested that LDX would provide a sustained release treatment of amphetamine with a reduced potential for oral, intravenous and intranasal abuse. (Decision, at paragraphs 122 and 132.) Stage 4: The Degree of Inventiveness of those Differences [ 103 ] Stage 4 of the obviousness inquiry asks whether the differences, in light of the prior art and viewed without any knowledge of the alleged invention as claimed, constitute steps which would have been obvious to the PSIA, or if they instead required any degree of invention ( Sanofi , at paragraphs 67 and 70).

Obviousness is assessed objectively and purposively, having regard to the problem addressed by the patent ( Apotex Inc. v. Pfizer , at paragraphs 32, 35 and 39). [ 104 ] If a patent pertains to an area “of endeavour where advances are often won by experimentation”, as here, “an ‘obvious to try’ test might be appropriate” ( Sanofi , at paragraph 68). However, an “obvious to try” analysis remains but one of many potentially relevant factors in the stage 4 analysis ( Bristol-Myers , at paragraph 38; Sanofi , at paragraphs 64–65). As noted in Apotex Inc . v.

Pfizer , at paragraph 32: .… while the Supreme Court introduced the “obvious to try” test, it favours “an expansive and flexible approach that would include ’any secondary considerations that [will] prove instructive’” ( Atazanavir at para. 61, referring to Sanofi at para. 63).

As a result, a categorical approach to the obviousness inquiry and the elaboration of a “hard and fast rule” was specifically deemed inappropriate and rejected … ( Atazanavir at para. 62). [ 105 ] For an invention to be “obvious to try”, there must be evidence establishing, on a balance of probabilities, “that it was more or less self-evident to try to obtain the invention” ( Sanofi , at paragraph 66). As such, this analysis flows from the identification of the “invention” described by the claim’s inventive concept.

For example in Sanofi , the focus on the properties of the isomers at the “obvious to try” stage was dictated by the fact that it was the special properties of the selection which made it inventive. The “obvious to try” test does not broaden the scope of the obviousness inquiry from a claim-by-claim analysis to an invention-overall analysis. [ 106 ] To assess whether it is more or less self-evident to try to obtain an invention, as defined by a claim’s identified inventive concept, Sanofi enumerated three non-exhaustive factors that should be considered (paragraphs 69 and 83–92).

While they must all be explicitly considered in order to answer the overall question of whether it is “more or less self-evident to try to obtain the invention”, they need not all be met ( Hospira , at paragraphs 89–90): 1. Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art? 2. What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine?

3. Is there a motive provided in the prior art to find the solution the patent addresses? [ 107 ] Beyond the enumerated factors, there are contextual factors that should also be considered, depending on the facts of the case. These contextual factors include but are not limited to the history of the invention, how “quickly, easily, directly and relatively inexpensively” it was reached and any “wild goose chases” that were pursued before arriving at the invention, etc. ( Sanofi , at paragraphs 70–71; Apotex Inc. v. Pfizer , at paragraphs 46–48).

Although these additional contextual factors may not be, on their own, determinative (see, e.g., Tearlab , at paragraphs 68–69), any that arise alongside the factors enumerated in Sanofi are to be considered and weighed before coming to a conclusion about whether the invention was obvious. [ 108 ] In this instance, Apotex claims the Judge committed the same error as in Hospira (at paragraphs 93 and 95) and solely focussed the analysis on only one of the three mandated “obvious to try” considerations: that it was not obvious that LDX ought to work.

However, unlike in Hospira , here the Judge made determinations of fact that relate directly to the other two “obvious to try” factors, both of which cement the Judge’s position, rather than detract from it. As pointed out by Shire, the Judge had previously found that the prior art taught away from CA ′646, that substantial work preceded CA ′646 and that the skilled person would not focus on prodrugs for the purpose of deterring abuse. There was therefore no motivation and the effort expended was substantial (Decision, at paragraphs 130– 138). The Judge’s findings at paragraph 13

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