Apotex Inc. v. Sanofi-Synthelabo Canada Inc.

Apotex Inc. v. Sanofi-Synthelabo Canada Inc.
Collection
Supreme Court Judgments
Date
2008-11-06
Neutral citation
2008 SCC 61
Report
[2008] 3 SCR 265
Case number
31881
Judges
Binnie, William Ian Corneil; LeBel, Louis; Deschamps, Marie; Fish, Morris J.; Abella, Rosalie Silberman; Charron, Louise; Rothstein, Marshall
On appeal from
Federal Court of Appeal
Subjects
Intellectual property
Notes
SCC Case Information: 31881
Decision Content
SUPREME COURT OF CANADA
Citation: Apotex Inc. v. Sanofi‑Synthelabo Canada Inc., [2008] 3 S.C.R. 265, 2008 SCC 61
Date: 20081106
Docket: 31881
Between:
Apotex Inc.
Appellant
and
Sanofi‑Synthelabo Canada Inc., Sanofi‑Synthelabo
and Minister of Health
Respondents
‑ and ‑
Canadian Generic Pharmaceutical Association,
BIOTECanada and Canada’s Research‑Based Pharmaceutical Companies
Interveners
Coram: Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein JJ.
Reasons for Judgment:
(paras. 1 to 117)
Rothstein J. (Binnie, LeBel, Deschamps, Fish, Abella and Charron JJ. concurring)
______________________________
Apotex Inc. v. Sanofi‑Synthelabo Canada Inc., [2008] 3 S.C.R. 265, 2008 SCC 61
Apotex Inc. Appellant
v.
Sanofi‑Synthelabo Canada Inc., Sanofi‑Synthelabo
and Minister of Health Respondents
and
Canadian Generic Pharmaceutical Association,
BIOTECanada and Canada’s Research‑Based Pharmaceutical
Companies Interveners
Indexed as: Apotex Inc. v. Sanofi‑Synthelabo Canada Inc.
Neutral citation: 2008 SCC 61.
File No.: 31881.
2008: April 16; 2008: November 6.
Present: Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein JJ.
on appeal from the federal court of appeal
Intellectual property — Patents — Medicines — Selection patents — Validity — Whether selection patent invalid on grounds of anticipation, obviousness or double patenting.
Intellectual property — Patents — Anticipation — Two‑step approach to anticipation — Requirements of “prior disclosure” and “enablement”.
Intellectual property — Patents — Obviousness — Four‑step approach to obviousness — When “obvious to try” test appropriate.
Intellectual property — Patents — Double patenting — Whether doctrine of selection patents invalid on ground of double patenting.
S is the holder of the ‘875 patent which discloses a large genus or class of over 250,000 possible compounds useful in inhibiting platelet aggregation activity in the blood. One of these compounds is the racemate relevant in this case. A racemate is a substance containing equal amounts of two structurally different compounds, called the dextro‑rotatory isomer and the levo‑rotatory isomer. S also holds the subsequent ‘777 patent which discloses and claims clopidogrel bisulfate, marketed by S under the trade name of Plavix as an anti‑coagulant that exhibits platelet aggregation inhibiting activity. Clopidogrel is the dextro‑rotatory isomer of the racemate that was selected from and is encompassed by the compounds claimed in the ‘875 patent, and is less toxic and better tolerated than the levo‑rotatory isomer and the racemate. In 2003, A, a generic manufacturer served a notice of allegation on S to obtain a notice of compliance from the Minister of Health in order to market its generic version of Plavix, claiming that it would not infringe S’s patent for Plavix because the ‘777 patent was invalid on the grounds of anticipation, obviousness and double patenting. S successfully sought an order in the Federal Court prohibiting the Minister from issuing the notice of compliance to A on the ground that the generic version of Plavix did infringe the ‘777 patent. The Federal Court of Appeal upheld the decision. The issue is whether selection patents are invalid in principle or on the facts of this case, on the grounds of anticipation, obviousness and double patenting.
Held: The appeal should be dismissed.
In the field of chemical patents, originating or genus patents are based on the discovery of a new invention, namely, a reaction or compound, while selection patents are for compounds chosen from the compounds described in the originating patent. Selection patents do not differ in nature from any other patent, but in order to be valid, the selected compound must be novel and possess a substantial advantage to be secured or disadvantage to be avoided. [9-10]
A system of genus and selection patents is acceptable in principle and does not necessarily involve anticipation and therefore invalidity. The real question is whether, on the facts of this case, the particular selection patent has been anticipated. This means that, having regard to s. 27(1) of the Patent Act , the claimed invention has already been made or publicly disclosed. Here, the applications judge set the bar for proving anticipation too high and overstated the stringency of the test by requiring that the “exact invention” must have already been made and publicly disclosed. Rather, for a successful anticipation claim, a two‑step approach should be adopted whereby the requirements of “prior disclosure” and “enablement” should be considered separately and proven. For prior disclosure, the genus patent must disclose subject matter which, if performed, would necessarily result in infringement of that patent. At this stage, the person skilled in the art is reading the prior patent to understand whether it discloses the special advantages of the second invention. No trial and error is permitted. If in reading the genus patent, there is no discovery of the special advantages of the selection patent, the genus patent does not anticipate the selection patent and the disclosure requirement to prove anticipation, as in this case, fails. For “enablement”, the person skilled in the art must have been able to perform the invention without undue burden. The question at this stage of the test is how much trial and error or experimentation is permitted. If an inventive step were required to get to the invention of the second patent, the specification of the first patent would not have provided enabling disclosure. The entire prior genus patent must provide enough information to allow a person skilled in the art to perform or make the selected subsequently claimed invention without “undue burden”. The skilled person may use his or her common general knowledge of the relevant art at the relevant time to supplement information contained in the prior genus patent and may conduct routine trials without being considered an undue burden, but prolonged or arduous trial and error experiments would not be considered routine. In this case, the allegation that the ‘777 patent is invalid on the basis of anticipation must fail. Twenty‑one examples from the ‘875 patent were made and tested, one of which was the relevant racemate. There was no evidence that a person skilled in the art would know, from reading the ‘875 patent, the specific beneficial properties associated with the more active dextro‑rotatory isomer and that it would be less toxic than the racemate or levo‑rotatory isomer or any of the other compounds made and tested. Since the ‘875 patent did not teach these special advantages, the invention of the ‘777 patent was not disclosed and was therefore not anticipated. Regarding enablement, the evidence with respect to trial and error and the methods of separating the racemate into its isomers, indicates that the identification of clopidogrel, its bisulfate salt and their advantageous properties required extensive investigation over a period of months. However, it was not necessary to determine the question of enablement in view of the finding that there was no disclosure of the ‘777 invention in the ‘875 patent. [18-20] [23-25] [31-33] [37-38] [40-42] [46-50] [116]
The allegation that the ‘777 patent is invalid on the basis of obviousness must also fail. Obviousness is largely concerned with how a skilled worker would have acted in the light of the prior art. An obviousness inquiry should follow a four‑step approach. First, the notional “person skilled in the art” and that person’s relevant common general knowledge must be identified. Here, that person is a trained pharmachemist. Second, the inventive concept of the claim in question must be determined or construed. The inventive concept of the claims in the ‘777 patent is that it is a compound useful in inhibiting platelet aggregation which has greater therapeutic effect and less toxicity than the other compounds of the ‘875 patent. Third, the differences, if any, that exist between the matters cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed must be identified. There is no disclosure in the ‘875 patent of the specific beneficial properties associated with the dextro‑rotatory isomer of this racemate or its bisulfate salt, in contrast to the ‘777 patent, which claims the invention of the dextro‑rotatory isomer of the racemate, clopidogrel, and its bisulfate salt, discloses their beneficial properties over the levo‑rotatory isomer and the racemate, and expressly describes how to separate the racemate into its isomers. Fourth, a court must consider whether, viewed without any knowledge of the alleged invention as claimed, those differences constitute steps which would have been obvious to the person skilled in the art or whether they require any degree of inventiveness. It is at this final step that the issue of “obvious to try” will arise and the nature of the invention in this case is such as to warrant this test. For a finding that an invention was “obvious to try”, there must be evidence to convince a judge on a balance of probabilities that it was more or less self‑evident to try to obtain the invention. Mere possibility that something might turn up is not enough. Here, when the relevant factors are considered, the invention was not self‑evident from the prior art and common general knowledge in order to satisfy the test. While there were five well‑known methods to separate this racemate into its isomers, there was no evidence that a person skilled in the art would have known which of the five known separation techniques would work with this racemate. Further, S spent millions of dollars and several years developing the racemate up to the point of preliminary human clinic trials before it was discovered that the dextro‑rotatory isomer was active and non‑toxic. As the ‘875 patent did not differentiate on the basis of efficacy and toxicity, what to select or omit was not then self‑evident to a person skilled in the art. It was also not self‑evident from the ‘875 patent or common general knowledge what the beneficial properties of the dextro‑rotatory isomer of this racemate or its bisulfate salt would be and therefore what was being tried ought to work. The course of conduct and the time involved throughout demonstrate that the advantage of the dextro‑rotatory isomer was not quickly or easily predictable. [66-68] [70] [74] [78-81] [85-86] [90-93]
Finally, the challenge to selection patents based on the ground of double patenting is not well founded. Strategies that attempt to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act , depending on the circumstances, but a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents. A selection patent may be sought by a party other than the inventor or owner of the original genus patent so that evergreening does not arise. In addition, selection patents encourage improvements over the subject matter of the original genus patent because that selection does something better than or different from what was claimed in the genus patent. There is no “same invention” double patenting because the claims of the ‘875 and ‘777 patents were not identical or coterminous and the former is broader than the latter. Further, as the claims in the ‘777 patent reflect a patentably distinct compound from the compounds in the ‘875 patent, it is not invalid for “obviousness” double patenting. [97-98] [100-101] [110-111] [113] [115] [117]
Cases Cited
Applied: In re I. G. Farbenindustrie A. G.’s Patents (1930), 47 R.P.C. 289; Synthon B.V. v. SmithKline Beecham plc, [2006] 1 All E.R. 685, [2005] UKHL 59; Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59; Pozzoli SPA v. BDMO SA, [2007] F.S.R. 37 (p. 872), [2007] EWCA Civ 588; Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67; Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; referred to: Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; Free World Trust v. _lectro Sant_ Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66; Beloit Canada Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289; General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457; Hills v. Evans (1862), 31 L.J. Ch. (N.S.) 457; E. I. Du Pont de Nemours & Co. (Witsiepe’s) Application, [1982] F.S.R. 303; Halliburton Energy Services Inc. v. Smith International (North Sea) Ltd., [2006] EWCA Civ 1715 (BAILII); Wobben v. Vestas‑Celtic Wind Technology Ltd., [2007] EWHC 2636 (BAILII); Application of Tomlinson, 363 F.2d 928 (1966); In re O’Farrell, 853 F.2d 894 (1988); KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007); Johns‑Manville Corporation’s Patent, [1967] R.P.C. 479; H. Lundbeck A/S v. Generics (UK) Ltd., [2008] R.P.C. 19 (p. 437), [2008] EWCA Civ 311; Angiotech Pharmaceuticals Inc. v. Conor Medsystems Inc., [2007] R.P.C. 20 (p. 487), [2007] EWCA Civ 5, rev’d [2008] R.P.C. 28 (p. 716), [2008] UKHL 49; Saint‑Gobain PAM SA v. Fusion Provida Ltd., [2005] EWCA Civ 177 (BAILII); Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, 2002 SCC 77; Ciba‑Geigy AG v. Commissioner of Patents (1982), 65 C.P.R. (2d) 73; May & Baker Ltd. v. Boots Pure Drug Co. (1950), 67 R.P.C. 23.
Statutes and Regulations Cited
Food and Drug Regulations, C.R.C. 1978, c. 870, s. C.08.004.
Patent Act, R.S.C. 1985, c. P‑4, ss. 2 , 27 , 34(1) (b) [rep. 1993, c. 15, s. 36], 55.2(4), 59.
Patented Medicines (Notice of Compliance) Regulations, SOR/93‑133, ss. 5, 6(1).
Patents Act 1977 (U.K.), 1977, c. 37.
Treaties and Other International Instruments
Convention on the Grant of European Patents, 1065 U.N.T.S. 199.
Authors Cited
Vaver, David. Intellectual Property Law: Copyright, Patents, Trade‑marks. Concord, Ont.: Irwin Law, 1997.
APPEAL from a judgment of the Federal Court of Appeal (Richard C.J. and Noël and Evans JJ.A.) (2006), 282 D.L.R. (4th) 179, 358 N.R. 135, 59 C.P.R. (4th) 46, [2006] F.C.J. No. 1945 (QL), 2006 CarswellNat 4587, 2006 FCA 421, affirming a decision of Shore J. (2005), 271 F.T.R. 159, 39 C.P.R. (4th) 202, [2005] R.P.C. 34 (p. 855), [2005] F.C.J. No. 482 (QL), 2005 CarswellNat 726, 2005 FC 390. Appeal dismissed.
Harry B. Radomski, Richard Naiberg, Andrew R. Brodkin and Miles Hastie, for the appellant.
Anthony G. Creber and Cristin A. Wagner, for the respondents Sanofi‑Synthelabo Canada Inc. and Sanofi‑Synthelabo.
No one appeared for the respondent the Minister of Health.
Edward Hore, for the intervener the Canadian Generic Pharmaceutical Association.
Peter Wilcox and Jana Stettner, for the intervener BIOTECanada.
Patrick E. Kierans, Jason Markwell and Cynthia L. Tape, for the intervener Canada’s Research‑Based Pharmaceutical Companies.
The judgment of the Court was delivered by
Rothstein J. —
I. Introduction
[1] This appeal raises questions relating to the validity of what are known as selection patents. In the context of chemical compounds, in general terms, a selection patent is one whose subject matter (compounds) is a fraction of a larger known class of compounds which was the subject matter of a prior patent.
[2] The appellant (“Apotex”) challenges the validity of the selection patent in this case on the grounds of anticipation, obviousness and double patenting. I would dismiss the appeal.
II. Facts
[3] The parties have accepted that the Sanofi respondents (“Sanofi”) are the relevant holders of patent 1,194,875 (‘875 patent). This patent disclosed a genus or class of compounds useful in inhibiting platelet aggregation activity in the blood which is important in treating coronary artery, peripheral vascular and cerebral vascular diseases. This genus patent discloses over 250,000 possible different compounds useful for this purpose. One of the compounds is a racemate described as methyl alpha-5 (4,5,6,7-tetrahydro (3, 2-c)-thieno pyridyl) (2-chlorophenyl)-acetate (the “racemate”).
[4] A racemate is a substance containing equal amounts of two structurally different compounds, called enantiomers or optical isomers. The two isomers, the dextro-rotatory isomer and the levo-rotatory isomer, are mirror images of each other and rotate plane-polarized light in opposite directions.
[5] The parties have accepted that Sanofi is also the relevant holder of subsequent Canadian patent 1,336,777 (‘777 patent), the patent in suit. It discloses and claims clopidogrel bisulfate, which is marketed by Sanofi under the trade name of Plavix as an anti-coagulant that inhibits platelet aggregation activity in the blood.
[6] Clopidogrel bisulfate is encompassed within the scope of the claims in the ‘875 patent. Clopidogrel is the dextro-rotatory isomer of the racemate, having beneficial properties over both the racemate and the levo-rotatory isomer. The dextro-rotatory isomer exhibits a platelet aggregation inhibiting activity and is less toxic and better tolerated than the levo-rotatory isomer and racemate. The salts of the dextro-rotatory isomer, such as clopidogrel bisulfate, have a better therapeutic index than the salts of the racemic mixture and in fact, the levo-rotatory isomer exhibits almost no platelet aggregation inhibiting activity, and its toxicity is markedly higher than that of the dextro-rotatory isomer.
[7] On March 10, 2003, Apotex served a notice of allegation under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (“NOC Regulations”), on Sanofi for the purpose of obtaining a notice of compliance pursuant to s. C.08.004 of the Food and Drug Regulations, C.R.C. 1978, c. 870, from the Minister of Health for a generic version of Plavix. The basis of Apotex’s notice of allegation was that it would not infringe Sanofi’s ‘777 patent for Plavix because the ‘777 patent was invalid on account of anticipation, obviousness and double patenting. On April 28, 2003, Sanofi initiated proceedings under s. 6(1) of the NOC Regulations in the Federal Court seeking an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex on the grounds that its generic version of Plavix would infringe the ‘777 patent. The Federal Court granted the order of prohibition ((2005), 271 F.T.R. 159, 2005 FC 390). The Federal Court of Appeal dismissed Apotex’s appeal ((2006), 282 D.L.R. (4th) 179, 2006 FCA 421).
III. Selection Patents
[8] This appeal requires the Court to determine whether selection patents are invalid in principle or on the facts of this case on the grounds of anticipation, obviousness and double patenting.
[9] The locus classicus describing selection patents is the decision of Maugham J. in In re I. G. Farbenindustrie A. G.’s Patents (1930), 47 R.P.C. 289 (Ch. D.). At p. 321, he explained that in the field of chemical patents (which would of course include pharmaceutical compounds), there are often two “sharply divided classes”. The first class of patents, which he called originating patents, are based on an originating invention, namely, the discovery of a new reaction or a new compound. The second class comprises patents based on a selection of compounds from those described in general terms and claimed in the originating patent. Maugham J. cautioned that the selected compounds cannot have been made before, or the selection patent “would fail for want of novelty”. But if the selected compound is “novel” and “possess[es] a special property of an unexpected character”, the required “inventive” step would be satisfied (p. 321). At p. 322, Maugham J. stated that a selection patent “does not in its nature differ from any other patent”.
[10] While not exhaustively defining a selection patent, he set out (at pp. 322-23) three conditions that must be satisfied for a selection patent to be valid.
1. There must be a substantial advantage to be secured or disadvantage to be avoided by the use of the selected members.
2. The whole of the selected members (subject to “a few exceptions here and there”) possess the advantage in question.
3. The selection must be in respect of a quality of a special character peculiar to the selected group. If further research revealed a small number of unselected compounds possessing the same advantage, that would not invalidate the selection patent. However, if research showed that a larger number of unselected compounds possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a special character.
[11] Although much has been written about selection patents since I. G. Farbenindustrie, Maugham J.’s analysis is consistently referred to and is well accepted. I find it is a useful starting point for the analysis to be conducted in this case.
IV. The Regulatory Scheme Under Which the Matter Proceeded
[12] At the outset, it is appropriate to refer to the words of Judson J. for this Court in Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49, at p. 57:
There is no inherent common law right to a patent. An inventor gets his patent according to the terms of the Patent Act , no more and no less.
The most recent reference to the law of patents being wholly statutory are the words of
Lord Walker in Synthon B.V. v. SmithKline Beecham plc, [2006] 1 All E.R. 685, [2005] UKHL 59, at paras. 57-58:
The law of patents is wholly statutory, and has a surprisingly long history. . . . In the interpretation and application of patent statutes judge-made doctrine has over the years done much to clarify the abstract generalities of the statutes and to secure uniformity in their application.
Nevertheless it is salutary to be reminded, from time to time, that the general concepts which are the common currency of patent lawyers are founded on a statutory text, and cannot have any other firm foundation.
I therefore turn to the regulatory scheme applicable in this case.
[13] The procedure under the NOC Regulations pursuant to which a manufacturer of drugs may apply to the Minister of Health for a notice of compliance is well known. A manufacturer, usually a generic manufacturer, wishes to compare its drug with that of a patent holder for which a patent list has been submitted to the Minister by the patent holder. The generic manufacturer’s purpose is to establish the safety and efficacy of its drug for the purposes of securing marketing approval from the Minister. The process of comparison saves the generic competitor time and resources. However, the Minister will not issue a notice of compliance unless the patent on the comparator drug has expired, is invalid, or the generic’s product will not otherwise infringe the patent. Thus the NOC Regulations create a connection between government approval to market a generic drug and the issue of patent validity and infringement.
[14] Section 5(1)(b) of the NOC Regulations states that the generic manufacturer, in its submission for a notice of compliance, may allege that the patent has expired, is not valid or will not be infringed. The patent holder may then apply to the Federal Court for an order prohibiting the Minister from issuing a notice of compliance to the generic manufacturer until after expiration of the patent that is the subject of the notice of allegation. The court will grant the prohibition order if it finds that the allegation of invalidity, expiry or non-infringement is not justified. If it finds the allegation justified, it will dismiss the application for prohibition and the Minister may then issue a notice of compliance to the generic manufacturer if all other requirements are met.
[15] The NOC Regulations do not provide guidance about how an allegation of “not valid” as stated in s. 5(1)(b)(iii) is to be considered and determined by the court. For this purpose, reference must be made to the relevant version of the Patent Act , which is R.S.C. 1985, c. P-4 , applicable to patent applications filed prior to October 1, 1989.
[16] The application for the ‘875 patent was filed in 1983. The patent was issued in 1985 and expired in 2002. The application for the ‘777 patent was filed in 1988. The patent was issued in 1995 and unless found to be invalid, will expire in 2012.
[17] The use of the term “not valid” in s. 5 of the NOC Regulations parallels what would otherwise be a defence to an infringement action referred to in s. 59 of the Act:
The defendant, in any action for infringement of a patent may plead as matter of defence any fact or default which by this Act or by law renders the patent void, and the court shall take cognizance of that pleading and of the relevant facts and decide accordingly.
The NOC Regulations are promulgated under s. 55.2(4) of the Act, and it seems apparent that the determination of the invalidity of a patent must be based on “any fact or default which by this Act or by law renders the patent void”. In this case, Apotex relies on anticipation, obviousness and double patenting to allege that the ‘777 patent is invalid. These allegations implicate both the Act and the judge-made doctrine based on the Act.
V. Anticipation
(a) Relevant Legislation
[18] For purposes of anticipation, it is necessary to have regard to s. 27 of the Act which sets forth the basic conditions necessary for obtaining a patent. The invention must not have been previously known or used nor described in any patent or other publication printed in any country more than two years before the filing of the patent application and must not have been in public use or sale in Canada more than two years prior to the filing of the patent application. Section 27(1) provided:
27. (1) Subject to this section, any inventor or legal representative of an inventor of an invention that was
(a) not known or used by any other person before he invented it,
(b) not described in any patent or in any publication printed in Canada or in any other country more than two years before presentation of the petition hereunder mentioned, and
(c) not in public use or on sale in Canada for more than two years prior to his application in Canada,
may, on presentation to the Commissioner of a petition setting out the facts, in this Act termed the filing in the application, and on compliance with all other requirements of this Act, obtain a patent granting to him an exclusive property in the invention.
[19] It is with s. 27 in mind that the law of anticipation must be considered. Apotex’s arguments based on anticipation are not that the applications judge erred in his analysis of the law of anticipation or its application to the facts of this case. Rather, Apotex implies that the current understanding of the law sets the bar for proving anticipation too high and that the acceptance of a system of genus and selection patents necessarily, or at least on the facts of this case, involves anticipation and therefore invalidity. I would reject the broader objection. A system of genus and selection patents is acceptable in principle, on the line of authority stemming from I. G. Farbenindustrie. The real question is whether, on the facts of this case, the particular selection patent has been anticipated.
(b) Reasons of the Applications Judge
[20] In his reasons after referring to s. 27(1) of the Act, the applications judge defined anticipation as meaning “that the exact invention had already been made and publicly disclosed” (para. 55). Shore J. cited this Court’s decision in Free World Trust v. _lectro Sant_ Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66, at para. 26, which approved of the test for anticipation described in Beloit Canada Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.), at p. 297:
One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention. [Emphasis added by the applications judge.]
[21] The applications judge noted that the English Court of Appeal stated in General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457, at p. 486:
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented . . . . [Emphasis added by the applications judge.]
He then noted that in Free World, at para. 26, this Court approved the following statement from General Tire:
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. [p. 486]
[22] The law of anticipation as explained in Beloit and General Tire has been accepted in Canada without reservation: see Free World, at para. 26. In his application of the law to the facts, there is no doubt that Shore J. was using the test as set out in Beloit when he stated, at para. 57:
Based on the law, the question before the Court is whether a person skilled in the art was given such a clear direction that, by reading and following the ’875 patent (or its U.S. or French equivalents) would in every case and without possibility of error make a compound or pharmaceutical composition within the claims of the ’777 patent (e.g. the bisulfate salt of clopidogrel).
(c) Recent United Kingdom Jurisprudence
[23] For the reasons that follow, and in light of recent jurisprudence, I am of the respectful opinion that the applications judge overstated the stringency of the test for anticipation that the “exact invention” has already been made and publicly disclosed.
[24] In the 2005 decision of the House of Lords in Synthon, Lord Hoffmann has brought some further clarity to the law of anticipation as understood since General Tire. His reference at para. 20 to the “unquestionable authority” of Lord Westbury in Hills v. Evans (1862), 31 L.J. Ch. (N.S.) 457, at p. 463, makes it plain that his analysis does not depend on any change on English law flowing from the enactment of the Patents Act 1977 (U.K.), 1977, c. 37, or the U.K.’s adoption of the Convention on the Grant of European Patents, 1065 U.N.T.S. 199 (entered into force October 7, 1977). He distinguishes between two requirements for anticipation that were not theretofore expressly considered separately, prior disclosure and enablement.
[25] He explains that the requirement of prior disclosure means that the prior patent must disclose subject matter which, if performed, would necessarily result in infringement of that patent, and states, at para. 22:
If I may summarise the effect of these two well-known statements [from General Tire and Hills v. Evans], the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent. . . . It follows that, whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied.
When considering the role of the person skilled in the art in respect of disclosure, the skilled person is “taken to be trying to understand what the author of the description [in the prior patent] meant” (para. 32). At this stage, there is no room for trial and error or experimentation by the skilled person. He is simply reading the prior patent for the purposes of understanding it.
[26] If the disclosure requirement is satisfied, the second requirement to prove anticipation is “enablement” which means that the person skilled in the art would have been able to perform the invention (para. 26). Lord Hoffmann held that the test for enablement for purposes of anticipation was the same as the test for sufficiency under the relevant United Kingdom legislation. (Enablement for the purposes of sufficiency of the patent specification under the Canadian Patent Act, s. 34(1)(b) of the pre-October 1, 1989 Act, now s. 27(3)(b), is not an issue to be decided in this case and my analysis of enablement is solely related to the test for anticipation. The question of whether enablement for purposes of sufficiency is identical in Canada is better left to another day.)
[27] Once the subject matter of the invention is disclosed by the prior patent, the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work. While trial and error experimentation is permitted at the enablement stage, it is not at the disclosure stage. For purposes of enablement, the question is no longer what the skilled person would think the disclosure of the prior patent meant, but whether he or she would be able to work the invention.
[28] The Beloit decision by which the applications judge rightly felt bound dealt with only one aspect of anticipation, that is, whether or not the invention in a patent had been disclosed in a single prior publication or patent. In that decision, Hugessen J.A. held that it had not. He had no need to consider the further point whether or not, had there been such a clear disclosure, the working of the invention was also enabled by that disclosure. That point was not in issue in Beloit. Explicitly separating disclosure and enablement is a refinement of the approach set out in Beloit. It explains the process a person skilled in the art would follow if the original patent anticipated the invention of the subsequent patent. I would adopt this approach.
[29] 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.
[30] Two questions now must be answered: (1) what constitutes disclosure at the first stage of the test for anticipation, and (2) how much trial and error or experimentation is permitted at the enablement stage?
i. Disclosure
[31] Section 27(1) of the Act requires as a condition for obtaining a patent that the invention was not “known or used” and was not “described” in any patent or any publication more than two years before the patent application was filed. In the context of genus and selection patents, in E. I. Du Pont de Nemours & Co. (Witsiepe’s) Application, [1982] F.S.R. 303 (H.L.), Lord Wilberforce stated, at p. 311:
It is the absence of the discovery of the special advantages, as well as the fact of non-making, that makes it possible for such persons to make an invention related to a member of the class.
The compound made for the selection patent was only soundly predicted at the time of the genus patent. It was not made and its special advantages were not known. It is for those reasons that a patent should not be denied to the inventor who made and discovered the special advantages of the selection compound for the first time.
[32] In the context of disclosure as explained in Synthon, “the absence of the discovery of the special advantages” to which Lord Wilberforce was referring in Witsiepe’s means that the genus patent does not disclose the special advantages of the invention covered by the selection patent. Where there is no such disclosure, there is no discovery of the special advantages of the selection patent as compared to the genus patent, and the disclosure requirement to prove anticipation fails. At this stage, the person skilled in the art is reading the prior patent to understand whether it discloses the special advantages of the second invention. No trial and error is permitted. If in reading the genus patent the special advantages of the invention of the selection patent are not disclosed, the genus patent does not anticipate the selection patent.
ii. Enablement
[33] What amount of trial and error or experimentation is permitted before a prior disclosure will not constitute enabling disclosure? Certainly, if the applications judge finds that an inventive step was required to get to the invention of the second patent, the specification of the first patent will not have provided enabling disclosure. But even if no inventive step is required, the skilled person must still be able to perform or make the invention of the second patent without undue burden.
[34] Two recent United Kingdom decisions are of assistance. In Halliburton Energy Services Inc. v. Smith International (North Sea) Ltd., [2006] EWCA Civ 1715 (BAILII), Jacob L.J., a highly experienced patent judge, states at para. 18:
Patents are meant to teach people how to do things. If what is “taught” involves just too much [work] to be reasonable allowing for all the circumstances including the nature of the art, then the patent cannot be regarded as an “enabling disclosure.” . . . The setting of a gigantic project, even if merely routine, will not do.
[35] Jacob L.J. characterizes the problem at para. 20 as: “[H]ow is one to say when the work involved to perform the invention is too much?” The determination of how much work is too much is inevitably a line-drawing exercise. His answer to the problem is at para. 21:
The answer is that the line is one to be drawn by an exercise of judgment, taking into account all of the relevant factors, one of which is of course the nature of the invention itself and its field of technology. But there are other factors too — for instance, the width of the patent claim or whether it has functional limitations which require too much work to explore.
[36] A more extensive review of the law of enablement as defined in Synthon is contained in a decision of Kitchin J. in Wobben v. Vestas-Celtic Wind Technology Ltd., [2007] EWHC 2636 (Pat.) (BAILII), at paras. 196-97. Although Wobben was a case in which the alleged infringer raised as one of its defences insufficiency under the United Kingdom legislation, I think guidance is provided as to what will or will not constitute enablement for purposes of anticipation.
[37] Drawing from this jurisprudence, I am of the opinion that the following factors should normally be considered. The list is not exhaustive. The factors will apply in accordance with the evidence in each case.
1. Enablement is to be assessed having regard to the prior patent as a whole including the specification and the claims. There is no reason to limit what the skilled person may consider in the prior patent in order to discover how to perform or make the invention of the subsequent patent. The entire prior patent constitutes prior art.
2. The skilled person may use his or her common general knowledge to supplement information contained in the prior patent. Common general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time.
3. The prior patent must provide enough information to allow the subsequently claimed invention to be perform