Pfizer Canada Inc. v. Canada (Health)

Pfizer Canada Inc. v. Canada (Health)
Court (s) Database
Federal Court of Appeal Decisions
Date
2007-05-31
Neutral citation
2007 FCA 209
File numbers
A-457-05
Notes
Digest
Decision Content
Date: 20070531
Docket: A-457-05
Citation: 2007 FCA 209
CORAM: LINDEN J.A.
NADON J.A.
SEXTON J.A.
BETWEEN:
PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC
and PARKE, DAVIS & COMPANY LLC
Appellants
and
THE MINISTER OF HEALTH
and APOTEX INC.
Respondents
Heard at Toronto, Ontario, on September 27 and 28, 2006.
Judgment delivered at Ottawa, Ontario, on May 31,, 2007.
REASONS FOR JUDGMENT BY: NADON J.A.
CONCURRED IN BY: LINDEN J.A.
SEXTON J.A.
Date: 20070531
Docket: A-457-05
Citation: 2007 FCA 209
CORAM: LINDEN J.A.
NADON J.A.
SEXTON J.A.
BETWEEN:
PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC
and PARKE, DAVIS & COMPANY LLC
Appellants
and
THE MINISTER OF HEALTH
and APOTEX INC.
Respondents
REASONS FOR JUDGMENT
NADON J.A.
[1] We are once again, but certainly not for the last time, called upon to determine a dispute between a patentee and a generic competitor which arises pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, March 12, 1993 (the “Regulations”).
[2] More particularly, the matter before us arises from an application brought by the appellants (“Pfizer”) pursuant to section 6 of the Regulations for an order prohibiting the Minister of Health (the “Minister”) from issuing a notice of compliance (a “NOC”) to the respondent Apotex in respect of its drug product apo-quinapril until the expiration of Canadian letters patent numbers 1,341,330 (the “ ‘330 patent ”) and 1,331,615 (the “ ‘615 patent ”).
[3] Pfizer’s application was heard by Heneghan J. of the Federal Court who, on September 28, 2005, dismissed it (2005 FC 1205). By its appeal, Pfizer seeks an order setting aside the Federal Court’s decision and declaring that the Minister is prohibited from issuing a NOC to Apotex until the expiration of the ‘330 and ‘615 patents.
[4] For a proper understanding of the questions which this appeal raises, the following review of the facts will be helpful.
THE FACTS
[5] Not surprisingly, the ‘330 patent, a genus patent for a novel group of compounds, including quinapril, and the ‘615 patent, a species patent for quinapril hydrochloride in various solid forms, are at the heart of this appeal.
[6] Quinapril-hydrochloride is an angiotensin-converting enzyme (ACE inhibitor). By inhibiting the transformation of angiotensin I to angiotensin II (the form which raises blood pressure), quinapril hydrochloride is useful in the treatment of high blood pressure, congestive heart failure and the prevention of kidney failure. Pfizer markets quinapril-hydrochloride in tablet form under the trade name Accupril.
[7] The ‘330 patent, entitled “Substituted Acyl Derivatives of 1,2,3,4- tetrahydroisoquinoline-3-Carboxylic Acids”, was applied for in the Canadian Patent Office on September 30, 1981, with a priority date of October 3, 1980. Because of conflict proceedings which were initiated in respect of the ‘330 patent and a patent involving a German patent owned by Hoechst Aktiengessellschaft (Hoechst), the patent was not issued until January 1, 2002. This followed a consent judgment entered on December 22, 1999 which allowed the claims of the patent to issue in Canada. The patent was issued to Parke, Davis & Company LLC. The ‘330 patent is a genus patent which claims a novel group or family of chemical compounds, including quinapril and other ACE inhibitors. All of the compounds claimed share a common structure consisting of a THIQ head and an enalapril tail.
[8] The ‘615 patent, entitled “Substituted Acyl Derivatives of 1,2,3,4,-Tetrahydroisoquinoline-3-Carboxylic Acids” was applied for, as a divisional application derived from the ‘330 patent, on June 23, 1992, by the assignee, Warner-Lambert Company LLC. The patent, which issued on August 23, 1994 claims a narrow subclass of the compounds claimed in the ‘330 patent, including the hydrochloride salt of quinapril.
[9] On July 18, 2003, pursuant to subsection 5(3) of the Regulations, Apotex filed and served a Notice of Allegation (“NOA”) which says that the ‘615 patent would not be infringed by the manufacturing and marketing of its drug product apo-quinapril in tablet form, on the grounds that its tablets would not comprise any of the compounds covered by the ‘615 patent, nor would such compounds be made, constructed or used in the manufacture of its tablets. As a result, Apotex says that the claims of the ‘615 patent would not be infringed.
[10] On July 24, 2003, Apotex filed a second NOA which says that the ‘330 patent is invalid for lack of utility, lack of sound prediction, anticipation, obviousness, overly-broad claims and double patenting.
[11] On September 5, 2003, Pfizer filed its application for an order of prohibition before the Federal Court, asserting that Apotex’s allegations of non-infringement and of invalidity were not justified.
[12] In dismissing Pfizer’s application, the learned Judge held that the claims of the ‘330 patent were broader than the invention disclosed and, thus, that Apotex’s allegation of invalidity was justified. She further concluded that since there was no evidence that Apotex’s drug product contained any quinapril hydrochloride, Pfizer had not met its burden of demonstrating that Apotex’s allegation of non-infringement in regard to the ‘615 patent was not justified.
THE DECISION OF THE FEDERAL COURT
A. Burden of Proof
[13] Heneghan J. first considered the evidentiary burden of proof applicable in proceedings under the Regulations. Although Pfizer accepted that it had the legal burden of proving non-infringement, it argued that with respect to the allegations of invalidity, it was entitled to the benefit of section 45 of the former Patent Act which creates a presumption that the patent is valid. As a result, Pfizer argued that the burden of proof was that of the party challenging the validity of the patent.
[14] Heneghan J. rejected Pfizer’s argument. Although, in her view, Apotex had an obligation to put the allegations of invalidity “in play”, the overall legal burden of proof was that of Pfizer.
B. Invalidity of the ‘330 Patent
(a) Construction of the Disputed Claims:
[15] In order to assess Apotex’s allegation of invalidity, Heneghan J. first construed claims 3 and 5 of the ’330 patent which were in dispute. Pfizer argued before her that a purposive construction of the claims would lead to a finding that the ’330 patent disclosed an invention relating to ACE inhibition. Conversely, Apotex argued that the invention only encompassed those compounds useful in relieving hypertension and not a broader group of ACE inhibitors, some of which did not have sufficient inhibition activity to be useful in treating hypertension.
[16] Heneghan J. accepted Apotex’s submissions and concluded that the purpose of the invention disclosed in claims 3 and 5 of the ’330 patent was the use of the compounds described as active ingredients in medicine for the treatment of hypertension, not merely the inhibition of ACE activity.
b) Invalidity of the ’330 Patent:
[17] Heneghan J. then went on to consider each of Apotex’s specific grounds for alleging invalidity of the ’330 patent. Only one such allegation succeeded. Heneghan J. concluded claims 3 and 5 of the ’330 patent were overly broad and, therefore, that Apotex’s allegation of invalidity was justified.
[18] Heneghan J. first considered the argument that the ’330 patent lacked utility. Although she was not satisfied that the utility of the invention disclosed in the patent had been demonstrated by the date the patent was applied for, she concluded that the inventors had been able to soundly predict the utility of the claimed compounds by that date. Therefore, the inutility argument was rejected.
[19] Next, Heneghan J. considered whether the invention was invalid because of anticipation. Apotex alleged that the Hoechst patent, which gave rise to conflict proceedings involving the ’330 patent, was anticipatory. The relevant date for assessing anticipation under the pre-1989 Patent Act was two years prior to the filing date of the patent at issue (former Patent Act at s. 27(1)). Since there was no evidence before her that the Hoechst patent had issued on or before that date, i.e. September 30, 1979, she concluded that Apotex had not adduced sufficient proof to put the anticipation argument “in play”.
[20] Thirdly, Heneghan J. considered whether the patent was invalid by reason of obviousness which is assessed at the date of invention. Heneghan J. accepted that the date of invention was the priority date of October 3, 1980. In her opinion, the evidence showed that on that date, persons skilled in the art would not have considered the discovery of quinapril hydrochloride obvious.
[21] Fourth, Heneghan J. considered whether claims 3 and 5 of the ’330 patent were broader than the invention or the disclosure. Apotex argued the disclosure limited the invention to those stereoisomers with a particular configuration (known as an “S-configuration”) but that claims 3 and 5 include all stereoisomers and therefore were overly broad. Heneghan J. accepted Apotex’s argument. She held that because she had construed claims 3 and 5 as including compounds useful for treating hypertension and because expert evidence illustrated that the S-configuration was the optimal configuration for high level ACE inhibition leading to anti-hypertensive results, the claims encompassing all stereoisomers were overly broad.
[22] Finally, Heneghan J. considered whether the ’330 patent was invalid on the basis of obvious-type double patenting because it was not patently distinct from the ’615 patent. Heneghan J. rejected this allegation. She was persuaded by the fact that the ’615 patent had not been involved in the conflict proceedings to which the ’330 patent was subject.
C. Non-infringement of the ’615 Patent
(a) Adequacy of the NOA:
[23] Pfizer argued that the non-infringement allegation in Apotex’s July 18, 2003 NOA was inadequate because it did not sufficiently describe the entire basis upon which the allegation rested. The NOA did not allege that ACCUPRIL tablets contained quinapril magnesium and therefore Pfizer argued that Apotex was precluded from relying on that allegation in this application.
[24] Heneghan J. concluded that the July 18, 2003 NOA partially complied with the legal test for adequacy. Apotex needed only to address the issue of non-infringement of claims for the medicine, quinapril hydrochloride, and it was justified in withholding certain information until a confidentiality order was in place. However, Heneghan J. concluded the NOA was insufficient in that if Apotex was alleging that ACCUPRIL contained quinapril magnesium, it should have said so. Nonetheless, Heneghan J. did not consider this defect fatal and went on to consider the merits of Apotex’s allegation of non-infringement.
(b) Non-Infringement of the ’615 Patent:
[25] Apotex’s drug, Apo-Quinapril, is allegedly comprised of a substance called quinapril magnesium. Apotex admits to using a solvated form of quinapril hydrochloride known as quinapril hydrochloride acetone solvate (“QHAS”) to make quinapril magnesium.
[26] In the Court below, Pfizer argued that claim 1 of the ’615 patent, when properly construed, encompasses both the solvated and unsolvated forms of quinapril hydrochloride. Accordingly, because Apotex uses a solvated form of quinapril hydrochloride, i.e. QHAS, in making ApO Quinapril, it infringes the ’615 patent. Pfizer also argued that Apotex had failed to establish on a balance of probabilities that there was only quinapril magnesium in its drug product, not quinapril hydrochloride.
[27] Apotex, on the other hand, argued that the medicine in Pfizer’s tablets is quinapril magnesium, not quinapril hydrochloride, and therefore the ’615 patent is irrelevant because it does not claim quinapril magnesium. In the alternative, Apotex argued that the ’615 patent did not encompass QHAS, which it uses in the production of quinapril magnesium, and therefore the patent was not infringed.
[28] Heneghan J. concluded that the appellants had not discharged their burden of showing that Apotex’s product infringed the ’615 patent. She based her decision on the fact that although the appellants were provided with a sample of Apotex’s Apo-Quinapril product, they elected not to test the material to determine its composition. At paragraph 155 of her Reasons, the Judge said:
[155] In my opinion, the inability to guarantee the success of a chosen testing process is no answer to the Applicants’ burden relative to the allegation of non-infringement. The '615 Patent claims quinapril hydrochloride as the medicine. The presence of that substance in Apotex's product would amount to infringement. One means of establishing that presence is testing and according to the applicants' evidence, no testing was done. In these circumstances, I conclude that the Applicants have failed to show that the allegation of non-infringement is not justified.
[29] Heneghan J. then went on to hold that it was not necessary for her to decide whether Accupril, as argued by Apotex, contained quinapril hydrochloride because of her view that the NOA was insufficient in that regard.
THE ISSUES
[30] With respect to the ‘615 patent, the issue is whether the learned Judge erred in concluding that Pfizer had failed to demonstrate that Apotex’s allegation of non-infringement was not justified. With respect to the ‘330 patent, the issue is whether the learned Judge erred in holding that the claims of the ‘330 patent were broader than the invention disclosed. If the Judge erred in that respect, the issue arises as to whether Pfizer’s application should be upheld on the basis of Apotex’s allegations of inutility, lack of sound basis to predict, anticipation, obviousness and double patenting.
THE RELEVANT LEGISLATION
[31] The following provisions of the NOC Regulations are relevant to the disposition of the appeal.
2. In these Regulations,
"claim for the medicine itself" includes a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents;
"claim for the use of the medicine" means a claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof;
"court" means the Federal Court of Canada or any other superior court of competent jurisdiction;
"expire" means, in relation to a patent, expire, lapse or terminate by operation of law;
"first person" means the person referred to in subsection 4(1);
"medicine" means a substance intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof;
"Minister" means the Minister of National Health and Welfare;
"notice of compliance" means a notice issued under section C.08.004 of the Food and Drug Regulations;
"patent list" means a list of all patents that is submitted pursuant to section 4;
"register" means the register maintained by the Minister under section 3.
"second person" means the person referred to in subsection 5(1) or (1.1), as the case may be.
…
5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
(1.1) Subject to subsection (1.2), where subsection (1) does not apply and where a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine found in another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent included on the register in respect of the other drug containing the medicine, where the drug has the same route of administration and a comparable strength and dosage form,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
…
(3) Where a person makes an allegation pursuant to paragraph (1)(b) or (1.1)(b) or subsection (2), the person shall
(a) provide a detailed statement of the legal and factual basis for the allegation;
(b) if the allegation is made under any of subparagraphs (1)(b)(i) to (iii) or (1.1)(b)(i) to (iii), serve a notice of the allegation on the first person;
(c) if the allegation is made under subparagraph (1)(b)(iv) or (1.1)(b)(iv),
(i) serve on the first person a notice of the allegation relating to the submission filed under subsection (1) or (1.1) at the time that the person files the submission or at any time thereafter, and
(ii) include in the notice of allegation a description of the dosage form, strength and route of administration of the drug in respect of which the submission has been filed; and
(d) serve proof of service of the information referred to in paragraph (b) or (c) on the Minister.
6. (1) A first person may, within 45 days after being served with a notice of an allegation pursuant to paragraph 5(3)(b) or (c), apply to a court for an order prohibiting the Minister from issuing a notice of compliance until after the expiration of a patent that is the subject of the allegation.
(2) The court shall make an order pursuant to subsection (1) in respect of a patent that is the subject of one or more allegations if it finds that none of those allegations is justified.
2. Les définitions qui suivent s’appliquent au présent règlement.
«avis de conformité» Avis délivré au titre de l’article C.08.004 du Règlement sur les aliments et drogues. ( notice of compliance )
«expiré» Se dit du brevet qui est expiré, qui est périmé ou qui a pris fin par l’effet d’une loi. ( expire )
«liste de brevets» Liste de brevets soumise aux termes de l’article 4. ( patent list )
«médicament» Substance destinée à servir ou pouvant servir au diagnostic, au traitement, à l’atténuation ou à la prévention d’une maladie, d’un désordre, d’un état physique anormal, ou de leurs symptômes. ( medicine )
«ministre» Le ministre de la Santé nationale et du Bien-être social. (Minister )
«première personne» La personne visée au paragraphe 4(1). ( first person)
«registre» Le registre tenu par le ministre conformément à l’article 3. (register )
«revendication pour le médicament en soi» S’entend notamment d’une revendication, dans le brevet, pour le médicament en soi préparé ou produit selon les modes du procédé de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes. ( claim for the medicine itself )
«revendication pour l’utilisation du médicament» Revendication pour l’utilisation du médicament aux fins du diagnostic, du traitement, de l’atténuation ou de la prévention d’une maladie, d’un désordre, d’un état physique anormal, ou de leurs symptômes. ( claim for the use of the medicine )
«seconde personne» Selon le cas, la personne visée aux paragraphes 5(1) ou (1.1). ( second person )
«tribunal» La Cour fédérale du Canada ou tout autre cour supérieure compétente. ( court )
5 (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue :
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
(1.1) Sous réserve du paragraphe (1.2), lorsque le paragraphe (1) ne s'applique pas, la personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament que l'on trouve dans une autre drogue qui a été commercialisée au Canada par suite de la délivrance d'un avis de conformité à la première personne et à l'égard de laquelle une liste de brevets a été soumise doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre visant cette autre drogue contenant ce médicament, lorsque celle-ci présente la même voie d'administration et une forme posologique et une concentration comparables :
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne soit pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
…
(3) Lorsqu'une personne fait une allégation visée aux alinéas (1)b) ou (1.1)b) ou au paragraphe (2), elle doit :
a) fournir un énoncé détaillé du droit et des faits sur lesquels elle se fonde;
b) si l'allégation est faite aux termes de l'un des sous-alinéas (1)b)(i) à (iii) ou (1.1)b)(i) à (iii), signifier un avis de l'allégation à la première personne;
c) si l'allégation est faite aux termes des sous-alinéas (1)b)(iv) ou (1.1)b)(iv) :
(i) signifier à la première personne un avis de l'allégation relative à la demande déposée selon les paragraphes (1) ou (1.1), au moment où elle dépose la demande ou par la suite,
(ii) insérer dans l'avis d'allégation une description de la forme posologique, de la concentration et de la voie d'administration de la drogue visée par la demande;
d) signifier au ministre une preuve de la signification effectuée conformément aux alinéas b) ou c).
6. (1) La première personne peut, au plus tard quarante-cinq jours après avoir reçu signification d’un avis d’allégation aux termes de l’alinéa 5(3)a), demander au tribunal de rendre une ordonnance interdisant au ministre de délivrer l’avis de conformité avant l’expiration du brevet en cause.
(2) Le tribunal rend une ordonnance en vertu du paragraphe (1) à l’égard du brevet visé par une ou plusieurs allégations si elle conclut qu’aucune des allégations n’est fondée.
[32] Because the ‘330 patent was filed before October 1, 1989, it is primarily subject to the provisions of the Patent Act, R.S.C. 1985, c. P-4, as they read immediately before that date.
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 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 of the application, and on compliance with all other requirements of this Act, obtain a patent granting to him an exclusive property in the invention.
…
45. Every patent granted under this Act shall be issued under the signature of the Commissioner and the seal of the Patent Office, shall bear on its face the date on which it is granted and issued and shall thereafter, in the absence of evidence to the contrary, be valid and avail the grantee and his legal representatives for the term mentioned therein.
…
61. (1) No patent or claim in a patent shall be declared invalid or void on the ground that before the invention therein defined was made by the inventor by whom the patent was applied for, it had already been known or used by some other person, unless it is established that,
(a) that other person had, before the date of the application for the patent, disclosed or used the invention in such a manner that it had become available to the public;
(b) that other person had, before the issue of the patent, made an application for patent in Canada on which conflict proceedings should have been directed; or
(c) that other person had at any time made an application in Canada which, by virtue of section 28, had the same force and effect as if it had been filed in Canada before the issue of the patent and on which conflict proceedings should properly have been directed had it been so filed.
(2) Notwithstanding section 41, an application for a patent for an invention for which a patent has already issued under this Act shall be rejected unless the applicant, within a time to be fixed by the Commissioner, commences an action to set aside the prior patent, so far as it covers the invention in question, but if that action is commenced and diligently prosecuted, the application shall not be deemed to have been abandoned unless the applicant fails to proceed on it within a reasonable time after the action has been finally disposed of.
(3) Where the application was filed within one year from the date of the filing of the application for the prior patent, the provisions of subsection (1) do not apply to the determination of the respective rights of the parties to the action.
27. (1) Sous réserve des autres dispositions du présent article, l’auteur de toute invention ou le représentant légal de l’auteur d’une invention peut, sur présentation au commissaire d’une pétition exposant les faits, appelée dans la présente loi le « dépôt de la demande », et en se conformant à toutes les autres prescriptions de la présente loi, obtenir un brevet qui lui accorde l’exclusive propriété d’une invention qui n’était pas :
a) connue ou utilisée par une autre personne avant que lui-même l’ait faite;
b) décrite dans un brevet ou dans une publication imprimée au Canada ou dans tout autre pays plus de deux ans avant la présentation de la pétition ci-après mentionnée;
c) en usage public ou en vente au Canada plus de deux ans avant le dépôt de sa demande au Canada.
…
45. Tout brevet accordé en vertu de la présente loi est délivré sous la signature du commissaire et le sceau du Bureau des brevets. Le brevet porte à sa face la date à laquelle il a été accordé et délivré, et il est par la suite, sauf preuve contraire, valide et acquis au titulaire et à ses représentants légaux pour la période y mentionnée.
…
61. (1) Aucun brevet ou aucune revendication dans un brevet ne peut être déclaré invalide ou nul pour la raison que l’invention qui y est décrite était déjà connue ou exploitée par une autre personne avant d’être faite par l’inventeur qui en a demandé le brevet, à moins qu’il ne soit établi que, selon le cas :
a) cette autre personne avait, avant la date de la demande du brevet, divulgué ou exploité l’invention de telle manière qu’elle était devenue accessible au public;
b) cette autre personne avait, avant la délivrance du brevet, fait une demande pour obtenir au Canada un brevet qui aurait dû donner lieu à des procédures en cas de conflit;
c) cette autre personne avait à quelque époque fait au Canada une demande ayant, en vertu de l’article 28, la même force et le même effet que si elle avait été enregistrée au Canada avant la délivrance du brevet et pour laquelle des procédures en cas de conflit auraient dû être régulièrement prises si elle avait été ainsi enregistrée.
(2) Nonobstant l’article 41, une demande de brevet pour une invention à l’égard de laquelle un brevet a déjà été délivré en vertu de la présente loi est rejetée, à moins que le demandeur n’intente, dans un délai fixé par le commissaire, une action pour écarter le brevet antérieur en tant qu’il couvre l’invention en question. Si pareille action est ainsi commencée et diligemment poursuivie, la demande n’est pas réputée avoir été abandonnée, à moins que le demandeur ne néglige de poursuivre sa demande dans un délai raisonnable après que l’action a été finalement réglée.
(3) Si la demande a été déposée dans le cours de l’année qui suit la date du dépôt de la demande du brevet antérieur, le paragraphe (1) ne s’applique pas à la détermination des droits respectifs des parties à cette action.
[33] The current Patent Act provides for the following transitional provisions:
78.2 (1) Subject to subsection (3), any matter arising on or after October 1, 1989 in respect of a patent issued before that date shall be dealt with and disposed of in accordance with sections 38.1 and 45 and with the provisions of this Act, other than section 46, as they read immediately before October 1, 1989.
(2) Subject to subsection (3), any matter arising on or after October 1, 1989 in respect of a patent issued on or after that date on the basis of an application filed before that date shall be dealt with and disposed of in accordance with sections 38.1, 45, 46 and 48.1 to 48.5 and with the provisions of this Act, other than section 46, as they read immediately before October 1, 1989.
(3) The provisions of this Act that apply as provided in subsections (1) and (2) shall be read subject to any amendments to this Act, other than the amendments that came into force on October 1, 1989 or October 1, 1996.
78.2 (1) Sous réserve du paragraphe (3), la présente loi dans sa version du 30 septembre 1989, à l’exception de l’article 46, s’applique aux affaires survenant, le 1er octobre 1989 ou par la suite, relativement aux brevets délivrés avant le 1er octobre 1989. Ces affaires sont également régies par les articles 38.1 et 45.
(2) Sous réserve du paragraphe (3), la présente loi dans sa version du 30 septembre 1989, à l’exception de l’article 46, s’applique aux affaires survenant, le 1er octobre 1989 ou par la suite, relativement aux brevets délivrés ce jour ou par la suite au titre de demandes déposées avant le 1er octobre 1989. Ces affaires sont également régies par les articles 38.1, 45, 46 et 48.1 à 48.5.
Les modifications, sauf certaines, sont prises en compte
(3) Les dispositions visées aux paragraphes (1) et (2) s’appliquent compte tenu des modifications apportées à la présente loi sauf celles de ces modifications entrées en vigueur le 1er octobre 1989 et le 1er octobre 1996.
ANALYSIS
A. The ‘615 Patent
[34] I begin with the ‘615 patent in regard to which Pfizer submits that by reason of her failure to construe claim 1 thereof, the Judge did not consider its main submission, i.e. that by making and using QHAS, Apotex will infringe claim 1 of the patent. More particularly, Pfizer says that in failing to construe claim 1, the Judge failed to consider whether solvated forms of quinapril hydrochloride were covered by the patent.
[35] It is undeniable that the Judge did not make any attempt to construe claim 1 as she disposed of the non-infringement issue on the sole basis that Pfizer had failed to test Apotex’s product. It is now settled law that construction of a patent must precede a determination of whether there is infringement thereof (see Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, and Free World Trust v. Electrosanté Inc., [2000] 2 S.C.R. 1024). It was therefore the Judge’s duty to construe claim 1 in the light of the expert evidence available to her and to segregate the non-essential elements of the patent from the essential ones. Thus, in failing to construe claim 1, the Judge erred in law and, as a result, it falls upon us to determine the matter de novo.
[36] Before turning to that task, it will be useful to briefly examine the principles governing the construction of patents which were clarified by the Supreme Court in its recent decisions in Whirlpool, supra and Free World, supra.
[37] In its decisions, the Supreme Court endorsed the purposive construction approach to patents and rejected the “grammatical” or “meticulous verbal analysis” approach which had prevailed in earlier times. In so concluding, the Court endorsed the description of “purposive construction” given by Lord Diplock at pages 242 and 243 of his Reasons for a unanimous House of Lords in Catnic Components Ltd. v. Hill and Smith Ltd., [1982] R.P.C. 183, where His Lordship made the following remarks:
My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. “skilled in the art”), for which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him a monopoly. It is those novel features only that he claims to be essential that constitute the so-called “pith and marrow” of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.
[38] In his Reasons for a unanimous Supreme Court in Whirlpool, supra, Binnie J. remarked that although the “purposive construction” approach was introduced into claims construction by Catnic, supra, it was consistent with the view expressed by Dickson J. (as he then was) in Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] S.C.R. 504, where he said at pages 520 and 521::
We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance, (Noranda Mines Limited v. Minerals Separation North American Corporation, [1950] S.C.R. 36), being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public. There is no occasion for being too astute or technical in the matter of objections to either title or specification for, as Duff C.J.C. said, giving the judgment of the Court in Western Electric Company, Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada, [1934] S.C.R. 570, at p. 574, “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction.
[39] The principles set forth by the Supreme Court in Whirlpool, supra,. and Free World,supra, can be summarized as follows:
The task of the Court is to construe the claims of the patent with the aid of expert witnesses (Whirlpool at paragraphs 43, 45 and 57). Construction of the claims is not to be a result-oriented exercise and must be conducted by the Court prior to its consideration of the issue of infringement (Whirlpool at paragraphs 43 and 49(a)). The claims are to be construed as of the publication date of the patent (Whirlpool at paragraph 42; Free World at paragraph 44). In construing the claims of the patent, the Court is called upon to determine, on an objective basis, what a skilled reader would have understood the inventor to mean (Whirlpool, at paragraph 48; Free World at paragraph 51). The claim of the patent which is to be construed by the Court must be read in the context of the rest of the specification. I would add to this, however, that reference to the rest of the specification cannot be used to expand the patentee’s monopoly as expressed in the claim (Whirlpool at paragraphs 48, 49(f) and 52). The expert witnesses are there to help the Court understand the invention and its context, as well as the meaning of the terms used in the patent. Needless to say, it is the Court’s duty to construe the claims and not that of the experts (Whirlpool at paragraphs 45 and 57). In construing the claims, the Court is to keep in mind that the patent is addressed to the “ordinary person skilled in the art”, i.e. a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him (Whirlpool at paragraphs 53, 70, 71 and 74). The “disclosure” found in the patent must describe the invention in a sufficiently complete and accurate manner so to allow the person skilled in the art to construct or use the invention when the period of monopoly has expired (Whirlpool at paragraph 42). The resulting construction of the claims should be one which is “in the interest of fairness both to the patentee and the public” (Free World at paragraph 50). As a result, the construction of the claim may lead to an expansion or limitation of the text of the claim. As Binnie J. said in Free World at paragraph 51:
51. The involvement in claims construction of the skilled addressee holds out to the patentee the comfort that the claims will be read in light of the knowledge provided to the Court by expert evidence on the technical meaning of the terms and concepts used in the claims. The words chosen by the inventor will be read in the sense the inventor is presumed to have intended and in a way that is sympathetic to accomplishment of the inventor’s purpose express or implicit in the text of the claims. However, if the inventor has misspoken or otherwise created an unnecessary or troublesome limitation in the claims, it is a self-inflicted wound. The public is entitled to rely on the words used provided the words used are interpreted fairly and knowledgeably.
(a) Claim 1 of the ‘615 Patent
[40] The parties are in agreement that the only claim of the ‘615 patent whic