Date: 20040302
Docket: T-2311-01
Citation: 2004 FC 313
Ottawa, Ontario, this 2nd day of March, 2004
PRESENT: THE HONOURABLE MR. JUSTICE JOHN A. O'KEEFE
BETWEEN:
ASTRAZENECA AB and ASTRAZENECA CANADA INC.
Applicants
- and -
APOTEX INC. and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
O'KEEFE J.
[1] This is an application by the applicants, AstraZeneca AB and AstraZeneca Canada Inc. (collectively "AstraZeneca"), pursuant to the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 ("NOC Regulations"), for an order prohibiting the Minister of Health (the "Minister) from issuing a Notice of Compliance ("NOC") to Apotex Inc. ("Apotex") in respect of Apo-Omeprazole capsules containing omeprazole in 20 mg strength for oral administration, until after the expiration of Canadian Patent No. 2,133,762 (the "762 Patent").
[2] AstraZeneca requests that the application be granted with costs.
Background
Introduction
[3] By letter dated November 16, 2001, Apotex sent AstraZeneca a Notice of Allegation ("NOA") which made the following allegation of non-infringement:
We have submitted to the Minister a New Drug Submission for Apo-Omeprazole capsules containing omeprazole in 20 mg strength for oral administration.
With respect to patent 2133762, we allege that 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 us of the said capsules.
[4] In response, AstraZeneca commenced this proceeding by notice of application issued December 31, 2001.
[5] The legal and factual basis relied upon by Apotex in alleging non-infringement of the '762 Patent is as follows:
Claims 1 to 34 inclusive and 41 to 57 inclusive relate only to compositions which comprise a combination of a histamine-H2 blocker or a proton pump inhibitor and an antibacterial compound.
Our product will not infringe any of these claims by reason of the fact that our product is not a combination product, but comprises only omeprazole as the sole active ingredient.
Claims 35 to 40 inclusive and 58 to 65 inclusive relate only to use of a histamine-H2 blocker or an antibacterial compound and an antibacterial compound for the treatment of gastritis and peptic ulcer caused by Heliobacter pylori.
Our product will not infringe these claims, because:
i) our product is not a combination product, so that its use would not infringe any of these claims; and
ii) we are not seeking approval for such use, and no such use will be included in our product monograph. Furthermore, our product monograph will make no mention whatsoever of Heliobacter pylori and will be limited to use for reduction of gastric acid secretion.
Claims 66 and 67 relate only to use of omeprazole and an antibiotic for the treatment of gastritis and peptic ulcer.
Our product will not infringe these claims because:
i) our product is not a combination product (i.e. contains no antibiotic) so that its use would not infringe the claims, and
ii) we are not seeking approval for such use and no such use will be included in our product monograph.
The remaining claims relate only to use for increasing the bioavailability of an antibacterial compound.
Our product will not infringe because we are not seeking approval for such use and no such use will be included in our product monograph.
[6] Apotex's NOA went on to state:
We further allege that this patent does not qualify for listing on a patent list for Losec capsules [AstraZeneca's omeprazole product], that the listing of the patent constitutes an abuse of the Regulations, and that the Regulations do not contemplate the bringing of an Application for an Order of Prohibition in relation to this patent with respect to our New Drug Submission. In particular:
i) listing of the patent is contrary to sections 4(4) and 4(6) of the Regulations, because the date of the application for the patent was April 20, 1993, which was after the filing of the New Drug Submission for Losec capsules; and
ii) in the alternative, if this patent is listed, it could only be listed in relation to a supplemental NDS for a product different from Losec capsules as previously approved, perhaps characterized by different indications, if not physically different. However, our NDS referred only to Losec capsules as previously approved, so that such listing would not cause the Regulations to be invoked in relation to the Apotex New Drug submission.
The '762 Patent
[7] The '762 Patent states that it relates to the following field of invention:
The present invention relates to a combination of a substance with inhibiting effect on gastric acid secretion, thus a substance which increases the intragastric pH e.g. a proton pump inhibitor or a histamine-H2-blocker, and one or more antibacterial compounds which are acid degradable.
[8] The '762 Patent discloses that certain antibiotic compounds which affect Helicobacter pylori ("H. pylori") are degraded into non-antibacterial metabolites in the presence of gastric acid, which drastically reduces their antibacterial efficacy.
[9] The inventors found unexpectedly that the combination of a substance with an inhibiting effect on gastric acid secretion with one or more acid degradable antibacterial compounds result in a high plasma concentration of the antibiotic following oral administration.
[10] The inventors also note that by combining the components of the present invention, synergism of the antibacterial effect of antibiotic compounds is achieved resulting in improved therapeutic efficacy.
[11] The '762 Patent also states:
The combination according to the present invention can be produced in one pharmaceutical formulation comprising both active ingredients or two separate tablets or capsules, powder, mixture, effervescence tablets or solution.
Claims of the '762 Patent
[12] The '762 Patent has 77 claims.
[13] Claim 1 of the '762 Patent states:
A pharmaceutical composition for the treatment of gastritis and peptic ulcer comprising a therapeutically effective amount of a histamine-H2 receptor blocking compound which increases intragastric pH or of a proton pump inhibitor which increases intragastric pH, and a therapeutically effective amount of an acid degradable antibacterial compound.
[14] Claims 2 to 10 depend on claim 1. Claim 3 relates to a pharmaceutical composition where the proton pump inhibitor is omeprazole or a pharmaceutically acceptable salt thereof. Other dependent claims identify specific antibacterial compounds.
[15] Claim 11 claims an oral pharmaceutical composition as follows:
11. An oral pharmaceutical composition for the treatment of gastritis and peptic ulcer caused by Helicobacter pylori infections comprising as active ingredients,
(a) . . . a therapeutically effective amount of a proton pump inhibitor compound which increases the intragastric pH and
(b) a therapeutically effective amount of an acid degradable antibacterial compound.
[16] Claims 12 through 20 depend on claim 11. They further particularize the invention by identifying specific antibiotics and proton pump inhibitors.
[17] Claim 41 claims a synergistic pharmaceutical combination for the treatment of gastritis and peptic ulcers:
A synergistic pharmaceutical combination of a therapeutic amount ranging from about 1-200 mg of proton pump inhibiting compound, which increases intragastric pH; and a therapeutic amount ranging from about 250 mg to 10g of an acid degradable antibacterial compound for the treatment of gastritis and peptic ulcer.
[18] Claims 42 to 46 further particularize the pharmaceutical combination of claim 41. Claim 47 also claims a synergistic pharmaceutical combination:
A synergistic pharmaceutical combination comprising a therapeutic amount of omeprazole or a pharmaceutically acceptable salt thereof and a therapeutic amount of a weak base antibiotic for the treatment of gastritis and peptic ulcer.
[19] Claims 48 through 57 are independent claims to synergistic pharmaceutical compositions for the treatment of gastritis and peptic ulcer.
[20] Claim 58 and its dependent claims specify use for the treatment of gastritis and peptic ulcer caused by H. pylori:
Use of a proton pump inhibiting compound which is an inhibitor of gastric acid secretion and an acid degradable antibacterial compound for the treatment of gastritis and peptic ulcer caused by Helicobacter pylori.
[21] Claim 66 claims the use of omeprazole or a pharmaceutically acceptable salt therefore and a weak base antibiotic for the treatment of gastritis and peptic ulcer. Claim 67 specifies the antibiotic. Claim 68 claims:
Use of a histamine-H2 receptor blocking compound or of a proton pump inhibitor for increasing the bioavailability of an acid degradable antibacterial compound.
[22] Claim 69 specifies use according to claim 68 of omeprazole or a pharmaceutically acceptable salt thereof. Claims 70 through 76 depend on claims 68 and/or 69. Claim 76 specifies use according to claims 68, 69 or 70 for increasing the bioavailability of clarithromycin. Claim 77 claims the use of omeprazole for increasing the bioavailability of erythromycin.
AstraZeneca's (Applicants') Submissions
[23] AstraZeneca submits that Apotex's NOA is fatally flawed because it fails to allege non-infringement by patients and fails to address the uses referred to in several of the '762 Patent claims. It is submitted that Apotex's product, if marketed, will be used by patients for uses within the '762 Patent claims. Therefore, as there will be infringement, it is submitted that Apotex's allegation of non-infringement cannot be justified.
[24] AstraZeneca submits that Apotex's allegation of non-infringement is not justified on the legal and factual basis relied on by Apotex. It is submitted that Apotex's product monograph makes reference to antibiotics and uses falling clearly within the claim language of the '762 Patent.
[25] AstraZeneca submits that Apotex also relies on a patent construction which is at odds with the clear language of the patent itself and is inconsistent with the evidence of Mr. Wilton, the only expert witness providing an interpretation of the patent.
[26] AstraZeneca submits that after it pointed out to Apotex the deficiencies in its allegation, Dr. Sherman attempted through his affidavit, to expand the legal and factual basis relied on for alleging non-infringement. It is submitted that the Federal Court of Appeal has recently confirmed that a generic is limited to the legal and factual basis detailed in its NOA.
[27] AstraZeneca further submits that the evidence of Dr. Sherman is not credible and hence cannot be given any weight because he gave specific assurances and undertakings on matters relevant to the allegation of non-infringement which have been shown to be false based on the documents subsequently produced by Apotex.
[28] AstraZeneca submits that there is no merit in the patent list issued raised by Apotex. Furthermore, such issues must be decided in another forum, not this proceeding, in AstraZeneca's view.
Apotex's (Respondent's) Submissions
[29] Apotex submits that AstraZeneca has failed to discharge its burden of establishing that Apotex's allegation of non-infringement is unjustified and, therefore, this application must be dismissed.
[30] Apotex submits that a "first person" under the NOC Regulations cannot rely on independent acts of third parties to establish that an allegation of non-infringement is either deficient or not justified. Apotex relies on the case of AB Hassle v. Canada (Minister of National Health and Welfare), [2002] F.C.J. No. 1533 (QL), 2002 FCA 421, to support this submission.
[31] In any event, Apotex submits that the evidence advanced by AstraZeneca to discharge its burden of establishing that future acts of infringement will occur if an NOC is issued is grossly lacking. Apotex characterizes AstraZeneca's position as a frivolous theory of infringement.
[32] Apotex alleges that the '762 Patent does not qualify for listing on the patent register, or, alternatively, that it does not apply to the Apo-Omeprazole product.
[33] Apotex submits that its allegation of non-infringement of the '762 Patent is justified and that this application should be dismissed with costs.
Issues - As Stated by AstraZeneca (Applicants)
[34] AstraZeneca submits that this application raises the following issues:
1. The credibility of Dr. Sherman, Apotex's witness, which touches on many issues.
2. Whether Apotex's NOA is fatally deficient, given that Apotex:
(a) has failed to assert that its product will not be used by patients for
the claimed uses;
(b) has failed to address at all the uses claimed in some of the claims;
(c) is not permitted to expand the legal and factual basis for the NOA; and
(d) relies on an improper construction of the claims.
3. Whether the allegation of non-infringement is justified on the specific legal and factual basis set out in the NOA.
4. Whether this Court has jurisdiction to determine the patent listing issue raised by Apotex, and if so, whether Apotex has established the alleged impropriety.
Issues - As Stated by Apotex (Respondent)
[35] Apotex submits that this proceeding raises the following issues:
1. Has AstraZeneca discharged its burden of establishing that Apotex's NOA is not justified?
2. Has AstraZeneca established that Apotex's NOA is insufficient in any way?
3. Does the '762 Patent qualify for listing on a patent list or alternatively, is the '762 Patent inapplicable to Apotex's product?
[36] For the purposes of these reasons, I have formulated the issues as follows:
1. Should the evidence of Dr. Sherman, witness for Apotex, be disregarded for lack of credibility?
2. Was Apotex's NOA sufficient?
3. Is Apotex's allegation of non-infringement justified on the specific legal and factual basis set out in the NOA?
Relevant Statutory Provisions
[37] The relevant sections of the Food and Drug Regulations, C.R.C., c. 870 state:
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C.08.002. (1) No person shall sell or advertise a new drug unless
(a) the manufacturer of the new drug has filed with the Minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the Minister;
(b) the Minister has issued, pursuant to section C.08.004, a notice of compliance to the manufacturer of the new drug in respect of the new drug submission or abbreviated new drug submission;
(c) the notice of compliance in respect of the submission has not been suspended pursuant to section C.08.006; and
(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with that new drug, and a statement setting out the proposed date on which those labels will first be used.
(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:
(a) a description of the new drug and a statement of its proper name or its common name if there is no proper name; |
C.08.002. (1) Il est interdit de vendre ou d'annoncer une drogue nouvelle, à moins que les conditions suivantes ne soient réunies:
a) le fabricant de la drogue nouvelle a, relativement à celle-ci, déposé auprès du ministre une présentation de drogue nouvelle ou une présentation abrégée de drogue nouvelle que celui-ci juge acceptable;
b) le ministre a, aux termes de l'article C.08.004, délivré au fabricant de la drogue nouvelle un avis de conformité relativement à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle;
c) l'avis de conformité relatif à la présentation n'a pas été suspendu aux termes de l'article C.08.006;
d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons des étiquettes-y compris toute notice jointe à l'emballage, tout dépliant et toute fiche sur le produit-destinées à être utilisées pour la drogue nouvelle, ainsi qu'une déclaration indiquant la date à laquelle il est prévu de commencer à utiliser ces étiquettes.
(2) La présentation de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle, notamment:
a) une description de la drogue nouvelle et une mention de son nom propre ou, à défaut, de son nom usuel; |
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(b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug;
(c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;
(d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;
(e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug;
(f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug;
(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;
(h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;
(i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;
(j) a draft of every label to be used in conjunction with the new drug;
(k) a statement of all the representations to be made for the promotion of the new drug respecting
(i) the recommended route of administration of the new drug,
(ii) the proposed dosage of the new drug,
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b) une mention de la marque nominative de la drogue nouvelle ou du nom ou code d'identification projeté pour celle-ci;
c) la liste quantitative des ingrédients de la drogue nouvelle et les spécifications relatives à chaque ingrédient;
d) la description des installations et de l'équipement à utiliser pour la fabrication, la préparation et l'emballage de la drogue nouvelle;
e) des précisions sur la méthode de fabrication et les mécanismes de contrôle à appliquer pour la fabrication, la préparation et l'emballage de la drogue nouvelle;
f) le détail des épreuves qui doivent être effectuées pour contrôler l'activité, la pureté, la stabilité et l'innocuité de la drogue nouvelle;
g) les rapports détaillés des épreuves effectuées en vue d'établir l'innocuité de la drogue nouvelle, aux fins et selon le mode d'emploi recommandés;
h) des preuves substantielles de l'efficacité clinique de la drogue nouvelle aux fins et selon le mode d'emploi recommandés;
i) la déclaration des noms et titres professionnels de tous les chercheurs à qui la drogue nouvelle a été vendue;
j) une esquisse de chacune des étiquettes qui doivent être employées relativement à la drogue nouvelle;
k) la déclaration de toutes les recommandations qui doivent être faites dans la réclame pour la drogue nouvelle, au sujet
(i) de la voie d'administration recommandée pour la drogue nouvelle,
(ii) de la posologie proposée pour la drogue nouvelle, |
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(iii) the claims to be made for the new drug, and
(iv) the contra-indications and side effects of the new drug;
(l) a description of the dosage form in which it is proposed that the new drug be sold;
(m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and
(n) for a drug intended for administration to food-producing animals, the withdrawal period of the new drug. |
(iii) des propriétés attribuées à la drogue nouvelle,
(iv) des contre-indications et les effets secondaires de la drogue nouvelle;
l) la description de la forme posologique proposée pour la vente de la drogue nouvelle;
m) les éléments de preuve établissant que les lots d'essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d'une manière représentative de la production destinée au commerce;
n) dans le cas d'une drogue nouvelle destinée à être administrée à des animaux producteurs de denrées alimentaires, le délai d'attente applicable. |
[38] The relevant sections of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 state:
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4. (1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug.
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, |
4. (1) La personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à l'égard de la drogue, accompagnée de l'attestation visée au paragraphe (7).
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: |
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(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.
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.
(3) The first person shall, within the 45 days referred to in subsection (1), serve the Minister with proof that an application referred to in that subsection has been made.
(4) Where the first person is not the owner of each patent that is the subject of an application referred to in subsection (1), the owner of each such patent shall be made a party to the application.
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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.
6. (1) La première personne peut, dans les 45 jours après avoir reçu signification d'un avis d'allégation aux termes des alinéas 5(3)b) ou c), demander au tribunal de rendre une ordonnance interdisant au ministre de délivrer un avis de conformité avant l'expiration du brevet visé par l'allégation.
(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.
(3) La première personne signifie au ministre, dans la période de 45 jours visée au paragraphe (1), la preuve que la demande visée à ce paragraphe a été faite.
(4) Lorsque la première personne n'est pas le propriétaire de chaque brevet visé dans la demande mentionnée au paragraphe (1), le propriétaire de chaque brevet est une partie à la demande.
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(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application
(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register or are irrelevant to the dosage form, strength and route of administration of the drug for which the second person has filed a submission for a notice of compliance; or
(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.
(6) For the purposes of an application referred to in subsection (1), where a second person has made an allegation under subparagraph 5(1)(b)(iv) or (1.1)(b)(iv) in respect of a patent and where that patent was granted 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, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes.
(7) On the motion of a first person, the court may, at any time during a proceeding,
(a) order a second person to produce any portion of the submission for a notice of compliance filed by the second person relevant to the disposition of the issues in the proceeding and may order that any change made to the portion during the proceeding be produced by the second person as it is made; and
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(5) Lors de l'instance relative à la demande visée au paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter la demande si, selon le cas:
a) il estime que les brevets en cause ne sont pas admissibles à l'inscription au registre ou ne sont pas pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue pour laquelle la seconde personne a déposé une demande d'avis de conformité;
b) il conclut qu'elle est inutile, scandaleuse, frivole ou vexatoire ou constitue autrement un abus de procédure.
(6) Aux fins de la demande visée au paragraphe (1), lorsque la seconde personne a fait une allégation aux termes des sous-alinéas 5(1)b)(iv) ou (1.1)b)(iv) à l'égard d'un brevet et que ce brevet a été accordé pour le médicament en soi préparé ou produit selon les modes ou procédés de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes, la drogue que la seconde personne projette de produire est, en l'absence d'une preuve contraire, réputée préparée ou produite selon ces modes ou procédés.
(7) Sur requête de la première personne, le tribunal peut, au cours de l'instance:
a) ordonner à la seconde personne de produire les extraits pertinents de la demande d'avis de conformité qu'elle a déposée et lui enjoindre de produire sans délai tout changement apporté à ces extraits au cours de l'instance;
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(b) order the Minister to verify that any portion produced corresponds fully to the information in the submission.
(8) A document produced under subsection (7) shall be treated confidentially.
(9) In a proceeding in respect of an application under subsection (1), a court may make any order in respect of costs, including on a solicitor-and-client basis, in accordance with the rules of the court.
(10) In addition to any other matter that the court may take into account in making an order as to costs, it may consider the following factors:
(a) the diligence with which the parties have pursued the application;
(b) the inclusion on the certified patent list of a patent that should not have been included under section 4; and
(c) the failure of the first person to keep the patent list up to date in accordance with subsection 4(6). |
b) enjoindre au ministre de vérifier que les extraits produits correspondent fidèlement aux renseignements figurant dans la demande d'avis de conformité.
(8) Tout document produit aux termes du paragraphe (7) est considéré comme confidentiel.
(9) Le tribunal peut, au cours de l'instance relative à la demande visée au paragraphe (1), rendre toute ordonnance relative aux dépens, notamment sur une base avocat-client, conformément à ses règles.
(10) Lorsque le tribunal rend une ordonnance relative aux dépens, il peut tenir compte notamment des facteurs suivants:
a) la diligence des parties à poursuivre la demande;
b) l'inscription, sur la liste de brevets qui fait l'objet d'une attestation, de tout brevet qui n'aurait pas dû y être inclus aux termes de l'article 4;
c) le fait que la première personne n'a pas tenu à jour la liste de brevets conformément au paragraphe 4(6). |
Analysis and Decision
[39] Issue 1
Should the evidence of Dr. Sherman, witness for Apotex, be disregarded for lack of credibility?
AstraZeneca's principal attack on the credibility of Dr. Sherman is based on his evidence that the Apo-Omeprazole product monograph would not refer to co-administration with an antibiotic, i.e. concomitant use, but in fact it turned out that the product monograph did contain such statements. The applicant also attacks Dr. Sherman's credibility because he was not aware of a document produced by Apotex entitled, "Pharmawise" as being literature on gastrointestinal conditions or disease. This document was published before the applicants obtained their patent.
[40] In order to assess Dr. Sherman's credibility with respect to the contents of the product monograph, it is necessary to review his evidence on cross-examination. The following excerpts of Dr. Sherman's cross-examination appear at pages 360 to 362 of the applicants' application record:
Q. And since you're familiar with the product monograph, and I know Mr. Radomski is reflecting on whether the entire document will be produced, can you at least confirm that there would be in the Apo-omeprazole capsule draft monograph a section that deals with information for the patient?
A. That may be. There probably is, yes, yes.
Q. Why are you hesitating? I thought that you were very familiar with the contents.
A. It's not the case with all drugs . I can't recall whether or not there is in this case.
Q. If you can't recall, I'm having some difficulty in you being so confident otherwise in looking at the pages that are attached to your affidavit that they're accurate. How can you be so confident about one matter and . . .
A. Because that's not the product monograph, that would be labeling information. Labeling information would certainly not have in it anything to do with indications beyond what the product is approved for. There may be an information for the patient leaflet as part of the labeling.
Q. Doesn't your draft product monograph for your omeprazole magnesium tablets include a section dealing with information for the patient?
A. I'm not certain. I don't have in front of me the whole thing. It may. I don't know if it does or not.
MR. RADOMSKI: It does.
THE WITNESS: Okay, but that wouldn't have anything in terms of use or indications beyond what is here.
MR. GAIKIS:
Q. I'm not asking you that, and again you're volunteering. I asked you whether the monograph that you provided an extract of, whether elsewhere in that monograph there would be a section that deals with information for the patent, and I think now you're saying there likely would be.
A. I don't recall specifically whether or not there was, but according to what Mr. Radomski indicates there is such a section.
MR. RADOMSKI: I believe there is.
Further, at pages 403 to 404 of the applicants' record, Dr. Sherman's cross-examination transcript reads:
Q. Insofar as the patient information section of the product monograph, assuming that your monograph for Apo-omeprazole capsules will contain a section Information For The Patient, will such a section be worded similarly to that section that you currently have in the draft monograph for your Apo-omeprazole tablets being the omeprazole magnesium tablets?
MR. RADOMSKI: Don't answer that. The section reads however it reads.
THE WITNESS: There will be nothing in it that has any suggestion that it should be used with antibiotics.
MR. GAIKIS:
Q. I think you should, if you're familiar with the contents, you should be able to advise me as to whether those two monographs will have similar language in respect of the information for the patient. That was the extent of my question.
MR. RADOMSKI: That's an irrelevant question because the monograph has what it has in it.
THE WITNESS: Whether or not it's similar is irrelevant. What is relevant is that it will have nothing in it that makes any suggestion of concomitant use with an antibiotic.
At pages 399 to 400 of the applicants' record, the transcript states:
Q. Am I correct that there would be a section dealing with pharmacology elsewhere in this monograph?
A. There will be other sections, but there's absolutely nothing that talks about the use in conjunction with antibiotics. The uses are limited, the approved uses are limited to what's on page 5. What was given to you was the pages that set out the use, the uses for which we seek approval by way of the indications and the dosage administration. That's all that would be relevant to whether or not the product will be sold for use or promoted for use, for any use that is covered by the patent and that's what you were given.
[41] With respect to the lack of knowledge of the Pharmawise document, Dr. Sherman's testimony on cross-examination included the following at pages 364 to 366 of the applicants' application record:
Q. Tell me about Apotex producing literature that discusses various diseases and conditions. Am I correct that Apotex does prepare and distribute such literature?
A. I don't know. We do have a promotions department that provides literature for pharmacies for certain purposes. I can't tell you that I'm familiar with the details of that.
Q. So you don't know what literature Apotex provides with respect to various diseases or conditions.
A. Specifically, no. We do provide materials that are of assistance to pharmacists in different ways, but none of it would be in any way relevant. If you want an assurance that we won't produce anything that gives any suggestion of use of antibiotics and omeprazole together, I'll give you that assurance. You have my undertaking.
Q. I didn't ask - again . . .
A. Presumably your questions have some relevance to the subject matter. You have my undertaking that Apotex will not so long as this patent is in force produce anything for the pharmacists that has any mention of the concomitant administration of antibiotics and omeprazole.
Q. I didn't ask that, and again I think you're simply volunteering evidence and, with respect, I think it's inappropriate. I'm simply asking you factual matters and let me continue. Given your acknowledged lack of knowledge with respect to the literature that I referred to, I'd like you to . . .
A. You're assuming there is such literature. I'm telling you that we do give various aids - we do help pharmacists in different ways. We have care days where we provide nurses in stores for certain things, checking blood pressure and the like, but I can't tell you I'm familiar with everything Apotex does in the way of services to pharmacists, so I can't tell you that there is or isn't any literature relating to pharmaceuticals, but there certainly is nothing that in any way is relevant to the claims of this patent.
Q. We would like to ascertain that for ourselves.
A. Well, go ahead.
Q. In that regard, I'd like you to produce a copy of literature . . .
A. You want to go on a fishing expedition.
Q. . . . a copy of literature that Apotex has produced dealing with gastrointestinal conditions or diseases.
A. I can tell you that there is no literature that in any way touches on anything that is covered by that patent and I will double-check that on Monday and if there is any basis to believe that that is in any way incorrect, what I'm sure will not be the case, we'll inform you.
Q. Are you telling me under oath that Apotex has no literature dealing with any gastrointestinal conditions?
A. I didn't say that.
Q. I know you didn't say that and that was my question and I'd like an answer to that question.
A. That touches on gastrointestinal conditions?
Q. Yes.
A. I can't say that categorically, but it wouldn't be relevant.
[42] I am not satisfied that the evidence outlined above, nor AstraZeneca's other allegations justify a conclusion that Dr. Sherman is not credible as a witness. Firstly, when you read the answers of Dr. Sherman, it is obvious that he is responding to questions about the "Information for the Patient" section of the product monograph and not the entire monograph. I would further note that the impugned language is contained in the "Pharmacology" section of the product monograph. Secondly, in relation to the Pharmawise publication, Dr. Sherman did not categorically state that Apotex did not have any literature dealing with any gastrointestinal conditions. In conclusion on this point, I am not prepared to find Dr. Sherman to be not credible based on a comparison of his cross-examination to the statements contained in the product monograph or his knowledge of Apotex literature.
[43] Issue 2
Was Apotex's NOA sufficient?
Apotex's NOA, dated November 16, 2001, reads in part as follows:
We have submitted to the minister a New Drug Submission for Apo-Omeprazole capsules containing omeprazole in 20 mg strength for oral administration.
With respect to patent 2133762, we allege that 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 us of the said capsules.
The legal and factual basis for this allegation is as follows:
Claims 1 to 34 inclusive and 41 to 57 inclusive relate only to compositions which comprise a combination of a histamine-H2 blocker or a proton pump inhibitor and an antibacterial compound.
Our product will not infringe any of these claims by reason of the fact that our product is not a combination product, but comprises only omeprazole as the sole active ingredient.
Claims 35 to 40 inclusive and 58 to 65 inclusive relate only to use of a histamine-H2 blocker or an antibacterial compound and an antibacterial compound for the treatment of gastritis and peptic ulcer caused by Heliobacter pylori.
Our product will not infringe these claims, because:
i) our product is not a combination product, so that its use would not infringe any of these claims; and
ii) we are not seeking approval for such use, and no such use will be included in our product monograph. Furthermore, our product monograph will make no mention whatsoever of Heliobacter pylori and will be limited to use for reduction of gastric acid secretion.
Claims 66 and 67 relate only to use of omeprazole and an antibiotic for the treatment of gastritis and peptic ulcer.
Our product will not infringe these claims because:
i) our product is not a combination product (i.e. contains no antibiotic) so that its use would not infringe the claims, and
ii) we are not seeking approval for such use and no such use will be included in our product monograph.
The remaining claims relate only to use for increasing the bioavailability of an antibacterial compound.
Our product will not infringe because we are not seeking approval for such use and no such use will be included in our product monograph.
[44] AstraZeneca, in its memorandum, lists four reasons why Apotex's NOA was "fatally deficient". These reasons are that Apotex: (1) has failed to assert that its products will not be used by patients for the claimed uses; (2) failed to address at all the uses claimed in some of the claims; (3) is not permitted to expand the legal and actual basis for the NOA; and (4) relies on an improper construction of the claims.
[45] What constitutes a sufficient allegation of non-infringement was considered by the Federal Court of Appeal in AB Hassle v. Canada (Minister of National Health and Welfare), [2000] F.C.J. No. 855 (C.A.) (QL) at paragraph 17:
Indeed, this Court has recognized that the detailed statement must be such as to make the patentee fully aware of the grounds for claiming that the issuance of an NOC would not lead to infringement of a listed patent for, otherwise, the patentee would be unable to decide whether or not to initiate a section 6 proceeding. Thus in Bayer AG, supra, at 337-338, Mahoney J.A. stated:
One further matter warrants comment. Section 5(3)(a) of the Regulations requires that the applicant for the NOC provide a detailed statement of the basis in fact and law of his statement of allegation. It seems intended that the patentee be fully aware of the grounds on which the applicant says issuance of a NOC will not lead to infringement of the patent before the patentee decides whether or not to apply to a court for a determination. Such disclosure would define the issues at a very early stage.
Further, at paragraphs 19 and 21:
The detailed statement is not a pleading per se but represents a pivotal step in the process leading up to the issuance of an NOC. By taking that step the second person puts the patentee on notice of the grounds on which he or she considers that the making, constructing, using or selling of the drug will not infringe the second [sic] person's patent rights during the unexpired term of the patent. In theory, this procedure ought to enable the patentee to confidently decide within the 45 day time limit whether to resist the issuance of an NOC. It is to be noted that, subject to business exigencies, the second person had no obligation to make its allegation and provide its detailed statement by an imposed deadline. As much time as the second person deems necessary is available under the scheme of the Regulations.
. . .
In my view, all of these considerations suggest that a second person must do what, in fact, paragraph 5(3)(a) requires, i.e. set forth in the detailed statement "the legal and factual basis" for the paragraph 5(1)(b) allegation and to do so in a sufficiently complete manner as to enable the patentee to assess its course of action in response to the allegation. See Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.), per Strayer J.A. at 216. An examination of the detailed statement in issue is thus required in order to determine whether it measures up to this requirement with respect to the allegation that the '693 and '891 Patents are not valid for obviousness.
[46] A second person's (here, Apotex's) allegation of non-infringement must let the first person patentee (here, AstraZeneca) know the grounds for stating that issuance of an NOC would not lead to infringement. It is my view that, in this case, AstraZeneca knew the grounds of Apotex's allegations in a sufficiently complete manner so as to enable them to decide whether to oppose the issuance of an NOC by the Minister. AstraZeneca led evidence through Mr. Wilton, a licenced pharmacist and AstraZeneca executive, regarding third-party infringement. With respect to addressing all the uses claimed in some of the claims, i.e. composition versus combinations, AstraZeneca raised this issue and alleged that even with that aside and using the proper construction, Apotex's Apo-Omeprazole still infringed the '762 Patent..
[47] AstraZeneca also alleges that Apotex expanded the legal and factual basis for the NOA by leading certain of the evidence provided by Dr. Sherman and Mr. Brown. Justice Muldoon of this Court in Merck Frosst Canada Inc. v. Canada (Minister of Health), [2000] F.C.J. No. 785 (T.D.) (QL), aff'd (2001) 274 N.R. 297, 2001 FCA 192, stated at paragraph 11:
The applicants also take exception to the corporate respondent's seeking refuge in Prof. Ross-Murphy's definition of gel, stating that the definition of a gel was not one of the grounds of non-infringement laid out in the NOA. The struggle surrounding the term "gel", however, was initiated by the applicants, through the first affidavit of Prof. Morris, in order to help disprove Alcon's allegation in its NOA that xanthan gum does not undergo a liquid to gel phase transition in situ. Alcon had, therefore, every right to adduce Prof. Ross-Murphy's competing definition of "gel" as a defence. To conclude otherwise would be to strip a respondent in a section 5 proceeding of any ability to defend itself. It would also force a respondent first, to prophesy down which path an applicant will march in construing the patent so as to attack the NOA and second, predict what scientific evidence it will need to guard the ramparts. Such a process, however, would be inefficient and serve no purpose. . . .
[48] I have reviewed the evidence of Dr. Sherman and I am of the view that he is responding to the evidence of AstraZeneca's witness, Mr. Wilton, regarding possible promotions, marketing documents and Apotex's website. Similarly, the evidence of Mr. Brown was tendered by Apotex in response to issues raised by AstraZeneca, namely, the interpretation of certain sentences in the product monograph and the importance of its various sections. In my opinion, this is evidence that, according to the law as outlined by Muldoon J. in Merck Frosst, supra, Apotex is allowed to raise in response to matters raised by AstraZeneca. It does not constitute an expansion of the legal and factual basis of the NOA.
[49] I will deal with AstraZeneca's argument regarding the proper construction of the '762 Patent under the next heading as I see this point addressing substantive infringement, not simply sufficiency of the NOA.
[50] In conclusion on this point, I am not of the opinion that the NOA is "fatally deficient", to use AstraZeneca's term. I am of the view that the NOA is sufficient.
[51] Issue 3
Is Apotex's allegation of non-infringement justified on the specific legal and factual basis set out in the NOA?
AstraZeneca argues that Apotex's allegation of non-infringement is not justified because the product monograph filed by Apotex contains the following references (at page 1):
There is an increase in bioavailability (AUC) and half life of omeprazole, and bioavailability (AUC) and CMAX of clarithromycin, during concomitant administration in healthy volunteers.
At page 5 of the Apo-Omeprazole product monograph:
APO-OMEPRAZOLE (omeprazole) is indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as:
1. duodenal ulcer;
2. gastric ulcer;
3. reflux esophagitis;
4. symptomatic gastroesophageal reflux disease (GERD);
5. Zollinger-Ellison Syndrome (pathological hypersecretory conditions);
6. NSAID-associated gastric and duodenal ulcers.
At page 16:
Read this leaflet carefully. It contains general points about APO-OMEPRAZOLE (omeprazole) and should add to more specific advice from your doctor or pharmacist.
At page 17:
. . .APO-OMEPRAZOLE works by reducing the amount of acid made in your stomach. This helps in treating acid-related and bacteria-related stomach problems.
And at page 25:
Clarithromycin 500 mg three times daily and omeprazole 40 mg once daily were studied following concomitant administration in fasting healthy adult subjects. When clarithromycin was administered with omeprazole, increases in omeprazole half-life and AUC0-24 were observed. For all subjects combined, the mean omeprazole AUC0-24 was 89% greater and the harmonic mean for omeprazole t1/2 was 34% greater when omeprazole was administered with clarithromycin than when omeprazole was administered alone. When clarithromycin was administered with omeprazole, the steady state CMAX, CMIN and AUC0-8 of clarithromycin were increased by 10%, 27% and 15%, respectively, over values achieved when clarithromycin was administered with placebo.
[52] AstraZeneca contends that the presence of these statements in the product monograph show an intention on Apotex's part to use Apo-Omeprazole in combination with a form of antibiotic or antibacterial compound to increase the efficacy of the treatment of certain stomach conditions, thereby infringing the '762 Patent. AstraZeneca argues that the whole product monograph is subject to approval by Health Canada. Once the product monograph is approved, AstraZeneca argues that Apotex will be able to promote uses not contained in the "Indication and Clinical Use" section, thereby leading to infringement of the '762 Patent.
[53] What is at issue in this case is whether Apotex intends to make use of Apo-Omeprazole for a use that is covered by AstraZeneca's '762 Patent.
[54] A product monograph consists of various sections including "Actions and Clinical Pharmacology", "Indications and Clinical Use", "Information for the Patient" and "Pharmacology". None of the statements impugned by AstraZeneca are contained in the "Indications and Clinical Use" section of the Apo-Omeprazle product monograph.
[55] Apotex called as an expert witness, Kenneth Brown, who holds a B.Sc. in pharmacy, practised as a community pharmacy manager and was employed as a Government of Manitoba pharmaceutical consultant. Mr. Brown states in his affidavit:
From 1973 to 1997, I was a pharmaceutical consultant, Manitoba Health, Government of Manitoba, responsible for effective and efficient drug program design, policy and management relating to virtually all pharmaceutical matters for the Government of Manitoba. In this position, I was responsible for all drug formulary, pricing and policy matters and all federal and provincial policy related matters. In this capacity, I had extensive interaction with the federal government regarding federal approval of drugs.
(Affidavit of Kenneth Brown, applicants' supplementary application record, volume I, page 6)
[56] Also, in his position with the Manitoba Government, Mr. Brown reviewed thousands of pharmaceutical submissions and many product monographs. I accept Mr. Brown as an expert witness in the area of the nature, content and purpose of product monographs.
[57] In his affidavit sworn to August 19, 2002, Mr. Brown stated his mandate as follows:
6. I have been asked by counsel to the Respondent, Apotex Inc. ("Apotex"), to describe the nature, content and purpose of a product monograph. I have also been asked whether the references in Apotex' Product Monograph for Apo-Omeprazole capsules to "concomitant administration" of omeprazole with an antibiotic or antibacterial compound, and to "increases in bioavailability" of antibiotics or antibacterial compounds, are contradictory to Apotex' statements that it will not seek approval for, and will not promote, market or sell its apo-Omeprazole capsules for use in combination with any antibiotic or antibiotic compound, or for use in increasing the bioavailablity of any antibiotic or antibiotic compound.
[58] Mr. Brown testified in essence, that the "Indications and Clinical Uses" section of the Apo-Omeprazole product monograph indicates the approved uses of Apotex's product and that it is only these uses that Apotex can lawfully promote.
[59] At pages 356 to 361 of the applicants' supplementary application record, volume II, Mr. Brown stated as follows during cross-examination by AstraZeneca's counsel:
MR. GAIKIS:
Q. My question is designed to get your understanding of this topic that we are talking about - - that is, that the product monograph is the standard against which all promotion and advertising of the drug can be compared.
My question is as simple as follows: Can Apotex, after it gets approval for the product monograph we are talking about, announce the availability in the marketplace of its Apo-Omeprzaole capsules and include in that announcement some or all of the language that we find in Apotex' monograph under the headings of "Pharmacology" and "Pharmacokinetics"?
A. The answer is that, if they were promoting or advertising the product for anything other than what is stated in the approved clinical indications, that would be against the standard as designated by Health Canada.
In other words, the statements that you were referring to at page 1 of the draft product monograph could not be made by Apotex as being approved clinical indications because they are not.
Q. I did not ask that. I just asked whether Apotex could lawfully distribute a flyer announcing the availability of its Apo-Omeprazole capsules and include in that promotional material some or all of the statements that we see in its monograph under the headings "Pharmacokinetics" and "Pharmacology".
MR BRODKIN: He answered that question.
- - - OBJECTION
MR. GAIKIS:
Q. To the extent that you introduced a limitation about indications, do you see that limitation anywhere in the Guidelines here, as to promotion and advertising?
A. Can I take a minute and go back to some of the documents that we have referred to already?
Q. Yes.
A. We mentioned earlier that there is a standard for the promotion and advertising which Health Canada requires as a measurement. That standard, as I have said before and I will say again, is that they cannot promote their product for more than what the approved indications are. Yes, they can provide a complete product monograph to whomever wishes to see it and review it. To promote or advertise that product they can do no more than what is in the approved clinical indications.
Q. Hence my question: Could Apotex advertise to physicians and pharmacists - - can they put in an advertisement the sentence that I read out from page 1 of the monograph that refers to the increase of bioavailability of clarithromycin with the concomitant administration of omeprazole? Could they put that statement in promotional or advertising material?
MR. BRODKIN: He has answered that question twice now.
MR. GAIKIS: I don't believe he has.
MR. BRODKIN: He has, Mr. Gaikis. He has told you on two separate occasions now that Apotex can promote only what is indicated in the clinical uses.
MR. GAIKIS:
Q. Mr. Brodkin wants us to assume that the implication of your answer is that Apotex is not able to set out the information in its product monograph in its promotional material. Do you agree with that?
A. I think you are now asking a different question.
Q. I don't think so. My question was quite simple. Can Apotex, if it gets this product monograph approved, have the particular sentence we have been referring to included in its promotional material?
A. No.
Q. Why do you say that?
A. Because it is not an approved indication.
MR. BRODKIN: THAT IS THE THIRD TIME, Mr. Gaikis. You will not ask it a fourth time. Repeatedly asking it because you are getting answers that are not what you want does not justify a basis to continue asking it.
MR. GAIKIS:
Q. You tell me with reference to Apotex' draft product monograph what information they will be able to promote after they get approval and which they will not.
If we start at page 1, I take it you are saying that none of the information on page 1 can be advertised?
A. Let's do it the simplest way. Let's go to the page that they can only promote and advertise, and that is on page 5, "Indications and Clinical Use". Assuming that this draft product monograph is what will ultimately be approved as a final product monograph with the issuance of a Notice of Compliance, the items under "Indications and Clinical Use" from 1 to 6 are the only indications for use that Apotex would be legally and lawfully allowed to promote and advertise.
Q. I did not ask you what indications they could promote. I asked you what portions of the monograph they could promote, and you are saying - -
A. That is the section that they can promote.
Q. It is your opinion that Apotex can only promote and advertise the information found under the heading "Indications and Clinical Use" in its monograph and that Apotex cannot advertise or promote other information in its monograph?
A. Yes.
[60] It is obvious from this exchange that Mr. Brown is of the opinion that the approved uses of a product are contained in the "Indications and Clinical Uses" section of its product monograph and that the uses contained therein are the only uses that can lawfully be promoted.
[61] Mr. Brown, in paragraphs 9 to 12 of his affidavit sworn to August 19, 2002 stated his conclusions as follows:
9. In my expert opinion, in Canada, a product monograph is a Health Canada document prepared in a specified form for the specific purpose of disseminating specific information to health professionals. In particular, a product monograph contains two types of information: scientific facts regarding the drug and the information regarding the brand of the drug which has been approved for use in Canada. The form and content of the product monograph is dictated by Health Canada. The finished document is issued by Health Canada in conjunction with the issuance of the Notice of Compliance for the same drug.
10. I am informed by Ms. Ildiko Mehes, one of the counsel to Apotex Inc. ("Apotex"), and do verily believe, that counsel to AstraZeneca Ab and AstraZeneca Canada Inc. (collectively "Astra") has argued in an interlocutory motion that the reference to "concomitant administration" in the above excerpts is evidence that Apotex will seek to promote, market or sell Apo-Omeprazole together with an antibiotic or antibacterial compound, and that Apotex will thereby infringe the claims of Canadian Patent No. 2,133,762 (the "'762 Patent").
11. I am also informed by Ms. Mehes, and do verily believe, that counsel to Astra has also argued in the same interlocutory motion that the reference to "increases in bioavailability" in the last paragraph of the above excerpt is evidence that Apotex will seek to promote, market or sell Apo-Omeprazole for increasing the bioavailability of antibiotics or antibacterial compounds, and that Apotex will thereby infringe the claims of the '762 Patent.
12. My considered opinion, as set out in detail below, is that the position taken by Astra is incorrect. The references to "concomitant administration" and "increased bioavailability" in Apotex' Product Monograph for Apo-Omeprazole capsules are factual scientific statements regarding the drug omeprazole, which are required to be included by Health Canada. These statements do not pertain to the permitted and intended uses of the brand for which approval is being sought, namely, Apo-Omeprazole capsules and, therefore, do not indicate that Apo-Omeprazole capsules will be promoted, sold or marketed together with an antibiotic or antibacterial compound, or for use in increasing the bioavailability of an antibiotic or antibacterial compound, or that Apo-Omeprazole will be approved by Health Canada for such promotion, sale, marketing or use.
[62] AstraZeneca tendered the evidence of Mr. Stephen Wilton, executive director of business development at AstraZeneca Inc., who holds a B.Sc. in pharmacy and an M.B.A. degree. The majority of Mr. Wilton's career has involved the business side of the pharmaceutical industry. Mr. Wilton's affidavit dealt with matters including the following:
1. what Apotex would promote if the product monograph was approved;
2. Apotex's web page;
3. the construction of the '762 Patent;
4. Apotex's sale of antibacterial compounds;
5. the influencing of patients' usage of the product;
6. promotion of the product to pharmacists;
7. Apotex being in a position to influence pharmacists to dispense the product.
[63] On cross-examination, it was obvious that Mr. Wilton had little personal knowledge of many of the issues his affidavit addressed. Mr. Wilton did not carry out any surveys or question anyone in order to establish a foundation for his statements.
[64] AstraZenecas also tendered the evidence of Dr. Karen Burke, vice-president of regulatory affairs with AstraZeneca Canada Inc., who holds a Ph.D. in chemistry from McMaster University. AstraZeneca opted to offer Dr. Burke as a witness instead of independent experts with whom they consulted. On cross-examination, Dr. Burke testified as follows (applicants' supplementary application record, volume II, page 414):
Q. I presume then the decision was made that some inquiries should be made of outside experts to ascertain whether they could give appropriate evidence, at least from the Applicants' perspective, correct?
A. Whether they could give appropriate evidence, yes.
Q. My question was, at least from the Applicant's perspective, correct?
A. Correct.
Q. That process then went forward and, ultimately having spoken to outside experts, you're telling me that the decision was made not to use such outside experts, correct?
A. That is correct.
Dr. Burke is also one of the individuals who instructs outside counsel in connection with this litigation.
[65] Dr. Burke's evidence related to the approval process for product monographs, what exactly is approved when a product monograph is approved by Health Canada, the regulatory scheme for obtaining approval to sell a drug in Canada, the Compendium of Pharmaceuticals and Specialties, the guidelines used in developing product monographs, comments on Dr. Brown's evidence and her interpretation of the impugned references to "concomitant administration" and "increase in bioavailability" in the Apo-Omeprazole product monograph.
[66] When cross-examined on paragraph 8 of her December 11, 2002 affidavit concerning what is actually approved when a product monograph is approved by Health Canada, Dr. Burke's evidence was as follows (applicants' supplementary application record, volume II, pages 440 to 441):
Q. You say in your affidavit beginning at the fourth line:
Division 8 did not make reference to a product monograph. However, the aforesaid statement would be understood to include the entire contents of a product monograph.
What do you base that on? First let me ask: It would be understood by whom to be the entire contents of the product monograph? I presume you mean by healthcare professionals. That is what you say on the next line. Correct?
A. By everyone.
Q. By everyone. By me, for example?
A. Anyone who understands the Food and Drugs Act would understand what that statement is.
Q. You would include, for example, healthcare professionals?
A. Yes.
Q. Have you surveyed any healthcare professionals to determine if they share that understanding?
A. No.
[67] This testimony of Dr. Burke, if accepted, would support AstraZeneca's position that once the entire product monograph is approved, then Apotex could promote not only the uses indicated in the "Indications and Clinical Use" section, but also other uses mentioned elsewhere in the product monograph.
[68] In this case, I prefer the evidence of Kenneth Brown who testified that the only uses that would be approved are the uses indicated in the "Indications and Clinical Use" section. This would appear to be logical as the "Indications and Clinical Use" section is a particular section of the monograph which deals with the indications proposed for the drug. I do not agree that by making references to "increase in bioavailability and concomitant administration" in the "Actions and Clinical Pharmacology" section of the monograph and in the "Pharmacology" (Pharmacokinetics) section of the product monograph at pages 1 and 25, Apotex is saying that it will make use of Apo-Omeprazole in this manner. It follows therefore, that I find no merit in AstraZeneca's argument that Apotex is relying on a patent construction which is at odds with the clear language of the patent itself. I find that this is not the case. Even if I accept that the '762 Patent refers to the use of omeprazole and an antibiotic in combination, approval is not sought by Apotex for this use.
[69] AstraZeneca submits that the use of the words "such as" in line 2 of the "Indications and Clinical Use" section indicates that the section is not limiting and this indicates that other portions of the monograph are relevant. I do not agree with this proposition.
[70] AstraZeneca also submits that the statement at page 17 of the product monograph that "Apo-Omeprazole works by reducing the amount of acid made in your stomach. This helps in treating acid-related and bacteria-related stomach problems" is an obvious reference to Heliobacter pylori, which Apotex's NOA stated would not be mentioned in its product monograph. This was in relation to claims 35 to 40 and 58 to 65 of the '762 Patent. There is no evidence to support this allegation. I do not take the Pharmawise document as supporting this allegation.
[71] In evaluating Dr. Burke's testimony, I note the following from paragraph 2 of her affidavit, which reads:
I am the Vice-President of Regulatory Affairs of AstraZeneca Canada Inc. I have a Ph.D. in chemistry from McMaster University. I have been employed by AstraZeneca Canada Inc. and its predecessor Astra Pharma Inc. (collectively "AstraZeneca") in the area of regulatory affairs since 1991. Since 1991, I have been extensively involved in the preparation and approval of many pharmaceutical product monographs. Consequently, I am familiar with the law and practice relating to the approval of new drug products in Canada, including how to obtain an approvable drug product monograph. I have personal knowledge of the matters herein unless indicated otherwise.
[72] On cross-examination, Dr. Burke commented that she did not have any experience with respect to the process for obtaining approval for Apotex's product monograph as her experience was exclusively with the process used by AstraZeneca (questions 164 to 187 at pages 444 to 450 of the applicants' supplementary application record, volume II). I also note from reading Dr. Burke's affidavit that certain statements relate to legal issues, i.e. what evidence Apotex should present (paragraph 45 of her December 11, 2002 affidavit). There is another problem with Dr. Burke's evidence in that she is one of the persons who is instructing counsel on the carriage of this case. I would also note that Dr. Burke is an employee of one of the applicants, and is therefore an interested person in the outcome of these proceedings. Based on the above, I would give very little weight to the testimony of Dr. Burke and where it conflicts with the evidence of Mr. Brown, I prefer the evidence of Mr. Brown.
[73] Counsel for AstraZeneca submits that in the case of a "use" patent, such as the "762 Patent at issue here, the purpose of the NOC Regulations is to prevent infringement by patients. Therefore, on the basis of the reasoning in Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) (1995), 61 C.P.R. (3d) 190 (F.C.T.D), rev'd on other grounds (1996), 206 N.R. 1 (F.C.A.) leave to appeal to the S.C.C. dismissed, [1996] S.C.C.A. No. 578 (QL), AstraZeneca argues that Apotex's allegation of non-infringement is unjustified. In Zeneca, supra, however, Apotex admitted that it sought approval of its product for congestive heart failure, a patented use. That is not the case here, as Apotex has steadfastly maintained that it is not seeking approval for uses that would infringe AstraZeneca's '762 Patent.
[74] AstraZeneca can only succeed on the facts of this case, if the references to concomitant use, increases in bioavailability and the other impugned product monograph references (pages 16 and 17) establish that Apotex is seeking approval to make use of Apo-Omeprazole concomitantly with antibiotic substances to increase bioavailability, that is to use Apo-Omeprazole with an antibiotic such as clarithromycin to achieve better treatment.
[75] AstraZeneca must establish on a balance of probabilities that Apotex's NOA is not justified on the legal and factual basis relied on. After having considered the matter, I am not satisfied that AstraZeneca has discharged this burden. I am of the view that the uses sought to be approved by Apotex are limited to those contained in the "Indications and Uses" section of the product monograph. AstraZeneca's arguments cannot succeed. After considering the evidence of Mr. Brown and Dr. Sherman, I cannot conclude that the references to concomitant use and increases in bioavailablity in the "Actions and Clinical Pharmacology", the "Pharmacology (Pharmacokinetics)" or the "Information for the Patient" sections indicate that Apotex is seeking approval for these uses.
[76] AstraZeneca did not pursue the argument that Apotex would induce or procure others to infringe the '762 Patent, therefore I need not deal with this issue. Nor is it necessary for me to assess Apotex's argument that the references in the Apo-Omeprazole product monograph to merely "omeprazole" should be attributed to the drug and not its brand. Whether such references in the "Indications and Clinical Use" section would ground infringement is left to be decided another day.
[77] The Minister did not take part in the proceedings.
[78] The patent listing issue will be dealt with separately.
Conclusion
[79] As I am not convinced on a balance of probabilities that issuing the NOC would result in an infringement of the '762 Patent, I cannot allow the application to prohibit the Minister from issuing an NOC. The application is dismissed with costs to Apotex.
ORDER
[80] IT IS ORDERED that:
1. The application is dismissed.
2. Costs shall be awarded to Apotex.
"John A. O'Keefe"
J.F.C.
Ottawa, Ontario
March 2, 2004
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-2311-01
STYLE OF CAUSE: ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: November 3 to 5, 2003
REASONS FOR ORDER AND ORDER: O'Keefe J.
APPEARANCES:
Gunars Gaikis
Yoon Kang
For the Applicants
H. B. Radomski
Andrew Brodkin
Ildiko Mehes
For the Respondent,
Apotex Inc.
Rick Woyiwada
For the Respondent,
Minister of Health
SOLICITORS OF RECORD:
SMART & BIGGAR
Toronto, Ontario
For the Applicants
GOODMANS LLP
Toronto, Ontario
For the Respondent,
Apotex Inc.
Morris Rosenberg
Deputy Attorney General of Canada
For the Respondent,
Minister of Health