AstraZeneca AB v. Apotex Inc.

AstraZeneca AB v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2004-03-02
Neutral citation
2004 FC 313
File numbers
T-2311-01
Notes
Digest
Decision Content
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:
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;
(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,
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,
(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:
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:
(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.
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.
(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
(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;
(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 tha