AB Hassle v. Canada (Minister of National Health and Welfare) (T.D.) [2002] 3 F.C. 221
Date: 20011116
Docket: T-2016-99
Neutral citation: 2001 FCT 1264
Toronto, Ontario, this 16th day of November, 2001
PRESENT: THE HONOURABLE MR. JUSTICE JOHN A. O'KEEFE
BETWEEN:
AB HASSLE and ASTRAZENECA CANADA INC.
Applicants
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE and
APOTEX INC.
Respondents
O'KEEFE J.
[1] This is an application made under section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended, for an Order prohibiting the Minister of National Health and Welfare from issuing a Notice of Compliance to Apotex Inc. in respect of omeprazole capsules in various dosage strengths for oral administration until after the expiration of Canadian Patent 2,025,668.
Background Facts
[2] The applicant, AB Hassle is the owner of Canadian Patent No. 2,025,668 ("‘668"), which is titled "Use of Omeprazole as an Anti-Microbial Agent".
[3] The applicant, AstraZeneca Canada Inc. ("Astra") is a Canadian company which is involved in the manufacture, marketing and sale of a variety of pharmaceutical products. AB Hassle and Astra are related companies.
[4] The respondent, Apotex Inc. ("Apotex") is a Canadian generic pharmaceutical manufacturer that seeks the issuance of a Notice of Compliance ("NOC") from the Minister of National Health and Welfare (the "Minister") for the manufacturing and selling of omeprazole.
[5] The respondent Minister has jurisdiction to issue an NOC, where appropriate, when an application has been made and the Patented Medicines (Notice of Compliance) Regulations, supra ("NOC Regulations") have been complied with.
[6] The ‘668 patent contains claims relating to the use of omeprazole in the treatment of infectious diseases due to bacteria of the genus Campylobacter. The claims of the ‘668 patent state:
1. Use of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl) -sulfinyl -1H-benzimidazole or a pharmaceutically acceptable salt thereof for the manufacture of a medicament for the treatment of Campylobacter infections.
2. Use of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl] -sulfinyl]-1H-benzimidazole or a pharmaceutically acceptable salt thereof for the treatment of Campylobacter infections.
3. A pharmaceutical preparation for use in the treatment of Campylobacter infections wherein the active ingredient is 5-methoxy-2- [[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-sulfinyl] -1H-benzimidazole or a pharmaceutically acceptable salt thereof.
[7] The applicants and Apotex are in agreement that for this proceeding, the Court should read the chemical nomenclature that appears in claims 1 through 3, namely "5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-sulfinyl]-1H-benzimidazole", as though it read "omeprazole". The parties further agree that Campylobacter and H.pylori are two synonymous scientific names for the types of infection referred to in this patent.
[8] The Notice of Allegation ("NOA") which gave rise to this proceeding stated in part:
With respect to patent 2025668, 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 capsules for oral administration containing omeprazole in strengths 10 mg, 20 mg and 40 mg.
The legal and factual basis for the aforesaid allegation is as follows:
The claims of this patent relate to the use and treatment of Campylobacter infections. Our product will not be made, used or sold for the treatment of Campylobacter infections and, more particularly, we are not seeking approval for such use and no such use will be included in our product monograph.
[9] The NOA was received by Astra in a letter from Apotex dated October 4, 1999.
[10] The applicants contend that it is not fatal to this application if they do not successfully demonstrate on a balance of probabilities, that the granting of an NOC will result in infringement of the ‘668 patent by Apotex. The applicants submit that they are only required to demonstrate, on a balance of probabilities, that there will be infringement by anyone as a result of the issuance of an NOC to Apotex. The viability of this alternative argument will turn on the interpretation of subparagraph 5(1)(b)(iv) of the NOC Regulations.
Applicant's Submissions
[11] In the pleadings, the applicants argued that Apotex has not complied with the requirements of the NOC Regulations which are a prerequisite to the making of an allegation. The applicants took issue as to whether Apotex had a New Drug Submission ("NDS") pending as of the relevant date, and whether this proceeding was moot. However, the applicants decided against arguing this issue at the hearing, asserting that the Trial Division was bound to assume that the facts in the NOA were true. The applicants would not expressly remove this argument from their pleadings as they expressed a desire to reserve a right to argue this point at the Appeal Division. As this argument was not advanced before this Court, it will not be discussed further in this judgment.
[12] The applicants submit that the NOA issued by Apotex was not justified on the factual and legal basis relied upon. The issues raised by the applicants in this regard can be summarized as:
(a) Does the alleged factual basis justify the conclusion of non-infringement;
(b) Will there be infringement of the ‘668 patent;
(c) Will Apotex itself directly infringe the ‘668 patent; and
(d) Will Apotex induce or procure infringement of the ‘668 patent?
[13] The applicants submit that Apotex is limited, factually and legally, to what it has said in the NOA.
[14] The applicants contend that the specific basis asserted by Apotex, namely that it is not seeking approval for its product to be used for the treatment of Campylobacter, even if true, does not justify the assertion of non-infringement. Therefore, the applicants submit that the specific basis relied on by Apotex is not supported or justified in fact and law on the broader assertion of non-infringement.
[15] Counsel for the applicants contend that the case turns on evidence that patients will be using Apotex's product for the treatment of Campylobacter infections if an NOC is issued.
[16] The applicants submit that the Apotex NOA specifically acknowledges the relevance of third party infringements by referring to what Apotex will be seeking approval for. The applicants submit that in so alleging, the respondent has cast the question of infringement generally by effectively saying that there would be no infringement by anyone as a result of Apotex receiving an NOC.
[17] The applicants contend that the statement in the Apotex allegation which provides "our product will not be made, used or sold for the treatment of Campylobacter infections" has no bearing on whether there in fact will be infringement in the marketplace should Apotex get marketing approval.
[18] The applicants refer to claim 2 of the patent, stating that Apotex as a company cannot suffer from a Campylobacter infection and can never use omeprazole for that treatment. Counsel for the applicants further contend that claim 2 is a typical claim for the use of a medicine, a claim that can only ever be infringed by patients. The applicants rely on this to suggest that the whole scheme of the NOC Regulations necessarily must extend to considering infringement beyond the second person or else the scheme would not make sense.
[19] The applicants submit that if the Court concludes that the NOC Regulations apply in respect of direct and indirect infringements by patients, then the Court does not need to consider the question of inducement. The Court would only need to look at inducement if the Court concludes that to succeed, the applicants must demonstrate that there is infringement by Apotex itself.
Respondent Apotex's Submissions
[20] The respondent, Apotex contends that the allegation is justified and that it complies with subparagraph 5(1)(b)(iv) of the NOC Regulations. The respondent submits that as Apotex was prevented from filing (late) affidavit evidence by the Order of Mr. Justice McKeown, failure to file affidavit evidence should not lead to any adverse inferences.
[21] Apotex contends that the only issue properly before the Court is whether any claim in the ‘668 patent would be infringed "by the making, constructing, using or selling" by Apotex of its omeprazole capsules.
[22] Apotex contends that the seller of an article of commerce which does not itself infringe a patent can only be held liable for the infringing acts of others if it knowingly, actively and directly participates or conspires with such a third party for the purpose of infringing the patent. The respondent contends that a patentee wishing to rely on the doctrine of induced infringement must allege and prove each of the following elements:
(a) that the act of infringement was completed by the direct infringer;
(b) completion of the act of infringement was influenced by the seller, to the point where without said influence, infringement by the buyer would not otherwise take place;
(c) the influence must knowingly be exercised by the seller, such that the seller knows that his influence will result in the completion of the act of infringement.
[23] The applicants agreed that this was the correct three part test to apply for inducement of infringement of a patent.
[24] Apotex submits that the applicants have failed to establish on the evidence that a direct infringement will take place. Apotex further submits that even if there was a direct infringement by a third party, Apotex has not and will not knowingly influence the direct infringer such that Apotex will have induced or procured the infringement. In sum, Apotex contends that there will be no infringement of any claim in the ‘668 patent by Apotex by the making, constructing, using or selling of generic omeprazole capsules.
Respondent Minister's Submissions
[25] The Minister takes no position on whether a prohibition order should issue on the merits. The Minister argued in written submissions that, at least on the ground argued by the applicants, the proceeding is not moot. Since the applicants waived this ground at the hearing, the Minister did not make submissions in the viva voce proceeding.
Issues
[26] I propose to deal with the issues as follows:
1. Have the applicants demonstrated on the evidence that Apotex will directly infringe the ‘668 patent if an NOC is issued?
2. What is the proper interpretation of subparagraph 5(1)(b)(iv) of the Patented Medicines (Notice of Compliance) Regulations, supra?
3. Have the applicants demonstrated on the evidence that there will be infringement generally of the ‘668 patent?
4. Have the applicants demonstrated on the evidence that Apotex will induce or procure infringement of the ‘668 patent if an NOC is granted?
5. Have the applicants successfully demonstrated that the NOA issued by Apotex was deficient in fact or law?
Law
[27] The relevant definitions from section 2 of the NOC Regulations state:
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2. In these Regulations, "claim for the medicine itself" includes a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents; "claim for the use of the medicine" means a claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof; . . . |
2. Les définitions qui suivent s'appliquent au présent règlement. « revendication pour le médicament en soi » S'entend notamment d'une revendication, dans le brevet, pour le médicament en soi préparé ou produit selon les modes du procédé de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes. « revendication pour l'utilisation du médicament » Revendication pour l'utilisation du médicament aux fins du diagnostic, du traitement, de l'atténuation ou de la prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs symptômes. . . . |
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"medicine" means a substance intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof; "notice of compliance" means a notice issued under section C.08.004 of the Food and Drug Regulations; . . . |
« médicament » Substance destinée à servir ou pouvant servir au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs symptômes. « avis de conformité » Avis délivré au titre de l'article C.08.004 du Règlement sur les aliments et drogues. . . . |
[28] Subsection 5(1) of the NOC Regulations state:
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5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug, (a) state that the person accepts that the notice of compliance will not issue until the patent expires; or (b) allege that (i) the statement made by the first person pursuant to paragraph 4(2)(c) is false, |
5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue: a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet; b) soit une allégation portant que, selon le cas: (i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse, |
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(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. |
(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. |
[29] Section 6 of the NOC Regulations state:
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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. |
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 |
(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: |
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: |
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(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). |
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). |
[30] Subsections 55.2(4) and (5) of the Patent Act, R.S.C., c. P-4 states:
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(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1) or (2) including, without limiting the generality of the foregoing, regulations |
(4) Afin d'empêcher la contrefaçon de brevet d'invention par l'utilisateur, le fabricant, le constructeur ou le vendeur d'une invention brevetée au sens des paragraphes (1) ou (2), le gouverneur en conseil peut prendre des règlements, notamment_: |
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(a) respecting the conditions that must be fulfilled before a notice, certificate, permit or other document concerning any product to which a patent may relate may be issued to a patentee or other person under any Act of Parliament that regulates the manufacture, construction, use or sale of that product, in addition to any conditions provided for by or under that Act; (b) respecting the earliest date on which a notice, certificate, permit or other document referred to in paragraph (a) that is issued or to be issued to a person other than the patentee may take effect and respecting the manner in which that date is to be determined; (c) governing the resolution of disputes between a patentee or former patentee and any person who applies for a notice, certificate, permit or other document referred to in paragraph (a) as to the date on which that notice, certificate, permit or other document may be issued or take effect; (d) conferring rights of action in any court of competent jurisdiction with respect to any disputes referred to in paragraph (c) and respecting the remedies that may be sought in the court, the procedure of the court in the matter and the decisions and orders it may make; and (e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent. |
a) fixant des conditions complémentaires nécessaires à la délivrance, en vertu de lois fédérales régissant l'exploitation, la fabrication, la construction ou la vente de produits sur lesquels porte un brevet, d'avis, de certificats, de permis ou de tout autre titre à quiconque n'est pas le breveté; b) concernant la première date, et la manière de la fixer, à laquelle un titre visé à l'alinéa a) peut être délivré à quelqu'un qui n'est pas le breveté et à laquelle elle peut prendre effet; c) concernant le règlement des litiges entre le breveté, ou l'ancien titulaire du brevet, et le demandeur d'un titre visé à l'alinéa a), quant à la date à laquelle le titre en question peut être délivré ou prendre effet; d) conférant des droits d'action devant tout tribunal compétent concernant les litiges visés à l'alinéa c), les conclusions qui peuvent être recherchées, la procédure devant ce tribunal et les décisions qui peuvent être rendues; e) sur toute autre mesure concernant la délivrance d'un titre visé à l'alinéa a) lorsque celle-ci peut avoir pour effet la contrefaçon de brevet. |
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(5) In the event of any inconsistency or conflict between (a) this section or any regulations made under this section, and (b) any Act of Parliament or any regulations made thereunder, this section or the regulations made under this section shall prevail to the extent of the inconsistency or conflict. |
(5) Une disposition réglementaire prise sous le régime du présent article prévaut sur toute disposition législative ou réglementaire fédérale divergente. |
[31] 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 |
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; |
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(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; (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; |
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) 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; |
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(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, (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. |
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) 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. |
Analysis
[32] Issue 1
Have the applicants demonstrated on the evidence that Apotex will directly infringe the ‘668 patent if an NOC is issued?
The ‘668 patent only reserves exclusive rights to omeprazole that are somehow related to the treatment of Campylobacter infections. The ‘668 patent does not contain any claims for the compound omeprazole itself, and the ‘668 patent does not contain any claims for pharmaceutical preparations or use of omeprazole apart from its use in the treatment Campylobacter infections.
[33] Claim 1 claims the exclusive right to use omeprazole for the manufacture of a medicine for the treatment of Campylobacter infections. In this case, Apotex is seeking approval to use omeprazole to manufacture a medicine. However, the manufacture by Apotex only falls within the exclusive domain of the patent holder if the medicine is being manufactured for the treatment of Campylobacter infections. Apotex alleges in the NOA, which this Court is to presume to be true, that it is not manufacturing the medicine for the treatment of Campylobacter infections. The applicants have not specifically argued that claim 1 was directly infringed by Apotex and, in my view, has not succeeded in entering evidence to successfully establish an infringement of claim 1.
[34] The applicants have conceded that as a corporation, it is impossible for Apotex to use omeprazole to treat a Campylobacter infection. Apotex does not and will not directly infringe claim 2.
[35] The applicants submit that Apotex will directly infringe claim 3, which claims a pharmaceutical preparation of omeprazole for use in the treatment of Campylobacter infections. The applicants submit that claim 3 is a claim for the medicine itself pursuant to the NOC Regulations. The Court notes that claim 3 is limited by the wording "for use in the treatment of Campylobacter infections" such that pharmaceutical preparations of omeprazole that are not for use in the treatment of Campylobacter infections would not infringe the ‘668 patent. This is a significant limitation and departure from an unencumbered claim for the medicine.
[36] For the applicants to successfully show that Apotex infringes claim 3, it is necessary for the applicants to demonstrate on the evidence that Apotex proposes to make and sell such a pharmaceutical preparation for use in the treatment of Campylobacter infections. In my view, the applicants have not shown on the evidence that Apotex intends to make, use or sell the pharmaceutical preparation for use in the treatment of Campylobacter infections.
[37] In SmithKline Beecham Inc. v. Apotex Inc., [1999] F.C.J. No. 533 (F.C.T.D.), McGillis J. stated:
Apotex has alleged in its notice of allegation that its tablets will not infringe the '060 patent. That allegation is presumed to be true, "... except to the extent that the contrary has been shown ..." by SmithKline. [See Merck Frosst Canada Inc. v. Canada (1994), 55 C.P.R. (3d) 302 at 319 (F.C.A.)]. In my opinion, the evidence adduced by SmithKline, including the two experiments, raises no more than a possibility of infringement by Apotex, and does not establish, on a balance of probabilities, that Apotex's allegation of non-infringement is not justified. I am also satisfied that the evidence of Apotex's witness Mr. Petrov does not advance the case for SmithKline, as suggested by its counsel. In my opinion, Mr. Petrov simply confirmed that he agreed with the conclusions of Dr. Apperley and Mr. Ward in the context of the experiments conducted by them.
[38] There have been no allegations by the applicants that any infringements have already taken place. Given the NOA issued by Apotex, in my view the evidence has not established, on a balance of probabilities, that if an NOC is issued, Apotex will directly infringe the ‘668 patent.
[39] For the reasons above, I do not find that Apotex will directly infringe the ‘668 patent if a Notice of Compliance is issued.
[33] Issue 2
What is the proper interpretation of subparagraph 5(1)(b)(iv) of the Patented Medicines (Notice of Compliance) Regulations, supra?
Subsection 5(1) of the NOC Regulations contains the requirements that must be met in order to trigger the application of the regulations. In this case, counsel for the applicants and the respondent submitted different interpretations for the requirement that appears in subparagraph 5(1)(b)(iv). Without repeating the wording that is common to all of paragraph 5(1)(b), subparagraph 5(1)(b)(iv) states:
|
(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. |
(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. 5(1.1) |
[41] At issue, are the words "by that person" and whether they are to be construed as if the paragraph read "no claim . . . would be infringed by that person" or whether the proper interpretation was that "no claim . . . would be infringed by anyone". For further clarity, the two proposed interpretations are placed in full context below.
[42] The applicants propose the following, open-ended, interpretation:
no claim for the medicine itself and no claim for the use of the medicine would be infringed [by anyone] by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
[43] The respondent proposes the following, more narrow, interpretation:
no claim for the medicine itself and no claim for the use of the medicine would be infringed [by that person] by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
[44] Under the interpretation of the applicants, a person applying for an NOC would be required to allege in a NOA that no person in the world would infringe the patent as a result of the making, constructing, using or selling by that person. This interpretation would require the person to allege that no other person would use the medicine, after it has entered the stream of commerce, for any purpose that would infringe the patent. That would be a high burden for the person to meet, particularly since it would require an assertion that extends to possible infringements that may be entirely outside the control of that person.
[34] Under the interpretation put forth by the respondent, the person applying for an NOC would only be required to allege in the NOA that the actions of that person would not infringe the patent. Such an undertaking would necessarily be limited to infringements under the control of that person.
[35] The applicants argue that the more narrow interpretation could not have been the intention in drafting the NOC Regulations because the purpose of the NOC Regulations is to ensure that the Minister does not issue an NOC where doing so could result in an infringement, regardless of the identity of the infringer.
[36] In order to place an interpretation on the words contained in subparagraph 5(i)(b)(iv) of the NOC Regulations, it is necessary to look at the nature of the Regulations. To begin, paragraph 55.2(4)(e) of the Patent Act, supra states:
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(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1) or (2) including, without limiting the generality of the foregoing, regulations . . . (e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent. |
(4) Afin d'empêcher la contrefaçon de brevet d'invention par l'utilisateur, le fabricant, le constructeur ou le vendeur d'une invention brevetée au sens des paragraphes (1) ou (2), le gouverneur en conseil peut prendre des règlements, notamment_: . . . e) sur toute autre mesure concernant la délivrance d'un titre visé à l'alinéa a) lorsque celle-ci peut avoir pour effet la contrefaçon de brevet. |
Subsection 55.2(4) of the Patent Act, supra is the enabling section that provides the Minister's authority to enact the NOC Regulations. The wording common to all of subsection 55.2(4) contains the authorization to make regulations "for preventing infringement of a patent by any person who makes, constructs, uses or sells a patented invention..." (emphasis mine). The wording specific to paragraph (e) includes the phrase "might result directly or indirectly in the infringement of a patent". When read together, it suggests that the authority to make regulations under this section enables the Governor in Council to make regulations that encompass direct and indirect infringements by the second person.
[37] Returning to the subordinate legislation, paragraph 5(1)(b) of the NOC Regulations creates the requirements of a second person to meet in an NOA. Subparagraph 5(1)(b)(iv) requires the second person to allege that "no claim . . . would be infringed by the making, constructing, using or selling by that person". The similarity of sentence construction to the enabling legislation does not go unnoticed. Subsection 55.2(4) enables the Minister to make regulations to prevent infringement by parties who make, construct, use or sell a patented invention, and through subparagraph 5(1)(b)(iv) of the NOC Regulations, the Minister has enacted such a regulation. In my view these phrases when read together indicate the proper interpretation of subparagraph 5(1)(b)(iv).
[38] The authority granted through the enabling legislation, along with my literal interpretation of the provision, lead me to conclude that the infringement referred to in subparagraph 5(1)(b)(iv) of the NOC Regulations is limited to that person, namely the generic pharmaceutical manufacturer that issues the NOA. The second person could, in the appropriate situation directly infringe the patent holders' rights or it could indirectly infringe these rights. The wording of the regulation does not place any limitation on the type of infringement by the second person and the regulation making authority granted by paragraph 55.2(4)(e) of the Patent Act, supra allows for such a regulation to be made. There is no necessity to read any words into the regulation. The regulation covers direct infringement as well as induced or procured infringement by the second person.
[39] The learned Motions Judge, in a motion to dismiss this application, at paragraph 22 of his decision, stated that "the intention of the Regulations is to prohibit the Minister from issuing an NOC where infringement will result following issuance of an NOC, regardless of the identity of the infringer". I take the Motions Judge to mean in cases of induced or procured infringement, the actual direct infringement would come from someone other than the second person.
[40] Having experienced the benefit of full submissions and reviewing the case on its merits, in my view, the intention of the Regulations is to prohibit the Minister from issuing an NOC where an infringement by the second person will result following the issuance of an NOC. As will be discussed below, infringement by third parties, such as use of a medicine by a patient, can be relevant under the NOC Regulations where it can be established that the second person has induced or procured the infringement. However, infringement by anyone is not relevant under the NOC Regulations unless it can be demonstrated that there is a connection to the second person such that the second person is involved in the infringement either directly or indirectly such as through inducement or procurement.
[41] In the interim between the hearing date and the issuance of these Reasons, the applicants submitted a copy of the Reasons for Order of McKeown J. in Procter & Gamble v. Genpharm [2001] F.C.J. No. 1583. It is a Notice of Compliance case where it was alleged, inter alia, that there was a deficient NOA.
[42] In the Procter & Gamble, supra case, claims 17 through 37 of the ‘376 patent are use claims, claiming the use of a medicine. The respondent did not properly allege in the NOA that the respondent would not infringe, whether directly or indirectly, the use claims in the ‘376 patent. On this issue, McKeown J. states at paragraphs 22 and 23:
Accordingly, if there are no detailed facts in the statement about the use or non-use for osteoporosis or nothing about the use that might be made of the GEN-ETIDRONATE for the treatment of osteoporosis whether it be a kit or in the cyclical regime use claim, that is fatal. Thus, if the first person, the brand name pharmaceutical applicant in the prohibition proceedings, can demonstrate an inadequacy in the Notice of Allegation and Detailed Statement, that is sufficient to discharge its legal burden on the application and one need not go beyond that to look at the facts.
. . .
The applicants P & G have discharged their legal burden by demonstrating the Notice of Allegation and detailed statement of facts are fatally flawed in not referring to the use claims as a patent and not referring to the use or treatment as meant for the GEN-ETIDRONATE product that is the subject of this lawsuit.
McKeown J. decided Procter & Gamble, supra on the basis of a deficient NOA
[43] I presume that the applicant submitted the case for the proposition, as stated by McKeown J. in paragraph 18, that "the basic purpose of the NOC Regulations is to prevent patent infringement". For this proposition, McKeown J. cited paragraph 16 of the Reasons of McGillis J. in SmithKline Beecham Pharma Inc. v. Apotex Inc., [1999] F.C.J. No. 1775 (F.C.T.D.).
[44] With one caveat, I agree with that proposition. The cited purpose neither confirms or denies that the relevant infringement is confined to direct or indirect infringements by the second person. I am not persuaded that McKeown J. or McGillis J. as cited above, turned their minds to the issue of whether the NOC Regulations were meant to prevent the issuance of an NOC where it cannot be demonstrated that any claims of a patent would be infringed directly, or indirectly (such as through inducement or procurement) by the second person. To prevent the issuance of an NOC to the second person for potential infringements where no infringement by the second person can be proven on a balance of probabilities, would be to hold the second person to a higher standard than is required in trial proceedings for patent infringement. Surely that would be inconsistent with the summary nature of the NOC proceedings.
[45] Having not been presented with a contrary authority that contemplates this point, I am not persuaded to sway from my interpretation of subparagraph 5(1)(b)(iv) of the NOC Regulations as described above.
[57] It should also be noted that prohibiting the issuance of an NOC is not the only remedy available for the applicants should patent infringement arise. My interpretation above of subparagraph 5(1)(b)(iv) of the NOC Regulations does not leave a first person without remedy or patent protection. In situations where an innovator fails to satisfactorily demonstrate infringement by the generic manufacturer in proceedings under the NOC Regulations, the innovator pharmaceutical company still has the full range of judicial remedies (apart from the preemptive NOC prohibition) that are available to address patent infringement.
[46] Issue 3
Have the applicants demonstrated on the evidence that there will be infringement
generally of the ‘668 patent?
For the reasons above, infringement generally, to the extent that persons other than Apotex may commit patent infringements is relevant in this proceeding, brought under section 6 of the NOC Regulations to challenge the NOA issued by Apotex, if Apotex was sufficiently involved such that their activity amounted to direct infringement or inducement or procurement of infringement.
[59] Even though it is not necessary to explain my reasons, I will expressly address the applicants' argument on this issue. The applicants submitted the judgment of Richard J. (as he then was) in Zeneca Pharma Inc. v. Canada, [1995] F.C.J. No. 823 for the proposition that infringement by third parties is covered under the NOC Regulations.
[60] In my view, the fact situation in Zeneca, supra is clearly distinguishable from the present case. In Zeneca, supra the second person acknowledged that it sought government approval for use in the treatment of congestive heart failure, which was use for the treatment that was expressly claimed in the patent. In that case, the evidence clearly demonstrated sufficient involvement by the second person (i.e. Apotex) in the infringements by third parties (i.e. patients) such that the second person could be found to infringe the patent. Whether the ultimate decision was coined as direct or indirect infringement by the second person, or as a deficient NOA, the section 6 application in that case was bound to succeed.
[61] In Zeneca, supra, Richard J. (as he then was) at paragraph 24 on page 203 wrote:
However, as noted above, Apotex acknowledged that the uses for which it sought governmental approval included congestive heart failure. I conclude on the basis of the material before me that the lisinopril tablets are intended by Apotex and capable of being used for the treatment of congestive heart failure. It makes no difference that a physician and a pharmacist are involved as intermediaries in the prescribing and sale of the medicine to the ultimate consumer. Section 55.2(4)(e) of the Patent Act specifically contemplates regulations governing the issue of a notice in circumstances where the issue of such notice might result directly or indirectly in the infringement of a patent (emphasis mine). In these circumstances, the claim for use in the '351 patent would be infringed, if not directly, then certainly indirectly.
[62] The applicants submit that the wording "directly or indirectly" used by Richard J. (as he then was) indicates that infringements generally, such as by arm's length third parties, is contemplated by the legislation. That wording used by Richard J. (as he then was) came from paragraph 55.2(4)(e) of the Patent Act, supra. Viewing paragraph 55.2(4)(e) in its entirety allows us to place the comments of Richard J. (as he then was) in context. For ease of reference, paragraph 55.2(4)(e) of the Patent Act, supra reads:
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(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1) or (2) including, without limiting the generality of the foregoing, regulations . . . (e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent. |
(4) Afin d'empêcher la contrefaçon de brevet d'invention par l'utilisateur, le fabricant, le constructeur ou le vendeur d'une invention brevetée au sens des paragraphes (1) ou (2), le gouverneur en conseil peut prendre des règlements, notamment_: . . . e) sur toute autre mesure concernant la délivrance d'un titre visé à l'alinéa a) lorsque celle-ci peut avoir pour effet la contrefaçon de brevet. |
[63] As stated previously under issue 2, subsection 55.2(4) of the Patent Act, supra, enables the Governor in Council to make regulations to prevent direct and indirect infringements by the second person.
[64] In Zeneca, supra, Richard J. (as he then was) found that the second person (Apotex) sought approval for and intended that the medicine be used by patients for the treatment of congestive heart failure, which infringed the patent. Richard J. (as he then was) concluded that "in these circumstances, the claim for use in the ‘351 patent would be infringed, if not directly, then certainly indirectly." This conclusion in the Zeneca, supra decision is consistent with my interpretation of the enabling statute and the regulatory regime.
[65] The actions and knowledge of the second person in Zeneca, supra were the route through which the potential infringements by third parties (patients) were relevant to the NOC Regulations proceeding. This connection was made clear when Richard J. (as he then was) wrote "I conclude on the basis of the material before me that the lisinopril tablets are intended by Apotex and capable of being used for the treatment of congestive heart failure." Although Richard J. (as he then was) did not ultimately label the patent infringing action by the second person (Apotex) as direct infringement or indirect infringement, or inducement or procurement, the necessary connection between the second person and the resulting infringement was clearly made.
[66] Returning to the case at hand, Apotex alleges that they are not seeking approval for a use of omeprazole that is protected by a patent. The NOA is not contradicted by the evidence. The connection between the second person and the resulting infringement that might result from the issuance of an NOC has not been made out. Furthermore, it is my view that my decision and that of Richard J. (as he then was) are not at odds.
[47] Issue 4
Have the applicants demonstrated on the evidence that Apotex will induce or procure infringement of the ‘668 patent if an NOC is granted?
A party who induces or procures another to infringe a patent is itself responsible for infringement of the patent. In this manner, the infringing actions of a third party can become relevant under the NOC Regulations where the applicant (first person) can demonstrate that the second person has induced or procured another to infringe the patent in question.
[68] A patentee wishing to rely on the doctrine of induced infringement must allege and prove each of the following elements:
(a) that the act of infringement was completed by the direct infringer;
(b) the completed act of infringement was influenced by the seller, to the point where without said influence, infringement by the buyer would not otherwise take place; and,
(c) the influence must knowingly be exercised by the seller, such that the seller knows that his influence will result in the completion of the act of infringement.
[48] Under part (a) of the test, in order for Apotex to induce or procure infringement of the ‘668 patent, a direct infringement by someone must take place. The applicants have the burden, on the balance of probabilities, to demonstrate that an infringement is likely to occur if an NOC is issued.
[70] The theory of the case that the applicants attempt to prove through affidavit evidence is that a pharmacist typically does not know the particular reason or indication for which a physician has prescribed a drug . As a result, even if a pharmacist was aware that Apotex' omeprazole product was not formally approved for use in the treatment of Campylobacter infections, the pharmacist typically would not know why a particular patient had been prescribed omeprazole and hence, would likely dispense the generic product, which is expected to be at a lower cost.
[71] The applicants entered three affidavits into evidence. The first affidavit was sworn by Ms. Murphy, who is an officer of the applicant, Astra. The second affidavit was sworn by Dr. Pinto, who is a physician and the third affidavit was sworn by Ms. Samuel, who is a pharmacist.
[72] All three affiants, in their affidavits, offered their opinion that a physician would likely prescribe the medicine omeprazole by its generic name for the treatment of Campylobacter infections and a pharmacist would likely dispense to the patient the lowest cost generic product, which would result in an infringement of the ‘668 patent.
[73] This theory of the case appeals to common sense as a reasonable proposition, but unfortunately for the applicants, it is not well supported by the evidence on record, given the cross examination of the affiants on their affidavits.
[74] Ms. Murphy, on her cross examination (Revised Amended Application Record at page 224, question 106) stated:
Q. And you would agree with me that if a product was approved by the Federal Government for limited indications, the Provincial Government could agree to treat product as interchangeable with limitations and name the limitations as to uses.
A. Yes.
And at page 218, question 80:
Q. Certainly. You have no reason to believe that if a drug manufacturer filed a submission seeking approval only for certain indications, the government would, nonetheless, give an approval for other indications?
A. I have no reason to believe that, no.
[49] Ms. Murphy also admitted on her cross examination that she had not worked for a generic drug company. This would mean that she has no actual experience as to how a generic company promotes its product.
[50] In addition, Ms. Murphy is not a physician nor a pharmacist. In fact, what I know about Ms. Murphy is that she was vice-president of Medical Affairs at Astra and that she had formerly held the positions of manager, director, executive director and vice-president of Regulatory Affairs for Astra. As well, she has B.Sc., M. Sc. degrees and a M.B.A. degree.
[51] Because Ms. Murphy has not been qualified to give opinion evidence, I do not accept any opinion evidence contained in paragraphs 13, 14, 15, 16, 17, 19 and 20 of her affidavit. Even if Ms. Murphy was accepted as an expert, I would place less weight on her testimony because she is employed by Astra.
[52] In the cross examination of the pharmacist, Ms. Samuel (Revised Amended Application Record at page 200, question 66), the following question and answer was evoked by Mr. Brodkin:
Q. If the government specifically excluded a particular use of a medicine, you, I presume, Ms. Samuel, would not dispense the medicine for that use, would you?
A. No, I would not.
[53] Ms. Samuel is entitled to testify to what she knows from her practice of pharmacy. She was not otherwise qualified as an expert. She would not have any expertise to testify, for example, as to what doctors do generally as outlined by Ms. Murphy in her affidavit.
[54] Dr. Pinto is a physician licensed to practice medicine in the province of Ontario since 1975. Dr. Pinto was not qualified as an expert other than to establish that he was a physician duly authorized to practice in Ontario. Consequently, his evidence as to what other physicians do is not admissible or in the alternative, if it is admissible, very little weight should be attached to it as there is no evidence as to how he reached these conclusions. For example, did he survey other doctors? Dr. Pinto stated in his cross examination (Revised Amended Application Record page 148, question 55):
Q. You would have no reason to suggest, would you, Dr. Pinto, that the federal government would give an approval for certain indications which had not been sought by a drug manufacturer?
A. I don't think they should or they would.
[55] The testimony of the applicants establishes that if the respondent does not seek approval for the use of omeprazole for the treatment of Campylobacter infections, then the Federal Government, on its own, would not grant such approval. The pharmacist, Ms. Samuel, would not dispense the generic omeprazole for the treatment of Campylobacter infections if the drug was not approved for that use. The affiants on the record did not provide evidence of an actual act of direct infringement that would be committed by a direct infringer. Therefore, in my view, on a balance of probabilities, the applicants have not met part (a) of the three part test for inducement of infringement.
[82] Even though it is not necessary to dispose of this case, for the sake of completeness, I will follow through the analysis as though the act of direct infringement had been found. To determine if the act of infringement was influenced by Apotex, the Court must interpret the law in relation to inducement or procurement of infringement, and then determine, on the strength of the evidence before the Court, whether such an infringement has taken place.
[83] The respondent, Apotex cites an American case for the proposition that even if Apotex knew that its product would erroneously be prescribed by doctors or dispensed by pharmacists for the treatment of Campylobacter infections, such knowledge would not in itself be sufficient to establish infringement on the part of Apotex. The case of Salvatore Catapano v. Wyeb Ayerst Pharmaceuticals, Inc. et al. [2000], 88 F. Supp. 2d 27 (U.S. Dist.) deals with induced infringement under 35 U.S.C.A. § 271(b). In that case, Spatt J. of the United States District Court, E.D. New York states at page 3:
Induced infringement under § 271(b) occurs where a party is "actively and knowingly aiding and abetting another's direct infringement." National Presto Industries v. West Bend Co., 76 F.3d 1185, 1194-95 (Fed.Cir.1996) citing Water Technologies Corp. v.Calco, Ltd., 850 F.2d 660, 668 (Fed. Cir.1988). A plaintiff alleging inducement of infringement must establish that the defendant possessed specific intent to encourage another's infringement and that he knew or should have known his actions would induce actual infringements. Manfille Sales Corp. b. Paramount Systems, Inc., 917 F.2d 544, 553 (Fed.Cir.1990). Of course, a finding that a claim has been infringed is a necessary prerequisite to finding that there has been an act constituting an inducement to infringe under § 271(b). Zenith Laboratories v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1423 n. 5 (Fed.Cir.1994).
Here, the court assumes, without necessarily finding, that Catapano's allegation that "doctors, hospitals and others in the medical field" are using the vaccine for the purpose of immune system stimulation in violation of his patent is sufficiently specific to allege a claim for actual infringement against these anonymous non-party "doctors, hospitals, and others in the medical field." However, even when viewed in the light most favorable to him, Catapano's complaint fails to allege that the Defendants specifically intend to encourage this behavior. Even if the Defendants are aware that doctors and hospitals are using the vaccine to stimulate patients' immune systems in violation of Catapano's patent, such knowledge alone does not suffice to hold the Defendants liable for inducement. [emphasis added] R2 Medical Systems, Inc. v.Katecho, Inc., 931 F.Supp. 1397, 1440 (N.D.I11.1996) (mere knowledge that its customers use its products in the infringing manner does not demonstrate the requisite intent for claim of inducement), citing Oak Industries Inc. v. Zenith Electronics Corp., 697 F.Supp. 988, 992-94 (N.D.I11.1988).
Catapano has not alleged that the Defendants have claimed or recommended to anyone, implicitly or explicitly, that the vaccine can be used for immune system stimulation. Compare Biacore v.Thermo Bioanalysis Corp., 79 F.Supp. 2d 422, 459 (D.Del. 1999) (manufacturer who actively marketed a product with instructions on how to use it in a manner that infringed on the plaintiff's patent was liable for inducement of infringement). Even the broadest reading of the complaint alleges nothing more than the Defendants' mere knowledge that doctors and hospitals are infringing on his patent, Consequently, Catapano has failed to sates a claim for inducement to infringe under § 271(b).
[840 Given that Catapano, supra is an American case which contemplates American patent legislation, it is not binding on this Court. Nonetheless, it is persuasive with regards to the analysis involved in finding induced infringement on a similar set of facts to this case.
[850 In the current case, Apotex alleges that it has not sought approval and will not market omeprazole for the treatment of Campylobacter infections. If this Court were to follow Catapano, supra, unless the applicants can demonstrate that Apotex will encourage the use of its omeprazole for the treatment of Campylobacter infections, even knowledge that pharmacists and doctors are prescribing the drug for that purpose would not be sufficient to hold Apotex liable under induced infringement.
[860 Returning to Canadian jurisprudence, Pratte J., speaking for the Federal Court of Appeal in Beloit Canada Ltee/Ltd. v. Valmet Oy, [1988] F.C.J. No. 103, states:
In order to induce or procure another person to infringe a patent, one must do something that leads that other person to infringe the patent. If one does nothing, there cannot be any inducement and there cannot be, either, breach of a negative injunction. Valmet was enjoined from doing certain things; it could not breach that injunction by simply remaining inactive.
I therefore disagree with the finding of the judge of first instance that Valmet's mere passivity amounted to an inducement to V.D.I. to infringe Beloit's patent. [footnote omitted]
On the basis of the evidence, it is impossible to say that Valmet or its representative Pesonen did anything to induce or procure V.D.I. to infringe Beloit's patent. On the contrary, the evidence suggests that, after February 10, 1986, both Valmet and Pesonen were very careful not to do anything that could induce V.D.I. to infringe Beloit's patent. The evidence does not show that they took any part in V.D.I.'s decision to continue manufacturing and selling Tri-Nip press sections.
I am therefore of opinion that Valmet did not breach the injunction in supplying parts to V.D.I.
[56] This case is not like the factual situation faced by Richard J. (as he then was) in Zeneca, supra or Urie J. in Windsurfing International Inc. et.al. v. Trilantic Corporation (now BIC Sports Inc.) (1985) 8 C.P.R. (3d) 241 (F.C.A.). In Zeneca, supra, Apotex sought governmental approval for uses including the treatment of congestive heart failure which was a use covered by the applicants' patent. In Windsurfing, supra the only known use for the components was their assembly into a sailboard. In the present case, the respondent is not seeking approval to use omeprozale for the treatment of Campylobacter infections which is the use protected by the patent. There are other uses for omeprozale in addition to the use covered by the applicants' patent. In fact, the Notice of Allegation states in part, "our product will not be made, used, or sold for the treatment of Campylobacter infections and more particularly, we are not seeking approval for such use and no such use will be included in our product monogram." In my view, the applicants have failed to disprove the allegation. The applicants have asserted that this Court must assume the allegation to be true. Thus, on the basis of the evidence before this Court, it is not possible to say that Apotex has done or will do anything to induce or procure pharmacists, doctors or other third parties to infringe the ‘668 patent.
[57] Having found that Apotex has not influenced a direct infringement in this case, it is not necessary to determine whether Apotex would knowingly exercise influence on the direct infringer. In sum, the applicants have failed to establish on the evidence that a direct infringement by pharmacists, doctors, patients or other third parties will necessarily take place if an NOC is issued to Apotex. Therefore, the applicants have failed to demonstrate that the allegation of non-infringement by Apotex is not justified.
[58] Issue 5
Have the applicants successfully demonstrated that the NOA issued by Apotex was deficient in fact or law?
The Motions Judge wrote at paragraph 18:
Consequently, Apotex submits that its product will not be, inter alia, used for the treatment of Campylobacter, on the basis that Apotex is not seeking approval for such use and no such use will be included with its product. In my view, the approval referred to by Apotex has no bearing in fact or law on the allegation of non-infringement. For example, the Regulations do not say that there is no infringement in respect of "use", if the generic does not seek "approval" for such use. Furthermore, the evidence is that Apotex' omeprazole product will be used by patients for the treatment of H.pylori, regardless of its approved indications. In my view, the Regulations must contemplate the use of medicine by patients. Thus, the legal and factual basis relied on by Apotex may not, in fact, justify the allegation of non-infringement.
[900 It is true that simply because approval for a use has not been sought or granted, or that such use will not be marketed does not in itself provide a complete factual or legal basis to conclude that no infringing use by anyone in the marketplace will take place if the NOC is issued. The burden of proof lies with the applicants to demonstrate that the allegation is legally or factually deficient.
[910 The Motions Judge, having not had the benefit of hearing the case on its merits, noted that the applicants tendered evidence to demonstrate that Apotex' omeprazole product will be used by patients for the treatment of Campylobacter, regardless of its approved indications. However, after hearing this case on its merits, I am not satisfied that the evidence supports that conclusion. Furthermore, as described above, it is my view that the NOC Regulations only contemplate the use of medicine by patients where there is a sufficient connection to the second person such that the second person can be said to infringe.
[920 As discussed above under issue two, the regulatory scheme created by the enabling provisions in the Patent Act, supra and the resulting NOC Regulations focuses on infringement by the second person (generic pharmaceutical manufacturer). Any infringing use of a medicine by an end user is contemplated and will be covered under the regulations where a first person (innovator) can successfully demonstrate that a second person (generic) is involved in the infringement, whether directly or indirectly through inducement or procurement. The regulatory framework is not designed to prohibit the Minister from issuing an NOC where no infringing activity of any type by the second person (generic) can be demonstrated on a balance of probabilities.
[930 Hugessen J.A. (as he then was) stated in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) at page 320:
As a further consequence of the application under section 6 not being an ordinary action for infringement, there is no opportunity for either party to have recourse to discovery, whether oral or documentary. Where either party files affidavits there is, of course, opportunity for the opposite party to cross-examine thereon, but since there is no requirement that the notice of allegation be in affidavit form, and no obligation on the respondent to produce any affidavits at all, [footnote omitted] the applicant cannot expect to be able to make his case out of the mouth of the respondent. Even when there is an opportunity to cross-examine, such cross-examination is far more limited in scope than examination for discovery and, apart from questions going to the witness' credibility, is limited to relevant matters arising from the affidavit itself.
[940 The Federal Court of Appeal has held that in a proceeding brought pursuant to the NOC Regulations, a second person, such as Apotex, is under no obligation to file any evidence and that the applicants cannot expect to make their case "out of the mouth of the respondent." (Merck Frosst, supra).
[950 Generally, an applicant in a proceeding under the Regulations bears the legal burden to satisfy the Court that the allegation made by the generic is not justified on the legal and factual basis relied on by the generic. The applicant contends that there can be an evidential burden on a generic, where the generic is in possession of information and the applicant is not in possession of that information and has no means of access to that information, which creates an evidential burden on the generic to prove the facts asserted. In this case, Apotex is alleging that it is not seeking approval for an infringing use and that the infringing use will not be marketed with the product. This is not a situation where an evidential burden is created on Apotex to prove the facts asserted as the applicants are not in a situation where they have no means to access that information. In any event, subsection 6(7) of the NOC Regulations was available to the applicants.
[960 We must now consider the wording in the Notice of Allegation put forth by Apotex. Given the interpretation above of subparagraph (5)(1)(b)(iv) of the NOC Regulations, and the parallel sentence structure that appears in the NOA, it would appear to me that the NOA given by Apotex is not deficient in fact or law.
[970 The NOA does not extend to or make any allegation regarding potential third party infringements - unless there is a sufficient connection to Apotex such that Apotex is also involved directly or indirectly in the infringement. The NOA allegation corresponds to and satisfies the requirements of subparagraph (5)(1)(b)(iv) of the NOC Regulations.
[980 The burden remains with the applicants to satisfy the Court that the allegation made by Apotex is not justified on the legal and factual basis relied on. I am not satisfied that the applicants have discharged this burden and as a result, I am not willing make an adverse finding that Apotex's allegation is not justified in fact or law.
[59] In the alternative, if I am incorrect in my conclusion that the infringement referred to in subparagraph 5(1)(b)(iv) of the Regulations refers to infringement by the second person either directly or indirectly, I would still find that the Notice of Allegation of Apotex was justified. I reach this conclusion because the applicants have not established that on the basis of the balance of probabilities, that there will be direct infringement of the applicants' patent if the Notice of Compliance is issued. Neither have the applicants persuaded me on the balance of probabilities that Apotex would indirectly infringe the applicants' patent by inducing or procuring patients to infringe the applicants' patent. My conclusion is based on my earlier analysis.
Conclusion
[1000 I am not convinced, on a balance of probabilities, that issuing the NOC would result in an infringement of the ‘668 patent, and in particular by Apotex. Therefore, I cannot allow the application to prohibit the Minister from issuing a Notice of Compliance.
[1010 In order to succeed in their application, the applicants were required to prove on a balance of probabilities that the Apotex allegation, the allegation that no claim for the ‘668 patent would be infringed by Apotex, was unjustified. In my view, the applicants have failed to do so and thus, the application should be dismissed.
[60] The respondent shall have its costs of the application.
ORDER
IT IS ORDERED that:
1. The applicants' application is dismissed.
2. The respondent shall have its costs of the application.
"John A. O'Keefe"
J.F.C.C.
Toronto, Ontario
November 16, 2001
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-2016-99
STYLE OF CAUSE: AB HASSLE and ASTRAZENECA CANADA INC.
- and -
THE MINISTER OF NATIONAL HEALTH AND
WELFARE and APOTEX INC.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: Monday, October 15, 2001
REASONS FOR ORDER AND ORDER OF O'Keefe J.
DATED: Thursday, November 15, 2001
APPEARANCES:
Mr. G. A. Gaikis
Mr. J. S. Hamilton
Ms. Y. Kang
FOR APPLICANTS
Mr. R. Woyiwada
FOR RESPONDENT,
Minister of National Health
and Welfare
Mr. H. B. Radomski
Mr. A. Brodkin
FOR RESPONDENT,
Apotex Inc.
SOLICITORS OF RECORD:
Smart & Biggar
Suite 1500, Box 111
438 University Avenue
Toronto, Ontario M5G 2K8
FOR APPLICANTS
Department of Justice
Suite 3400, Box 36, The Exchange Tower
130 King Street West
Toronto, Ontario M5X 1K6
FOR RESPONDENT,
Minister of National Health
and Welfare
Goodmans
Suite 2400
250 Yonge Street West
Toronto, Ontario M5B 2M6 FOR RESPONDENT,
Apotex Inc.
FEDERAL COURT OF CANADA
TRIAL DIVISION
Date: 20011115
Docket: T-2016-99
BETWEEN:
AB HASSLE and
ASTRAZENECA CANADA INC.
Applicants
- and -
THE MINISTER OF NATIONAL HEALTH
AND WELFARE and APOTEX INC.
Respondents
REASONS FOR ORDER AND ORDER