Hassle v. Canada (Minister of National Health and Welfare)

Hassle v. Canada (Minister of National Health and Welfare)
Court (s) Database
Federal Court Decisions
Date
2001-11-15
Neutral citation
2001 FCT 1264
File numbers
T-2016-99
Notes
Reported Decision
Decision Content
Federal Court Reports 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
REASONS FOR ORDER AND ORDER
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:
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. . . .
"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:
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,
(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:
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.
(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:
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) 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:
(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_:
(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.
(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:
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;
(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;
(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:
(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 vende