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Pfizer Canada Inc. v. Canada (Attorney General) (T.D.) [2003] 1 F.C. 423

                                                                                                                                            Date: 20020625

                                                                                                                                     Docket:    T-1103-01

                                                                                                               Neutral Citation: 2002 FCT 706

Ottawa, Ontario, this 25th day of June, 2002

PRESENT:     THE HONOURABLE MR. JUSTICE BLANCHARD

BETWEEN:

                                                              PFIZER CANADA INC.

                                                                                                                                                       Applicant

                                                                              - and -

                                                ATTORNEY GENERAL OF CANADA

                                                                                                                                                   Respondent

                                                                              - and -

                        THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION

                                                                                                                                                     Intervener

                                                                                                                                     Docket:    T-1104-01

AND BETWEEN:

                                                          SCHERING CANADA INC.

                                                                                                                                                       Applicant

                                                                              - and -

                                            THE ATTORNEY GENERAL OF CANADA

                                                                                                                                                   Respondent


                                                                                                                                     Docket:    T-1120-01

AND BETWEEN:

                                                              PFIZER CANADA INC.

                                                                                                                                                       Applicant

                                                                              - and -

                                                ATTORNEY GENERAL OF CANADA

                                                                                                                                                   Respondent

                                                                              - and -

                        THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION

                                                                                                                                                     Intervener

                                               REASONS FOR ORDER AND ORDER

[1]                 The Court has before it three applications for judicial review of decisions of the Minister of Health wherein the Minister's delegate refused to list certain Canadian patents on the Patent Register maintained pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended , (the "Regulations"). The Minister decided that the patents were ineligible for inclusion on the Patent Register as they did not meet the regulatory requirements of subsection 4(4) of the Regulations.
  

  • [2]                 In accordance with subsection 4(4) of the Regulations, first persons such as the applicants, may, after the date of filing of a submission for a Notice of Compliance ("NOC"), and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list or an amendment to an existing patent list.
  • [3]                 The Minister interpreted the words "filing date" in subsection 4(4) of the Regulations to refer solely to the filing date of an application for patent in Canada and found the patents ineligible for inclusion on the Patent Register as the filing date of the patent application did not precede the filing date of the supplemental new drug submission.
  

Facts

[4]                 The following is a chronology of the factual situation of each application.

T-1103-01, Applicant: Pfizer Canada Inc. (hereinafter "Pfizer"), Product: ZITHROMAX azithromycin dihydrate (hereinafter "ZITHROMAX")

  • [5]                 Pfizer is a company that carries on business as a manufacturer and distributor of pharmaceutical products.
  • [6]                 On April 29, 1994, U.S. patent application 80/235,069 was filed in the United States relating to new oral dosage form of ZITHROMAX. This new oral dosage form does not exhibit an adverse food effect, which means that it can be taken without regard to meals.

  • [7]                 On September 15, 1994, Pfizer filed, in Canada, a Supplemental New Drug Submission for a new oral dosage form of ZITHROMAX, 250 mg Tablets. This submission was approved and a NOC was issued on February 21, 1996.
  • [8]                 On April 27, 1995, Pfizer filed a Canadian Patent Application 2,148,071 in respect of the new ZITHROMAX Tablets dosage form (the Canadian filing date). The patent was issued on October 17, 2000 (the "'071 Patent").
  
  • [9]                 On March 6, 1996, Pfizer filed another Supplemental New Drug Submission for a new dosage strength of ZITHROMAX, namely 600 mg Tablets. This submission was approved and a NOC was issued on April 17, 1997.
  • [10]            On November 13, 2000, Pfizer sought to have the '071 Patent added to the Patent Register in respect of the ZITHROMAX 250 mg and 600 mg tablets.
  
[11]            By letter dated November 23, 2000, the Minister advised Pfizer that the '071 Patent was eligible for listing in respect of ZITHROMAX 600 mg tablets but could not add the 250 mg tablets as the Canadian filing date of the patent application (April, 27, 1995) does not precede the date of filing of the submission for the 250 mg tablets (September 15, 1994).


T-1120-01, Applicant: Pfizer, Product: LIPITOR atorvastatin calcium (hereinafter "LIPITOR")

  • [12]            Pfizer, through Parke-Davis Canada, the previous manufacturer and co-marketer, sought approval for a new drug, known as LIPITOR, a lipid metabolism regulator.
  • [13]            On July 17, 1995, U.S. patent application 60/001,452 was filed in the United States relating to this invention.
  
  • [14]            On June 21, 1996, Pfizer filed a new drug submission for its LIPITOR 10, 20 and 40 mg tablets. On February 19, 1997, the submission was approved and a NOC was issued. Further submissions were filed on September 25, 1997, December 31, 1998 and December 16, 1999. NOCs for these submissions were issued respectively on January 12, 1999, June 16, 2000 and December 8, 2000.
  • [15]            On July 8, 1996, a Canadian patent application was filed and on April 17, 2001, the 2,220,018 Patent (the "'018 Patent") was issued.
  
  • [16]            On May 2, 2001, Pfizer sought to have the '018 Patent added on the Patent Register.
  • [17]            By letter dated May 23, 2001, the Minister stated that the '018 Patent could not be added to the Patent Register as the Canadian filing date of the patent application (July 8, 1996) for the '018 Patent did not precede the date of filing of the submission (June 21, 1996).

T-1104, Applicant: Schering Canada Inc. (hereinafter "Schering"), product: REBETRON ribavirin/interferon alfa 2-b (hereinafter "REBETRON")

  • [18]            Schering is a company that carries on business as a manufacturer and distributor of pharmaceutical products. REBETRON is a product used in the treatment of the hepatitis C virus.
  • [19]            This new product was under development in 1997. As part of this development, inventions were made by Schering's scientists relating to a new formulation for the REBETRON capsules. On December 22, 1997, U.S. patent applications 08/997,172 and 08/997,169 were filed relating to these inventions.
  
  • [20]            On April 27, 1998, Schering filed a new drug submission even though the clinical work had not yet been completed. On October 28, 1998, Schering filed another submission for the naive indicator for this product. NOCs for theses submissions were issued respectively on February 26, 1999 and April 22, 1999.
  • [21]            On December 21, 1998, Canadian patent applications were filed, which resulted in the issuance of the 2,287,056 Patent (the "'056 Patent") and the 2,300,452 Patent (the "'452 Patent").
  

[22]            On August 15, 2000 and on November 28, 2000, Schering sought to have the '056 Patent and '452 Patent respectively added to the Patent Register. By letters dated September 7, 2000 and December 11, 2000, the Minister rejected the listing of both patents on the basis that the Canadian filing date of the patent applications (December 21, 1998) did not precede the filing date of the submissions (April 27, 1998).

Patent Application Filing Dates

  • [23]            In all three cases, the applicants argue that the "filing date" set out in subsection 4(4) of the Regulations should be interpreted to be the priority filing date, which would be the date of filing in the United States, and not the Canadian filing date.
  • [24]            In a letter dated January 23, 2001, counsel for the Minister of Health advised the applicant Pfizer that the current policy relating to filing dates may be subject to change since the matter was being referred for policy consultation.
  
[25]            The Therapeutic Products Program (TPP) of the Ministry of Health then proposed an amendment to the Patent Medicines (Notice of Compliance) Guidance Document by letter dated February 12, 2001. The letter sought input from "Main Trade Associations", including the intervener to the within applications. The proposed amendment would henceforth consider "filing date" to include priority date.

  • [26]            Following the consultation exercise, the Minister declined to implement the proposed changes which had the effect of maintaining the practice that the priority date could not be used to meet the timing requirements under subsection 4(4) of the Regulations. An issue analysis on the subject entitled "Patent Application Filing Dates, Patented Medicines (Notice of Compliance) Regulations" was circulated to all stakeholders.
  • [27]            The Canadian Drug Manufacturer's Association ("CDMA"), an association representing generic drug manufacturers with respect to business, political and legal issues, was added as an intervener by order of this Court dated October 26, 2001. The order provided that the intervener's right to appeal should be decided by the judge hearing the applications for judicial review.
  

Legislative Framework

  • [28]            It is useful to reproduce the pertinent statutory and regulatory provisions.
  • [29]            The Minister of Health is the authority responsible for creating and maintaining the Patent Register, pursuant to s. 3 of the Regulations:

3. (1) The Minister shall maintain a register of any information submitted under section 4. To maintain it, the Minister may refuse to add or may delete any information that does not meet the requirements of that section.


3.(1) Le ministre tient un registre des renseignements fournis aux termes de l'article 4. À cette fin, il peut refuser d'y ajouter ou en supprimer tout renseignement qui n'est pas conforme aux exigences de cet article.


Section 4(4) of the Regulations reads as follows:


4. (4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2).


4.(4) La première personne peut, après la date de dépôt de la demande d'avis de conformité et dans les 30 jours suivant la délivrance d'un brevet qui est fondée sur une demande de brevet dont la date de dépôt est antérieure à celle de la demande d'avis de conformité, soumettre une liste de brevets, ou toute modification apportée à une liste de brevets, qui contient les renseignements visés au paragraphe (2).



Although the term "filing date" is not defined in the Regulations, it is defined in section 2 of the Patent Act, R.S.C. 1985, c. P-4, as amended:


2. "filing date" means, in relation to an application for a patent in Canada, the date on which the application is filed, as determined in accordance with section 28.


2. « _date de dépôt_ » La date du dépôt d'une demande de brevet, déterminée conformément à l'article 28.


Section 28 of the Patent Act reads as follows:


Filing date

28. (1) The filing date of an application for a patent in Canada is the date on which the Commissioner receives the documents, information and fees prescribed for the purposes of this section or, if they are received on different dates, the last date.


Date de dépôt

28. (1) La date de dépôt d'une demande de brevet est la date à laquelle le commissaire reçoit les documents, renseignements et taxes réglementaires prévus pour l'application du présent article. S'ils sont reçus à des dates différentes, il s'agit de la dernière d'entre elles.


Deemed date of receipt of fees

(2) The Commissioner may, for the purposes of this section, deem prescribed fees to have been received on a date earlier than the date of their receipt if the Commissioner considers it just to do so.

R.S., 1985, c. P-4, s. 28; R.S., 1985, c. 33 (3rd Supp.), s. 10; 1993, c. 15, s. 33.


Taxes réglementaires

(2) Pour l'application du paragraphe (1), le commissaire peut, s'il estime que cela est équitable, fixer une date de réception des taxes antérieure à celle à laquelle elles ont été reçues.

L.R. (1985), ch. P-4, art. 28; L.R. (1985), ch. 33 (3e suppl.), art. 10; 1993, ch. 15, art. 33.


[30] Sections 28.1 to 28.4 of the Patent Act deal essentially with previously regularly filed claims in Canada and in other countries.

Claim date

28.1(1) The date of a claim in an application for a patent in Canada (the "pending application") is the filing date of the application, unless


Date de la revendication

28.1 (1) La date de la revendication d'une demande de brevet est la date de dépôt de celle-ci, sauf si_:


(a) the pending application is filed by


a) la demande est déposée, selon le cas_:


(i) a person who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for Canada an application for a patent disclosing the subject-matter defined by the claim, or


(i) par une personne qui a antérieurement déposé de façon régulière, au Canada ou pour le Canada, ou dont l'agent, le représentant légal ou le prédécesseur en droit l'a fait, une demande de brevet divulguant l'objet que définit la revendication,



(ii) a person who is entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party and who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for any other country that by treaty, convention or law affords similar protection to citizens of Canada an application for a patent disclosing the subject-matter defined by the claim;


(ii) par une personne qui a antérieurement déposé de façon régulière, dans un autre pays ou pour un autre pays, ou dont l'agent, le représentant légal ou le prédécesseur en droit l'a fait, une demande de brevet divulguant l'objet que définit la revendication, dans le cas où ce pays protège les droits de cette personne par traité ou convention, relatif aux brevets, auquel le Canada est partie, et accorde par traité, convention ou loi une protection similaire aux citoyens du Canada;


(b) the filing date of the pending application is within twelve months after the filing date of the previously regularly filed application; and


b) elle est déposée dans les douze mois de la date de dépôt de la demande déposée antérieurement;


(c) the applicant has made a request for priority on the basis of the previously regularly filed application.


c) le demandeur a présenté, à l'égard de sa demande, une demande de priorité fondée sur la demande déposée antérieurement.


Claims based on previously regularly filed applications

28.1(2) In the circumstances described in paragraphs (1)(a) to (c), the claim date is the filing date of the previously regularly filed application.


Date de dépôt de la demande antérieure

28.1(2) Dans le cas où les alinéas (1)a) à c) s'appliquent, la date de la revendication est la date de dépôt de la demande antérieurement déposée de façon régulière.


Subject matter of claim must not be previously disclosed

28.2(1) The subject-matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed


Objet non divulgué

28.2(1)L'objet que définit la revendication d'une demande de brevet ne doit pas_:


(a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere;


a) plus d'un an avant la date de dépôt de celle-ci, avoir fait, de la part du demandeur ou d'un tiers ayant obtenu de lui l'information à cet égard de façon directe ou autrement, l'objet d'une communication qui l'a rendu accessible au public au Canada ou ailleurs;


(b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere;


b) avant la date de la revendication, avoir fait, de la part d'une autre personne, l'objet d'une communication qui l'a rendu accessible au public au Canada ou ailleurs;


(c) in an application for a patent that is filed in Canada by a person other than the applicant, and has a filing date that is before the claim date; or


c) avoir été divulgué dans une demande de brevet qui a été déposée au Canada par une personne autre que le demandeur et dont la date de dépôt est antérieure à la date de la revendication de la demande visée à l'alinéa (1)a);





(d) in an application (the "co-pending application") for a patent that is filed in Canada by a person other than the applicant and has a filing date that is on or after the claim date if


d) avoir été divulgué dans une demande de brevet qui a été déposée au Canada par une personne autre que le demandeur et dont la date de dépôt correspond ou est postérieure à la date de la revendication de la demande visée à l'alinéa (1)a) si_:


(i) the co-pending application is filed by


(i) cette personne, son agent, son représentant légal ou son prédécesseur en droit, selon le cas_:


(A) a person who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for Canada an application for a patent disclosing the subject-matter defined by the claim, or


(A) a antérieurement déposé de façon régulière, au Canada ou pour le Canada, une demande de brevet divulguant l'objet que définit la revendication de la demande visée à l'alinéa (1)a),


(B) a person who is entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party and who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for any other country that by treaty, convention or law affords similar protection to citizens of Canada an application for a patent disclosing the subject-matter defined by the claim,


(B) a antérieurement déposé de façon régulière, dans un autre pays ou pour un autre pays, une demande de brevet divulguant l'objet que définit la revendication de la demande visée à l'alinéa (1)a), dans le cas où ce pays protège les droits de cette personne par traité ou convention, relatif aux brevets, auquel le Canada est partie, et accorde par traité, convention ou loi une protection similaire aux citoyens du Canada,


(ii) the filing date of the previously regularly filed application is before the claim date of the pending application,


(ii) la date de dépôt de la demande déposée antérieurement est antérieure à la date de la revendication de la demande visée à l'alinéa a),


(iii) the filing date of the co-pending application is within twelve months after the filing date of the previously regularly filed application, and


(iii) à la date de dépôt de la demande, il s'est écoulé, depuis la date de dépôt de la demande déposée antérieurement, au plus douze mois,


(iv) the applicant has, in respect of the co-pending application, made a request for priority on the basis of the previously regularly filed application.


(iv) cette personne a présenté, à l'égard de sa demande, une demande de priorité fondée sur la demande déposée antérieurement.


Withdrawal of application

28.2(2) An application mentioned in paragraph (1)(c) or a co-pending application mentioned in paragraph (1)(d) that is withdrawn before it is open to public inspection shall, for the purposes of this section, be considered never to have been filed.


Retrait de la demande

28.2(2) Si la demande de brevet visée à l'alinéa (1)c) ou celle visée à l'alinéa (1)d) a été retirée avant d'être devenue accessible au public, elle est réputée, pour l'application des paragraphes (1) ou (2), n'avoir jamais été déposée.







Invention must not be obvious

28.3 The subject-matter defined by a claim in an application for a patent in Canada must be subject-matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to


Objet non évident

28.3    L'objet que définit la revendication d'une demande de brevet ne doit pas, à la date de la revendication, être évident pour une personne versée dans l'art ou la science dont relève l'objet, eu égard à toute communication_:


(a) information disclosed more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant in such a manner that the information became available to the public in Canada or elsewhere; and


a) qui a été faite, plus d'un an avant la date de dépôt de la demande, par le demandeur ou un tiers ayant obtenu de lui l'information à cet égard de façon directe ou autrement, de manière telle qu'elle est devenue accessible au public au Canada ou ailleurs;


(b) information disclosed before the claim date by a person not mentioned in paragraph (a) in such a manner that the information became available to the public in Canada or elsewhere.


b) qui a été faite par toute autre personne avant la date de la revendication de manière telle qu'elle est devenue accessible au public au Canada ou ailleurs.


Request for priority

28.4 (1) For the purposes of sections 28.1, 28.2 and 78.3, an applicant for a patent in Canada may request priority in respect of the application on the basis of one or more previously regularly filed applications.


Demande de priorité

28.4 (1) Pour l'application des articles 28.1, 28.2 et 78.3, le demandeur de brevet peut présenter une demande de priorité fondée sur une ou plusieurs demandes de brevet antérieurement déposées de façon régulière.


Requirements governing request

(2) The request for priority must be made in accordance with the regulations and the applicant must inform the Commissioner of the filing date, country of filing and number of each previously regularly filed application on which the request is based.


Conditions

(2) Le demandeur la présente selon les modalités réglementaires; il doit aussi informer le commissaire du nom du pays où a été déposée toute demande de brevet sur laquelle la demande de priorité est fondée, ainsi que de la date de dépôt et du numéro de cette demande de brevet.


Withdrawal of request

(3) An applicant may, in accordance with the regulations, withdraw a request for priority, either entirely or with respect to one or more previously regularly filed applications.


Retrait de la demande

(3) Il peut, selon les modalités réglementaires, la retirer à l'égard de la demande déposée antérieurement; dans les cas où la demande de priorité est fondée sur plusieurs demandes, il peut la retirer à l'égard de toutes celles-ci ou d'une ou de plusieurs d'entre elles.


Multiple previously regularly filed applications

(4) Where two or more applications have been previously regularly filed as described in paragraph 28.1(1)(a), subparagraph 28.2(1)(d)(i) or paragraph 78.3(1)(a) or (2)(a), either in the same country or in different countries,


Plusieurs demandes

(4) Dans le cas où plusieurs demandes de brevet ont été déposées antérieurement dans le même pays ou non_:







(a) paragraph 28.1(1)(b), subparagraph 28.2(1)(d)(iii) or paragraph 78.3(1)(b) or (2)(b), as the case may be, shall be applied using the earliest filing date of the previously regularly filed applications; and


a) la date de dépôt de la première demande est retenue pour l'application de l'alinéa 28.1(1)b), du sous-alinéa 28.2(1)d)(iii) et des alinéas 78.3(1)b) et (2)b), selon le cas;


(b) subsection 28.1(2), subparagraph 28.2(1)(d)(ii) or paragraph 78.3(1)(d) or (2)(d), as the case may be, shall be applied using the earliest filing date of the previously regularly filed applications on the basis of which a request for priority is made.


b) la date de dépôt de la première des demandes sur lesquelles la demande de priorité est fondée est retenue pour l'application du paragraphe 28.1(2), du sous-alinéa 28.2(1)d)(ii) et des alinéas 78.3(1)d) et (2)d), selon le cas.


Withdrawal, etc., of previously regularly filed applications

(5)    A previously regularly filed application mentioned in section 28.1 or 28.2 or subsection 78.3(1) or (2) shall, for the purposes of that section or subsection, be considered never to have been filed if


Retrait de demandes déposées antérieurement

(5) Pour l'application des articles 28.1 et 28.2 et des paragraphes 78.3(1) et (2), une demande de brevet déposée antérieurement est réputée ne pas l'avoir été si les conditions suivantes sont réunies_:


(a) it was filed more than twelve months before the filing date of

(i) the pending application, in the case of section 28.1,

(ii) the co-pending application, in the case of section 28.2,

(iii) the later application, in the case of subsection 78.3(1), or

(iv) the earlier application, in the case of subsection 78.3(2);


a) la demande a été déposée plus de douze mois avant la date de dépôt de la demande à l'égard de laquelle une demande de priorité a été présentée;


(b) before the filing date referred to in paragraph (a), another application


b) avant la date de dépôt de la demande à l'égard de laquelle une demande de priorité a été présentée, une autre demande de brevet divulguant l'objet que définit la revendication de celle-ci a été déposée_:


(i) is filed by the person who filed the previously regularly filed application or by the agent, legal representative or predecessor in title of that person,


(i) par la personne qui a déposé la demande antérieurement déposée, ou par l'agent, le représentant légal ou le prédécesseur en droit de celle-ci,


(ii) is filed in or for the country where the previously regularly filed application was filed, and


(ii) dans le pays ou pour le pays où l'a été la demande antérieurement déposée;


(iii) discloses the subject-matter defined by the claim in the application mentioned in paragraph (a); and






(c) on the filing date of the other application mentioned in paragraph (b) or, if there is more than one such application, on the earliest of their filing dates, the previously regularly filed application

(i) has been withdrawn, abandoned or refused without having been opened to public inspection and without leaving any rights outstanding, and

(ii) has not served as a basis for a request for priority in any country, including Canada.


c) à la date de dépôt de cette autre demande - ou s'il y en a plusieurs, à la date de dépôt de la première demande -, la demande antérieurement déposée a été retirée, abandonnée ou refusée, sans avoir été accessible pour consultation et sans laisser subsister de droits, et n'a pas été invoquée pour réclamer une priorité au Canada ou ailleurs.


The Minister's decision

  • [31]            The Minister's decision in each of the three applications is that the patent in question was not eligible for listing on the Patent Register as it did not meet the timing requirements of subsection 4(4) of the Regulations. While the patent list was submitted within 30 days of the issuance of the patent, the filing date of the patent application in Canada did not precede the date of filing of the new drug submission.
  • [32]            By order of this Court dated December 28, 2001, the three within applications for judicial review and contained in Court files T-1103-01, T-1104-01 and T-1120-01 were ordered to be heard together on an expedited basis.
  

Issues

[33]            The only issue to be determined is whether the words "filing date" in subsection 4(4) of the Regulations refer solely to the filing date of an application for patent in Canada or whether they can also refer to a priority filing date.

Standard of Review

[34]            There is no dispute as to the applicable standard of review. The issue before me deals with the interpretation of a regulatory provision and involves a question of law. The jurisprudence has established that in such instances the Minister should be entitled to little, if any, deference and that correctness is the proper standard of review. This is the standard I will apply in these judicial review applications. [See Merck v. Nu-Pharm (1999) 176 F.T.R. 21, affirmed (2000), 5 C.P.R. (4th) 138 (F.C.A.)].

Analysis

[35]            The applicants contend that the Minister's interpretation of subsection 4(4) of the Regulations is incorrect and that his decision refusing to list the patents was therefore wrong. The applicants submit that the correct interpretation of subsection 4(4) is that the words "a filing date" includes a priority filing date and that the phrase "a filing date" should be interpreted with the help of the approach set out by the Supreme Court in Rizzo & Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27 at page 41, where the Court endorsed Elmer Dreidger's approach in Construction of Statutes (2nd ed. 1983):

...the words are to be read in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament.


  • [36]            The applicants' position is that a plain reading of the section and the use of the words "a filing date", rather than "the filing date" or "a filing date of the application in Canada", could only lead to the conclusion that so long as there is a filing date for the patent application that precedes the submission filing date, and so long as the patent list is provided within 30 days of issuance of the patent, the first person is entitled to list the patent. They argue that such an interpretation is consistent with the plain meaning of these words and the purpose of the Regulations, namely to prevent patent infringement and Canada's international treaty obligations.
  • [37]            The applicants raise four arguments in support of their position, each of which is contested by the respondent and the intervener:

(a)        The use of the indefinite article "a" before the words "filing date" in subsection 4(4) of the Regulations supports the proposition that the words "filing date" can refer to any filing date, including the priority date;

(b)        The words "filing date" are sometimes used in certain provisions of the Patent Act to refer to a priority date (i.e., paragraph 28.1(1)(b));

(c)        In Bayer AG v. Apotex Inc., (1998), 84 C.P.R. (3d) 23 (F.C.T.D.) the words "filing of an application in Canada" in former section 28 of the Patent Act were interpreted by this Court as including the priority filing date of a patent application; and

(d)        The Minister's interpretation of subsection 4(4) of the Regulations is inconsistent with Canada's international treaty obligations, more specifically those of the Paris Convention.

I will deal with each of these arguments in turn.


  • [38]            The applicants argue that the use of the indefinite article "a", as apposed to the definite article "the", in subsection 4(4) of the Regulations, supports an interpretation that a filing date is not meant to be restricted to just one filing date (i.e. the Canadian filing date) but to any filing date (i.e. either the priority filing date or the Canadian filing date).
  • [39]            Any ambiguity that may have been created by the use of the indefinite article in the English version of the Regulation is dispelled by the French version which uses a definite article and reads:

"...dont la date de dépôt est antérieure..."

The French version would lend support to the respondent's position that the term "filing date" refers solely to one date, namely the Canadian filing date.

  • [40]            Where there is ambiguity or contradiction in two official versions of an enactment reconciliation must be attempted. In cases where one version is itself ambiguous, while the other is plain and unequivocal, the jurisprudence has favoured the latter. (See Tupper v. The Queen [1967] S.C.R. 589.] The courts have also adopted an approach that would favour a more narrow meaning over a broader one in the practice of attempting to find a shared or common meaning in the two enactments. [See P.A. Coté, The Interpretation of Legislation in Canada, 3ed. ed. (Toronto: Carswell, 2000) at page 326.]
  • [41]            I am guided by the above cited authorities in my attempt to find a shared or common meaning in the two enactments. The French version in the case at bar, is unambiguous and is narrower than the interpretation of the English version submitted by the applicants in that it refers to "La date de dépôt" as opposed to "a filing date". I therefore have no difficulty in favouring the narrower meaning as reflected in the French version of the enactment.
  

  • [42]            I am also of the view that by adopting a narrower meaning, and interpreting "filing date" to mean the "Canadian filing date" is consistent with the intention of Parliament since the term "filing date" is expressly defined in the Patent Act as the Canadian filing date.
  • [43]            Determination of the main issue in these applications, that is the interpretation of the words "a filing date" in the Regulations, will not turn on the use of an indefinite or definite article in the Regulations although it is a factor to be considered.
  
  • [44]            The term "filing date" is not defined in the Regulations but is defined in section 2 and subsection 28(1) of the Patent Act.
  • [45]            The definition of "filing date" in section 2 of the Patent Act is exhaustive and, in my view, unambiguous. "Filing date" in the Patent Act, is expressly defined as the date on which a patent application is filed in Canada and not the priority date. In addition, as discussed above, the French version leaves no doubt that "filing date" refers to the Canadian filing date as defined in section 28. Authority under the Regulations must be exercised within the scope of the Patent Act. Having regard to the definition of "filing date" in section 2 of the Patent Act, it would be unreasonable, in my view, to attribute a meaning to "filing date" other than that provided for and defined in the Act, that is to say the Canadian filing date.
  
[46]            The applicants further contend that the phrase "filing date" is used in at least three contexts under the Patent Act:

1.         the Canadian filing date;

2.         the priority filing date; and,

3.         the international filing date where an application is filed based on the Patent Cooperation Treaty.

[47]            The applicant points to the following sections of the Act in support of the argument that the phrase "filing date" is not restricted to a Canadian filing date but could also include a priority filing date:

(a)        In each of subsections 28.4(2) and 28.4(4) the reference to "filing date" clearly is referring only to the priority filing date;

(b)        In paragraph 28.1(1)(b) "filing date" is used twice, once to refer to the Canadian filing date and the second time to refer to the priority filing date;

(c)        In subsection 28(1) the reference to "filing date" is to the Canadian filing date;

(d)        In subsection 10(3) the reference to "filing date" is used twice, once to refer to the Canadian filing date and the second time to refer to the priority filing date; and

(e)        In some instances, it may even refer to an international filing date.

  

  • [48]            I disagree with the applicant's argument. Paragraph 28.1(1)(b), subsections 28.4(2) and 28.4(4) of the Act essentially deal with the previously regularly filed applications in other countries. Since the term "filing date" in subsection 4(4) of the Regulations refers to Canadian patents, reference to other provisions in the Act relating to Patents filed in other countries is of little help in construing subsection 4(4). The term "filing date" is consistently used in the Patent Act to refer to the date on which the application is filed in Canada.
  • [49]            I agree with the submissions of the intervener that the Act uses the term "claim date", not the term "filing date", to refer to a previously regularly filed application or the priority date. Section 2 of the Act defines claim date:

"Claim date means the date of a claim in an application for a patent in Canada, as determined in accordance with section 28.1;

  

Subsection 28.1(1) provides that a claim date is the priority date if the three conditions in paragraphs 28.1(1)(a) through (c) are met. I am of the view that the definition of a "claim date" would be meaningless if the term "filing date" and "priority date" could be used interchangeably. It is therefore reasonable to conclude that had the Governor in Council intended to refer to the priority date in subsection 4(4) of the Regulations, the term "claim date" would have been used.

[50]            At the risk of stating the obvious, the Patent Act is Canadian legislation and provides for the grant of a patent to an inventor, "...if an application for the patent in Canada is filed..." [See subsection 27(1) of the Patent Act]. Moreover, the Patent Act specifically defines "filing date" to be the Canadian filing date. In my view, any reference to "filing date" in the Act, or in the Regulations thereunder, must be read with regard to this definition. Such an interpretation is consistent with other provisions of the Patent Act and the Regulations which, for the most part, explicitly set out, in the context of the specific section, when "filing date" is meant as a date other than the Canadian filing date.

  • [51]            I therefore conclude that the words "a filing date", read in their entire context and in their grammatical and ordinary sense, harmoniously with the scheme of the Act and the intention of Parliament, should be interpreted to be exhaustive and refer solely to the filing date for an application for patent in Canada.
  • [52]            The applicants rely on a decision of Mr. Justice Gibson in Bayer A.G. v. Apotex Inc. (1998), 84 C.P.R. (3d) 23 (F.C.T.D.) ("Bayer") wherein my colleague, in considering former section 28, held that a Canadian patent is entitled to the benefit of the priority filing date.
  
  • [53]            In the Bayer case, Mr. Justice Gibson held that the Chilean "Patent" had not issued when the Canadian application was filed and concluded that the "foreign patent bar" provided for in the former subsection 28(2) of the Patent Act did not disentitle Bayer from obtaining the Canadian patent. By way of obiter, Justice Gibson added that on the facts of that case, and with respect to the Act as it then read, "...references to 'filing' of an application in Canada in subsection 28(2) are not simply to the actual filing but to any effective or priority filing date to which the applicant is entitled by virtue of subsection 29(1)." [Para. 55 of Bayer.]
  • [54]            I am of the view that the Bayer case has limited application to the case at bar. Mr. Justice Gibson had to consider the novelty requirements under the Patent Act, as it then read, and no consideration was given to the Regulations. Further, the current provisions of the Patent Act clearly distinguish between a "filing date" and a priority or claim date. This distinction was not part of the Patent Act that was considered by Mr. Justice Gibson in Bayer.

[55]            Having determined that section 4(4) of the Regulations and section 2 and subsection 28(1) of the Act are clear and unambiguous, there is no need, in my view, to have recourse to the international conventions as intrinsic aids to interpretation. Mr. Justice Bastarache in R. v. Cook, [1998] 2 S.C.R. 597 at para. 129, wrote that where a statutory provision offends international law principles of jurisdiction, there is a presumption that the provision must be interpreted in conformity with those international law principles unless the offending interpretation is clear and unmistakable. The learned Justice cited Pigeon J. in Daniels v. White and The Queen, [1968] S.C.R. 517, at p. 541:

...Parliament is not presumed to legislate in breach of a treaty or in any manner inconsistent with the comity of nations and the established rules of international law...if a statute is unambiguous, its provisions must be followed even if they are contrary to international law, as was said recently in Inland Revenue Commissioners v. Collco Dealings Ltd. ([1962] A.C. l), where all relevant authorities are reviewed. In that case, the House of Lords came to the conclusion that the intent of Parliament was clear and unmistakable and, therefore, the plain words of a statute could not be disregarded in order to observe the comity of nations and the established rules of international law. However, the principle of construction was recognized as applicable in a proper case.

  • [56]            Even if I had found ambiguity in the Act and the Regulations, with regards to the interpretation to be afforded "a filing date", I am not convinced that the Minister's interpretation of subsection 4(4) of the Regulations or section 2 and subsection 28(1) of the Patent Act is inconsistent with the Paris Convention, the North American Free Trade Agreement ("NAFTA") or with Trade Related Aspects of Intellectual Property Rights ("TRIPS")
  • [57]            Both NAFTA and TRIPS impose an obligation to comply with the Paris Convention. It is therefore useful to reproduce the pertinent articles of the Paris Convention.
    

Article 2(1) of the Paris Convention provides:

(1) Nationals of any country of the Union shall, as regards the protections of industrial property, enjoy all in all the other countries of the Union the advantages that their respective laws now grant, or may hereafter grant to nationals; all without prejudice to the rights specially provided for by this convention. Consequently, they shall have the same protection as the latter, and the same remedy against any infringement of their rights, provided that the conditions and formalities imposed upon nationals are complied with. [Italics added].

Article 4B of the Paris Convention provides:

Consequently, any subsequent filing in any of the other countries of the Union before the expiration of the periods referred to above shall not be invalidated by reason of any acts accomplished in the interval, in particular, another filing, the publication or exploitation of the invention, the putting on sale of the copies of the design, or the use of the mark, and such acts cannot give rise to any third-party right or any right of personal possession. Rights acquired by third parties before the date of the first application that serves as the basis for the right of priority are reserved in accordance with the domestic legislation of each country of the Union.

  
[58]            The applicants argue that the Minister's interpretation of "filing date" in section 4(4) of the Regulations places patentees who file their patent applications first in a country other than Canada at a disadvantage compared to patentees who choose to file first in Canada. Such an interpretation results in unequal treatment depending upon which country they file first in and is, according to the applicants, contrary to Article 2, paragraph 1 of TRIPS which provides that member states shall comply with the Paris Convention.

  • [59]            Essentially, the applicants argue that an interpretation of "filing date" in subsection 4(4) of the Regulations that refers only to the Canadian filing date would result in a loss of rights during the priority period, contrary to the Paris Convention, in particular, the equality of national treatment provided for in Article 2.
  • [60]            A careful review of the pertinent Articles of the Paris Convention leads me to adopt the more compelling position advanced by the intervener on this issue which I incorporate in the following paragraphs of these reasons.
  
  • [61]            Under subsection 4(4) of the Regulations, "nationals" of Canada and "nationals" of any other country are entitled to the same advantages provided they comply with the same conditions and formalities. This requirement to comply with the same conditions and formalities is specifically provided for in Article 2(1) of the Paris Convention.
  • [62]            Further, Article 4B of the Paris Convention speaks of a subsequent filing "not be invalidated" by reason of an intervening act. I am of the view that Canada complies with article 4B by allowing a party that files a foreign patent application to claim priority in Canada under paragraph 28.1(1)(c) of the Act, in the circumstances set out in paragraphs 28.1(1)(a) and (b). The effect of such priority is set out at paragraphs 28.1 to 28.4 of the Act. Interpreting "filing date" as the Canadian filing date, as did the Minister, does not constitute an "act" that "invalidates" the subsequent Canadian filing. A patent which cannot be listed under the Regulations does not thereby become invalid. The patentee can always enforce its patent rights by action. The scope of the Regulations does not impact upon patent rights.

  • [63]            For the above reasons, I conclude that the Minister was correct in interpreting the phrase "filing date" in subsection 4(4) of the Regulations to refer solely to the filing date of an application for patent in Canada. The Minister's refusal to list the patents was therefore correct.
  • [64]            The applications for judicial review will accordingly be dismissed.
   
[65]            In view of the fact that my disposition favours the position advanced by the intervener, it is not necessary for me to determine whether leave to appeal ought to be granted to the intervener.

                                                                            ORDER

THIS COURT ORDERS that:

1.                    The applications for judicial review are dismissed.

2.         The respondent shall have its costs on each of the applications.

  

                                                                                                                                 "Edmond P. Blanchard"          

                                                                                                                                                               Judge                    


                                                    FEDERAL COURT OF CANADA

                                                                 TRIAL DIVISION

                              NAMES OF COUNSEL AND SOLICITORS OF RECORD

  

DOCKET:                                             T-1103-01

STYLE OF CAUSE:                           Pfizer Canada Inc. v. Attorney General of Canada and the Canadian Drug Manufacturers' Association (Intervenor)

PLACE OF HEARING:                     Ottawa, Ontario

DATE OF HEARING:                       April 15, 2002

REASONS FOR ORDER AND ORDER:                          BLANCHARD J.

DATED:                                                June 25, 2002

  

APPEARANCES:

Anthony G. Creber/Jennifer L. Wilkie FOR PLAINTIFF / APPLICANT

Marie Crowley                                                                               FOR DEFENDANT/ RESPONDENT

Edward Hore                                                                                  FOR INTERVENER

  

SOLICITORS OF RECORD:

Gowling Lafleur Henderson LLP                                                   FOR PLAINTIFF/APPLICANT

160 Elgin Street Suite 2600

Ottawa, Ontario    K1P 1C3

Morris Rosenberg                                                                           FOR DEFENDANT/RESPONDENT

Deputy Attorney General of Canada

Department of Justice

East Memorial Building

284 Wellington Street

Ottawa, Ontario K1A 0H8

Hazzard & Hore

141 Adelaide Street W., Suite 1002

Toronto, Ontario, M5h 3L5


                                                    FEDERAL COURT OF CANADA

                                                                 TRIAL DIVISION

                              NAMES OF COUNSEL AND SOLICITORS OF RECORD

  

DOCKET:                                             T-1104-01

STYLE OF CAUSE:                           Schering Canada Inc. v. Attorney General of Canada

PLACE OF HEARING:                     Ottawa, Ontario

DATE OF HEARING:                       April 15, 2002

REASONS FOR ORDER AND ORDER:                          BLANCHARD J.

DATED:                                                June 25, 2002

  

APPEARANCES:

Anthony G. Creber/Jennifer L. Wilkie FOR PLAINTIFF / APPLICANT

Marie Crowley                                                                               FOR DEFENDANT/ RESPONDENT

Edward Hore                                                                                  FOR INTERVENER

  

SOLICITORS OF RECORD:

Gowling Lafleur Henderson LLP                                                   FOR PLAINTIFF/APPLICANT

160 Elgin Street Suite 2600

Ottawa, Ontario    K1P 1C3

Morris Rosenberg                                                                           FOR DEFENDANT/RESPONDENT

Deputy Attorney General of Canada

Department of Justice

East Memorial Building

284 Wellington Street

Ottawa, Ontario K1A 0H8

Hazzard & Hore

141 Adelaide Street W., Suite 1002

Toronto, Ontario, M5h 3L5


                                                    FEDERAL COURT OF CANADA

                                                                 TRIAL DIVISION

                              NAMES OF COUNSEL AND SOLICITORS OF RECORD

  

DOCKET:                                             T-1120-01

STYLE OF CAUSE:                           Pfizer Canada Inc. v. Attorney General of Canada and the Canadian Drug Manufacturers' Association (Intervenor)

PLACE OF HEARING:                     Ottawa, Ontario

DATE OF HEARING:                       April 15, 2002

REASONS FOR ORDER AND ORDER:                          BLANCHARD J.

DATED:                                                June 25, 2002

  

APPEARANCES:

Anthony G. Creber/Jennifer L. Wilkie FOR PLAINTIFF / APPLICANT

Marie Crowley                                                                               FOR DEFENDANT/ RESPONDENT

Edward Hore                                                                                  FOR INTERVENER

  

SOLICITORS OF RECORD:

Gowling Lafleur Henderson LLP                                                   FOR PLAINTIFF/APPLICANT

160 Elgin Street Suite 2600

Ottawa, Ontario    K1P 1C3

Morris Rosenberg                                                                           FOR DEFENDANT/RESPONDENT

Deputy Attorney General of Canada

Department of Justice

East Memorial Building

284 Wellington Street

Ottawa, Ontario K1A 0H8

Hazzard & Hore

141 Adelaide Street W., Suite 1002

Toronto, Ontario, M5h 3L5

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