Apotex Inc. v. Canada (Minister of National Health and Welfare), docket T-20-98

Date: 19980729

Docket: T-20-98

BETWEEN:

     APOTEX INC., and NOVOPHARM LIMITED

                                         Applicants

     - and-

     THE MINISTER OF NATIONAL HEALTH AND WELFARE and

     GLAXO BIOCHEM INC.

                                         Respondents

     REASONS FOR ORDER

GIBSON J.:

[1]      These reasons arise out of an application for judicial review filed on behalf of the applicants on the 7th of January, 1998. While the "matter"¹ in respect of which relief is sought is not described in the applicants" originating notice of motion, it may be generally described as the action or decision of the Minister of National Health and Welfare, now the Minister of Health, (the "Minister") in adding to the Register required to be maintained by section 3 of the Patented Medicines (Notice of Compliance) Regulations² (the "Regulations"), Canadian Patent No.2,069,063 (the "Patent"). The applicants allege that the Patent claims only processes or intermediates and accordingly does not contain a claim or claims for a medicine or the use of a medicine, as required to conform to the Regulations and case law of this Court if the patent is to be eligible for inclusion on the Register. The applicants claim that the respondent, Glaxo Biochem Inc. ("Glaxo"), asserts that it has an exclusive licence to the Patent. Glaxo filed no material on this application and took no part in these proceedings.

[2]      The applicants seek the following relief:

1.      An order setting aside the decision of the Minister of National Health and Welfare...

to add to the Patent Register ..., maintained by the Minister pursuant to section 3 of

the Patented Medicines (Notice of Compliance) Regulations..., Canadian Patent Number 2, 069,063... .

2.      An order of mandamus requiring the Minister to remove the Patent from the Register.

3.      An order of mandamus requiring the Minister to maintain the Register in accordance with the law.

4.      A declaration that the Minister"s decision to include the Patent on the Register was ultra vires .

5.      Such further and other relief as counsel may advise.

[3]      In their memorandum of argument, the applicants revise the relief claimed to the following:

The applicants seek a declaration that the Minister"s decision to include the Patent on the Register is ultra vires . The applicants also request that the Minister"s decision to accept the patent information be set aside, that the Minister be ordered to purge the Register of the information and that the Minister be ordered to maintain the Register in accordance with the law.

[4]      This application was heard together with a similar, but more broadly based, application brought by the same applicants on Court file T-2070-97. In that matter, the applicants attacked the manner in which the Minister maintains the Register, in general, and without reference to any specific patent. I am satisfied that my reasons in respect of the application for judicial review on Court file T-2070-97 are generally applicable to this matter. Accordingly, they are attached for ease of reference and are made part of these reasons. With the exception of the portion of those reasons that relates to the issue of whether the subject matter of that application was properly the subject of judicial review, the issues and analysis are essentially identical.     

[5]      I am satisfied that this application is a proper subject matter for judicial review. It identifies a specific matter, that being a decision or action of the Minister to which the application for judicial review relates. That being said, on the basis of an analysis substantially similar to that set out in the attached reasons, I am not satisfied that the applicants have standing to bring this application for judicial review. Neither has filed for a notice of compliance by comparison or reference to a drug to which the Patent relates and neither has sent to the holder of the Patent a notice of allegation of non-infringement. By reference to affidavit material in support of the application, the applicants state in their memorandum of points to be argued:

Both applicants may one day make a submission for a notice of compliance for Lamivudint [the drug to which the Patent relates].          [emphasis added]

[6]      If and when a notice of compliance submission is made, if then Glaxo Biochem Inc. brings an application for judicial review to determine whether the allegation of non-infringement is justified, the issue of whether the Patent is properly on the Register will be before this Court and the applicant or applicants in connection with the new drug submission will also be properly before this Court.

[7]      On the evidence before me on this matter, I make no determination as to whether the applicants would be entitled to relief in respect of the inclusion of the Patent on the Register, if it were determined that this application is properly before the Court. The issue of whether the Patent contains only process or intermediate claims and not a claim or claims for a medicine or use of a medicine was not fully argued before me, although the only evidence before me on that issue was that it contains only claims for processes or for intermediates.

[8]      Assuming, without deciding, that the applicants have standing and that they are entitled to relief in respect of the inclusion of the Patent on the Register, my findings in the attached reasons as to an appropriate remedy would, I conclude, here apply for the reasons set out therein.

[9]      This application for judicial review will be dismissed. There will be no order as to costs.

                         ___________________________________

                             Judge

Ottawa, Ontario

July 29, 1998

[10]     

Date: 19980729

Docket: T-2070-97

BETWEEN:

APOTEX INC., and

NOVOPHARM LIMITED

     Applicants

- and -

THE MINISTER OF NATIONAL HEALTH AND WELFARE, and

THE ATTORNEY GENERAL FOR CANADA

     Respondents

    

     REASONS FOR ORDER

GIBSON, J.:

THE APPLICATION

[1]      These reasons arise out of an application for judicial review brought by the applicants. While the "matter"³ in respect of which relief is sought is not described in the applicants" originating notice of motion, it may be generally described as the manner in which the Minister of National Health and Welfare, now the Minister of Health, (the "Minister ") is maintaining the Register required to be maintained by section 3 of the Patented Medicines (Notice of Compliance) Regulations³ (the "Regulations"). More specifically, the applicants are concerned with the fact that the Register continues to include certain "process", "intermediate" and irrelevant patents, all of which do not contain a claim or claims for a medicine or the use of a medicine. These types of patents, following the jurisprudence of this Court, are not properly included in a patent list and therefore, by extension it is argued, on the Register.³

RELIEF REQUESTED

[2]      The applicants seek the following relief:

1.      An Order of mandamus requiring the Minister of National Health and Welfare (the "Minister") to maintain the Patent Register (the "Register") under the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 (the "Regulations") in accordance with the Regulations;

2.      An injunctive order requiring the Minister not to list any patent on the Register unless fully satisfied that the patent "contains a claim for the medicine itself or a claim for the use of the medicine" within s. 4 of the Regulations, and in particular, that the patent does not contain only claims for processes, only claims for intermediates, or only otherwise irrelevant claims;

3.      An order of mandamus requiring the Minister to delete any patent now listed on the Register unless fully satisfied that the patent "contains a claim for the medicine itself or a claim for the use of the medicine" within s. 4 of the Regulations, and in particular, that the patent does not contain merely claims for processes, only claims for intermediates, or only otherwise irrelevant claims;

4.      An order for mandamus requiring the Minister to amend the current "Form IV" under the Regulations so that the patentee must certify that the patent it seeks to list contains a claim for the medicine or the use of the medicine;

5.      Such further and other relief as counsel may advise.

BACKGROUND

[3]      In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare)³, ("Merck"), Mr. Justice Nadon considered a judicial review application, also in relation to the maintenance of the Register. I can do no better than to quote at length from the "Background and Facts" set out in his reasons for decision. In doing so, to reflect the fact that the Regulations have been recently extensively amended, and as amended are applicable to this matter, I have inserted into Mr. Justice Nadon's reasons the amended version of the provisions of the Regulations that were quoted by him in their earlier form. The amendments do not affect the applicability of his comments:

     The Regulations ... were enacted pursuant to s-s. 55.2(4) of the Patent Act, R.S.C. 1985, c. P-4 (the "Act") which states:

55.2.(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      (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.

55.2(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) 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.

     By the terms of s. 3 of the Regulations the Minister is required to open and maintain a patent Register..

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. [The second sentence of subsection 3.(1) was added by the recent amendments.]

3. (1) Le ministre ouvre un registre de tout renseignement soumis aux termes de l'article 4 et le tient à jour. À cette fin, il peut refuser d'y ajouter ou en supprimer tout renseignement qui n'est pas conforme aux exigences de cet article. [La seconde phrase de l'article 3.(1) a été ajoutée par les récents amendements.]

     Section 4 of the Regulations states that persons who hold a notice of compliance ("NOC") or persons who make a new drug submission ("NDS") may submit a patent list to the Minister.

4.(1) A person who files or has filed a submission for or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug.      (2) A patent list submitted in respect of a drug must      (a) indicate the dosage form, strength and route of administration of the drug;      (b) set out any Canadian patent that is owned by the person, or in respect of which the person has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list, that contains a claim for the medicine itself or the use of the medicine and that the person wishes to have included on the register;      (c) contain a statement that, in respect of each patent, the person applying for a notice of compliance is the owner, has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list;      (d) set out the date on which the term limited for the duration of each patent will expire pursuant to section 44 or 45 of the Patent Act; and      (e) set out the address in Canada for service on the person of any notice of an allegation referred to in paragraphs 5(3) (b) or (c), or the name and address in Canada of another person on whom service may be made, with the same effect as if service had been made on the person.

4.(1) La personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à l'égard de la drogue, accompagnée de l'attestation visée au paragraphe (7).      (2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants:      (a) la forme posologique, la concentration et la voie d'administration de la drogue;      (b) tout brevet canadien dont la personne est propriétaire ou à l'égard duquel elle détient une licence exclusive ou a obtenue le consentement du propriétaire pour l'inclure dans la liste, qui comporte une revendication pour le médicament en soi ou une revendication pour l'utilisation du médicament, et qu'elle souhaite voir inscrit au registre;      (c) une déclaration portant, à l'égard de chaque brevet, que la personne qui demande l'avis de conformité en est le propriétaire, en détient la licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste.      (d) la date d'expiration de la durée de chaque brevet aux termes des articles 44 ou 45 de la Loi sur les brevets;      (e) l'adresse de la personne au Canada aux fins de signification de tout avis d'allégation visé aux alinéas 5(3)b) ou c), ou les nom et adresse au Canada d'une autre personne qui peut en recevoir signification avec le même effet que s'il s'agissait de la personne elle-même.

Any subsequent person seeking a NOC, i.e. a generic drug company, may compare or refer to any drug for which a NOC has already issued. When doing so, this person, referred to as a "second person" in the Regulations, must look at all the patents on the patent Register which are filed with respect to the drug to which a comparison will be made and must allege that the drug for which they seek a NOC will not infringe any of the related patents on the Register. Additionally, the second person must send to the holder of the patent a notice of the allegation of non-infringement ("NOA"). Once a first person receives this notice, it may bring an application for judicial review to determine whether the allegations of non-infringement are justified. Sections 5 and 6 set out this procedure.

     [The text of sections 5 and 6 is quoted at length by Mr. Justice Nadon. That      text is not repeated here.]

While this process is unfolding, the Minister is prohibited from issuing a NOC to the second person for a defined period. For our purposes, the relevant parameters are the latest of 45 days after receiving proof that the NOA was served on the first person or 30 [now 24] months after receiving proof that a judicial review proceeding has been commenced by the first person or the expiration of the patents on the list which are not subject to an allegation. Section 7 of the Regulations deals with the statutory stay.

[The text of subsection 7(1) is not repeated here.]

In order to fully understand this process it must be emphasized that the regulations bridge two distinct statutes. The Food and Drugs Act, R.S.C., 1985, c. F-27 requires that anyone who wishes to market a drug in Canada must satisfy the Minister that the drug meets the required safety and effectiveness standards. Once these standards are met, the Minister, pursuant to s. C.08.004 of the Food and Drug Regulations, C.R.C. 1978, c. 870, will issue a NOC thus enabling the applicant to market that particular drug. The Patent Act protects the property rights of inventors. The Regulations also establish a framework with a view to the prevention of patent infringement. Under the Regulations, anyone wishing to market a drug without having to independently establish the safety and effectiveness of the drug, i.e. a generic drug company, may submit a NDS to the Minister and compare the drug to be marketed with one which has already received approval. Thus, the Regulations facilitate the marketing of generic drugs by relieving generic manufacturers from having to independently establish the safety of their products. At the same time the Regulations help ensure that the patents held by brand name manufacturers are not infringed.

[4]      The matter that was before Mr. Justice Nadon was an application by patent holders, or "brand name manufacturers" in the terms used by Mr. Justice Nadon, "first persons", in the terms of the Regulations , objecting to a purging from the Register, apparently in response to jurisprudence of this Court cited earlier, of patents which had expired, which covered only a process or which were clearly irrelevant such as, for example, a patent for a medical device and not for a medicine at all. Mr. Justice Nadon concluded at page 322:

On the premise that the identification of process claims is accomplished merely by reading the claim, without even having to understand the contents of the claim, I fail to comprehend how anything further is required of this Court. The Court has stated that such patents do not fall within the ambit of the Regulations. The Minister, in maintaining the Register, has the power to remove process patents. Should a dispute arise as to whether a particular patent contains only process claims, then that issue must be addressed. It may be that an application to this Court will eventually be required and that the claim at issue will be interpreted. However, I cannot state that, a priori, the Court is required to pronounce in every instance whether a simple phrase such as "a process for" is found in a claim. If the evidence had been inconclusive with respect to how pure process claims are identified, my decision might have been otherwise.

Mr. Justice Nadon further concluded at page 328:

I accept the position of the Minister that the task of identifying process only and irrelevant patents was a ministerial act. That is to say that there was in fact no decision to be made. (See generally S. A. de Smith, Judicial Review of Administrative Action, 6th ed. (London: Stevens & Sons, 1996)). The determination of whether a claim is one for only a process involved a mere reading of the claim. Consequently, as the Regulations require that patents submitted by first persons and placed on the Register by the Minister comply with the requirements of s. 4, as interpreted by this Court, it is merely a ministerial act for the patents to be added or removed. The Minister shall maintain the Regulations [sic/Register] in accordance with the Regulations.                              [emphasis added]

[5]      In the result, Mr. Justice Nadon dismissed the application before him.

[6]      This application represents, to some extent, the converse of the application that was before Mr. Justice Nadon. The applicants here are concerned that the process of purging of the Register that the Minister engaged in did not go far enough. It did not purge all patents containing only process claims. Those that were the subject of litigation were left on the Register. Further, the Minister made no attempt to purge patents containing only intermediate claims.

[7]      The Director General of the Canadian Drug Manufacturing Association wrote to an official within the Minister's department of government on July 2, 1997 requesting a more thorough purging of the Register. While that request was not rejected, it has not been acted upon. Thus, then, this application to achieve a more thorough purging was filed.

[8]      I turn to an analysis of the issues on this application for judicial review.

ANALYSIS OF THE ISSUES

1)      Is the subject matter of this application properly the subject of judicial review

[9]      Subsection 18.1(1) of the Federal Court Act, quoted in footnote 1 to these reasons, is repeated here for ease of reference:

18.1 (1) An application for judicial review may be made by the Attorney General of Canada or by anyone directly affected by the matter in respect of which relief is sought.                                   [emphasis added]

18.1 (1) Une demande de contrôle judiciaire peut être présentée par le procureur général du Canada ou par quiconque est directement touché par l'objet de la demande.                  [Je souligne]

[10]      I had occasion to consider the issue of "matters" amenable to judicial review in Her Majesty in Right of Alberta v. Canadian Wheat Board.³ In that case, I concluded that judicial review was there being sought of a "program" of the Canadian Wheat Board. I wrote:I am further satisfied that the "program" in respect of which judicial review is being sought here is a single matter. It is a complex program. It directly affects a wide range of individuals and businesses, both producers and many others. Its objective, within the broader context of the overall program of the Canadian Wheat Board, is directed to the object for which the Board is incorporated by the Canadian Wheat Board Act , namely, the marketing in an orderly manner, in interprovincial and export trade, of grain grown in Canada. It is a matter directed to the implementation of public policy. As such it is not easily amenable to judicial review, nor does it lend itself readily to some of the forms of relief contemplated on an application for judicial review, particularly the remedy of setting aside of the "matter" and referring it back for reconsideration. Rather, as a tool of public policy, the grain delivery program is, by nature, in my opinion, more amenable to review through pre-adoption public consultation and the political process. That opinion is consistent with the fact that, on the evidence before me, the respondent engaged in a broad public consultation in the development of the grain delivery policy for the crop year, 1995/96. The applicant was a party to that consultation process.

[11]      Here, the matter sought to be reviewed, which I will generally describe as the course of conduct of the Minister in the maintenance of the Register, is not a "program" but rather a general course of conduct in maintaining the Register which is a critical element of a program aptly described by Mr. Justice Nadon in Merck. That program is "... a matter directed to the implementation of public policy." The Minister's course of conduct, within the context of that program but without a specific action under section 3 of the Regulations, is not easily amenable to judicial review, nor does it lend itself readily to some of the forms of relief contemplated on an application for judicial review. As with the grain delivery program of the Canadian Wheat Board, I conclude that the Minister's course of conduct is more amenable to review through public consultation and the political process. The Regulations, presumably including the maintenance of the Register provided for in the Regulations have recently been the subject of an extensive public consultation in the course of the development of the recent amendments to the Regulations. The applicants were, or could have been, party to that consultation process.

[12]      I conclude as I did in Her Majesty in Right of Alberta v. Canadian Wheat Board, supra. I conclude that Parliament, in enacting subsection 55.2(4) of the Patent Act, and the Governor in Council, in enacting pursuant to that subsection the regulatory scheme of which the Register is a component, could not have contemplated judicial review of the Minister's course of conduct in the maintenance of the Register; that is to say, the conduct of the Minister or his or her delegate in determining the information to be added to, maintained on or deleted from the Register. On the basis of the broad public policy characteristics of the program of which the Minister's conduct in the maintenance of the Register is a part, I conclude that that course of conduct is not a proper subject of judicial review within the contemplation of subsection 18.1(1) of the Federal Court Act.

2)      Are the applicants persons "directly affected" by the matter in respect of which relief is here sought or do they otherwise have a form of public interest standing that would entitle them to bring this application for judicial review?

[13]      For ease of reference, I once again quote subsection 18.1(1) of the Federal Court Act:

18.1 (1) An application for judicial review may be made by the Attorney General of Canada or by anyone directly affected by the matter in respect of which relief is sought.                  [emphasis added]

18.1 (1) Une demande de contrôle judiciaire peut être présentée par le procureur général du Canada ou par quiconque est directement touché par l'objet de la demande.                  [Je souligne]

[14]      The applicants are generic drug manufacturers and, as such, are each regularly engaged in the process of making new drug submissions in accordance with the Regulations. Each is also regularly engaged in the litigation contemplated by those Regulations, litigation brought against them by "brand name manufacturers" or "first persons". However, there is no specific patent or patents on the Register that is or are identified in this proceeding and in relation to which either of the applicants has filed a new drug submission.

[15]      Once again, I examined this question at some length in Her Majesty in Right of Alberta v. Canadian Wheat Board, supra, where I concluded that Her Majesty in Right of Alberta was not a person directly affected, taking into account the reasons of Madame Justice Reed in Friends of the Island Inc. v. Canada (Minister of Public Works)⁴ and the reasons of Mr. Justice MacKay in Nova Scotia (Attorney General) v. Ultramar Canada Inc.⁵

[16]      On the evidence before me, I find no basis to conclude that the applicants are "anyone directly affected" by the Minister"s course of conduct in maintaining the Register, within the meaning of subsection 18.1(1) of the Federal Court Act . The applicants are not "second persons" with identifiable direct interests at stake under the Regulations under which the Minister maintains the Register. I conclude that while they are, or may some day become so, in respect of a specific entry or entries on the Register, that is insufficient to constitute a direct interest to support this application.

[17]      It is undoubtedly true that the applicants have a general interest in the manner in which the Minister maintains the register. That is not sufficient, I conclude, to establish direct effect⁶. In the broader context of public interest standing or a broad interpretation of "directly affected", I cannot conclude on the facts of this matter that there is no other effective way that this matter could come before this Court, given the procedures provided for in the Regulations in circumstances where the applicants, or either of them, identify a specific patent or patents in a new drug submission and a proceeding is commenced against them or either of them as provided in the Regulations.

[18]      I conclude that, even if the subject matter of this application is a proper subject of judicial review, the applicants nonetheless lack standing to bring this application.

[19]      Either of my conclusions to this point in these reasons is determinative of this application for judicial review. I will nonetheless go on to consider the substantive issue raised by the application and the question of the appropriate relief, if any, in favour of the applicants to minimize the risk that the application might have to be reheard if I am determined to be wrong in my conclusions to this point.

3)      Are the applicants entitled to relief?

[20]      The Minister filed no evidence on this application that would go to the question of why, in the light of the jurisprudence referred to earlier in these reasons, the Register has been purged in part only of process patents and not at all with respect to intermediate patents.⁶ There was, of course, no obligation on the part of the Minister to file such evidence.

[21]      In the affidavit of Randall Stuart Mitchell filed on behalf of the applicants, Dr. Mitchell, a patent agent, attested in part as follows:3.      I am informed by Edward Hore, and verily believe, that after the Deprenyl decision, Health Canada commissioned the Canadian Intellectual Property Office ("CIPO"), to carry out an audit of the Register maintained by the Minister under section 3 of the Regulations. The audit merely identified process patents and "irrelevant" patents, meaning patents not for a pharmaceutical at all. It appears Health Canada has made no attempt to identify patents claiming only intermediates or pharmaceutical patents (other than process patents) containing no claim for the medicine itself or the use of the medicine itself, either now listed on the Register, or that may be submitted for listing.

4.      It would [be]feasible for Health Canada to commission an agency such as CIPO to do an audit and on-going review that would identify such patents. The listed "medicine" on the Register in each case is a drug for which a Notice of Compliance (NOC) has been granted. Information about the medicine, its chemical composition, formulation, dosage form and so on is contained in the product monograph, a publicly available document approved by Health Canada as part of the process of granting an NOC. Such information is also contained in standard pharmaceutical reference works.

5.      An official with some background in pharmaceutical patents, such as a CIPO patent examiner, could without much difficulty review a patent on the Register or submitted for listing and satisfy himself or herself whether it claimed the medicine itself or the use of the medicine, or merely an intermediate or something not relevant to the medicine or its use.

6.      In the great majority and possibly all cases, this determination could be made easily on the basis of the public information about the medicine. In any case where there was doubt, the patentee, which would be familiar with its own product, could be asked to provide information clarifying that the patent indeed claims the medicine itself or the use of the medicine. If the official was not satisfied on this point, the patent could be removed from the Register or not listed.

[22]      On cross-examination on his affidavit, Dr. Mitchell acknowledged that such a review would require the involvement of "...someone in possession of certain chemical knowledge that would not be necessary in the case of the process patents". However, he remained unshaken in the expert opinion expressed in his affidavit.

[23]      In material filed on behalf of the Minister, a letter dated the 7th of October, 1996 from Michael Howarth, a patent examiner in the Canadian Intellectual Property Office who assisted the Minister's officials in the limited purging of the Register that was carried out and who has since reviewed lists of patents to be added to the Patent Register, wrote:As a consequence of our meeting the other day I also checked the subject matter of the patents to see what they actually claimed. [These were patents on a list of patents proposed for addition to the Register.] Out of the 70 patents checked only 4 were claimed intermediates and these were clearly identified as such in the patent disclosures. If the new additions to the Register are any guide therefore there would seem to be no difficulty in identifying those patents which claim intermediates so that they can be screened out. It took me about a day and a half to check the patents so I would estimate that it would take 15 to 20 working days to check the entire Register. I am glad to say the process was easier than I expected so if it is decided that the whole Register needs to be done there would be no problem .                                           [emphasis added]

[24]      On the basis of the evidence before me, while I will not speculate as to the reasoning of the Minister in not conducting a full purging of the Register, I conclude that difficulty and cost could not be major considerations.

[25]      In Padfield and others v. the Minister of Agriculture, Fisheries and Food and others,⁷ Lord Pearce wrote at page 714:I do not regard a Minister's failure or refusal to give any reasons as a sufficient exclusion of the court's surveillance. If all the prima facie reasons seem to point in favour of his taking a certain course to carry out the intentions of Parliament in respect of a power which it has given him in that regard, and he gives no reason whatever for taking a contrary course, the court may infer that he has no good reason and that he is not using the power given by Parliament to carry out its intentions.

I conclude that the same might be said in respect of a power given to a Minister by the Governor in Council through regulations enacted pursuant to an Act of Parliament.

[26]      More recently, to the same effect, Mr. Justice Chadwick wrote in Ottawa-Carleton Dialysis Services v. Ontario (Minister of Health)⁷ at page 230:

As indicated based upon the material before me, I am unable to conclude true reasons for the cancellation of the RFP. In view of the lack of responding material I can only draw the inference that it was made for political reasons or other unknown reasons outside of the provision of the Independent Health Facilities Act. The only inference that can be drawn is that the Ministry of Health could not provide any evidence to establish that the decision to cancel was based upon proper considerations and not upon extraneous grounds. (See Bernardi v. Guardian Royal Exchange Assurance Co., [1997] I.L.R. 1-1143 (Ont. C.A.) at pg. 390).

[27]      I draw a similar inference here in the absence of evidence on behalf of the Minister. I infer that the Minister could not provide evidence to establish that the decision to not fully purge the Register in accordance with the decisions of this Court, was based upon proper considerations and not upon extraneous grounds. In the recent amendments to the Regulations, the Minister was given explicit authority to "...consult with officers or employees of the Patent Office". This is in fact the practice that he has for some time engaged in for the purpose of purging the Register, in part at least, of process patents and for the further purpose of ensuring that new process patents are not added to the Register. In light of the advice that the Minister has received from Mr. Howarth and in the absence of evidence on behalf of the Minister, I conclude that, in the absence of the considerations previously addressed in these reasons, the applicants would be entitled to relief.

4)      What relief, if any, is appropriate?

[28]      In their Memorandum of Argument, the applicants modified the relief which they request to read as follows:The applicants request

C      an order that the Minister be prohibited from listing any patent unless fully satisfied that the patent "contains a claim for the medicine itself or a claim for the use of the medicine", and in particular that the patent does not contain only claims for processes, only claims for intermediates, or only otherwise irrelevant claims.

C      an order of mandamus requiring the Minister to delete any patent now listed on the Register unless fully satisfied that the patent "contains a claim for the medicine itself or a claim for the use of the medicine", and in particular that the patent does not contain only claims for processes, only claims for intermediates, or only otherwise irrelevant claims.

[29]      The requested relief reflects the position of the applicants that the Minister has a legal duty to maintain the Register in accordance with the Regulations, as interpreted by jurisprudence of this Court holding that patents that contain only claims for processes, only claims for intermediates, or only otherwise irrelevant claims are outside the scope of the Regulations and, therefore, are improperly on the Register. On this basis, the applicants argued that the Minister should be compelled, by an order in the nature of mandamus, to further purge the Register and thereafter to maintain it in a manner that ensures that no patents containing only process, intermediate, or otherwise irrelevant claims appear on it.

[30]      In Apotex Inc. v. Canada (Attorney General)⁷ the Federal Court of Appeal reviewed the law on when relief in the nature of mandamus is available. The conditions required to support such relief are summarized as follows:

     1.      There must be a public legal duty to act;

     2.      The duty must be owed to the applicant;

     3.      There is a clear right to the performance of that duty, in particular:

(a)      the applicant has satisfied all conditions precedent giving rise to the duty; and

(b)      there was

(i)      a prior demand for performance of the duty;

(ii)      a reasonable time to comply with the demand unless refused outright; and

(iii)      a subsequent refusal which can be either expressed or implied, e.g. unreasonable delay;

4.      Where the duty sought to be enforced is discretionary, the following rules apply:

(a)      in exercising a discretion, the decision-maker must not act in a manner which can be characterized as "unfair", "oppressive" or demonstrate "flagrant impropriety" or "bad faith";

(b)      mandamus is unavailable if the decision-maker"s discretion is characterized as being "unqualified", "absolute", "permissive" or "unfettered";

(c)      in the exercise of a "fettered" discretion, the decision-maker must act upon "relevant" as opposed to "irrelevant" considerations;

(d)      mandamus is unavailable to compel the exercise of a "fettered discretion" in a particular way; and

(e)      mandamus is only available when the decision-maker"s discretion is "spent"; i.e. , the applicant has a vested right to the performance of the duty;

     5.      No other adequate remedy is available to the applicant;

6.      The order sought will be of some practical value or effect;

7.      The Court in the exercise of its discretion finds no equitable bar to the relief sought;

8.      On a "balance of convenience" an order in the nature of mandamus should (or should not) issue.

[31]      Having regard to the foregoing conditions, particularly the second, third and fifth, I am not satisfied that the Minister"s duty under section 3 of the Regulations is, on the facts of this matter, properly enforceable by an order in the nature of mandamus. The relevant portions of section 3 provide:

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.      ...

(4) For the purpose of deciding whether information submitted under section 4 should be added to or deleted from the register, the Minister may consult with officers or employees of the Patent Office.

(4)      Pour décider si tout renseignement fourni aux termes de l"article 4 doit être ajouté au registre ou en être supprimé, le ministre peut consulter le personnel du Bureau des brevets.

[32]      The Minister"s duty under section 3 of the Regulations is to maintain a register of information submitted under section 4. In my view, this is a public duty. It is a duty owed to the public, not exclusively or even primarily to first or second persons. Put another way, it is not a duty relating exclusively or even primarily to the protection of proprietary interests or rights of brand name manufacturers or to the balancing of the interests of such manufacturers with those of generic manufacturers.⁸ This is distinguishable from the nature of the Regulations, taken as a whole, which regulate the relationship between those manufacturers.⁹

[33]      It is well established that the Minister"s duty is purely administrative and ministerial in nature.¹⁰ I conclude that it is also clear from the wording of section 3 of the Regulations that the Minister has discretion, however limited, in how he or she discharges the duty to maintain the Register. The second sentence of subsection 3(1) is permissive, not mandatory; the Regulations confirm the Minister"s authority to remove or exclude information. Although the Minister may consult the Patent Office regarding information submitted to determine whether it should be added to or deleted form the Register, he retains discretion as to whether or not to do so.

[34]      I note the fifth condition cited above, that no other adequate remedy is available to the applicant. The applicants herein are concerned about the potential delay in their market entry in respect of generic versions of drugs by otherwise unnecessary prohibition proceedings in respect of patents on the Register, but not eligible for inclusion on, the Register. In my view, this is a valid and justiciable concern which is more properly raised in prohibition proceedings themselves and in relation to which provisions for summary dismissals and costs awards with regard to patents improperly included on the Register have recently been added to the Regulations. The applicants therefore have alternative remedies that I conclude are "adequate".

[35]      Having regard to the conditions required to support relief in the nature of mandamus noted above, I therefore conclude that compelling performance of the Minister"s duty under section 3 of the Regulations is not something for which mandamus should issue in favour of the applicants on the facts of this matter..

[36]      I reach the same conclusion, for essentially the same reasons, in respect of relief in the nature of prohibition.

[37]      That said, I am satisfied that if relief were to be granted on this application, declaratory relief could issue since it is clear, on the evidence before me, that some patents remain improperly on the Register. Accordingly, if the applicants were to be found, on the facts of this matter, to have standing in respect of a judicially reviewable matter, I would issue an order declaring that the Minister is required to maintain the Register in accordance with law and, on the evidence before me, is not doing so.

CONCLUSION

[38]      This application for judicial review will be dismissed. There will be no order as to costs.

                             ________________________________

                                 Judge

Ottawa, Ontario

July 29, 1998

__________________

¹      Subsection 18.1(1) of the Federal Court Act , R.S.C. 1985 c. F-7 (as amended) provides as follows:

18.1(1) An application for judicial review may be made by the Attorney General of Canada or by anyone directly affected by the matter in respect of which relief is sought.                                      [emphasis added]

18.1 (1) Une demande de contrôle judiciaire peut être présentée par le procureur général du Canada ou par quiconque est directement touché par l'objet de la demande. [Je souligne]

²      SOR/93-133 as amended by SOR/98-166, 12 March, 1998

1      Subsection 18.1(1) of the Federal Court Act , R.S.C. 1985 c. F-7 (as amended) provides as follows:
        

18.1(1) An application for judicial review may be made by the Attorney General of Canada or by anyone directly affected by the matter in respect of which relief is sought.                                  [emphasis added]	18.1 (1) Une demande de contrôle judiciaire peut être présentée par le procureur général du Canada ou par quiconque est directement touché par l'objet de la demande. [Je souligne]

2      SOR/93-133 as amended by SOR/98-166, 12 March, 1998

3      In Eli Lilly and Co. et al. v. Novopharm Ltd. et al., (1997), 76 C.P.R. (3d) 312 (F. C.T.D.), Mr. Justice Dubé wrote at page 322:
         It is now settled, insofar as to the Trial Division of this Court is concerned, that patents which contain only process claims, or claims to an intermediate, are not properly included in a patent list, as they do not contain either in fact or in law a claim to a medicine in itself or to its use, as required by the Regulations.
     For this proposition, Justice Dubé cites Deprenyl Research Ltd. v. Apotex Inc.(1994), 55 C.P.R. (3d) 171 (F.C.T.D.), aff"d (1995), 60 C.P.R. (3d) 501 (F.C.A.). See also: Eli Lilly and Co. et al. v. Apotex Inc. et al. (1995), 63 C.P.R. (3d) 245 (F.C.T.D.), aff"d (1996), 68 C.P.R. (3d) 126 (F.C.A.). The register is made up of information included in patent lists.

4      (1997), 74 C.P.R. (3d) 307 (F.C.T.D.). Notice of Appeal filed 11 July, 1997, to the Federal Court of Appeal: A-502-97.

³      [1997] F.C.J. No. 1484 (T.D.) (QL) Notice of Appeal filed 27 November 1997, to the Federal Court of Appeal: A-863-97. (This issue was not raised by either of the parties nor was this case cited. The Court raised the issue and the case and provided counsel an opportunity for consideration and to make submissions).

⁴      [1993] 2 F.C. 229 (T.D.), rev'd (1995), 18 C.E.L.R. (N.S.) (F.C.A.) on other grounds.

⁵      [1995] 3 F.C. 713 (T.D.)

          See Merck Frosst Canada Inc.v. Canada (Minister of National Health and Welfare) (1997), 72 C.P.R. (3d) 187 at 191-2, where MacKay J. wrote:
[T]he essential difference in the standing of a party respondent when compared with that of an intervenor is that the former is deemed to have an interest adverse to that of the applicant which is a legal interest to be directly affected by the decision of the tribunal or officer that is subject to review... Neither Apotex nor Novopharm have made application for an NOC for any of the other drug products concerned in these proceedings... In this case I am not persuaded that Apotex and Novopharm should be named as respondent.
See also: United Telegraph Workers v. Canadian Brotherhood of Railway, Transport and General Workers et al., [1982] 1 F.C. 603 (C.A.)

⁶      See the quotation from Nadon J. in Merck, supra , note 4, where he wrote: "The Minister shall maintain the Regulations [sic/Register] in accordance with the Regulations."

10      [1968] 1 All E.R. 694 (H.L.)     

11      (1996), 41 Admin. L.R. (2d) 211 (Ont. Ct. (Gen. Div.)), leave to appeal to the Ontario Court of Appeal granted 3 December 1996.

⁷      [1994] 1 F.C. 742 at 766-69 (C.A.), aff"d [1994] 3 S.C.R. 1100.

⁸      See Apotex v. Canada (Attorney General),[1986] 2 F.C. 233 (T.D.), per Walsh J. and Merck & Co. v. Canada (Minister of Health), [1998] F.C.J. No. 412 (T.D.) (QL), per Wetston J.

⁹      Novopharm Ltd. v. Canada (Minister of National Health and Welfare), [1998] F.C.J. No. 130 at para. 19 (T.D.) (QL), per Hugessen J.

¹⁰      Ibid. at para 16. See also supra, note 4, per Nadon J.