Glaxosmithkline Inc. v. Apotex Inc.

Glaxosmithkline Inc. v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2003-09-10
Neutral citation
2003 FC 1055
File numbers
T-876-02
Notes
Digest
Decision Content
Date: 20030910
Docket: T-876-02
Citation: 2003 FC 1055
OTTAWA, ONTARIO, this 10th day of September, 2003
PRESENT: The Honourable Mr. Justice James Russell
BETWEEN:
GLAXOSMITHKLINE INC. and
SMITHKLINE BEECHAM P.L.C.
Applicants
and
APOTEX INC. and
THE MINISTER OF NATIONAL HEALTH
Respondents
REASONS FOR ORDER AND ORDER
NATURE OF APPLICATION
[1] This is an application pursuant to subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations, S.C. 1993, c. 2, s. 4 (the "Regulations") by which the Respondent Apotex Inc. ("Apotex") seeks an order dismissing an application made under subsection 6(1) of the Regulations by Glaxosmithkline Inc. and Smithkline Beecham P.L.C. ("GSK"). The GSK application under subsection 6(1) was for an order prohibiting the Minister of Health (the "Minister") from issuing a Notice of Compliance ("NOC") to Apotex for its paroxetine hydrochloride anhydrate tablets with 10, 20 and 30mg strengths.
[2] The subsection 6(1) application was commenced by notice of allegation ("NOA") dated June 6, 2002.
[3] Apotex takes the position that GSK's subsection 6(1) application should be dismissed because Canadian Letters Patent Nos. 2,168,829 ( the "829 Patent"), 2,210,023 (the "023 Patent") and 2,211,522 (the "522 Patent") (collectively the "Patents") are improperly listed on the register maintained by the Minister pursuant to the Regulations (the "Register").
[4] The Minister of Health filed no materials in response to the application and did not appear at the hearing.
BACKGROUND
[5] The basic facts behind this application under subsection 6(5) of the Regulations are not in dispute.
[6] GSK markets paroxetine hydrochloride hemihydrate tablets in 10, 20 and 30mg dosage strengths. GSK's original NOC for paroxetine hydrochloride hemihydrate tablets issued on May 4, 1993, as a result of an abbreviated new drug submission ("ANDS") submitted on June 11, 1990.
[7] The applications for all three of the Patents were filed on February 5, 1996, several years after GSK received the original NOC for paroxetine hydrochloride hemihydrate tablets. The '829 Patent was issued on December 16, 1997, the '023 Patent was issued on February 9, 1999 and the '522 Patent was issued on December 7, 1999.
[8] GSK submitted the Patents for inclusion on the Register in connection with a number of supplementary New Drug Submissions ("NDS").
[9] The '829 Patent and the '023 Patent were first added to the Register on October 18, 1999. The '522 Patent was added to the Register on January 10, 2000.
NATURE OF DISPUTE
[10] Apotex cites several reasons why a dismissal order should be granted pursuant to subsection 6(5) of the Regulations:
. The Patents were not listed in accordance with the strict timing requirements of section 4 of the Regulations and so were not properly included on the Register and cannot be used to prohibit the issuance of an NOC in favour of Apotex by the Minister; and
. The Patents were not eligible for inclusion on the Register because of their subject matter and so cannot be used to prohibit the issuance of an NOC in favour of Apotex by the Minister; and
. Even if the Patents were properly listed on the Register, they are not relevant to Apotex's NOC application so that the subsection 6(1) application by GSK is frivolous, vexatious and an abuse of process within the meaning of subsection 6(5)(b) of the Regulations.
STANDARD TO BE MET
[11] The parties disagree on the standard to be met to allow this Court to dismiss a subsection 6(1) application in accordance with subsection 6(5)(a) of the Regulations.
[12] Subsection 6(5)(b) of the Regulations uses the words "redundant, scandalous, frivolous or vexatious or is otherwise an abuse of the process," thus inviting the "plain and obvious" test enunciated in Hunt v.Carey, [1990] 2 S.C.R. 959 at 970.
[13] In Bayer Inc. v. Apotex Inc. (1998), 85 C.P.R. (3d) 334, Joyal J., on a motion to dismiss under subsection 6(5)(b) of the Regulations, decided that such a motion should only be granted where the Notice of Application is clearly improper and bereft of any possibility of success. This is because subsection 6(5)(b) merely gives the Court explicit jurisdiction to consider motions to dismiss where, previously, the Court had relied upon its own rules to do so. Hence, the restrictive standard in Hunt, supra, should apply.
[14] Where the parties in the present application disagree is in relation to the standard to be applied under subsection 6(1)(a). GSK argues that is should be the same restrictive "plain and obvious" standard and relies upon the recent decision of Gauthier J. in Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2003] FCJ No. 750 at para. 9 (F.C.T.D.).
[15] Apotex argues that the decision of Gauthier J. in Procter, supra, is wrong on this point and invites me to apply the normal civil standard of balance of probabilities. In this regard, Apotex points out that subsection 6(5)(a) is not, in effect, equivalent to the Court's own rules in the way that subsection 6(5)(b) is. Thus it involves significantly different considerations. Apotex points to the words of Rothstein J.A. in Apotex Inc. et al v. Minister of National Health and Welfare et al (2000), 3 C.P.R. (4th), concerning the general scheme of the Regulations:
22. [...]The Regulations expressly provide a process by which generic manufacturers may obtain relief in the event they are prejudiced by reason of ineligible patents being included on the Register.[...]
[...]
23. It is apparent that in enacting paragraph 6(5)(a) of the Regulations, the Governor in Council was aware of, and allowed for, the possibility that ineligible patents may find their way onto the Register and may not be readily capable of being deleted under subsection 3(1). Paragraph 6(5)(a) provides generic drug manufacturers [page10] with the opportunity, if and when prohibition proceedings are commenced by a patent holder in respect of a Notice of Allegation served by the generic, to apply to the Court to dismiss the prohibition application because it is based on an ineligible patent included on the Register.
24. This form of relief may not be a perfect solution for the generic manufacturers because, as appellants' counsel pointed out, the prohibition application will only be dismissed if all the patents at issue are not eligible for inclusion on the Register and because the proceeding does not provide for a court order requiring the Minister to purge the Register of ineligible patents. However, the remedy provided by paragraph 6(5)(a) does directly address the problem of a generic manufacturer having to compare its product with the drug of a patent holder whose drug is based on an ineligible patent. It provides a judicial forum in which the eligibility of the specific patent or patents at issue can be decided by the Court after hearing from the patent holder and the generic competitor.
[16] Given the general purpose of subsection 6(5)(a) as articulated by Rothstein J.A. in Apotex Inc., supra, there is no reason, Apotex argues, why the restrictive, Hunt, supra, "plain and obvious" standard should be applied to this kind of application.
[17] In Procter, supra, the judgment of Gauthier J. reads as follows on this point:
9. Before addressing the main issues raised by Genpharm's motion, it is also important to note that there has been no decision made pursuant to paragraph 6(5)(a) of the NOC Regulations since the provision was added in 1998 and the parties disagree on the standard or test to be applied in assessing the merits of this motion.
[...]
12. Procter argues that the reasoning adopted in Bayer applies when dealing with a motion under paragraph 6(5)(a) while Genpharm submits that the purpose of this provision is to get rid of groundless notices of application and there is thus no reason to adopt such a restrictive approach.
13. The parties said little more to support their respective position.
14. The administrative scheme set out in sections 5 and 6 of the NOC Regulations is intended to apply only where a notice of compliance is filed in respect of a drug that can be compared with another drug for which a patent was properly included in a patent list on the Register. Thus, a motion to strike a notice of application filed under subsection 6(1) based on the fact that the only patent currently on the Register should not be there, is or is akin to a motion to strike out the proceeding on the basis that there is no reasonable cause of action.
15. It is settled law that if this interpretation is correct, the restrictive standard set out in Hunt, supra, should apply. Genpharm would thus have to prove that it is plain and obvious that the '376 Patent was not eligible for inclusion in the Register.
[18] It is clear from these passages that Gauthier J. did not have the benefit of full argument on this issue and was not asked to consider the general rationale for subsection 6(5)(a) enunciated by Rothstein J.A. in Apotex, supra. This being the case, Gauthier J.'s decision cannot be considered as strong authority on this point and, in any event, Gauthier J. went on to decide that the relevant standard to be applied under subsection 6(5)(a) was not determinative in Procter, supra, because the Court "would have reached the same conclusion even if it had not applied [the restrictive standard]."
[19] The judgment of Rothstein J.A. in Apotex, supra, does not specifically state what standard should be applied in applications under subsection 6(5)(a), but, rather than characterizing such an application as being analogous to a motion to strike on the basis that there is no reasonable cause of action, it concludes that such an application "provides a judicial forum in which the eligibility of the specific patent or patents at issue can be decided by the Court after hearing from the patent holder and the generic competitor."
[20] If the court is not being asked to decide that there are no reasonable grounds for GSK's section 6(1) application, but is merely examining eligibility after hearing from the parties, there is no justification, as far as Apotex is concerned, for applying the restrictive Hunt, supra, "plain and obvious" test under subsection 6(5)(a).
[21] In my opinion, the issue of which standard applies under 6(5)(a) still remains to be determined. In the case before me, the matter is not determinative because, even if I apply the less restrictive standard that is urged upon me by Apotex, I cannot, for reasons that follow, allow this application.
ELIGIBILITY AND TIMING
[22] Of the several grounds advanced by Apotex to show that the Patents are not properly listed on the Register, the most significant involves a consideration of crucial timing issues. Those timing issues bring into play the whole scheme of the Regulations and a detailed consideration of the following provisions:
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 a claim for 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 paragraph 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.
(3) Subject to subsection (4), a person who submits a patent list must do so at the time the person files a submission for a notice of compliance.
(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).
(5) When a first person submits a patent list or an amendment to an existing patent list in accordance with subsection (4), the first person must identify the submission to which the patent list or the amendment relates, including the date on which the submission was filed.
(6) A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in accordance with subsection (4).
(7) A person who submits a patent list or an amendment to an existing patent list under subsection (1) or (4) must certify that
(a) the information submitted is accurate; and
(b) the patents set out on the patent list or in the amendment are eligible for inclusion on the register and are relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for a notice of compliance has been filed.
5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
(1.1) Subject to subsection (1.2), where subsection (1) does not apply and where a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine found in another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent included on the register in respect of the other drug containing the medicine, where the drug has the same route of administration and a comparable strength and dosage form,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
(1.2) Where a person referred to in subsection (1.1) has served, in accordance with paragraph (3)(b) or (c), a notice of allegation on a first person in respect of a patent included on the register, the person is not required to serve a notice of allegation in respect of the same submission, the same allegation and the same patent on another first person.
(2) Where, after a second person files a submission for a notice of compliance but before the notice of compliance is issued, a patent list or an amendment to a patent list is submitted in respect of a patent pursuant to subsection 4(4), the second person shall amend the submission to include, in respect of that patent, the statement or allegation that is required by subsection (1) or (1.1), as the case may be.
(3) Where a person makes an allegation pursuant to paragraph (1)(b) or (1.1)(b) or subsection (2), the person shall
(a) provide a detailed statement of the legal and factual basis for the allegation;
(b) if the allegation is made under any of subparagraphs (1)(b)(i) to (iii) or (1.1)(b)(i) to (iii), serve a notice of the allegation on the first person;
(c) if the allegation is made under subparagraph (1)(b)(iv) or (1.1)(b)(iv),
(i) serve on the first person a notice of the allegation relating to the submission filed under subsection (1) or (1.1) at the time that the person files the submission or at any time thereafter, and
(ii) include in the notice of allegation a description of the dosage form, strength and route of administration of the drug in respect of which the submission has been filed; and
(d) serve proof of service of the information referred to in paragraph (b) or (c) on the Minister.
RIGHT OF ACTION
6. (1) A first person may, within 45 days after being served with a notice of an allegation pursuant to paragraph 5(3)(b) or (c), apply to a court for an order prohibiting the Minister from issuing a notice of compliance until after the expiration of a patent that is the subject of the allegation.
(2) The court shall make an order pursuant to subsection (1) in respect of a patent that is the subject of one or more allegations if it finds that none of those allegations is justified.
(3) The first person shall, within the 45 days referred to in subsection (1), serve the Minister with proof that an application referred to in that subsection has been made.
(4) Where the first person is not the owner of each patent that is the subject of an application referred to in subsection (1), the owner of each such patent shall be made a party to the application.
(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application
(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register or are irrelevant to the dosage form, strength and route of administration of the drug for which the second person has filed a submission for a notice of compliance; or
(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.
(6) For the purposes of an application referred to in subsection (1), where a second person has made an allegation under subparagraph 5(1)(b)(iv) or (1.1)(b)(iv) in respect of a patent and where that patent was granted for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes.
(7) On the motion of a first person, the court may, at any time during a proceeding,
(a) order a second person to produce any portion of the submission for a notice of compliance filed by the second person relevant to the disposition of the issues in the proceeding and may order that any change made to the portion during the proceeding be produced by the second person as it is made; and
(b) order the Minister to verify that any portion produced corresponds fully to the information in the submission.
(8) A document produced under subsection (7) shall be treated confidentially.
(9) In a proceeding in respect of an application under subsection (1), a court may make any order in respect of costs, including on a solicitor-and-client basis, in accordance with the rules of the court.
(10) In addition to any other matter that the court may take into account in making an order as to costs, it may consider the following factors:
(a) the diligence with which the parties have pursued the application;
(b) the inclusion on the certified patent list of a patent that should not have been included under section 4; and
(c) the failure of the first person to keep the patent list up to date in accordance with subsection 4(6).
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 obtenu 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.
(3) Sous réserve du paragraphe (4), la personne qui soumet une liste de brevets doit le faire au moment du dépôt de la demande d'avis de conformité.
(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).
(5) Lorsque la première personne soumet, conformément au paragraphe (4), une liste de brevets ou une modification apportée à une liste de brevets, elle doit indiquer la demande d'avis de conformité à laquelle se rapporte la liste ou la modification, en précisant notamment la date de dépôt de la demande.
(6) La personne qui soumet une liste de brevets doit la tenir à jour mais ne peut ajouter de brevets à une liste que si elle le fait en conformité avec le paragraphe (4).
(7) La personne qui soumet une liste de brevets ou une modification apportée à une liste de brevets aux termes des paragraphes (1) ou (4) doit remettre une attestation portant que :
a) les renseignements fournis sont exacts;
b) les brevets mentionnés dans la liste ou dans la modification sont admissibles à l'inscription au registre et sont pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue visée par la demande d'avis de conformité.
5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue :
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
(1.1) Sous réserve du paragraphe (1.2), lorsque le paragraphe (1) ne s'applique pas, la personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament que l'on trouve dans une autre drogue qui a été commercialisée au Canada par suite de la délivrance d'un avis de conformité à la première personne et à l'égard de laquelle une liste de brevets a été soumise doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre visant cette autre drogue contenant ce médicament, lorsque celle-ci présente la même voie d'administration et une forme posologique et une concentration comparables :
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne soit pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
(1.2) Si une personne visée au paragraphe (1.1) a signifié, conformément aux alinéas (3)b) ou c), un avis d'allégation à une première personne à l'égard d'un brevet inscrit au registre, elle n'est tenue de signifier un avis d'allégation à l'égard de la même demande, de la même allégation et du même brevet à aucune autre première personne.
(2) Lorsque, après le dépôt par la seconde personne d'une demande d'avis de conformité mais avant la délivrance de cet avis, une liste de brevets ou une modification apportée à une liste de brevets est soumise à l'égard d'un brevet aux termes du paragraphe 4(4), la seconde personne doit modifier la demande pour y inclure, à l'égard de ce brevet, la déclaration ou l'allégation exigées par les paragraphes (1) ou (1.1), selon le cas.
(3) Lorsqu'une personne fait une allégation visée aux alinéas (1)b) ou (1.1)b) ou au paragraphe (2), elle doit :
a) fournir un énoncé détaillé du droit et des faits sur lesquels elle se fonde;
b) si l'allégation est faite aux termes de l'un des sous-alinéas (1)b)(i) à (iii) ou (1.1)b)(i) à (iii), signifier un avis de l'allégation à la première personne;
c) si l'allégation est faite aux termes des sous-alinéas (1)b)(iv) ou (1.1)b)(iv) :
(i) signifier à la première personne un avis de l'allégation relative à la demande déposée selon les paragraphes (1) ou (1.1), au moment où elle dépose la demande ou par la suite,
(ii) insérer dans l'avis d'allégation une description de la forme posologique, de la concentration et de la voie d'administration de la drogue visée par la demande;
d) signifier au ministre une preuve de la signification effectuée conformément aux alinéas b) ou c).
DROITS D'ACTION
6. (1) La première personne peut, dans les 45 jours après avoir reçu signification d'un avis d'allégation aux termes des alinéas 5(3)b) ou c), demander au tribunal de rendre une ordonnance interdisant au ministre de délivrer un avis de conformité avant l'expiration du brevet visé par l'allégation.
(2) Le tribunal rend une ordonnance en vertu du paragraphe (1) à l'égard du brevet visé par une ou plusieurs allégations si elle conclut qu'aucune des allégations n'est fondée.
(3) La première personne signifie au ministre, dans la période de 45 jours visée au paragraphe (1), la preuve que la demande visée à ce paragraphe a été faite.
(4) Lorsque la première personne n'est pas le propriétaire de chaque brevet visé dans la demande mentionnée au paragraphe (1), le propriétaire de chaque brevet est une partie à la demande.
(5) Lors de l'instance relative à la demande visée au paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter la demande si, selon le cas :
a) il estime que les brevets en cause ne sont pas admissibles à l'inscription au registre ou ne sont pas pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue pour laquelle la seconde personne a déposé une demande d'avis de conformité;
b) il conclut qu'elle est inutile, scandaleuse, frivole ou vexatoire ou constitue autrement un abus de procédure.
(6) Aux fins de la demande visée au paragraphe (1), lorsque la seconde personne a fait une allégation aux termes des sous-alinéas 5(1)b)(iv) ou (1.1)b)(iv) à l'égard d'un brevet et que ce brevet a été accordé pour le médicament en soi préparé ou produit selon les modes ou procédés de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes, la drogue que la seconde personne projette de produire est, en l'absence d'une preuve contraire, réputée préparée ou produite selon ces modes ou procédés.
(7) Sur requête de la première personne, le tribunal peut, au cours de l'instance :
a) ordonner à la seconde personne de produire les extraits pertinents de la demande d'avis de conformité qu'elle a déposée et lui enjoindre de produire sans délai tout changement apporté à ces extraits au cours de l'instance;
b) enjoindre au ministre de vérifier que les extraits produits correspondent fidèlement aux renseignements figurant dans la demande d'avis de conformité.
(8) Tout document produit aux termes du paragraphe (7) est considéré comme confidentiel.
(9) Le tribunal peut, au cours de l'instance relative à la demande visée au paragraphe (1), rendre toute ordonnance relative aux dépens, notamment sur une base avocat-client, conformément à ses règles.
(10) Lorsque le tribunal rend une ordonnance relative aux dépens, il peut tenir compte notamment des facteurs suivants :
a) la diligence des parties à poursuivre la demande;
b) l'inscription, sur la liste de brevets qui fait l'objet d'une attestation, de tout brevet qui n'aurait pas dû y être inclus aux termes de l'article 4;
c) le fait que la première personne n'a pas tenu à jour la liste de brevets conformément au paragraphe 4(6).
[23] Apotex interprets this scheme to mean that, pursuant to section 4 of the Regulations and the jurisprudence of this Court concerning section 4, a patentee is permitted to add patents to the Register only in specific and limited circumstances.
[24] Under the Regulations, a manufacturer who files a NDS for an NOC may submit a patent list to be added to the Register. The Register is to be maintained by the Minister and consists of eligible patent lists submitted in respect of particular drugs for which an NOC has been issued.
[25] Apotex says it is clear from the plain language of the Regulations that patent lists are filed in relation to a drug, and not a submission for an NOC, and that there can be only one patent list in respect of a drug, regardless of the issuance of multiple NOCs. (Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 C.P.R. (4th) 318 at 324-325 (F.C.T.D.); (2002), 16 C.P.R. (4th) 425 (F.C.A.); Toba Pharma Inc. v. Canada (Attorney General) (2002), 21 C.P.R. (4th) 232 at paras. 28, 34 (F.C.T.D.)).
[26] Subsection 4(3) of the Regulations provides that a person who submits a patent list in respect of a drug must do so at the time the person files a submission for an NOC for that drug. Subsection 4(4) contains an exception to this timing requirement. The exception is that, where an application has been made for a patent prior to the submission of an NDS for the drug, but the patent has not issued at the time of filing the NDS, the person may submit a patent list within thirty days of the issuance of the patent.
[27] Apotex argues that the March 1998 amendments to the Regulations make it clear that the timing requirements for filing a patent list are to be strictly observed. Those amendments added subsection 4(6), which requires that a person who submits a patent list must keep the list up to date, but may not add a patent to an existing patent list except in accordance with subsection 4(4). (Bristol-Myers, supra, at 324-325; Toba Pharma Inc.,supra, at paras. 28, 34).
[28] Apotex takes the position that it is clear under section 4 that a patent list may only be submitted at the time of first filing an NDS for the drug, or, where a patent has not issued but was applied for prior to the filing of the NDS, within thirty days after the issuance of the patent. The intention, according to Apotex, is clearly to limit the patents listed on the Register to those which either have been obtained or applied for at the time that a patentee begins marketing a particular drug product.
[29] In accordance with the scheme of the Regulations, and in light of the drastic consequences to second persons, it is important that the strict conditions outlined in section 4 for the addition of patents to the Register be respected, and that patents should not be added to the Register outside these strict timelines. As this Court has confirmed, these stipulations were designed to ensure that generic manufacturers are not impeded unfairly from accessing the market. (Novopharm Ltd. v. Canada (Minister of National Health and Welfare) (1998), 78 C.P.R. (3d) 54 at 61-64 (F.C.T.D.); Toba Pharma, supra, at paras. 28, 34; Patent Regulations, s. 4).
[30] In Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General), 2002 FCA 32, [2002] F.C.J. No. 96, the Federal Court of Appeal has recently confirmed that, since the amendments to the Regulations which introduced subsection 4(6), the timing requirements of the Regulations are to be strictly observed, and that patentees may not subvert those timing requirements and add patents to an existing list by filing a subsequent NDS and including a patent list with that submission. Rather, once a patent list exists in respect of a drug product, patents may only be added to the list in respect of that drug product if the patent was applied for before the original NDS was filed, and issues thereafter. A subsequent NDS leading to the issuance of a subsequent NOC are for a new drug product, in respect of which there is no existing patent list.
[31] Apotex asks the Court to note that all of GSK's submissions against which the Patents are listed relate to paroxetine hydrochloride hemihydrate and, pursuant to the Regulations and the relative jurisprudence, there can only be one patent list in respect of this drug. The timing restrictions for that patent list must be respected. Each of the Patents comprises a claim pertaining to anhydrous polymorphs of paroxetine hydrochloride.
[32] Apotex feels it is clear on the basis of the foregoing that the Patents were improperly added to the Register. The original NOC for paroxetine hydrochloride hemihydrate tablets was issued on May 4, 1993, long before the applications for the Patents were filed. In accordance with the strict timing requirements of section 4 of the Regulations, the Patents could not properly be added to the Register because the applications for the Patents had not been filed before the submission for the original NOC was made.
[33] Apotex takes the position that the four supplemental submissions against which the Patents are listed were not issued in respect of a different drug product, and, therefore, the time restrictions do not run afresh from the date of the submissions for these NOCs. Rather, the drug product which is the subject of each of these NOCs is identical to GSK's paroxetine hydrochloride hemihydrate product marketed under the original NOC. This is clear from the fact that no new drug identification numbers ("DINs") have been assigned in respect of the new NOCs. Following issuance of the four supplemental NOCs, in respect of which the Patents are listed, GSK has continued to market paroxetine hydrochloride hemihydrate tablets in 10, 20 and 30mg strengths under the same DINs as it had used previously.
[34] Accordingly, Apotex is of the view that the time requirements under section 4 of the Regulations, in relation to the drug product, were not satisfied, and cannot be extended by the issuance of a Supplementary NOC in relation to the very same drug product.
[35] Apotex feels it is directly contrary to the intention of the Regulations and the interpretation of the Regulations as set out in the jurisprudence of this Court and the Court of Appeal for a patentee to be permitted to add a patent to the Register in respect of the very same drug for which an NOC has previously issued when the time limits for the addition of such a patent have expired. In the circumstances, GSK has attempted to circumvent the strict timing requirements of the Regulations by adding the Patents, out of time, in respect of the very same paroxetine hydrochloride hemihydrate drug product for which an NOC issued in 1993.
[36] In support of this interpretation, Apotex relies heavily upon the judgment of Hugessen J. in Novopharm Ltd. v. Minister of National Health and Welfare et al (1998), 78 C.P.R. (3d) 54 (F.C.T.D.).
[37] In reply, GSK asserts that the timing requirements of the Regulations were met in this case and that the Patents were properly allowed on the Register.
[38] GSK says that the requirements that must be met in order to list a patent on the Register pursuant to the Regulations are as follows:
(a) a submission for a NOC must be filed;
(b) there must be a claim for the medicine itself or use of the medicine in the patent;
(c) the timing requirements of either subsection 4(3) or 4(4) must be met; and
(d) the relevance requirements of subsection 4(7)(b) must be met.
[39] Each of these factors is a prerequisite or condition precedent for the listing of a patent on the Register.
[40] GSK argues that the critical nexus between the patent and the first person's product has always been the medicine itself. In this regard, the requirement that the patent contain a claim to the medicine itself has been in the Regulations since their inception. The only requirement relating to the drug product itself is the requirement set out in subsection 4(7)(b) that the patent be relevant to the dosage form, strength and route of administration of the drug. This requirement was added in 1998. (Regulations Amending the Patented Medicines (Notice of Compliance) Regulations SOR/98-166, March 12, 1998).
[41] As such, patents are listed in respect of the medicine itself and not the individual drug product represented by individual notices of compliance. This is evident in looking at GSK's drug products, namely it's 10, 20 and 30mg tablets represented by the same DINs in respect of each of GSK's NOCs. The explanation for this is that subsequent NOCs relating to the same medicine encompass the drug product represented in any previous NOC.
[42] Apotex takes the position that patents are listed in respect of individual drug products and not in respect of the medicine itself. For all the above reasons, G