Parke Davis Division Warner Lambert Canada Inc. v. Canada (Minister Of Health)

Parke Davis Division Warner Lambert Canada Inc. v. Canada (Minister Of Health)
Court (s) Database
Federal Court Decisions
Date
2001-08-22
Neutral citation
2001 FCT 931
File numbers
T-1715-99
Notes
Reported Decision
Decision Content
Federal Court Reports Parke-Davis Division v. Canada (Minister of Health) (T.D.) [2002] 1 F.C. 517
Date: 20010822
Docket: T-1715-99
Neutral citation: 2001 FCT 931
Vancouver, British Columbia, Wednesday the 22nd day of August 2001
PRESENT: The Honourable Madam Justice Dawson
BETWEEN:
PARKE-DAVIS DIVISION,
WARNER-LAMBERT CANADA INC.
and WARNER-LAMBERT COMPANY
Applicants
- and -
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR ORDER AND ORDER
DAWSON J.
[1] In this application for judicial review the applicants seek an order pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 ("Regulations") prohibiting the respondent Minister of Health ("Minister") from issuing a Notice of Compliance ("NOC") to the respondent Apotex Inc. ("Apotex") in connection with the medicine known as atorvastatin calcium until after the expiration of Canadian Patent No. 1,268,768 (" ‘768 Patent ").
[2] The impetus for this application is a dispute over the legal nature of a dedication of a patent to the public use, and the circumstances, if any, whereby such a dedication can be revoked.
[3] The Minister of Health neither filed material nor appeared at the hearing of the application.
BACKGROUND FACTS
[4] The applicants assert that Warner-Lambert Company ("Warner-Lambert") is, and at all material times was, the owner of the ‘768 Patent and Canadian Patent No. 2,021,546 (" ‘546 Patent ") which both pertain to the medicine atorvastatin calcium. They further assert that Parke-Davis Division, Warner-Lambert Canada Inc. ("Parke-Davis"), a subsidiary of Warner-Lambert, is the exclusive licensee in Canada of the ‘768 and ‘546 Patents.
[5] On February 19, 1997, Parke-Davis received a NOC for the medicine atorvastatin calcium which is marketed in Canada as 10, 20 and 40 mg tablets under the trade-mark LIPITOR.
[6] The ‘768 and ‘546 Patents were included in two Patent Lists submitted by Parke-Davis pursuant to subsection 4(1) of the Regulations in connection with 10, 20 and 40 mg tablets of atorvastatin calcium. As a result, Health Canada entered the ‘768 and ‘546 Patents on the Patent Register.
[7] After receiving the NOC, Parke-Davis began selling LIPITOR in Canada. It is said to be a drug of choice for lowering cholesterol, to be Parke-Davis' top selling prescription drug, and to have been in 1999 the second largest selling prescription drug in Canada. Atorvastatin calcium was the winner of the Prix Galien Canada award as the most innovative drug product for 1999.
[8] On December 21, 1994, a Canadian patent agent for Warner-Lambert wrote to the Canadian Intellectual Property Office ("CIPO") enclosing a number of documents which dedicated various patents to the public, stating that "[w]e submit that filing of these dedications for publication constitutes irrevocable dedication of these patents, effective as of the date of filing, namely, December 21, 1994" and further stating that "[c]onfirmation that the requested notices will be published is earnestly solicited".
[9] One of the enclosures with the December 21, 1994 letter was a dedication in the following terms:
DEDICATION
The Warner-Lambert Company, owner of the Canadian patents listed in the attached schedule, whose full post office address is 201 Tabor Road, Morris Plains, N.J. 07950, hereby irrevocably dedicates said patents to the public, effective
Dated at Morris Plains NJ USA
this 20 day of October 1994.
For Warner Lambert Company:
The document was signed by Andrea Ryan, then the Assistant Secretary of Warner-Lambert. Listed among some 278 patents on the attached schedule was the ‘768 Patent.
[10] On April 4, 1995, CIPO published a notice in the Canadian Patent Office Record ("CPOR") stating that the listed patents had been dedicated "to Public Use by the present registered owner".
[11] The applicants assert that in mid-1997 a patent counsel at Warner-Lambert discovered that the ‘768 Patent had been inadvertently included among the patents listed for dedication to the public use. Correspondence followed from the Canadian patent agent for Warner-Lambert to the CIPO requesting that the alleged error be corrected and that notice of the retraction be published in the CPOR.
[12] Further requests were made and on August 25, 1998 CIPO published the following notice in the CPOR:
16. Notice from Patentee
In a Notice published in the April 4, 1995 issue of the Canadian Patent Office Record, Warner-Lambert Company dedicated 278 patents to public use. Patents Nos. 1,268,768, for an invention entitled "Trans-6-[2-(3- or 4-Carboxamido-Substituted Pyrrol-1-YI) Alkyl]-4-Hydroxpyran-2- One Inhibitors of Cholesterol Synthesis" and 1,270,763, for an invention entitled "Contraceptive Method and Kit", were mistakenly included in the list of dedicated patents. Warner-Lambert Company hereby gives notice that it has not and does not waive its exclusive rights in and to the inventions defined in Canadian Patents Nos. 1,268,768 and 1,270,763.
[13] Subsequent to the purported dedication Parke-Davis paid all maintenance fees for the ‘768 Patent and CIPO accepted those fees.
[14] Health Canada questioned the notice of dedication to public use but apparently, upon being furnished with an explanation of the error and a copy of the retraction of the dedication of the ‘768 Patent in the CPOR, accepted the ‘768 Patent for retention on the Patent Register.
[15] On August 16, 1999, the president of Apotex wrote to Parke-Davis as follows:
This is a Notice of Allegation pursuant to the Patented Medicines (Notice of Compliance) Regulations in relation to tablets for oral administration containing atorvastatin calcium.
In relation to patent no. 1268768, we allege that the statement made by you pursuant to paragraph 4(2)(c) of the Regulations is false, and/or the patent has expired, and/or the patent is not valid.
The legal and factual basis for the allegation is that this patent was dedicated to the public.
ISSUES
[16] The following issues are raised in this application:
1. Do the applicants have status to maintain an application under subsection 6(1) of the Regulations?
2. Is the Notice of Allegation ("NOA") valid?
3. Have the applicants established that the allegation was not justified?
ANALYSIS
1. Do the applicants have status to maintain an application under subsection 6(1) of the Regulations?
[17] Apotex argued that the applicants lack standing to bring this application. To consider that submission it is necessary to review the regulatory framework found in the Regulations.
(a) The regulatory framework
[18] Section 4 of the Regulations entitles a patent owner, exclusive licensee, or other person with the patent owner's consent who applies for, or has been issued, a NOC in respect of a drug to submit a Patent List in respect of the drug. The Patent List is to include a statement of the ownership or license or other interest in the relevant patent. In subsections (1) and (2) section 4 provides:
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.
4(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.
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).
4(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 don't 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.
[19] Section 5 of the Regulations imposes requirements on a person who files or has filed a submission for a NOC in respect of a drug and who compares that drug with another for the purpose of demonstrating bio-equivalence. Section 5 provides in part:
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.
[...]
5(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.
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.
[...]
5(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).
[20] Section 6 confers rights on a "first person" served with a NOA pursuant to paragraphs 5(3)(b) or (c) of the Regulations as follows:
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.
6(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.
[...]
6(4) Where the first person is not the owner of each patent that is the subject of an application referred to in subsection (1), the owner of each such patent shall be made a party to the application.
6(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(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.
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.
6(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.
[...]
6(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.
6(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(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.
[21] The terms "first person" and "second person" are defined as follows in section 2 of the Regulations:
"first person" means the person referred to in subsection 4(1);
[...]
"second person" means the person referred to in subsection 5(1) or (1.1), as the case may be.
« première personne » La personne visée au paragraphe 4(1).
[...]
« _seconde personne_ » Selon le cas, la personne visée aux paragraphes 5(1) ou (1.1).
[22] In the context of that framework Apotex correctly noted that:
(i) only the person, the first person, who has filed for, or been issued, a NOC and has submitted a Patent List has standing to commence an application for prohibition;
(ii) that first person must indicate on the Patent List the basis upon which it asserts rights under the patents listed on the Patent List; and
(iii) in the present case Parke-Davis is the first person as defined in the Regulations and claims, both in its Patent List and in the notice of application issued to commence this application, status as the exclusive licensee in Canada of the ‘768 and ‘546 Patents.
[23] Apotex submitted that it follows that a first person must lead evidence of its standing. Apotex further stated that an adverse inference will be drawn where a party fails to produce evidence of its license, and that affidavit evidence simply asserting the existence of an exclusive license is not sufficient evidence to establish standing.
[24] In the present case, the representative of Parke-Davis refused on cross-examination to produce its exclusive license. Apotex submitted that, as a result, the application cannot succeed because of the failure of the applicants to establish their standing.
[25] Parke-Davis did put some evidence before the Court as to its standing. Its Director of Government Affairs and Healthcare Systems swore in an affidavit that:
4. Parke-Davis is the exclusive licensee in Canada for marketing and selling atorvastatin calcium under the ‘768 and ‘546 Patents.
[26] On cross-examination, the applicants' deponent confirmed the existence of the license and advised that he did not have a copy of the license agreement with him. Concerns were expressed at the cross-examination by the applicants' counsel that the license is confidential. Ultimately, the applicants declined to produce the license agreement.
[27] In submitting that this evidence was deficient, Apotex relied upon the decision of the Federal Court of Appeal in Eli Lilly and Co. v. Novopharm Ltd. (1996), 69 C.P.R. (3d) 455 (F.C.A.) and the decision of Muldoon J. in Merck Frosst Canada v. Canada (Minister of National Health and Welfare) (1997), 74 C.P.R. (3d) 131 (F.C.T.D.).
[28] In Eli Lilly, supra, the Court found that a statement in an affidavit to the effect that "my Company benefits from [a third party's] sales" was inadequate to satisfy the evidentiary burden which the plaintiff there faced in order to establish irreparable harm sufficient to support the grant of an interlocutory injunction.
[29] I do not find this case to be of assistance because what was there in issue was an absence of evidence to prove that an alleged loss would be that of the plaintiff and that the loss would be irreparable. Here the issue is not the total absence of relevant evidence but rather the question of the sufficiency of the evidence proffered.
[30] Of more relevance is the Merck Frosst decision, supra, relied upon by Apotex. There, in a prohibition application under the Regulations, Mr. Justice Muldoon in obiter commented on the sufficiency of the evidence presented to establish the applicants' exclusive license rights. Justice Muldoon commented, at page 141, that:
Proving this interest requires nothing more than showing the authentic licence (or at least those parts which demonstrate the existence of a licensing agreement). If this basic element were not required, the inevitable result would be the Court ordering the extraordinary remedy of prohibition - if the respondent manufacturer's allegations were not justified - against the Minister, on the mere assumption that the applicants have an interest in the patent. Even the applicants' sworn ipse dixit does not demonstrate a licence. Simply put, proof of the licence is an essential ingredient of the applicants' case. The cross-examination of Mr. Saheb clearly establishes that the applicants have not discharged their onus. [emphasis in original]
[31] I do not, however, read Justice Muldoon's words to require that in every case a license agreement be put in evidence before the Court. Justice Muldoon found that it was the nature of the evidence given on the cross-examination of the applicants' deponent, and not the simple absence of the license agreement, which established that the applicants had not discharged their onus. On cross-examination the deponent had admitted that he had never seen the license agreement and Justice Muldoon noted that the deponent's knowledge of any licence was "sketchy at best and based on elderly hearsay". The patent owner was not an applicant then before the Court.
[32] In the present case the applicants' deponent's evidence was not so impugned on cross-examination. The witness was not asked about the nature of his knowledge of the license agreement nor was he asked any question about the terms of the license agreement. No suggestion was made to the witness on cross-examination challenging the existence of the exclusive license agreement. Moreover, the ‘768 and ‘546 Patents were exhibited to the deponent's affidavit, the patent owner is also an applicant in this proceeding, and the deponent swore that Parke-Davis was a subsidiary of the owner of the patents.
[33] In those circumstances, I find that Parke-Davis has adduced sufficient evidence of its standing to bring this application. I find support for that conclusion in the comments of the Federal Court of Appeal in Apotex Inc. v. Wellcome Foundation Ltd., [2001] 1 F.C. 495 (C.A.), applications for leave to appeal granted [2000] S.C.C.A. No. 610 (QL) (S.C.C.), where Rothstein J.A. noted for the Court, at paragraph 99, that:
It is perhaps not uncalled for to observe that this is not a case in which the alleged licensee is alone in advancing its claim for patent infringement. Here, the patentee is also before the Court as a co-plaintiff supporting the claim of GWI. It is difficult to conceive of what more is necessary to prove the existence of a licence than to have the licensor and licensee both attesting to the validity of the licence. Where both the patentee and the person claiming under the patentee are before the Court, are affiliated as being owned by the same parent and have an identity of interest in the litigation - with the patentee supporting the person claiming under the patentee - it is, to say the least, surprising that technical questions of status to sue would be advanced as a defence to infringement.
[34] Finally on this issue, in view of the concern expressed with respect to the confidentiality of the terms of the license agreement I am not prepared to accede to Apotex's submission that I should draw an adverse inference from the failure of the applicants to produce the agreement.
2. Is the NOA valid?
[35] The applicants asserted that the NOA is invalid because:
a) Apotex has not yet filed a submission for a NOC for atorvastatin calcium; and
b) The NOA fails to make an allegation for every patent on the Patent Register in respect of the particular dosage forms of atorvastatin calcium.
(a) The failure of Apotex to have filed a submission for a NOC in respect of atorvastatin calcium
[36] The applicants argued that it is contrary to the Regulations for Apotex to file a NOA where it has not filed a New Drug Submission ("NDS") and where its president on cross-examination indicated no immediate intention to do so.
[37] In support of their submission the applicants argued that while in Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.) the Court of Appeal held that the requirements of section 5 of the Regulations may be met in any order, the Court did not there suggest that all of the requirements need not be met. It was submitted that there is no authority which provides that a valid NOA can be filed simply to preserve a procedural advantage with no immediate intention to file a submission for a NOC. Further, the applicants asserted that implicit in decisions such as Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R. (3d) 368 (S.C.C.) is that all of the requirements of section 5 of the Regulations must be met by the date of the prohibition hearing.
[38] The applicants also argued that subsection 6(7) of the Regulations permits a first person to seek an order requiring the second person to produce any portion of the submission for a NOC filed by the second person relevant to the disposition of the issues in the proceeding. This was said to evidence the fact that a NOA must be supported by a submission for a NOC.
[39] I do not find these submissions persuasive for the following reasons.
[40] First, it is now settled law that the process embodied in the Regulations is one separate and distinct from the administrative process imposed by the Food and Drug Regulations, C.R.C., c. 870. Those processes need not be engaged concurrently. The processes are only linked in the sense that the Minister can only issue a NOC having regard to the end result of each process.
[41] Therefore, in Smithkline Beecham Pharma Inc. v. Canada (Minister of Health and Welfare) (1997), 77 C.P.R. (3d) 147 (F.C.T.D.) McKeown J. dismissed an application to declare a NOA invalid and to prohibit the Minister of Health and Welfare from treating a letter as a NOA in circumstances where the second party had not filed a NDS seeking issuance of a NOC. Justice McKeown noted that it is the NOA and not the NDS which forms the factual underpinning of any prohibition proceeding. Thus, he concluded that while at some point a NDS would have to be filed by the second party, the only linkage between a non-infringement allegation and the NDS is that the allegation must be included as part of the NDS, so that when the NDS is filed the Minister is required to inquire whether the allegation filed with the NDS is the same as that contained in the NOA.
[42] In my view this is consistent with the conclusion that allegations other than those of non-infringement may be considered in the absence of any NDS. The contents of a NDS are not relevant to allegations of patent invalidity.
[43] Subsequent to the Smithkline Beecham decision, supra, the Regulations were amended. Those amendments in my view are dispositive of the applicants' objection to the absence of a NDS. Subsections 5(1) and 5(3) of the Regulations formerly provided that:
5(1) Where a person files or, before the coming into force of these Regulations, has filed a submission for a notice of compliance in respect of a drug and wishes to compare that drug with, or make a reference to, a drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the patent list,
(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)(b) 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.
[...]
(3) Where a person makes an allegation pursuant to paragraph (1)(b) or subsection (2) the person shall
(a) provide a detailed statement of the legal and factual basis for the allegation; and
(b) serve a notice of the allegation on the first person and proof of such service on the Minister.
5(1) Lorsqu'une personne dépose ou, avant la date d'entrée en vigueur du présent règlement, a déposé une demande d'avis de conformité à l'égard d'une drogue et souhaite comparer cette drogue à une drogue qui a été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard duquel une liste de brevets a été soumise ou qu'elle souhaite faire un renvoi à la drogue citée en second lieu, elle doit indiquer sur sa demande, à l'égard de chaque brevet énuméré dans la liste :
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)b) 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.
[...]
(3) Lorsqu'une personne fait une allégation visée à l'alinéa (1)b) ou au paragraphe (2), elle doit :
a) fournir un énoncé détaillé du droit et des faits sur lesquels elle se fonde;
b) signifier un avis d'allégation à la première personne et une preuve de cette signification au ministre.
[44] Effective March 12, 1998, subsection 5(3) was amended by SOR/98-166 as follows:
(4) Subsection 5(3) of the Regulations is amended by striking out the word "and" at the end of paragraph (a) and by replacing paragraph (b) with the following:
(b) if the allegation is made under any of subparagraphs 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),
(i) serve on the first person a notice of the allegation relating to the submission filed under subsection (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.
(4) L'alinéa 5(3)b) du même règlement est remplacé par ce qui suit :
b) si l'allégation est faire aux termes de l'un des sous-alinéas (1)b)(i) à (iii), signifier un avis de l'allégation à la première personne;
c) si l'allégation est faite aux termes du sous-alinéa (1)b)(iv) :
(i) signifier à la première personne un avis de l'allégation relative à la demande déposée selon le paragraphe (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).
[45] This amendment dealt with the issue of timing and required that only where an allegation of non-infringement was made would a NOA have to be served at or subsequent to the time of filing a NDS submission. The Regulatory Impact Analysis Statement described the amendment in the following terms:
No premature NOA: An NOA relating to non-infringement may only be served on a patentee by a generic manufacturer when or after it has filed a submission for an NOC with the Minister of Health.
[46] I interpret the absence of any regulatory requirement that a NDS be filed by the time a NOA is served where allegations are made pursuant to subparagraphs (i) through (iii) of paragraph 5(1)(b) of the Regulations to mean that in such cases a NOA is not invalidated solely on the basis that no NDS or amended new drug submission has been filed by the time the NOA is served.
[47] To the extent that the applicants sought support for their submission in the wording of subsection 6(7) of the Regulations, I note that subsection 6(7) only makes any portion of a NDS producible on Court order where it is "relevant to the disposition of the issues in the proceeding". As noted above the contents of a NDS submission, while of relevance to allegations of non-infringement, are not relevant to allegations of patent invalidity. Thus, I do not find the wording of subsection 6(7) of the Regulations to be inconsistent with my interpretation of the Regulations as set out above.
(b) The failure of the NOA to make any allegation with respect to the ‘546 Patent
[48] It is next necessary to consider the applicants' submission that the NOA is invalid because it fails to make allegations in respect of the ‘546 Patent which is also on the Patent Register in respect of the relevant dosage forms of atorvastatin calcium.
[49] To advance such argument the applicants relied upon an obiter comment made by Teitelbaum J. in Glaxo Wellcome Inc. v. Canada (Minister of National Health and Welfare) (1997), 75 C.P.R. (3d) 129 (F.C.T.D.) to the effect that the second person must make an allegation with respect to every patent on a patent list in respect of the particular form of the drug for which it seeks a NOC. However, I do not find the authority relied upon determinative as in that case Justice Teitelbaum was not required to consider when those allegations must be made.
[50] Of more assistance, I find, is the decision of Lutfy J., as he then was, in Bayer Inc. v. Canada (Minister of National Health and Welfare) (1998), 82 C.P.R. (3d) 359 (F.C.T.D.), aff'd (2000) 6 C.P.R. (4th) 285 (F.C.A.), relied upon by the respondents. There Justice Lutfy concluded that it was not an abuse of process for a second person to bring more than one NOA before the Court provided they were "separate and distinct from others". From this I conclude that allegations concerning successive patents listed on a Patent List may be the subject of separate NOAs and may be litigated separately. It further follows that a NOA is not vitiated on the ground that it does not deal with every patent on the Patent List.
[51] Every patent must be dealt with only by the time that the Minister comes to deal with the NDS for the purpose of issuing a NOC.
3. Have the applicants established that the allegation was not justified?
(a) The nature of this proceeding and the burden of proof
[52] At this juncture I think it helpful to review briefly the nature of this proceeding, the burden of proof upon an applicant, and the operation of what is called the common law presumption.
[53] Proceedings under section 6 of the Regulations are summary in nature directed solely to whether the Minister should be prohibited from issuing a NOC. Patent invalidity or patent infringement is not litigated in this summary proceeding. Those issues, and related claims for damages, are to be determined in conventional actions which may proceed in parallel proceedings: Eli Lilly & Co. v. Novopharm Ltd.; Eli Lilly & Co. v. Apotex Inc., [1998] 2 S.C.R. 129 at paragraph 97.
[54] In this proceeding, Parke-Davis has the burden of proving that the allegation of invalidity made by Apotex was not justified: Bayer Inc. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285 (F.C.A.). That burden requires Parke-Davis to establish its case on the civil standard of proof, which has been described to be a "difficult burden" because "it must be to disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would have allowed the Minister to issue a notice of compliance": Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 70 C.P.R. (3d) 206 (F.C.A.) at page 210 quoting with approval Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) at page 319.
[55] In the present case, the purported dedication of the patent to the public is asserted in the NOA (hence is presumed to be true per Merck Frosst, supra, at page 319) and is, in any event, in evidence before the Court. Thus, Parke-Davis must meet the burden of disproving the allegation of invalidity, expiration and false statement contained in the NOA.
[56] As for the evidentiary basis upon which proceedings of this nature are to be determined, in Merck Frosst, supra, at page 320, the Court noted:
As a further consequence of the application under s. 6 not being an ordinary action for infringement, there is no opportunity for either party to have recourse to discovery, whether oral or documentary. Where either party files affidavits there is, of course, opportunity for the opposite party to cross-examine thereon, but since there is no requirement that the notice of allegation be in affidavit form, and no obligation on the respondent to produce any affidavits at all (Rule 1603(2) permits but does not require such affidavits), the applicant cannot expect to be able to make his case out of the mouth of the respondent. Even when there is an opportunity to cross-examine, such cross-examination is far more limited in scope than examination for discovery and, apart from questions going to the witness' credibility, is limited to relevant matters arising from the affidavit itself.
[57] The absence of discovery may therefore, in appropriate cases, give rise to the operation of a common law presumption, or what is known as the drawing of an adverse inference: Hoffmann-La Roche, supra, at page 212.
[58] The nature of the common law presumption was explained in the following terms by the Court of Appeal in Eli Lilly and Co. v. Nu-Pharm Inc. (1996), 69 C.P.R. (3d) 1 (F.C.A.) at pages 18-19:
The Motions Judge described the common law presumption at pages 7-8 [pp. 152-3]:
...where a party fails to lead evidence of a fact that it is in a better position to establish, the Court will infer that the facts are adverse to that party's interest.
The maxim underlying this exce