Date: 20040419
Dockets: A-49-04
A-50-04
A-51-04
CORAM: RICHARD C.J.
A-49-04
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Appellants
-and-
THE MINISTER OF HEALTH and PHARMASCIENCE INC.
Respondents
A-50-04
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Appellants
-and-
THE MINISTER OF HEALTH and RATIOPHARM INC.
Respondents
A-51-04
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Appellants
-and-
THE MINISTER OF HEALTH and APOTEX INC.
Respondents
Heard at Ottawa, Ontario, on April 7, 2004.
Judgment delivered at Ottawa, Ontario, on April 19, 2004.
REASONS FOR JUDGMENT BY: RICHARD C.J.
CONCURRED IN BY: ROTHSTEIN J.A.
SHARLOW J.A.
Date: 20040419
Dockets: A-49-04
A-50-04
A-51-04
CORAM: RICHARD C.J.
A-49-04
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Appellants
-and-
THE MINISTER OF HEALTH and PHARMASCIENCE INC.
Respondents
A-50-04
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Appellants
-and-
THE MINISTER OF HEALTH and RATIOPHARM INC.
Respondents
A-51-04
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Appellants
-and-
THE MINISTER OF HEALTH and APOTEX INC.
Respondents
REASONS FOR JUDGMENT
Introduction
[1] The issue before this Court is whether the Motions Judge properly interpreted and applied the provisions of the Patented Medicines (Notice of Compliance) Regulations concerning the listing of a patent in respect of a pharmaceutical product.
[2] In the course of an application pursuant to subsection 6(5)(a) of thePatented Medicines (Notice of Compliance)Regulations SOR/93-133, as amended SOR/98-166, SOR/99-379 (the PM(NOC) Regulations) , the Motions Judge determined that the underlying Supplemental New Drug Submission was insufficient to support the listing of Abbott's Canadian Patent No. 2,261,732 ("the '732 patent") on the Patent Register (2004 FC 465).
Background
The Regulatory Regime
[3] In order to set the subsequent chronology in context, I will offer a brief comment on the regulatory regime that governs the current appeal. The applicable regulations are set out in an appendix to these reasons.
[4] The sale and marketing of pharmaceuticals in Canada is regulated by the Food and Drug Regulations C.R.C., c. 870. A manufacturer cannot sell or market its products without the regulatory approval of the Minister of Health, who must be satisfied that the manufacturer has complied with these regulations. In order to obtain approval, a manufacturer must submit a New Drug Submission (NDS) to the Minister. If the Minister is satisfied that the drug is safe, effective and otherwise complies with the regulations, a Notice of Compliance (NOC) will be issued to the manufacturer.
[5] If an NDS has already been filed and the manufacturer subsequently makes changes to its drug such that the information contained in the NDS is now significantly different in respect of certain specified matters, a manufacturer must make a Supplemental New Drug Submission (SNDS) in respect of its product. The Minister's approval of an SNDS is also indicated by an NOC.
[6] Submitting either an NDS or an SNDS, and obtaining an NOC, grants an administrative remedy to protect a manufacturer's pre-existing patent rights. Specifically, if the timing requirements in section 4 of the PM(NOC) Regulations are met, the manufacturer can file patent lists with the Minister. Listing an eligible patent gives the patent holder an opportunity to invoke the PM(NOC) Regulations that will shield the manufacturer's product against generic competition for a statutorily-specified period of time, as the PM(NOC) Regulations stipulate that a generic drug manufacturer cannot obtain an NOC for its product without proving that its product does not infringe a listed pharmaceutical patent.
[7] As the preceding summary sets out, both of these regulatory regimes touch Canadian patented pharmaceutical products. The Food and Drug Regulations are concerned with the safety and effectiveness of pharmaceutical products. The PM(NOC) Regulations balance the rights of holders of pharmaceutical patents and generic drug manufacturers. This second regulatory regime is driven by concerns relating to intellectual property and the appropriate scope of protection that it should be afforded. However, the Food and Drug Regulations and the PM(NOC) Regulations are connected. Compliance with the former is required to obtain concomitant patent benefits under the latter regime.
[8] With the foregoing as context, I turn now to the specific facts of this appeal.
Facts Specific to this Appeal
[9] The appellant, Abbott, is a Canadian innovative drug company who manufactures BIAXIN® ("Biaxin"), a product whose active ingredient is clarithromycin. The respondents, Apotex, Ratiopharm and Pharmascience, are generic drug manufacturers.
[10] Abbott Laboratories, Abbott's American parent company, owns the '732 patent, which protects a process for the direct isolation of clarithromycin.
[11] Initially, Biaxin was used in the treatment of upper and lower respiratory infections. It was later discovered that Biaxin could also be used in the treatment of gastrointestinal infections, such as ulcers, caused by Helicobacter pylori (H. pylori) bacteria. The regulatory approvals sought as a consequence of this new discovery lie at the root of this appeal.
[12] After obtaining various NOCs for the use of Biaxin in the treatment of respiratory illness, Abbott sought an SNDS for the use of Biaxin in a dual drug therapy for the treatment of gastrointestinal illness caused by H. pylori bacteria. The second drug was a Proton Pump Inhibitor (PPI) called omeprazole. An NOC was later granted in respect of this SNDS in February 1996.
[13] In December of 1996, Abbott filed another SNDS in order to have Biaxin (clarithromycin) approved in the use of a triple drug therapy for the eradication of H. pylori, adding a second antibiotic, amoxicillin, to the combination of Biaxin (clarithromycin) and omeprazole. The NOC in respect of this submission issued in May of 1998.
[14] Also relevant are TAP Pharmaceuticals' (TAP) activities in approximately the same time period . TAP, owned by Abbott Laboratories and a third party, produces a PPI called lansoprazole. This PPI can be used in place of omeprazole in triple therapy. Abbott, acting on behalf of TAP filed an SNDS in regard to a triple therapy combination of Biaxin (clarithromycin), amoxicillin and lansoprazole in 1997. An NOC in respect of this submission was issued to TAP on April 7, 1998.
[15] Subsequently, Abbott filed an NDS on behalf of TAP for approval of the so-called HP-PAC, a prepackaged drug regimen consisting of Biaxin (clarithromycin), amoxicillin and lansoprazole. An NOC in respect of this submission was issued on July 30, 1998.
[16] On April 8, 1998, Abbott filed SNDS 055754, the SNDS currently in dispute. The effect of this SNDS was to allow Abbott to amend its product monograph to incorporate TAP's product monograph by reference and allow Abbott to sell and market Biaxin (clarithromycin) in triple therapy with amoxicillin and lansoprazole. This NOC was issued on July 30, 1998. Within 30 days of the issuance of that NOC, Abbott submitted the '732 patent for listing. Although the parties disagree as to whether the SNDS supports the patent listing, the respondents agreed before the Motions Judge that if the SNDS is sufficient for this purpose, Abbott complied with the time limitations set out in section 4(4) the PM(NOC) Regulations.
[17] In 2002, the respondents served Abbott with Notices of Allegation (NOA) regarding the '732 patent. Abbott then commenced prohibition proceedings against all three respondents pursuant to the PM(NOC) Regulations.
[18] Subsequently, the respondents brought motions to dismiss Abbott's applications pursuant to section 6(5)(a) of the PM(NOC) Regulations, alleging that the '732 patent was not eligible for listing. The respondents' position was that the underlying SNDS was trivial and did not relate to a new use or indication for Biaxin. In their view, the SNDS pertained to a mere labelling revision.
[19] Ultimately, the Motions Judge found that the SNDS lacked substance and could not support the listing of the '732 patent. She ordered this patent removed from the Patent Register and dismissed Abbott's prohibition applications. These orders led to the present appeals.
Analysis
The Issue
[20] The issue before this Court is whether the Motions Judge erred in her conclusion. For the reasons that follow, I am satisfied that she was incorrect, and that the intervention of this Court is warranted.
Standard of Review
[21] Housen v. Nikolaisen [2002] 2 S.C.R. 235 sets out the standard of review applicable to a judicial decision. Questions of law are subject to review on the correctness standard. Questions of fact and factual inferences are reviewed on the palpable and overriding error standard.
The Decision Below
[22] I find it useful to set out some of the undisputed factual determinations made in the decision below. The Motions Judge found that once Abbott decided to market Biaxin (clarithromycin) in concert with amoxicillin and lansoprazole, an SNDS was required by Health Canada under the Food and Drug Regulations. She also determined that the SNDS was not filed in an effort to circumvent the time limitations stipulated in section 4 of the PM(NOC) Regulations. Further, Abbott's filing of the '732 patent in conjunction with the disputed SNDS was described by the Motions Judge as "bona fide".
[23] In the circumstances of this case, and given the express findings of fact made by the Motions Judge, her inquiry should have gone no further and the respondents' motions ought to have been dismissed . However, since she proceeded with her analysis and arrived at the opposite conclusion, I will make the following comments.
[24] After making the factual determinations set out above, the Motions Judge stated that the SNDS was "without substance". In her estimation, the fact that Abbott's product monograph amendment related to the use of Biaxin (clarithromycin) in triple therapy for the eradication of H. pylori, an established use, meant that there was no new indication. With respect, this is incorrect.
[25] Although not defined in the Food and Drug Regulations, an indication is essentially the purpose for which a pharmaceutical product is used (see e.g. Apotex Inc. v. Minister of Health et al, (1999) 87 C.P.R. (3d) 271 at 273). For the purposes of filing an SNDS, an indication does not have to be new or novel, in the sense that this term is used in patent law. However, if a manufacturer proposes to use its pharmaceutical product for a purpose for which it has no prior approval, an SNDS is required. This is what occurred in the present matter. Thus, the Motions Judge was correct in stating that the SNDS related to the eradication of H. pylori and that Abbott had no prior authorization to sell or market the specific combination of Biaxin (clarithromycin), amoxicillin and lansoprazole to combat H. pylori infection. The fact that TAP had previously obtained approval for this combination is immaterial, as TAP is a different manufacturer.
[26] Moreover, the SNDS filed by Abbott falls within section C.08.003(h)(iii) of the Food and Drug Regulations, as relating to a new claim made for Biaxin. In filing the SNDS, Abbott was complying with a regulatory requirement.
[27] This Court has previously contemplated when an SNDS will not support a patent listing. Bristol -Myers Squibb Canada Inc. v. Attorney General of Canada et al. (2002) 16 C.P.R. (4th) 425 (F.C.A.), aff'g (2001), 10 C.P.R. (4th) 318 and Ferring Inc. v. Canada (Attorney General) (2003), 26 C.P.R. (4th) 155 (F.C.A.) offer examples of manifest attempts to list patents after the time limitations set out in section 4 of the PM(NOC) Regulations had expired.
[28] The case at bar falls outside of the scope of Bristol-Myers Squibb and Ferring. As I have already determined, the SNDS was in respect of a new indication, for Abbott and Abbott required Ministerial approval to sell or market the combination of Biaxin (clarithromycin), amoxicillin and lansoprazole in Canada. As stated by the Motions Judge, this was not an attempt by Abbott to circumvent the time limitations set out in the PM(NOC) Regulations.
[29] The SNDS in the current appeal was necessary in order for Abbott to comply with the Food and Drug Regulations, and Abbott was entitled to file the '732 patent for listing. It is not for this Court to alter the patent benefits to which a manufacturer is entitled after validly complying with the various requirements set out in the regulations.
[30] Before concluding, I will briefly treat the argument made by the respondent, Pharmascience, on the question of jurisdiction. Pharmascience suggested that this Court had no jurisdiction to entertain the present appeal, as the PM(NOC) Regulations do not provide for an appeal from an Order dismissing an application pursuant to section 6(5)(a) of the PM(NOC) Regulations.
[31] I am unable to endorse the respondent's position. Section 27.1 of the Federal Courts Act expressly provides for an appeal to this Court from a final or interlocutory judgment of the Federal Court. Emphatic statutory language would be required to preclude the right of appeal set out in this Act.
Disposition
[32] These appeals should be allowed, the order of the Motions Judge should be set aside and the respondents' motions to dismiss Abbott's applications for notices of prohibition should be dismissed with costs to the appellants both here and below.
"J. Richard"
Chief Justice
"I agree
Marshall Rothstein J.A."
"I agree
K. Sharlow J.A."
APPENDIX
Patented Medicines (Notice of Compliance) Regulations
|
Interpretation 2. "patent list" means a list of all patents that is submitted pursuant to section 4... |
Définitions 2. « liste de brevets » Liste de brevets soumise aux termes de l'article 4... |
|
Patent List 4(4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2) |
Liste de brevets (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). |
|
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...
|
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... |
|
(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... |
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... |
Food and Drug Regulations
|
C.08.003 (1) Notwithstanding section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended pursuant to section C.08.006, if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission or abbreviated new drug submission, unless
(a) the manufacturer of the new drug has filed with the Minister (i) a supplement to that new drug submission...
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C.08.003 (1)Malgré l'article C.08.002, il est interdit de vendre une drogue nouvelle à l'égard de laquelle un avis de conformité a été délivré à son fabricant et n'a pas été suspendu aux termes de l'article C.08.006, lorsqu'un des éléments visés au paragraphe (2) diffère sensiblement des renseignements ou du matériel contenus dans la présentation de drogue nouvelle ou la présentation abrégée de drogue nouvelle, à moins que les conditions suivantes ne soient réunies :
a) le fabricant de la drogue nouvelle a déposé auprès du ministre : (i) soit un supplément à la présentation de drogue nouvelle... |
|
(2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following: (a) the description of the new drug;
(b) the brand name of the new drug or the identifying name or code proposed for the new drug;
(c) the specifications of the ingredients of the new drug;
(d) the plant and equipment used in manufacturing, preparation and packaging the new drug;
(e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;
(f) the tests applied to control the potency, purity, stability and safety of the new drug;
(g) the labels used in connection with the new drug;
(h) the representations made with regard to the new drug respecting (i) the recommended route of administration of the new drug,
(ii) the dosage of the new drug,
(iii) the claims made for the new drug,
(iv) the contra-indications and side effects of the new drug, and
(v) the withdrawal period of the new drug; and
(i) the dosage form in which it is proposed that the new drug be sold.
g (i) |
(2) Pour l'application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants :
a) sa description;
b) sa marque nominative ou le nom ou code sous lequel il est proposé de l'identifier;
c) les spécifications de ses ingrédients;
d) les installations et l'équipement à utiliser pour sa fabrication, sa préparation et son emballage;
e) la méthode de fabrication et les mécanismes de contrôle à appliquer pour sa fabrication, sa préparation et son emballage; f) les analyses effectuées pour contrôler son activité, sa pureté, sa stabilité et son innocuité; g) les étiquettes à utiliser pour la drogue nouvelle;
h) les observations faites relativement : (i) à la voie d'administration recommandée pour la drogue nouvelle,
(ii) à sa posologie,
(iii) aux propriétés qui lui sont attribuées,
(iv) à ses contre-indications et à ses effets secondaires,
(v) au délai d'attente applicable à celle-ci;
i) sa forme posologique proposée pour la vente.
|
|
(i) the dosage form in which it is proposed that the new drug be sold. |
i) sa forme posologique proposée pour la vente.
|
|
(3) A supplement to a new drug submission or to an abbreviated new drug submission, with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters. SOR/85-143, s. 2; SOR/93-202, s. 25; SOR/95-411, s. 6. |
(3) Le supplément à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle doit contenir, à l'égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, les renseignements et le matériel nécessaires pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle relativement à ces éléments. DORS/85-143, art. 2; DORS/93-202, art. 25; DORS/95-411, art. 6. |
|
C.08.003.1. The Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed. SOR/95-411, s. 6; SOR/2001-203, s. 5. |
C.08.003.1. Le ministre peut examiner les renseignements ou le matériel que lui présente toute personne, conformément au titre 5 ou aux articles C.08.002, C.08.002.1, C.08.003, C.08.005 ou C.08.005.1, pour déterminer l'innocuité et l'efficacité de la drogue nouvelle visée par la présentation ou le supplément. DORS/95-411, art. 6; DORS/2001-203, art. 5.
|
|
C.08.004. (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,
(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.
(2) Where a new drug submission or abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material... |
C.08.004. (1) Sous réserve de l'article C.08.004.1, après avoir terminé l'examen d'une présentation de drogue nouvelle, d'une présentation abrégée de drogue nouvelle ou d'un supplément à l'une de ces présentations, le ministre :
a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l'article C.08.005.1, délivre un avis de conformité;
b) si la présentation ou le supplément n'est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, en informe le fabricant.
(2) Lorsqu'une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l'une de ces présentations n'est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, le fabricant qui l'a déposé peut le modifier en déposant des renseignements ou du matériel supplémentaires...
|
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
Appeal from an Order of the Federal Court dated January 29, 2004,
Court File No. T-1035-02
DOCKET: A-49-04
STYLE OF CAUSE: Abbott Laboratories and Abbott Laboratories Limited v. The Minister of Health and Pharmascience Inc.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: April 7, 2004
REASONS FOR JUDGMENT BY: RICHARD C.J.
CONCURRED IN BY: ROTHSTEIN J.A.
SHARLOW J.A.
APPEARANCES:
William Richardon For the Appellants
Andrew Reddon
Steven Mason
Carol Hitchman For the Respondent, Pharmascience Inc.
Jeff North
SOLICITORS OF RECORD:
McCarthy Tétrault
Toronto, Ontario For the Appellants
Hitchman & Sprigings
Toronto, Ontario For the Respondent
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
Appeal from an Order of the Federal Court dated January 29, 2004,
Court File No. T-1847-02
DOCKET: A-50-04
STYLE OF CAUSE: Abbott Laboratories and Abbott Laboratories Limited v. The Minister of Health and Ratiopharm Inc.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: April 7, 2004
REASONS FOR JUDGMENT BY: RICHARD C.J.
CONCURRED IN BY: ROTHSTEIN J.A.
SHARLOW J.A.
APPEARANCES:
William Richardon For the Appellants
Andrew Reddon
Steven Mason
David Aitken For the Respondent, Ratiopharm Inc.
Bradley White
SOLICITORS OF RECORD:
McCarthy Tétrault
Toronto, Ontario For the Appellants
Osler, Hoskin & Harcourt LLP
Ottawa, Ontario For the Respondent
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
Appeal from an Order of the Federal Court dated January 29, 2004,
Court File No. T-1133-02
DOCKET: A-51-04
STYLE OF CAUSE: Abbott Laboratories and Abbott Laboratories Limited v. The Minister of Health and Apotex Inc.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: April 7, 2004
REASONS FOR JUDGMENT BY: RICHARD C.J.
CONCURRED IN BY: ROTHSTEIN J.A.
SHARLOW J.A.
APPEARANCES:
William Richardon For the Appellants
Andrew Reddon
Steven Mason
Harry Radomski For the Respondent, Apotex Inc.
David Lederman
SOLICITORS OF RECORD:
McCarthy Tétrault
Toronto, Ontario For the Appellants
Goodmans LLP
Toronto, Ontario For the Respondent