[1] This is an appeal of a judgment of the Federal Court (Hoffmann-La Roche Ltd. v. Canada (Minister of Health), 2004 FC 1547), dismissing the application of Hoffman-La Roche Limited for an order requiring the Minister of Health to add Canadian Patent No. 1,218,613 (the 613 patent) and Canadian Patent No. 1,341,082 (the 082patent) to the patent register in respect of trastuzumab 21 mg/ml lyophilized powder, a medicine used in the treatment of patients with breast cancer and sold in Canada under the brand name Herceptin. The Minister refused to list the two patents because the application for listing was submitted too late.

[2] The patent register is maintained by the Minister pursuant to thePatented Medicines (Notice of Compliance) Regulations, SOR/93-133. For the purposes of this appeal, it is necessary to understand certain elements of the scheme of those Regulations and the Food and Drug Regulations, C.R.C. 1978, c. 870.

[3] No drug may be marketed in Canada unless it is the subject of a "notice of compliance" issued by the Minister under the Food and Drug Regulations. To obtain a notice of compliance, the manufacturer must provide the Minister with specified information in the form of a "new drug submission". If the Minister is satisfied as to the drug's safety and efficacy, then a notice of compliance is issued. The safety and efficacy of a proposed new drug may be established either by proof in the form of detailed clinical studies, or by establishing that the proposed new drug is equivalent to another drug (a Canadian reference product), that has already been established to be safe and effective.

[4] Typically, a drug manufacturer that owns or is licensed to use a patent for a medicine found in a drug will file a "new drug submission" that contains detailed clinical studies, while a generic drug manufacturer will file an "abbreviated new drug submission" that makes a comparison to a Canadian reference product. Such a comparison becomes the link between the Food and Drug Regulations and the Patented Medicines (Notice of Compliance) Regulations if, but only if, the manufacturer of the Canadian reference product has submitted a patent list to be included in the patent register in respect of that product. The listed patents are those that are owned by or licensed to the manufacturer, and that contain a claim for the medicine, or for the use of the medicine, found in the drug.

[5] Where there is a patent list for a Canadian reference product, the Minister is not entitled to issue a notice of compliance for the generic version unless a specified notice is first given to the manufacturer of the Canadian reference product. That notice may result in an application by the manufacturer under section 6 of the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister from issuing a notice of compliance for the generic product.

[6] If a section 6 application is commenced, the Minister is precluded from issuing a notice of compliance to the generic drug manufacturer for a certain period of time. This statutory stay runs for 24 months unless terminated earlier by the expiry of the patent, by a declaration that the patent is not valid or that a non-infringement allegation is justified, or by the withdrawal, discontinuance or dismissal of the section 6 proceedings. The period of the statutory stay may be shortened or lengthened by the court in certain circumstances.

[7] It is clear that the manufacturer of a drug that contains a medicine that is the subject of a patent obtains significant benefits by listing the patent on the patent register maintained under the Patented Medicines (Notice of Compliance) Regulations. One benefit is the legal right to be notified of any attempt by another drug manufacturer to obtain a notice of compliance for a generic form of the drug. Another is the availability of the statutory stay. The listing of a patent is the gateway to those benefits.

[8] Drug manufacturers are subject to rather strict deadlines for submitting an application to have a patent listed under Patented Medicines (Notice of Compliance) Regulations. Those deadlines are set out in section 4, the relevant parts of which read as follows:

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. (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) A patent list submitted in respect of a drug must

(2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants :

(a) indicate the dosage form, strength and route of administration of the drug;

a) la forme posologique, la concentration et la voie d'administration de la drogue;

(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;

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) 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;

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) 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

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) 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.

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) 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.

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

(4) 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).

[9] I turn now to the facts of this case. On or about October 1, 1998, Hoffmann-La Roche filed a new drug submission for Herceptin. No patent list was submitted in respect of that new drug submission. A notice of compliance was issued for Herceptin on August 13, 1999.

[10] The 613 patent, entitled "Recombinant Immunoglobin Preparations", was filed in Canada on April 9, 1984, and granted on March 3, 1987. As indicated above, when Hoffmann-La Roche filed its new drug submission for Herceptin in October of 1998, it did not apply under subsection 4(3) of the Patented Medicines (Notice of Compliance) Regulations to have the 613 patent listed. The record gives no reason for that omission. It is undisputed that the 613 patent would have been eligible for listing it if had been submitted within the deadline.

[11] The 082 patent, entitled "Method of Treating Tumour Cells by Inhibiting Growth Factor Receptor Function", was filed in Canada on January 12, 1989, and granted on August 8, 2000. Within 30 days of the granting of the 082 patent, Hoffmann-La Roche could have applied under subsection 4(4) of the Patented Medicines (Notice of Compliance) Regulations to have the 082 patent included on the patent list for Herceptin. Again, the record gives no reason for that omission. It is undisputed that the 082 patent would have been included on the patent list for Herceptin if Hoffmann-La Roche had made such a timely application.

[12] On May 10, 2002, Hoffmann-La Roche filed a supplemental new drug submission for Herceptin to reflect an additional drug substance manufacturing site. That supplemental new drug submission was required because of the combined operation of ss. C.08.003(1) and C.08.003(2)(d) of the Food and Drug Regulations, which read as follows:

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

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) the manufacturer of the new drug has filed with the Minister

a) le fabricant de la drogue nouvelle a déposé auprès du ministre :

(i) a supplement to that new drug submission, or

(i) soit un supplément à la présentation de drogue nouvelle,

(ii) a supplement to that abbreviated new drug submission;

(ii) soit un supplément à la présentation abrégée de drogue nouvelle;

(b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement;

b) le ministre a délivré au fabricant un avis de conformité relativement au supplément;

c) l'avis de conformité relatif au supplément n'a pas été suspendu aux termes de l'article C.08.006;

(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any label, including any package insert, product brochure and file card, intended for use in connection with the new drug, where a change with respect to any of the matters specified in subsection (2) is made that would require a change to the label.

d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons de toute étiquette-y compris une notice jointe à l'emballage, un dépliant et une fiche sur le produit-destinée à être utilisée pour la drogue nouvelle, dans le cas où la modification d'un des éléments visés au paragraphe (2) nécessite un changement dans l'étiquette.

(2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following:

(2) Pour l'application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants :

(a) the description of the new drug;

a) sa description;

(b) the brand name of the new drug or the identifying name or code proposed for the new drug;

b) sa marque nominative ou le nom ou code sous lequel il est proposé de l'identifier;

c) les spécifications de ses ingrédients;

(d) the plant and equipment used in manufacturing, preparation and packaging the new drug;

d) les installations et l'équipement à utiliser pour sa fabrication, sa préparation et son emballage;

(e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;

e) la méthode de fabrication et les mécanismes de contrôle à appliquer pour sa fabrication, sa préparation et son emballage;

(f) the tests applied to control the potency, purity, stability and safety of the new drug;

f) les analyses effectuées pour contrôler son activité, sa pureté, sa stabilité et son innocuité;

(g) the labels used in connection with the new drug;

g) les étiquettes à utiliser pour la drogue nouvelle;

(h) the representations made with regard to the new drug respecting

h) les observations faites relativement :

(i) the recommended route of administration of the new drug,

(i) à la voie d'administration recommandée pour la drogue nouvelle,

(ii) the dosage of the new drug,

(ii) à sa posologie,

(iii) the claims made for the new drug,

(iii) aux propriétés qui lui sont attribuées,

(iv) the contra-indications and side effects of the new drug, and

(iv) à ses contre-indications et à ses effets secondaires,

(v) the withdrawal period of the new drug; and

(v) au délai d'attente applicable à celle-ci;

(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.

(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.

[13] Hoffmann-La Roche included in its supplemental new drug submission an application to list the 613 and 082 patents on the patent register. In doing so, Hoffmann-La Roche was relying on jurisprudence from this Court that the term "submission" in section 4 of the Patented Medicines (Notice of Compliance) Regulations may mean either a new drug submission or a supplemental new drug submission: Apotex Inc. v. Minister of Health (1999), 87 C.P.R. (3d), 371 (F.C.T.D., per Justice McGillis), affirmed 11 C.P.R. (4^th) 538 (F.C.A.).

[14] It is important to understand the factual context for the Apotex decision. The case involved the drug Paxil, which was manufactured by SmithKline Beecham Pharma Inc. Paxil contains the medicine paroxetine. In 1993, SmithKline had been issued a notice of compliance approving the sale of Paxil in Canada for the treatment of depression. In 1994, a patent application was filed in Canada for paroxetine tablets and a process to prepare them. In 1995, SmithKline filed two supplemental new drug submissions to seek approval to sell Paxil for the treatment of obsessive compulsive disorder and panic disorder. Notices of compliance for the new indications were issued in 1995. In 1997, the patent filed in 1994 was issued. It was held that SmithKline was entitled to have the paroxetine tablet patent listed in relation to the drugs for which the supplemental new drug submissions had been filed in 1995.

[15] Since 1999, drug manufacturers have been testing the limits of Apotex. Broadly speaking, patent holders seem to be attempting to establish that if section 4 of the Patented Medicines (Notice of Compliance) Regulations applies to a supplemental new drug submission, the filing of a supplemental new drug submission is an opportunity for the patent holder to make an application to list a patent for which a prior deadline was missed. The attempt has failed where the supplemental new drug submission was required only because of a change in the brand name of the drug, the name of the manufacturer or both: Ferring Inc. v. Canada (Attorney General) (2003), 26 C.P.R. (4^th) 155 (F.C.A.); Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General), (2001) 10 C.P.R. (4^th) 318 (F.C.T.D.), affirmed (2002), 16 C.P.R. (4^th) 425 (F.C.A.), Toba Pharma Inc. v. Canada (Attorney General) (2002), (2002) 21 C.P.R. (4th) 232 (F.C.), AstraZeneca Canada Inc. v. Minister of Health (2004), 36 C.P.R. (4^th) 58 (F.C.) (appeal pending).

[16] In Ferring, Bristol-Myers and Toba, there was either a finding or a suggestion that the name change was adopted as a strategy to avoid the filing deadlines in the Patented Medicines (Notice of Compliance) Regulations. There was no such finding or suggestion in Astrazeneca.

[17] In Abbott Laboratories v. Canada (Minister of Health), (2004), 31 C.P.R. (4^th) 321 (F.C.A.), section 4 of the Patented Medicines (Notice of Compliance) Regulations was held to apply to a supplemental new drug submission that was not part of a strategy adopted to circumvent the filing deadlines. However, it was also found in that case that the supplemental new drug submission related to a new indication for the medicine.

[18] In this case, it is conceded that the change of manufacturing site and the filing of the supplemental new drug submission were bona fide, in the sense that Hoffmann-La Roche did not change its manufacturing site for the purpose of circumventing the filing deadlines. Hoffmann-La Roche argues that the facts of this case are not distinguishable from the facts in Abbott, and that the Minister should be obliged to list the 613 and 082 patents.

[19] However, the Minister argues that the governing jurisprudence is represented by Ferring, Bristol-Myers Squib, and Toba. The Minister says that although it was found in each of those cases that the drug manufacturer was pursuing a strategy for extending the filing deadline, the actual basis for the decision in each case was the need to avoid any extension of the filing deadline that is not consistent with the statutory scheme. By the same reasoning, the Minister submits that Hoffmann-La Roche should not be permitted to use a supplemental new drug submission filed in respect of a change of manufacturing site as a gateway to the benefits of the Patented Medicines (Notice of Compliance) Regulations.

[20] The logic of the Minister's position is compelling. The Patented Medicines (Notice of Compliance) Regulations operate through a linkage to the Food and Drug Regulations. The two regulations use identical terminology. It was by considering the two schemes together that Justice McGillis was able to conclude, in Apotex (cited above), that the word "submission" in section 4 of the Patented Medicines (Notice of Compliance) Regulations could mean either a new drug submission or a supplemental new drug submission. However, she reached that conclusion in a particular factual context, in which a relatively expansive reading of section 4 was consistent with the statutory scheme. She did not decide that section 4 would necessarily apply to every possible supplemental new drug submission.

[21] After Apotex, it became apparent that unless some supplemental new drug submissions are found to be outside the scope of section 4, the time limit set out in that provision may be rendered useless. Gradually, exclusions have been recognized for supplemental new drug submissions that are made only because of a change in the brand name of the drug or the manufacturer. In my view, the Minister was correct in this case to recognize the same exclusion for a supplemental new drug submission that is made only because of a change of the manufacturing site.

[22] It is argued for Hoffmann-La Roche that there is no principled basis upon which to make a distinction between those supplemental new drug submissions that are, and those that are not, within the scope of section 4 of the Patented Medicines (Notice of Compliance) Regulations.

[23] In paragraph 24 of the reasons for decision under appeal, it is suggested that a supplementary new drug submission is outside the scope of section 4 of the Patented Medicines (Notice of Compliance) Regulations unless it relates in some way to the safety or efficacy of the drug. This reflects the following comment, found in paragraph 37 of Astrazeneca (quoted above):

[37] The operation of the [Patented Medicines (Notice of Compliance) Regulations] is connected with the assessment of the safety and efficacy of pharmaceutical products, pursuant to the Food and Drug Regulations. It is reasonable to conclude that the underlying submission for a patent list be related to the purpose of that regulatory scheme. In the present case, that relationship is not apparent. The underlying submission is only for an administrative change in the record of the manufacturer's name.

[24] The safety and efficacy of drugs is dealt with in the Food and Drug Regulations. Contrary to the statement quoted above, the Patented Medicines (Notice of Compliance) Regulations have no bearing on the assessment of safety or efficacy. Although they are linked to the Food and Drug Regulations, their purpose is to prevent patent infringement by providing certain drug manufacturers with the advantages described above. Thus, I am not persuaded that there is a rational basis for limiting the scope of section 4 of the Patented Medicines (Notice of

Compliance) Regulations to supplemental new drug submissions that have some bearing on the safety or efficacy of the drug.

[25] It does not follow that there is no principled basis for excluding some supplemental new drug submissions from the scope of section 4 of thePatented Medicines (Notice of

Compliance) Regulations. However, the principle for exclusion must be related to the purpose of the Regulations, which is the prevention of patent infringement. A change in the name of a drug or a drug manufacturer, or a change of manufacturing site, cannot possibly be relevant to any potential claim for infringement of a patent for a medicine found in the drug. There is no justification for permitting patent holders to use such a change to enhance the advantage they obtain under the Patented Medicines (Notice of Compliance) Regulations. Thus, a supplemental new drug submission is outside the scope of section 4 if it is filed to reflect a change in the name of a drug or a drug manufacturer, or a change of manufacturing site.

[26] I would dismiss this appeal with costs.

(s) "K. Sharlow"

J.A.

"I agree.

Marshall Rothstein J.A."

"I agree.

B. Malone J.A."

FEDERAL COURT OF APPEAL

NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET: A-595-04

STYLE OF CAUSE: HOFFMAN-LAROCHE LIMITED v. THE MINISTER OF HEALTH ETAL

PLACE OF HEARING: TORONTO

DATE OF HEARING: MARCH 2, 2005

REASONS FOR JUDGMENT : SHARLOW J.A.

CONCURRED IN BY: ROTHSTEIN J.A.

MALONE J.A.

DATED: MAY 12, 2005

APPEARANCES:

Mr. Gunars Gaikis FOR THE APPELLANT

Ms. Nancy Pei

Mr. F. B. Woyiwada FOR THE RESPONDENTS

SOLICITORS OF RECORD:

Smart & Biggar FOR THE APPELLANT

Toronto, Ontario

Mr. John H. Sims Q.C.

Deputy Attorney General of Canada

Ottawa, Ontario FOR THE RESPONDENTS

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Hoffman-La Roche Ltd. v. Canada (Minister of Health), 2005 FCA 140

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2005 FCA 140