Date: 20010524
Docket: T-994-00
Neutral Citation: 2001 FCT 514
Between:
WARNER-LAMBERT CANADA INC. and
WARNER-LAMBERT COMPANY
Applicants
- and -
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER
PINARD, J.:
[1] This is an application by Warner-Lambert Canada Inc. (the applicant) and Warner-Lambert Company for judicial review in respect of a decision of the Minister of Health (the Minister) dated May 24, 2000 pursuant to subsection 3(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended (the Regulations).
[2] In the decision, the Minister decided that:
(a) a patent list for Canadian Patent No. 1297023 (the ‘023 patent) and Canadian Patent No. 1297024 (the ‘024 patent), submitted by the applicant along with Supplemental New Drug Submission #064751 (the SNDS) would not be added to the patent register maintained by the Minister pursuant to subsection 3(1) of the Regulations; and
(b) the ‘023 and ‘024 patents will be removed from the patent register in respect of the applicant's quinapril hydrochloride 5, 10, 20 and 40 mg oral tablets and quinapril hydrochloride/hydrochlorothiazide 10/12.5 mg (hydrochloride/hydrochlorothiazide), 20/12.5 mg and 20/25 mg oral tablets.
[3] Warner-Lambert Company is the owner of the ‘023 and ‘024 patents, and the applicant is the exclusive licensee in Canada of Warner-Lambert Company in respect of the ‘023 and ‘024 patents.
[4] The applicant markets in Canada, through its Parke-Davis Division (Parke-Davis), two lines of products used in the treatment of hypertension in humans. Both contain an active pharmaceutical ingredient known as quinapril hydrochloride.
[5] One line of products is marketed under the trade-mark ACCUPRIL and contains quinapril hydrochloride as the sole active ingredient. ACCUPRIL is marketed in 5, 10, 20 and 40 mg oral tablets. The other line of products is marketed under the trade-mark ACCURETIC and, in addition to quinapril hydrochloride, contains a further active pharmaceutical ingredient known as hydrochlorothiazide. ACCURETIC is marketed in 10/12.5 mg (hydrochloride/hydrochlorothiazide), 20/12.5 mg and 20/25 mg oral tablets.
[6] Pursuant to the Regulations, the applicant submitted patent lists including the ‘023 and ‘024 patents in association with its ACCUPRIL products, most recently on December 24, 1999, along with the SNDS for quinapril hydrochloride. Such patent lists, other than those accompanying the SNDS, were added to the patent register by the Minister in respect to the applicant's ACCUPRIL products, beginning in 1993. In the decision, the Minister has decided he will refuse to add to the patent register, upon issuing a Notice of Compliance in respect of the SNDS, the patent lists accompanying the SNDS, including the ‘023 and ‘024 patents.
[7] Also pursuant to the Regulations, the applicant submitted patent lists including the ‘023 and ‘024 patents in association with its ACCURETIC products. Such patent lists were added to the patent register by the Minister in respect of the applicant's ACCURETIC products, beginning in 1995.
[8] It is common ground that both patents are directed to pharmaceutical compositions containing the medicinal ingredient quinapril hydrochloride in combination with an inactive ingredient:
(a) an ascorbic acid containing stabilizer in respect of the ‘023 patent; and
(b) an ascorbic acid and/or sodium ascorbate in respect of the ‘024 patent.
[9] The applicant wishes to list these patents in respect of:
(a) its 5, 10, 20 and 40 mg oral tablets of the drug ACCUPRIL which contains the medicinal ingredient quinapril hydrochloride; and
(b) its 10/12.5 mg, 20/12.5 mg and 20/25 mg oral tablets of the drug ACCURETIC, which contains quinapril hydrochloride in combination with the medicinal ingredient hydrochlorothiazide.
[10] It is also common ground that the ACCUPRIL and ACCURETIC tablets currently marketed, and for which Parke-Davis sought approval in an SNDS, do not contain either an ascorbic acid containing stabilizer or ascorbic acid and/or sodium ascorbate.
[11] The relevant portion of the impugned decision reads as follows:
The ‘023 and ‘024 patents meet all requirements for addition to the patent register except that they contain claims to a composition for which Parke-Davis has agreed approval was not sought.
The PM(NOC) Regulations do not allow the TPP to add a patent to the register in respect of a drug which has not been issued a NOC under the Food and Drug Regulations.
In your representations you discussed the relevance of the ‘023 and ‘024 patents to ACCUPRIL and ACCURETIC at some length. In particular, you stressed the fact that the claims in the patents include a composition containing quinapril hydrochloride in the same dosage form, strength and route of administration as ACCUPRIL and ACCURETIC.
The relevance of the dosage form, strength and route of administration are factors in consideration of the eligibility of a patent to be listed against an approved drug. The patents accepted for addition against ACCUPRIL and ACCURETIC were all in this sense relevant. However, the consideration of such relevance is not a pertinent factor where the drug addressed in the claims of the patent has not yet been approved.
The TPP objects to the listing of the ‘023 and ‘024 patents on the basis that ACCUPRIL and ACCURETIC are not drugs which contain the composition claimed in your patents. Parke-Davis has not yet sought or received the necessary approval for the drugs against which it might seek to add the patents.
Should Parke-Davis choose to apply for, and receive, a Notice of Compliance for the subject matter of the ‘023 and ‘024 patents, they could be added to the patent register at that time, subject to the requirements of the Patented Medicines (Notice of Compliance) Regulations [SOR/93-133 as amended].
[. . .]
Pursuant to the authority vested in the Minister of Health by subsection 3(1) of the Patented Medicines (Notice of Compliance) Regulations [SOR/93-133 as amended] the patent lists for the ‘614, ‘023, and ‘024 patents submitted with the above SNDS will not be added on the Patent Register and the ‘614, ‘023, and ‘024 patents will be removed June 5, 2000 from any previously submitted patent lists for the above ACCUPRIL and ACCURETIC products.
[12] The applicant claims that in rendering his decision, the Minister essentially decided that the listing of patents on the patent register is dependent on precisely matching the claims for the patent with the ingredients of a drug product which is the subject of an application for a notice of compliance. However, the applicant submits that nothing in the Regulations requires that the inactive ingredients precisely match those in the drug. As a result, this premise by the Minister constitutes an error of law in that the Minister took into account an irrelevant consideration in rendering his decision.
[13] In other words, in order to be eligible for listing, in addition to being relevant to at least one of the active ingredients in a particular product, patents must be relevant only to the dosage form, strength and route of administration of products in respect of which notices of compliance were or are being sought.
[14] As such, the applicant claims that the ‘023 and ‘024 patents are properly listed against the ACCUPRIL and ACCURETIC tablets since both patents contain claims to the medicine quinapril itself or the use of quinapril, and are relevant to the dosage form, strength and route of administration of the drug described in the submission.
[15] The relevant provisions of the Regulations read:
| 3. (1) The Minister shall maintain a register of any information submitted under section 4. To maintain it, the Minister may refuse to add or may delete any information that does not meet the requirements of that section. (2) The register shall be open to public inspection during business hours. (3) No information submitted pursuant to section 4 shall be included on the register until after the issuance of the notice of compliance in respect of which the information was submitted. (4) For the purpose of deciding whether information submitted under section 4 should be added or deleted from the register, the Minister may consult with officers or employees of the Patent Office. |
3. (1) Le ministre tient un registre des renseignements fournis aux termes de l'article 4. À cette fin, il peut refuser d'y ajouter ou en supprimer tout renseignement qui n'est pas conforme aux exigences de cet article. (2) Le registre est ouvert à l'inspection publique durant les heures de bureau. (3) Aucun renseignement soumis aux termes de l'article 4 n'est consigné au registre avant la délivrance de l'avis de conformité à l'égard duquel il a été soumis. (4) Pour décider si tout renseignement fourni aux termes de l'article 4 doit être ajouté au registre ou en être supprimé, le ministre peut consulter le personnel du Bureau des brevets. |
| 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 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. [. . .] (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. [. . .] (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.
|
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 a 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. [. . .] (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. [. . .] (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. |
[16] Thus, under subsection 3(1) of the Regulations, the Minister is required to maintain a register of any information or patent lists submitted by a person under section 4. By virtue of the same provision, the Minister may refuse to add or delete any information or patent lists which do not meet the requirements of section 4. At the hearing before me, counsel for the parties agreed that the Minister's decision to refuse to add or delete information or patent lists is to be reviewed by this Court against the standard of correctness.
[17] To me, the language of subsections 4(1), (2) and (7) of the Regulations is clear : for a patent set out on a patent list to be eligible for inclusion on the register, it must be relevant to a drug for which a submission for a notice of compliance has been filed. This requirement obviously contributes to ensuring a "product-specific" patent list, which is an objective clearly stated in the Regulatory Impact Analysis Statement accompanying the amendments to section 4 of the Regulations in 1998:
Patentees are required to certify that the patents submitted on the list for a drug are relevant to that particular version of the drug. This will ensure that patents that do not apply to the particular version of the drug will not impede the generic's market entry.
[18] In the case at bar, the evidence shows that the ‘023 and ‘024 patents contain claims for pharmaceutical compositions which are considered, within the meaning of the Regulations, drugs that contain claims for a medicine (see Hoffman-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.); aff'd (1995), 67 C.P.R. (3d) 25 (F.C.A.); application for leave to appeal to Supreme Court of Canada denied [1996] S.C.C.A. No. 65 (S.C.C.) (QL)).
[19] However, the evidence also shows that the specific drugs covered by the ‘023 and ‘024 patents have never been the subject of a drug submission (NOC) under the Food and Drug Regulations, C.R.C., c. 870, as amended. Further, the evidence shows that the ACCUPRIL and ACCURETIC drug products for which drug submissions have been filed and approved by the Minister do not contain an ascorbic acid containing stabilizer, ascorbic acid or sodium ascorbate, which are the stabilizers found in the pharmaceutical compositions covered by the ‘023 and ‘024 patents. As such, the later patents are not relevant to the drug products for which a submission for a notice of compliance has been filed. As a result, they do not meet the eligibility requirements contained in subsections 4(1), (2) and (7) of the Regulations. Consequently, it was correct for the Minister to conclude that the ‘023 and ‘024 patents were ineligible for inclusion on the register.
[20] For all the above reasons, the application for judicial review is dismissed, with costs.
JUDGE
OTTAWA, ONTARIO
May 24, 2001
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD
COURT FILE NO.: T-994-00
STYLE OF CAUSE: WARNER LAMBERT CANADA INC. AND OTHERS v. THE MINISTER OF HEALTH
PLACE OF HEARING: VANCOUVER, BRITISH COLUMBIA
DATE OF HEARING: 01-MAY-2001
REASONS FOR ORDER OF THE HONOURABLE JUSTICE PINARD
DATED: MAY 24, 2001
APPEARANCES:
MR. JOSEPH ARVAYFOR APPLICANT
MR. CHRISTOPHER JONES FOR APPLICANT
MR. F.B. WOYIWADAFOR RESPONDENT
SOLICITORS OF RECORD:
ARVAY FINLAYFOR APPLICANT
VICTORIA, BRITISH COLUMBIA
MR. MORRIS ROSENBERGFOR RESPONDENT
DEPUTY ATTORNEY GENERAL OF CANADA
OTTAWA, ONTARIO