Date: 20010119
Docket: T-1768-00
BETWEEN:
BRISTOL-MYERS SQUIBB CANADA INC.
Applicant
- and -
ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH and APOTEX Inc.
Respondents
REASONS FOR ORDER AND ORDER
CAMPBELL J.
[1] In 1992, Brystol-Myers Squibb Canada Inc. ("BMS") applied for a Notice of Compliance ("NOC") pursuant to the Patented Medicines (Notice of Compliance) Regulations 1 with respect to the medicine nefazadone hydrochloride under the brand name SERZONE. In making the application, BMS filed a patent list as it was entitled to do under NOC Regulation 4(1). 2
[2] Apparently, due to inadvertence, an important patent was omitted from the patent list filed. BMS admits that, ever since, it has attempted to rectify this situation. Most recently, BMS was successful in having the omitted patent placed on a patent list, only to have it subsequently removed by the Minister of Health ("the Minister"). In the present application, BMS challenges the legal correctness of this decision. 3
A. Factual background 4
[3] BMS originally filed its submission for an NOC in respect of the medicine nefazadone hydrochloride in 50, 100, 150, 200 and 300 mg strength tablets on April 30, 1992 under the brand name SERZONE. On April 11, 1993, within 30 days of the coming into force of the 1993 NOC Regulations, BMS submitted a patent list for nefazadone hydrochloride in 50, 100, 150, 200 and 300 mg strength tablets. However, the patent list submitted contained only Canadian Patent No. 1,233,826 (the "'826 Patent"). The '436 Patent was not included on the patent list during the 30 days in which it would have been possible to do so.
[4] Subsequently, on June 16, 1993, BMS attempted to list the '436 Patent on the Patent Register by purporting to file a revised patent list containing both the '826 and '436 Patents. This patent list was rejected by the Minister on the basis that the time for submitting such lists had expired.
[5] BMS was issued an NOC for SERZONE on April 27, 1994. The patent list containing the '826 Patent was included on the Patent Register referable to this NOC on May 10, 1994.
[6] Having failed in its initial attempt to have the '436 Patent included on the Patent Register in respect of SERZONE, on March 18, 1999, BMS submitted a supplementary new drug submission ("NDS") for a product monograph update. This submission included a patent list containing the '436 Patent and Canadian Patent No. 1,237,723 (the "'723 Patent").
[7] The Minister found that the '723 Patent was not eligible for listing on the Patent Register as it did not contain a claim to the medicine nefazadone hydrochloride or its use. In addition, the Minister determined that the supplemental NDS should have been filed as a "notifiable change" instead of as a supplemental NDS, the result being that BMS was ineligible to file a patent list, and, therefore, was unsuccessful in getting the '436 Patent including on the Patent Register.
[8] Subsequently, it was determined that the '826 Patent was ineligible for inclusion on the Patent Register as it did not contain a claim for the medicine nefazadone hydrochloride or its use. The '826 Patent was removed from the Patent Register on October 22, 1999.
[9] Following this removal, BMS once again attempted to have the '436 Patent included on the Patent Register in respect of SERZONE. By letter dated October 28, 1999, BMS asserted that, in filing its original patent list in respect of SERZONE, it had inadvertently listed the '826 Patent while intending to list the '436 Patent. In light of this representation, BMS requested that it be allowed to correct this "clerical error" by substituting the '436 Patent on the Patent Register in place of the '826 Patent.
[10] By letter dated November 9, 1999, the Minister rejected BMS's request to allow the '436 Patent to be added to the Patent Register in respect of SERZONE on the basis of "clerical error".
[11] BMS's fourth attempt to overcome the timing restrictions in NOC Regulation 4 involved use of Regulation C.08.003 of the Food and Drug Regulations, C.R.C. 1978, c. 870, as amended. On January 25, 2000, BMS filed a supplemental NDS, the only purpose of which was to slightly modify the brand name of its nefazadone hydrochloride product by adding a suffix to the name SERZONE, thus resulting in the new brand name SERZONE-5HT2. At the time of making this submission, BMS certified that all aspects of the submission pertaining to SERZONE-5HT2 were identical to SERZONE, save for a change to the product name. In addition, BMS requested that the drug identification numbers ("DIN") for all dosage forms remain unchanged.
[12] BMS filed a patent list along with this supplemental NDS for the change in product name, which included the '436 Patent. On February 7, 2000, an NOC issued for SERZONE-5HT2. As requested by BMS, the DINs were maintained under the new product name. Following issuance of the NOC, the '436 Patent was included on the Patent Register on February 18, 2000, on the basis that the supplemental NDS was a submission for an NOC.
[13] On August 8, 2000, the Minister wrote the following letters to BMS:
| It has come to our attention that patent 11983436 (the '436 patent) listed by Bristol-Myers Squibb Canada Inc. (Bristol-Myers Squibb) for nefazadone hydrochloride 50, 100, 150 and 200 mg tablets on the patent register on February 18, 2000, was added incorrectly. |
| As you know, the '436 patent was added to the Patent Register on the basis of a patent list in respect of a supplemental new drug submission (S/NDS) for a change in brand-name from SERZONE to SERZONE-5HT2. The notice of compliance (NOC) for the S/NDS was issued on February 7, 2000. At your request, the Drug Identification Numbers (DINs) were maintained under the new brand-name SERZONE-5HT2. |
| When auditing the patent list containing the '436 patent, we allowed the patent to be added to the patent register. In so doing, we took note of the decision of Madame Justice McGillis of the Federal Court, Trial Division in Apotex Inc. v. Canada (Minister of Health) (1999), 165 F.T.R. 42; 87 C.P.R. (3d) 271. In that case, Justice McGillis conducted an analysis as to whether a supplement was a submission for purposes of section 4 of the PM(NOC) Regulations. She answered in the affirmative, on the grounds that a supplement was a `submission for NOC'. |
| It has subsequently come to our attention that the above case was based upon an analysis of the PM(NOC) Regulations prior to the 1998 amendments. Justice McGillis specified at paragraph 48 of her reasons that she had interpreted and applied the PM(NOC) Regulations as they existed prior to 1998. She did not, therefore, have the opportunity to consider the introduction of subsection 4(6) of the PM(NOC) Regulations. That subsection provides: |
| 4(6) A person who submits a patent list, must keep the list up to date but may not add a patent to an existing patent except in accordance with subsection (4) |
| The introduction of subsection 4(6) appears to be a reconfirmation by the government that, although first persons are required to make updates to their patent lists (such as change of address for service of a NOA), patents must be added to the register within the strict time requirements specified in section 4. The wording is clear that a new patent cannot be introduced to an existing list, except through subsection 4(4). |
| The '436 patent was not added under subsection 4(4). The addition of the patent was through subsection 4(1) on the basis of the S/NDS. In this particular case, since the nature of the supplemental submission, being a brand name change, does not change the drug, the '436 is effectively added to the existing patent list for nefazadone hydrochloride. This is contrary to the express wording of subsection 4(6). |
| We also note that in the Apotex case, Justice McGillis did not have the opportunity to consider the effect of the introduction of subsection 4(6) in circumstances where the supplement was for a brand name change - a change for which the drug necessarily remains the same. |
| 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 '436 patent will be removed from the Patent Register for the above products, subject to any written representations. Any representations made in response to this letter should be forwarded to the undersigned within 30 calendar days from the date of this letter. Any written representations that are received may be forwarded by this office to the Canadian Intellectual Property Office (CIPO) for review. If, after 30 days following the date of this letter and having taken into account CIPO's review and any representations, the TPP [Therapeutic Products Programme of the Minister of Health] remains of the view that the patent should not be listed, then the identified patent will be removed from the Register. 5 |
[14] By letter dated September 8, 2000, BMS made representations as to why the '436 Patent should not be removed. However, by letter dated September 18, 2000, the Minister informed BMS of the final decision taken that the '436 Patent was improperly included on the Patent Register, and, accordingly, the '436 Patent would be removed within seven days. In doing so, the Minister made the following statement:
| Notably, SERZONE and SERZONE-5HT2 are the same drug, and retain the same DINs. The drug cannot be treated as a different set of products under sections 4 and 5 of the PM(NOC) Regulations. The patent list is added to the patent register on the basis of an individual submission, but is added in reference to a particular drug, not a particular drug submission. Thus, under section 5, the second person does not address patents listed for SERZONE separately from those listed for SERZONE-5HT2. Otherwise, a second person using SERZONE as the Canadian Reference Product would arguably not be required to address a patent listed for SERZONE-5HT2 pursuant to subsection 5(1), when the drug is known to be identical except for the brand name. |
| The TPP does not, therefore, agree that where a first person has, for some reason, failed to list a patent against a drug in respect of its original drug submission, by simply changing the brand name without changing the drug or use of the drug, a first person may ignore the listing requirements in the legislation expressed in section 4, which have been noted by the Court to be strict. The clear working of subsections 4(1) and 4(3) requires that new patents cannot be added to an existing list, except through the exception under 4(4), which relates to the grant of a patent application filed with the Canadian Intellectual Property Office prior to the drug submission. 6 |
B. The issue
[15] In my opinion, BMS cannot be faulted for attempting to rectify the inadvertent omission of its important '436 Patent, and I agree with BMS's argument that it is not engaging in negative behaviour to use any legal means available to rectify the situation.
[16] To accomplish the objective of having the '436 Patent registered in its most recent attempt, BMS used the trade name change element of Food and Drug Regulation C.08.003. The critical issue for determination is whether the Minister was correct in law in deciding that the '436 Patent was ineligible for inclusion in the Register by this means.7
C. Conclusion
[17] I find that the Minister's decision is correct in law.
[18] BMS argues that it has the right to exercise a right to act under Food and Drug Regulation C.08.003 to change the brand name of SERZONE, which in turn, allows the filing of a patent list which can include the '436 Patent. However, I reject this argument since I agree with the Minister's interpretation of the law as expressed in the August 8, 2000 and September 18, 2000 letters as quoted above.
[19] It is evident from the record that the underlying concern held by the Minister in reversing the decision to register the '436 Patent is forward looking. That is, to allow the use of Food and Drug Regulation C.08.003 by BMS in the present case would allow innovative companies to circumvent the timing requirements of NOC Regulation 4 by changing brand names in order to put patents on the Patent Register that were not there before, for which the time lines had not been complied with originally. 8 In oral argument, counsel for the Minister submitted that the effect of allowing the practice of concern would be to inhibit the entry of generics into the market place. There is evidence that the introduction of NOC Regulation 4(6) was to overcome this effect.
[20] In the Regulatory Impact Analysis Statement to the 1998 Regulations, under the heading "Benefits and Costs" the following statement is made:
| The link between the patent status of a drug and approval for a generic version of the drug is being maintained, to provide effective enforcement of patent rights, while at the same time ensuring that generic drugs can enter the market as soon as possible; either as soon as it is determined that they are not covered by a patent, or, where they are covered by a patent, immediately after the expiry of the patent. Overall, since the amendments are designed to make Regulations fairer and more effective, and reduce unnecessary litigation, compliance costs to private sector parties should be reduced. The amendments will not significantly alter the costs of administering, or adjudicating cases under the Regulations. |
| The amendments reinforce the balance between providing a mechanism for the effective enforcement of patent rights and ensuring that generic drug products enter the market as soon as possible. 9 |
I accept this evidence as a helpful guide to resolving the statutory interpretation question under consideration. 10
[21] I agree with the Minister's argument that to allow innovative companies to potentially add patents to the Patent Register by filing a patent list using BMS's Food and Drug Regulation C.08.003 strategy, is contrary to the specific intention of Parliament as expressed in NOC Regulation 4(6). Thus, I find that Food and Drug Regulation C.08.003 cannot be used to achieve the result pursued by BMS.
O R D E R
Accordingly, the application is dismissed.
I award costs against the Applicant in favour of the Attorney General of Canada and the Minister of Health jointly, and in favour of Apotex Inc.
| Judge |
OTTAWA
A P P E N D I X
| Patented Medicines Regulations, Règlement sur les médicaments |
| SOR/98-166 brevetés, DORS/98-166 |
| PATENT LIST 4. (1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug. (2) A patent list submitted in respect of a drug must (a) indicate the dosage form, strength and route of administration of the drug; (b) set out any Canadian patent that is owned by the person, or in respect of which the person has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list, that contains a claim for the medicine itself or a claim for the use of the medicine and that the person wishes to have included on the register; (c) contain a statement that, in respect of each patent, the person applying for a notice of compliance is the owner, has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list; (d) set out the date on which the term limited for the duration of each patent will expire pursuant to section 44 or 45 of the Patent Act; and (e) set out the address in Canada for service on the person of any notice of an allegation referred to in paragraph 5(3)(b) or (c), or the name and address in Canada of another person on whom service may be made, with the same effect as if service had been made on the person. (3) Subject to subsection (4), a person who submits a patent list must do so at the time the person files a submission for a notice of compliance. (4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission,submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2). (5) When a first person submits a patent list or an amendment to an existing patent list in accordance with subsection (4), the first person must identify the submission to which the patent list or the amendment relates, including the date on which the submission was filed. (6) A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in |
| accordance with subsection (4). (7) A person who submits a patent list or an amendment to an existing patent list under subsection (1) or (4) must certify that (a) the information submitted is accurate; and (b) the patents set out on the patent list or in the amendment are eligible for inclusion on the register and are relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for a notice of compliance has been filed. SOR/98-166, s. 3. 5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug, (a) state that the person accepts that the notice of compliance will not issue until the patent expires; or (b) allege that (i) the statement made by the first person pursuant to paragraph 4(2)(c) is false, (ii) the patent has expired, (iii) the patent is not valid, or (iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. (1.1) Subject to subsection (1.2), where subsection (1) does not apply and where a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine found in another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent included on the register in respect of the other drug containing the medicine, where the drug has the same route of administration and a comparable strength and dosage form, (a) state that the person accepts that the notice of compliance will not issue until the patent expires; or (b) allege that |
| (i) the statement made by the first person pursuant to paragraph 4(2)(c) is false, (ii) the patent has expired, (iii) the patent is not valid, or (iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. (1.2) Where a person referred to in subsection (1.1) has served, in accordance with paragraph (3)(b) or (c), a notice of allegation on a first person in respect of a patent included on the register, the person is not required to serve a notice of allegation in respect of the same submission, the same allegation and the same patent on another first person. (2) Where, after a second person files a submission for a notice of compliance but before the notice of compliance is issued, a patent list or an amendment to a patent list is submitted in respect of a patent pursuant to subsection 4(4), the second person shall amend the submission to include, in respect of that patent, the statement or allegation that is required by subsection (1) or (1.1), as the case may be. (3) Where a person makes an allegation pursuant to paragraph (1)(b) or (1.1)(b) or subsection (2), the person shall (a) provide a detailed statement of the legal and factual basis for the allegation; (b) if the allegation is made under any of subparagraphs (1)(b)(i) to (iii) or (1.1)(b)(i) to (iii), serve a notice of the allegation on the first person; (c) if the allegation is made under subparagraph (1)(b)(iv) or (1.1)(b)(iv), (i) serve on the first person a notice of the allegation relating to the submission filed under subsection (1) or (1.1) at the time that the person files the submission or at any time thereafter, and (ii) include in the notice of allegation a description of the dosage form, strength and route of administration of the drug in respect of which the submission has been filed; and (d) serve proof of service of the information referred to in paragraph (b) or (c) on the Minister. SOR/98-166, ss. 4, 9; SOR/99-379, s. 2. |
| LISTE DE BREVETS 4. (1) La personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à l'égard de la drogue, accompagnée de l'attestation visée au paragraphe (7). (2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants : a) la forme posologique, la concentration et la voie d'administration de la drogue; b) tout brevet canadien dont la personne est propriétaire ou à l'égard duquel elle détient une licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste, qui comporte une revendication pour le médicament en soi ou une revendication pour l'utilisation du médicament, et qu'elle souhaite voir inscrit au registre; c) une déclaration portant, à l'égard de chaque brevet, que la personne qui demande l'avis de conformité en est le propriétaire, en détient la licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste; |
| d) la date d'expiration de la durée de chaque brevet aux termes des articles 44 ou 45 de la Loi sur les brevets; e) l'adresse de la personne au Canada aux fins de signification de tout avis d'allégation visé aux alinéas 5(3)b) ou c), ou les nom et adresse au Canada d'une autre personne qui peut en recevoir signification avec le même effet que s'il s'agissait de la personne elle-même. (3) Sous réserve du paragraphe (4), la personne qui soumet une liste de brevets doit le faire au moment du dépôt de la demande d'avis de conformité. (4) La première personne peut, après la date de dépôt de la demande d'avis de conformité et dans les 30 jours suivant la délivrance d'un brevet qui est fondée sur une demande de brevet dont la date de dépôt est antérieure à celle de la demande d'avis de conformité, soumettre une liste de brevets, ou toute modification apportée à une liste de brevets, qui contient les renseignements visés au paragraphe (2). (5) Lorsque la première personne soumet, conformément au paragraphe (4), une liste de brevets ou une modification apportée à une liste de brevets, elle doit indiquer la demande d'avis de conformité à laquelle se rapporte la liste ou la modification, en précisant notamment la date de dépôt de la demande. (6) La personne qui soumet une liste de brevets doit la tenir à jour mais ne peut ajouter de brevets à une liste que si elle le fait en conformité avec le paragraphe (4). (7) La personne qui soumet une liste de brevets ou une modification apportée à une liste de brevets aux termes des paragraphes (1) ou (4) doit remettre une attestation portant que : a) les renseignements fournis sont exacts; b) les brevets mentionnés dans la liste ou dans la modification sont admissibles à l'inscription au registre et sont pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue visée par la demande d'avis de conformité. DORS/98-166, art. 3. 5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue : a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet; |
| b) soit une allégation portant que, selon le cas : (i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse, (ii) le brevet est expiré, (iii) le brevet n'est pas valide, (iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité. (1.1) Sous réserve du paragraphe (1.2), lorsque le paragraphe (1) ne s'applique pas, la personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament que l'on trouve dans une autre drogue qui a été commercialisée au Canada par suite de la délivrance d'un avis de conformité à la première personne et à l'égard de laquelle une liste de brevets a été soumise doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre visant cette autre drogue contenant ce médicament, lorsque celle-ci présente la même voie d'administration et une forme posologique et une concentration comparables : a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne soit pas délivré avant l'expiration du brevet; b) soit une allégation portant que, selon le cas : (i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse, (ii) le brevet est expiré, (iii) le brevet n'est pas valide, (iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité. (1.2) Si une personne visée au paragraphe (1.1) a signifié, conformément aux alinéas (3)b) ou c), un avis d'allégation à une première personne à l'égard d'un brevet inscrit au registre, elle n'est tenue de signifier un avis d'allégation à l'égard de la même demande, de la même allégation et du même brevet à aucune autre première personne. (2) Lorsque, après le dépôt par la seconde personne d'une demande d'avis de conformité mais avant la délivrance de cet avis, une liste de brevets ou une modification apportée à une liste de brevets est soumise à l'égard d'un brevet aux termes du paragraphe 4(4), la seconde personne doit modifier la demande pour y inclure, à l'égard de ce brevet, la déclaration ou l'allégation exigées par les paragraphes (1) ou (1.1), selon le cas. (3) Lorsqu'une personne fait une allégation visée aux alinéas (1)b) ou (1.1)b) ou au paragraphe (2), elle doit : |
| a) fournir un énoncé détaillé du droit et des faits sur lesquels elle se fonde; b) si l'allégation est faite aux termes de l'un des sous-alinéas (1)b)(i) à (iii) ou (1.1)b)(i) à (iii), signifier un avis de l'allégation à la première personne; (c) si l'allégation est faite aux termes des sous-alinéas (1)b)(iv) ou (1.1)b)(iv) : (i) signifier à la première personne un avis de l'allégation relative à la demande déposée selon les paragraphes (1) ou (1.1), au moment où elle dépose la demande ou par la suite, (ii) insérer dans l'avis d'allégation une description de la forme posologique, de la concentration et de la voie d'administration de la drogue visée par la demande; (d) signifier au ministre une preuve de la signification effectuée conformément aux alinéas b) ou c). DORS/98-166, art. 4 et 9; DORS/99-379, art. 2. |
Food and Drug Regulations, C.R.C., c. 870 C.08.003 (1) (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, or (ii) a supplement to that abbreviated new drug submission; |
| (b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement; (c) the notice of compliance in respect of the supplement has not been suspended pursuant to section C.08.006; and (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. C.08.003 (2) (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
C.08.003 (3) (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. C.08.003.1 In the examination of a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission, a supplement to an abbreviated new drug submission or a preclinical new drug submission, the Minister may examine any information or material filed with the Minister by any manufacturer, pursuant to 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. C.08.004 (1) (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. C.08.004(2) (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. (3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an 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 the requirements of 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. (4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug. SOR/84-267, ss. 1 to 3; SOR/85-143, s. 3; SOR/86-1009, s. 1; SOR/86-1101, s. 1; SOR/88-42, s. 1; SOR/88-257, s. 1; SOR/95-411, s. 6. C.08.004.1 (1) Where a manufacturer files a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or a supplement to an abbreviated new drug submission for the purpose of establishing the safety and effectiveness of the new drug for which the submission or supplement is filed, and the Minister examines any information or material filed with the Minister, in a new drug submission, by the innovator of a drug that contains a chemical or biological substance not previously approved for sale in Canada as a drug, and the Minister, in support of the manufacturer's submission or supplement, relies on data contained in the information or material filed by the innovator, the Minister shall not issue a notice of compliance in respect of that submission or supplement earlier than five years after the date of issuance to the innovator of the notice of compliance or approval to market that drug, as the case may be, issued on the basis of the information or material filed by the innovator for that drug. (2) Subsection (1) does not apply where the manufacturer of a new drug for which a notice of compliance was issued pursuant to section C.08.004 gives written permission to another manufacturer to rely on the test or other data filed in respect of that new drug. (3) Subsection (1) does not apply where the data relied upon by the Minister was contained in information or material filed by the innovator before January 1, 1994. SOR/95-411, s. 6. |
| Règlement sur les aliments et drogues C.R.C., ch. 870 C.08.003 (1) (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, (ii) soit un supplément à la présentation abrégée de drogue nouvelle; 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) 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. C.08.003 (2) (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;
C.08.003 (3) (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 Au cours de l'examen d'une présentation de drogue nouvelle, d'une présentation abrégée de drogue nouvelle, d'un supplément à l'une de ces présentations ou d'une présentation préclinique de drogue nouvelle, le ministre peut examiner les renseignements ou le matériel que lui présente tout fabricant conformément 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. C.08.004 (1) (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. C.08.004(2) |
| (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. (3) Sous réserve de l'article C.08.004.1, après avoir terminé l'examen des renseignements et du matériel supplémentaires déposés relativement à une présentation de drogue nouvelle, à une présentation abrégée de drogue nouvelle ou à 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. (4) L'avis de conformité délivré à l'égard d'une drogue nouvelle d'après les renseignements et le matériel contenus dans la présentation déposée conformément à l'article C.08.002.1 indique le nom du produit de référence canadien mentionné dans la présentation et constitue la déclaration d'équivalence de cette drogue. DORS/84-267, art. 1 à 3; DORS/85-143, art. 3; DORS/86-1009, art. 1; DORS/86-1101, art. 1; DORS/88-42, art. 1; DORS/88-257, art. 1; DORS/95-411, art. 6. C.08.004.1 (1) Lorsque le fabricant dépose une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l'une de ces présentations en vue de faire déterminer l'innocuité et l'efficacité de la drogue nouvelle qui en est l'objet, et que le ministre examine les renseignements et le matériel présentés, dans une présentation de drogue nouvelle, par l'innovateur d'une drogue contenant une substance chimique ou biologique dont la vente comme drogue n'a pas été préalablement approuvée au Canada et s'appuie sur les données y figurant pour étayer la présentation ou le supplément du fabricant, il ne peut délivrer un avis de conformité à l'égard de cette présentation ou de ce supplément avant l'expiration du délai de cinq ans suivant la date à laquelle est délivré à l'innovateur l'avis de conformité ou l'approbation de commercialiser cette drogue, selon le cas, d'après les renseignements ou le matériel présentés par lui pour cette drogue. (2) Le paragraphe (1) ne s'applique pas lorsque le fabricant d'une drogue nouvelle pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 autorise par écrit un autre fabricant à se fonder sur les résultats d'essais ou d'autres données présentés au sujet de la drogue nouvelle. (3) Le paragraphe (1) ne s'applique pas lorsque les données sur lesquelles le ministre s'appuie étaient contenues dans les renseignements et le matériel présentés par l'innovateur avant le 1er janvier 1994. DORS/95-411, art. 6. |
1 In Apotex Inc. v. Bristol-Myers Squib Canada Inc. et. al. (January 9, 2001), Ottawa A-721-00 (F.C.A), at para. 2-5 Sharlow J.A. summarized the regulatory scheme of the Patent Medicines (Notice of Compliance) Regulations, 1993, SOR/93-133 as follows: To put this issue in context, it is necessary to describe certain aspects of the regulatory scheme. The Regulations were enacted in 1993 as part of a major reform of the patent law respecting pharmaceutical products. The Regulations link the system of regulatory approval for new drugs to the protection of patent rights. They permit the holder of a patented medicine used in a marketable drug to have the patent included in a public document called the "patent register" maintained by the Minister. A drug is marketable in Canada only if it is the subject of a notice of compliance issued by the minister under the Food and Drug regulations.
If a drug manufacturer wishes to market a new drug that is bioequivalent to an existing marketable drug, and believes it can produce the new drug without infringing any patent shown on the patent register in relation to the existing drug, a submission must be made for a notice of compliance for the new drug, and the patent holder must be served with a notice of allegation stating the basis on which it is alleged that the rights of the patent holder will not be infringed if a notice of compliance is issued for the new drug.
Within 45 days of being served with a notice of allegation, the patent holder may apply for a court order prohibiting the issuance of a notice of compliance for the new drug until it is established that the patent holder's rights will not be infringed. The prohibition application takes the form of an application for judicial review in the Trial Division of the Federal Court.
When a patent holder commences a prohibition application under the Regulations, the Minister's authority to issue the notice of compliance for the new drug is automatically stayed pending the determination of the prohibition proceedings. This automatic stay is in place for a maximum of 24 months, unless extended pursuant to Regulation 7(5). The automatic stay prescribed by the Regulations has been described as draconian because it permits a patent holder to delay the entry of competitors into the market without having to establish even a prima facie case of patent infringement: Apotex v. Merck Frosst Canada Inc., [1998] 2 S.C.R. 193, (1998) 80 C.P.R. (3d) 368.
See also Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] F.C.J. No. 1882 (F.C.T.D.).
2 At the time of filing of this patent list the Regulations in effect were the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, March 12, 1993 (the "1993 Regulations"). The 1993 Regulations were subsequently amended by Regulations Amending The Patent and Medicines (Notice of Compliance) Regulations, SOR/98-166, March 12, 1998 (the "1998 Regulations"). The 1993 Regulations in effect at the time of the original filing of the Patent List are the same as the 1998 Regulations, except for the addition of Regulation 4(6) which is discussed below. All Regulations referred to in these reasons are quoted in the attached Appendix.
3 It is agreed between the parties that this is the standard of review to be applied.
4 The following précis of the factual background is derived from the Statement of Fact of Law of Apotex Inc. (Application Record of the Respondent Apotex Inc., pp. 3-7).
5 Applicant's Application Record, pp. 112-113.
6 Ibid, pp. 121, 121B, 122.
7 In it's application, BMS made a supplemental argument that a breach of procedural fairness occurred by the Minister not providing to BMS the complaint which caused the Minister to reverse the decision taken to register the '436 Patent on February 18, 2000. With respect to this argument, I find that, in the letter of August 8, 2000, the Minister did provide complete notice of the concern held by the Minister, and that a most fair opportunity was provided for argument before a decision was made. Thus, I dismiss the due process concern.
8 See the cross-examination of Ms. Ann Bowes, employed by the Patent Unit, Therapeutic Products Programme, Department of Health (Applicant's Application Record, p. 253). This concern is appropriately based on the decisions of this Court which underscore that the NOC Regulations are a code which must be adhered to. (See Pfizer Canada Inc. and Pfizer Corporation v. Apotex Inc. v. The Minister of National Health and Welfare (File number A-69-98, decision rendered January 10, 2001)).
9 See the Applicant's "Consolidation of the Patented Medicines (Notice of Compliance) Regulations", Tab 2.
10 See Flavell v. Deputy M.N.R., Customs and Excise, [1997] 1 F.C. 640 (F.C.T.D.) for a description of how historical factors can guide statutory interpretation with specific reference to the House of Lords ruling in Pepper (Inspector of Taxes) v. Hart, [1993] 1 All E.R. 42 (H.L.), where at 64 the acceptance of parliamentary history in statutory interpretation was approved by Lord Browne-Wilkinson.