Ferring Inc. v. Canada (Attorney General), 2003 FCT 293

Date: 20030311

Docket: T-1524-00 and T-1830-00

Neutral citation: 2003 FCT 293

BETWEEN:

                                                                     FERRING INC.

                                                                                                                                                       Applicant

                                                                                 and

                                                ATTORNEY GENERAL OF CANADA

                                                  THE MINISTER OF HEALTH AND

                                                                       APOTEX INC.

                                                                                                                                               Respondents

                                                            REASONS FOR ORDER

SIMPSON, J.

[1]                 Two applications for judicial review ("Applications") were before the Court and were heard together on November 9 and December 19, 2001. They relate to a dispute between the Applicant, Ferring Inc. ("Ferring") and the Respondents, the Minister of Health ("Minister") and Apotex Inc. ("Apotex") about whether Ferring filed a patent list in a timely manner.

The Applications and the Orders Sought

[2]                 Ferring's first application for judicial review ("First Application") was filed in Federal Court File Number T-1524-00 on August 21, 2000. At that time, Canadian Patent 2,166,296 for Ferring's antidiuretic drug Desmopressin Acetate ("296 Patent") was on the patent register maintained by the Minister under section 3 of the Patented Medicines (Notice of Compliance) Regulations, SOR/ 98-166 ("Patent Register"). In that context, Ferring sought an order of certiorari quashing a decision of the Minister dated July 18, 2000 in which he had issued a Notice of Compliance to Apotex for Apo-desmopressin, its generic version of Ferring's Desmopressin Acetate. Ferring also sought an order of mandamus compelling the Minister to revoke the Apotex Notice of Compliance.

[3]                 Ferring's second application for judicial review in Federal Court File Number T-1830-00 ("Second Application") was made on October 3, 2000 after the Minister had deleted the 296 Patent from the Patent Register. Ferring asked again for the orders it had sought in the First Application and also asked for (i) an order of certiorari quashing the Minister's decision of September 1, 2000 to delete Ferring's 269 Patent from the Patent Register (ii) an order of mandamus compelling the Minister to reinstate the 296 Patent on the Patent Register and (iii) costs.

The Legal Context

[4]                 Two statutory schemes are relevant. They are the Food and Drugs Act and, in particular, Division 8 of Part C of the Food and Drug Regulations, C.R.C. 1978, c.870 ("F & D Regulations"); and the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended ("PM(NOC) Regulations") under the Patent Act. The relevant portions of both sets of regulations are included as an appendix to these reasons.

[5]                 Under the F & D Regulations, new drugs require regulatory approval before they are marketed. They cannot be sold or advertised in Canada unless the company that developed the drug ("Innovator") has obtained a Notice of Compliance ("NOC") from the Minister. In order to apply for an NOC, an Innovator must forward a new drug submission ("NDS") to the Minister which includes detailed reports about the composition, manufacture, safety and effectiveness of the drug. A Generic drug manufacturer ("Generic") also requires an NOC to market its products and is permitted to apply for an NOC prior to the expiry of an Innovator's patent. In this regard, a Generic may submit an "abbreviated new drug submission" ("ANDS"), which compares its version of the drug to the Innovator's product. This procedure means that a Generic need not conduct the clinical trials and provide the detailed reports which normally accompany an Innovator's NDS.

[6]                 Innovators have the opportunity to prevent the issuance of an NOC to a Generic if they file patent lists with the Minister under section 4 of the PM(NOC) Regulations and if the Minister lists their patent on the Patent Register. A patent list is a Health Canada document entitled "Form IV: Patent List - Pertaining to Patented Medicines, Patented Medicines (Notice of Compliance) Regulations - First Person Application". If a patent is listed on the Patent Register, the Generic must address the patent by serving the Innovator with a notice of allegation ("NOA"). The purpose of the NOA is to show how the Generic proposes to manufacture and market the drug without infringing the Innovator's patent. To this end, the NOA may notify the Innovator that the Generic agrees that an NOC for the generic drug will not issue until the Innovator's patent has expired. On the other hand, the NOA may attack the patent and allege that it is not owned by the Innovator or that it is invalid or has expired. On receipt of an NOA, the Innovator may seek a prohibition order and, if it can demonstrate that, in spite of its allegations, the Generic will be infringing the Innovator's patent, the Minister will be prohibited from issuing an NOC to the Generic company until the expiry of the Innovator's patent.

[7]                 The provisions of section 4 of the PM(NOC) Regulations are central to the disposition of the Applications in this case because they specify when an Innovator may file a patent list. Section 4 provides that a patent list may be filed either: (i) at the time that a submission for an NOC is filed (subsection 4(3)); or (ii) within 30 days of the issuance of a patent for the drug if the application for the patent was filed prior to the date on which the submission for an NOC was filed (subsection 4(4)). If an Innovator's patent list is not accepted by the Minister, the patent will not be listed on the Patent Register. In such cases, a Generic need not serve an NOA on the Innovator.

The Facts

[8]                 For many years Ferring was engaged in the development of an antidiuretic drug called Desmopressin Acetate. Initially, it could only be administered through a tube inserted in a patient's nose. However, a spray formulation was developed and, on April 30, 1987, Ferring filed an NDS for Desmopressin Acetate Nasal Solution 10 mcg/metered dose using the brand name DDAVP. This formulation was described as unstable because it required refrigeration. In June of 1989 the Minister issued an NOC in respect of "DDAVP Nasal Solution 10 mcg/metered dose. Ferring did not apply for a patent before it filed its NDS.

[9]                 On January 7 1994, Ferring filed a supplement to its NDS ("SNDS") for a stable formulation of Desmopressin Acetate that no longer required refrigeration. As of that date, Ferring had still not made a patent application. On March 9, 1995, the Minister issued Ferring an NOC for "Desmopressin Acetate 10 mcg/spray" with the brand name DDAVP.

[10]            Ferring filed its Canadian application for the 296 Patent on June 22, 1994 and it was issued on June 23, 1998. It is entitled "Stabilized Pharmaceutical Peptide Compositions" and covers, inter alia, Desmopressin Acetate.

[11]            On July 21, 1998, Ferring submitted a Form IV patent list for the 296 Patent. However, on July 22, 1998 the Minister refused to add the 296 Patent to the Patent Register because, contrary to subsection 4(4) of the PM(NOC) Regulations, the date of the application for the 296 Patent, which was July 24, 1994, did not predate the filing of Ferring's SNDS on January 7, 1994.

[12]            The following day, in a letter dated July 23, 1998, Ferring sent a second SNDS to obtain an NOC for the formulation of Desmopressin Acetate Nasal Spray which did not require refrigeration. However, this SNDS mentioned the brand name MINIRIN rather than DDAVP. Ferring advised the Minister that brand names MINIRIN and DDAVP both referred to Desmopressin Acetate Nasal Spray . With this second SNDS, Ferring again submitted a Form IV patent list for the 296 Patent. On Form IV in Section I, Ferring indicated that the purpose of the form was not to change an existing list but to "create" an original patent list for Desmopressin Acetate with the brand name MINIRIN. In my view , this form was completed correctly because, as of July 23, 1998 there was no existing patent list for Desmopressin Acetate. This was so because the Minister had rejected the patent list for the 296 Patent dated July 20, 1998 which Ferring had filed for the drug Desmopressin Acetate with the brand name DDAVP.

[13]            On August 17, 1998, the Minister issued Ferring an NOC for MINIRIN and, 10 days later, on August 27, 1998, the 296 Patent was listed on the Patent Register. It described the medicine as Desmopressin Acetate. No reference to either brand name (DDAVP or MINIRIN) appeared on the Patent Register. However, each brand name had its own Drug Identification Number ("DIN") and the DIN shown on the Patent Register was the one which had been assigned to MINIRIN.

[14]            On April 9, 1999, Apotex filed an ANDS for Apo-Desmopressin pursuant to subsection 5(1) of the PM(NOC) Regulations and made reference to the brand name DDAVP but not to the drug Desmopressin Acetate. In June of 2000, the Minister decided that Apotex did not need to serve an NOA on Ferring pursuant to subsection 5(1) of the PM(NOC) Regulations because DDAVP was not on the Patent Register. However, the Minister also concluded that subsection 5(1.1) of the PM(NOC) Regulations applied and that Ferring was entitled to received an NOA because a patent list had been submitted and an NOC had been issued for MINIRIN.

[15]            The Minister informed Apotex of these decisions on July 4, 2000. On July 10, 2000 Apotex replied and said that subsection 5(1.1) was inapplicable and that it was not obliged to serve an NOA because MINIRIN had not been marketed in Canada. The Minister then determined that Ferring had not notified the Minister of the sale of MINIRIN in Canada as it was required to do pursuant to subsection C.01.014.3 of the F & D Regulations. The Minister's office subsequently contacted Ferring and was told that MINIRIN was not being sold in Canada. It was not until September 20, 2000, that Ferring notified the Minister that MINIRIN was being sold in Canada and that the first sale had occurred on August 21, 2000. The Minister therefore decided that subsection 5(1.1) of the PM(NOC) Regulations was not applicable and, on July 18, 2000, issued Apotex an NOC for Apo-Desmopressin without requiring Apotex to serve an NOA on Ferring.

[16]            Ten days later, on July 28, 2000, Ferring learned that an NOC had been issued to Apotex ("Apotex NOC") for Apo-Desmopressin. On August 11, 2000, after meeting with relevant officials, Ferring wrote to the Minister and asked for a reconsideration of the Apotex NOC. Ferring argued that the brand names DDAVP and MINIRIN were both used to describe Desmopressin Acetate and that both brands were marketed interchangeably in Canada.

[17]            In correspondence dated August 15, 2000, the Minister's representative at the Therapeutics Products Programme ("TPP") acknowledged that DDAVP and MINIRIN were brand names for the same drug, that subsection 5(1) of the PMNOC Regulations therefore applied and that the Apotex NOC had been issued in error because Ferring had not been served with an NOA based on the 296 Patent that was listed on the Patent Register. However, it was also decided that, because DDAVP and MINIRIN were different brand names for the same drug, the 296 Patent should not have been added to the Patent Register. The letter read in part:

Eligibility of the '296 Patent

The '296 patent was added to the Patent Register on the basis of a patent in respect of a NDS for an additional brand-name, namely MINIRIN, the NOC for which was issued on August 17, 1998.

In this particular case, you have established the fact that the nature of the NDS did not change the drug. Therefore, the '296 was effectively added against the two original NOCs for desmopressin acetate in 10 µg/metered dose nasal spray. The first NOC for the NDS was issued on June 2, 1989 and a subsequent NOC for a supplemental NDS for a revised formulation was issued March 9, 1995.

Ferring had previously submitted on July 21, 1998 a patent list for DDAVP in relation to its supplemental NDS #22257 which included the '296 patent, however the patent list was rejected on July 22, 1998 on the basis that the patent list did not meet the time-requirements of section 4 of the PM(NOC) Regulations. The patent list submitted on July 21, 1998 was submitted pursuant to subsection 4 of the PM(NOC) Regulations. Subsection 4(4) allows first persons to submit a patent list in respect of a patent that issued within the previous 30 days on the basis of a patent application filed before the date of filing of the submission. In the case of the '296 patent, the date of filing of the patent is June 22, 1994, therefore, the '296 patent application was not filed before the date of filing of the supplemental NDS for DDAVP which was filed on January 7, 1994.

The requirements of section 4 for adding a patent list to the patent register are strict, including 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 list except in accordance with subsection (4)

...

The introduction of subsection 4(6) in 1998 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 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 '296 patent was not added under subsection 4(4). The addition of the patent was through subsection 4(1). That Ferring added the '296 patent on the basis of a submission for an additional brand name for which a NOC was issued on August 17, 1998 is contrary to the scheme of section 4, which provides for the addition of a patent to be made within the strict time-requirements of subsection 4(1) and 4(4) of the PM(NOC) Regulations, subsection 4(4) being the only exception to add new patents to the register.

For these reasons, the TPP has made the decision to remove the '296 patent from the patent list in respect of desmopressin acetate in 10µg/metered dose nasal spray.

[18]            The letter added that the Apotex NOC would also be revoked, as it had been issued in error, and gave both Ferring and Apotex ten (10) days to submit written responses prior to any action being taken. Both parties made representations and, on September 1, 2000, they were advised by the Minister that the 296 Patent had been ineligible for inclusion on the Patent Register and that it had been de-listed. Further, once the 296 patent was no longer on the Patent Register, Ferring was not entitled to an NOA from Apotex. Accordingly, since Apotex had received its NOC without providing Ferring with an NOA, the Minister decided that the Apotex NOC need not be revoked.

The Issues

[19]            The issues raised in these Applications are as follows:

(1)        Did the Minister err when he deleted the 296 Patent from the Patent Register on September 1, 2000 and, if so, should he be ordered to reinstate the 296 Patent?

(2)        Did the Minister err when he refused to revoke the NOC issued to Apotex for Apo-Desmopressin and, if so, should he be ordered to revoke the NOC?

Issue 1 - The 296 Patent

[20]            The starting point is section C.08.003 of the F & D Regulations which says that an SNDS is required if a brand name a company proposes to use is different from the brand name given in a drug's NDS. All parties agreed that Ferring was required to file an SNDS for Desmopressin Acetate when it proposed to use MINIRIN as a brand name in addition to DDAVP.

[21]            The question is whether an SNDS is a submission for a notice of compliance as that term is used in section 4 of the PM(NOC) Regulations. "Notice of compliance" is defined in section 2 therein. It says:

[22]            Subsection C.08.004(1) of the F & D Regulations applies, inter alia, to the issuance of an NDS, an ANDS and to supplements to both. It provides in part:

[23]            In my view, these provisions indicate that an SNDS is a submission for a notice of compliance within the meaning of section 4 of the PM(NOC) Regulations. In this regard, I am in complete agreement with the decision of my colleague, McGillis J, in Apotex Inc. v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.). However, because Her Ladyship acknowledged that she did not consider subsection 4(6), which was added when the PM(NOC) Regulations were amended in 1998, respondents' counsel suggested that her decision no longer serves as a reliable precedent. Instead, they asked me to treat Bristol Myers Squibb Canada Inc. v. Attorney General of Canada and the Minister of Health and Apotex Inc. (2001), 10 C.P.R. (4^th) 318 ("BMS") as the relevant decision. In BMS, my colleague Campbell J., was asked to review a decision by the Minister to de-list a patent. BMS had correctly filed a patent list with its submission for an NOC. However, it had mistakenly omitted a patent from the list and sought to add the missing patent to the existing patent list. To accomplish this, it filed an SNDS to change the brand name of its drug from Serzone to Serzone-5HT. The Minister added the missing patent to the Patent Register but later de-listed it based on subsection 4(6) of the PM(NOC) Regulations. Campbell J. upheld the de-listing and found that the decision of McGillis J. in Apotex could be distinguished because (i) it was made without regard for subsection 4(6) of the PM(NOC) Regulations and (ii) because, in Apotex, the submission for an NOC concerned a new use for the drug as opposed to a mere change in brand name.

[24]            The Federal Court of Appeal dismissed the BMS appeal on the basis that McGillis J.'s decision in Apotex could be distinguished for the reasons described above.

[25]            However, I have concluded that, BMS does not apply to the facts of this case. In BMS, subsection 4(6) came into play because BMS had submitted a patent list for the drug in question and sought to add the missing patent to the existing list. In contrast, in this case, the Minister had rejected the patent list for Desmopressin Acetate on July 22, 1998 and had refused to place the 296 Patent on the Patent Register. Accordingly, when Ferring filed its SNDS for an NOC showing MINIRIN as a brand name, there was no existing patent list for Desmopressin Acetate.

[26]            Counsel for Apotex submitted that one of the policy objectives of section 4 of the PM(NOC) Regulations is to provide a Generic with certainty about when patents can and cannot appear on the Patent Register. The Respondents also submitted that, because subsection 4(6) of the PM(NOC) Regulations expressly prohibits using SNDSs to amend an existing patent list, logic suggests that it was Parliament's intention that SNDSs would not be used to create new patent lists.

[27]            On reviewing the regulations, it appears to me that the only certainty to which a Generic is entitled is that which flows from seeing patents listed on the Patent Register and that patents can be listed in circumstances in which the timing cannot be foreseen. For example, if patent applications predate the filing of submissions for NOCs under subsection 4(4) of the PM(NOC) Regulations, patents will be submitted within thirty days of their issuance and there is no way of forecasting when that will occur. In this case, for example, the 296 Patent application was made in June of 1994 and the patent did not issue until June of 1998.

[28]            However, this is not to say that there is no order to the listing of patents on the Patent Register. Subsection 4(4) of the PM(NOC) Regulations must be followed and Ferring failed to comply when it submitted the 296 Patent for DDAVP on July 21, 1998. The Minister correctly rejected the listing under subsection 4(4) on the basis that the 296 Patent had not accompanied the submission for the SNDS on January 7, 1994 and the 296 Patent application had not been filed before the SNDS was submitted.

[29]            It is noteworthy that the initial reference in subsection 4(1) of the PM(NOC) Regulations is to "a notice of compliance in respect of a drug that contains medicine". The question, therefore, is whether the words "in respect of a drug" should be read in a limited way to mean that only NOCs "for" drug approval are covered or whether a broader meaning should be assigned such that section 4 of the PM(NOC) Regulations deals with NOCs for all the purposes described in subsection C.08.003(2) of the F & D Regulations.

[30]            In my view, by using the phase "in respect of" instead of the word "for" or instead of the words "new drug submission" to describe notices of compliance, Parliament meant "in relation to" a drug and this meaning would include notices of compliance which deal with a drug's brand name and all the other matters listed in subsection C.08.003(2) of the F & D Regulations.

[31]            I have, therefore, concluded that McGillis J.'s reasoning in Apotex is not changed by the introduction of subsection 4(6). It still remains the case that a submission for an NOC is required for all the changes listed in C.08.003(2) of the F & D Regulations. No distinction is drawn based on the importance of the enumerated changes. Changes in brand names and labels, as well as more substantive matters such as changes in a drug's ingredients, uses and side effects all require an NOC. All subsection 4(6) does is confirm that subsection 4(4) is the only method available for adding a patent to an existing list.

[32]            I now turn to the respondents' section submission which is that the addition of subsection 4(6) creates a situation in which logic suggests that subsection 4(3) of the PM(NOC) Regulations should be read in a new and narrow way so that supplements to new drug submissions for NOCs which are required by C.08.003(2) of the F & D Regulations are not covered by the language of 4(3).

[33]            The objective of the PM(NOC) Regulations has often been described as the prevention of patent infringement. In this regard, see Smith Kline Beecham Pharma Inc. v. Apotex Inc., [1999] F.C.J. No. 1775 at paragraph 16.

[34]            With this purpose in mind, I do not find it anomalous for Parliament to say that patent lists, once on the Patent Register, can only be changed by the addition of patents which were pending when the lists were submitted while at the same time providing a broad right to file initial patent lists with all submissions for notices of compliance. In other words, patent lists can be submitted with all types of submissions for NOCs but, once submitted, they can only be changed in the exceptional circumstances described in subsection 4(4) of the PM(NOC) Regulations. This interpretation, it seems to me, is consistent with the purpose of the PM(NOC) Regulations and is not inconsistent with the Regulatory Impact Analysis Statement which accompanied the 1998 amendments to the PM(NOC) Regulations. It made no specific reference to subsection 4(6) but stated generally that:

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.

[35]            In my view, if Parliament had intended to curtail an Innovator's rights under subsections 4(1) and (3) of the PM(NOC) Regulations, I would have expected to see clear language indicating that patent lists can only be filed in respect of new drug submissions and not in respect of supplements. No text of this kind is to be found in the PM(NOC) or F & D Regulations.

[36]            Turning to the facts of these applications, it appears to me that Ferring anticipated the Minister's refusal to list the 296 Patent because the next day it submitted an SNDS for the second brand name MINERIN and resubmitted the 296 Patent. Apotex and the Minister both said that this tactic was contrary to the strict time frames in the PM(NOC) Regulations. However, subsections C.08.003(1) and (2)(b) of the F & D Regulations indicate that, if the brand name for a new drug is "significantly different" from the information in the drug's NDS, an SNDS must be submitted to the Minister and an NOC must be issued for the new brand name. Because I have concluded that MINIRIN was significantly different from DDAVP, Ferring was obliged to submit an SNDS and, as I read them, subsections 4(1) and (3) of the PM(NOC) Regulations gave Ferring the opportunity to submit a patent list for the 296 Patent when it submitted its SNDS for the brand name MINIRIN.

[37]            The Minister's letter of August 15, 2000 (see paragraph 17 supra) indicated that, in his view, there was a difference between submissions for notices of compliance that changed a drug's formulation and those which merely changed a drug's brand name. However, as described above, I can find no justification in the PM(NOC) or the F & D Regulations for drawing such a distinction. The only distinction in the régime is between matters that are significant enough to warrant the filing of an SNDS and those that are not. It is clear from both the PM(NOC) Regulations and from the Guidelines entitled Health Canada, Therapeutic Products Programme, "Changes to Marketed New Drug Products", April 6, 1994, on pages 1 and 2, that brand name changes require an SNDS.

[38]            The evidence also disclosed that, as a policy matter, the Minister distinguished between submissions for NOCs which required scientific evaluation and those that did not. The latter were described as "administrative" and the Minister treated Ferring's submission for MINIRIN as administrative even though the policy which governs administrative changes does not expressly refer to a submission to add rather than change a brand name. What matters however, is that no such distinction appears in either the F & D or the PM(NOC) Regulations and there is no basis to suggest that submissions which do not require scientific evaluation are not submissions for an NOC. Accordingly, in my view, because it had been properly listed under subsections 4(1) and (3) of the PM(NOC) Regulations, the Minister erred when he deleted the 296 Patent from the Patent Register.

Issue 2 - The Apotex NOC

[39]            Given my conclusion that the 296 Patent was properly on the Patent Register as of August 27, 1998, Apotex is not entitled to the Apotex NOC because it was issued without prior service of an NOA on Ferring.

[40]            Apotex suggested that, because MINIRIN had not been marketed in Canada, it need not serve Ferring with an NOA. In my view, this submission missed the point. The issue under subsections 5(1) and 5(1.1) of the PM(NOC) Regulations is whether the "drug" to which the Generic compares itself has been marketed in Canada. As I understand it, there is no issue that Desmopressin Acetate has been marketed in Canada as DDAVP since March 9, 1995 when it received its NOC.

Conclusion

[41]            An order will be made directing the Minister to re-list the 296 Patent on the Patent Register as of August 27, 1998 and directing the Minister to revoke the Apotex NOC for Apo-Desmopressin.

                "Sandra J. Simpson"           

JUDGE

Ottawa, Ontario

March 11, 2003

                                                APPENDIX

Ferring Inc. v. Attorney General of Canada, The Minister of Health and Apotex Inc.

Patented Medicines Regulations, SOR/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.

(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

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,

(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,

(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

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

(c) the notice of compliance in respect of the supplementhas not been suspended pursuant to section C.08.006; and

C.08.003 (2)

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

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,

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,

(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 médicaments brevetés, DORS/98-166

LISTE DE BREVETS

4. (1) La personne qui dépose ou a déposé une demande d'avis de conformitépour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets àl'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 :

(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 conformitéet 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 apportéé 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 àune 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 :

5. (1) Lorsqu'une personne déépose ou a dééposéé une demande d'avis de conformitépour une drogue et la compare, ou fait référence, àune 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 :

(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 conformitépour 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 conformitéà la première personne et à l'égard de laquelle une liste de brevets a été soumise doit inclure dans la demande, àl'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 :

(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, àl'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 :

Règlement sur les aliments et droguesC.R.C., ch. 870

C.08.003 (1)

(1) Malgrél'article C.08.002, il est interdit de vendre une drogue nouvelle à l'égard de laquelle un avis de conformitéa 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 :

C.08.003 (2)

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

C.08.003 (3)

(3) Le supplément à la présentation de drogue nouvelle ou àla 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 terminél'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 :

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 terminél'examen des renseignements et du matériel supplémentaires déposés relativement à une présentation de drogue nouvelle, àune présentation abrégée de drogue nouvelle ou à un supplément à l'une de ces présentations, le ministre :

(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'innocuitéet l'efficacitéde 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 préésentation ou le supplément du fabricant, il ne peut délivrer un avis de conformitéà l'égard de cette présentation ou de ce supplément avant l'expiration du délai de cinq ans suivant la date àlaquelle 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 éétaient contenues dans les renseignements et le matériel présentés par l'innovateur avant le 1er janvier 1994. DORS/95-411, art. 6.

                          FEDERAL COURT OF CANADA

                                       TRIAL DIVISION

    NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKETS:              T-1524-00 and T-1830-00

STYLE OF CAUSE:FERRING INC. v. ATTORNEY GENERAL OF

CANADA ET AL.

PLACE OF HEARING:                                   TORONTO

DATE OF HEARING:                                     NOVEMBER 9, 2001 and DECEMBER 19, 2001

REASONS FOR ORDER :                           SIMPSON, J.

DATED:                      MARCH 11, 2003

APPEARANCES:

PATRICK KIERANS                                                     FOR THE APPLICANT

DARREN NOSEWORTHY                                           

ANDREW BRODKIN                                                    FOR THE RESPONDENT

JULIE PERRIN                                                   APOTEX INC.

MARIE CROWLEY                                            FOR THE RESPONDENTS

ATTORNEY GENERAL OF

CANADA AND MINISTER OF

HEALTH

SOLICITORS OF RECORD:

OGILVY RENAULT                                           FOR THE APPLICANT

TORONTO

GOODMANS LLP                                             FOR THE RESPONDENT

TORONTO                                                          APOTEX INC.

MORRIS ROSENBERG                                                 FOR THE RESPONDENTS

DEPUTY ATTORNEY                                                   ATTORNEY GENERAL OF

GENERAL OF CANADA                                              CANADA AND MINISTER OF

HEALTH