BETWEEN:
and
THE ATTORNEY GENERAL OF CANADA
REASONS FOR ORDER
[1] This is a judicial review of the Minister of Health's decision not to list one of Hoffmann-La Roche's patents on the Patent Register. The reasons for that decision are a) that Hoffmann-La Roche, by mistake, listed a name change submission as the basis for requesting such listing - a basis not permitted by the case law - and, b) that a later and corrected filing for listing was outside the 30-day time limit provided under the Regulations. In effect, the error in quoting the "control number" on the filing form deprived Hoffmann-La Roche of certain patent protection for its medicine BONDRONAT - ibandronate sodium. Except for that error, Hoffmann-La Roche would have been entitled to have the patent included on the Patent Register.
[2] The question is whether the Hoffmann-La Roche patent was eligible to be put on the Patent Register. The Minister says that the case law has held that name change submissions (even in this instance) cannot be used as a basis upon which to obtain a patent listing and that the Minister has no discretion to extend the 30-day time limit stipulated in section 4(4) of the Patented Medicines (Notice of Compliance) Regulations.
BACKGROUND
[3] The Minister maintains the Patent Register on which are listed patents for medicines found in prescription drugs. Where a patent is listed on the Patent Register, the Minister cannot issue a "notice of compliance" ("NOC") authorizing a generic version of that drug without notice to the drug manufacturer or licensee (typically the patentee or licensee).
[4] One of the key benefits of having a patent listed on the Patent Register is the legal right to be given notice of another manufacturer's attempt to obtain a NOC. Another benefit is that a contested NOC results in a statutory stay of 24 months, which deprives the second manufacturer of the benefits of obtaining a NOC for that period.
[5] The listing of a patent is the key to these and other legal rights. The basic procedures for patent listing are set out in s. 4 of the Patented Medicines (Notice of Compliance) Regulations of which subsections (4) and (5) are particularly important.
| 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. |
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. |
[6] For ease of reference, the following chronology presents the key facts of this judicial review:
| August 19, 1993 |
'964 Patent filed. |
| August 8, 1996 |
The "original" new drug submission for BONDRONAT filed by Boehringer-Mannheim - Control # 044900. |
| August 27, 1997 |
Boehringer-Mannheim received Notice of Compliance for BONDRONAT. No application for listing on Patent Register filed. |
| April 30, 1998 |
An "administrative" new drug submission was filed by Boehringer-Mannheim to reflect change of name in the manufacturer from Boehringer-Mannheim to Hoffmann-La Roche (Control # 056442). This was part of the amalgamation of the two companies. |
| June 8, 1998 |
NOC issued to Hoffmann-La Roche. |
| June 29, 1998 |
Amalgamation of Hoffmann-La Roche and Boehringer-Mannheim. |
| October 21, 2003 |
Patent '964 issued. (N.B. Hoffmann-La Roche then had 30 days to file a Form IV listing the '964 patent against any eligible, previously filed BONDRONAT drug submission.) |
| November 18, 2003 |
Hoffmann-La Roche made an application by way of Form IV and identified the submission to which the patent list was said to relate as Control #056442 (the administrative submission filed in respect of the change in the manufacturer's name). |
| December 2, 2003 |
The Minister informed Hoffmann-La Roche that the submission Control #056442 did not afford a valid opportunity to add a patent to the Register. |
| December 22, 2003 |
Hoffmann-La Roche provided a second Form IV seeking to list the '964 patent. This form specified both submissions - #056442 and #044900 (the original new drug submission of August 8, 1996). Hoffmann-La Roche relied on the new drug submission in connection with which the patent list was being filed. |
| July 12, 2004 |
The Minister issued the final decision that the '964 patent was not eligible to be listed on the Patent Register because the only submission with respect to which it was filed within the timeframe allowed by subsection 4(4) of the Regulations was a submission that did not provide a valid opportunity to list a patent. |
[7] There is no issue in this case that Hoffmann-La Roche was bona fides in seeking to register the patent in a timely fashion by filing the Form IV. Unlike other cases before this Court, it was not part of a strategy to make up for the failure to file within 30 days of the patent's issuance. Patent '964 having just been issued, this was Hoffmann-La Roche's first opportunity to file for listing on the Patent Register.
[8] Hoffmann-La Roche raises three issues:
1) that the Minister misapplied the law regarding the filing for listing on the Patent Register.
2) that the form used in filing complied with the Regulations in that it contained sufficient information to permit the Minister to list the patent on the Register.
3) the Minister had the authority to permit the late filing of a correct Form IV.
ANALYSIS
[9] As the central issue before the Court is the interpretation of the Minister's power and duties under the NOC Regulations, the parties agree that the standard of review is correctness. I concur.
[10] The Applicant's first point, and one with which I agree, is that the Form IV originally filed meets specific plain wording of NOC Regulation s. 4(3). Save and except for court interpretations of the operation of that Regulation, Hoffmann-La Roche's original filing of November 18, 2003, on its face, should have been accepted by the Minister.
[11] The Applicant then traces through a number of this Court's and the Court of Appeal's decisions to support the argument that all of these cases dealt with situations where the company filing had missed a filing date and was using some pretext (such as a change of name) to justify a new filing and to claim entitlement to filing with the 30-day stipulated timeframe. The purpose of those filings was to resurrect the opportunity to list the patent on the Register.
[12] In cases such as Bristol-Myers Squibb Canada Inc. v. Canada (2002), 16 C.P.R. 4th 425 (F.C.A.) ((2001) 10 C.P.R. 4th 318 (F.C.)) and Ferring Inc. v. Canada (2003), 26 C.P.R. 4th 155 (F.C.A.) ((2003), 26 C.P.R. (4th) 136), the Court was clearly influenced by the fact that the companies were attempting to circumvent the filing time limits. The events used as a springboard to justify a new filing were technical matters having little or nothing to do with the prevention of patent infringement.
[13] In Abbott Laboratories et al v. Canada (Minister of Health) (2004), 31 C.P.R. (4th) 321, the Court of Appeal described, at paragraph 27, cases like those referred to as "examples of manifest attempts to list patents after the time limitations set out in s. 4 of the Patented Medicines (Notice of Compliance) Regulations had expired".
[14] In Abbott, supra, the Supplementary New Drug Submission ("SNDS") was for a new indication of use for the drug for which Abbott needed Ministerial approval to sell or market. As such, it was a situation which fell outside the Bristol-Myers and Ferring line of cases which precluded the late filing attempts to secure listing.
[15] The principle of this line of cases was crystallized in Astrazeneca Canada Inc. v. Canada(Minister of Health)(2005), 39 C.P.R. (4th) 366. The Court was dealing with a name change and stated at paragraph 4:
"... there is no justification for allowing a patent holder to enhance the advantages it obtains under the NOC Regulations as a result of a mere administrative change in the name of the manufacturer."
[16] All of this law would be helpful to Hoffmann-La Roche if its timely filing had been on the basis that this was the first opportunity it had to list its new patent. It is evident that at the time of filing the Form IV, Hoffmann-La Roche was not attempting to enhance any of its rights.
[17] However, this Court is sitting in judicial review of the Minister's decision and both the Court and the Minister have to deal with the facts as they were when the Minister received the Form IV filing, in particular the identification of "the submission to which the patent list or the amendment relates" (subsection 4(5)).
[18] When the Form IV was filed, Hoffmann-La Roche listed as the basis for its filing, the amalgamation with Boehringer-Mannheim. Canadian amalgamation law holds that under an amalgamation, the two corporate entities continue as one. A name change to that of one of the amalgamating companies or to a new name is required (R. v. Black & Decker Canada Inc. (1974), 13 C.P.R. (2d) 97). It is nonetheless a name change and that was the basis upon which Hoffmann-La Roche made its Form IV filing - even though that apparently was not its true intention upon which to base its filing.
[19] This Court is bound by the Court of Appeal's decision in Hoffmann-La Roche Limited v. Canada(Minister of Health) (2005), 40 C.P.R. (4th) 108. In particular, at paragraph 25, the Court of Appeal held that exclusions from the operation of s. 4 of the NOC Regulations must be related to the prevention of patent infringement:
"It does not follow that there is no principled basis for excluding some supplemental new drug submissions from the scope of section 4 of the Patented Medicines (Notice of Compliance) Regulations. However, the principle for exclusion must be related to the purpose of the Regulations, which is the prevention of patent infringement. A change in the name of a drug or a drug manufacturer, or a change of manufacturing site, cannot possibly be relevant to any potential claim for infringement of a patent for a medicine found in the drug. There is no justification for permitting patent holders to use such a change to enhance the advantage they obtain under the Patented Medicines (Notice of Compliance) Regulations. Thus, a supplemental new drug submission is outside the scope of section 4 if it is filed to reflect a change in the name of a drug or a drug manufacturer, or a change of manufacturing site."
[20] As the Court of Appeal has held that a supplemental new drug submission is outside the scope of section 4 if it is filed to reflect a name change, and Hoffmann-La Roche's original filing was ostensibly based on a name change (flowing from amalgamation), the Minister was correct in refusing to accept the filing.
[21] Hoffmann-La Roche argues that, in any event, the Minister had sufficient information on which to proceed to list the patent. However, the obligation to identify the submission on which the filing is based rests with an applicant. There is no duty on the Minister to try to divine which of two numbers (the submission number v. the file number) is the basis upon which an applicant relies.
[22] Lastly, Hoffmann-La Roche argues that the Minister has the discretion to accept an out-of-time filing because the Minister has an obligation to maintain the accuracy and currency of the Patent Register.
[23] With respect, I cannot read ss. 4(4)'s 30-day time limit as admitting to an exception. If it was intended to give the Minister this type of discretion, there must be a clearer indication of its existence than the obligation of the Minister under s. 3 of the NOC Regulations to maintain the Register. This is particularly so where s. 3 refers to s. 4 information but gives no suggestion of a power to extend the deadlines in s. 4.
CONCLUSION
[24] The Minister was correct on the basis of the material before him in rejecting the first Form IV filing as not being in accordance with the interpretations given to s. 4 of the Regulations. The Minister was correct in not accepting a corrected Form IV filed after the 30-day period provided for in the NOC Regulations.
[25] For these reasons, this application will be dismissed with costs to the Respondents.
JUDGE
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-1468-04
STYLE OF CAUSE: HOFFMANN-LA ROCHE LTD.
and
THE MINISTER OF HEALTH et al
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: September 7, 2005
REASONS FOR ORDER: The Honourable Mr. Justice Phelan
APPEARANCES:
Mr. Anthony Creber
Mr. Jay Zakaib
Mr. F.B. Woyiwada
SOLICITORS OF RECORD:
Gowling Lafleur Henderson LLP
Barristers & Solicitors
Ottawa, Ontario FOR APPLICANT
Mr. John H. Sims, Q.C.
Deputy Attorney General of Canada
Ottawa, Ontario FOR RESPONDENTS
Date: 20051017
Docket: T-1468-04
Ottawa, Ontario, October 17, 2005
PRESENT: THE HONOURABLE MR. JUSTICE PHELAN
BETWEEN:
HOFFMANN-LA ROCHE LIMITED
Applicant
and
THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
ORDER
IT IS ORDERED THAT this application is dismissed with costs to the Respondents.
"Michael L. Phelan"
JUDGE