T-1635-97
Novopharm Limited (Applicant)
v.
The Minister of National Health and Welfare and Abbott Laboratories Limited (Respondents)
Indexed as: Novopharm Ltd. v.Canada (Minister of National Health and Welfare) (T.D.)
Trial Division, Hugessen J."Toronto, January 28 and February 3, 1998.
Patents — Judicial review of Minister's refusal to issue notice of compliance (NOC) to Novopharm — NOCs issued to Abbott in 1985, 1992 for same drug — Within 30 days of coming into force of Patented Medicines (Notice of Compliance) Regulations, Abbott filing patent lists in respect of individual dosages for which NOCs issued — Patents listed with expiry dates of July 1996, July 1997 — In 1995 NOC issued to Abbott in respect of starter pack, consisting of three different dosages — In 1997 Abbott obtaining three new patents based upon applications filed between 1991, 1995 — Within 30 days, filing amendments to patent lists filed in respect of NOCs issued for individual dosages, but not for starter pack — Minister accepting amended lists, holding prohibiting issuance of NOC to Novopharm — Regulations, s. 4(5) providing at any time after date of filing submission for NOC, first person may submit patent list or amend existing patent list in respect of patent issuing within previous 30 days, on basis of application filed before date of filing of submission — Since Abbott's three new patents applied for long after issuance of 1985, 1992 NOCs, could not be added by amendment to patent lists — Minister erred in treating out-of-time amendment as if original patent list — Minister's duty to identify, not correct, errors — Meaning of —drug—, —medicine— in Regulations — Drug (subject of NDS), not medicine (subject of patent), link between patent lists/register and Regulations — Since NOC issued in respect of starter pack, —drug— in respect of which patent list filed — Novopharm's new drug submission only referring to drugs subject of Abbott's 1985, 1992 NOCs — Patents listed on patent list filed in respect of those drugs expired — S. 5 not applying to prohibit issuance of NOC to Novopharm.
Construction of statutes — Patented Medicines (Notice of Compliance) Regulations, s. 4(5) — English version clearly requiring any new patent to have been applied for prior to filing of new drug submission, not have been issued more than 30 days prior to filing of patent list — No merit to argument French text supporting interpretation filing of new patent list subject to conditions, but amendment to patent list may be made at any time, without conditions — Reference in French text to —un brevet . . . qui était fondé sur une demande au tribunal— puzzling — Court (tribunal) not issuing patents — As French text ambiguous, common meaning rule requiring adoption of interpretation consistent with unambiguous English text — Proposed interpretation untenable in context — No rational policy objective for imposing tight time restrictions on filing new original patent list, but allowing amendments at any time, without conditions — Patent applications filed long after issuance of NOCs could not be added by amendment to patent lists.
This was an application for judicial review of the Minister's refusal to issue a notice of compliance (NOC) to Novopharm. In 1985 a notice of compliance issued to Abbott for three different dosages of Terazosin Hydrochloride (TH). In 1992 a second NOC issued in respect of a fourth dosage. In 1993, within 30 days of the coming into force of the Patented Medicines (Notice of Compliance) Regulations, Abbott filed patent lists in respect of all four dosages covered by the two NOCs. Two patents were listed with respective expiry dates of July 1996 and July 1997. Novopharm subsequently filed a new drug submission (NDS) in respect of all four dosages of TH. In 1995 an NOC was issued to Abbott in respect of a "starter pack" consisting of three dosages of TH packaged together. In 1997 Abbott obtained three new patents containing claims to the medicine TH. Each of these patents was based upon an application which had been filed between 1991 and October 1995. Within 30 days of their issuance, Abbott filed amendments to its patent lists filed in respect of the NOCs issued in 1985 and 1992, but not the 1995 NOC. The Minister accepted the amended lists, added the information contained therein to the register and based thereon, maintained that section 7 prohibited issuing an NOC to Novopharm.
Regulations, subsection 4(5) provides that at any time after the date of filing of the submission for a notice of compliance, the first person may submit a patent list or amend an existing patent list in respect of a patent that issued within the previous 30 days on the basis of an application filed before the date of filing of the submission.
The issues were (1) whether subsection 4(5) permits an amendment to an existing patent list to be made at any time and without conditions; and (2) whether the medicine claimed in the listed patents, or the drug which is the subject of the NDS, triggers the application of the prohibitory provisions of the Regulations and prevents a generic manufacturer from obtaining an NOC during the life of the listed patents.
Held, the Minister was ordered to purge the register of the amendments to the patent list filed by Abbott in June 1997, and to consider Novopharm's NDS on its merits and without reference to the patents listed therein.
(1) The English version of subsection 4(5) clearly requires that any new patent must have been applied for prior to the filing of the NDS and must not have been issued more than 30 days prior to the filing of the amended (or new) patent list. There was no merit to Abbott's argument that the French text supported an interpretation such that the filing of a new patent list is subject to these conditions, but an amendment to an existing patent list may be made at any time and without conditions. The reference in the French text to "un brevet . . . qui était fondé sur une demande au tribunal" was puzzling. "Tribunal" is defined as a superior court; it is not part of a court's normal functions to issue patents. As the final phrase of the French text was at best ambiguous, and since only one of the possible interpretations was consistent with the English text, which was unambiguous, the common meaning rule required that it be preferred. Absent a rational policy objective which would support the imposition of tight time restrictions on the filing of a new original patent list, and yet allow patents to be added to an existing list virtually at will, the proposed interpretation made no sense. Since Abbott's three new patents had been applied for long after the issuance of its original NOCs with respect to the individual dosages of TH, they could not be added by amendment to the patent lists which had been filed in respect of those notices of compliance and the drugs covered by them.
The standard of review was that of correctness, and the Minister erred. The Minister was faced with an amendment to an existing patent list which clearly referred to the drugs which had been the subject of the 1985 and 1992 NOCs issued to Abbott. The Minister had the choice of accepting that amendment as filed or of rejecting it as being non-compliant. He did neither. He correctly viewed the amendment as being out of time, but proceeded to treat it as though it was an original patent list rather than an amendment to an existing list. He then failed to apply it to the only NDS in respect of which it might arguably have been filed, i.e. the NDS filed for the starter pack in 1995, but instead applied it to the NOCs of 1985 and 1992. The Minister's duty is to keep the register and to administer the Regulations fairly. That does not involve making corrections or modifications in documents, or interpreting them so as to make them conform with the Minister's conception of the law.
Further, the Minister demonstrated a serious misconception as to the proper operation of the Regulations. Patent lists are filed in respect of drugs covered by an NDS or by the NOC which results therefrom. According to the Regulations, patent lists are only filed in respect of "a drug that contains a medicine" which is said to be claimed in the patents listed. The Minister erred in assuming that it is the medicine claimed in the listed patents which triggers the application of the prohibitory provisions of the Regulations and prevents a "second person" (generic manufacturer) from obtaining an NOC during the life of the listed patents. The link between the patent lists and the register containing the information therefrom, on the one hand, and the prohibitory provisions of the Regulations on the other, is found in subsection 5(1). That subsection refers to a person (the "second person") filing an NDS in which reference is made to "a drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person in respect of which a patent list has been submitted". The prohibitory provisions of section 7 apply only to such a second person. The fact that the medicine claimed in listed patents may form part of or even be a drug for which an NDS is filed by a person does not make that person a "second person" unless and until there is a reference in the NDS to another drug in respect of which a notice of compliance has been issued to another person and a patent list filed. It is the subject of the NDS (the "drug") and not the subject of the patent (the "medicine") which constitutes the critical link.
Abbott's amendment to the patent list could only have been filed in respect of Abbott's 1995 NDS for the starter pack. Since the NOC was issued in respect of the starter pack, the "drug" in respect of which the patent list had been filed was the starter pack. However, Novopharm's NDS did not seek to refer to that "drug" but only to the drugs that were the subject of Abbott's 1985 and 1992 NOCs. Since the patents listed on the patent list filed in respect of those drugs have expired, subsection 5(1) did not apply and the Minister was not prohibited from issuing an NOC to Novopharm.
statutes and regulations judicially considered
Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 "second person", 3, 4, 5(1), 7.
cases judicially considered
applied:
Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58; 97 F.T.R. 288 (F.C.T.D.); affd (1995), 67 C.P.R. (3d) 25; 193 N.R. 394 (F.C.A.).
referred to:
Pezim v. British Columbia (Superintendent of Brokers), [1994] 2 S.C.R. 557; (1994), 114 D.L.R. (4th) 385; [1994] 7 W.W.R. 1; 22 Admin. L.R. (2d) 1; 46 B.C.A.C. 1; 92 B.C.L.R. (2d) 145; 14 B.L.R. (2d) 217; 4 C.C.L.S. 117; 168 N.R. 321; 75 W.A.C. 1.
APPLICATION for judicial review of the Minister's refusal to issue a notice of compliance (NOC) to Novopharm. The Minister was ordered to purge the register of amendments to the patent list filed by Abbott in June 1997, and to consider Novopharm's NDS on its merits and without reference to the patents listed therein.
counsel:
Donald H. MacOdrum and Stephanie Chong for applicant.
Ronald E. Dimock and Michelle L. Wassenaar for respondent Abbott Laboratories Limited.
Rick Woyiwada for respondent Minister of National Health and Welfare.
solicitors:
Ridout & Maybee, Toronto, for applicant.
Dimock, Stratton, Clarizio, Toronto, for respondent Abbott Laboratories Limited.
Deputy Attorney General of Canada for respondent Minister of National Health and Welfare.
The following are the reasons for judgment rendered in English by
Hugessen J.: This case raises two questions, both apparently as yet unresolved in the case law, arising from the troubled Patented Medicines (Notice of Compliance) Regulations.1 The first question has to do with the circumstances in which a patent list can be amended and involves an apparent conflict between the English and French texts of subsection 4(5) of the Regulations. The second question involves the complex interrelationship between patent lists, the patent register required to be kept by section 3 of the Regulations, new drug submissions (NDSs), notices of compliance (NOCs), and drugs containing medicines for which patent protection is claimed.
Omitting irrelevant details, the facts are as follows.
In 1983, Abbott filed an NDS in respect of Terazosin Hydrochloride (TH) in dosages of 1, 2 and 5 milligram tablets; this resulted in the issuance of a first NOC in 1985 in respect of those dosages.
In 1991, Abbott filed a second NDS in respect of 10 milligram dosage tablets of TH which resulted, in 1992, in the issuance of a second NOC in respect of that dosage.
In April 1993, within 30 days of the coming into force of the Regulations, Abbott filed patent lists in respect of the 1, 2, 5, and 10 milligram tablet dosages of TH covered by the two above-mentioned NOCs. As required, the drugs in question were identified by their respective drug identification numbers (DINs). Two patents were listed with expiry dates respectively of July 3, 1996 and July 8, 1997.
In December 1993, Novopharm filed an NDS in respect of TH in dosages of 1, 2 5, and 10 milligram tablets and sought to compare its drug specifically with the drugs covered by the NOCs previously issued to Abbott. As permitted by the Regulations, Novopharm agreed that the requested NOC should not issue until the expiry of the last of the listed Abbott patents, i.e. July 8, 1997.
In October 1995, Abbott filed an NDS in respect of a "starter pack" consisting of 1, 2 and 5 milligram tablets of TH packaged together in such a way that the patient would take gradually increasing doses of the drug over a four-week period. The drug itself was identical to that which had been covered by the previous NOCs issued to Abbott and an NOC in respect of the starter pack was issued in the same month in which it was applied for. As is the practice, the new NOC gave the starter pack a new DIN.
In June 1997, Abbott obtained three new patents which are said to contain claims to the medicine TH. Each of these patents was based upon an application which had been filed prior to October 1995 but subsequent to 1991. Within 30 days of their issuance, Abbott filed amendments to its patent lists filed in respect of the NOCs earlier issued to it for the individual dosages (1, 2, 5, and 10 milligrams) but did not file a new patent list in respect of the NOC issued for the starter pack. The Minister accepted the amended lists, added the information contained therein to the register and, based thereon, maintained that he was prohibited by the terms of section 7 of the Regulations from issuing an NOC to Novopharm. These judicial review proceedings attack that decision.
For the purposes of these reasons, sections 3, 4 and subsection 5(1) of the Regulations are most relevant:
3. (1) On the 30th day after the coming into force of these Regulations, the Minister shall open and thereafter maintain a register of any information submitted pursuant to section 4.
(2) The register shall be open to public inspection during business hours.
(3) No information submitted pursuant to section 4 shall be included on the register until after the issuance of the notice of compliance in respect of which the information was submitted.
Patent List
4. (1) A person who files, or before the coming into force of these Regulations 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.
(2) A patent list submitted pursuant to subsection (1) must be certified by the person to be accurate, and must set out
(a) 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 patent list;
(b) a statement that, in respect of each patent, the person applying for a notice of compliance is the owner, has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list;
(c) the date on which the term limited for the duration of each patent will expire pursuant to section 44 or 45 of the Patent Act; and
(d) the address in Canada for service on the person of any notice of an allegation referred to in paragraph 5(3)(b), 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 subsections (4) and (5), a person submitting a patent list shall do so at the time the person files a submission for a notice of compliance.
(4) Subject to subsection (5), a person who has already filed a submission for, or has been issued, a notice of compliance before the coming into force of these Regulations and who wishes to submit a patent list shall do so within 30 days after the day on which these Regulations come into force.
(5) At any time after the date of filing of the submission for a notice of compliance, the first person may submit a patent list that includes, or amend an existing patent list to include, the information referred to in subsection (2) in respect of a patent that issued within the previous 30 days on the basis of an application filed before the date of filing of the submission.
5. (1) Where a person files or, before the coming into force of these Regulations, has filed a submission for a notice of compliance in respect of a drug and wishes to compare that drug with, or make a reference to, a drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the patent list,
(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)(b) 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.
As indicated earlier, the first question which arises has to do with the proper interpretation of subsection 4(5) of the Regulations and the conditions under which a patent list may be amended to add a new patent. While the English version seems clear in requiring that any such new patent must have been applied for prior to the filing of the NDS and must not have been issued more than 30 days prior to the filing of the amended (or new) patent list, Abbott argues that the French text supports a different interpretation. According to this argument, while the filing of a new patent list is subject to these conditions, an amendment to an existing patent list may be made at any time and without any conditions. In my view, the argument is without merit.
In the first place, and while there can be no doubt that the French text is equally authoritative and authentic as the English text, there is some reason to doubt that the draftsperson of the French text had a very clear understanding of Canadian patent law. The reference to "un brevet . . . qui était fondé sur une demande au tribunal" is puzzling in the extreme. "Tribunal" is a defined term and means this or another superior court; it is not part of a court's normal functions to issue patents.
Second, the French text is, at best, ambiguous. While it might be possible, reading the text in isolation, to interpret the final phrase commencing with the words "ou elle peut" as creating an independent and unconditional right to amend an existing list, it is at least equally possible to read the words "ces éléments" as being a reference not only to the earlier mention of the word "éléments" but also to all the qualifying clauses which follow, down to "la date de ce dépôt". Since the second of these interpretations is the only one which is consistent with the English text, which is unambiguous, the common meaning rule requires that it be preferred.
Finally, it would appear to me that a contextual reading of subsection 4(5) in the light of the Regulations as a whole makes the interpretation proposed by Abbott untenable. Counsel was unable to suggest any rational policy objective which would support the imposition of tight time restrictions on the filing of a new or original patent list and yet allow patents to be added to an existing list virtually at will. Absent such a rationale, the proposed interpretation simply makes no sense.
I conclude, therefore, on this aspect of the case, that since Abbott's three new patents had been applied for long after the issuance of its original notices of compliance with respect to the 1, 2, 5 and 10 milligram tablet dosages of TH, they could not be added by amendment to the patent lists which had been filed in respect of those notices of compliance and the drugs covered by them.
This brings us to the second question. As indicated earlier, Abbott's filing in June 1997 purported to be an amendment to the patent lists filed with respect to the NOCs issued in 1985 and 1992. The amendment clearly identified the drugs by their DINs as being those covered by the 1985 and 1992 notices of compliance. Nonetheless, the Minister seems to have taken the view that what he in fact had before him was an original patent list filed in respect of Abbott's NDS for the starter pack. Thus, even though the Minister does not agree with Abbott's interpretation of subsection 4(5), he acted as though the list filed in June 1997 was in compliance with that provision since the three new patents had been applied for prior to the filing of the NDS for the starter pack and the list had been filed within 30 days of their issuance. Accordingly, the Minister decided to accept the list and to add the new patents to the register. This is the root decision which is impugned by the present proceedings launched by Novopharm.
As a preliminary matter on this aspect of the case, I must deal, albeit briefly, with the question of the standard of review. Relying on such well-known cases as Pezim,2 Abbott submits that the Minister is a specialized tribunal and that his decisions should only be subject to judicial review on a standard of patent unreasonableness. In my view, this submission is without merit. Indeed, not even the Minister supports it. The Minister is not a specialized tribunal; he is not a tribunal at all. He has no independent decision-making power, no discretion and no policy-making role under the Regulations; his functions are purely ministerial. He is charged with the duty of applying and administering the Regulations and he must do so properly. The standard of review is that of correctness.
In my view, the Minister has erred.
In the first place, and on the particular facts of this case, I can see no justification whatever for the Minister acting as he has. He was faced with what was clearly stated to be an amendment to an existing patent list and one which equally clearly referred, by citing their appropriate DINs, to the drugs which had been the subject of the notices of compliance issued to Abbott in 1985 and 1992. The Minister had the choice of accepting that amendment as filed or of rejecting it as being non-compliant with the Regulations. In fact, he did neither. Rather, having correctly viewed the amendment as being non-compliant (it was long out of time on the proper reading of subsection 4(5)) he proceeded to treat it as though it was an original patent list rather than an amendment to an existing list. Even more critical, however, he then failed to apply it to the only NDS in respect of which it might arguably have been filed, namely the NDS filed for the starter pack in 1995, but instead applied it to the NOC of 1985 and 1992 in respect of which it could not have been filed.
The Minister's duty is to keep the register and to administer the Regulations. It is not a duty which sits lightly with a Minister whose primary function is the protection of public health and safety since these Regulations have nothing to do with that subject and everything to do with the regulation of the conflicting relationships between brand name and generic drug manufacturers. The duty is, however, cast upon him by the Regulations and he must carry it out fairly and even-handedly. That may involve drawing the attention of persons who submit documents to what the Minister conceives of as defects or errors in those documents; it most certainly does not involve the Minister taking upon himself the task of making corrections or modifications in such documents or of interpreting them so as to make them conform with what the Minister conceives of as being the law. On this basis alone, the Minister's decision must be set aside.
There is more, however. In my view, the Minister's actions in this matter demonstrate a serious misconception as to the proper operation of the Regulations. Patent lists are filed in respect of drugs covered by either an NDS or by the NOC which results therefrom. The Regulations make it clear that patent lists can only be filed in respect of "a drug that contains a medicine" which is said to be claimed in the patents listed. The Minister apparently takes the view that it is the medicine claimed in the listed patents which triggers the application of the prohibitory provisions of the Regulations and in effect prevents a "second person" or generic manufacturer from obtaining an NOC during the life of the listed patents. In my view, this is wrong. The link between the patent lists and the register containing the information derived therefrom, on the one hand, and the prohibitory provisions of the Regulations on the other hand, is found in subsection 5(1). That subsection refers to a person filing an NDS in which reference is made to "a drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person in respect of which a patent list has been submitted" [underlining added]. The person so described is defined in section 2 as the "second person" and the prohibitory provisions of section 7 apply only to such a second person. Thus, the fact that the medicine claimed in listed patents may form part of or even be a drug for which an NDS is filed by a person does not make that person a "second person" unless and until there is a reference in the NDS to another drug in respect of which a notice of compliance has been issued to another person and a patent list filed. It is the subject of the NDS (the "drug") and not the subject of the patent (the "medicine") which constitutes the critical link.
Part of the difficulty here is the usage within the Regulations of the words "drug" and "medicine" in apparent contradistinction with one another. Mr. Justice Noël explained this usage in Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.), at page 70; affd (1995), 67 C.P.R. (3d) 25 (F.C.A.), as follows:
Nevertheless, as a medicine is a drug and as an NOC must be obtained by reference to a drug, the word "drug" appears in the Regulations wherever it is used in connection with the obtention of an NOC under the Food and Drugs Act. Conversely, under the Patent Act, it is the medicine that is the focus of the protection against infringement which the Act seeks to achieve with respect to pharmaceutical patents, and the word "medicine" as defined in the Regulations appears therein wherever used by reference to the protection against infringement of patents which the Regulations seek to provide.
In other words, the "drug" is the subject of the NOC, while the "medicine" is the subject of the patent claim. Within the working of the Regulations, multiple NOCs may issue with respect to the same patented "medicine" resulting, conceptually, in different "drugs" corresponding to the different subjects of the multiple NOCs.
Returning to the facts of the present case, even after the Minister's irregular handling of Abbott's amendment to the patent list so as to treat it as an original patent list, that list could only have been filed in respect of Abbott's 1995 NDS for the starter pack. Since the resulting NOC was issued in respect of the starter pack, the "drug" in respect of which the patent list had been filed was the starter pack. However, Novopharm's NDS did not seek to refer to that "drug" but only to the drugs that were the subject of Abbott's 1985 and 1992 NOCs. Since the patents listed on the patent list filed in respect of those drugs have expired, the provisions of subsection 5(1) are not engaged and the Minister is not prohibited from issuing an NOC to Novopharm.
Novopharm has asked that I order the Minister to issue an NOC to it. I am reluctant to do so since I cannot be certain that the Minister does not have any remaining health and safety concerns. However, for the reasons given, I shall order that the register be purged of the amendments to the patent list filed by Abbott with its letter of June 9, 1997 and that the Minister consider Novopharm's new drug submission on its merits and without reference to the patents listed therein.
No costs have been sought and no special reasons have been advanced to justify the making of an order as to costs.
1 SOR/93-133.
2 Pezim v. British Columbia (Superintendent of Brokers), [1994] 2 S.C.R. 557.