ViiV Healthcare ULC v. Teva Canada Limited

ViiV Healthcare ULC v. Teva Canada Limited
Court (s) Database
Federal Court Decisions
Date
2014-09-18
Neutral citation
2014 FC 893
File numbers
T-1517-13, T-333-14, T-335-14
Decision Content
Date: 20140918
Dockets: T-1517-13
T-333-14
T-335-14
Citation: 2014 FC 893
Docket: T-1517-13
BETWEEN:
VIIV HEALTHCARE ULC,
VIIV HEALTHCARE UK LIMITED AND
GLAXO GROUP LIMITED
Applicants
and
TEVA CANADA LIMITED AND
THE MINISTER OF HEALTH
Respondents
Docket: T-333-14
AND BETWEEN:
VIIV HEALTHCARE ULC,
VIIV HEALTHCARE UK LIMITED AND
GLAXO GROUP LIMITED
Applicants
and
APOTEX INC. AND
THE MINISTER OF HEALTH
Respondents
Docket: T-335-14
AND BETWEEN:
VIIV HEALTHCARE ULC,
VIIV HEALTHCARE UK LIMITED AND
GLAXO GROUP LIMITED
Applicants
and
APOTEX INC. AND
THE MINISTER OF HEALTH
Respondents
JUDGMENT AND REASONS
HUGHES J.
[1] The issue is arcane. Can a patent claiming but one medicinal ingredient be listed by the Minister of Health under the provisions of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended SOR/2006-242, where the underlying Notice of Compliance is directed to a fixed-dose combination of two or more medicines?
[2] This is an appeal from two decisions for three proceedings of Prothonotary Milczynski, in which she determined that such a patent could not be listed. I have determined that those decisions were correct for the Reasons that follow.
[3] Also before me was another claim of the same patent directed to a formulation containing one named medicinal ingredient, and another medicinal ingredient to be selected from a group of medicinal ingredients. Counsel for the Appellant did not pursue that claim in oral argument. I have determined, based on the written material which the Appellant did not withdraw, that this claim also does not support a listing.
I. THE THREE PROCEEDINGS [4] There are three proceedings under consideration. The Applicants ViiV, et al, are common Applicants in all three. Under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended SOR/2006-242 [“NOC Regulations”], ViiV, et al, are referred to as the “first person” (s 2, 4(1)).
[5] The Minister of Health (the “Minister”), who is charged with administering the provisions of the NOC Regulations, including maintaining the Patent Register, is a common Respondent in all three proceedings.
[6] In the first proceeding, T-1517-13 (the “Teva Proceedings”), Teva Canada Limited, a “second person” under the NOC Regulations, is a Respondent (s 2, 5(1)-(2)). In the other two proceedings, T-333-14 and T-335-14, Apotex Inc., also a “second person’, is a Respondent.
[7] The Teva proceedings T-1517-13 were the first in time to be filed. Teva brought a motion under subsection 6(5) of the NOC Regulations for an Order that Canadian Patent No. 2,289,753 (the '753 patent) be struck from the Patent Register kept by the Minister under those NOC Regulations. Prothonotary Milczynski heard that motion and, for Reasons cited as 2014 FC 328, gave an Order on April 3, 2014 that the '753 patent was not eligible for inclusion on the Patent Register (the “Teva Order”).
[8] It should be noted that the Teva Order did not terminate the Teva proceedings, since ViiV has also asserted another patent in those proceedings. Canadian Patent No. 2,216,634 (the '634 patent) which was not challenged by Teva on a subsection 6(5) motion.
[9] In two later proceedings against Apotex (T-333-14 and T-335-14) ViiV asserted only one patent; the '753 patent. Apotex brought a subsection 6(5) motion on the same basis as Teva; namely, that the '753 patent was ineligible for inclusion on the Patent Register. It was agreed by ViiV and Apotex that the evidence on the Teva motion would be evidence in the Apotex motion. Prothonotary Milczynski gave the same Order that she did on the Teva motion; namely, that the '753 patent was ineligible for listing (the “Apotex Order”). That Apotex Order would have terminated the two Apotex proceedings since there was only one patent involved; therefore, her Apotex Order also provided for a stay permitting this appeal.
[10] The parties agreed that the evidence presented on the Teva motion is common to all three appeals. Teva’s motion and the Apotex motion in T-333-14 are closely related, as the “reference” drug of ViiV in each case is a Fixed-Dose Dual Combination drug, called KIVEXA, which contains two medicinal ingredients. In the second Apotex proceedings, T-335-14, the ViiV reference drug contains three medicinal ingredients, and is called TRIZIVIR. I will discuss these two drugs in respect of the Notice of Compliance (“NOC”) listings.
II. NOC LISTINGS [11] Pursuant to the regulatory scheme under the Food and Drugs Act, RSC 1985, c F-27 and the Food and Drug Regulations, CRC 1978, c 870: in order that a drug may legitimately be distributed for sale in Canada, the Minister must approve it for that purpose (see Bristol-Myers Squibb Co v Canada (Attorney General), 2005 SCC 26 at paras 13-17, [2005] 1 SCR 533 [“Bristol-Myers”] and GD Searle & Co and Pfizer Canada Inc, 2009 FCA 35 at paras 2-4, 71 CPR (4th) 389 [“GD Searle”] for a description of this regulatory scheme). In brief, the Minister must be satisfied that the drug is safe and effective for the stated use. This usually involves lengthy and expensive trials. Once approved, the Minister provides the party seeking to distribute that drug with an NOC and a Drug Identification Number (DIN) in respect off the particular drug.
[12] ViiV has two such drugs. One is KIVEXA, which is a Fixed-Dose Combination (“FDC”) (sometimes referred to in the evidence as Fixed-Dosed Combination) tablet containing as the active ingredients, 600 mg of abacavir sulphate and 300 mg of lamivudine. To use acronyms, KIVEXA is an FDC containing A and L.
[13] The second such drug for which ViiV has received approval is TRIZIVIR, which is a FDC tablet containing 300 mg of abacavir sulphate, 150 mg lamivudine, and 300 mg zidovudine. Again, to use acronyms, TRIZIVIR is an FDC containing A, L and Z.
[14] Pursuant to the NOC Regulations, the Minister listed the '753 patent on the Patent Register in respect of each of KIVEXA and TRIZIVIR.
[15] Teva, known as a second person under the NOC Regulations - often called a “generic” - wishes to market in Canada a generic copy of KIVEXA.
[16] Apotex, a second person or generic, wishes to market generic copies of each of KIVEXA (proceeding T-333-14) and TRIZIVIR (proceeding T-335-14).
[17] As is required by the NOC Regulations, each of Teva and Apotex served on ViiV Notices of Allegations, which prompted ViiV to institute the three proceedings now before the Court.
III. THE '753 PATENT [18] Canadian Patent No. 2,289,753 (the '753 patent) was issued and granted to Glaxo Group Limited, one of the ViiV Applicants, on January 23, 2007. The application for that patent has an effective filing date of May 14, 1998, which means that the term of that patent will expire twenty years from that date; namely, May 14, 2018.
[19] The description of the '753 patent begins at page 1. I repeat the first paragraph without the complex chemical terms:
The present invention relates to a novel salt of [abacavir] or a solvate thereof, pharmaceutical formulations containing such a compound and their use in medicine, specifically in the treatment of human immunodeficiency virus (HIV) and hepatitis B viris (HPV) infection.
[20] In the second paragraph, it is acknowledged that [abacavir] has already been described in a European Patent Specification. In the third paragraph, it is acknowledged that [abacavir] is currently under clinical investigation as an anti-HIV agent.
[21] At page 2 of the '753 patent, it states that the invention lies in the discovery of advantages of the hemisulfate salt of abacavir over the previously known hydrochloride salt.
[22] Two claims of the '753 patent are at issue here - claim 2 and claim 32 – although ViiV’s Counsel expressly refrained from addressing claim 32 in oral argument. Claim 2 is a claim simply to abacavir hemisulfate. Claim 32 claims a pharmaceutical formulation of abacavir hemisulfate and another medicinal ingredient selected from a defined group. There is no claim directed to the specific combination of abacavir and lamivudine, although the description of the '753 patent at page 4 says that lamivudine is a member of one of the groups defined in claim 32.
[23] There is no claim in the '753 patent specifically directed to a three-medicinal ingredient combination such as found in TRIZIVIR.
[24] ViiV, in its Written Submissions at paragraph 33, said that it accepted the factual findings of Prothonotary Milczynski. At paragraphs 15 to 17 of her Reasons, she states that there was no dispute between the parties as to the proper construction of the '753 patent. I set out, and agree with, what she wrote:
15 There is no dispute between the parties regarding the proper construction of the 753 Patent. The 753 Patent relates to the hemisulfate salt of abacavir. Claim 1 is a claim to abacavir hemisulfate and solvates thereof. Claim 2 depends on Claim 1, and expressly and exclusively claims abacavir hemisulfate, one of the medicinal ingredients in KIVEXA(R). There is no claim of the 753 Patent that specifically claims the combination of abacavir and lamivudine, the two medicinal ingredients in KIVEXA(R). Claim 32 of the 753 Patent, however, claims abacavir in combination with another or other medicinal ingredient(s), as follows:
32. A pharmaceutical formulation as claimed in any one of claims 25 to 31, additionally comprising one or more therapeutic agents selected from the group consisting of [1] nucleoside reverse transcriptase inhibitors, [2] non-nucleoside reverse transcriptase inhibitors, [3] protease inhibitors, [4] immune modulators and [5] interferons.
16 The 753 Patent elaborates at page four, that abacavir may be used alone or in combination with a number of these therapeutic agents suitable in the treatment of HIV and HBV infections:
The compounds of the invention may be administered alone or in combination with other therapeutic agents suitable in the treatment of HIV infections, such as Nucleoside Reverse Transcriptase Inhibitors (NRTIs) for example zidovudine, zalcitabine, lamivudine, didanosine, stavudine, 5-chloro-2',3'-dideoxy-3'-fluorouridine, adefovir and (2R,5S)-5fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5yl]cytosine, lovaride, non-NRTIs for example nevirapine, delavuridine, [alpha]-APA, HBY-1293 and efavirenz HIV protease inhibitors for example saquinavir, indinavir, nelfinavir, ritonavir and VX-478, other anti-HIV agents for example soluble CD4, immune modulators for example interleukin II, erthyropoetin, tucaresol, and interferons for example [alpha]-interferon. In addition the compound of the invention may be administered in combination with other therapeutic agents suitable in the treatment of HBV infections for example lamivudine, (2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5yl]cytosine, immune modulators, and interferons as described above. Such combinations may be administered together or sequentially providing that any duration between the administration of each therapeutic agent does not diminish their additive effect.
17 Claim 32 thus claims a fixed dose combination of abacavir hemisulfate and one or more of the therapeutic agents selected from the above-noted five defined classes, one of which is the class of nucleoside reverse transcriptase inhibitors, or NRTIs. There are nine specific NRTIs identified, one of which is lamivudine and some twenty-one therapeutic agents in all identified across the five classes (NRTIs, non-NRTIs, protease inhibitors, immune modulators and interferons) that may be selected in combination with abacavir. In other words, claim 32 of the 753 Patent is not limited to a two drug combination with a pharmaceutical formulation comprising abacavir hemisulfate and lamivudine. Claim 32 only includes or encompasses within its scope, a formulation that contains abacavir and another (unspecified) NRTI. Claim 32 contemplates any one or more classes of therapeutic agents that may be combined with abacavir, only one of which is lamivudine.
IV. THE PROTHONOTARY’S DETERMINATION [25] Prothonotary Milczynski determined that the '753 patent was not eligible for listing as against KIVEXA. She concluded, at paragraph 31 of her Reasons:
31 The 753 Patent is not eligible to be listed on the Patent Register against KIVEXA(R) as it does not claim the medicinal ingredient as required by section 4(2)(a) of the PMNOC Regulations or the formulation of abacavir sulfate and lamivudine as required by section 4(2)(b) of the Regulations, as approved through the issuance of the NOC in respect of the drug submission for abacavir sulfate (600 mg) and lamivudine (300 mg) KIVEXA(R) tablets.
[26] In the Apotex proceedings T-335-14, her Order was directed to ViiV’s TRIVIZIR listing, in respect of which it can be reasonably concluded, her reasoning respecting KIVEXA would equally apply.
[27] The Prothonotary, in her Reasons of the Teva Order, set out the positions of the parties and reviewed, in particular, the decision of the Federal Court of Appeal in Gilead Sciences Canada v The Minister of Health, 2012 FCA 254 [“Gilead”]. The basis for her decision is set out at paragraphs 28 to 30 of her Reasons:
28 Similarly, in the case of KIVEXA(R), no claim of the 753 Patent specifically claims the combination of the two medicinal ingredients that are the subject of the NOC for KIVEXA(R), namely abacavir sulfate and lamivudine. There is nothing in the 753 Patent that requires lamivudine. The 753 Patent claims only abacavir in combination with another unnamed medicinal ingredient. Section 4(2)(a) of the PMNOC Regulations, as held in Gilead, requires all of the medicinal ingredients identified in the submission that results in the issuance of the NOC to be claimed in the patent for that patent to be listed on the Patent Register. In the same manner, the specific formulation identified in the submission that led to the issuance of the NOC must be claimed in the patent. In the case of the 753 Patent, it is not enough that it encompasses the medicinal ingredient lamivudine (among others) in combination with abacavir for the purposes of section 4(2)(b) of the Regulations.
29 The requisite degree of product specificity is the same for section 4(2)(a) of the PMNOC Regulations as it is for each of sections 4(2)(b), (c) and (d). The medicinal ingredient, formulation, dosage form or use of the medicinal ingredient claimed in the patent sought to be listed must match that in the drug submission that was approved through the issuance of the NOC. Different listing requirements in the case of section 4(2)(a) would not be consistent with the purpose and object of the PMNOC Regulations to require product specificity, and also contrary to the Federal Court of Appeal's reasons for judgment in Gilead (see also: Purdue Pharma v. The Minister of Health, 2011 FCA 132, and in the case of subsection 4(2)(b), Bayer Inc. v. The Minister of Health, 2010 FCA 161 and Eli Lilly Canada Inc. v. A.G. of Canada and Minister of Health, 2014 FC 152). The Court in Gilead states at para.39:
There is no sound reason to adopt different legislative requirements for the paragraphs set out in subsection 4(2). Each paragraph uses the definitive form in referring to both the substance of the claim and the substance in the notice of compliance: "the medicinal ingredient", "the formulation", "the dosage" and "the use" (in French, "l" ingrédient, "la formulation", "la forme posologique", l'utilisation"). The content of each paragraph is otherwise completely consistent.
30 Applied to the 753 Patent, it is clear that it does not contain:
(i) a claim for the medicinal ingredient, which medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission;
(ii) a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the submission;
(iii) a claim for the dosage form and the dosage form has been approved through the issuance of a notice of compliance in respect of the submission; or
(iv) a claim for the use of the medicinal ingredient, and the use has been approved through the issuance of a notice of compliance in respect of the submission.
V. ISSUES [28] The overall issue before me is whether the Prothonotary erred in finding that the '753 patent was not eligible for listing under the NOC Regulations in respect of ViiV’s KIVEXA or TRIZIVIR products.
[29] The question dealt with by the Prothonotary is, as stated by ViiV in setting out the issues at paragraph 30 of its Written Representations, whether subsections 4(2)(a) and/or 4(2)(b) of the NOC Regulations allow a person to list on the Patent Register kept under the NOC Regulations in respect of a FDC product, a patent containing:
a) a claim to a compound (A) that corresponds to one of two medicinal ingredients of an FDC (A + B); in particular, claim 2 of the '753 patent; and/or
b) a claim to a formulation of an FDC that specifically names one of two medicinal ingredients and incorporates the second by reference to a class of therapeutic agents, wherein the second medicinal ingredient is a member of the class referenced, and is specifically identified in the description of the patent; in particular, claim 32 of the '753 patent. This can be described as a claim to A, plus a medicinal ingredient selected from Group B, Group C, Group D or Group E.
[30] ViiV’s Counsel’s oral representations were directed only to subsection 4(2)(a) of the NOC Regulations and only claim 2 as set out in (a) above.
VI. STANDARD OF REVIEW [31] This is an appeal; not a judicial review. As to matters of law, the Court must address them on the basis of correctness. As to findings of fact, they are to be dealt with on the basis of palpable and overriding error (Housen v Nikolaisen, 2002 SCC 33 at paras 8, 10, 22-23, [2002] 2 SCR 235).
VII. A BRIEF HISTORY OF DRUG PATENTS IN CANADA [32] For quite some time, Canada simply did not permit patents that claimed a food or medicine. Many other countries did the same.
[33] Matters evolved; Canada permitted patents directed to a medicine, provided that the medicine was claimed as produced by a particular process (Parke, Davis & Co v Fine Chemicals of Canada Ltd, [1959] SCR 219 at paras 11, 15, 17 DLR (2d) 153). Thus, if a person made the same medicine by a different process, there would be no infringement.
[34] Subsequently, Canada permitted patents to claim medicines alone, however produced. However, any person wishing to make or sell such a medicine in Canada could apply to the Commissioner of Patents and, almost always, receive a “compulsory licence” under the patent upon payment of a royalty; usually 15% for the bulk product, and 4% to 5% for a finished product (Bristol-Myers Squibb Co v Canada (Attorney General), 2005 SCC 26 at para 8, [2005] 1 SCR 533 [“Bristol-Myers”]).
[35] Canada was put under pressure by its trading partners to abandon the compulsory licence scheme, and did so in 1993 (Bristol-Myers, at para 10). In its stead came the NOC Regulations, imperfectly modelled after the United States Hatch Waxman Act, colloquially called the “Orange Book” proceedings because of the colour of the cover of the booklet containing the United States Act and Regulations (Pfizer Canada Inc v Canada (Minister of Health), 2009 FC 1165 at para 40, 78 CPR (4th) 428.
[36] There is no dispute that the Canadian NOC Regulations are not perfect. Several amendments have been made over the years. The interested parties, the so-called “brand” and “generic” drug companies, compete vigorously in the political sphere to secure or prevent changes being made to the legislation. It is not for the Court to decide whether particular facets of the legislation, or changes made, provide a perfect “balance” between the interests of the parties.
[37] As the late Justice Layden-Stevenson wrote in Purdue Pharma v Canada (Attorney General), 2011 FCA 132, 93 CPR (4th) 186 [“Purdue”], in respect of listing a patent under the NOC Regulations at paragraph 45:
45 I do not disagree with Purdue that the purpose of the Regulations is to prevent patent infringement by a person making use of a patented invention in reliance on the early working exception. However, there is no obligation to provide the advantages of the Regulations in every case. The fact that the Governor in Council establishes eligibility criteria for the listing of patents does not detract from the legitimate purpose.
VIII. SCHEME OF THE NOC REGULATIONS – LISTING A PATENT [38] The NOC Regulations provide a scheme whereby a “first person”, usually called a “brand” or “innovator” who has secured from the Minister permission to market a drug in Canada - the mechanism being the issuance of the Minister to that person of a NOC - may “list” on a Register kept by the Minister under those NOC Regulations, a patent or patents that they own or are licensed (s 4(1)). Those patents are placed on a Patent Register (a computer database) kept by the Minister (s 3(2)).
[39] A “second person”, usually called a “generic” who wishes to market a similar drug in Canada, and who does not wish to submit all the clinical and other data required to obtain a NOC, may apply under an “abbreviated” process whereby it would submit a limited amount of data and “reference” the data already provided by the first person (s 5(1)). Considerable time, money, and effort would be saved.
[40] However, the second person must come to grips with the patents listed by the first person by serving on the first person a Notice of Allegation setting out the legal and factual basis for alleging, usually, that the patents will not be infringed and/or are invalid (s 5(1)).
[41] The first person may do nothing and, after forty-five days have passed, the second person usually receives a Notice of Compliance from the Minister opening the door for it to market its generic product Canada (s 7(1)(d)). However, if the first person chooses, it may institute proceedings to prohibit the Minister from issuing an NOC to the second person (s 6(1)). Those proceedings must be completed within two years (s 7(1)(e)). The usual issues are whether the allegations as to non-infringement or invalidity are justified. If they are not justified, the Minister is prohibited from issuing an NOC to the second person until all relevant patents expire (s 7(1)(f)). Until the matter is decided, the first person has, in effect, an injunction preventing the second person – the generic – from entering the marketplace with its generic copy.
[42] Thus, critical to the process is the listing of a patent. There are certain somewhat complex timing requirements, which are not at issue here. The subject-matter requirements are at issue here.
[43] The subject matter listing requirements pertinent to the patent at issue here are set out in subsections 4(2)(a) and 4(2)(b) of the NOC Regulations, as amended by SOR/2006-242, effective October 5, 2006. They read:
4. (2) A patent on a patent list in relation to a new drug submission is eligible to be added to the register if the patent contains
(a) a claim for the medicinal ingredient and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission;
(b) a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the submission;
4. (2) Est admissible à l’adjonction au registre tout brevet, inscrit sur une liste de brevets, qui se rattache à la présentation de drogue nouvelle, s’il contient, selon le cas :
a) une revendication de l’ingrédient médicinal, l’ingrédient ayant été approuvé par la délivrance d’un avis de conformité à l’égard de la présentation;
b) une revendication de la formulation contenant l’ingrédient médicinal, la formulation ayant été approuvée par la délivrance d’un avis de conformité à l’égard de la présentation;
[44] The terms “claim for the medicinal ingredient”, as found in subsection 4(2)(a) of the NOC Regulations; and “claim for the formulation”, as found in subsection 4(2)(b) of the NOC Regulations, are defined in section 2 of those NOC Regulations, as follows:
2. “claim for the medicinal ingredient”
“claim for the medicinal ingredient” includes a claim in the patent for the medicinal ingredient, whether chemical or biological in nature, when prepared or produced by the methods or processes of manufacture particularly described and claimed in the patent, or by their obvious chemical equivalents, and also includes a claim for different polymorphs of the medicinal ingredient, but does not include different chemical forms of the medicinal ingredient; (revendication de l’ingrédient médicinal)
“claim for the formulation”
“claim for the formulation” means a claim for a substance that is a mixture of medicinal and non-medicinal ingredients in a drug and that is administered to a patient in a particular dosage form; (revendication de la formulation)
2. « revendication de l’ingrédient médicinal »
« revendication de l’ingrédient médicinal » S’entend, d’une part, d’une revendication, dans le brevet, de l’ingrédient médicinal — chimique ou biologique — préparé ou produit selon les modes ou procédés de fabrication décrits en détail et revendiqués dans le brevet ou selon leurs équivalents chimiques manifestes, et, d’autre part, d’une revendication pour différents polymorphes de celui-ci, à l’exclusion de ses différentes formes chimiques. (claim for the medicinal ingredient)
« revendication de la formulation »
« revendication de la formulation » Revendication à l’égard d’une substance qui est un mélange des ingrédients médicinaux et non médicinaux d’une drogue et qui est administrée à un patient sous une forme posologique donnée. (claim for the formulation)
[45] The NOC Regulations prior to the 2006 amendments respecting listing stated:
4. (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;
4. (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;
[46] Sharlow JA, in GD Searle & Co v Canada (Minister of Health), 2009 FCA 35, 71 CPR (4th) 389, explained the change to the NOC Regulations at paragraphs 13 to 15:
13 In this case, the interpretive debate relates to section 4 of the NOC Regulations. For the holder of a patent, the gateway to the advantages of the NOC Regulations is to list the patent against an approved drug on the patent register. Section 4 of the NOC Regulations states the conditions that must be met to list a patent on the patent register. Subsection 3(2) of the NOC Regulations gives the Minister the authority to delist any patent that does not meet the requirements of section 4.
14 Section 4 was substantially amended by SOR/2006-242, effective October 5, 2006. According to section 6 of SOR/2006-242, the post-October 5, 2006 version of section 4 does not apply to patents on a patent list submitted for listing prior to June 17, 2006. However, the patent in issue in this case was submitted for listing after June 17, 2006. Therefore, the post-October 5, 2006 version of section 4 governs its eligibility for listing. In these reasons, references to section 4 of the NOC Regulations are references to the post-October 5, 2006 version, unless the context indicates otherwise.
15 The jurisprudence relating to the eligibility of patents for listing pursuant to section 4 of the NOC Regulations (as they read prior to the October 5, 2006 amendments) had adopted an interpretation that the government considered so broad as to unduly delay market entry of generic drugs. The October 5, 2006 amendments were intended to restore the balance. This is fully explained in the Regulatory Impact Analysis Statement published with the amending regulation (SOR/2006-242).
The Regulatory Impact Statement that Sharlow JA referred to said, in part:
Patent Listing Requirements
. . .
Consistent with this understanding of the PM(NOC) Regulations is the fact that not every patent pertaining to an approved drug qualifies for enforcement under the scheme. Only those patents which meet the current timing, subject matter and relevance requirements set out in section 4 of the regulations are entitled to be added to Health Canada's patent register and to the concurrent protection of the 24-month stay. Embodied in each of these requirements are certain fundamental principles which must be respected if the PM(NOC) Regulations are to operate in balance with early-working. While the operation of some of these requirements is described in more detail below, a brief discussion of the principles they represent is warranted.
By stipulating that the application filing date of the patent precede the date of the corresponding drug submission, the timing requirement promotes a temporal connection between the invention sought to be protected and the product sought to be approved. This ensures that patents for inventions discovered after the existence of a product do not pre-empt generic competition on that product Similarly, the relevance requirement limits the protection of the PM(NOC) Regulations to that which the innovator has invested time and money to test and have approved for sale. This prevents hypothetical innovation from impeding generic market entry and encourages innovators to bring their latest inventions to market. Finally, in only allowing patents to be listed which contain claims for the medicine or its use, the subject matter requirement makes it clear that innovations without direct therapeutic application, such as processes or intermediates, do not merit the special enforcement protection of the PM(NOC) Regulations.
It is recognized that there may be instances where a patent which does not qualify for the protection of the PM(NOC) Regulations is ultimately infringed by the fact of generic market entry. However, the Government's view is that where the patent fails to meet the listing requirements described above, policy considerations tip the balance in favour of immediate approval of the generic drug, and the matter is better left to the alternative judicial recourse of an infringement action. It follows that the continued viability of the regime greatly depends upon the fair and proper application of these listing requirements.
It has come to the Government's attention that an increasing number of court decisions interpreting the PM(NOC) Regulations have given rise to the need to clarify the patent listing requirements. These decisions, which turn on timing and relevance issues, are not the product of judicial error but rather of deficiency in the language of the PM(NOC) Regulations themselves. Of particular concern is the failure of the language to fully account for the range of submission types possible under the Food and Drug Regulations, .the various pharmaceutical patent claims available under the Patent Act and, most importantly, the breadth of scenarios which can arise from the linkage between the two established by the PM(NOC) Regulations.
Les exigences relatives à l'inscription des brevets
. . .
Il s'ensuit que ce ne sont pas tous les brevets protégeant une drogue approuvée qui peuvent se prévaloir du mécanisme d'application prévu par le règlement de liaison. Seuls les brevets respectant les exigences énoncées à l'article 4 du règlement relatives au délai, à l'objet et à la pertinence, peuvent être inscrits au registre des brevets de Santé Canada et bénéficier de la protection correspondante de la suspension de 24 mois. Ces exigences reposent sur certains principes fondamentaux devant être respectés afin que le règlement de liaison fonctionne de manière équilibrée avec l'exception relative à la fabrication anticipée. Avant de passer à l'explication du fonctionnement de quelques-unes de ces exigences, les principes qui les sous-tendent seront d'abord décrits.
En stipulant que la date de dépôt de la demande de brevet doit précéder celle de la demande d'avis de conformité correspondante, l'exigence relative au délai procure un lien temporel entre l'invention que l'on cherche à protéger et le produit visé par la demande d'approbation. Ceci permet de faire en sorte que les brevets protégeant des inventions dont la découverte est postérieure à l'existence d'une drogue n'empêchent pas l'arrivée sur le marché de versions génériques de cette même drogue. De la même façon, l'exigence relative à la pertinence vise à faire en sorte que le règlement de liaison protège uniquement ce pourquoi l'innovateur a investi temps et argent afin d'effectuer les études et l'approbation nécessaires en vue de l'entrée sur le marché. Ceci fait en sorte que l'innovation hypothétique n'entrave pas la mise en marché du produit générique et encourage les innovateurs à commercialiser leurs inventions les plus récentes. Enfin, en permettant uniquement l'inscription des brevets contenant des revendications à l'égard du médicament ou de son utilisation, l'exigence relative à l'objet signale clairement que les innovations ne comportant aucune application thérapeutique directe, comme les procédés ou les intermédiaires, ne méritent pas la protection spéciale prévue au règlement de liaison.
Bien entendu, il peut y avoir des cas où un brevet n'étant pas admissible à la protection conférée par le règlement de liaison soit finalement contrefait suite à l'arrivée d'un produit générique sur le marché. Toutefois, le gouvernement estime que dans le cas où le brevet ne respecterait pas les exigences susmentionnées, les intérêts de la politique sous jacente font pencher la balance en faveur de l'approbation immédiate du produit générique et qu'il est préférable que la question soit tranchée au moyen d'une action en contrefaçon ordinaire. Il s'ensuit que la viabilité du régime dépend en grande partie de l'application juste et équitable de ces exigences.
Le gouvernement a constaté qu'un nombre accru de décisions judiciaires portant sur l'interprétation du règlement de liaison ont donné lieu à la nécessité d'apporter des précisions quant aux exigences relatives à l'inscription des brevets décrites ci-dessus. Ces décisions, concernant les exigences relatives au délai et à la pertinence, ne sont pas le résultat d'erreurs de la part des tribunaux, mais plutôt d'une lacune dans le libellé du règlement lui-même. Plus précisément, le libellé du règlement de liaison ne tient pas pleinement compte de l'éventail de types de demandes d'avis de conformité possibles en vertu du Règlement sur les aliments et drogues, des différentes revendications relatives aux brevets pharmaceutiques pouvant être formulées en vertu de la Loi sur les brevets et, surtout, de la foule de scénarios pouvant découler du lien entre les deux lois résultant du règlement de liaison.
IX. THE CURRENT JURISPRUDENCE [47] There have been a number of decisions of this Court and the Federal Court of Appeal dealing with the propriety of the listing of certain patents under the NOC Regulations as amended in 2006. They include:
• Abbott Laboratories Ltd v Canada (Attorney General), 2008 FCA 244, 68 CPR (4th) 445 [“Abbott”] dealt with a decision of the Minister to de-list a patent directed to the use of a medicinal ingredient. The Federal Court of Appeal considered the meaning of “claim for the dosage form”, as found in subsections 4(3)(b) and 4(2)(c) as well as the “change in the use” requirement under subsections 4(3)(c) and 4(2)(d) of the NOC Regulations. That Court held that while the patent included a general claim that may cover the use identified in the listing party’s amended NOC, it did not cover the specific use found in the amended NOC; thus, it was not properly listed. Pelletier JA, for the Court, at paragraphs 46 to 49, addressed the need for the patent claims to match specifically the dosage form in respect of which the amended NOC was granted:
46 That controversy was resolved by amendments which specified the characteristics of patents which could be listed against specific types of SNDS's. Thus, where a manufacturer submitted an SNDS with respect to a new dosage form, the Regulations now require any patent sought to be filed against that submission to contain "a claim for the changed dosage form...": see paragraph 4(3)(b) of the Regulations. In the present case, the SNDS in question is with respect to a new indication for an existing drug PREVACID. That drug was originally approved for use in the treatment of "duodenal ulcers, gastric ulcers, and reflux esophagitis". The SNDS relevant to these proceedings claims as a new indication for the drug "Healing of NSAID-associated gastric ulcer and reduction of risk of NSAID-associated gastric ulcer". Paragraph 4(3)(c) of the Regulations requires that any patent sought to be listed on the Patent Register against that submission must contain "a claim for the changed use of the medicinal ingredient".
47 It stands to reason that if a patent must contain a claim for the changed use identified in Abbott's SNDS, that patent cannot simply claim the use which formed the basis of the original submission. Such a patent does not specifically claim the changed use, even though the changed use may come within the claims of the patent. In other words, the Regulations envisage as a condition of listing a patent in respect of a change in the use of a medicinal ingredient that the patent specifically claims the changed use as opposed to non-specific claims which are wide enough to include the changed use.
48 It is this distinction between specific claims and broad non-specific claims which led to the discussion in the jurisprudence about the nature of the patented invention: see Wyeth Canada, at paragraph 22, affirmed [2007] F.C.J. No. 1062 at paragraph 29. That discussion has now been overtaken by the amendments to the Regulations.
49 Even if one were inclined to look to the nature of the invention, the difficulty is that the language of the Regulations speaks only of "a claim for the changed use of the medicinal ingredient". I conclude that paragraph 4(3)(c) of the Regulations requires, as a condition of listing a patent on the Patent Register, that the patent must specifically claim the very change in use which was approved by the issuance of a Notice of Compliance with respect to an SNDS.
• GD Searle & Co v Canada (Minister of Health), 2009 FCA 35, 71 CPR (4th) 389 [“Searle”] dealt with the decision of the Minister to de-list a patent directed to the use of a medicine. The Federal Court of Appeal addressed subsection 4(2)(d) of the NOC Regulations, and a claim to use. Sharlow JA, for the Court, made it clear that a general claim for use (here a claim for treatment of pain) was insufficient to support a listing where the use was specific to treatment of short-term pain. She wrote at paragraphs 44 to 47:
44 The problem with the analysis presented by Pfizer and Searle is that a claim for the use of Celebrex "for pain"