G.D. Searle & Co. v. Canada (Health)

G.D. Searle & Co. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2008-04-04
Neutral citation
2008 FC 437
File numbers
T-884-07
Notes
Reported Decision
Decision Content
Date: 20080404
Docket: T-884-07
Citation: 2008 FC 437
Ottawa, Ontario, April 4, 2008
PRESENT: The Honourable Justice Johanne Gauthier
BETWEEN:
GD SEARLE & CO. and PFIZER CANADA INC.
and
MINISTER OF HEALTH
REASONS FOR ORDER AND ORDER
[1]This judicial review of the decision of the Minister of Health to remove Canadian patent number 2,319,201 (‘201 patent) from the Patent Register raises a new question with respect to the construction of subsection 4(3) of the October 5, 2006 amendments to the Patented Medicines Notice of Compliance Regulations, SOR/98-166; SOR/93-133 as amended (NOC Regulations). The amendments were adopted to clarify the eligibility requirements of patents listed in relation to Supplementary New Drug Submissions (SNDS).
[2]For the reasons that follow, the Court finds that the Minister’s decision is well-founded and should not be interfered with.
BACKGROUND
[3]Pfizer Canada Inc. (Pfizer) manufactures and markets the drug Celebrex® ® in Canada in capsule dosage (100 mg, 200 mg and 400 mg). Celebrex® ® is a non-steroidal anti-inflammatory drug (NSAID) [1]that functions by acting as a cyclooxygenase-2 (COX-2) inhibitor. It contains the medicinal ingredient celecoxib.
[4]On April 14, 1999, pursuant to an original New Drug Submission (NDS) for celecoxib, Health Canada issued Pfizer an NOC for use in “the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis in adults”. Canadian patents No. 2, 177, 576 (‘576 patent) and 2, 267,186 (‘186 patent) owned by GD Searle and Co were listed by Pfizer against that NOC. The ‘576 Patent claims a class of compounds which includes celecoxib as well as the use of such compounds in the treatment inter alia of arthritis and inflammation associated disorders including pain and fever, whereas the ‘186 patent claims a new therapeutic use for COX-2 inhibitors, that is, the treatment and prevention of neoplasia.
[5]Since then, Pfizer has filed and received approval for several SNDSs including SNDS 072375, which was filed on July 4, 2001. That SNDS describes a new indication or new use of Celebrex® ®, namely the “short term (≤ 7 days) management of moderate to severe acute pain in adults in conditions such as: musculoskeletal and/or soft-tissue trauma including sprains, post-operative orthopaedic, and pain following dental extraction”. This SNDS was approved by Health Canada and resulted in the issuance of an NOC on September 7, 2004.
[6]About two years later, on July 11, 2006, the ’201 Patent was issued to GD Searle and Co. in respect of a patent application that had been filed on November 30, 1999. Under subsection 4(4) of the NOC Regulations as they read prior to the October 5, 2006 amendments, patent owners were granted 30 days from the date of patent issue to submit a patent for listing on the Patent Register in relation with eligible drug submissions, provided the application for said patent had been filed before the date of filing of the drug submission. Thus, the ’201 patent could not be listed against the 1999 NOC for Celebrex® ® but could be listed in respect of SNDS 072375, as it contained a claim for the medicine celecoxib (formulation[2]). It was added by the Minister to the Patent Register on July 27, 2006. The submission to list the patent was made by Pfizer with GD Searle’s consent.
[7]As mentioned, on October 5, 2006, the NOC regulations were amended. Section 6 of the transitional provisions specifies that all patent lists filed after June 17, 2006 would be subject to the newly introduced patent listing requirements. As the ‘201 patent was submitted for listing on July 19, 2006, it was subject to the amended NOC Regulations.
[8]The Minister reaudited the patents filed after June 17, 2006 and concluded that the ‘201 patent did not meet the requirements of subsection 4(3) of the NOC Regulations.
[9]The Minister informed Pfizer that it proposed to delist the ’201 patent. Pfizer made oral and written submissions opposing the proposed delisting on the basis, among other things, that the patent should be listed if the new indication falls within the scope of one or more claims in the patent. Pfizer submitted reports from five experts to show that, as a matter of fact, the new indication was covered by claims 14 and 15 of the ‘201 patent.
[10] Ultimately, the Minister found that the ’201 patent did not meet the requirements of the NOC Regulations and it was delisted on May 1, 2007.
[11] Claims 14 and 15 of the '201 patent read as follows:
14. Use of a composition as defined in any one of claims 1 to 10 for the preparation of a medicament for the treatment and/or prophylaxis of a medical condition or disorder in a subject where treatment with a cyclooxygenase-2 inhibitor is indicated.
15. The use according to claim 14, wherein the condition or disorder is rheumatoid arthritis, osteoarthritis or pain.
[12] It is agreed by the parties that the approved version of Celebrex® currently on the market embodies a drug composition covered by the ‘201 patent. Thus, product specificity is not an issue here.
LEGISLATIVE PROVISIONS
[13] For ease of reference, the legislative and regulatory provisions relevant to this matter are reproduced here:
Section 55.2 (1) of the Patent Act, R.S.C. 1985, c. P-4;
55.2 (1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.
(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1), including, without limiting the generality of the foregoing, regulations
(a) respecting the conditions that must be fulfilled before a notice, certificate, permit or other document concerning any product to which a patent may relate may be issued to a patentee or other person under any Act of Parliament that regulates the manufacture, construction, use or sale of that product, in addition to any conditions provided for by or under that Act;
(b) respecting the earliest date on which a notice, certificate, permit or other document referred to in paragraph (a) that is issued or to be issued to a person other than the patentee may take effect and respecting the manner in which that date is to be determined;
(c) governing the resolution of disputes between a patentee or former patentee and any person who applies for a notice, certificate, permit or other document referred to in paragraph (a) as to the date on which that notice, certificate, permit or other document may be issued or take effect;
(d) conferring rights of action in any court of competent jurisdiction with respect to any disputes referred to in paragraph (c) and respecting the remedies that may be sought in the court, the procedure of the court in the matter and the decisions and orders it may make; and
(e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent.
55.2 (1) Il n’y a pas contrefaçon de brevet lorsque l’utilisation, la fabrication, la construction ou la vente d’une invention brevetée se justifie dans la seule mesure nécessaire à la préparation et à la production du dossier d’information qu’oblige à fournir une loi fédérale, provinciale ou étrangère réglementant la fabrication, la construction, l’utilisation ou la vente d’un produit.
(4) Afin d’empêcher la contrefaçon d’un brevet d’invention par l’utilisateur, le fabricant, le constructeur ou le vendeur d’une invention brevetée au sens du paragraphe (1), le gouverneur en conseil peut prendre des règlements, notamment :
a) fixant des conditions complémentaires nécessaires à la délivrance, en vertu de lois fédérales régissant l’exploitation, la fabrication, la construction ou la vente de produits sur lesquels porte un brevet, d’avis, de certificats, de permis ou de tout autre titre à quiconque n’est pas le breveté;
b) concernant la première date, et la manière de la fixer, à laquelle un titre visé à l’alinéa a) peut être délivré à quelqu’un qui n’est pas le breveté et à laquelle elle peut prendre effet;
c) concernant le règlement des litiges entre le breveté, ou l’ancien titulaire du brevet, et le demandeur d’un titre visé à l’alinéa a), quant à la date à laquelle le titre en question peut être délivré ou prendre effet;
d) conférant des droits d’action devant tout tribunal compétent concernant les litiges visés à l’alinéa c), les conclusions qui peuvent être recherchées, la procédure devant ce tribunal et les décisions qui peuvent être rendues;
e) sur toute autre mesure concernant la délivrance d’un titre visé à l’alinéa a) lorsque celle-ci peut avoir pour effet la contrefaçon de brevet.
Section 2 of the Patented Medicines (Notice of Compliance) Regulations;
In these Regulations,
"claim for the dosage form" means a claim for a delivery system for administering a medicinal ingredient in a drug or a formulation of a drug that includes within its scope that medicinal ingredient or formulation; ( revendication de la forme posologique )
"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 )
"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 medicine itself" [Repealed, SOR/2006-242, s. 1]
"claim for the use of the medicinal ingredient" means a claim for the use of the medicinal ingredient for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms; ( revendication de l’utilisation de l’ingrédient médicinal )
Les définitions qui suivent s’appliquent au présent règlement :
(…) «revendication de la forme posologique» Revendication à l’égard d’un mécanisme de libération permettant d’administrer l’ingrédient médicinal d’une drogue ou la formulation de celle-ci, dont la portée comprend cet ingrédient médicinal ou cette formulation. ( claim for the dosage form )
«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 )
«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 l’utilisation de l’ingrédient médicinal» Revendication de l’utilisation de l’ingrédient médicinal aux fins du diagnostic, du traitement, de l’atténuation ou de la prévention d’une maladie, d’un désordre, d’un état physique anormal, ou de leurs symptômes. ( claim for the use of the medicinal ingredient )
Section 3 (2) of the Patented Medicines (Notice of Compliance) Regulations;
3. (2) The Minister shall maintain a register of patents and other information submitted under section 4. To maintain the register, the Minister may refuse to add or may delete any patent or other information that does not meet the requirements of that section.
3. (2) Le ministre tient un registre des brevets et des autres renseignements fournis aux termes de l’article 4. À cette fin, il peut refuser d’y ajouter, ou en supprimer, tout brevet ou tout autre renseignement qui n’est pas conforme aux exigences de cet article.
Section 4 of the Patented Medicines (Notice of Compliance) Regulations;
4. (1) A first person who files or who has filed a new drug submission or a supplement to a new drug submission may submit to the Minister a patent list in relation to the submission or supplement for addition to the register.
(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;
(c) 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
(d) 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.
(3) A patent on a patent list in relation to a supplement to a new drug submission is eligible to be added to the register if the supplement is for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient, and
(a) in the case of a change in formulation, the patent contains a claim for the changed formulation that has been approved through the issuance of a notice of compliance in respect of the supplement;
(b) in the case of a change in dosage form, the patent contains a claim for the changed dosage form that has been approved through the issuance of a notice of compliance in respect of the supplement; or
(c) in the case of a change in use of the medicinal ingredient, the patent contains a claim for the changed use of the medicinal ingredient that has been approved through the issuance of a notice of compliance in respect of the supplement.
(4) A patent list shall contain the following:
(a) an identification of the new drug submission or the supplement to a new drug submission to which the list relates;
(b) the medicinal ingredient, brand name, dosage form, strength, route of administration and use set out in the new drug submission or the supplement to a new drug submission to which the list relates;
(c) for each patent on the list, the patent number, the filing date of the patent application in Canada, the date of grant of the patent and the date on which the term limited for the duration of the patent will expire under section 44 or 45 of the Patent Act;
(d) for each patent on the list, a statement that the first person who filed the new drug submission or the supplement to a new drug submission to which the list relates is the owner of the patent or has an exclusive licence to the patent, or has obtained the consent of the owner of the patent to its inclusion on the list;
(e) the address in Canada for service, on the first person, of a notice of allegation referred to in paragraph 5(3)(a) or the name and address in Canada of another person on whom service may be made with the same effect as if service were made on the first person; and
(f) a certification by the first person that the information submitted under this subsection is accurate and that each patent on the list meets the eligibility requirements of subsection (2) or (3).
(5) Subject to subsection (6), a first person who submits a patent list must do so at the time the person files the new drug submission or the supplement to a new drug submission to which the patent list relates.
(6) A first person may, after the date of filing of a new drug submission or a supplement to a new drug submission, and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date in Canada that precedes the date of filing of the submission or supplement, submit a patent list, including the information referred to in subsection (4), in relation to the submission or supplement.
(7) A first person who has submitted a patent list must keep the information on the list up to date but, in so doing, may not add a patent to the list.
(8) The Minister shall insert on the patent list the date of filing and submission number of the new drug submission or the supplement to a new drug submission in relation to which the list was submitted.
4. (1) La première personne qui dépose ou a déposé la présentation de drogue nouvelle ou le supplément à une présentation de drogue nouvelle peut présenter au ministre, pour adjonction au registre, une liste de brevets qui se rattache à la présentation ou au supplément.
(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;
c) une revendication de la forme posologique, la forme posologique ayant été approuvée par la délivrance d’un avis de conformité à l’égard de la présentation;
d) une revendication de l’utilisation de l’ingrédient médicinal, l’utilisation ayant été approuvée par la délivrance d’un avis de conformité à l’égard de la présentation.
(3) Est admissible à l’adjonction au registre tout brevet, inscrit sur une liste de brevets, qui se rattache au supplément à une présentation de drogue nouvelle visant une modification de la formulation, une modification de la forme posologique ou une modification de l’utilisation de l’ingrédient médicinal, s’il contient, selon le cas :
a) dans le cas d’une modification de formulation, une revendication de la formulation modifiée, la formulation ayant été approuvée par la délivrance d’un avis de conformité à l’égard du supplément;
b) dans le cas d’une modification de la forme posologique, une revendication de la forme posologique modifiée, la forme posologique ayant été approuvée par la délivrance d’un avis de conformité à l’égard du supplément;
c) dans le cas d’une modification d’utilisation de l’ingrédient médicinal, une revendication de l’utilisation modifiée de l’ingrédient médicinal, l’utilisation ayant été approuvée par la délivrance d’un avis de conformité à l’égard du supplément.
(4) La liste de brevets comprend :
a) l’identification de la présentation de drogue nouvelle ou du supplément à la présentation de drogue nouvelle qui s’y rattachent;
b) l’ingrédient médicinal, la marque nominative, la forme posologique, la concentration, la voie d’administration et l’utilisation prévus à la présentation ou au supplément qui s’y rattachent;
c) à l’égard de chaque brevet qui y est inscrit, le numéro de brevet, la date de dépôt de la demande de brevet au Canada, la date de délivrance de celui-ci et la date d’expiration du brevet aux termes des articles 44 ou 45 de la Loi sur les brevets;
d) à l’égard de chaque brevet qui y est inscrit, une déclaration portant que la première personne qui a déposé la présentation de drogue nouvelle ou le supplément à une présentation de drogue nouvelle qui s’y rattachent en est le propriétaire, en détient la licence exclusive ou a obtenu le consentement du propriétaire pour l’inclure dans la liste;
e) l’adresse au Canada de la première personne aux fins de signification de l’avis d’allégation visé à l’alinéa 5(3)a) ou les nom et adresse au Canada d’une autre personne qui peut en recevoir signification comme s’il s’agissait de la première personne elle-même;
f) une attestation de la première personne portant que les renseignements fournis aux termes du présent paragraphe sont exacts et que chaque brevet qui y est inscrit est conforme aux conditions d’admissibilité prévues aux paragraphes (2) ou (3).
(5) Sous réserve du paragraphe (6), la première personne qui présente une liste de brevets doit le faire au moment du dépôt de la présentation de drogue nouvelle ou du supplément à une présentation de drogue nouvelle qui s’y rattachent.
(6) La première personne peut, après la date de dépôt de la présentation de drogue nouvelle ou du supplément à une présentation de drogue nouvelle et dans les trente jours suivant la délivrance d’un brevet faite au titre d’une demande de brevet dont la date de dépôt au Canada est antérieure à celle de la présentation ou du supplément, présenter une liste de brevets, à l’égard de cette présentation ou de ce supplément, qui contient les renseignements visés au paragraphe (4).
(7) La première personne qui a présenté une liste de brevets doit tenir à jour les renseignements y figurant, mais ne peut toutefois y ajouter de brevets.
(8) Le ministre inscrit sur la liste de brevets la date de dépôt et le numéro de la présentation de drogue nouvelle ou du supplément à une présentation de drogue nouvelle qui se rattache à la liste présentée.
Section 2 of the pre-October 2006 Patented Medicines (Notice of Compliance) Regulations
[Repealed, SOR/2006-242, s. 1];
2. In these Regulations,
"claim for the medicine itself" includes a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents; ( revendication pour le médicament en soi )
"claim for the use of the medicine" means a claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof; ( revendication pour l’utilisation du médicament )
2. Les définitions qui suivent s’appliquent au présent règlement.
«revendication pour le médicament en soi» S’entend notamment d’une revendication, dans le brevet, pour le médicament en soi préparé ou produit selon les modes du procédé de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes. ( claim for the medicine itself )
«revendication pour l’utilisation du médicament» Revendication pour l’utilisation du médicament aux fins du diagnostic, du traitement, de l’atténuation ou de la prévention d’une maladie, d’un désordre, d’un état physique anormal, ou de leurs symptômes. ( claim for the use of the medicine )
ANALYSIS
A) Standard of review
[14] In their written representations, the applicants had raised an issue of procedural fairness as well as preliminary issues in respect of the filing of new evidence not before the decision maker. Affidavit evidence explaining the Minister’s decision was also submitted. At the hearing, the parties agreed that the Court will not have to deal with such issues and that this application should be decided on the merits of the main question, which is whether the ’201 patent meets the requirements set out in subsection 4(3) of the NOC Regulations.
[15] The Minister submitted that the application of the NOC Regulations to a particular patent is a question of mixed fact and law which normally requires assessing the subject matter of the drug submission and comparing it with the patent that has been submitted for listing. Such an issue is normally subject to the standard of patent unreasonableness.[3]
[16] However, at the hearing the Minister also agreed that as set out in the recent Federal Court of Appeal recent decision in Ferring Inc. v. Canada (Minister of Health), 2007 FCA 276 at paragraph 8:
“…where there is a mixed question of law and fact then the standard of review is patent unreasonableness unless the question of law is extricable from the question of fact in which case the question of law is determined on the basis of correctness”.
[17] Because the Minister conceded that the relevant SNDS was for a change in the use of the medicinal ingredient that was approved through the issuance of an NOC[4], the parties agree that the ‘201 patent’s eligibility for listing depends entirely on the construction of claims 14 and 15 as well as the construction of subsection 4 (3) of the NOC Regulations. Both issues are pure questions of law.
[18] The Court is satisfied that in this particular case, the two questions of law are extricable from the question of fact (which was conceded) and that therefore, the decision of the Minister in respect of those two questions will be reviewed on the basis of correctness.
B) Did the Minister err by concluding that the ‘201 Patent was not eligible?
[19] At the hearing and later, in written submissions provided to answer specific queries from the Court, the parties clarified and refined their respective positions.
[20] The main differences between their respective interpretations of the NOC Regulations and how they apply to the ‘201 Patent are as follows:
[21] On the one hand, the applicants say that the October 5, 2006 amendment added specific listing criteria for patents filed in association with an SNDS in order to specifically eliminate the existing piecemeal approach set out in Hoffman- LaRoche Ltd.v. Canada (Minister of Health), 2006 FCA 335, and Wyeth Canada v. Ratiopharm, 2007 FCA 264; thus questions relating to what the patented invention is, what the spirit of the invention is or what the patent is about are irrelevant to the task the Minister must perform to apply paragraph 4(3)(c) of the NOC Regulations.
[22] According to the applicants, the new system is a simple one; if an SNDS is submitted for a change in formulation, dosage or in the use of a medicinal ingredient, the only requirement to be met for a patent to be eligible for listing (excluding timing from the discussion at this stage) is that it contain one claim that covers within its ambit the relevant change requested in the SNDS and approved by Health Canada through the issuance of an NOC.
[23] More specifically here, to determine whether pursuant to paragraph 4(3)(c) of the NOC Regulations a particular claim in a patent is for the changed use of the medicinal ingredient, the Court must employ the principles of construction set out by the Supreme Court of Canada in Free World Trust v. Electro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 and Whirlpool v. Camco Inc., [2000] SCC 67, [2000] 2 S.C.R. 1067 for there can be only one construction of a claim for all the purposes of the Patent Act, be it validity, infringement, or eligibility for listing which is at issue.
[24] For the applicants, there is thus no doubt that the new definition of “claims for the use of a medicinal ingredient” includes, as it used to under the old version of the NOC Regulations, claims for the use of a formulation wherein the only active ingredient is the medicinal ingredient. It is irrelevant to ask the question of whether the use of the medicinal ingredient is the novel element of the claim, as this issue is to be dealt with by the Court (not the Minister) when and only when allegations of patent invalidity or the invalidity of the specific claims mentioned in subsection 5(1) of the NOC Regulations are challenged through the issuance of an application under subsection 6(1).
[25] Moreover, given the general principle of construction whereby words used in a regulation or provision must be ascribed the same meaning throughout, it is evident that claims 14 and 15 in the ‘201 Patent are for the use of the medicinal ingredient in Celebrex® , for the Minister has conceded that the 07375 SNDS is for a change in the use of the medicinal ingredient as required under the first part of paragraph 4(3)(c).
[26] In respect of the Minister’s arguments that the language of the claim for the changed use must closely correspond to the language used to describe the indication in the SNDS, the applicants submit that all of the evidence before the Court indicates that the exact condition described in the new indication in the 07375 SNDS approved by Health Canada would be understood by a person skilled in the art to be covered by claims 14 and 15. In respect of claim 14, this is because a person skilled in the art would know that celecoxib is a COX-2 inhibitor, and that COX-2 inhibitors are useful in the treatment of inflammatory pain and are not indicated to treat neuropathic pain (these being the two broad classes of pain). Also, the disclosure of the ‘201 Patent clearly refers to the specific conditions covered by the new indication (for example, sprains – page 9, line 31 and page 11, line 22; postoperative orthopaedic and dental pain – page 9, line 31, page 12, lines 17 and 18, page 16, lines 4 and 5) Finally, claim 15, which is dependent on claim 14, is even clearer in that respect as it expressly refers to “pain”.
[27] Finally, the applicants also adduced evidence explaining that the drafting of claims is done well before the patentee concludes clinical trials or Health Canada reviews the indications of the product that embodies its invention. The concerns of Health Canada when reviewing the wording of indications are totally different from those of a claim drafter. It would thus be impractical and would lead to an absurd result (i.e. the exclusion of most if not all patents) to require that the language of a patent claim closely match the language of the indication that will ultimately be approved by Health Canada in an NOC.
[28] It also bears mention that the applicants urged the Court to follow the conclusion adopted in Abbott Laboratories v. Canada (Attorney General), wherein a patent delisted by the Minister pursuant to the new NOC Regulations was ordered restored to the Register, as the Court found the patent included a claim for the changed use on the basis of what appears to have been a literal interpretation of that claim. However, given that in Abbott the Court did not engage in a detailed analysis that would enable one to assess the similarities or differences in the arguments considered there and those before the Court here, and given that the decision is presently on appeal and is being strongly contested by the Minister, the Court will proceed with its own analysis.
[29] The Minister takes the position that the Regulatory Impact Analysis Statement[5] (RIAS) which accompanied the October 2006 amendments to the NOC Regulations clearly indicates that the “subject matter of a patent” is still relevant to determine eligibility for listing. The Minister must thus consider the fact that the ‘201 Patent is not a “use patent”. The patented invention here is a novel formulation (special dose units comprising particles of celecoxib of certain sizes) and not a new use of celecoxib.
[30] In addition, the NOC Regulations require a specific link between at least one claim of the “relevant patent” and the change described in the SNDS. The subject matter of such a claim must be the changed formulation or dosage form or use of the medicinal ingredient, and the claims must fall within the very specific definitions of such claims in the NOC Regulations.
[31] To make a determination as to whether or not a particular claim falls within said definitions, the Minister must adopt the approach followed by the Federal Court of Appeal when it was required to determine the somewhat similar issue of whether a claim in a given patent met the regulatory requirements set out in paragraph 4(2)(b) (see also subparagraph 5(1)(b)(iv)) of the “old” version of the NOC Regulations (see for example Biovail Corp. v. Canada (Minister of National Heath and Welfare), [2006] F.C.J No. 475, 2006 FCA 105 and Proctor & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2006] F.C.J. No.515.)
[32] Here, the Court does not understand the Minister to say that no claim for the use of a formulation or dosage form could meet the definition of a “claim for the use of a medicinal ingredient”, but simply that in this particular case, when one considers the language of claims 14 and 15 individually as well as in the context of the ‘201 Patent as a whole (i.e., alongside the other claims and the disclosure), it becomes clear that what is claimed in claims 14 and 15 is not a particular use of the medicinal ingredient celecoxib.
[33] Finally (and it is not clear if this is an alternative position), the Minister says that at the very least, the wording of the claim for the changed use of the medicinal ingredient referred to in paragraph 4(3)(c) must be very specific and align closely with the changed indication sought in the SNDS. A general reference to all uses for which the medicinal ingredient can be used, as in claim 14 or even claim 15, is not sufficient.
[34] It is evident here that the Minister is concerned that the interpretation proposed by the applicant in this case will trivialize the specific linkage required by the legislator and referred to in paragraph 4(3)(c) of the NOC Regulations.
[35] Although not spelled out as such, one can also appreciate that the interpretation proposed by the applicants could favour or create an imbalance in the protection afforded an innovator whose inventive contribution is solely in developing new formulations or dosage forms, over those innovators whose inventions relate to new medicinal ingredients or new uses of a medicinal ingredient itself. That is to say that a patent for a new medicinal ingredient[6] could only be listed against an NDS and would be subject to the NOC Regulations’ strict timing requirements, while a new use patent for the medicinal ingredient itself could only be listed against an NDS which specifically describes the new use, or an SNDS that covers a change in use covered by one of the claims of the patent. Given that in a typical new use patent, the claims would have to be limited to those where the novelty resides in the new use itself, the number of such new use(s) would normally be limited.
[36] With respect to patents wherein the patented invention is a new formulation or a new dosage form that contain a claim that falls within the definitions of the NOC Regulations, it must be borne in mind that the inventor is entitled to claim all aspects of his invention and may include use claims if they are described in the disclosure and are based on the utility upon which the patentability of the product (the formulation on dosage form) is predicated. Such use claims will typically cover all known uses of the active ingredient contained in the formulation or dosage form unless there is some good reasons not to.[7] Applying the applicants' interpretation, such patents could thus be listed against an NDS on the basis of a claim for the formulation as well as a use of the formulation (as a use of the medicinal ingredient) or an SNDS covering a change in the formulation or any change in indication (all known uses of the medicinal ingredient being referred to in the use claims relating to the novel formulations), even though such uses are not attributable to the inventive ingenuity of the innovator. It would therefore be possible for the innovator to completely bypass the philosophy underlying the timing requirements set out in the NOC Regulations.
[37] This apparent imbalance is difficult to reconcile with the fact that from the outset the legislator appears to have been concerned first and foremost to afford protection through this regulatory scheme to the innovator bringing about patents for new medicinal ingredients or new uses of medicinal ingredients (courts then extended this protection to compositions or formulations that in fact described or claimed the medicinal ingredient [8]). As mentioned in the RIAS, claims for dosage forms were only brought under the umbrella of the NOC regime because the legislator was convinced by representations made to the effect that those falling within the new statutory definition have significant therapeutic value.
[38] But identifying the problem does not automatically mean that the Minister or the Court can solve it without amendments to the NOC Regulations, for the question remains as to whether the new provisions lend themselves to the interpretation proposed by the Minister, having regard to the applicable principles of statutory interpretation and claims construction.
[39] Before commenting any further in this regard, however, the Court will first turn to the issue of whether or not the ‘201 Patent contains a claim for the changed use of the medicinal ingredient, as this was the main focus of the parties’ arguments and the answer to this question is decisive of the outcome of this application.
Does the ‘201 Patent contain a claim for the changed use of the medicinal ingredient in Celebrex®?
[40] To answer this question, one must first determine whether the ‘201 Patent contains a “claim for the use of the medicinal ingredient” as defined in the NOC Regulations, and if so whether it is a claim that covers the “changed use” described in the SNDS.
[41] Underlying the applicants’ position is the assumption that a “claim for the use of a medicinal ingredient” still covers the use of all compositions or formulations which previously fell under the definition of “medicine”. This seems to be based on the principle enunciated in Hoffman–La Roche v Minister of Health and Welfare, [1995] F.C.J. No. 1775 and is not in my view a proper assumption.
[42] In Hoffman-La Roche, above, the Federal Court of Appeal had to construe the then recent NOC regulations to determine if the definition of “claim for the medicine itself” encompassed claims for a pharmaceutical composition (formulation). It concluded that it could. This principle was never put in question thereafter. But it quickly became clear that its application was not as easy as it seemed, for it remained to be determined in each given instance whether a particular claim was directed to the active ingredient in the composition or formulation, or whether instead it covered a particular dosage form or delivery system[9] as opposed to the medicine itself (Biovail Corp. v. Canada (Minister of Health), 2005 FCA 105, at para. 7; GlaxoSmithKline v. Canada (A.G.), 2005 FCA 197, paras. 19, 25, 29-44). As discussed below, the Court believes that the approach taken to answer this question is still relevant to determining whether a particular claim is a “claim for the use of the medicinal ingredient”.
[43] But otherwise, the conclusion in Hoffman- La Roche (1995) is no longer relevant insofar as the new NOC Regulations expressly distinguish between a “claim for a formulation” and a “claim for a medicinal ingredient”. What is required, therefore, is to consider how this distinction bears upon the meaning of a “claim for the use of the medicinal ingredient.” Is one to construe the words “medicinal ingredient” in that definition in the same limited way (as excluding formulations or dosage form), or is it meant to also include claims for the use of a formulation or a dosage form.?
[44] In this respect, the RIAS provide little guidance; the only relevant passage in respect of the definition of “claim for the use of the medicinal ingredient” says as follows:
Although the definition for “claim for the use of the medicinal ingredient” in these amendments is unchanged from the current definition for “claim for the use of the medicine”,