Glaxosmithkline Inc. v. Apotex Inc., 2003 FC 1055

Date: 20030910

Docket: T-876-02

Citation: 2003 FC 1055     

OTTAWA, ONTARIO, this 10^th day of September, 2003

PRESENT:      The Honourable Mr. Justice James Russell

BETWEEN:

                                                    GLAXOSMITHKLINE INC. and

SMITHKLINE BEECHAM P.L.C.

                                                                                                                                                      Applicants

                                                                                 and

                                                                 APOTEX INC. and

THE MINISTER OF NATIONAL HEALTH

                                                                                                                                               Respondents

                                               REASONS FOR ORDER AND ORDER

NATURE OF APPLICATION

[1]                 This is an application pursuant to subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations, S.C. 1993, c. 2, s. 4 (the "Regulations") by which the Respondent Apotex Inc. ("Apotex") seeks an order dismissing an application made under subsection 6(1) of the Regulations by Glaxosmithkline Inc. and Smithkline Beecham P.L.C. ("GSK"). The GSK application under subsection 6(1) was for an order prohibiting the Minister of Health (the "Minister") from issuing a Notice of Compliance ("NOC") to Apotex for its paroxetine hydrochloride anhydrate tablets with 10, 20 and 30mg strengths.

[2]                 The subsection 6(1) application was commenced by notice of allegation ("NOA") dated June 6, 2002.

[3]                 Apotex takes the position that GSK's subsection 6(1) application should be dismissed because Canadian Letters Patent Nos. 2,168,829 ( the "829 Patent"), 2,210,023 (the "023 Patent") and 2,211,522 (the "522 Patent") (collectively the "Patents") are improperly listed on the register maintained by the Minister pursuant to the Regulations (the "Register").

[4]                 The Minister of Health filed no materials in response to the application and did not appear at the hearing.

BACKGROUND

[5]                 The basic facts behind this application under subsection 6(5) of the Regulations are not in dispute.

[6]                 GSK markets paroxetine hydrochloride hemihydrate tablets in 10, 20 and 30mg dosage strengths. GSK's original NOC for paroxetine hydrochloride hemihydrate tablets issued on May 4, 1993, as a result of an abbreviated new drug submission ("ANDS") submitted on June 11, 1990.

[7]                 The applications for all three of the Patents were filed on February 5, 1996, several years after GSK received the original NOC for paroxetine hydrochloride hemihydrate tablets. The '829 Patent was issued on December 16, 1997, the '023 Patent was issued on February 9, 1999 and the '522 Patent was issued on December 7, 1999.

[8]                 GSK submitted the Patents for inclusion on the Register in connection with a number of supplementary New Drug Submissions ("NDS").

[9]                 The '829 Patent and the '023 Patent were first added to the Register on October 18, 1999. The '522 Patent was added to the Register on January 10, 2000.

NATURE OF DISPUTE

[10]            Apotex cites several reasons why a dismissal order should be granted pursuant to subsection 6(5) of the Regulations:

.           The Patents were not listed in accordance with the strict timing requirements of section 4 of the Regulations and so were not properly included on the Register and cannot be used to prohibit the issuance of an NOC in favour of Apotex by the Minister; and

.           The Patents were not eligible for inclusion on the Register because of their subject matter and so cannot be used to prohibit the issuance of an NOC in favour of Apotex by the Minister; and

.           Even if the Patents were properly listed on the Register, they are not relevant to Apotex's NOC application so that the subsection 6(1) application by GSK is frivolous, vexatious and an abuse of process within the meaning of subsection 6(5)(b) of the Regulations.

STANDARD TO BE MET

[11]            The parties disagree on the standard to be met to allow this Court to dismiss a subsection 6(1) application in accordance with subsection 6(5)(a) of the Regulations.

[12]            Subsection 6(5)(b) of the Regulations uses the words "redundant, scandalous, frivolous or vexatious or is otherwise an abuse of the process," thus inviting the "plain and obvious" test enunciated in Hunt v.Carey, [1990] 2 S.C.R. 959 at 970.

[13]            In Bayer Inc. v. Apotex Inc. (1998), 85 C.P.R. (3d) 334, Joyal J., on a motion to dismiss under subsection 6(5)(b) of the Regulations, decided that such a motion should only be granted where the Notice of Application is clearly improper and bereft of any possibility of success. This is because subsection 6(5)(b) merely gives the Court explicit jurisdiction to consider motions to dismiss where, previously, the Court had relied upon its own rules to do so. Hence, the restrictive standard in Hunt, supra, should apply.

[14]            Where the parties in the present application disagree is in relation to the standard to be applied under subsection 6(1)(a). GSK argues that is should be the same restrictive "plain and obvious" standard and relies upon the recent decision of Gauthier J. in Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2003] FCJ No. 750 at para. 9 (F.C.T.D.).

[15]            Apotex argues that the decision of Gauthier J. in Procter, supra, is wrong on this point and invites me to apply the normal civil standard of balance of probabilities. In this regard, Apotex points out that subsection 6(5)(a) is not, in effect, equivalent to the Court's own rules in the way that subsection 6(5)(b) is. Thus it involves significantly different considerations. Apotex points to the words of Rothstein J.A. in Apotex Inc. et al v. Minister of National Health and Welfare et al (2000), 3 C.P.R. (4^th), concerning the general scheme of the Regulations:

22.    [...]The Regulations expressly provide a process by which generic manufacturers may obtain relief in the event they are prejudiced by reason of ineligible patents being included on the Register.[...]

[...]

23.     It is apparent that in enacting paragraph 6(5)(a) of the Regulations, the Governor in Council was aware of, and allowed for, the possibility that ineligible patents may find their way onto the Register and may not be readily capable of being deleted under subsection 3(1). Paragraph 6(5)(a) provides generic drug manufacturers [page10] with the opportunity, if and when prohibition proceedings are commenced by a patent holder in respect of a Notice of Allegation served by the generic, to apply to the Court to dismiss the prohibition application because it is based on an ineligible patent included on the Register.

24.     This form of relief may not be a perfect solution for the generic manufacturers because, as appellants' counsel pointed out, the prohibition application will only be dismissed if all the patents at issue are not eligible for inclusion on the Register and because the proceeding does not provide for a court order requiring the Minister to purge the Register of ineligible patents. However, the remedy provided by paragraph 6(5)(a) does directly address the problem of a generic manufacturer having to compare its product with the drug of a patent holder whose drug is based on an ineligible patent. It provides a judicial forum in which the eligibility of the specific patent or patents at issue can be decided by the Court after hearing from the patent holder and the generic competitor.

[16]            Given the general purpose of subsection 6(5)(a) as articulated by Rothstein J.A. in Apotex Inc., supra, there is no reason, Apotex argues, why the restrictive, Hunt, supra, "plain and obvious" standard should be applied to this kind of application.

[17]            In Procter, supra, the judgment of Gauthier J. reads as follows on this point:

9.     Before addressing the main issues raised by Genpharm's motion, it is also important to note that there has been no decision made pursuant to paragraph 6(5)(a) of the NOC Regulations since the provision was added in 1998 and the parties disagree on the standard or test to be applied in assessing the merits of this motion.

[...]

12.     Procter argues that the reasoning adopted in Bayer applies when dealing with a motion under paragraph 6(5)(a) while Genpharm submits that the purpose of this provision is to get rid of groundless notices of application and there is thus no reason to adopt such a restrictive approach.

13.     The parties said little more to support their respective position.

14.     The administrative scheme set out in sections 5 and 6 of the NOC Regulations is intended to apply only where a notice of compliance is filed in respect of a drug that can be compared with another drug for which a patent was properly included in a patent list on the Register. Thus, a motion to strike a notice of application filed under subsection 6(1) based on the fact that the only patent currently on the Register should not be there, is or is akin to a motion to strike out the proceeding on the basis that there is no reasonable cause of action.

15.     It is settled law that if this interpretation is correct, the restrictive standard set out in Hunt, supra, should apply. Genpharm would thus have to prove that it is plain and obvious that the '376 Patent was not eligible for inclusion in the Register.

[18]            It is clear from these passages that Gauthier J. did not have the benefit of full argument on this issue and was not asked to consider the general rationale for subsection 6(5)(a) enunciated by Rothstein J.A. in Apotex, supra. This being the case, Gauthier J.'s decision cannot be considered as strong authority on this point and, in any event, Gauthier J. went on to decide that the relevant standard to be applied under subsection 6(5)(a) was not determinative in Procter, supra, because the Court "would have reached the same conclusion even if it had not applied [the restrictive standard]."

[19]            The judgment of Rothstein J.A. in Apotex, supra, does not specifically state what standard should be applied in applications under subsection 6(5)(a), but, rather than characterizing such an application as being analogous to a motion to strike on the basis that there is no reasonable cause of action, it concludes that such an application "provides a judicial forum in which the eligibility of the specific patent or patents at issue can be decided by the Court after hearing from the patent holder and the generic competitor."

[20]            If the court is not being asked to decide that there are no reasonable grounds for GSK's section 6(1) application, but is merely examining eligibility after hearing from the parties, there is no justification, as far as Apotex is concerned, for applying the restrictive Hunt, supra, "plain and obvious" test under subsection 6(5)(a).

[21]            In my opinion, the issue of which standard applies under 6(5)(a) still remains to be determined. In the case before me, the matter is not determinative because, even if I apply the less restrictive standard that is urged upon me by Apotex, I cannot, for reasons that follow, allow this application.

ELIGIBILITY AND TIMING

[22]            Of the several grounds advanced by Apotex to show that the Patents are not properly listed on the Register, the most significant involves a consideration of crucial timing issues.    Those timing issues bring into play the whole scheme of the Regulations and a detailed consideration of the following provisions:

[23]            Apotex interprets this scheme to mean that, pursuant to section 4 of the Regulations and the jurisprudence of this Court concerning section 4, a patentee is permitted to add patents to the Register only in specific and limited circumstances.

[24]            Under the Regulations, a manufacturer who files a NDS for an NOC may submit a patent list to be added to the Register. The Register is to be maintained by the Minister and consists of eligible patent lists submitted in respect of particular drugs for which an NOC has been issued.

[25]            Apotex says it is clear from the plain language of the Regulations that patent lists are filed in relation to a drug, and not a submission for an NOC, and that there can be only one patent list in respect of a drug, regardless of the issuance of multiple NOCs. (Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 C.P.R. (4^th) 318 at 324-325 (F.C.T.D.); (2002), 16 C.P.R. (4^th) 425 (F.C.A.); Toba Pharma Inc. v. Canada (Attorney General) (2002), 21 C.P.R. (4^th) 232 at paras. 28, 34 (F.C.T.D.)).

[26]            Subsection 4(3) of the Regulations provides that a person who submits a patent list in respect of a drug must do so at the time the person files a submission for an NOC for that drug. Subsection 4(4) contains an exception to this timing requirement. The exception is that, where an application has been made for a patent prior to the submission of an NDS for the drug, but the patent has not issued at the time of filing the NDS, the person may submit a patent list within thirty days of the issuance of the patent.

[27]            Apotex argues that the March 1998 amendments to the Regulations make it clear that the timing requirements for filing a patent list are to be strictly observed. Those amendments added subsection 4(6), which requires that a person who submits a patent list must keep the list up to date, but may not add a patent to an existing patent list except in accordance with subsection 4(4). (Bristol-Myers, supra, at 324-325; Toba Pharma Inc.,supra, at paras. 28, 34).

[28]            Apotex takes the position that it is clear under section 4 that a patent list may only be submitted at the time of first filing an NDS for the drug, or, where a patent has not issued but was applied for prior to the filing of the NDS, within thirty days after the issuance of the patent. The intention, according to Apotex, is clearly to limit the patents listed on the Register to those which either have been obtained or applied for at the time that a patentee begins marketing a particular drug product.

[29]            In accordance with the scheme of the Regulations, and in light of the drastic consequences to second persons, it is important that the strict conditions outlined in section 4 for the addition of patents to the Register be respected, and that patents should not be added to the Register outside these strict timelines. As this Court has confirmed, these stipulations were designed to ensure that generic manufacturers are not impeded unfairly from accessing the market. (Novopharm Ltd. v. Canada (Minister of National Health and Welfare) (1998), 78 C.P.R. (3d) 54 at 61-64 (F.C.T.D.); Toba Pharma, supra, at paras. 28, 34; Patent Regulations, s. 4).

[30]            In Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General), 2002 FCA 32, [2002] F.C.J. No. 96, the Federal Court of Appeal has recently confirmed that, since the amendments to the Regulations which introduced subsection 4(6), the timing requirements of the Regulations are to be strictly observed, and that patentees may not subvert those timing requirements and add patents to an existing list by filing a subsequent NDS and including a patent list with that submission. Rather, once a patent list exists in respect of a drug product, patents may only be added to the list in respect of that drug product if the patent was applied for before the original NDS was filed, and issues thereafter. A subsequent NDS leading to the issuance of a subsequent NOC are for a new drug product, in respect of which there is no existing patent list.

[31]            Apotex asks the Court to note that all of GSK's submissions against which the Patents are listed relate to paroxetine hydrochloride hemihydrate and, pursuant to the Regulations and the relative jurisprudence, there can only be one patent list in respect of this drug. The timing restrictions for that patent list must be respected. Each of the Patents comprises a claim pertaining to anhydrous polymorphs of paroxetine hydrochloride.

[32]            Apotex feels it is clear on the basis of the foregoing that the Patents were improperly added to the Register. The original NOC for paroxetine hydrochloride hemihydrate tablets was issued on May 4, 1993, long before the applications for the Patents were filed. In accordance with the strict timing requirements of section 4 of the Regulations, the Patents could not properly be added to the Register because the applications for the Patents had not been filed before the submission for the original NOC was made.

[33]            Apotex takes the position that the four supplemental submissions against which the Patents are listed were not issued in respect of a different drug product, and, therefore, the time restrictions do not run afresh from the date of the submissions for these NOCs. Rather, the drug product which is the subject of each of these NOCs is identical to GSK's paroxetine hydrochloride hemihydrate product marketed under the original NOC. This is clear from the fact that no new drug identification numbers ("DINs") have been assigned in respect of the new NOCs. Following issuance of the four supplemental NOCs, in respect of which the Patents are listed, GSK has continued to market paroxetine hydrochloride hemihydrate tablets in 10, 20 and 30mg strengths under the same DINs as it had used previously.

[34]            Accordingly, Apotex is of the view that the time requirements under section 4 of the Regulations, in relation to the drug product, were not satisfied, and cannot be extended by the issuance of a Supplementary NOC in relation to the very same drug product.

[35]            Apotex feels it is directly contrary to the intention of the Regulations and the interpretation of the Regulations as set out in the jurisprudence of this Court and the Court of Appeal for a patentee to be permitted to add a patent to the Register in respect of the very same drug for which an NOC has previously issued when the time limits for the addition of such a patent have expired. In the circumstances, GSK has attempted to circumvent the strict timing requirements of the Regulations by adding the Patents, out of time, in respect of the very same paroxetine hydrochloride hemihydrate drug product for which an NOC issued in 1993.

[36]            In support of this interpretation, Apotex relies heavily upon the judgment of Hugessen J. in Novopharm Ltd. v. Minister of National Health and Welfare et al (1998), 78 C.P.R. (3d) 54 (F.C.T.D.).

[37]            In reply, GSK asserts that the timing requirements of the Regulations were met in this case and that the Patents were properly allowed on the Register.

[38]            GSK says that the requirements that must be met in order to list a patent on the Register pursuant to the Regulations are as follows:

(a)        a submission for a NOC must be filed;

(b)       there must be a claim for the medicine itself or use of the medicine in the patent;

(c)        the timing requirements of either subsection 4(3) or 4(4) must be met; and

(d)        the relevance requirements of subsection 4(7)(b) must be met.

[39]            Each of these factors is a prerequisite or condition precedent for the listing of a patent on the Register.

[40]            GSK argues that the critical nexus between the patent and the first person's product has always been the medicine itself. In this regard, the requirement that the patent contain a claim to the medicine itself has been in the Regulations since their inception. The only requirement relating to the drug product itself is the requirement set out in subsection 4(7)(b) that the patent be relevant to the dosage form, strength and route of administration of the drug. This requirement was added in 1998. (Regulations Amending the Patented Medicines (Notice of Compliance) Regulations SOR/98-166, March 12, 1998).

[41]            As such, patents are listed in respect of the medicine itself and not the individual drug product represented by individual notices of compliance. This is evident in looking at GSK's drug products, namely it's 10, 20 and 30mg tablets represented by the same DINs in respect of each of GSK's NOCs. The explanation for this is that subsequent NOCs relating to the same medicine encompass the drug product represented in any previous NOC.

[42]            Apotex takes the position that patents are listed in respect of individual drug products and not in respect of the medicine itself. For all the above reasons, GSK says this position is not tenable.

[43]            Furthermore, GSK argues that Apotex's interpretation would thwart the purpose of the Regulations, which is to prevent infringement of GSK's patents. Apotex should not be permitted to manipulate the system in order to avoid having to address GSK's patents relating to the medicine in question.

[44]            Apotex' position is that a patent list may only be submitted at the time of first filing a NDS for the drug but the Food and Drug Regulations (the "F.D. Regulations") specifically recognize that a supplement to a NDS or ANDS can form the basis for the issuance of an NOC:

C.08.004(1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,

(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

(b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.01, notify the manufacturer that the submission or supplement does not so comply.

Food and Drug Regulations, C.R.C. 1978, c. 870, s. C.08.004(1), AMR, Tab 4.

[45]            As such, GSK feels it is clear that a supplement is a submission for an NOC as contemplated by section 4 of the Regulations. Furthermore, this Court has found that the word "submission" for the purposes of Section 4 and Section 5 of the Regulations expressly includes a supplemental submission.

[46]            In the circumstances, the expression "submission for a Notice of Compliance", as used in Sections 4 and 5 of the Regulations means a new drug submission, an abbreviated new drug submission and a supplement to a new drug submission or to an abbreviated new drug submission as was clearly established in Apotex Inc. v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 at 287 (F.C.T.D.), affirmed (2001), 11 C.P.R. (4^th) 538 (F.C.A.) (Hereinafter Apotex Inc., supra).

[47]            The Apotex Inc., supra, case dealt with the 2,178,637 Patent (the "637 Patent"), of which GSK is the owner. Apotex had sought judicial review of a decision made by the Minister to add the 637 Patent to the Register on the basis of a supplemental new drug submission. It was found by the Court, and upheld by the Court of Appeal, that the Minister had not erred in including the 637 Patent on the Register.

[48]            It is noted that the decision of McGillis J. in Apotex Inc., supra, was made pursuant to the Regulations as they existed before the 1998 amendment. But this same issue has been decided by the Court pursuant to the Regulations as amended.

[49]            In Ferring Inc. v. Canada (Attorney General), [2003] F.C.J. No. 409, the Court concluded that the reasoning in Apotex Inc., supra, was not changed by the introduction of subsection 4(6) of the Regulations. It is still necessary that a submission for a NOC be made for all changes listed in C.08.003(2) of the F. D. Regulations, and there is no distinction drawn based on the importance of the enumerated changes.

[50]            Thus, GSK argues, it is clear that, although the submissions that provided the basis for listing the Patents at issue in this proceeding on the Register were supplemental submissions, this is contemplated under the Regulations; and a supplemental submission is sufficient to form the basis for the issuance of a NOC. As such, the remaining timing issue relates to whether the Patents were either listed at the time that the submission for an NOC was made if the patent had already issued, or within 30 days of granting of the patent whose application was filed before the date of filing of a submission for an NOC.

[51]            GSK concludes that the evidence in this motion shows that these timing requirements were met in the case of the Patents. This is due to the fact that, as stated above, the patent list in question was either filed within 30 days of Patent issuance or with the submission itself when the Patent issuance pre-dated the submission filing date. Further, the filing date of each Patent pre-dated the filing date of the submission.

[52]            It will be noted that the GSK's reasoning places heavy reliance upon the decision of McGillis J. in Apotex Inc., supra. In order to distinguish the facts of the present case from the decision in Novapharm,supra, GSK argues that, in Novapharm, supra, Hugessen J. was dealing with the way that patents are listed in the first place in accordance with section 4 of the Regulations. In this instance, we are dealing with supplemental submissions which, as the case law makes clear, are eligible for inclusion on the Register and encompass the original 08356 submission made June 11, 1990. In my opinion, the timing issues raised by Apotex in the present case were squarely before McGillis J. in Apotex Inc., supra. That case also dealt in some detail with the Novapharm, supra, situation and its relevance to supplemental submissions. The detailed reasoning of McGillis J. (at page 285-290) in this regard is central to the issues before me in the present case:

In his argument concerning the interpretation to be accorded to subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, counsel for Apotex focussed on the meaning of the word "submission". In particular, he argued that "submission" means only a new drug submission or an abbreviated new drug submission, and does not include a supplement to either of those submissions. In support of that argument, he referred to the wording of subsection C.08.004(1) of the Food and Drug Regulations that draws a distinction between a "submission or supplement". However, he did not refer to the word "submission" in the context in which it appears throughout sections 4 and 5 of the Patented Medicines (Notice of Compliance) Regulations, namely as a "submission for a notice of compliance".

In interpreting the term "submission", reference must be made to its use and meaning in both the Patented Medicines (Notice of Compliance) Regulations and in the Food and Drug Regulations, in particular sections C.08.003 and C.08.004.

A review of the Patented Medicines (Notice of Compliance) Regulations reveals that the expression used throughout sections 4 and 5 is not a "submission", but rather a "submission for a notice of compliance". The term "notice of compliance" is defined in section 2 as meaning a notice issued under section C.08.004 of the Food and Drug Regulations. As a result, that provision must be examined, as well as the related sections in the Food and Drug Regulations.

As indicated previously, the word "submission" appears throughout the provisions of Division 8 in the Food and Drug Regulations in the phrases "a new drug submission", an "abbreviated new drug submission" and "a supplement to a new drug submission or to an abbreviated new drug submission". Under paragraph C.08.003(1)(a) of the Food and Drug Regulations, the manufacturer must file a supplement to "that new drug submission" or to "that abbreviated new drug submission", following the issuance of a notice of compliance, in circumstances where certain matters in relation to the new drug differ significantly from the information or material contained in the new or the abbreviated new drug submission. Paragraph C.08.003(1)(b) also provides for the issuance of a notice of compliance in respect of the supplement.

Furthermore, under subsection C.08.003(3), the supplement to the new drug submission or to the abbreviated new drug submission becomes the vehicle by which a manufacturer provides the Minister with sufficient information and material "with respect to the matters that are significantly different from those contained in the submission" in order to enable him to assess the safety and effectiveness of the new drug "in relation to those matters". In other words, a supplement does not vitiate or supplant the new or the abbreviated new drug submission, but rather constitutes an independent submission by the manufacturer in relation to certain specified matters which differ in significant respects from the information or material in the new or the abbreviated new drug submission. The independent or "stand alone" characteristic of a supplement to a new or to an abbreviated new drug submission is reinforced by paragraphs C.08.003(1)(b) and C.08.004(1)(a) which provide for the issuance of a notice of compliance in response to a supplement. In particular, paragraph C.08.004(1)(a) further reinforces the notion that a supplement constitutes a submission, in that it specifies unequivocally that all three informational mechanisms, namely a new drug submission, an abbreviated new drug submission or a supplement to either submission will give rise to the issuance of a notice of compliance in certain defined circumstances. As a result, the legislative scheme indicates clearly that a supplement to a new or to an abbreviated new drug submission is one type of submission that may be made by a drug manufacturer to obtain a notice of compliance to market a drug in Canada.

In considering the expression "a submission for a notice of compliance" in sections 4 and 5 of the Patented Medicines (Notice of Compliance) Regulations, the mechanisms which trigger the issuance of a notice of compliance are, by virtue of the definition of "notice of compliance" in section 2, those specified in section C.08.004 of the Food and Drug Regulations, namely a new drug submission, an abbreviated new drug submission and a supplement to a new drug submission or to an abbreviated new drug submission. In the circumstances, the expression "submission for a notice of compliance", as used in sections 4 and 5 of the Patented Medicines (Notice of Compliance) Regulations means a new drug submission, an abbreviated new drug submission and a supplement to a new drug submission or to an abbreviated new drug submission.

A review of the French version of the legislative scheme also supports my interpretation of the meaning to be accorded to the phrase "submission for a notice of compliance". In paragraph C.08.004(1)a) of the Food and Drug Regulations, the Minister "après avoir terminé l'examen d'une présentation de drogue nouvelle, d'une présentation abrégée de drogue nouvelle ou d'un supplément à l'une de ces présentations...si la présentation ou le supplément est conforme... délivre un avis de conformité". The French and English versions are therefore entirely consistent, and the word "présentation" is used for the word "submission". However, there is an important change between the terminology used in the legislative drafting of the French version of paragraph C.08.004(1)a) and subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations. The importance of the change may be best illustrated by first making reference to the English text of the two regulatory provisions. In the English text of subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, the legislative drafters used the expression "submission for a notice of compliance" without making any reference to a supplement, contrary to the express terminology used in paragraph C.08.004(1)(a) of the Food and Drug Regulations. However, in subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, the French legislative drafters chose not to use either "présentation" or "supplément" as those words appeared in paragraph C.08.004(1)a) of the Food and Drug Regulations, but rather used the broader expression "une demande d'avis de conformité". By virtue of section 2 of the Patented Medicines (Notice of Compliance) Regulations, "avis de conformité" is defined as "avis délivré au titre de l'article C.08.004..." of the Food and Drug Regulations. Since it is clear beyond any question that "une demande d'avis de conformité" can be made by a new drug submission, an abbreviated new drug submission and a supplement to either submission, the language used in the French text unequivocally incorporates a supplement within the term "demande d'avis de conformité", and thereby expressly includes it within the ambit of subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations.

In support of his position on the interpretation to be accorded to subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, counsel for Apotex relied on the decision Novopharm Ltd. v. Canada (Minister of National Health and Welfare) (1998), 78 C.P.R. (3d) 54 (F.C.T.D.), in which Hugessen J. dealt with an application to purge from the Register information from an amended patent list. In that case, Hugessen J. was not required, on the facts before him, to consider the meaning of the expression "submission for a notice of compliance", as used in subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, or the applicable provisions of the Food and Drug Regulations. However, since counsel for Apotex placed considerable reliance on that case, I will indicate why, in my opinion, it does not support his position in the present case.

In Novopharm Ltd. v. Canada (Minister of National Health and Welfare), supra, the patentee was granted a notice of compliance in 1985 for terazosin hydrochloride in dosages of 1, 2 and 5 mg tablets, and a second notice of compliance in 1992 for 10 mg tablets. The new drug submissions in relation to which the notices of compliance issued were filed, respectively, in 1983 and 1991. In April 1993, within thirty days of the coming into force of the Patented Medicines (Notice of Compliance) Regulations, the patentee filed patent lists relating to the drugs covered by the notices of compliance. In October 1995, the patentee filed a new drug submission and was granted a notice of compliance for a "starter pack" of 1, 2 and 5 mg tablets of terazosin hydrochloride, packaged in order to permit a patient to take gradually increasing doses of the drug over a four week period. The drug was identical to the drug referred to in the notices of compliance granted in 1985 and 1992. In June 1997, the patentee obtained three new patents containing claims to the medicine terazosin hydrochloride. The applications for the patents were filed between 1991 and October 1995. Within thirty days of the issuance of the patents, the patentee filed amendments to the patent lists filed in respect of the 1985 and 1992 notices of compliance. The patentee did not file a new patent list in relation to the notice of compliance issued in October 1995 for the starter pack. The Minister accepted the amended patent lists and added the information to the Register.

In dealing with the interpretation to be accorded to subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, Hugessen J. noted, at p. 60, that the English version was "...clear in requiring that any such new patent must have been applied for prior to the filing of the [new drug submission] and must not have been issued more than thirty days prior to the filing of the amended (or new) patent list." However, the patentee argued, on the basis of the wording in the French text, that an amendment to an existing patent list could be made at any time and without any conditions. Hugessen J. found that the wording of the French text was problematic and, at best, "ambiguous" in certain respects. In particular, he emphasized the "puzzling" reference to "un brevet...qui était fondé sur une demande au tribunal", and the final phrase commencing with the words "ou elle peut". However, he rejected, on the basis that it had no merit, the patentee's argument that an existing patent list could be amended at any time and without any conditions. In the light of that particular factual context, Hugessen J. made the following observations at page 61:

[13] 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.                

The second question considered by Hugessen J. related to the correctness of the Minister's decision to accept the amended list and to add the patents to the Register. In that regard, Hugessen J. stated as follows, at page 62:

[18] 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 to their appropriate DINs, to the drugs which had been the subject of the Notice of Compliance issued to Abbot 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 of 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.

In other words, Hugessen J. concluded that the amended patent lists fell outside of the time limits prescribed in subsection 4(5), in that the applications for the patents were filed between 1991 and October 1995 and not before the dates of the filing of the submissions for the notices of compliance in 1983 and 1991. Finally, at page 64, Hugessen J. reiterated that the patentee's list "could only have been filed" in relation to the new drug submission in 1995 for the starter pack.

[53]            I see no reason on the facts of the present case why the meticulous and extensive analysis of McGillis J. in Apotex Inc., supra, should not be applicable. The word "submission" as it appears throughout sections 4 and 5 of the Regulations means a "submission for a Notice of Compliance" and this includes a "new drug submission, an abbreviated new drug submission and a supplement to a new drug submission or to an abbreviated new drug submission."

[54]            The position taken by McGillis J. in Apotex Inc.,supra, was confirmed by Simpson J. in the recent case of Ferring Inc., supra, which concluded that the introduction of subsection 4(b) of the Regulations did not change the analysis given in Apotex Inc., supra. Simpson J. also made the following point concerning the importance of the Regulations for the recognition of innovator's rights:

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

[55]            I do not regard the recent decision of the Federal Court of Appeal in Ferring Inc. v. Canada (Attorney General), 2003 FCA 274, [2003] F.C.J. No. 982 (T.D.) which overturns the ruling of Simpson J. on the basis that the supplemental new drug submission in that case was nothing more than a name change, as having any relevance to the reasoning in Apotex Inc.,supra, and its applicability to the issues before me. Here, we are not dealing with a mere name change.

[56]            As there appears to be no argument that the Patents in the present case were not supplemental submissions, I am not convinced under any relevant standard that they were not properly on the Register, at least in so far as the timing issues raised by Apotex are concerned. Hence, a dismissal order cannot be granted on this ground.

ELIGIBILITY AND SUBJECT MATTER

[57]            Apotex argues further that the Patents are not eligible for inclusion on the Register because of their subject matter. The grounds put forward for this argument are that, first, the only paroxetine products sold by GSK are paroxetine hydrochloride hemihydrate products. All of GSK's NOCs in respect of paroxetine are for paroxetine hydrochloride hemihydrate products. However, each of the Patents at issue relates to anhydrous polymorphs of paroxetine. Anhydrous polymorphs of paroxetine and paroxetine hemihydrate are different substances and therefore different medicines.

[58]            Subsection 4(2) of the Regulations provides that, in order to be eligible for inclusion on the Register, a patent must, among other things, contain a claim for "the medicine itself" or the use of the medicine in respect of which it is listed. The Patents do not, Apotex claims, contain a claim for the medicine paroxetine hydrochloride hemihydrate or to its use and, accordingly, are improperly listed.

[59]            In response, GSK takes the position that the Patents are not improperly listed for this reason because paroxetine hydrochloride hemihydrate is equivalent to the anhydrate form.

[60]            It should first be noted that GSK's NOC lists only "paroxetine hydrochloride" as the medicine included in GSK's tablets, although the form of paroxetine hydrochloride sold by GSK is the hemihydrate form.

[61]            It is clear from GSK's product monograph for PAXIL brand paroxetine hydrochloride tablets that both the hemihydrate and the anhydrate forms of paroxetine hydrochloride can be used as the medicine in the tablets.

[62]            Furthermore, GSK has received a NOA from Apotex indicating that Apotex has filed an ANDS comparing its tablets of paroxetine hydrochloride to GSK's tablets of paroxetine hydrochloride.

[63]            Pursuant to Section C.08.002.1 of the F.D. Regulations, when a generic drug manufacturer such as Apotex files an ANDS it must compare the drug product that it intends to market to an already approved Canadian reference product. In this case, Apotex obviously chose GSK's tablets of the medicine paroxetine hydrochloride as a Canadian reference product for its tablets of the medicine paroxetine hydrochloride. In so doing, Apotex is relying on Health Canada's approval of GSK's product for the approval of its own product. Indeed, Apotex essentially must show only that its tablet is bioequivalent to GSK's tablets.

[64]            In addition, Section C.-08.002.1 requires that Apotex's product be the pharmaceutical equivalent of a Canadian reference product. In Section C.08.001.1 of the F.D. Regulations, "pharmaceutical equivalent" is defined to mean a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, and comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients.

[65]            GSK argues, therefore, that any generic company that files an ANDS must be seeking approval of a drug product containing the identical medicine and in a comparable dosage form as its Canadian reference product. However, since the non-medicinal ingredients need not be identical, the generic is free to seek approval of a different tablet formulation containing different non-medicinal ingredients from the Canadian reference product. As such, Apotex's paroxetine hydrochloride tablets must contain the same identical medicine as GSK's paroxetine hydrochloride products, but Apotex is free to seek approval for a different tablet formulation using other non-medicinal ingredients.

[66]            GSK points out that, in this proceeding, Apotex has alleged that the form of paroxetine hydrochloride that will be used in its tablets will be in the form of an anhydrate. The form marketed by GSK is a hemihydrate form. By permitting Apotex to use GSK's hemihydrate tablets as a Canadian reference product for its anhydrate tablets, the Minister has, in effect, confirmed that these forms are pharmaceutical equivalents and that the particular crystalline form or polymorphic forms of the medicine are not relevant to the identification of the medicine.

[67]            Moreover, GSK says that, on the assumption that Apotex will eventually receive an NOC to market its paroxetine hydrochloride tablets in Canada, Apotex's tablets will receive a Declaration of Equivalence to GSK's tablets in accordance with Section C.08.004.4 of the F.D. Regulations. Therefore, Apotex's tablets must be equivalent to GSK's tablets and must contain identical amounts of the identical medicine, namely paroxetine hydrochloride.

[68]            GSK asks the court to conclude that, on the basis that Apotex is comparing its anhydrate product to GSK's product, Apotex is not free to assert that anhydrate forms of paroxetine hydrochloride and paroxetine hydrochloride hemihydrate are different substances and therefore different medicines.

[69]            The '829 Patent relates to and claims the medicine paroxetine hydrochloride in the anhydrate form substantially free of bound organic solvent characterized in Form A, Form B, Form C and Form D. As such, the '829 Patent includes claims to the medicine itself, namely paroxetine hydrochloride.

[70]            The '522 Patent relates to and claims the use of the medicine paroxetine hydrochloride in the anhydrate form substantially free of bound organic solvent characterized in Form A, Form B, Form C and Form D for the treatment of a variety of different disorders including depression, obsessive compulsive disorder and panic disorder, among others. As such, the '522 Patent clearly has claims to the use of the medicine itself, namely paroxetine hydrochloride.

[71]            The '023 Patent relates to and claims novel processes for the production of Form A of paroxetine hydrochloride anhydrate. Claim 5 of this patent is a claim to the medicine paroxetine hydrochloride, namely paroxetine hydrochloride anhydrate as Form A, as made by the claimed processes. Product by process claims to the medicine itself constitute claims to the medicine itself. As such, the '023 Patent includes claims to the medicine itself, name paroxetine hydrochloride.

[72]            On the basis of GSK's reasoning on this point, I cannot conclude under any relevant standard that the Patents should be excluded from the Register because of their subject matter, and that the GSK 6(1) application should be dismissed under subsection 6(5).

ELIGIBILITY AND RELEVANCE

[73]            Apotex advances a further argument that the Patents are not relevant to the medicine or the submission in respect of which they are listed and so are not eligible for inclusion on the Register.

[74]            The basis for this argument is that each of the Supplemental NOCs is for a new indication, a change of method of manipulation to direct compression, or an administrative change. Because the Patents claim the anhydrate form of paroxetine, they are not relevant to either of the submissions in respect of which they are listed or to the product actually sold by GSK, which is paroxetine hydrochloride anhydrate.

[75]            GSK takes serious issue with this allegation and points out that, pursuant to Section 4(7)(b) of the Regulations, the Patents set on the patent list or in an amendment need only be relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for an NOC has been filed (Patented Medicines (Notice of Compliance) Regulations, SOR/98-166, s. 4(7)(b)).

[76]            In addition to addressing whether a supplemental submission was a submission for the purposes of Section 4 and 5 of the Regulations, McGillis J. in Apotex Inc., supra, also addressed the issue of relevance. Apotex argued in that case that the '627 Patent was not relevant to the drug in relation to which the Notice of Compliance was issued. This argument was rejected by McGillis J. at p. 292:

[...]The argument of Apotex's counsel that the '637 patent is not relevant to the drugs in relation to which the notices of compliance issued therefore has no merit. Furthermore, the argument advanced by counsel for Apotex would lead to the incongruous result that the newest patented formulation of the medicine paroxetine would not receive the protection accorded by the procedures provided in the Patented Medicines (Notice of Compliance) Regulations. That result would be inconsistent with the recognized purpose of those Regulations, namely the prevention of patent infringement by strengthening the rights of patentees. [...]

[77]            This reasoning of McGillis J. was affirmed by the Court of Appeal.

[78]            The Federal Court of Appeal recently affirmed that a patent that does not relate to the commercial formulation of a drug can be listed on the Register with respect to that drug (Eli Lilly Canada Inc. v. Canada (The Minister of Health), [2003] F.C.J. No. 75 at para. 32, 34 (F.C.A.)).

[79]            Furthermore, the Court of Appeal affirmed in Eli Lilly, supra, at para. 35-36, that any other interpretation would defeat the objectives of the Regulations.

According to Eli Lilly, the Minister's interpretation would tend to defeat the objectives of the PMNOC Regulations. It is theoretically possible that a generic drug manufacturer could produce a drug consisting of a formulation of ceftazidime and amorphous lactose that is bioequivalent to Tazidime (even though it would not be exactly the same as Tazidime because Tazidime does not contain amorphous lactose). Such a product could infringe the 969 patent. If the 969 patent is not permitted to stay on the patent lists for Tazidime, Eli Lilly will be deprived of its right to apply to stop the issuance of a notice of compliance for the new drug until after the expiry of the 969 patent. If that happens, the PMNOC Regulations will not have been permitted to operate as intended. I note that a similar argument was accepted in Apotex Inc. v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.), but only in obiter dicta, in the context of the PMNOC Regulations before the 1998 amendments.

On balance, it seems to me that the interpretation propounded by Eli Lilly should be favoured over the interpretation propounded by the Minister, for two reasons. First, it is more consistent with the words of the PMNOC Regulations. Second, it has at least the potential of preventing infringement of the 969 patent, while the Minister's interpretation cannot possibly have that result.

[80]            Subsection 4(7) of the Regulations is the section that sets out the current relevance requirements. It reads as follows:

A person who submits a patent list or an amendment to an existing patent list under subsection (1) or (4) must certify that [...] the patents set out on the patent list or in the amendment are eligible for inclusion on the register and are relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for a notice of compliance has been filed.

[81]            In Eli Lilly, supra, the Court of Appeal (at para. 32) held that "relevance" is limited to the requirement for certification of relevance as to dosage form, strength and route of administration.

A review of the 1998 Regulatory Impact Analysis Statement as a whole indicates that the passage cited in Warner Lambert refers specifically to paragraph 4(7)(b) of the PMNOC Regulations. From that I infer that the "relevance" mentioned in the quoted passage from the 1998 Regulatory Impact Analysis Statement relates to the new requirement for a certification of relevance as to dosage form, strength and route of administration. If that is so, then the desired "product specific patent list" will be achieved by ensuring compliance with paragraph 4(7)(b). [...]

[82]            In addition, the Court held that the words in paragraph 4(7)(b) of the Regulations did not describe any additional relationship between the drug named and the Notice of Compliance in the patents that may be included on the Patent List.

[83]            GSK argues that, as framed in the Apotex Inc.,supra, decision, the real issue in respect of relevance is whether a formulation patent could be used by a generic drug manufacturer to produce a bioequivalent formulation of the drug products sold by the patentee. A generic need only have the identical medicine as the innovative product, but is free to use a different formulation. Thus, if no formulation other that the marketed formulation could be listed, a patent claiming the non-marketed formulation would not be protected by the Regulations. This could not have been the intent of the Regulations, as has been confirmed by the jurisprudence.

[84]            It follows, says GSK, that the relevance requirements under the Regulations must be those three specific requirements listed in subsection 4(7) of the Regulations.

[85]            As such, it is clear that, in accordance with the amendments to the Regulations made in 1998, a tablet formulation patent need only be "relevant to the dosage form, strength and route of administration" of the drug containing the medication. It is irrelevant whether a tablet formulation patent could be used by a patentee to prepare the commercial tablet formulations of the particular medicine.

[86]            The Patents in issue are relevant to the submissions in respect of which the Patent Lists relating to these Patents were filed. In this regard, GSK points to the following:

(a)        the dosage form of each of the submissions in respect of which Patent Lists were filed listed each of the patents in issue as tablets;

(b)        the dosage strength in the submissions include 10mg, 20mg, 30mg and 50mg;

(c)        the route of administration set out in each of the submissions is oral administration.

[87]            Each of the Patents in issue is clearly relevant to the dosage form because, GSK argues:

(a)        the Patents disclosed that the invention could be embodied in tablets;

(b)        none of the Patents in issue is restricted to any particular dosage strength, so the inventions could be embodied in tablets of the listed strength;

(c)        the Patents disclosed that the inventions could involve oral administration.

[88]            On the basis of the arguments advanced, I am not convinced by Apotex's argument that the Patents are not relevant to the medicine or the submission in respect of which they are listed to the extent required under any relevant standard to warrant dismissal under subsection 6(5) of the Regulations.

FRIVOLOUS AND VEXATIONS

[89]            Apotex finally seeks to invoke subsection 6(5)(b) of the Regulations to dismiss GSK's 6(1) application on the grounds that it is frivolous, vexatious and an abuse of process. This is because, Apotex argues, even if the Patents are properly listed, they cannot be listed in the way they currently are, and they cannot be relevant to Apotex's submission for an NOC.

[90]            Apotex argues that, given the strict timing requirements under the Regulations, and given that the Patents are out of time for listing on the original patent list for paroxetine hydrochloride hemihydrate, the Patents could only be properly listed if they are listed in respect of a new drug product. The Patents, therefore, could only be applicable to this new drug, and could not be listed against paroxetine hydrochloride hemihydrate, for which there is already an existing patent list.

[91]            Subsection 5(1) of the Regulations provides that a generic manufacturer is only required to serve an NOA where it makes comparison to a drug product that is marketed in Canada pursuant to an NOC.

[92]            Apotex filed its submission for an NOC in respect of its paroxetine hydrochloride tablets well before May 28, 1998. At the time that Apotex filed its submission for an NOC, none of GSK's NOCs pertaining to the submissions against which the Patents are listed had issued. Apotex claims it did not, therefore, compare its product to a product marketed in Canada pursuant to an NOC for a submission against which the Patents were listed.

[93]            Accordingly, Apotex says that subsection 5(1) does not apply and Apotex is not required to address the Patents. If the Patents are eligible for listing, which they are not, they can only be eligible in respect of a drug to which Apotex made no comparison.

[94]            As a result, Apotex argues GSK's 6(1) application is frivolous, vexatious and an abuse of process as it seeks to prohibit issuance of an NOC to Apotex on a basis that cannot apply to Apotex's submission.

[95]            GSK counters that these allegations by Apotex have no basis in law and are not relevant to the issues at hand.

[96]            The standard for dismissal under subsection 6(5)(b) is the restrictive Hunt, supra, "plain and obvious test" which, in my opinion, Apotex clearly fails to meet on this ground.

ORDER

THIS COURT HEREBY ORDERS THAT:

1.          The Application is dismissed.

2.         GSK shall have the costs of this application, irrespective of the event.

                                                                                          "James Russell"                 

                                                                                                      J.F.C.C.                        

FEDERAL COURT OF CANADA

Names of Counsel and Solicitors of Record

DOCKET:                                              T-876-02

STYLE OF CAUSE:              Glaxosmithkline Inc., et al v. Apotex Inc.et al

DATE OF HEARING:                        June 16, 2002.

PLACE OF HEARING:                     Toronto, Ontario.

REASONS FOR ORDER BY:         RUSSELL, J.

DATED:                                                 SEPTEMBER 10, 2003

APPEARANCES BY:                          Mr. James Mills,

Ms. Chantal Saunders

For the Applicant

Mr. Andrew Brodkin

For the Respondent

SOLICITORS OF RECORD:           Mr. James Mills

Ms. Chantal Saunders

Gowlings

Toronto, Ontario

For the Applicant

Mr. Andrew Brodkin

Goodmans

Toronto, Ontario

For the Respondent