OTTAWA, ONTARIO, December 21, 2006
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
and
NOVOPHARM LIMITED and THE MINISTER
OF HEALTH
REASONS FOR ORDER AND ORDER
[1] This is a motion brought by the Respondent, Novopharm, to dismiss the application in whole or in respect of one or more of the patents at issue under the provisions of section 6(5) of the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 as periodically amended. For the Reasons that follow, I find that the motion is dismissed with costs in the cause.
[2] The application at issue is one of the now familiar Notice of Compliance (NOC) proceedings brought before this Court in the ongoing battles between innovator drug companies and the generics. The drug at issue is one commonly known as ramipril and sold by the Applicant, Sanofi-Aventis, under the name ALTACE. There is no real dispute that ramipril has been known for quite some time and has been used in the treatment of high blood pressure (the old use). At issue here, at least until a very few days ago, were four patents directed to new uses of ramipril. At the hearing of this motion, I was advised by counsel for Novopharm that two of these patents may have dropped out of consideration however, the extent to which they are or are not in contention is not agreed by counsel. I will refer to that matter, briefly, later in these reasons. It is sufficient to say that Novopharm’s counsel at the outset of argument before me restricted that party’s argument to two patents, Canadian Patent 2,023,089, the ‘089 patent, which Sanofi-Aventis counsel agreed was directed to a new use of ramipril, namely the treatment of cardiac hypertrophy and hyperplasia, and to Canadian Patent 2,055,948, the ‘948 patent, which Sanofi-Aventis counsel agreed was directed to a new use of ramipril, namely the prevention and therapy of proteinuria.
[3] The history of these and related proceedings is complex and requires explanation for the understanding of the issues raised in the motion. I will endeavor to present them somewhat in chronological order:
1. At various times in the period from October 1993 to February 2001 Sanofi-Aventis or a predecessor, obtained a number of Notices of Compliance (NOC) to market various forms of ramipril in Canada. Sanofi-Aventis was, in the lingo of these matters, the innovator drug company. It is important to note that Sanofi-Aventis has never received an NOC for any “new” use, its NOC’s are restricted to the “old” use only.
2. On June 22, 2001, Novopharm acquired some of Sanofi-Aventis’ ramipril product for the purposes of using it as a comparator for bioequivalent studies to support its subsequent application called an Abbreviated New Drug Submission (ANDS). It is important to note two things, first a bioequivalent study simply addresses the scientific issue as to the drug found in the human system after some form of administration, it has nothing to do with the use of the drug. Second, an ANDS means that if a generic, such as Novopharm, can demonstrate bioequivalence, it need not perform many of the clinical studies undertaken by the innovator; it cannot seek uses of the drug beyond those already awarded to the innovator in its pre-existing NOC.
3. On December 24, 2001, Novopharm filed its ANDS for ramipril directed to the old uses, for capsules containing ramipril in 2.5 mg, 5 mg and 10 mg strength.
4. On November 12, 2002, the ‘948 Patent, directed to a new use of ramipril, issued. Presumably it was placed on the NOC patent list shortly after that. It is important to note that this is after Novopharm filed its ANDS for the old uses and that Sanofi-Aventis never got an NOC for this new use in the ‘948 Patent.
5. On January 14, 2003, the ‘089 Patent was directed to another new use of ramipril. Presumably, it also was placed on the NOC patent but shortly after Novopharm filed its ANDS. Sanofi-Aventis never got an NOC for this new use.
6. On March 15, 2005, yet another patent, the ‘549, was issued and presumably listed by Sanofi-Aventis shortly thereafter. It is directed to yet another new use called by the acronym HOPE. Again this was after the Novopharm ANDS was filed. Sanofi-Aventis never got an NOC for this use.
7. On October 14, 2003, the Minister approves Novopharm’s ANDS meaning that Novopharm has met the Minister’s requirements but the application put on “patent hold” until NOC matters such as this one are completed.
8. On June 21, 2005, a final patent (for those purposes), the ‘387 patent issues and was listed by Sanofi-Aventis shortly thereafter. This patent is directed to a new HOPE use. Again, this patent issued well after Novopharm filed its ANDS and, in this case, after approval of that ANDS. Sanofi-Aventis never got an NOC for this use.
9. On February 12, 2005, Novopharm sent a Notice of Allegation to Sanofi-Aventis alleging that a ‘206 patent, not at issue here, but apparently also listed in respect of ramipril, was invalid. This allegation became the subject of other proceedings before this Court, T-1965-05, and a decision of Justice Tremblay-Lamer to be discussed later.
10. On August 25, 2005, Novopharm filed a Supplementary ANDS (SANDS) to add a lower strength capsule to its list, a 1.25 mg strength. That SANDS was approved, subject to “patent hold” on August 3, 2006.
11. On September 14, 2005, Novopharm sent a Notice of Allegation to Sanofi-Aventis respecting its ramipril capsules in 1.25 mg, 2.5 mg, 5 mg and 10 mg strengths. That Notice addressed each of the ‘089, the ‘948, the ‘549 and the ‘387 patents. It alleged that Novopharm was seeking approval only for the old uses and no other use and that those patents would not be infringed. Invalidity was also alleged in respect of the ‘549 and ‘387 patents.
12. On November 2, 2005, this application now the subject of this motion was filed with the Court. Sanofi-Aventis challenged Novopharm’s allegations in respect of all four patents. Affidavits have been filed by all parties, a schedule was agreed to, some but not all cross-examinations have been conducted and a trial date fixed for June 2007.
13. On October 27, 2005, this Court, in proceedings between Sanofi-Aventis and another generic, Apotex, held that the applicant did not establish that the allegation of non-infringement was not justified (Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1461).
14. On July 10, 2006, this Court made the same finding in respects of another generic, Pharmascience, as to the ‘089 patent (Aventis Pharma Inc. v. Pharmascience Inc., 2006 FC 861).
15. On July 18, 2006, this Court made a similar finding in respect of Pharmascience as to the ‘948 patent (Aventis Pharma Inc. v. Pharmascience Inc., 2006 FC 898).
16. On September 25, 2006, Justice Danièle Tremblay-Lamer of this Court found that Sanofi-Aventis’ proceeding against Novopharm in respect of the ‘206 patent was an abuse of process, in that, in an earlier NOC proceeding, Justice Anne L. Mactavish of this Court had found that patent to be invalid for exactly the same reasons as alleged in the proceedings before Justice Tremblay-Lamer (Sanofi-Aventis Canada Inc. v. Novopharm Limited, 2006 FC 1135; Justice Mactavish, Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1283). That decision is under appeal and scheduled to be heard in January 2007.
17. On October 5, 2006, the NOC Regulations were amended. Some of these amendments will be discussed later but they include amendments as to what constitutes infringement and put a freeze on adding new patents in certain circumstances. The amendments addressed in particular whether patents directed to uses not approved in an innovator’s NOA could be listed.
18. October 18, 2006, this motion was filed to be heard October 23, 2006. Various adjournments were sought in the result that this motion was not heard until December 19, 2006.
19. On November 3, 2006, the Supreme Court of Canada delivered its decision in AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49. This is a significant decision dealing with many NOC matters and will be discussed more fully later.
20. On December 8, 2006, the Minister issued a letter to Novopharm advising that as a result of the Supreme Court decision, Novopharm no longer needed to address the ‘549 or ‘387 patents in its ANDS but still needed to address the ‘089 and ‘948 patents. As a result, Novopharm did two things:
a) On December 15, 2006, it filed an application with this Court challenging the decision that the ‘089 and ‘948 patents are to remain for NOC purposes; and
b) Wrote to Sanofi-Aventis abandoning its Notice of Allegation respecting the ‘549 and ‘387 patents.
21. On December 13, 2006, another generic, Apotex, received an NOC in respect of ramipril. Sanofi-Aventis has brought an application to this Court to quash that NOC. The background appears to be that Apotex received a letter from the Minister similar to the one received by Novopharm wherein apparently, impediments were lifted from a patent point of view.
22. On December 13, 2006, another generic, Ratiopharm, also received an NOC for ramipril. Sanofi-Aventis has not challenged this NOC. Novopharm calls Ratiopharm an “authorized” generic but I have no evidence as to this.
23. On December 6, 2006, Sanofi-Aventis moved requesting that I remove myself from this proceeding on the grounds of alleged apprehension of bias, a matter which I rejected by Order dated December 8, 2006. Sanofi-Aventis have appealed, requesting that I postpone hearing the motion until the appeal was determined. I rejected that request.
24. On December 19, 2006, this motion was heard and taken under reserve.
[4] The motion then, as presented by Counsel for Novopharm, was to dismiss this proceeding in whole or in part in respect of the ‘089 and ‘948 patents or one of them under the provisions of section 6(5)(b) of the NOC Regulations on the ground that the proceeding is redundant, scandalous, frivolous or vexatious or otherwise and abuse in respect of one or both patents.
[5] A preliminary objection was raised by Counsel for Novopharm as to the propriety of the affidavit of Junyi Chen sworn 27th October, 2006, filed by Sanofi-Aventis in support of its position in this motion. The objection, with which I agreed, was that the affidavit, while attesting to factual matters, did so in an argumentative manner such that, when viewed as a whole, it clearly resembled a memorandum of argument and not a simple factual recital. There is clear precedent that an affidavit from a member of a firm of solicitors arguing a motion, particularly one submitting evidence as to contested matters or opinion, should not be permitted (Cross-Canada Auto Body Supply (Windsor) Ltd. v. Hyundai Auto Canada, 2006 FCA 133). Counsel for Sanofi-Aventis appear to have agreed, reluctantly, with this observation. I suggested, and the parties agreed, that in order to get on with the matter, the affidavit would remain on the file and could be referred to, if needed, but only as to factual, non-contentious matters, and that the argument and contentious matters would be ignored.
[6] Novopharm based its motion, on either of two independent grounds; either or both of which, Counsel argues, would result in a dismissal of these proceedings in respect of the two patents. They are:
1. The decision of the Supreme Court of Canada in AstraZeneca, supra, results Novopharm argues in the ‘089 and ‘948 patents being irrelevant to Novopharm’s ANDS and thus the proceedings brought by Sanofi-Aventis are irrelevant; or
2. The evidence as to infringement by Novopharm is inadequate to demonstrate that Novopharm’s allegation of non-infringement is not justified and it would be an abuse of the proceedings to continue.
[7] Counsel for Sanofi-Aventis take the position that while the Minister may have stated to Novopharm that does not have to address the ‘549 and ‘387 patents and while Novopharm has written to Sanofi-Aventis abandoning those portions of the its Notice of Allegation addressing those patents, this Application brought by Sanofi-Aventis still addresses those two patents. As I understand it, Sanofi-Aventis does not yet wish to take a position as to whether those two patents remain at issue in this Application. Novopharm takes the position that they are not, and for the purpose of this motion has abandoned them. I will make no determination at this time as to the status of this Application in respect of these two patents.
[8] I will consider each of the two grounds raised by Novopharm upon which they argue that the proceeding should be dismissed in respect of the ‘089 and ‘948 patents. First, however, it is important to consider what is the meaning of section 6(5)(b) of the NOC Regulations.
[9] Section 6(5)(b) of the NOC Regulations did not exist in any form when the Regulations were introduced in 1993. There did exist the Federal Court Rules which provided, as Rule 419, that an action could be dismissed for grounds including the litany of words now found in section 6(5)(b). In a case that has become classic in the area, David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588, the Federal Court of Appeal refused to strike out an NOC application on the basis that the Rules, including Rule 5, which directed that the court may adopt analogous situations, did not contemplate the striking out of applications of this kind. The court said at pages 597-598:
“The contrast between actions and motions in this Court is even more marked where the motion involved is for judicial review, as these applications for prohibition under Patented Medicines (Notice of Compliance) Regulations, subsection 6(1) have been held to be. Unlike the rules pertaining to actions, the rules governing judicial review provide a strict timetable for preparation for hearing and a role for the Court in ensuring that there is no undue delay. The focus in judicial review is on proceeding to the hearing as quickly as possible, with objections to the originating notice being disposed of promptly in considering the merits of the case.”
[10] In 1998, the Regulations were amended to include, among other things, section 6(5)(b). The commentary appearing in the Canada Gazette, Part II, Vole 132, No. 7 at page 1057 states simply that a generic manufacturer will be able to seek dismissal of the patentee’s case, at an early stage, in certain circumstances. Thus the provision is remedial, it overcomes the David Bull objection and puts NOC Applications on a similar footing with actions under Rule 419 of the Federal Court Rules, as they then were, and Rule 221 as it presently stands.
[11] Taking section 6(5)(b) on an equal footing with old Rule 419 or present Rule 221 we must start with the well entrenched proposition as stated by the Supreme Court in Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959 that a party should not be driven from the judgment seat at an early stage before trial unless it is “plain and obvious” that the matter cannot succeed. In dealing with an application not an action, the Federal Court of Appeal in Norton v. Via Rail Canada (2005), 255 D.L.R. (4th) 311, at paragraph 15, states that striking out an application before hearing is an extraordinary remedy, granted only in narrowly defined circumstances. Finally, another classic decision of this Court should be cited, Creaghan Estate v. The Queen, [1972] F.C. 732 at 736:
(3) Finally, in my view, a statement of claim should not be ordered to be struck out on the ground that it is vexatious, frivolous or an abuse of the process of the Court, for the sole reason that in the opinion of the presiding judge, plaintiff's action should be dismissed. In my opinion, a presiding judge should not make such an order unless it be obvious that the plaintiff's action is so clearly futile that it has not the slightest chance of succeeding, whoever the judge may be before whom the case could be tried. It is only in such a situation that the plaintiff should be deprived of the opportunity of having “his day in Court”.
[12] With the general principles in mind some cases in which section 6(5)(b) of the NOC Regulations have been considered by this Court should be reviewed.
1. Hoffman LaRoche Ltd. v. Canada, (1999), 87 C.P.R. (3rd) 251 (FC). The Court dismissed an application where it was demonstrated that the applicant, the innovator, failed to take the appropriate steps in the appropriate sequence in respect of filing its NOC. The Application was dismissed as failure to follow the correct sequence was fatal.
2. There are several cases where there had been previous NOC litigation between the same parties. Subsequent NOC litigation between the same parties respecting the same patents was dismissed as being an abuse. Among these are Janssen-Ortho Inc. v. Novopharm Limited, (2005), 46 C.P.R. (4th) (FC); AB Hassle v. Apotex Inc., (2005), 38 C.P.R. (4th) and Glaxo Group Ltd. v. Canada, 2006 FCT 16.
3. These are two cases where in a previous NOC decision a patent had been held to be invalid and another generic in a subsequent application involving the same patent sought the dismissal on the basis of the prior invalidity finding. The Federal Court of Appeal in Pharmascience Inc. v. Sanofi-Aventis Canada Inc., (2006) FCA 210 held that where the generic in the subsequent proceeding was alleging invalidity on a ground different from the basis upon which invalidity had previously been found, the proceeding should not be dismissed. In the second case, Tremblay-Lamer, J. of this Court held that where the patent was held invalid in the first proceeding on the same ground of invalidity raised by the generic in the second proceeding, it would be an abuse to continue the second proceeding and thus it was dismissed, see Sanofi-Aventis Pharma Inc. v. Novopharm Limited, 2006 FC 1135. That decision is under appeal.
[13] There appears to be no precedent directly on point in respect of the grounds for dismissal raised in the present motion which I will now discuss substantively.
Ground 1 – Effect of Supreme Court Decision in AstraZeneca
[14] The situation which confronted the Supreme Court of Canada in AstraZeneca, supra, was succinctly put in the head note provided by the Court which I repeat here:
In 1989, the respondent, Astra, an innovator manufacturer, obtained from the Minister of Health a notice of compliance (“NOC”) enabling it to market its drug omeprazole for use in the treatment of acidic stomach conditions. It was sold in Canada as Losec 20 from 1989 until 1996, when Astra decided to remove it from the market and replace it with another formulation. Astra’s patent for omeprazole then expired in 1999. In 2002, despite the absence of Losec 20 from the market, Astra obtained and registered with the Minister of Health two more patents associated with Losec 20, but did not incorporate this new technology into any of its products. In 1993, Apotex filed an abbreviated new drug submission for a NOC for its generic version of omeprazole, comparing its product to Astra’s 1989 version of Losec 20. The Minister determined that Apotex was not required to address the after-issued patents and granted Apotex the NOC in 2004. Astra applied for judicial review of this decision, and the motions judge upheld the Minister’s decision. The Federal Court of Appeal overturned this judgment and quashed Apotex’s NOC.
[15] The Supreme Court allowed the appeal, reversing the Federal Court of Appeal. It is important to note that the two patents at issue dealt with physical characteristics of the drug, one addressed a particular formulation, the other addressed a particular crystaline form. Neither patent dealt with new uses. The innovator was able to list those patents via a Supplementary New Drug Submission (SNDS) which it filed which SNDS was directed to a new use even though the patents were not directed to the new use. The generic wanted to copy the old form of the drug for the old use. As Binnie, J. said at paragraph 21:
21 I emphasize the words in s. 4(5) that in the case of patents added afterwards, "the first person must identify the submission to which the patent list or the amendment relates, including the date on which the submission was filed". In addition, s. 3(3) provides that "[n]o information submitted pursuant to section 4 shall be included on the register until after the issuance of the notice of compliance in respect of which the information was submitted". These provisions, it seems to me, provide an important key to understanding the scheme. Entry of the "Patent list" does not destroy the linkage between the patent and the submission(s) to which it relates, nor to the NOC to which the submission(s) are directed. Specific patents are associated with one or more NDS, ANDS or SNDS, which in turn (if approved) give rise to specific NOCs, which in turn approve a specific manufacturer's product, which a generic manufacturer may seek to copy. There is no linkage between the 037 and 470 patents and the submissions that lead to the Losec 20 product copied by Apotex. Those after-acquired patents were listed in relation to a SNDS dated January 22, 1999 by AstraZeneca for a new medical use for Losec 20 (treatment of H. Pylori), a use for which the Apotex product is not approved, and to an administrative SNDS submitted by AstraZeneca dated July 12, 2000, which submission has nothing at all to do with the technology incorporated in Losec 20.
[16] Binnie, J. recited the argument of the innovator and the Federal Court of Appeal at paragraph 23:
23 AstraZeneca relies on Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140, 2003 FCA 24, for the proposition that a patent list is submitted in respect of a drug and not in respect of any particular submission. This is also the view taken by the majority judgment of the Federal Court of Appeal in this case. On this view a "first person" could carry on "evergreening" its product indefinitely by the addition of new patents of marginal significance which would trigger an indefinite series of 24-month statutory freezes even though such subsequently listed patents are not the subject of "early working" by the generic manufacturer, and from which (as in the circumstances here) the generic manufacturer derives no advantage. As this case further illustrates, AstraZeneca even managed to piggy-back the 037 and 470 patents onto an administrative SNDS. An interpretation that would freeze the generic product out of the market vacated by AstraZeneca in 1996 for a further two years or more in these circumstances flies in the face of the limited purpose authorized by s. 55.2(4) of the Act. It is not to be presumed that s. 4(5) of the NOC Regulations insisted on linking particular patents to particular submissions for no purpose.
[17] Their argument was found to be wrong. Without reciting the whole of the remainder of the decision, the following paragraphs illustrate the view of the Supreme Court:
35 In my opinion, the rules governing acceptable "comparator" drugs give a further important clue to the legislative intention. If, as subs. (b) says, a drug cannot be used as a comparator unless acceptable to the Minister "because it is no longer marketed in Canada", it seems obvious that a drug cannot be used as a comparator if it has never been marketed in Canada. That is the significance of the fact that AstraZeneca has never had a product on the market based on AstraZenaca's later submissions in relation to which the 037 and 470 patents were listed.
36 Viewed in this light, it seems to me inescapable that the expression "another drug" in s. 5(1) refers to the actual comparator drug - not a drug that never became available for comparison -- and that the words "with respect to each patent on the register in respect of the other drug" carries the same meaning.
37 The whole obligation incurred by the generic manufacturer under the NOC Regulations is based on its "early working" of patents embodied in "another drug for the purpose of demonstrating bio-equivalence". The only drug that fits the description is the version of Losec 20 approved in the June 19, 1989 NOC.
H. The Broader Statutory Purpose
38 I repeat that Parliament's stated purpose in authorizing the NOC Regulations was to permit the early working of the patented invention (s. 55.2(4)). As Apotex did not make use of the patented inventions taught by the 037 and 470 patents, Apotex is not on this occasion within the mischief aimed at by the NOC Regulations.
39 By imposing the 24-month delay called for by the NOC Regulations, the decision of the Federal Court of Appeal undermines achievement of the balance struck by Parliament between the objectives of the FDA and regulations thereunder (making safe and effective drugs available to the public) and the Patent Act and its regulations (preventing abuse of the early working exception to patent infringement). Given the evident (and entirely understandable) commercial strategy of the innovative drug companies to evergreen their products by adding bells and whistles to a pioneering product even after the original patent for that pioneering product has expired, the decision of the Federal Court of Appeal would reward evergreening even if the generic manufacturer (and thus the public) does not thereby derive any benefit from the subsequently listed patents. In my view, s. 5(1) of the NOC Regulations requires a patent-specific analysis, i.e. the generic manufacturer is only required to address the cluster of patents listed against submissions relevant to the NOC that gave rise to the comparator drug, in this case the 1989 version of Losec 20.
40 If AstraZeneca had brought to market a Losec 20 product pursuant to the later NOCs and if Apotex had made reference to that modified product for the purpose of demonstrating bioequivalence, Apotex would have been required to file a notice of allegation with respect to the 037 and 470 patents.
41 However, it is clear that AstraZeneca did not market any product pursuant to the subsequent NOCs and that the preconditions to any obligations of Apotex under s. 5(1) were therefore not triggered.
[18] In the present proceeding we have a case where the physical drug is the same, ramipril. For the purpose of bioequivalence all that is important is how the drug of the generic behaves in the human body compared to that of the innovator, a new use is immaterial.
[19] As far as new use is concerned, the innovator, Sanofi-Aventis, never got approval, it never got an NOA, for the new use as claimed in the patents at issue. It never sold its ramipril drug in Canada for the new uses. The only purpose of the new use patents seemingly, is to act as an impediment to early entry by a generic into the old use marketplace. Novopharm argues that the Reasons of the Supreme Court at paragraph 35 and 42 are significant in determining that a patent which does not pertain to a product that has been marketed by the innovator, need not be engaged by the generic:
35 In my opinion, the rules governing acceptable "comparator" drugs give a further important clue to the legislative intention. If, as subs. (b) says, a drug cannot be used as a comparator unless acceptable to the Minister "because it is no longer marketed in Canada", it seems obvious that a drug cannot be used as a comparator if it has never been marketed in Canada. That is the significance of the fact that AstraZeneca has never had a product on the market based on AstraZenaca's later submissions in relation to which the 037 and 470 patents were listed.
…
42 Apotex acknowledges that its NOC dated January 27, 2004 does not permit Apotex to produce a product formulated or manufactured in accordance with the 037 and 470 patents, nor to claim that the Apotex product is indicated for the treatment of H. Pylori. This opinion deals only with the obligations of Apotex under the NOC Regulations. AstraZeneca seemed to suggest at various points during the oral hearing that Apotex is indeed infringing AstraZeneca patents. If this be so (and there is no evidence before us either way), then of course AstraZeneca retains all its remedies under the Patent Act, including, in appropriate circumstances, an interlocutory injunction. The only patent-related consequence of the present decision is to deny AstraZeneca the benefit of a 24-month freeze without any proof of patent infringement.
[20] Sanofi-Aventis argues that AstraZeneca must be confined to a situation where the drug in its patented physical form has never been marketed. It says that here, the drug is in its physical form and has been marketed; it was purchased by Novopharm and used as a comparator for bioequivalent studies. The “new” use patents are not immaterial.
[21] Perhaps this difference in interpretation of the Supreme Court decision could be resolved on a motion such as this. However, there is a complication. The Minister, in his letter of December 8, 2006, to Novopharm, disagrees with Novopharm’s view, at least to the extent that it affects the ‘089 and ‘948 patents at issue here, so much so that Novopharm has instituted other proceedings in this Court to quash the Minister’s decision. I will not repeat the whole of the Minister’s view of the decision because of its length, however, a portion states:
While the AstraZeneca decision arose from an unusual factual basis, namely the addition of a patent list for a drug that was no longer marketed, it appears that Mr. Justice Binnie, for the court, entertained a broader discussion as to the assessment of which patents must be addressed by a second person under section 5 of the PM(NOC) Regulations. He held, at paragraph 39, that a “patent-specific” analysis” is necessary in order to determine which patents on the Patent Register must be addressed by a second person under the PM(NOC) Regulations. He went on to determine that a second person “is only required to address the cluster of patents listed against submissions relevant to the NOC that gave rise to the comparator drug.”
…
If, at the end of the patent-specific analysis, it is determined that a second person is not required to address a given patent, the OPML will consider whether the Minister if statutorily barred from issuing the relevant NOC due to an order of prohibition granted to the first person under section 6 of the PM(NOC) Regulations or due to the requirements for the issuance of an NOC under section 7. The OPML will not issue an NOC if it is statutorily barred from doing so.
[22] A motion to dismiss should not be used as a vehicle to resolve important, controversial points of law. This is particularly so in an area which the law is currently evolving (Daniels v. Canada, [2002] 4 F.C. 550). For this reason I will not dismiss the proceeding in respect of the ‘089 and ‘948 patent on this ground.
Ground 2: Is there Sufficient Evidence on the Non-Infringement Issue
[23] The issue of infringement in NOC proceedings is expressed in a convoluted way. Once a generic, in its Notice of Allegation, has stated that there will not be infringement of a patent, the innovator, in NOC proceedings before this Court, has the burden to show that such an allegation is not justified. (e.g. Abbott Laboratories Limited v. Novopharm Limited, 2006 FC 1411 at paragraph 10).
[24] The parties concede that the jurisprudence as to use by a generic, after a controversial start, is now quite well settled. The mere sale by a generic of an old drug for an old use will not constitute infringement of a patent directed to a new use for that drug unless “something more” than sale is shown in the evidence. That something more would include the procuring or inducing others to infringe (Sanofi-Aventis Canada Inc. v. Apotex Inc., 2006 FCA 357). Evidence showing that “off label” uses of a drug would occur in that physicians may prescribe, pharmacists may dispense and patients may consume old drugs for new uses is not sufficient to implicate the generic in infringement as defined by the NOC Regulations unless the generic is shown to do “something more” than simply make the drug available for the old use.
[25] Novopharm asserts that the evidence in this case fails to show “something more”. It says that Sanofi-Aventis has filed all of its affidavits in the proceeding and none of them show “something more”. To the extent that Sanofi-Aventis’ evidence addressed either the ‘089 or ‘948 patent that evidence is simply that alleging that “off label” uses will occur. That is, the same sort of evidence that the courts have found to be insufficient.
[26] Sanofi-Aventis says that the evidence is not yet complete in that it has not yet concluded the cross-examination of all of Novopharm’s affiants. This, says Novopharm, is mere speculative hope that something unexpected may arise from cross-examination. A party, Novopharm says, cannot sustain a proceeding based merely on such a hope (Kastner v. Painblanc, [1994] F.C.J. No. 1671 (C.A.)).
[27] Sanofi-Aventis also argues that Novopharm has only supplied a redacted version of a proposed product monograph and labeling. Until Sanofi-Aventis receives verification as to the actual monograph and labeling to be used unredacted form it says that there will not be sufficient evidence before the Court on the infringement issue. It points to cases such as Abbott, supra, and ABHassle v. Genpharm Inc., 2003 FC 1443 where certain information contained in a product monograph was sufficient to constitute the “something more” which the case law requires.
[28] Novopharm says that the evidence is clear that the monograph and labels are those which it intends to use and that the redactions have nothing to do with the “new use” issue. They relate to formulations or “numbers only” as to clinical trials. It remains puzzling as to why Novopharm, given that there is a Confidentiality Order in this case, would not simply have turned over an unredacted copy of the monograph and labeling. Whatever mystery existed would have been put to rest.
[29] Further, Sanofi-Aventis points to a passage in the Novopharm proposed product monograph, not redacted, which says:
Recommended Dose and Dosage Adjustment
Essential Hypertension
Dosage of NOVO-RAMIPRIL (ramipril) must be individualized. Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation and salt restriction. The dosage of other antihypertensive agents being used with NOVO-RAMIPRIL may need to be adjusted.
[30] This statement, Sanofi-Aventis says, taken with the evidence of one of its experts, may lead some patients to combine the generic ramipril with another drug to arrive at a new use claimed by at least the ‘948 patent.
[31] Novopharm says that such speculation is very thin evidence indeed and wholly insufficient to support a finding that a non-infringement allegation is not justified.
[32] Sanofi-Aventis raises another objection to Novopharm’s motion on this second ground. Sanofi-Aventis counsel put it on the basis that Novopharm has “already engaged the process” such that the parties have filed their evidence in-chief, some cross-examination has been conducted and a trial date fixed. Being a summary proceeding, it says, a motion for dismissal at this stage should not be entertained. Such an argument has been couched by the courts as delay. (e.g. Sofila Canada Inc. v. Contour Optic Inc., 2005 FC 278; Inventions Armand Morin Inc. v. Risley Mfg. Ltd., 2005 FC 362).
[33] I make no finding on the evidence presently on the record even though I have some skepticism that a party should be allowed to proceed simply because it might obtain something useful on cross-examination. However, combining what little evidence there is or may be with the fact that these proceedings were instituted over a year ago and a trial date has been fixed for six months hence, I make the observation that the motion, on this ground, could have been initiated at the outset of this case just after Sanofi-Aventis filed its affidavit evidence, I find that it would be inappropriate to dismiss the proceedings on this ground at this time. The sufficiency of evidence on the infringement issue, now that the matter has gone this far, should be left to the hearing at trial.
[34] Counsel for the parties have indicated that they would co-operate in seeking an earlier trial date than that presently fixed and I encourage them to apply to the Office of the Chief Justice to determine if an earlier date can be obtained.
[35] As to costs, this is a matter best left for determination at trial. They will be in the cause.
ORDER
FOR THE REASONS GIVEN:
THIS COURT ORDERS that:
1. The motion is dismissed; and
2. Costs are in the cause.
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1979-05
STYLE OF CAUSE: Sanofi-Aventis v. Novopharm Limited
PLACE OF HEARING: Toronto, Ontario
DATES OF HEARING: December 19, 2006
REASONS FOR ORDER
AND ORDER: HUGHES J.
DATED: December 21, 2006
APPEARANCES:
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Mr. Gunnars Gaikis Mr. J. Sheldon Hamilton Mr. Mark Beirnacki |
FOR THE APPLICANTS |
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Mr. Jonathan Stainsby Mr. Mark Edward Davis |
FOR THE RESPONDENT, NOVOPHARM LIMITED |
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No one appearing |
FOR THE RESPONDENT, THE MINISTER OF HEALTH |
SOLICITORS OF RECORD:
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Smart & Biggar Windsor, Ontario |
FOR THE APPLICANTS |
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Heenan Blaikie LLP Toronto, Ontario |
FOR THE RESPONDENT, NOVOPHARM LIMITED |
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John H. Sims, Q.C. Deputy Attorney General of Canada |
FOR THE RESPONDENT, THE MINISTER OF HEALTH |