Ottawa, Ontario, June 15, 2007
PRESENT: The Honourable Mr. Justice Phelan
BETWEEN:
and
THE MINISTER OF HEALTH and APOTEX INC.
and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondent/Patentee
REASONS FOR JUDGMENT AND JUDGMENT
I. INTRODUCTION
[1] This is an application by Pfizer Canada Inc. (Pfizer) for an order declaring that (a) a letter of undertaking not to use the product for a particular purpose is not part of a Notice of Allegation as contemplated by the Patented Medicines (Notice of Compliance) Regulations and therefore the Notice of Allegation is insufficient for purposes of granting a Notice of Compliance, and (b) in the alternative, an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. (Apotex) for quinapril until the expiry of Canadian Patent No. 2,023,089 (089 Patent).
[2] At the centre of Pfizer’s contention is (a) that Apotex’s Notice of Allegation (NOA) is insufficient in that it contains evidence as to intended use infringing the 089 Patent which cannot be rectified by an undertaking not to engage in infringing use and (b) that Apotex’s quinapril will be used by physicians and patients in ways which will infringe Pfizer’s 089 Patent.
II. FACTUAL BACKGROUND
[3] Accupril is the brand name of a drug product marketed by Pfizer containing quinapril as the active ingredient. Quinapril belongs to a class of drugs called ACE inhibitors. Accupril is approved in Canada for the treatment of hypertension and congestive heart failure.
[4] Apo-Quinapril is the name of a drug product which Apotex intends to make, use and sell in 5, 10, 20 and 40 mg. doses. The Apo-Quinapril draft product monograph and draft labels stated that Apo-Quinapril is intended to be used for both hypertension and congestive heart failure. Whether this is an accurate statement of intended use and the consequences of its accuracy or otherwise is a central issue in this proceeding.
[5] Pfizer’s 089 Patent limits the claims to the treatment of cardiac and vascular hypertrophy and hyperplasia by administration of angiotensin converting enzyme (ACE) inhibitors (“Patented Use”).
[6] Apotex’s NOA alleges that it would not infringe the 089 Patent because it would not make, use or sell Apo-Quinapril for the Patented Use – the treatment of cardiac or vascular hypertrophy and hyperplasia - and it undertakes that it will only make, use or sell the Apo-Quinapril for the treatment of hypertension. The NOA also alleged invalidity but that allegation has not been pressed and is treated as abandoned.
[7] Congestive heart failure is a common ailment whereas cardiac hypertrophy is quite rare. Cardiac hypertrophy may be, but is not necessarily, “co-morbid” (exist together) with congestive heart failure. There are many instances where the congestive heart failure exists without hypertrophy.
[8] In the arguments before this Court, the conditions of vascular hypertrophy and vascular and cardiac hyperplasia played no significant role.
[9] The Patented Use for cardiac and vascular hypertrophy and hyperplasia has not been approved by the Minister of Health under the Food and Drug Regulations. Therefore, even Pfizer cannot sell Accupril for use in the treatment of these conditions.
[10] The root of the problem in this case is that the NOA stated that Apo-Quinapril would only be used for hypertension whereas the draft product monograph and draft labels as well as the Abbreviated New Drug Submission (ANDS) all referred to the intended use for hypertension and congestive heart failure.
[11] The NOA of June 3, 2005 is quite specific as to its non-use for the Patented Use:
There will be no infringement because our tablets will be made, used and sold only as an ACE inhibitor for treatment of hypertension. More particularly, we will not make, use, or sell for treatment of cardiac and/or vascular hypertrophy and/or hyperplasia.
More particularly, we undertake that we will ensure that, in our Product Monograph issued with our Notice of Compliance, we will ensure that the only indication is for treatment of hypertension and that any use for treatment of cardiac and/or vascular hypertrophy, and/or hyperplasia is excluded.
This NOA was signed by the Chairman and CEO of Apotex.
[12] It has been Pfizer’s contention that the allegations in Apotex’s NOA are insufficient because of the inconsistency between the NOA letter of June 3, 2005 and the draft product monograph, and draft labels filed with the Minister of Health. Pfizer further contends that the allegation of non-infringement is unjustified because Apotex will be marketing Apo-Quinapril to treat congestive heart failure which will treat cardiac hypertrophy in some cases because of the close relationship between the two conditions.
[13] Therefore, the two issues to be addressed are:
(a) the sufficiency of the NOA; and
(b) the allegation of non-infringement of the 089 Patent.
III. ANALYSIS
A. Sufficiency of NOA
[14] The purpose of the NOA is to frame the factual and legal issues with sufficient particularity that a potential applicant in this Court can know whether and how to rebut the allegations of non-infringement (or other grounds as the case may be).
[15] As confirmed in Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA 229, “insufficiency” is used in two senses:
· primary – whether there is sufficient information in the NOA to know whether to seek a prohibition order; and
· secondary – whether a non-infringement allegation is not justified because it fails to address a relevant patent claim or because it is not capable of establishing non-infringement.
[16] Pfizer does not allege primary insufficiency. It knew enough from the NOA to know whether to seek a prohibition order. Pfizer’s actions in vigorously opposing Apotex, as it is entitled to do, establishes that it knew what it had to do.
[17] The Applicant’s complaint of insufficiency is of the secondary type. It says that the Respondent’s NOA is deficient and inaccurate because its undertaking to use Apo-Quinapril for hypertension ignores the fact that it intends to use it for congestive heart failure (which arguably includes hypertrophy) as evidenced by the drafts of the product monograph and labels.
[18] The Applicant relies extensively on AB Hassle v. Canada (Minister of National Health and Welfare) (2000) 7 C.P.R. (4th) 272 (F.C.A.) to argue that a “second person” – Apotex – cannot add facts to those contained in the detailed statement. The Applicant takes the position that the “Undertaking” contained in the NOA restricting the use of Apo-Quinapril to hypertension is an addition to the detailed statement and is not permitted.
[19] However, this AB Hassle decision was based on the principle that the detailed statement had to be sufficiently clear that it would allow a first person to decide whether to contest the Notice of Compliance. The Court of Appeal discussed the problem of adding new facts and evidence to the NOA which are different from those contained in the detailed statement. In that case, the second person was adding new prior art in the Notice of Compliance proceeding.
[20] The Court of Appeal was concerned about the prejudice caused to the first person by having to deal with a Notice of Compliance on a piecemeal basis, the potential for delay in proceedings that have a 24-month time frame and the need for expeditious dealing with the matter.
[21] None of those factors exist in this instance. There is no question that the Applicant had sufficient information to decide whether to contest the Notice of Compliance. There has been no evidence of prejudice. The Undertaking given in the NOA and confirmed at the Court hearing withdraws a potential area of dispute, and does not add to the issues in dispute. The Undertaking should have had the effect of shortening the Notice of Compliance proceeding by withdrawing an area of contention.
[22] Taken to its logical conclusion, the Applicant’s position is that any variance between the detailed statement and other parts of the NOA constitutes insufficiency and therefore results in the granting of a prohibition order. The position ignores the type of variance and the purposes underlying the principles of sufficiency. There is no reason in this case, applying the principles of sufficiency, to find against the Respondent.
[23] Pfizer also attacks the Undertaking as being inaccurate in that Apotex will infringe the 089 Patent. It says so because Apo-Quinapril will be used to treat hypertrophy and hypertrophy is co‑morbid with congestive heart failure – in this case, the treatment of one is the treatment of the other.
[24] The Applicant’s position in this regard is more related to the issue of infringement than to the issue of sufficiency. The challenge to the Undertaking and its force and effect is answered in two ways – (a) it is an undertaking signed by Apotex’s CEO and binding on the company, and (b) the undertaking can be incorporated in any Notice of Compliance issued by the Minister.
[25] Pfizer has also complained that Apotex has added to the NOA in terms of factual and legal proposition. (However, these facts and legal proposition arose in response to Pfizer’s contentions.) As held in AstraZeneca AB v. Apotex Inc. (2005), 335 N.R. 1 by Evans J.A.:
11. … A second person should not be required to anticipate every theory of possible infringement, however speculative, in the detailed statement supporting its allegations.
[26] Therefore, Apotex’s NOA is not “insufficient” or otherwise inadequate. The Court must then turn to the issue of non-infringement of the 089 Patent.
B. Non-Infringement
[27] There is no issue that if Apotex’s sale of Apo-Quinapril was for hypertension only, there is no basis of infringement. The contentious area is in respect of the treatment of congestive heart failure and the derivative use that may be made of Apo-Quinapril.
[28] Pfizer contends that because Apotex’s draft product monograph included an indication for “congestive heart failure” and those with congestive heart failure may (but not necessarily do) suffer from hypertrophy, use for congestive heart failure will infringe the 089 Patent.
[29] It is well established that incidental treatment of a patented use through the administration of medicine to treat a non-patented use is not grounds, on its own, to grant prohibition (see H. Lundbeck A/S v. Canada (Minister of Health) (2004), 30 C.P.R. (4th) 97). Pfizer accepts that in order to succeed, it must show “something more” than non-patented use. In this case, that “something more” is the product labels and draft product monograph which include treatment for congestive heart failure which will induce use for which there is patent protection.
[30] Firstly, it is my view that the Undertaking in the NOA is a complete answer to that allegation. The completeness of that answer is reinforced by the incorporation of the Undertaking in any Notice of Compliance issued. Apotex would be limited to selling Apo-Quinapril for use in the treatment of hypertension only, and will have to modify the draft product monograph and draft labels so that the only indication for Apo-Quinapril is hypertension.
[31] Secondly, if physicians engage in “off label” use by prescribing Apo-Quinapril for something other than the approved use, Apotex can only be said to infringe the 089 Patent if it is implicated in inducing the infringing use by a physician or pharmacist. This liability has been made clear in the Federal Court of Appeal’s recent decision of Sanofi-Aventis Canada Inc. v. Novopharm Ltd., 2007 FCA 167:
10. … Unless Novopharm is so implicated, the infringement by the physician or pharmacist would not be the kind of infringement that can support the granting of a prohibition order under the NOC Regulations.
11. A generic drug manufacturer may be implicated in the infringement by others of a claim for a new use of a medicine if the generic drug manufacturer induces that infringement. Infringement by inducement may be established, for example, by inferences reasonably drawn from the contents of the product monograph for the generic drug product, or evidence relating to the dosage form of the generic product, or its labelling or marketing. However, an inducement to infringe generally cannot be inferred from a mere reference to the new use in the product monograph, for example, in the course of explaining contraindications or drug interactions, or as part of a list of scientific references.
[32] There is no evidence that Apotex will actively induce physicians to prescribe quinapril pills to treat hypertrophy. Quite apart from any limitations imposed on the Notice of Compliance by virtue of the undertaking, if the 089 Patent covered a valid use of the drug, one would have thought Pfizer would have used its patent rights to do so. However, that specific use has not been approved by Health Canada.
IV. CONCLUSION
[33] Pfizer has attempted to use the 089 Patent, restricted to hypertrophy and hyperplasia, to prevent Apotex’s drug from coming to market despite the failure of Pfizer to obtain authority to sell its own drug for the Patented Use. Such a result would allow a non-using monopoly holder to prevent a lower cost drug from coming to market.
[34] This was never the intention of the legislation. Justice Sexton in AB Hassle Inc. v. Canada (Minister of National Health and Welfare) (2002), 22 C.P.R. (4th) 1 (F.C.A.) commented on this policy issue and the potential for societal harm as follows:
57. Thus Apotex cannot be prevented from obtaining a NOC solely on the basis that it will sell omeprazole. If it were otherwise, then serious policy issues would arise. If there was any likelihood that a patient would consume a generic product for a patented use, then the generic product would not be approved. This would prevent new uses from being approved for existing drugs because there is always the possibility that someone somewhere will use the drug for the prohibited, patented purpose. This would result in a real injustice: since a generic company cannot possibly control how everyone in the world uses its product, the prevention of the generic from marketing the product would further fortify and artificially extend the monopoly held by the patent holders. The patent holder would, therefore, effectively control not just the new uses for the old compound, but the compound itself, even though the compound itself is not protected by the patent in the first place. The patent holders, as a result, would obtain a benefit they were not meant to have. In the end, society would be deprived of the benefit of new methods of using existing pharmaceutical medicines at a lower cost.
[35] For these reasons, this application will be dismissed with costs. Any Notice of Compliance to be issued shall contain a condition consistent with the Undertaking contained in the NOA letter of June 3, 2005.
JUDGMENT
THIS COURT ORDERS AND ADJUDGES that this application will be dismissed with costs. Any Notice of Compliance to be issued shall contain a condition consistent with the Undertaking contained in the NOA letter of June 3, 2005.
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1232-05
STYLE OF CAUSE: PFIZER CANADA INC.
and
THE MINISTER OF HEALTH et al
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: April 23 and 24, 2007
APPEARANCES:
|
Mr. Peter R. Wilcox Mr. Andrew Bernstein Ms. Alisse Houweling
|
|
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Mr. Andrew R. Brodkin Mr. John H. Simpson
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APOTEX INC. |
|
Mr. J. Sheldon Hamilton |
FOR THE RESPONDENT/PATENTEE |
SOLICITORS OF RECORD:
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TORYS LLP Barristers & Solicitors Toronto, Ontario
|
|
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MR. JOHN H. SIMS, Q.C. Deputy Attorney General of Canada Toronto, Ontario
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THE MINISTER OF HEALTH |
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GOODMANS LLP Barristers & Solicitors Toronto, Ontario
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FOR THE RESPONDENT, APOTEX INC. |
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SMART & BIGGAR Barristers & Solicitors Toronto, Ontario |
FOR THE RESPONDENT/PATENTEE |