SHARLOW J.A.
MALONE J.A.
BETWEEN:
Appellant (Respondent)
and
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
and
THE MINISTER OF HEALTH AND
SCHERING CORPORATION
Respondents (Respondents)
Heard at Montreal, Quebec, on June 6 and 7, 2006.
Judgment delivered at Ottawa, Ontario, on June 21, 2006.
REASONS FOR JUDGMENT BY: SHARLOW J.A.
CONCURRED IN BY: SEXTON J.A.
MALONE J.A.
Docket: A-155-05
Citation: 2006 FCA 229
CORAM: SEXTON J.A.
SHARLOW J.A.
MALONE J.A.
BETWEEN:
PHARMASCIENCE INC.
Appellant (Respondent)
and
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondents (Applicants)
and
THE MINISTER OF HEALTH AND
SCHERING CORPORATION
Respondents (Respondents)
REASONS FOR JUDGMENT
[1] The respondents Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (collectively, Aventis) produce and market ramipril capsules under the trade name AAltace@. Altace capsules are approved for use in the treatment of hypertension and cardiac insufficiency. In 2001, the appellant Pharmascience Inc. submitted an abbreviated new drug submission to the Minister of Health to obtain a notice of compliance under the Food and Drug Regulations, C.R.C., c. 870, for its proposed ramipril capsules. In that submission, Pharmascience compared its ramipril capsules to Altace. Although the Pharmascience ramipril capsules will be therapeutically equivalent to Altace, Pharmascience seeks the Minister=s approval for its ramipril capsules only for use in the treatment of hypertension.
[2] Three patents are listed for Altace on the register maintained by the Minister pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the NOC Regulations): Canadian Patent Numbers 1,341,206 (the 206 patent), 1,187,087 (the 087 patent), and 1,246,457 (the 457 patent).
[3] The 206 patent was issued to a corporate predecessor of the respondent Schering Corporation, and is now owned by Schering. The claims of the 206 patent that are relevant to this case are claims 1, 2, 3, 6 and 12, each of which claims a class of compounds. Claim 1 claims the largest class, Claim 12 the smallest (eight compounds). Ramipril is included within each of those claims, although ramipril is not specifically disclosed in the patent.
[4] The 206 patent was issued in 2001 from an application filed in 1981. The delay was caused by conflict proceedings under the Patent Act, R.S.C. 1985, c. P-4 (as it read before 1989), which were finally resolved in Schering=s favour. In the notice of allegation served by Pharmascience in relation to its ramipril capsules, Pharmascience alleged that claims 1, 2, 3, 6 and 12 of the 206 patent are invalid because they cover subject matter that is not patentably distinct from the subject matter of the claims of the 087 patent and the 457 patent.
[5] The 087 patent was issued to Aventis in 1985 from an application filed in 1982. The 087 patent claims certain processes for making ramipril. The 087 patent expired on November 4, 2002, and therefore need not be addressed by Aventis under the NOC Regulations. The 087 patent is relevant in this case only because it is raised in arguments relating to the 206 patent and the 457 patent.
[6] The 457 patent was issued to Aventis in 1988 from an application filed in 1985. The 457 patent claims ramipril for use in the treatment of cardiac insufficiency. In the notice of allegation served by Pharmascience in relation to its ramipril capsules, Pharmascience alleged that the 457 patent would not be infringed because Pharmascience would seek approval for its ramipril capsules, and market them, only for use in the treatment of hypertension.
[7] The inventors of the 457 patent and the 087 patent worked independently of the inventor of the 206 patent.
[8] In 1986, the 206 patent was licensed to Aventis in consideration of the payment of a royalty. The license agreement was entered into to avoid the risk of infringement litigation in the event the 206 patent was issued (as it finally was in 2001). Neither the 087 patent nor the 457 patent were raised in the conflict proceedings that delayed the issuance of the 206 patent. The evidence in this case does not establish that Schering was responsible for any undue delay in the resolution of the conflict proceedings.
[9] Aventis did not accept the allegations of Pharmascience in respect of the 457 and 206 patents, and commenced an application in the Federal Court under the NOC Regulations for an order prohibiting the Minister from issuing a notice of compliance to Pharmascience for its ramipril capsules until after the expiry of the 457 patent and the 206 patent. Schering was a respondent in those proceedings because it is the owner of the 206 patent.
[10] The application of Aventis was heard in December of 2004 and it was successful, resulting in a prohibition order dated March 11, 2005 (2005 FC 340, reported as Aventis Pharma Inc. v. Pharmascience Inc. (F.C.), [2005] 4 F.C.R. 301). Pharmascience now appeals to this Court, seeking to set aside the prohibition order, or in the alternative to have the prohibition order varied so that it terminates upon the expiry of the patents to which it relates.
First preliminary point B the duration of a prohibition order
[11] An order made pursuant to the NOC Regulations prohibiting the Minister from issuing a notice of compliance ceases to have effect upon the expiry of the patent or patents in respect of which the order is made. Therefore, it was not necessary in this case for Pharmascience to seek, as an alternative remedy, an order limiting the duration of the order under appeal so that it would terminate upon the expiry of the 457 patent and the 206 patent: Zeneca Pharma Inc. v. Canada(Minister of National Health and Welfare) (1996) 66 C.P.R. (3d) 169 (F.C.T.D.).
[12] The order under appeal ceased to have effect in relation to the 457 patent when that patent expired on December 13, 2005, but it remains in effect in relation to the 206 patent, and unless it is reversed on appeal, it will remain in effect in relation to the 206 patent until the 206 patent expires (or, if in other proceedings the 206 patent is declared to be invalid, on that date; see Hoffmann-La Roche Ltd. v. Canada(Minister of National Health and Welfare) (1999), 167 F.T.R. 111 (F.C.T.D.)).
[13] Confusion on this point might have been avoided if the legal effect of the order had been stated more precisely. The order under appeal means this:
| (1) Pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, the Minister of Health is prohibited from issuing a notice of compliance under the Food and Drug Regulations to Pharmascience Inc. for ramipril capsules until the expiry of Canadian Patent Number 1,246,457. (2) Pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, the Minister of Health is prohibited from issuing a notice of compliance under the Food and Drug Regulations to Pharmascience Inc. for ramipril capsules until the expiry of Canadian Patent Number 1,341,206. |
Second preliminary point B why the appeal relating to the 457 patent was heard
[14] The 457 patent expired on December 13, 2005, and therefore this appeal strictly speaking is moot in relation to the 457 patent. However, the appeal is not moot in relation to the 206 patent. If the appeal of Pharmascience succeeds in relation to the 206 patent but Pharmascience is not permitted to pursue its appeal in relation to the 457 patent, its claim for damages under section 8 of the NOC Regulations may be limited to the delay from the date of the expiry of the 457 patent (December 13, 2005) to the date of the issuance of the notice of compliance. That is a sufficient justification to hear the appeal of Pharmascience in relation to the 457 patent.
Standard of review
[15] The first issue in the appeal relating to the 457 patent is whether the judge erred in determining that the notice of allegation was inadequate. The adequacy of a notice of allegation is a question of mixed law and fact. The standard of review is palpable and overriding error, except to the extent that a question of law can be extricated from the judge=s determination, in which case that question of law must be determined correctly: AB Hassle v. Apotex Inc., 2006 FCA 51 at paragraph 17, Pfizer Canada Inc. v. Novopharm Ltd., 2005 FCA 270 at paragraph 11, AstraZeneca AB v. Apotex Inc., 2005 FCA 183 at paragraph 9, Pfizer Canada Inc. v. Apotex Inc., 2004 FCA 398 at paragraph 25.
[16] The central point in the appeal relating to the 457 patent is a question of law, namely the interpretation of subparagraph 5(1)(b)(iv) of the NOC Regulations. The standard of review for that question of law is correctness.
[17] The judge did not consider it necessary to determine whether Pharmascience was justified in its allegation that the 457 patent would not be infringed, because she found the notice of allegation to be inadequate. If the judge erred in determining that the notice of allegation was inadequate, this Court may consider whether the non-infringement allegation was justified, or it may return the justification question to the Federal Court for determination. If that question is determined for the first time in this Court, no standard of review will apply.
[18] The issue raised in the appeal relating to the 206 patent is whether the allegation of invalidity was justified. In that regard, there is a dispute about the applicable legal principles but no substantial factual dispute. The standard of review is correctness.
[19] Counsel for Schering raised an issue suggesting that there may be two different schemes for determining the standard of appellate review where there is a dispute as to the invalidity of a patent. Generally, the standard of review in an appeal from a trial decision is correctness for questions of law, and palpable and overriding error for questions of fact: Housen v. Nikolaisen, [2002] 2 S.C.R. 235 and H.L. v. Canada(Attorney General), [2005] 1 S.C.R. 401. A challenged decision of any other decision maker, which ordinarily would be initiated by way of an application for judicial review, is reviewed on a standard of correctness, reasonableness, or patent unreasonableness, depending upon the outcome of a pragmatic and functional analysis of the relevant factors (Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982).
[20] Counsel for Schering referred to paragraph 24 of Schmeiser v. Monsanto Canada Inc., [2004] 1 S.C.R. 902 (the canola case) and paragraphs 41 to 42 of Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153 (the AZT case) as authority for the proposition that a decision of the Commissioner of Patents on the validity of a patent is a question of mixed law and fact, for which the standard of review is reasonableness. I note that those cases also indicate that the standard of review for such a decision of the Commissioner is correctness for questions of law (Harvard Collegev. Canada(Commissioner of Patents), [2002] 4 S.C.R. 45). Counsel for Schering argued that the comments in the canola case and the AZT case, combined with the statutory presumption of validity in section 43 of the Patent Act, indicate that some degree of deference is owed to the Commissioner whenever the validity of a patent is in question.
[21] Neither the canola case nor the AZT case were applications for judicial review of a decision of the Commissioner. Rather, they involved appeals of judgments of the Federal Court after a trial. For that reason, it is not clear why the standard of review in those cases was not governed by Housen v. Nikolaisen and H.L. v. Canada, especially since the evidence presented at the trial would not have been the same as the evidence before the Commissioner. Nor is it clear whether, as a practical matter, the two different schemes of standard of review would or should result necessarily in different outcomes. In any event, the submissions of counsel for Schering have not persuaded me that the canola case and the AZT case require this Court to reconsider its established jurisprudence relating to the standard of review in proceedings under the NOC Regulations.
The 457 patent B sufficiency of the notice of allegation
[22] The notice of allegation served by Pharmascience in connection with its abbreviated new drug submission states that no claim of the 457 patent would be infringed by the making, constructing, using, or selling by Pharmascience of its ramipril capsules. The notice of allegation also contains these statements (Appeal Book, Volume 1, page 78):
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In particular, the Pharmascience products for which a Notice of Compliance is sought will not be made, constructed, used or sold by Pharmascience for treating cardiac insufficiency and will not be a composition for treating cardiac insufficiency as claimed in the claims of the 457 Patent. |
The judge found this to be a bald assertion of non-infringement, and therefore inadequate, because it failed to set out the basis upon which marketing would not include marketing for the treatment of cardiac insufficiency. Pharmascience submits that in making that determination, the judge made a palpable and overriding error of fact, and also erred in law.
[23] The factual component of the judge=s determination turns on the contents of the notice of allegation and the detailed statement of fact and law that is attached to it. In that regard, it appears that the judge disregarded the following particulars about marketing that are contained in the detailed statement (Appeal Book, Volume 1, page 79):
| Ramipril falls within the scope of Formula I referred to in Claim 1 of the 457 Patent, but the product to be made and sold by [sic] will not be made or sold to be used to treat cardiac insufficiency in mammals. Pharmascience's product will be made and sold for the treatment of hypertension. In particular, the product monograph will not list cardiac insufficiency as an indicated use, a Notice of Compliance is not be [sic] sought for use for the treatment of cardiac insufficiency and the marketing of the product by Pharmascience will not include any references to the treatment of cardiac insufficiency. |
There are two senses in which a notice of allegation may be said to be "inadequate" or "insufficient". In these reasons, I am using those words as they are used in AstraZeneca AB v. Apotex Inc., 2005 FCA 183 (and a long line of prior cases) to describe a judicial determination as to whether the person to whom the notice of allegation has sufficient information to determine whether to seek a prohibition order.
[24] The same words are sometimes used in what I call their Asecondary sense@, to describe a situation where 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 (for example, where it is based on an incorrect construction of a patent claim). A notice of allegation cannot be found to be inadequate or insufficient in that secondary sense without addressing the allegation on the merits. Because the judge in this case did not assess the merits of the non-infringement allegation, I conclude that when she used the word Ainadequate@ to describe the notice of allegation, she was not using that word in its secondary sense. Therefore, in this case the applicable legal principle is that a notice of allegation is adequate if it sets out the grounds for the allegation well enough to enable the person to whom it is addressed to make an informed decision about whether to commence prohibition proceedings (AstraZeneca AB v. Apotex Inc., cited above, at paragraph 12). For the following reasons, I have concluded that the judge did not apply the correct legal test when she found the notice of allegation to be inadequate.
[25] The record contains no evidence that was capable of establishing that the notice of allegation and detailed statement left Aventis guessing at the grounds for Pharmascience=s non-infringement allegation (see SmithKline Beecham Inc. v. Apotex Inc. (2001), 10 C.P.R. (4th) 338 (F.C.A.) at paragraph 27). On the contrary, the record establishes that Aventis was in no doubt, after being served with the notice of allegation and the detailed statement, that Pharmascience was proposing to market its product for use in the treatment of hypertension and not for use in the treatment of cardiac insufficiency. Based on that information, Aventis concluded that infringement of the 457 patent would be inevitable if a notice of compliance were issued to Pharmascience for its ramipril capsules. That belief is the foundation of its application under the NOC Regulations for a prohibition order.
[26] In support of its application for a prohibition order, Aventis submitted evidence relating to the operation of provincial drug formularies, and in particular the policy of certain provincial authorities to require, in certain circumstances, that patients be provided with a cheaper generic version of the more expensive patented product. Given that the Pharmascience product is therapeutically equivalent to Altace in the treatment of either hypertension or cardiac insufficiency, that evidence was intended to establish the contention of Aventis that infringement of the 457 patent would be inevitable once Pharmascience was permitted to market its ramipril capsules.
[27] Pharmascience responded to the Aventis evidence with affidavits explaining Alimited interchangeability@. That evidence suggests that at least one province may accede to a request to list a generic product only for the conditions for which it has been approved. Apparently, the argument of Pharmascience was that since that flexibility exists within provincial policy, infringement would not be inevitable.
[28] The judge considered the responding evidence of Pharmascience to be an impermissible attempt to expand the basis of its non-infringement allegation. Assuming that conclusion is valid (a point which I need not decide), the remedy was to disregard the evidence, not to find the notice of allegation to be inadequate. Logically, the responding evidence is not capable of establishing that Aventis did not have enough information to make an informed decision as to whether to make its application.
The 457 patent B whether the non-infringement allegation is justified
[29] I turn now to the question of whether the allegation of non-infringement of the 457 patent was justified. As that question was not determined by the judge, this Court may either determine the question itself, or return the matter to the Federal Court. In my view, the record on this point is sufficiently clear that it would be appropriate for this Court to determine the question.
[30] The statements made by Pharmascience in its notice of allegation and detailed statement are set out above and need not be repeated. It is sufficient to say that any factual statements made by Pharmascience in those documents are presumed to be true in the absence of evidence to the contrary. There is no such evidence in this case. Therefore, Pharmascience is entitled to the benefit of the presumption that it will market its ramipril capsules only for use in the treatment of hypertension.
[31] Pharmascience has provided some particulars about how it proposes to market its ramipril capsules. First, Pharmascience is seeking approval for its ramipril capsules only for use in the treatment of hypertension. Second, the packaging for the Pharmascience ramipril capsules will be labeled in a manner that will inform anyone who reads the label that the capsules are approved for use in the treatment of hypertension. Third, the product monograph will say that Pharmascience ramipril capsules are approved for use in the treatment of hypertension, and it will not say that they can or may or should be used in the treatment of cardiac insufficiency. Cardiac insufficiency and related conditions are mentioned in the product monograph only in the context of contraindications. Those references cannot be construed as an attempt to encourage the use of the Pharmascience ramipril capsules for the treatment of cardiac insufficiency.
[32] Aventis points out that the Pharmascience product is proposed to be similar in appearance to the Altace product. It is common practice for a drug manufacturer who produces a generic version of a comparable product to make its product similar in appearance to the comparable product. Pharmascience proposes to adopt such a practice in this case. The Pharmascience ramipril capsules will be similar in colour and shape to Altace capsules, although they will bear the word Aramipril@ and the Pharmascience logo, and not the name AAltace@. However, the similarity in appearance between Altace and the Pharmascience ramipril capsules does not contradict the assertion of Pharmascience that it will be marketing its capsules only for use in the treatment of hypertension because Altace is approved for use in the treatment of both hypertension and cardiac insufficiency.
[33] There is evidence, and indeed Pharmascience now concedes, that because of the drug prescription policies of some or all provincial governments relating to drug formularies, it is inevitable that if Pharmascience is given a notice of compliance for its ramipril capsules, some physicians will prescribe Pharmascience ramipril capsules for use in the treatment of cardiac insufficiency, and some pharmacists will dispense Pharmascience ramipril capsules for that use, and some patients will take Pharmascience ramipril capsules for that use. That is likely to happen even if the Pharmascience product is approved by the Minister only for use in the treatment of hypertension, and regardless of the steps taken by Pharmascience to ensure that its product is labeled and described in its product monograph as being only for use in the treatment of hypertension.
[34] For the purposes of this appeal, I will assume without deciding that any patient who takes Pharmascience ramipril capsules for the treatment of cardiac insufficiency will infringe the 457 patent. I will also assume without deciding that a prescribing physician or a dispensing pharmacist may be found to have induced that infringement if Pharmascience ramipril capsules are prescribed or dispensed for use in the treatment of cardiac insufficiency. Pharmascience and Aventis are in substantial agreement on these points (although they also agree that certain defences may be made out; for the purposes of this appeal I need not consider that possibility). The inescapable conclusion is that some infringement of the 457 patent by patients is probable if Pharmascience is permitted to market its ramipril capsules.
[35] Aventis does not and cannot argue that mere marketing by Pharmascience of its product for use in the treatment of hypertension, without more, amounts to infringement by Pharmascience of the 457 patent, or infringement through inducement or procurement of infringement by others: see Valmet Oy v. Beloit Canada Ltd. (1988), 20 C.P.R. (3d) 1 (F.C.A.). Rather, Aventis argues that it is entitled to an order prohibiting the Minister from issuing a notice of compliance to Pharmascience for its ramipril capsules because infringement of the 457 patent by patients is inevitable if that notice of compliance is issued.
[36] In support of that argument, Aventis cites the decision of this Court in what is commonly called AGenpharm@, Procter & Gamble Pharmaceutical Canada, Inc. v. Canada (Minister of Health) (C.A.), [2003] 1 F.C. 402 (affirming the decision of Justice McKeown in 2001 FCT 1151; application for leave to appeal dismissed). Aventis relies on the following statements from Genpharm, at paragraphs 50 and 51:
| [50] In this case, if a patient used the Genpharm product for osteoporosis, the use claims of P & G's '376 Patent would be infringed. It would be Genpharm's selling of its product that would result in the infringement. Here, the evidence is overwhelming that it is not only probable, but inevitable, that Genpharm's Gen-etidronate product would, if notices of compliance issue, be used for the treatment of osteoporosis in the cyclical regimen that constitutes the invention under the '376 Patent. [51] Accordingly, Genpharm's allegations of non-infringement are not justified and, on the merits, a prohibition order should be issued.
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The argument made by Aventis in this appeal was accepted in another case, Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1381 (appeal pending).
[37] Pharmascience argues that the NOC Regulations do not require it to address the possibility or the probability of infringement of the 457 patent by patients. In support of that argument, Pharmascience cites the decision of this Court in AB Hassle v. Canada(Minister of National Health and Welfare), 2002 FCA 421 (affirming the decision of Justice O=Keefe in 2001 FCT 1264; application for leave to appeal dismissed). Pharmascience relies on the following statements from AB Hassle, at paragraphs 57 and 58:
| [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. [58] Nor can Apotex be held liable in patent infringement proceedings under the Patent Act if, contrary to the evidence presented in the NOC proceeding, third party infringements do occur after the issue of a NOC, unless Apotex has implicated itself in the infringements by, for example, inducing or encouraging them. Genpharm has no application to a generic's liability under the Patent Act for any patent infringement by a third party that occurs after a NOC has been issued. |
[38] AB Hassle has been followed in a number of cases in the Federal Court: AstraZeneca AB v. Apotex Inc., 2006 FC 7 (appeal pending), Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1461 (appeal pending), Pfizer Canada Inc. v. Apotex Inc., 2005 FC 1421 (not appealed), Axcan Pharma Inc. v. Pharmascience Inc., 2005 FC 1231 (not appealed), H. Lundbeck A/S v. Canada (Minister of Health), 2003 FC 1334 (appeal discontinued), H. Lundbeck A/S v. Canada (Minister of Health), 2003 FC 1145 (appeal discontinued), AB Hassle v. Apotex Inc., 2004 FC 379 (appeal discontinued), AstraZeneca AB v. Apotex Inc., 2004 FC 313 (appeal filed but dismissed as moot; leave to appeal to the Supreme Court of Canada refused).
[39] Although the excerpts quoted above give the impression of a conflict between Genpharm and AB Hassle, the appearance of conflict is largely resolved when the cases are understood in light of their respective facts.
[40] The inevitable infringement referred to in Genpharm was the result of particular steps Genpharm proposed to take in marketing its generic product, leading this Court to infer that Genpharm would in fact be marketing its product for a patented use although it denied doing so. The medicine in issue, etidronate disodium, had been used for many years in the treatment of Paget=s disease and hypercalcemia of malignancy. For that purpose, it was sold by Procter & Gamble in 200 mg pills under the name Didronel. The patent in issue claimed the use of etidronate disodium for use in the treatment of osteoporosis. The patented use of etidronate disodium involved a particular regimen of intermittent dosage of the medicine. An osteoporosis patient was required to take a 400 mg pill containing the medicine for a specified number of days, and then no medicine for a specified number days. Procter & Gamble sold its osteoporosis treatment under the name Didrocal. The intermittent dosage regimen was facilitated by selling Didrocal in a kit containing blister packages with 14 pills, one for each day in a two week cycle, but some of the pills would be the medicine and others would be a placebo.
[41] Genpharm claimed to be marketing its product for use in the treatment of Paget=s disease and hypercalcemia of malignancy, and yet it proposed to produce 400 mg pills rather than 200 mg pills, and it proposed to use 14 pill blister packaging that could perform the same function as the packaging for the patented product. In addition, the product monograph for the generic product included studies that compared the bioavailability of the generic product to Didrocal (the osteoporosis product) rather than Didronel (the product for Paget=s disease and hypercalcemia of malignancy).
[42] The AB Hassle case was decided a few months after Genpharm. The medicine in issue in AB Hassle was omeprazole, which had long been established as a useful treatment for the reduction of gastric acid secretions. The patent in issue claimed the use of omeprazole for the treatment of campylobacter (H. Pylori) infections. Apotex proposed to market its own omeprazole product, and alleged that the patent would not be infringed because Apotex would not seek approval for its product for use in the treatment for the treatment of campylobacter infections, and would not refer to that use in its product monograph. AB Hassle sought a prohibition order. Its application in the Federal Court failed for lack of evidence that there would be any infringement by Apotex, or any infringement induced by Apotex. That aspect of the decision was upheld on appeal.
[43] An argument was made in AB Hassle based on Genpharm. That argument was essentially the same argument made by Aventis in this case B that if infringement of a use patent is inevitable once a generic product is approved, even for a different use, then the Minister should be prohibited from approving the generic product. That argument failed in AB Hassle, for two reasons.
[44] First, the Court found the facts of Genpharm to be distinguishable (AB Hassle, paragraph 54), because of the inference that Genpharm would in fact be marketing its product for a patented use, an inference that could not be made on the evidence in AB Hassle.
[45] Second, the Court concluded that Genpharm does not stand for the proposition that mere sale by a generic producer of a medicine subject to a use patent is sufficient to constitute infringement of that patent for the purpose of subparagraph 5(1)(b)(iv) of the NOC Regulations (AB Hassle, paragraphs 55 to 56), confirming the interpretation of subparagraph 5(1)(b)(iv) of the NOC Regulations as stated by Justice O=Keefe (2001 FCT 1264 at paragraph 49).
[46] As I understand the argument of Aventis in this case, it is a challenge to the correctness of the interpretation of subparagraph 5(1)(b)(iv) upon which the decision of this Court in AB Hassle is based. In my view, the AB Hassle interpretation of subparagraph 5(1)(b)(iv) is correct.
[47] The leading authority on the general principles to be applied in interpreting the NOC Regulations is Bristol-Myers Squibb Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533 (usually referred to as ABiolyse@). That case involved Biolyse Pharma Corporation, a drug manufacturer that was seeking a notice of compliance for a new drug containing the medicine paclitaxel. Its new drug submission did not compare its new drug to any other drug. Bristol-Myers Squibb Company (BMS) had previously been issued a notice of compliance for its paclitaxel drug, Taxol. A number of patents relating to paclitaxel were listed on the patent register for Taxol. BMS argued Biolyse was required by section 5(1.1) of the NOC Regulations to serve a notice of allegation addressing its listed patents, failing which the Minister could not issue Biolyse a notice of compliance.
[48] Biolyse would have had a legal obligation to serve BMS with a notice of allegation only if the statutory condition in the following words of section 5(1.1) of the NOC Regulations were met:
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... where a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine found in another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted ... |
... la personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament que l'on trouve dans une autre drogue qui a été commercialisée au Canada par suite de la délivrance d'un avis de conformité à la première personne et à l'égard de laquelle une liste de brevets a été soumise ... |
BMS argued that the statutory condition was met because Biolyse had filed a submission for a notice of compliance in respect of its product, its product contained paclitaxel, which is found in Taxol, and BMS had a notice of compliance for Taxol in respect of which a patent list had been submitted.
[49] Justice Binnie, writing for the majority of the Supreme Court of Canada in Biolyse, characterized the issue as a dispute as to the correct interpretation of subsection 5(1.1) of the NOC Regulations. He referred to the modern approach to statutory interpretation as set out in Rizzo & Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27, which like many cases before and since have adopted the following words from Driedger, Construction of Statutes (2nd ed. 1983), at page 87:
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Today there is only one principle or approach, namely, the words of an Act are to be read in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament. |
He also noted that the same edition of Driedger says this about the interpretation of regulations (at page 247):
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It is not enough to ascertain the meaning of a regulation when read in light of its own object and the facts surrounding its making; it is also necessary to read the words conferring the power in the whole context of the authorizing statute. The intent of the statute transcends and governs the intent of the regulation.
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[50] The provision of the Patent Act authorizing the NOC Regulations was part of a package of amendments to the Patent Act that included the abolition of the former compulsory licensing regime, the extension of the term of patents from 17 to 20 years, and the addition of a number of exceptions to the infringement provisions, including what is called the "early working exception" in subsection 55.2(1) of the Patent Act. The early working exception permits the use of patented inventions for certain research and development work. Subsection 55.2(1) reads as follows:
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55.2 (1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product. |
55.2 (1) Il n'y a pas contrefaçon de brevet lorsque l'utilisation, la fabrication, la construction ou la vente d'une invention brevetée se justifie dans la seule mesure nécessaire à la préparation et à la production du dossier d'information qu'oblige à fournir une loi fédérale, provinciale ou étrangère réglementant la fabrication, la construction, l'utilisation ou la vente d'un produit.
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[51] In the same package of legislative amendments, subsection 55.2(4) was added to the Patent Act to authorize the Governor in Council to make regulations for the purpose of deterring abuse of the early working exception. Subsection 55.2(4) reads as follows:
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(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1), including, without limiting the generality of the foregoing, regulations |
(4) Afin d'empêcher la contrefaçon d'un brevet d'invention par l'utilisateur, le fabricant, le constructeur ou le vendeur d'une invention brevetée au sens du paragraphe (1), le gouverneur en conseil peut prendre des règlements, notamment_: |
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(a) respecting the conditions that must be fulfilled before a notice, certificate, permit or other document concerning any product to which a patent may relate may be issued to a patentee or other person under any Act of Parliament that regulates the manufacture, construction, use or sale of that product, in addition to any conditions provided for by or under that Act; |
a) fixant des conditions complémentaires nécessaires à la délivrance, en vertu de lois fédérales régissant l'exploitation, la fabrication, la construction ou la vente de produits sur lesquels porte un brevet, d'avis, de certificats, de permis ou de tout autre titre à quiconque n'est pas le breveté;
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(b) respecting the earliest date on which a notice, certificate, permit or other document referred to in paragraph (a) that is issued or to be issued to a person other than the patentee may take effect and respecting the manner in which that date is to be determined; |
b) concernant la première date, et la manière de la fixer, à laquelle un titre visé à l'alinéa a) peut être délivré à quelqu'un qui n'est pas le breveté et à laquelle elle peut prendre effet; |
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(c) governing the resolution of disputes between a patentee or former patentee and any person who applies for a notice, certificate, permit or other document referred to in paragraph (a) as to the date on which that notice, certificate, permit or other document may be issued or take effect; |
c) concernant le règlement des litiges entre le breveté, ou l'ancien titulaire du brevet, et le demandeur d'un titre visé à l'alinéa a), quant à la date à laquelle le titre en question peut être délivré ou prendre effet; |
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(d) conferring rights of action in any court of competent jurisdiction with respect to any disputes referred to in paragraph (c) and respecting the remedies that may be sought in the court, the procedure of the court in the matter and the decisions and orders it may make; and |
d) conférant des droits d'action devant tout tribunal compétent concernant les litiges visés à l'alinéa c), les conclusions qui peuvent être recherchées, la procédure devant ce tribunal et les décisions qui peuvent être rendues; |
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(e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent. |
e) sur toute autre mesure concernant la délivrance d'un titre visé à l'alinéa a) lorsque celle-ci peut avoir pour effet la contrefaçon de brevet. |
[52] In Biolyse, Justice Binnie says that the NOC Regulations must be interpreted in light of the purpose of subsection 55.2(4) of the Patent Act and the related legislative amendments. His analysis includes an observation that seems to me to be germane to the issue of statutory interpretation raised in this case. He said at paragraph 53:
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Section 55.2(4) is specifically directed to preventing infringement by persons who use "the patented invention" for the "early working" exception [...]. That is all the Governor in Council is authorized to regulate. |
[53] Justice Binnie went on to conclude that the NOC Regulations were not engaged by the new drug submission of Biolyse, because Biolyse was seeking approval for a new drug without making any comparisons to an existing drug. As Biolyse was not within the scope of subsection 55.2(4), it could not be within the scope of the NOC Regulations either.
[54] The interpretive principle from Biolyse weighs against an interpretation of the NOC Regulations that assumes that they are intended to prevent all patent infringement. Biolyse is more consistent with an interpretation of the NOC Regulations that assumes that they are intended to prevent only infringement by (or infringement induced or procured by) generic drug producers who make abbreviated new drug submissions containing one of the stipulated comparisons to an existing drug product.
[55] I turn now to the relevant words of subparagraph 5(1)(b)(iv) of the NOC Regulations, which sets out the required contents of a non-infringement allegation. It states that in a non-infringement allegation, the generic drug producer must allege that:
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... no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. |
... aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
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[56] Pharmascience argues that the words Aby that person@ means that this provision refers only to acts of Pharmascience that would constitute infringement of the 457 patent (which I understand would include acts of Pharmascience that induce or procure infringement by others). Aventis argues that subparagraph 5(1)(b)(iv) is capable of being read more broadly, and should be read more broadly, so that it includes any infringement by anyone of the 457 patent that results in any way from the issuance of a notice of compliance to Pharmascience.
[57] In my view, the interpretation proposed by Pharmascience is more consistent with the ordinary grammatical meaning of subparagraph 5(1)(b)(iv) of the NOC Regulations, and is also more consistent with the legislative scheme and purpose. Subsection 55.2(4) of the Patent Act and by extension the NOC Regulations are intended to prevent patent infringement by Pharmascience, not by patients.
[58] The narrower interpretation proposed by Pharmascience is also more consistent with the general scheme of the Patent Act. The bargain represented by the 087 patent permits anyone to use the patented invention (that is, to make ramipril using one of the claimed processes) once the term of that patent expired in November of 2002. If Pharmascience is now prevented from obtaining a notice of compliance for its ramipril capsules for use in the treatment of hypertension only because the inevitable result is infringement of the 457 patent by patients who use the Pharmascience product for the treatment of cardiac insufficiency, the practical result will be an artificial extension of the monopoly represented by the now expired 087 patent. I do not believe that Parliament intended the NOC Regulations to permit such a result. (This point is also made in AB Hassle, at paragraph 57.)
[59] I acknowledge that there are statements in Genpharm that could be taken to support the broader interpretation of subparagraph 5(1)(b)(iv) proposed by Aventis (see, for example, paragraphs 45 to 50). I make three observations about those statements. First, they are obiter dicta, made in the context of evidence that Genpharm would in fact market its product for a use that came within the claims of one of the listed patents, which was not true in AB Hassle and is not true in this case. Second, Genpharm was decided before this Court had the benefit of the decision of the Supreme Court of Canada in Biolyse. In my view, the statements in paragraphs 45 to 50 of Genpharm interpret subparagraph 5(1)(b)(iv) in a manner that is not consistent with Biolyse. Third, although I remain of the view that Genpharm was correct in result, paragraphs 45 to 50 of Genpharm, read in isolation, do not reflect the correct interpretation of subparagraph 5(1)(b)(iv) of the NOC Regulations, and to that limited extent should be taken to have been reversed by AB Hassle.
[60] For these reasons, I conclude that the narrower interpretation of subparagraph 5(1)(b)(iv) of the NOC Regulations, as proposed by Pharmascience, is correct. As there is no evidence that Pharmascience will infringe the 457 patent, or that it will induce or procure the infringement by others of the 457 patent, the allegation of non-infringement of the 457 patent is justified. It follows that, even before the 457 patent expired on December 13, 2005, there was no basis upon which the Federal Court could have granted the application of Aventis for an order prohibiting the Minister from issuing a notice of compliance to Pharmascience for its ramipril capsules.
[61] After the expiry of the 457 patent on December 13, 2005, it was open to Pharmascience to amend its abbreviated new drug submission to seek approval for its ramipril capsules for use in the treatment of cardiac insufficiency as well as hypertension, and to change its marketing plans accordingly.
The 206 patent B whether the invalidity allegation is justified
[62] Several claims of the 206 patent (claims 1, 2, 3, 6 and 12) claim a genus of compounds that include ramipril (although ramipril is not specifically disclosed in the 206 patent). The allegation of invalidity of the 206 patent is that the relevant claims (claims 1, 2, 3, 6 and 12) cover subject matter that is not patentably distinct from subject matter covered by the 087 patent (which claims ramipril made by certain processes). The detailed statement says that the legal basis for that allegation is Adouble patenting@.
[63] The judge found that the allegation of invalidity was not justified because, in 1981 when the application for the 206 patent was filed, the invention disclosed in the 206 patent would not have been obvious to a person skilled in the art. Pharmascience appears to accept that the judge was correct to use the established legal test for obviousness in the context of its double patenting argument, but argues that obviousness should have been assessed in 2001, the date of the issuance of the 206 patent, rather than 1981, the date of the filing of the application. The position of Pharmascience is that by 2001, both the 087 patent and the 457 patent had been issued, and it would have taught the skilled person the invention disclosed in the 206 patent.
[64] The main difficulty with the argument of Pharmascience as to the relevant date for assessing obviousness is that the record contains no evidence that is capable of establishing that the 206 invention would have been obvious in 2001 from the 087 invention or the 457 invention. The evidence that is most favourable to Pharmascience on this point is the affidavit of Professor Kluger (Appeal Book, Volume VII, pages 1756-7). Professor Kruger was not cross examined, and his evidence is not challenged. I paraphrase his evidence as follows:
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In 2001, it would have been obvious to a person skilled in the art that: |
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(1) the claims of the 087 patent cover ramipril when prepared by certain processes; |
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(2) claims 1, 2, 3, 6 and 12 of the 206 patent cover ramipril, and therefore cover ramipril when made by any of the processes in the claims of the 087 patent; |
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(3) the claims of the 457 patent cover certain compositions of ramipril for use in the treatment of cardiac insufficiency; |
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(4) claims 1, 2, 3, 6 and 12 of the 206 patent cover ramipril, and therefore cover any composition of ramipril covered in the claims of the 457 patent for treating cardiac insufficiency. |
This evidence is capable of proving that, to a person skilled in the art, the existence of ramipril would have been obvious in 2001 from the claims of the 087 patent and the 457 patent. However, it falls considerably short of proving, on a balance of probabilities, that the range of compounds covered by any of the relevant claims of the 206 patent (even Claim 12, which covers eight compounds, one of which is ramipril) would have been obvious to a skilled person in 2001.
[65] Given the evidence of Professor Kluger, it is even less likely that the invention disclosed in the 206 patent would have been obvious in 1981 when the application for the 206 patent was filed. Therefore, whether the judge assessed obviousness as of 2001 or 1981, the result would be the same.
[66] This conclusion is fatal to the Pharmascience appeal in respect of the 206 patent. It is unnecessary to consider whether the judge was correct to conclude that the doctrine of double patenting is not limited to cases involving a single inventor. However, since the point was fully argued, I will discuss it.
[67] ADouble patenting@ refers to certain judge made rules that have been devised to prevent the Aevergreening@ of patents. Evergreening is the undue extension of the statutory monopoly in a particular patent by means of a series of patents with obvious or uninventive additions (Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, at paragraph 37).
[68] The jurisprudence has so far identified two categories of double patenting. In the first category, Asame invention patenting@, two patents are the same or have an identical or conterminous claim. The second category, Aobviousness double patenting@, is somewhat broader. In obviousness double patenting, the claims of the patents are not identical or conterminous, but the later patent has claims that are not patentably distinct from the other patent, or involve no novelty or ingenuity.
[69] The claims of the 206 patent are not identical or conterminous with the claims of the 087 patent or the 457 patent. Therefore, the invalidity allegation in this case must be understood as an allegation of obviousness double patenting. The classic example of obviousness double patenting is Commissioner of Patents v. Farbwerke Hoechst Aktien-Gesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49. Farbwerke Hoechst applied for a patent for a medicine that was a diluted version of a medicine for which it had already obtained a patent. The claims were not identical or conterminous. Justice Judson held that the patent was invalid. He said (at page 53):
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A person is entitled to a patent for a new, useful and inventive medicinal substance but to dilute that new substance once its medical uses are established does not result in further invention. The diluted and undiluted substance are but two aspects of exactly the same invention. In this case, the addition of an inert carrier, which is a common expedient to increase bulk, and so facilitate measurement and administration, is nothing more than dilution and does not result in a further invention over and above that of the medicinal itself.
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[70] Aventis and Schering argue that the doctrine of double patenting cannot apply unless there are multiple patents issued to the same inventor. In this case, the inventor of the 206 patent is not the same as the inventor of the 087 or 457 patents. They also argue that it would be wrong to extend the doctrine of double patenting to this case, because the result would be inconsistent with the scheme of the Patent Act as it read when the application for the 206 patent was filed.
[71] I agree with Aventis and Schering that in this case, applying the doctrine of double patenting would be inconsistent with the relevant statutory scheme. The issues relating to the validity of the 206 patent are governed by the Patent Act as it read prior to 1989 (the old Patent Act). Under paragraph 27(1)(a) of the old Patent Act, the first inventor of an invention was entitled to a patent regardless of the date upon which the application was filed, and the term of the patent began when the patent was issued and ran for a term of 17 years from that date. Delays in the commencement of the term could and often did result from conflict proceedings. Such delays were inherent in the statutory scheme.
[72] The inventions disclosed in the 087 patent and the 457 patent are not only narrower in scope than the inventions disclosed in the 206 patent, but are later in time (based on their respective application dates).Given that the inventors of the 087 and 457 patents were working independently of the inventor of the 206 patent, it cannot reasonably be found in this case that the filing of the application for the 206 patent was an attempt to extend unduly the term of the 087 patent and the 457 patent. On the contrary, to apply the doctrine of double patenting to the 206 patent in the circumstances of this case would deprive Schering unfairly of the patent rights to which it became entitled as a result of the disclosure of the 206 patent, and that outcome would be caused merely by the delay in the issuance of the 206 patent.
[73] That is not to say that I would be prepared at this point to adopt the proposition that double patenting can never apply unless there is a single inventor. Although it is difficult at this point to envisage a case involving more than one inventor that is or should be vulnerable to a claim of double patenting, I see no reason to foreclose such a possibility. In my view the doctrine of double patenting, as a set of judge made rules, should be left to evolve on a case by case basis.
[74] For these reasons, I conclude that the judge was correct to find that the allegation of invalidity of the 206 patent was not justified.
Conclusion
[75] For these reasons, I would dismiss the appeal with costs. The prohibition order dated March 11, 2005 ceased to have effect with respect to the 457 patent when that patent expired on December 13, 2005, but it remains in effect with respect to the 206 patent.
"I agree.
J. Edgar Sexton J.A."
"I agree.
B. Malone J.A."
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-155-05
STYLE OF CAUSE: PHARMASCIENCE INC. v. SANOFI-AVENTIS CANADA INC. and SANOFI-AVENTIS DEUTSCHLAND GmbH and THE MINISTER OF HEALTH AND SCHERING CORPORATION
PLACE OF HEARING: Montreal
DATE OF HEARING: June 6 and 7, 2006
REASONS FOR JUDGMENT BY: SHARLOW J.A.
CONCURRED IN BY: SEXTON J.A.
MALONE J.A.
DATED: June 21, 2006
APPEARANCES:
| Donald H. MacOdrum Mark Mitchell |
FOR THE APPELLANT (RESPONDENT) |
| A. David Morrow
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FOR THE RESPONDENTS (APPLICANTS) SANOFI-AVENTIS
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| Anthony Creber |
FOR THE RESPONDENT (RESPONDENT) SCHERING |
SOLICITORS OF RECORD:
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Toronto, Ontario
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FOR THE APPELLANT (RESPONDENT) |
| Smart & Biggar Toronto, Ontario
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FOR THE RESPONDENTS (APPLICANTS) SANOFI-AVENTIS |
| Gowling Lafleur Henderson LLP Ottawa, Ontario |
FOR THE RESPONDENT (RESPONDENT) SCHERING |