and
SANOFI-AVENTIS DEUTSCHLAND GmbH, and
THE MINISTER OF HEALTH
Respondents
Heard at Ottawa, Ontario, on April 24, 2007.
Judgment delivered at Ottawa, Ontario, on April 27, 2007.
REASONS FOR JUDGMENT BY: SHARLOW J.A.
CONCURRED IN BY: NADON J.A.
RYER J.A.
Docket: A-607-06
Citation: 2007 FCA 167
CORAM: NADON J.A.
SHARLOW J.A.
RYER J.A.
BETWEEN:
NOVOPHARM LIMITED
Appellant
and
SANOFI-AVENTIS CANADA INC.,
SANOFI-AVENTIS DEUTSCHLAND GmbH, and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT
[1] Novopharm Limited has appealed a Federal Court order dismissing its motion under paragraph 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the NOC Regulations) to dismiss a prohibition application by the respondents Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (collectively, “Sanofi”). The reasons for the order under appeal are reported as Sanofi-Aventis Canada Inc. v. Novopharm Ltd., 2006 FC 1547.
[2] Paragraph 6(5)(b) permits the Federal Court to dismiss a prohibition application that is “redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.” A decision on a motion to dismiss a proceeding is a discretionary one. It will not be reversed on appeal unless there is an error of law or principle, or a failure to exercise the discretion judicially: see Sanofi-Aventis Canada Inc. v. Novopharm Ltd., 2007 FCA 163, at paragraph 13.
[3] The medicine in issue is ramipril. The respondent Sanofi-Aventis Canada Inc. has a number of notices of compliance permitting it to market ramipril under the name “Altace” for certain uses. It was approved in Canada in 1993 for use in the treatment of hypertension. Later, other uses were approved, but those other approved uses are not relevant to this appeal. It is not alleged in this case that there is any patent for ramipril itself, or for the use of ramipril in the treatment of hypertension.
[4] Canadian Patent Number 2,023,089 (the 089 patent) and Canadian Patent Number 2,055,948 (the 948 patent) contain claims for the use of ramipril for certain “new uses” (that is, uses other than those for which ramipril has been approved in Canada). Sanofi has no notice of compliance that permits it to sell ramipril for any of the new uses claimed in the 089 patent or the 948 patent.
[5] The 089 patent and the 948 patent are listed on the patent register in relation to Altace. Paragraph 6(5)(a) of the NOC Regulations permits the propriety of a listing to be challenged by a motion. No such motion was before the Federal Court in this case. Therefore, this appeal has been decided on the basis that the 089 patent and the 948 patent are properly listed.
[6] In 2001, before the 089 patent and the 948 patent were issued, and before they were listed in respect of Altace, Novopharm filed an abbreviated new drug submission to obtain a notice of compliance for a generic version of ramipril for use in the treatment of hypertension. Altace is named as the comparator product. Novopharm proposes to market its generic product only for use in the treatment of hypertension. Novopharm is not seeking a notice of compliance that would permit it to market its generic product for any of the new uses claimed in the 089 patent or the 948 patent. Indeed, it could not do so because none of the new uses are approved for Altace.
[7] In the notice of allegation that led to this prohibition application by Sanofi, Novopharm alleges that its proposed ramipril product will not infringe the 089 patent or the 948 patent because its product will not be made or sold for any of the uses claimed in those patents. Novopharm also says in its notice of allegation that it will not make any representations about its proposed product that will induce infringement by others. Sanofi’s position is that the non-infringement allegations made by Novopharm are not justified.
[8] There were two main grounds for the motion of Novopharm to dismiss the prohibition application. The Judge’s decision rejected both grounds. Novopharm submits that the Judge was wrong on both points. In my view, it is necessary to consider only one of the grounds for Novopharm’s motion, and that is the ground based on Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA 229, leave to appeal to the Supreme Court of Canada refused, [2007] S.C.C.A. No. 362 (QL) and Sanofi-Aventis Canada Inc. v. Apotex Inc., 2006 FCA 357, leave to appeal to the Supreme Court of Canada refused, [2007] S.C.C.A. No. 5 (QL).
[9] Those cases establish that an allegation of non-infringement of a claim for the use of a medicine is justified if the generic drug manufacturer is seeking a notice of compliance only for a use that is not within the new use claim and the evidence fails to establish that the generic drug producer will infringe the new use claim by inducing others to prescribe or use the generic product for that new use.
[10] Infringement of a use claim by a person other than a generic drug manufacturer may occur because of the “off label” use of drug products. For example, if a notice of compliance is issued to Novopharm to permit it to market its generic ramipril product for use in the treatment of hypertension, and if a physician were to prescribe the Novopharm product, or a pharmacist were to dispense it, for one of the uses claimed in the 089 patent or the 948 patent (despite the fact that no such use has been approved even for Altace), the physician or pharmacist may be infringing the claims of the 089 patent or the 948 patent. However, Novopharm would not necessarily be implicated in those acts of infringement by the physician or pharmacist. 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.
[12] Novopharm argues that it is inevitable that its non-infringement allegation will be found to be justified because Novopharm is not seeking approval to market its product for any of the new uses claimed in the 089 patent or the 948 patent, and there is no evidence that Novopharm will induce others to use its product for any of those new uses. The Judge rejected this argument because the evidence on the question of infringement is not yet complete and because, given the time already taken to get the proceedings to this stage, Sanofi should not be deprived of its opportunity to complete the cross-examinations on the affidavits even though there is only a slim chance of any improvement in the evidentiary foundation for its application.
[13] In my view, the Judge erred in law in rejecting Novopharm’s argument on this point. The evidence in the prohibition proceedings consists of the affidavits filed by Sanofi and the affidavits filed by Novopharm. An exhibit to one of the affidavits submitted by Sanofi includes the product monograph for the proposed Novopharm ramipril product. It is redacted, but only in respect of the composition of the generic product and specific information about research relating to bioavailability. All of the information in the product monograph touching on the use of the generic product is unredacted. There is nothing in the redacted product monograph, or any of the other documents in the record, that is capable of establishing that Novopharm will infringe the 089 patent or the 948 patent, either directly or by inducing infringement by others. Sanofi does not contend that there is such evidence, but argues that something might emerge on cross-examination. In my view, that argument should have been rejected as entirely speculative. Once the speculative possibility of additional evidence is set aside, it is inevitable that the prohibition application in this case would fail because Novopharm’s non-infringement allegation is justified.
[14] Novopharm also submits that the Judge dismissed its motion for delay, and argues that delay is not a proper basis for denying relief under paragraph 6(5)(b) of the NOC Regulations. Whether delay by itself can be a complete answer to a motion under paragraph 6(5)(b) to dismiss prohibition proceedings is a question upon which I express no opinion. I agree with the Judge that Novopharm could have brought this motion as soon as Sanofi filed its affidavits, although at that time the issues relating to infringement through off label use were still being debated. Also, Novopharm brought its motion soon after it obtained a favourable result in other litigation that might have barred the issuance of its notice of compliance. Given my conclusion that the non-infringement allegation is justified, I see no basis for giving any weight to delay in this case.
[15] Novopharm also based its motion for dismissal on AstraZeneca Canada Inc. v. Canada (Minister of Health), [2006] 2 S.C.R. 560. Novopharm argues that, according to AstraZeneca, the NOC Regulations do not require Novopharm to address the 089 patent or the 948 patent because Novopharm cannot have benefited from the early working exception in subsection 55.2(1) of the Patent Act, R.S.C. 1985, c. P-4, in relation to those patents. The Judge noted that there is a debate as to the scope of the AstraZeneca decision. Given the conclusions I have already stated, I decline to express an opinion on the meaning of AstraZeneca.
[16] I would allow this appeal with costs in this Court and in the Federal Court, set aside the
order of the Federal Court, and make an order granting the motion of Novopharm to dismiss Sanofi’s prohibition application.
“I agree
M. Nadon J.A.”
“I agree
C. Michael Ryer J.A.”
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-607-06
APPEAL FROM A JUDGMENT OR ORDER OF THE FEDERAL COURT DATED DECEMBER 21, 2006, DOCKET NO. T-1979-05
STYLE OF CAUSE: NOVOPHARM LIMITED v. SANOFI-AVENTIS CANADA INC. ET AL.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: April 24, 2007
REASONS FOR JUDGMENT BY: SHARLOW J.A.
RYER J.A.
APPEARANCES:
|
Ms. Andy Radhakant |
FOR THE APPELLANT
|
|
Mr. Mark G. Biernacki
|
FOR THE RESPONDENTS, SANOFI-AVENTIS CANADA INC. ET AL. |
SOLICITORS OF RECORD:
|
Toronto, Ontario |
FOR THE APPELLANT
|
|
Toronto, Ontario |
FOR THE RESPONDENTS, SANOFI-AVENTIS CANADA INC. ET AL. |