Fournier Pharma Inc. v. Canada (Health)

Fournier Pharma Inc. v. Canada (Health) Court (s) Database Federal Court of Appeal Decisions Date 2005-10-11 Neutral citation 2005 FCA 326 File numbers A-3-05 Decision Content Date: 20051012 Docket: A-3-05 Citation: 2005 FCA 326 CORAM: SEXTON J.A. EVANS J.A. SHARLOW J.A. BETWEEN: FOURNIER PHARMA INC. and LABORATOIRES FOURNIER S.A. Appellants and THE MINISTER OF HEALTH and CIPHER PHARMACEUTICALS LIMITED Respondents Heard at Toronto, Ontario on October 11, 2005 Judgment delivered from the Bench at Toronto, Ontario on October 11, 2005. AMENDED REASONS FOR JUDGMENT OF THE COURT BY: SHARLOW J.A. Date: 20051012 Docket: A-3-05 Citation: 2005 FCA 326 CORAM: SEXTON J.A. EVANS J.A. SHARLOW J.A. BETWEEN: FOURNIER PHARMA INC. and LABORATOIRES FOURNIER S.A. Appellants and THE MINISTER OF HEALTH and CIPHER PHARMACEUTICALS LIMITED Respondents AMENDED REASONS FOR JUDGMENT OF THE COURT (Delivered from the Bench at Toronto, Ontario on October 11, 2005) SHARLOW J.A. [1] This is an appeal from a judgment of the Federal Court, 2004 FC 1718, dismissing Fournier's application under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Cipher for its product, a generic form of Fournier's product, 100 mg and 160 mg Lipidil Supra fenofibrate. Fournier's Canadian patent number 2,219,475 is listed on the patent register with respect to Fournier's product. [2] It is common ground that three of the essential elements of the claims of the 475 patent, at least in so far as they are relevant to this proceeding, are that the formulation of fenofibrate covered by the claim must be an immediate release formulation, that the fenofibrate be in micronized form, and that there be at least one layer of micronized fenofibrate, or a substance containing micronized fenofibrate, on an inert hydrosoluble carrier. Cipher alleged non-infringement based on each of those three essential elements. [3] The applications judge found that Fournier had failed to establish that any of the three non-infringement allegations was not justified. [4] We are all of the view that there is at least one of the three conclusions that withstands appellate scrutiny, and that is the second of the three. It is conceded by counsel for Fournier that this is sufficient to dispose of this appeal. We prefer to express no opinion on the other grounds of appeal. [5] The applications judge interpreted the relevant patent claims as constituting claims with respect to the finished formulation or composition. It is not suggested that she erred in that interpretation. [6] Cipher's notice of allegation includes these statements about the form of the fenofibrate: The second essential element in claim 1 is fenofibrate in "micronized form" [...]. The fenofibrate in the Cipher Products is not micronized. It is not in particulate form. Nor is it in the form of particles having any specified size. Rather, the non-micronized fenofibrate in the Cipher products is melted with other excipients to form, when cooled, a homogeneous phase or paste. The making, constructing, using or selling by Cipher of the Cipher Products does not infringe claim 1 of the '475 Patent [7] Fournier adduced evidence that was intended to disprove the factual allegation that the fenofibrate in the finished Cipher product would be non-micronized. The applications judge concluded that the evidence did not achieve that result. We can find no palpable and overriding error in that factual conclusion. [8] It is argued for Fournier, based on a statement made by the apparent author of the notice of allegation in cross-examination, that Cipher's notice of allegation is intended to describe fenofibrate in the form in which it is supplied to the formulator, and not the form in which it appears in the finished product. Thus, when the applications judge concluded that Fournier had failed to establish that Cipher's finished product contains fenofibrate in micronized form, she was finding a justification that was not asserted in the notice of allegation. [9] It is apparent that the applications judge did not read the notice of allegation as narrowly as Fournier contends. It is equally apparent that Fournier's own expert responded to the notice of allegation by opining on the finished Cipher product. We can detect no error of law, and no palpable and overriding error of fact, in the judge's interpretation of the notice of allegation. [10] This appeal will be dismissed with costs. "Karen R. Sharlow" J.A. FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-3-05 STYLE OF CAUSE: FOURNIER PHARMA INC. and LABORATOIRES FOURNIER S.A. Appellants and THE MINISTER OF HEALTH and CIPHER PHARMACEUTICALS LIMITED Respondents PLACE OF HEARING: TORONTO, ONTARIO DATE OF HEARING: OCTOBER 11, 2005 AMENDED REASONS FOR JUDGMENT OF THE COURT: (SEXTON, EVANS & SHARLOW JJ.A.) DELIVERED FROM THE BENCH BY: SHARLOW J.A. APPEARANCES: David Reive Angela Furlanetto FOR THE APPELLANTS Shonagh Mc Vean Paul Thomas FOR THE RESPONDENTS SOLICITORS OF RECORD: Dimock Stratton LLP Toronto, Ontario FOR THE APPELLANTS Gilberts LLP Toronto, Ontario FOR THE RESPONDENTS