PM(NOC) - Second Person Entitled to Its Day in Court
Apotex Inc. v. Janssen-Ortho Inc. and Daiichi Sankyo Company Inc. 2009 FCA 212 (Nadon, J.A, Layden-Stevenson, J.A., Trudel, J.A.)

June 22, 2009

Andrew Brodkin, Richard Naiberg and Belle Van for the Appellant, Apotex Inc. (“Apotex”)
Neil Belmore and Lindsay Neidrauer for the Respondent, Janssen-Ortho Inc. (“Janssen-Ortho”)
Michael Charles and Andrew McIntosh for the Respondent, Daiichi Sankyo Company Inc.

This was an appeal by Apotex of the decision of Shore J., prohibiting the Minister from issuing a NOC for levofloxacin hemihydrate tablet until the expiry of Canadian Patent No. 1,304,080 (“‘080 Patent”). The ‘080 Patent had been the subject of previous litigation between Janssen-Ortho and Novopharm, and its validity was previously confirmed by Hughes J. of the Federal Court (2006 FC 1234) and affirmed by the Court of Appeal (2007 FCA 217).

Shore J. had found that Janssen-Ortho was entitled to an order of prohibition and found that “no demonstration has been made as to invalidity or infringement”.

The Court of Appeal held that Shore J. erred in holding that the finding of validity in the previous litigation involving Novopharm made Apotex’s attempt to contest validity an abuse of process. The Court of Appeal found that a second person was entitled to have its day in court and was not required to show that it had “better evidence or a more appropriate legal argument” before it was permitted to send a NOA to a patentee and respond to an application for prohibition on similar grounds raised by a different generic in other proceedings involving the same patentee.

Appellate Justices Nadon and Trudel allowed the appeal with costs, set aside the previous decision and remitted the matter back for redetermination on the basis that there was no abuse of process by Apotex for filing its NOA and contesting the application for a prohibition order commenced by Janssen-Ortho. Appellate Justices Nadon and Trudel also found that Shore J. had simply adopted the findings of Hughes J. and accordingly directed Justice Shore to assess the evidence in the instant matter independently of any findings made by Justice Hughes in the previous litigation.

Layden-Stevenson J.A. agreed with the majority that Shore J. had erred on the issue of abuse of process. Layden-Stevenson J.A. disagreed with the finding by the majority that Shore J. had allowed the issue of abuse of process to taint the finding regarding anticipation and obviousness and would have dismissed the appeal with costs.

The appeal was allowed with costs to Apotex and a direction to the Judge to redetermine on the basis that there was no abuse of process by Apotex and to assess the evidence before him independently of findings made by Hughes J. in the preceding Novopharm decision.

By: Etienne de Villiers, Dimock Stratton LLP