Court Refusing to Prohibit Issuance of Notice of Compliance for Levofloxacin

In a decision rendered on November 19, 2004, Justice Richard Mosley of the Federal Court dismissed an application that had been commenced by Janssen-Ortho Inc. and Daiichi Pharmaceutical Co., Ltd. under the Patented Medicines (Notice of Compliance) Regulations for an order to prohibit the Minister of Health from issuing a notice of compliance (NOC) to Novopharm Ltd. for its generic version of the antimicrobial medicine levofloxacin, NOVO-LEVOFLOXACIN.

The applicants were the patentee and licensee of a patent that claimed
levofloxacin. The patentee was also the owner of an earlier, expired patent that disclosed and claimed ofloxacin, an antibiotic. Ofloxacin was a racemic compound that contained equal amounts of two optical isomers, otherwise known as enantiomers, one of which is levofloxacin. The court
dismissed the application on the basis that levofloxacin patent was
obvious in view of the prior art, and therefore invalid. Novopharm was
subsequently issued a NOC by Health Canada in relation to NOVO-LEOFLOXACIN.

The applicants appealed the decision of Justice Mosley, and sought an order to stay the judgment, expedite the appeal and quash the NOC. Novopharm brought a separate motion to dismiss the appeal on the ground of mootness in view of the issuance of the NOC. On January 4, 2005, Chief Justice Richard dismissed Janssen-Ortho’s motions.

On January 6, 2005, Chief Justice John Richard, writing on behalf of Justice Marshall Rothstein and Justice Denis Pelletier, allowed Novopharm\'s motion, and dismissed the appeal as being moot.

Jannsen-Ortho and Daiichi are seeking leave to appeal the decision of Chief Justice Richard, to the Supreme Court of Canada and have also commenced a patent infringement action in the Federal Court.

Novopharm was represented throughout by David Aitken and J. Bradley White, both of Osler, Hoskin & Harcourt LLP. Before the trial division, Janssen Ortho was represented by Anthony Creber and Cristin Wagner of Gowling Lafleur Henderson LLP in Ottawa, and on the appeal by Neil Belmore of Gowlings in Toronto. It is represented by Anthony Creber, Neil Belmore, Jennifer Wilkie and Ken Clark in the recentlyExecutive Knowledge Warscommenced patent infringement action. Daiichi Pharmaceutical was represented throughout by Michael Charles of Bereskin & Parr.