In AB Hassle v Apotex Inc (September 4 2002, Neutral Citation FCT 931) the Trial Division of the Federal Court prohibited the issuance of a notice of compliance to Apotex for omeprazole/omeprazole magnesium tablets on the basis that it failed to disclose product samples that would have assisted in determining whether its tablets infringed patents owned by Hassle.

The principal issue in the proceeding, brought under the Patented Medicines (Notice of Compliance) Regulations, was whether Apotex's product would incorporate a subcoating. The parties submitted conflicting expert evidence on this issue which Justice Kelen was unable to resolve. He noted that the experts retained by the parties disagreed as to whether the material at the interface of the core and the outer coating was a subcoating within the meaning of the patents. Referring to a related case, AB Hassle v RhoxalPharma (2000)10 CPR (4th) 38, where tablets were produced and tested in respect of two of the same patents, the court found that Apotex's tablets could have been analyzed to identify the existence and characteristics of the subcoating. Further, Apotex could have submitted evidence to prove non-infringement, but declined to do so. As a result, the court found that Apotex's allegation was deficient and granted an order of prohibition against the sale of Apotex's products during the term of the patent.

The case is particularly significant for pharmaceutical patentees as it suggests that, in circumstances where product samples are the best evidence for assessing infringement, the generic manufacturer must produce such samples or risk having the court grant an order of prohibition.

For further information on this topic please contact J Sheldon Hamilton or Gunars A Gaikisat Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or by fax (+1 416 591 1690) or by email ([email protected] or [email protected]).