In AB Hassle v. Apotex Inc., September 4, 2002, (Neutral Citation FCT 931), the Federal Court, Trial Division, has prohibited issuance of a Notice of Compliance to Apotex Inc. for omeprazole/omeprazole magnesium tablets on the basis that Apotex 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' product would incorporate a subcoating. The parties submitted conflicting expert evidence on this issue, which Mr. Justice Kelen was unable to resolve. He noted that the experts retained by the parties disagreed over the issue of 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 C.P.R. (4th) 38, where tablets were produced and tested in respect of two of the same patents, the Court found that Apotex' tablets could have been analysed 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' allegation was deficient and granted an Order of Prohibition against the sale of Apotex' products during the term of the patent.
This case is particularly significant to pharmaceutical patentees as it suggests that, in circumstances where product samples are the best evidence for assessing infringement, the generic must produce such samples or risk having the Court grant an Order of Prohibition.
AB Hassle was represented by Gunars A. Gaikis and J. Sheldon Hamilton of Smart & Biggar.