Recently, in AB Hassle v. Apotex Inc. ("AB Hassle") (2004 FCA 255), the Federal Court of Appeal confirmed that, in proceedings under the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"), when a generic manufacturer tests samples of its proposed product and files evidence regarding the results of the testing, an innovator has the right to immediately bring a motion for production of samples with which to conduct its own testing.
The issue arose as a result of a motion brought by AstraZeneca to file an expert affidavit analyzing samples of omeprazole magnesium tablets produced by Apotex. Earlier in the proceedings, Apotex filed an affidavit relating to the testing of samples of its proposed product. AstraZeneca requested the samples during the cross-examination of one of Apotex' affiants, and was provided with the samples following that cross-examination.
The Prothonotary denied AstraZeneca's motion to file an expert affidavit, finding that AstraZeneca had failed to bring the motion for the production of samples in a timely manner (2004 FC 694). A motions judge allowed AstraZeneca's appeal, finding that evidence based on testing is vital and that both parties were responsible for the delay, and allowed the expert affidavit to be filed (2004 FC 762). Apotex appealed this decision to the Federal Court of Appeal.
The Court of Appeal dismissed Apotex' appeal, finding that the motions judge was correct in allowing the expert affidavit, and stated:
[6]…Subsection 6(7) of the Regulations allows a party to compel the production of samples where such samples have been filed with the Minister as part of an applicant's regulatory submissions (NDS). Since the appellant did not submit samples of its product to the Minister, Astra could not exercise the right conferred by subsection 6(7) and compel production.
Further, the Court indicated, "The Prothonotary has cited no authority, and I know of none, to support the conclusion that Astra could and should have sought production of the samples at an earlier stage than it did and, therefore, should be blamed for the delay which resulted from its failure to do so… At best, the law is unclear and uncertain on the issue. At worst, Astra had no right to compel the production of the samples prior to cross-examination". The Court continued:
[11]…In my view, in circumstances where the disclosure process envisaged in subsection 6(7) of the Regulations cannot be resorted to because the samples have not been provided to the minister and where the second person proceeds to their testing and file affidavit evidence of the results of these tests in the prohibition proceedings, expediency, fairness and the overall interest of justice give the first person the right to, immediately after such filing, seek by motion the production of these samples for a testing of its own. This should remedy the unfortunate delay encountered in the present proceedings. The first person can then be held accountable for its failure to proceed promptly.
The Court's decision confirms that:
- an innovator cannot obtain production of samples pursuant to section 6(7) of the Regulations unless the samples have been filed with the Minister; and
- an innovator has the right to bring a motion for production of samples immediately after a generic manufacturer files an affidavit regarding testing of its proposed product.
This decision is significant because in certain cases under the Regulations the issue of infringement may turn on the evidence of testing conducted on samples of the generic manufacturer's proposed product.
Heather E. Tonner, Toronto