This was an appeal to the Federal Court of Appeal (FCA) of the decision of Justice Hughes refusing to strike an affidavit from the record. The affidavit indicated that Apotex had decided to only use one of the two suppliers it had identified in its ANDS. A portion of the ANDS was disclosed in Apotex’s NOAs. AstraZeneca said that the affidavit indicated a significant change to the source of Apotex’s drug substance set out in its NOAs and that Apotex should therefore withdraw the NOAs and initiate fresh ones. The FCA dismissed the appeal because the change of source of the drug substance (from two possible suppliers to one) did not materially alter the NOAs but narrowed them.

For more information, please see the following link:

http://decisions.fca-caf.gc.ca/en/2010/2010fca111/2010fca111.html