Drug: ALERTEC modafinil
This is an appeal of an Order of the Case Management Prothonotary, denying leave to Shire to amend its Statement of Defence to plead infringement as a Defence and Counterclaim. The Court considered the appropriate standard of review and concluded that the decision should be reviewed de novo because the proposed amendment adds a new defence and is therefore a question vital to the final issue in the case.
The Court noted that Shire had a heavier burden in respect of making this amendment as it would lead to a radical change in the nature of the questions to be considered. The Court concluded that the proposed amendment would lead to significant delays and the inability to have the action dealt with expeditiously, which could not be remedied with costs. Accordingly the Court refused leave. The Court noted that Shire should have brought the issue of infringement forward in its initial pleadings.