Apotex brought an action against MDS (now Nordion) for breach of contract and negligence arising from bioequivalence studies conducted by MDS for Apotex's generic drug applications to the FDA.
The FDA refused to accept the studies due to MDS's failure to comply with U.S. regulatory requirements, forcing Apotex to repeat or certify the studies and delaying the launch of its drugs.
The court found MDS breached the Master Laboratory Services Agreement and its duty of care.
The court rejected MDS's defences regarding standing and the limitation period.
Apotex was awarded over $11.3 million in damages for the costs of repeating/certifying the studies and for lost profits due to the delayed market entry.
