Canada’s Intellectual Property Firm

Prior Allegation of Non-infringement Precludes Generic from Making Allegation of Invalidity

We have previously reported on the decision in AB Hassle v. Apotex (2005 FC 234), which applied the doctrines of issue estoppel/abuse of process in a proceeding under the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) to prevent a generic from raising an allegation of invalidity subsequent to having unsuccessfully raised an allegation of non-infringement in respect of the same drug and the same patent.

On February 10, 2006, the Federal Court of Appeal (2006 FCA 51) dismissed the appeal of this decision and confirmed that a subsequent allegation, even where based on a different legal and factual basis, may be an abuse of process. The Court of Appeal provided specific examples of situations in which a second or subsequent notice of allegation (NOA) may not be an abuse of process, stating that for example “it may be that there would be no abuse of process if based on new facts, a newly discovered process, a change in the law, a situation that limits the scope or application of an existing prohibition order or a new and definitive decision as to the validity or construction of the patent.” On the other hand, this decision confirms that where a generic could have raised invalidity allegations in a prior NOA asserting non-infringement, estoppel or abuse of process may apply to preclude the generic from raising invalidity allegations in a subsequent proceeding.