Federal Court Of Appeal Confirms No Litigation By Installments In Patent Cases'even Under The PM(NOC) Regulations

• Published date: 22 January 2024
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Torys LLP
• Author: Ms Alexandra Peterson, Kylie de Chastelain, Yael Bienenstock and Andrew Bernstein

In Janssen Inc. v. Apotex Inc., 2023 FCA 243, the Federal Court of Appeal found that it was an abuse of process for Apotex to challenge the validity of a patent after it had already (unsuccessfully) argued that it would not infringe the same patent. Each of the non-infringement and invalidity proceedings was triggered by Apotex sending Janssen notices of allegation (NOAs) under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). In deciding that the second proceeding was abusive, the Court emphasized that a key goal of the 2017 amendments to the PM(NOC) Regulations was to avoid multiple proceedings about the same patent. Whether a patent case is under the PM(NOC) Regulations or simply under the Patent Act, it appears that it is now an abuse of process to raise arguments in a second patent case that could have been raised in the first case about the same patent.

What you need to know

• Successive patent cases in respect of the same product and patent will usually constitute an abuse of process. A party arguing that they are not infringing a patent must also address the validity of the patent. Under the PM(NOC) Regulations parties must include both allegations of non-infringement and invalidity in their NOAs if they intend to raise these defences. It will ordinarily be an abuse of process for a party to raise a defence in a second NOA that it could have raised in a first NOA.
• Parties under the PM(NOC) Regulations must put their best foot forward. While the PM(NOC) Regulations do not prevent a party from serving successive NOAs in respect of the same patent and the same medicine, this is subject to the Court's inherent power to prevent misuses of its procedure through the doctrine of abuse of process. Successive NOAs will usually only be appropriate in specific circumstances, for example, where the law or the facts change, a situation limits the scope or application of an existing prohibition order, or a new decision is issued in respect of the validity or construction of the patent. Parties should carefully consider any strategic decision not to allege invalidity or non-infringement in a first NOA since failure to do so may prevent them from raising these defences in the future.

Background and summary judgment decision

Apotex sought to market a generic version of Janssen's paliperidone palmitate (marketed as INVEGA SUSTENNA), used to treat schizophrenia and other disorders. In 2020, Apotex served Janssen with an NOA in which it...