Declaration Of Infringement Does Not Preclude Further NOA Based On Invalidity

• Law Firm: Smart & Biggar
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Author: Malcolm Harvey
• Published date: 31 July 2023

On June 28, 2023, Manson J. of the Federal Court dismissed Janssen's motion for summary judgment in actions relating to Janssen's patent for dosing regimens of paliperidone palmitate (INVEGA SUSTENNA) (Canadian Patent No. 2,655,335 (335 patent)): Janssen v Apotex, 2023 FC 912. Janssen argued that Apotex's sole invalidity defence of unpatentable subject matter (method of medical treatment) was res judicata, an abuse of process and precluded by the doctrine of election having regard to prior allegations/decisions based on infringement.

Procedural history

As previously reported (see our articles from May 2020, February and September 2022, and April 2023), the 335 patent has been the subject of separate proceedings involving Teva, Pharmascience and Apotex.

Janssen commenced an action against Apotex pursuant to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) in 2021 (the "2021 Action"). The 2021 Action related to Apotex's Notice of Allegation (NOA) in respect of an Abbreviated New Drug Submission (ANDS) for pre-filled syringes of paliperidone palmitate ("ANDS#1"). Apotex alleged non-infringement but not invalidity in this NOA. The 2021 Action was determined by summary trial in a decision released in January 2022, with Manson J. holding that Apotex would induce infringement of the 335 patent (appeal ongoing).

An affidavit submitted by Apotex for the summary trial of the 2021 Action included copies of the Form Vs submitted to Health Canada for ANDS#1 as well as for a second ANDS ("ANDS#2"). In the Form V for ANDS#2'also relating to pre-filled syringes of paliperidone palmitate'Apotex accepted that a Notice of Compliance would not issue until expiry of the 335 patent, and did not serve an NOA.

After the summary trial decision in the 2021 Action, Apotex amended its Form Vs for ANDS#1 and ANDS#2 to include allegations of invalidity. Apotex then delivered to Janssen an NOA for each ANDS, each alleging that the claims of the 335 patent are invalid as methods of medical treatment.

In response, Janssen commenced actions pursuant to the Regulations. After a trial date for the actions was set by Order of the Court (and after first-round examinations for discovery), Janssen brought the present motion for summary judgment.

Preliminary issues

Apotex argued that Janssen was barred from moving for summary judgment, as, contrary to subsection 213(1) of the Federal Courts Rules (the Rules), Janssen had delivered its notice of motion four months after...