Update: Janssen has appealed after obtaining leave from the Federal Court of Appeal (A-229-23).
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.
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.
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 the time and place for trial had been fixed. The Court rejected this argument, holding that it was instead incumbent on Apotex to bring a motion (under Rule 58 of the Rules) to challenge Janssen’s non-compliance as soon as practicable. The Court could not of its own volition invalidate proceedings or steps in proceedings based on procedural irregularities under the Rules. The Court held that in any event, special circumstances exist to allow Janssen to proceed.
The Court was satisfied that the issues raised by Janssen were appropriate for determination on summary judgment – the sole dispute related to questions of law and the application of law to facts that were not at issue between the parties (i.e., the litigation history of the 335 patent).
Res judicata, abuse of process and doctrine of election
Janssen argued that Apotex’s invalidity defence was res judicata based on cause of action estoppel and issue estoppel.
Cause of action estoppel: Janssen asserted that, though the subject of an ongoing appeal, the Court’s decision in the 2021 Action was a “final decision” under the applicable legal test. The Court rejected this argument in view of higher court rulings indicating that orders or judgments under appeal are not considered “final” for the purposes of res judicata. The test for cause of action estoppel was therefore not met.
Issue estoppel: Janssen asserted that (i) the relevant question was whether Apotex would infringe a valid claim of the 335 patent with its paliperidone palmitate product (in accordance with ANDS#1), and (ii) this had been squarely answered in the 2021 Action. The Court rejected this framing of the relevant question (and noted that its finding on the finality of the 2021 Action applied equally to the test for issue estoppel).
Instead, the relevant question was whether the 335 patent was valid, which the Court stated was not determined in the 2021 Action or by implication. While Janssen may have raised the presumption of patent validity (under subsection 43(2) of the Patent Act) in its pleadings in the 2021 Action, Apotex did not allege invalidity in that case and the Court there had expressly observed that invalidity was not at issue between the parties.
Abuse of process and doctrine of election: The Court further rejected Janssen’s assertions that Apotex’s defence was an abuse of process and precluded by the doctrine of election:
- Abuse of process: the Court noted that the Regulations do not preclude successive dual NOAs (one alleging non-infringement and one alleging invalidity) for the same patent. Rather, the Regulations (at subparagraphs 5(2.1)(c)(ii) and (iv)) clearly distinguish allegations of invalidity from allegations of non-infringement. The “duplicative litigation” targeted by the 2017 amendments to the Regulations was litigation under the Regulations followed by infringement actions under the Patent Act, as opposed to proceedings stemming from successive distinct NOAs in respect of the same patent and same regulatory submission.
- Doctrine of election: the Court reviewed the summary trial transcripts in the 2021 Action. There, Apotex had made no conscious and unequivocal representation to the Court to await expiry of the 335 patent before seeking approval for the product of ANDS#2. Instead, Apotex had left open the possibility of amending its Form V in respect of ANDS#2 and subsequently serving Janssen with an NOA.
Janssen has not sought leave to appeal or appealed to date.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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