The Federal Court of Appeal (FCA) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation (NOAs) under the Patented Medicines (Notice of Compliance) Regulations (Regulations). Reversing the Federal Court (FC), the FCA found that the generic or biosimilar manufacturer should raise all of its allegations in its NOA, and it should not keep some in reserve in the event that it is not initially successful.

Background

Janssen markets INVEGA SUSTENNA® (paliperidone palmitate). Apotex sought a Notice of Compliance (NOC) to market a generic version of INVEGA SUSTENNA, which is protected on the patent register by Janssen’s Canadian Patent No. 2,655,335 (the 335 Patent).

In 2021, Janssen commenced an action under section 6 of the Regulations (No. T-124-21) in response to an NOA by Apotex. This NOA did not allege that the 335 Patent was invalid. Instead, it alleged Apotex’s proposed product would not infringe the 335 Patent. The FC found that Apotex would induce infringement of the 335 Patent. Apotex appealed this decision and a decision from the FCA is pending.

In four later NOAs, Apotex alleged that the claims of the 335 Patent are invalid, leading to four further patent infringement actions brought by Janssen pursuant to section 6 of the Regulations (Nos. T-1121-22, T-1122-22, T-1248-22 and T-1249-22, the Underlying Actions). Consistent with its NOAs, Apotex defended these actions by arguing that the 335 Patent is invalid. Janssen moved for summary judgment on the basis that Apotex’s defences were an abuse of process, amongst other reasons. The FC refused to grant summary judgment and Janssen appealed to the FCA.

Using multiple NOAs to case-split is an abuse of process

The FCA set aside the FC’s judgment and decided that Apotex’s defences in the Underlying Actions were an abuse of process.

The FCA held that litigation under section 6 of the Regulations is supposed to proceed much in the same way as a “normal” impeachment action under section 55 of the Patent Act. In that context, if a defendant defended itself solely on the basis of non-infringement and lost, it would – absent special circumstances – be an abuse of process to commence a separate impeachment action to challenge the validity of the patent afterward. The same reasoning applies under the Regulations.

The FCA rejected the proposition that this would lead to invalidity allegations being withheld from the NOA and introduced only in litigation. While section 6 proceedings are no longer confined to the allegations in the NOA, the FCA held that an invalidity allegation that was deliberately withheld from an NOA might be excluded from a subsequent action under section 6 of the Regulations as itself being an abuse of process for failing to follow the requirements of the Regulations.

The FCA allowed the appeal and, rather than remitting the matter to the FC for reconsideration, granted the actions. The FCA issued relief including an injunction restraining Apotex from making, constructing, using, or selling its generic version of INVEGA SUSTENNA®, and from otherwise infringing or inducing infringement of the 335 Patent.

Update on parallel litigation

Two other generic companies have also been unsuccessful in their attempts to market generic versions of INVEGA SUSTENNA®:

  • As we previously reported, Pharmascience Inc.’s (PMS) proposed product was found by the FC to infringe the claims of the 335 Patent in a summary trial (see here). PMS appealed and the FCA decision remains under reserve. In the trial related to invalidity, the 335 Patent was found to be valid. PMS appealed and the FCA decision remains under reserve.
  • As we previously reported, Teva Canada Limited’s (Teva) proposed product was found by the FC to directly infringe certain claims of the 335 Patent; and the 335 Patent was valid (see here). Teva’s appeal to the FCA was unsuccessful (see here). Janssen’s appeal regarding induced infringement was successful.

Links to decisions:

Janssen Inc. v Apotex Inc., 2023 FCA 253

Janssen Inc. v Apotex Inc., 2023 FC 912