The Federal Court of Appeal’s decision in Janssen v. Apotex (here) harkens back to its 2007 decision Sanofi-Aventis v Novopharm (here) and the Courts’ treatment of multiple Notices of Allegations (“NOA”) under the Patented Medicines (Notice of Compliance) Regulations (“Regulations”). This is the latest development in Apotex’s efforts to bring a generic paliperidone palmitate product to the market.
Apotex had served a NOA which alleged that the 335 Patent listed on the Patent Register would not be infringed by Apotex’s paliperidone palmitate product. The NOA did not allege that the 335 Patent was invalid. Following a summary trial, the Federal Court concluded that Apotex’s product would infringe the 335 Patent (see decision here). Apotex’s appeal of that decision is under reserve.
Apotex then served further NOAs on Janssen which alleged that the 335 Patent was invalid. Janssen commenced actions in response to those NOAs and brought a motion for summary judgment on the basis that Apotex’s defences were an abuse of process. The Federal Court dismissed Janssen’s motions, holding that it would have been an abuse of process for Apotex to allege one ground of invalidity in a first NOA and a different ground of invalidity in a subsequent NOA, but that it was not an abuse of process to allege noninfringement in a first NOA and invalidity in a subsequent NOA (see decision here).
Janssen appealed that decision. Writing for the Court of Appeal, Justice Locke noted that the aim of the 2017 amendments to the Regulations was to avoid a multiplicity of proceedings and rejected Apotex’s argument that generics should be permitted to serve multiple NOAs with limited allegations to facilitate the summary nature of proceedings under the Regulations.
Justice Locke concluded:
The concerning fact that remains in the present appeal is that Apotex decided to argue the invalidity of the 335 Patent only after being unsuccessful in the Prior Action, where it could have, but decided not to, raise the invalidity issue in its NOA or as part of its defence. This appears to be an attempt by Apotex to split its case and to litigate by instalments in a way that has been found to be an abuse of process. Even though Apotex did not raise invalidity as an issue in the Prior Action, it was implicitly considered. Subsection 43(2) of the Patent Act provides that a patent is presumed to be valid. Moreover, the imposition of injunctive remedies by the Federal Court in its decision in the Prior Action implies that it found the 335 Patent to be valid.
As was decided under the prior version of the Regulations, the service of multiple NOAs respecting the same patent is likely to be regarded as abuse of process and all allegations (whether of noninfringement or invalidity) should be included in the first served NOA.