Justice McVeigh’s recent decision in AbbVie Corporation v JAMP Pharma is noteworthy because it is one of the few cases to refuse a permanent injunction notwithstanding a concession of infringement and a failed validity attack on a patent.
The decision was issued in the context of patent infringement and impeachment actions relating to JAMP’s SIMLANDI product, a biosimilar of AbbVie’s HUMIRA. AbbVie asserted that JAMP’s product infringed the 868 Patent, the 917 Patent, and the 458 Patent; and JAMP contended all three were invalid. The Court held the 868 Patent and 917 Patent were invalid, but the 458 Patent was valid.
Section 57 of the Patent Act gives the Court discretion to grant an injunction to prevent a party from further use, manufacture, or sale of the subject-matter of the patent. This discretionary power is usually exercised unless there is an equitable reason to not do so. AbbVie sought an injunction that would have restrained JAMP from making, using, promoting, or selling SIMLANDI in Canada until the 458 Patent expired on November 28, 2028.
The Court’s decision to deny the injunction focussed on the public interest factor. The Court noted that forcing SIMILANDI patients, who were using the only formulation approved in Canada of 80 mg/0.8mL, to switch to another biosimilar involved some risk, albeit a low risk. There was some evidence that actual physical harm could befall patients who had to switch to an alternative biosimilar which are marketed in higher injection volume and possibly contain citrate. The Court noted it was also possible for AbbVie to be compensated by a reasonable, running royalty on future sales of SIMLANDI for any loss, and that rate should easily be determined given the licensing agreements it has with seven other biosimilar pharmaceutical companies. The Court noted the action had been bifurcated such that assessment of damages remained to be determined.
Although notable, the result is not a marked departure from the result AbbVie obtained in its prior HUMIRA-related action for infringement of a different patent and a different competing product, Janssen’s STELARA (2014 FC 489). After a trial upholding the validity of Canadian Patent No. 2,365,281, the Court considered AbbVie’s request for an injunction on terms. The requested terms would have permitted continued use of STELARA by existing patients, permitted use by new patients in particular circumstances, and required a letter from the Defendants to physicians acknowledging the patent validity success and explaining why STELARA would no longer be promoted. In that case, the Court permitted continued use of the infringing medicine, provided each patient’s physician had to determine a prescription was necessary for treatment and the infringing company was prohibited from trying to influence the decisions of such doctors. The injunction also restrained marketing activity by sales representatives to physicians and declined to order Janssen to send a letter to physicians.
Read the full decision here.