This is an informal case summary prepared for the purposes of facilitating exchange during the 2024 WIPO IP Judges Forum.
Session 6
Federal Court of Canada [2023]: AbbVie Corporation v Jamp Pharma Corporation, 2023 FC 1520
Date of judgment: December 4, 2023
Issuing authority: Federal Court
Level of the issuing authority: First instance
Type of procedure: Judicial (Administrative)
Subject matter: Patents (Inventions); Enforcement of IP and Related Laws
Plaintiffs: AbbVie Corporation and AbbVie Biotechnology Ltd.
Defendant: Jamp Pharma Corporation
Keywords: Patent infringement, Impeachment, Patent invalidity, Obviousness, Pharmaceutical formulation
Basic facts: This proceeding involved two patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and two patent impeachment actions pursuant to subsection 60(1) of the Patent Act.
The case involved disputes between AbbVie Corporation (the plaintiff) and Jamp Pharma Corporation (the defendant) concerning the biosimilar product SIMLANDI, which Jamp Pharma Corporation developed as a lower-cost alternative to AbbVie’s highly successful biologic drug HUMIRA.
HUMIRA is used to treat a range of autoimmune conditions, such as rheumatoid arthritis, Crohn’s disease, and hidradenitis suppurativa (HS), and is protected by several patents.
AbbVie claimed that Jamp's biosimilar, SIMLANDI, infringed upon its patents, which cover dosing regimens and pharmaceutical formulations of HUMIRA’s active ingredient, adalimumab.
Specifically, the patents in question were following:
· Canadian Patents No. 2,504,868 (hereinafter the 868 patent): covering adalimumab dosing regimens for treating inflammatory bowel disease, including Crohn’s disease and ulcerative colitis;
· Canadian Patent No. 2,801,917 (hereinafter the 917 patent): covering adalimumab dosing regimens for treating hidradenitis suppurativa, a skin disorder; and
· Canadian Patent No. 2,904,458 (hereinafter the 458 patent): protein-containing aqueous pharmaceutical formulations (including of adalimumab).
In response to Jamp’s notices of AbbVie commenced the patent infringement actions under the Regulations in March 2021 (in response to Jamp Pharma Corporation’s notices of allegation).
In April 2021, Jamp Pharma Corporation countered by launching patent impeachment actions under the Patent Act, seeking declarations of invalidity for AbbVie's patents.
Pharma Corporation obtained regulatory approval from Health Canada for SIMLANDI in early 2022. AbbVie objected to the regulatory approval and launched judicial review proceedings against the Minister of Health’s decision to issue the approvals for SIMLANDI. The claims were dismissed in a related Federal Court ruling (AbbVie Corporation v Canada (Health), 2022 FC 1209).
In the present matter, the parties agreed that Jamp’s impeachment actions were unaffected by the ongoing appeal of AbbVie 2022. The Court thus released its decision without waiting for determination of the AbbVie 2022 appeal, noting that AbbVie’s infringement actions under the Regulations were “not presently at issue”.
Held: The Federal Court issued following ruling:
· The 868 and 917 patents were found to be invalid on the grounds of obviousness. The court concluded that the dosing regimens described in these patents were obvious to try in light of prior knowledge and studies regarding the use of adalimumab for treating autoimmune conditions like Crohn’s disease and HS. Therefore, Jamp Pharma Corporation was not liable for infringing these two patents.
· The 458 patent was upheld as valid, with the court rejecting Jamp’s claims of overbreadth and anticipation.
Despite the finding of infringement regarding the 458 patent, the court declined to grant a permanent injunction that would have prohibited Jamp Pharma Corporation from continuing to market SIMLANDI in Canada.
The court found that issuing such an injunction would have negative consequences for Canadian patients using SIMLANDI, given its unique characteristics (high concentration, low volume, and citrate-free).
Instead, the court suggested that monetary compensation in the form of a reasonable running royalty would be a more appropriate remedy for AbbVie.
Relevant holdings in relation to permanent injunctions: In addressing the request for a permanent injunction, the court considered several factors, most notably the public interest in ensuring access to medications that best serve patients' needs. The court observed that SIMLANDI was the only biosimilar on the Canadian market that was available in an 80 mg/0.8 mL concentration, which is citrate-free. Other biosimilars on the market either had a lower concentration (requiring a higher injection volume) or contained citrate, which was linked to increased injection site pain for some patients.
Key considerations for the court’s refusal to grant a permanent injunction:
Public interest and patient welfare: Evidence from Jamp’s experts suggested that forcing patients to switch from SIMLANDI to another biosimilar that had a higher volume or contained citrate could result in greater injection site pain. Evidence further suggested that non-medical switching could cause a perceived increase in injection site pain (through the “nocebo effect”).Accordingly, it was not in the public interest to force SIMLANDI patients to switch to another biosimilar.
Availability of alternative remedies: Noting AbbVie’s licensing agreements with seven other pharmaceutical companies in Canada that offer adalimumab biosimilars, the Court found – as argued by JAMP – that AbbVie could be compensated by a reasonable, running royalty on future sales of SIMLANDI. This rate was left to be determined at the bifurcated quantification and specific damages assessment.
No impact on the sale of HUMIRA: JAMP argued that the sale of SIMLANDI did not negatively affect the sale of HUMIRA, citing the reimbursement policies of provincial drug plans. JAMP further asserted that if SIMLANDI were removed from the market, it would not result in increased sales of HUMIRA, as patients would likely be switched to another biosimilar for which AbbVie was already receiving royalties. The Court agreed with JAMP’s position.
The decision to decline a permanent injunction reflects a balancing of public and private interests. The court’s reasoning showcases how public interest can play a decisive role in pharmaceutical patent cases, particularly in instances where patients' access to important medications could be compromised by a legal remedy.
AbbVie has appealed the decision, and the appeal is still pending.
Relevant legislation:
· Patented Medicines (Notice of Compliance) Regulations, SOR/93-133