The Canadian Federal Court has refused AbbVie’s application for a permanent injunction against JAMP for exploitation of Simlandi® until the expiration of AbbVie’s Humira® patent no. 2,904,458. Despite JAMP conceding it infringed the ‘458 patent, it successfully argued that the injunction should not be granted for public interest reasons. It argued that:
- there was an alternative remedy available (a reasonably royalty paid by JAMP to AbbVie);
- Humira® would not benefit from additional sales if Simlandi® was removed from the market as Simlandi® patients would be switched to another biosimilar for which AbbVie is likely receiving a royalty;
- the removal of Simlandi® would deprive patients of the only 80 mg/0.8 mL formulation available in Canada; and
- if Simlandi® and Yuflyma® (Celltrion) are removed, all Simlandi® patients will have to switch to a biosimilar with a higher injection volume and possibly citrate, which could increase injection site pain for these patients and cause them harm.
The Court also found that two of AbbVie’s Humira® dosing regimen patents (nos. 2,504,868 and 2,801,917) were invalid for obviousness.