Monday, December 18, 2023

Canadian Court Denies Permanent Injunction in Biosimilar Case

The case is AbbVie Corp. v. JAMP Pharma Corp., 2023 FC 1520, decision by Madam Justice McVeigh.  (Thanks to Professor Norman Siebrasse for calling this to my attention.)  The decision is very long (217 pages), and I will admit that I haven’t read all of it for purposes of writing this post, but as the judge puts it “the dispute relates to JAMP’s SIMLANDI product – a biosimilar of AbbVie’s HUMIRA” (para. 1).  The dispute involves three patents, the relevant claims of two of which are found to be invalid; the judge rejects the validity challenge to the third patent, and JAMP concedes infringement of that patent.  The relevant question for purposes of the subject matter of this blog is whether AbbVie is entitled to an injunction.  The court concludes it is not.

The relevant portions are found in paragraphs 628-643 (pp. 182-88).  To summarize, the court states that under Canadian law injunction relief is discretionary, but that “this discretionary power is usually granted unless there is an equitable reason not to” (para. 630).  The court notes JAMP’s argument that removing SIMLANDI from the market “would deprive patients of the only 80 mg/0.8 mL formulation available in Canada” (para. 634), and that two of its experts suggested that patients who had to switch to the AbbVie formulation in the event of a removal might suffer injection site pain or suffer other possible detriment (paras. 635-37).  Ultimately, the court concludes:

[642] This is one of those rare cases where I will not grant a permanent injunction given the public interest factor. Forcing SIMLANDI patients to switch to another biosimilar, given it is the only 80 mg/0.8 mL formulation in Canada, is not in the public interest. AbbVie can be compensated. Even though the risk is low to those patients, it is preferable to compensate AbbVie rather than take SIMLANDI off the market. JAMP does not need to deliver up its infringing product.


[643] As suggested it is possible that AbbVie can be compensated by a reasonable, running royalty on future sales of SIMLANDI for any loss. This rate should easily be determined given the licensing agreements it has with seven other biosimilar pharmaceutical companies. But I will not make this determination as it is left to be determined at the bifurcated trial if the parties do not reach an agreement before.

Canadian law therefore would appear similar to U.K. law in permitting a court to exercise its discretion to deny injunctive relief in the public interest, subject to payment of a royalty, outside the framework established in the statutory provisions on compulsory licensing.  In Germany, some of the courts thus far have suggested they would go the other way on this issue, though several commentators (including those I mentioned on the blog last week) believe that German law should follow the U.K. (and now Canadian) approach.    

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