The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Canada until the expiration of Alexion’s 810 Patent (Canadian Patent No. 2,645,810).
In Alexion Pharmaceuticals, Inc v Amgen Canada Inc, 2025 FC 754, publicly released on May 12, 2025, Justice Furlanetto concluded that Amgen did not meet its burden of establishing anticipation or obviousness.
Background
The 810 Patent is listed on the Patent Register against Alexion’s eculizumab product SOLIRIS.
Eculizumab is a recombinant humanized antibody that targets complement protein C5, stabilizing hemoglobin levels in patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare blood disorder that causes breakdown of red blood cells.
SOLIRIS is the only medicine approved in Canada for the treatment of PNH.
For the purposes of the proceedings under subsection 6(1) the Patent Medicines (Notice of Compliance Regulations), Amgen admitted infringement but alleged invalidity of claims 1 and 2 of the 810 Patent.
Claim 1 claims a full-length antibody having sequences for eculizumab:
An antibody that binds C5 comprising a heavy chain consisting of SEQ ID NO:2 and a light chain consisting of SEQ ID NO:4.
Use of a document “incorporated by reference” in anticipation
Amgen alleged anticipation based on a United States patent application publication, ‘US972’.
Without disputing that US972 did not disclose the full sequence of eculizumab, and despite the test for anticipation requiring disclosure in a “single publication”, Amgen argued that the person skilled in the art could simply look to another prior art reference, ‘US245’ that US972 “incorporated herein by reference”.
The Court accepted that an incorporation by reference can be considered in the test for anticipation, holding:
The critical factor is whether the prior reference provides clear direction so that the [person skilled in the art] arrives inevitably at the claimed invention. Where an incorporation by reference is used, this will depend on what directions are provided in the primary source as to how the incorporated reference is to be used.
In this case, the “critical question is what is disclosed to the [person skilled in the art] by reading Example 4 of US972 and the reference in paragraph [0191] to … US245”.
The Court also rejected Amgen’s reliance on US245. The exercise proposed by Amgen’s expert extended beyond the teachings and disclosure of US972 and necessitated the skilled person choosing specific bits and pieces from US245 and assembling this with other information from US972, rather than being directed by US972 to specific information in US245. This was inconsistent with US245 being a “single disclosure” with US972.
Claims not anticipated or obvious
While the above finding was sufficient to conclude that the disclosure requirement for anticipation was not met, the Court nonetheless considered a more expansive incorporation by reference of US245 as proposed by Amgen. On the evidence, the disclosure requirement for anticipation was still not met.
On the evidence, the Court also found that Amgen did not establish the asserted claims were obvious as the person skilled in the art specifically looking for the sequence of eculizumab would not have been led by the prior art to the claimed sequences.
Amgen may appeal as of right.
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