In Bayer Inc v Amgen Canada Inc, 2024 FC 1849, the Court granted a motion brought by Amgen for a declaration that Canadian Patent No. 3,007,276 (276 patent) was ineligible for inclusion on the Patent Register and that the 24-month statutory stay be lifted in relation to Amgen’s submission and the 276 patent.
Background
Bayer brought a patent infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations against Amgen regarding ABP 938, a biosimilar of Bayer’s aflibercept product EYLEA, based on Canadian Patent No. 2,654,510 and the 276 patent, which triggered a 24-month statutory stay.
Amgen alleged that the 276 patent—which was added to the Patent Register in relation to a Supplementary New Drug Submission (SNDS)—was not eligible for listing for failing to meet the product specificity requirement.
The Court’s decision
The parties agreed that listing eligibility could be determined based on claim 58, which, when considered together with claims 46, 47 and 49, claims:
Aflibercept for treatment of wet macular degeneration in a subject, wherein the aflibercept is formulated for intravitreal administration to the subject in an amount of about 2 mg quarterly, and wherein the subject has at least one of the following single nucleotide polymorphisms (SNPs): rs2056688, rs5962084, rs5962087, rs5915722, rs5962095, and rs1405303, and was previously treated with a 2 mg dose of aflibercept every four weeks for about one year.
The Court applied the test set out in Abbott Laboratories Limited v Canada (Attorney General), 2008 FC 700 (aff’d 2008 FCA 354), which requires the determination of three questions:
- What use is claimed in the patent?;
- What is the change in use approved by the notice of compliance (NOC) issued in response to the SNDS?; and
- Does the patent claim the very change in use approved by the NOC issued in response to the SNDS?
The Court found that:
- Claim 58 claims “the use of 2 mg aflibercept injections in wet AMD [age-related macular degeneration] patients who have any of the claimed SNPs […] on a less frequent quarterly dosing schedule after having been dosed on a more frequent monthly dosing schedule throughout their first year of treatment”.
- The SNDS provides physicians a second treatment option during year 1, “the use of EYLEA® for any patient (with or without the claimed SNPs) every month (four weeks) after the first three months (12 weeks) during the first year of treatment, at the treating physician’s discretion and based on the monitoring of visual and anatomic outcomes”.
- Claim 58 does not claim the change in use approved by the NOC issued in response to the SNDS.
On the third question, the Court accepted Amgen’s argument that:
[T]here is a fatal mismatch as the use claimed in Claim 58 requires knowledge and consideration of the patient’s SNP status in making treatment decisions, whereas the change in use approved by the NOC in response to SNDS 204121 is divorced from any consideration of the patient’s genetics.
In doing so, the Court highlighted that the change in use permits the additional dosing regime for all patients—regardless of whether they have any of the claimed SNPs—and provides that the treating physician’s treatment decision is guided by the patient’s visual and/or anatomic outcomes, with no reference to a patient’s genetics. As the genetic component of the 276 patent was divorced from the change in use approved by the NOC that issued from the SNDS, the Court concluded that the 276 patent was ineligible for listing.
Bayer has sought leave to appeal to the Federal Court of Appeal.
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