The Federal Court (FC) has provided fresh guidance on applying the test for challenging patent-listing eligibility in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Granting the delisting motion before it, the FC reiterated that a patent listed on the basis of a Supplementary New Drug Submission (SNDS) for a change in use must claim the “very change in use” approved by the issuance of a Notice of Compliance (NOC).

Background

Regeneron Pharmaceuticals Inc. (Regeneron) owns Canadian Patents No. 2,654,510 (the 510 Patent) and 3,007,276 (the 276 Patent). Bayer Inc. (Bayer) listed the 510 and 276 Patents on the Patent Register for EYLEA® (aflibercept) with the consent of Regeneron. This motion concerns the 276 Patent, which relates to a particular use of aflibercept. The 276 Patent was listed in connection with an SNDS on the basis that it claimed a “change in use” that was approved by the SNDS. The Minister of Health (Minister) agreed that it did.

Bayer and Regeneron (the Plaintiffs) brought an action under subsection 6(1) of the Regulations alleging that Amgen’s biosimilar aflibercept product will infringe various claims of the 510 and 276 Patents. In response, Amgen brought a motion under subsection 6.07(1) of the Regulations for a declaration that the 276 Patent is ineligible for inclusion on the Patent Register on the basis that it did not, in fact, claim the very change in use approved by the SNDS.

The “product specificity” requirements for listing

Under the Regulations, patent-listing eligibility requires “product specificity” between at least one claim of an eligible patent and the submission that supports listing. In the case of an SNDS for a change in use, the Regulations require consistency between the use claimed and the new use approved. This is determined by applying a three-part test:

  1. What use is claimed in the patent?
  2. What is the change in use approved by the NOC issued in response to the SNDS?
  3. Does the patent claim the very change in use approved by the NOC issued in response to the SNDS? This test may be satisfied where “the changes in use as reflected in the amended product monograph are broad and the use claimed in the patent falls within those changes in use.”

When listing eligibility is challenged in the context of an infringement action under the Regulations, the FC determines the issue on a de novo basis, on a balance of probabilities; it is not akin to a judicial review of the Minister’s decision to grant listing in the first place.

The 276 Patent did not claim the very use in the SNDS

The FC determined that in this case, the 276 Patent was not eligible for listing against the SNDS for EYLEA®. Applying the three-part test, the FC concluded as follows:

  1. Use claimed in 276 Patent? The parties agreed that listing eligibility turned on a single claim—claim 58—and also agreed upon its construction. Claim 58 covers the use of 2 mg aflibercept injections in wet age-related macular degeneration patients who have any of the claimed single nucleotide polymorphisms (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 patient’s SNP status needed to be known by the physician and factored into their assessment of the patient’s visual and/or anatomic outcomes.
  2. Change in use approved by the NOC issued in response to the SNDS? The FC found that the approved change was the use of EYLEA® every month after the first three months during the first year of treatment, at the discretion of the physician and based on monitoring of visual and anatomic outcomes. The FC found this new use applied to any patient, whether they had the claimed SNPs or not.
  3. Does the patent claim the very change in use approved by the NOC issued in response to the SNDS? The FC held that only one of Amgen’s arguments had merit: “there 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.”

The FC’s decision and its effect on the litigation

The FC granted Amgen’s motion and held that the 276 Patent is ineligible for listing on the Patent Register. As a result, the Plaintiffs are no longer entitled to avail themselves of the 24-month statutory stay under the Regulations with respect to the de-listed patent.

Notably, this does not mean that the action itself is dismissed. Although the FC did not comment on this issue, subsection 6.07(3) of the Regulations provides that the FC “shall not, in whole or in part, dismiss the action solely on the basis that a patent or certificate of supplementary protection is ineligible for inclusion on the register.”

Link to decision:

Bayer Inc. v Amgen Canada Inc., 2024 FC 1849