Bayer Inc. v. Amgen Canada Inc.

Bayer Inc. v. Amgen Canada Inc.

Claim 58 is ineligible for listing because it requires known patient SNP status to inform reduced quarterly dosing after a year of monthly treatment, whereas the NOC-approved change permits monthly dosing in year one for all patients based solely on visual/anatomic outcomes with no genetic criterion; this mismatch means the patent does not claim the very change in use approved by the SNDS and therefore fails paragraph 4(3)(c).

Citation
2024 FC 1849
Parties
Plaintiff/defendant by Counterclaim: Bayer Inc.; Plaintiff/defendant by Counterclaim: Regeneron Pharmaceuticals, Inc.; Defendant/plaintiff by Counterclaim: Amgen Canada Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
4 December 2024
Procedural Posture
Patent Infringement Under the Patented Medicines (notice of Compliance) Regulations / Motion Under Subsection 6.07(1) for Declaration of Ineligibility of Patent for Listing and Lifting of 24 Month Stay
Outcome
Motion granted. Canadian Patent No. 3,007,276 declared ineligible for inclusion on the Patent Register; costs awarded to defendant in accordance with parties' agreement.
Legal Topics
PMNOC Regulations, Patent Listing Eligibility, Claim Construction, Abbott Test, Notice of Compliance, Biosimilar Regulatory Stay
Source Language
English
Intellectual Property Patent Law Administrative Law Health Regulatory Law PMNOC Regulations Patent Listing Eligibility Claim Construction Abbott Test +2 more

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Parties

Bayer Inc.

Plaintiff/defendant by Counterclaim

Regeneron Pharmaceuticals, Inc.

Plaintiff/defendant by Counterclaim

Amgen Canada Inc.

Defendant/plaintiff by Counterclaim

Procedural Posture

Patent Infringement Under the Patented Medicines (notice of Compliance) Regulations / Motion Under Subsection 6.07(1) for Declaration of Ineligibility of Patent for Listing and Lifting of 24 Month Stay

Legal Issues

  1. 1 What use is claimed by Claim 58 of the 276 Patent?
  2. 2 What change in use was approved by the NOC issued in response to SNDS 204121?
  3. 3 Does Claim 58 claim the very change in use approved by the NOC?

Ratio Decidendi

Claim 58 is ineligible for listing because it requires known patient SNP status to inform reduced quarterly dosing after a year of monthly treatment, whereas the NOC-approved change permits monthly dosing in year one for all patients based solely on visual/anatomic outcomes with no genetic criterion; this mismatch means the patent does not claim the very change in use approved by the SNDS and therefore fails paragraph 4(3)(c).

Court Disposition

Motion granted. Canadian Patent No. 3,007,276 declared ineligible for inclusion on the Patent Register; costs awarded to defendant in accordance with parties' agreement.

Orders

  • The Defendant’s motion is granted.
  • Canadian Patent No. 3,007,276 is ineligible for inclusion on the register maintained by the Minister in accordance with subsection 3(2) and section 4 of the PMNOC Regulations with respect to EYLEA® 2 mg/0.05 mL solution, DINs 02415992 and 02505355.