• Case Context: Janssen Inc. received notices of compliance for two drug submissions in 2020 and 2021. After being granted a patent in 2022, Janssen submitted a patent list for one submission but faced rejection when trying to add the second submission outside the allowed timeframe.

• Judicial Review & Appeal:

  • Federal Court Decision: Dismissed Janssen's application. Main issue: Janssen's failure to include the second submission in the patent list within the 30-day period post-patent issuance, as required by regulations.
  • Federal Court of Appeal: Upheld the Federal Court's decision, emphasizing the non-compliance with the regulatory timeframe. Appeal dismissed with costs.

• Legal Implications:

  1. Regulatory Adherence: Strict compliance with the 30-day period for patent list updates is mandatory.
  2. Inclusion Specificity: Patent lists must explicitly identify the submissions they cover.
  3. Reasonableness of OSIP's Decision: OSIP’s rejection deemed reasonable, focusing on the regulation’s timing requirements.

• Outcome: Janssen's failure to adhere to specific regulatory timelines for patent list submissions led to the dismissal of their application and subsequent appeal.

Key Takeaway: This case underscores the critical nature of adhering to regulatory timelines in patent listings related to drug submissions.