Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
As previously reported, Amgen sought leave to appeal a decision of the Federal Court of Appeal (2020 FCA 188) affirming Justice Southcott’s decision that the relevant claims of its filgrastim (NEUPOGEN) patent were invalid...more
UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here). On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the...more
UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more
On October 4, 2019, the Federal Court of Appeal dismissed Pfizer’s appeal of its failed motion to dismiss Amgen’s action under section 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for a...more
September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more
Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action - This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of...more
In public reasons released on July 30, 2018, the Federal Court dismissed the first motion for summary dismissal brought under section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC...more
Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more