The Federal Court recently released the first decision in which the scope of Section 53.1 of the Patent Act – the so-called 'file wrapper estoppel' provision – has been considered. The court's decision suggests that, notwithstanding the clear language of the provision, foreign prosecution histories may be admissible for the purposes of claim construction in certain extraordinary circumstances.
Two requirements under the new Patent Rules warrant particular attention for new Canadian patent applications and national phase entries: the Patent Cooperation Treaty national phase entry deadline and the requirement for certified copies of priority documents. Applicants should plan now to ensure that applications under the new rules enter the Canadian national phase within 30 months of the earliest priority date.
The recent amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies – one in the Quebec Superior Court and the other in the Federal Court. The applicants before the Quebec court brought a constitutional challenge to the Patented Medicine Prices Review Board provisions of the Patent Act and the regulations, while the applicants before the Federal Court challenged the validity of the amending regulations.
The amended Patented Medicines (Notice of Compliance) Regulations, which came into force two years ago, heralded significant changes to the IP landscape for pharmaceutical companies in Canada. Among other changes, the amendments ended dual litigation and provided innovators with a right of appeal. This article provides an update as of the second anniversary of the amendments.
The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.