Following a recent practice notice, the Trademarks Office will not grant time extensions for office actions issued on or after 17 January 2020 unless exceptional circumstances are demonstrated. The Trademarks Office has also expanded the list of potential exceptional circumstances.
There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines (Notice of Compliance) Regulations.
The United States, Mexico and Canada recently signed the Protocol of Amendment to the Agreement between the United States of America, the United Mexican States and Canada (USMCA). If ratified, the amended USMCA will replace the North American Free Trade Agreement and require a number of changes to Canada's IP laws. Many requirements of the original USMCA have already been met by recent changes in Canadian IP legislation, but more amendments will be required to implement the USMCA.
The Federal Court recently dismissed an action for delay following a status review under Section 382.1 of the Federal Courts Rules where the proceeding remained at the documentary discovery stage with outstanding motions pending more than six years after the action had been commenced. The plaintiff's had alleged infringement of Canadian Patent 2,595,723 in respect of water treatment processes used in Cenovus's steam-assisted gravity drainage oil production facilities.
In IP litigation, expert testimony is common and important. Experts may provide the court with a scientific primer in highly complex cases. Given this, it is important for IP litigators to appreciate the role of experts, understand the test for admissibility and be familiar with all applicable procedural rules. This article focuses on the more theoretical aspects of expert testimony.
In 2018 the Federal Court granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva's bortezomib product. According to Justice Locke, Teva would not have infringed Patents 2,203,936 and 2,435,146 because their relevant claims were invalid for obviousness. The Federal Court of Appeal has now upheld the finding of obviousness, dismissing Millennium Pharmaceuticals' and Janssen's appeal.
The Patented Medicines Prices Review Board recently released new draft guidelines for consultation and a backgrounder. The new guidelines aim to operationalise the amended Patented Medicines Regulations, which come into force on 1 July 2020, and provide a number of circumstances in which categories or price ceilings may be reassessed.
The Federal Court recently issued two decisions relating to Pharmascience's claim for Section 8 damages under the pre-amended Patented Medicines (Notice of Compliance) Regulations for its pregabalin product (Pfizer's Lyrica). In the first, the court granted motion for summary trial on the relevance of Pfizer's ex turpi causa defence; in the second, it overturned the prothonotary's order, which had denied Pfizer leave to amend a pleading.
The Federal Court of Appeal recently dismissed Pfizer's appeal of its failed motion to dismiss Amgen's action regarding an infringing patent under Section 6 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Pfizer had argued that Amgen's action ought to be dismissed as an abuse of process on the basis that Amgen had unsuccessfully litigated the same patent under the pre-amended PMNOC Regulations.
Since June 2018 a number of biosimilar developments have taken place in Canada. For example, Amgen has sued BGP Pharma dba Mylan for patent infringement in respect of the pegfilgrastim biosimilar Fulphila, and Janssen succeeded in its patent infringement action against Hospira in respect of Hospira's biosimilar Inflectra.
Canada has now reached the end of its journey to implement the Patent Law Treaty, with new Patent Rules and associated amendments to the Patent Act recently coming into force. To help ease the transition, this article summarises the more significant changes to Canadian patent practice and procedure that are now in effect.
The Supreme Court recently issued a highly anticipated decision in which it found that Ontario holds the copyright in plans of survey published by the third-party operator of the province's electronic land registry system. This case was the Supreme Court's first opportunity to examine the scope and application of Crown copyright in the nearly 100 years since the enactment of the applicable provision under the Copyright Act.
The certificate of supplementary protection (CSP) regime recently celebrated its second anniversary. This article looks back on the previous year and provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips, including (among others) that it is important to consider the possibility of a CSP early in the drug development and approval lifecycle.
An updated Manual of Patent Office Practice (MOPOP) was recently published, explaining Patent Office administrative and examination practice effective from 30 October 2019. The updated MOPOP provides important information as to how the Patent Office will handle certain aspects of patent practice under the Patent Act and Patent Rules. Most significantly, the updated MOPOP provides details concerning (among other things) the new requirement for the submission of certified copies of priority documents.
Eli Lilly was recently granted leave to amend its pleadings to introduce a new cause of action for the direct infringement of claims relating to a new use without including an allegation that the product had been directly infringed. However, the court ordered that all issues relating to the new cause of action must be bifurcated and tried at the quantification phase, after all other issues have been determined.
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 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 – was 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.
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 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 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.