The Federal Court of Appeal recently issued public reasons for its decision dismissing Teva's appeal relating to the damages and costs that the Federal Court had awarded against it for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court had awarded close to C$19 million in damages and pre-judgment interest to the plaintiffs and subsequently granted C$1 million in costs.
The federal government is moving quickly towards legalising the possession and consumption of cannabis for recreational purposes. However, Canada's cannabis industry is already 'overgrown' with both licensed and unlicensed producers, all vying for consumers' attention. Brand owners, start-ups and so-called 'ganjapreneurs' in Canada's cannabis industry face a number of unique challenges and should strategise accordingly – ideally before launching a cannabis brand in Canada.
Although the new trademark law was finalised in 2014, it has yet to come into force. Before it can be implemented, the government must finalise new trademarks regulations and the Trademarks Office's IT system must be modified to accommodate the changes to the law. Once implemented, the changes will be the most significant in 50 years – both procedurally and substantively.
Health Canada previously announced January 1 2018 as the proposed date for mandatory filing of specified regulatory activity. As such, all new drug submission, supplementary new drug submission, abbreviated new drug submission and supplemental abbreviated new drug submission regulatory activities for human drugs – as well as additional information and subsequent regulatory activities and transactions – must be filed in Electronic Common Technical Document format as of this date.
Health Canada and the Institute for Safe Medication Practices Canada recently opened their consultation on different approaches to the naming of biologic drugs, including biosimilars. The consultation aims to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication use process, including prescribing, dispensing and adverse drug reaction reporting.
Health Canada recently announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway. The administrative pathway will be available, with some restrictions, for manufacturer and product name change applications, additional product name applications and licensing agreements between two manufacturers. The guidance will be effective from March 1 2018.
Health Canada recently published a notice soliciting comments and recommendations from stakeholders regarding potential changes to its guidance document on the use of a foreign-sourced reference product as a Canadian reference product. Stakeholder feedback should be submitted to Health Canada by March 18 2018, preferably in electronic form.
The Federal Court recently dismissed a Patented Medicines (Notice of Compliance) Regulations application concerning Apotex's generic aripiprazole product on a summary basis under Section 6(5)(b) of the regulations. An appeal was subsequently filed. On December 15 2017 the Federal Court of Appeal granted a motion by the appellants to stay the dismissal order until the appeal could be heard. The appeal was recently allowed on the parties' consent.
The Ontario Superior Court of Justice recently held that Apotex was entitled to damages for losses resulting from delays in the US Food and Drug Administration's approval of two of its products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services. Due to MDS's failure to comply with the US regulatory framework for conducting bioequivalence studies, Apotex had been unable to rely on the MDS studies and was forced to repeat them, thus delaying US market entry.
Ontario Bill 160, the Strengthening Quality and Accountability for Patients Act 2017, enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. The act will require payors – including manufacturers of pharmaceutical or medical devices – to report financial relationships with healthcare professionals and organisations, as well as other prescribed recipients.
The Federal Court recently issued its judgment in Bristol-Myers Squibb v Apotex Inc, in which it granted Apotex's motion under Section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations. As a result, the court granted an order dismissing the underlying application in respect of Apotex's proposed generic aripiprazole product.
Canada launched its Patent Prosecution Highway programme in 2008 with the goal of fast tracking patent examination and improving patent quality. The programme has been a phenomenal success and offers numerous benefits to applicants. Data published by the Canadian Intellectual Property Office suggests that applicants which use it have their applications examined sooner and encounter fewer office actions.
Among other changes, Health Canada recently released proposed amendments to the Food and Drug Regulations. Under the amendments, "clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission" would cease to be treated as confidential and would be released to the public following a final regulatory decision, with no requirement to notify the affected party of the release.
With major developments regarding patent linkage, patent term and other substantive patent issues, 2017 was one of the most significant years in history for Canadian life sciences IP and regulatory law. Highlights included the Supreme Court's striking down of the promise doctrine, the Canada-EU Comprehensive Economic and Trade Agreement amendments and the laying of the foundations to overhaul the Patented Medicine Prices Review Board regulations and guidance.
Canadian IP law and practice saw significant developments in 2017, including the largest award for patent infringement in Canadian history and the Supreme Court's abolition of the controversial 'promise of the patent' doctrine. Further, in terms of foreshadowing a significant overhaul to Canada's IP legislation across all areas, 2017 was an active year.
In April 2017 the Federal Court of Appeal overturned the Federal Court's conclusion that Apotex had failed to mitigate the loss that it incurred as a result of Health Canada's tortious conduct in considering Apotex's Apo-Trazodone drug submission. The Federal Court of Appeal otherwise dismissed the parties' appeals relating to Apotex's claims in negligence, misfeasance in a public office and contract. The Supreme Court recently dismissed Apotex's leave application.
The so-called 'Cannabis Act', which provides a framework for restricted access to cannabis and is intended to come into force no later than July 2018, recently passed its first reading in the Senate. Concurrently, Health Canada issued a notice of intent to develop regulations under the proposed act and launched a public consultation, which was open for comments until January 20 2018.
There were a number of developments concerning biosimilars in 2017. For example, new certificates of supplementary protection now apply to biologics and numerous patent litigations involved biosimilars. In addition, Health Canada held a workshop and issued a report which notes that it intends to consult with stakeholders about the impact of the naming of biosimilars on prescribing, dispensing and pharmacovigilance needs.
There were a number of developments concerning biosimilars in 2017. For example, Health Canada held a workshop and issued a report which notes that it intends to consult with stakeholders about the impact of the naming of biosimilars on prescribing, dispensing and pharmacovigilance needs. In addition, the Comprehensive Economic and Trade Agreement amendments have had an effect on biologics and numerous patent litigations involved biosimilars.
Health Canada recently issued a guidance document on the use of foreign-sourced reference products as Canadian reference products. The guidance is directed at sponsors of all abbreviated new drug submissions and abbreviated extraordinary use new drug submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed outside Canada.