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.
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.
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.
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.
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.
The governor in council recently took the formal step of publishing proposed new Industrial Design Regulations in the Canadian Gazette. The regulations are being amended in order to allow Canada to join the Hague Agreement Concerning the International Registration of Industrial Designs, which provides a mechanism for registering an industrial design in several countries by means of a single application.
With the start of 2018, the countdown to the implementation of Canada's new trademark law has begun in earnest. While the changes will have benefits, there will also be some new challenges. However, a number of key strategies can be employed now in order to obtain maximum benefit from the existing legal landscape for trademarks in Canada and prepare brand owners for the new law.
A recent Federal Court of Appeal decision has shed light on a streamlined litigation procedure that brand owners may find attractive. In its decision, the court suggested that trademark owners which commence infringement proceedings in the Federal Court, by way of the summary procedure known as 'application', may still be able to recover damage awards – even by way of a reference.
The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.
The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.
The plaintiff in a patent infringement action against Pfizer recently brought a motion seeking approval of a litigation funding agreement (LFA) with a third party, as required by the terms of the agreement. The prothonotary dismissed the motion on the basis that such approval is not required beyond class proceedings. Further, the Federal Court had no jurisdiction to determine the validity of the LFA.
The Federal Court of Appeal recently heard Alexion's appeal of a decision striking out its constitutional challenge to the price regulation scheme and confiscatory powers found in the Patent Act. A decision is under reserve. Alexion also has a pending judicial review of the Patented Medicine Prices Review Board's decision that it sold Soliris (eculizumab) at excessive prices.
The Federal Court recently found that the Patented Medicine Prices Review Board's assessment that a patent pertained to Galderma Canada's Differin was unreasonable, as it had failed to consider the entire patent. As a result, the court quashed the board's decision requiring Galderma to file pricing information for Differin.
The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.
The Federal Court of Appeal recently ruled that Pfizer's failure to pay the correct issue fee did not render its patent void. In the context of a Section 8 case, Apotex had brought a partial summary judgment motion to have Pfizer's patent declared void for failure to comply with the Patent Act. The court cited the general principle that "pre-patent issuance defects in the administrative process for applying for a patent cannot be relied upon by an alleged infringer to render a patent void".
The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents concerning Gilead's SOVALDI (sofosbuvir). The Court of Appeal upheld the validity of Gilead's Patent 2,527,657 and declared Idenix's Patent 2,490,191 invalid on the basis of insufficiency of disclosure and inutility. Idenix has applied to the Supreme Court for leave to appeal.
The Federal Court recently granted prohibition orders preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine products (based on Pfizer's Pristiq) until the expiry of Patent 2,436,668. The court held that Apotex's allegations regarding non-infringement and invalidity on the basis of obviousness, inutility, anticipation double patenting and overpromising and Teva's allegations of invalidity on the basis of obviousness and inutility were not justified.
The Supreme Court recently dismissed Apotex's motion to amend its judgment in AstraZeneca Canada Inc v Apotex Inc. Apotex had asked that the case be remanded to the Federal Court to determine whether overpromising has rendered the 653 Patent invalid. Two recent Federal Court decisions also illustrate attempts to raise overpromising as a ground of invalidity outside the promised utility doctrine rejected in AstraZeneca.
In Canada, trademarks for pharmaceutical preparations and related products have faced numerous challenges, some of which are unique to the industry. In addition, a number of important changes and new opportunities will be introduced by upcoming amendments to the trademark law, which are expected to come into force in 2019.
The Federal Court of Appeal – in its first decision to consider the Supreme Court's landmark decision in AstraZeneca Canada Inc v Apotex Inc on the utility requirement – recently overturned a finding of inutility made under the promise doctrine, with practical guidance for the requirement of a scintilla of utility. Following the Supreme Court's decision, the Federal Court of Appeal reversed the Federal Court's decision, noting that the Supreme Court had unanimously abolished the promise doctrine.