Canada has historically been a much less active jurisdiction for patent litigation compared to the United States, which can be explained in part by the simple fact that the US market is almost 10 times the size of the Canadian market. However, there are a few notable differences in the procedure and substantive law applied in both jurisdictions that have resulted in Canada becoming an increasingly attractive option for high-stakes patent litigation in recent years.
The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.
Two recent decisions addressed procedure under the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations. In the first case, Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5). In the second case, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08.
The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.
The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.
Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.
Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.
The amendments to the Patent Act and the enactment of the Certificate of Supplementary Protection (CSP) Regulations flowing from the Canada-EU Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of CSPs. CSPs provide an additional patent-like protection term and are intended to partly compensate innovators for the time required to research and obtain regulatory approval in Canada.
In a recent case, the Federal Court granted the plaintiff's motion to strike a rival pharmaceutical company's statement of claim for infringement of a patent relating to oxycodone salt. The court overturned the prothonotary's dismissal of the motion, finding that the facts alleged nothing beyond the regulatory use exemption and that the imminence branch of the test for a quia timet action had not been met.
A number of changes will soon be made to Canadian trademark law, which will make it possible to protect a colour per se as a trademark (as opposed to a colour applied to a product with a particular shape). Rights holders seeking to protect colours as trademarks in Canada may therefore benefit from the new regime. However, overcoming objections based on functionality or establishing distinctiveness may present significant new hurdles to the registration of such marks.
The Patented Medicine Prices Review Board (PMPRB) recently released its March 2018 newsletter (the first since July 2017). Highlights include an update on the PMPRB guidelines, the release of the PMPRB's 2016 annual report and notice that several publications will be released in 2018.
The Federal Court recently found certain claims of a patent relating to a chip for measuring the osmolarity of a sample of bodily fluid, including tear film, invalid on the basis of obviousness and anticipation. The court agreed with the claim construction urged by the plaintiffs, finding that the claims encompassed both in vivo and ex vivo applications of the invention. Thus, the defendant's competing medical device – which measured osmolarity in vivo – fell within the scope of the claims.
Alexion Pharmaceuticals recently filed an application for leave to appeal a Federal Court of Appeal decision to the Supreme Court. In its decision, the Federal Court of Appeal had dismissed Alexion's challenge of the constitutionality of certain Patented Medicine Prices Review Board provisions provided for in the Patent Act.
The Federal Court recently upheld the validity of Kennedy Trust's patent covering a use of infliximab (Janssen's Remicade) and granted Kennedy's counterclaim that Hospira's biosimilar Inflectra had infringed the patent. This is the third patent infringement action decision relating to a biologic and the second on the merits relating to a biosimilar.
If a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) Regulations against a generic entrant, but subsequently prevails in an infringement action regarding the same patent, can it be liable for Section 8 damages under the regulations? According to a recent Federal Court decision, the answer appears to be no.
The Federal Court of Appeal recently issued public reasons for its dismissal of Eli Lilly Canada Inc's appeal of a Federal Court decision that had awarded Teva Canada Limited more than C$70 million under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Further, the court granted Teva's cross-appeal – which sought to add to its recovery of lost pipefill sales – and an adjustment to account for an underreporting of sales in the data relied on by both parties' experts.
The availability of an accounting of profits in Canada as a remedy for patent infringement can offer significant benefits to patentees, including in cases involving infringing goods sourced from Canada that are being sold elsewhere. The availability of such a remedy and a number of other factors, including the ability to expedite proceedings and the lower cost of litigation, make Canada an attractive jurisdiction for patentees from the United States and elsewhere to litigate patent infringement matters.
The federal government is moving quickly towards legalising the possession and consumption of cannabis for recreational purposes. Although Canada's cannabis industry is already 'overgrown' with many licensed and unlicensed producers all vying for consumers' attention with different brands and strains of cannabis, only a few have taken advantage of the exclusive rights afforded producers under the Plant Breeders' Rights Act.
In 2016 the Federal Court found that Apotex and Cobalt had infringed Bayer's valid patent for an oral contraceptive composition. The Federal Court subsequently held that Bayer was entitled to elect between damages and an accounting of Apotex's profits. In so holding, the court disagreed with Apotex's argument that it, rather than Bayer, should be entitled to elect whether Bayer should be limited to recovering Apotex's profits. The Federal Court of Appeal recently dismissed Apotex's appeal of the latter decision.
In some cases, trolls (or 'squatters') apply for trademarks that are used by brand owners in other countries with the goal of forcing those owners to negotiate with the trolls when they enter the new market. In light of Canada's use-based trademark system, this had not previously been viewed as a serious problem. However, the announcement that amendments to the Canadian Trademarks Act will eliminate use requirements poses the risk of trolls targeting Canada.