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New Health Canada Guidance on Biosimilars to Streamline Submissions
On May 19, 2026, Health Canada published the final version of its Guidance on information and submission requirements for biosimilar biologic drugs. This Guidance Document, which applies to all biosimilar drug submissions in Canada, introduces significant changes to the data required for submission and approval. Most notably, comparative clinical efficacy studies (typically Phase III clinical trials) will no longer be required in most cases. Instead, a sponsor can rely on data establishing the biosimilar is “highly similar” to a Canadian…
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U.S. Supreme Court considers inducement liability for skinny-label generics
Last Wednesday, April 29, the Supreme Court of the United States (SCOTUS) heard oral arguments in Hikma Pharmaceuticals USA Inc. v. Amarin Inc. (docket no. 24-889), a case on induced infringement liability for “skinny label” generic drugs. The case raises important questions for generic drug manufacturers: when marketing under a skinny label, can public statements referencing the brand drug lead to liability for induced infringement? Below are some views of this issue from a cross-border US/Canadian perspective. During oral arguments,…
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Announcing Canadian AI Case Tracker
It is no surprise that the proliferation of generative AI has led to a plethora of lawsuits. In Canada, a number of lawsuits have been filed against AI companies on many grounds. Many issues are currently being litigated including relating to ownership of intellectual property, moral rights, scraping, privacy, product liability, deepfake liability, and professional responsibility. We have been internally keeping track of many of these cases, but to help facilitate further research and discussion, we have now published our…
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Did the Federal Court of Appeal rein in overbreadth invalidity?
The Federal Court of Appeal overturned a trial court finding that a patent was invalid for overbreadth. In its reasons, the FCA appeared to limit the extent of extrinsic evidence (i.e. inventor and expert testimony) relevant to the overbreadth inquiry. Instead, the FCA focused on the invention made or contemplated as disclosed in the patent specification.
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Is password sharing circumvention? Blacklock’s Reporter copyright saga continues on appeal
The FCA overturned a lower court decision that declared sharing of passwords by Parks Canada was fair dealing that did not constitute circumvention of TPMs. The scope of fair dealing and whether password sharing and paywalls constitute TPMs are now re-opened as live legal questions.
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Federal Court strikes down proposed class action against generic pharmaceutical manufacturers for alleged industry-wide conspiracy
The Federal Court of Canada in Eaton v Teva Canada Ltd et al, 2026 FC 239 refused to certify a proposed class action claiming over $5 billion against more than 80 generic pharmaceutical companies for an alleged conspiracy to fix generic drug prices and allocate in the market in violation of the Competition Act.
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Federal Court sets threshold for filing new evidence on appeal of Trademark Opposition Board proceedings
The Federal Court has clarified when parties can file new evidence on appeal from TMOB decisions under the amended Trademarks Act. Leave will depend on factors such as relevance, materiality, delay, and prejudice. The Court departed from the stricter Palmer test, noting that statutory appeals from administrative tribunals are more flexible, though whether evidence could have been before the TMOB remains important. Applicants should no longer assume that new evidence is automatically permitted on appeal.
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AI Litigation in Canada: What to Watch for in 2026
Watch for these three developments in AI law in 2026: (1) the ongoing OpenAI v. Canadian Media Companies lawsuit which could set a precedent for AI copyright ownership; (2) the DABUS appeal, which could answer whether GenAI can be an “inventor” of a patent, and (3) the Suryast copyright registration battle, which could set out whether AI art can be copyrighted.