PMPRB Rules Amend 'Patentee' to Rights Holder

Summary#

These are final rules called Rules Amending the Patented Medicine Prices Review Board Rules of Practice and Procedure: SOR/2021-117. They update wording in the Board’s hearing rules to match amendments made to the Patent Act under the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act. The instrument was registered June 1, 2021 and published in the Canada Gazette on June 9, 2021.

What it does#

• Changes how the term “respondent” is defined in Rule 1 so it refers to a “rights holder, or a former rights holder” instead of the older term (previously “patentee”).
• Replaces paragraph 6(1)(b) to confirm the Board may take notice of judicially noticed facts and of generally recognized scientific or technical facts about patented or protected medicines.
• Updates paragraph 14(2)(b) on electronic filing names so file names must include the medicine name or company name (when a hearing is not about a specific medicine), the party name, the document title and the document date, or meet alternative requirements set by the Secretary.
• Rewrites paragraphs 15(3)(a) and (b) to clarify how Board Staff must present two kinds of allegations:
  • For alleged excessive price: a numbered “statement of allegation” listing material facts, the allegations and the order sought.
  • For alleged failure to provide information: a numbered “notice of application” stating the relief sought, the grounds, and the material facts relied on.
• Sets the rules’ coming-into-force timing to the day section 46 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act comes into force, or, if the rules are registered after that day, to the registration day.

Who's affected#

• Patented Medicine Prices Review Board proceedings and the people who take part in them.
• Drug manufacturers, rights holders (formerly called patentees), and former rights holders who may be the subject of Board orders.
• Lawyers, consultants, and Board staff who prepare and file documents for hearings.
• The change is mostly terminological and procedural; the government says it does not add costs to businesses. If it is unclear whether a particular party is affected, they should check whether they appear in PMPRB proceedings.

Why it matters#

• These are technical wording updates meant to make the Board’s rules match the revised Patent Act language introduced through the Canada–EU trade implementation act.
• In practice, the changes mainly affect the labels and format of filings and the terms used to identify who is a respondent.
• For companies and lawyers involved in PMPRB hearings, the changes remove possible confusion about who the rules apply to and clarify how allegations and electronic files must be presented.
• The changes do not, according to the government, create new costs for businesses.