On May 20, 2022, the Competition Bureau announced that it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered during the two investigations suggested the agreements did not contravene the Competition Act. The parties and drugs involved were not identified.
In Canada, companies are not required to notify the Competition Bureau of settlement agreements between branded and generic drug manufacturers in actions involving patented medicines. However, as the Bureau notes, the Bureau proactively monitors such actions using publicly available information, identifies actions resolved on the consent of the parties and gathers information about whether an agreement may contravene the Competition Act.
On May 20, 2022, the Bureau also released a position statement outlining its approach to reviewing these types of agreements. The Bureau states, “[t]he Bureau’s Intellectual Property Enforcement Guidelines (IPEGs) identify that patent litigation settlement agreements may be anticompetitive, such as when payments (whether monetary or non-monetary) are made to delay the entry of generic drugs into the market”. See our previous article on the IPEGs, which were modestly updated in 2019 to reflect the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance group.