On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years currently provided under Canadian law.
Changes to the CUSMA
As we reported, the previous version of CUSMA required two notable changes to Canadian law concerning pharmaceuticals and biologics:
- Extended data protection for biologics. CUSMA previously required Canada to provide a minimum of 10 years of data protection to biologics, an increase from the 8 years currently provided under Canadian law.
- Patent-term restoration. CUSMA required Canada to adopt a patent-term restoration system to recover time lost due to “unreasonable delays” in the issuance of a patent.
In its statement on the changes agreed among the parties this week, the Government identified three amendments to the Intellectual Property Chapter. The parties agreed to:
- “remove the obligation on data protection for biologics, meaning that Canada will no longer need to amend its domestic regime to provide 10 years of data protection in this area”;
- “remove a provision on the availability of patents for new uses, new methods or new processes of using a known product, as well as a provision on data protection for “new indications” of existing drugs”; and
- “include additional language on an exception related to regulatory reviews, and new language on how parties may meet obligations dealing with patent-term restoration, patent linkage and data protection for small molecule drugs.”
The Government also stated that as a result of these changes, “Canada will not be required to make changes to its domestic patent or pharmaceutical IP regimes in order to implement the amended provisions.”
Each country must now ratify the amended CUSMA before it will come into force. The expected timing of the ratification procedures in each country is not yet known.
As we reported, the Government had introduced a bill to implement the previous version of the CUSMA on May 29, 2019. That bill, known as Bill C-100, did not pass into law before the October federal election and can no longer be advanced. As a result, it will be necessary for the Government to introduce a new implementation bill. The Government has not yet indicated when this is likely to occur.
The full text of the amended CUSMA is not yet available. The Canadian government has published a “Summary of revised outcomes”.