As a result of the Comprehensive Economic Trade Agreement with the European Union, significant changes to the patent linkage provisions and patent litigation framework relating to generic and biosimilar drug approval in Canada are on the near horizon.

Under the patent linkage provisions, a generic/biosimilar entrant who compares, or makes reference to, an innovator product in its submission for approval must make an allegation with respect to the patents listed in association with the innovative product.

When the innovator opposes the allegations, a 24-month statutory stay is imposed and, under the current regime, summary proceedings are initiated to determine whether the generic/biosimilar will obtain approval to sell the product.

While such proceedings often involve complex legal and scientific issues, they are litigated solely on a paper record, with no right to discovery and with no viva voce evidence (oral testimony given under oath) before the court at the hearing. In addition, any findings relating to issues of infringement and/or validity are limited to the regulatory proceeding and are not otherwise binding. As a result, subsequent patent infringement proceedings involving the same patents are common, sometimes with inconsistent results.

What is changing: key points

The expected changes will shift the structure of the current regime closer to that followed in the United States under the Hatch-Waxman Act.

  • The current summary proceedings will be replaced with full actions that will provide a right to discovery, culminating in a trial involving oral evidence to be determined within the 24-month time period.
  • Significantly, any determination of infringement and/or validity of the patents at issue will be binding, thus eliminating duplicative proceedings; determinations of invalidity will also have in rem effect.
  • When the generic/biosimilar manufacturer is successful, the innovator will obtain a right of appeal of the court's findings.

The amendments to the patent linkage provisions are expected to be introduced in the coming weeks, and counsel will need to be quick off the mark to advise their clients.