In a decision rendered on 17 August 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its statement of defence to add new allegations, contingent on an adjournment of the trial and an extension of a 24-month stay under the Patented Medicines (Notice of Compliance) Regulations (the Regulations).(1)


The underlying action was brought by Bayer Inc and Adverio Pharma GmbH (collectively, Bayer) against Sandoz pursuant to subsection 6(1) of the Regulations. A trial is scheduled to begin in September 2023.

Sandoz's notice of allegations (NOA) alleged non-infringement and did not raise any invalidity issue other than the Gillette defence. Its statement of defence filed in February 2022 asserted only the defences set out in the NOA.

In June 2022, following the exchange of affidavits of documents and oral discovery plans, Sandoz changed its solicitors of record and proposed to add new invalidity defences and to plead allegations that the patent at issue was ineligible for listing. Bayer consented to some amendments but objected to most, on the basis that there was insufficient time left before trial to adequately defend against the new allegations.


Case Management Judge Tabib concluded that Sandoz did not meet its burden of demonstrating that Bayer would not be prejudiced. She found that the contested amendments were lengthy and raised complex and multifaceted arguments. Moreover, adding an entirely new defence of invalidity to a case previously focused on infringement could be expected to bring significant strain on Bayer and its litigation team. While Sandoz offered to defer the production of invention documents and limit its discovery on the new invalidity issues, the proposed compromise was unrealistic.

The Court declined to dismiss the motion, however, as any procedural or substantive prejudice could be alleviated by the adjournment of the trial and a commensurate extension of the 24-month period. Sandoz was therefore granted leave to make the proposed amendments on such conditions.

In the Court's view, the order will allow Sandoz to choose whether it wishes to make the disputed amendments or to forgo them in favour of keeping the trial dates.

For further information on this topic please contact Chen Li at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.


(1) Bayer Inc v Sandoz Canada Inc, 2022 FC 1187.