Allegations in an NOA should be assessed as of the date of the hearing –not when served
Sanofi-Aventis Canada v. Hospira Healthcare Corporation and the Minister of Health, 2009 FC 1077 (Zinn, J.)

October 22, 2009

Anthony Creber and James Mills for the Applicant, Sanofi-Aventis Canada Inc. (Sanofi)
Warren Sprigings and George Murti for the Respondent, Hospira Healthcare Corporation (Hospira)

Sanofi brought an application for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Hospira until after the expiration of Canadian Patent No. 2,102,778 (“the ‘778 Patent”). In the Notice of Allegation (NOA) dated October 15, 2007, Hospira alleged non-infringement and invalidity against the ‘778 Patent. Over a month later, Sanofi filed a notice of disclaimer disclaiming parts of claims 1 to 8 of the ‘778 Patent. Only claim 8, as disclaimed was at issue in the proceeding. Hospira later argued that the disclaimer filed was invalid as it improperly broadened rather than narrowed the scope of claim 8 and that it was filed as a deliberate litigation tactic to preserve and NOC proceeding that was doomed to failure from the start and was not because of a legitimate mistake, accident or inadvertence.

The application was dismissed. Even though Sanofi filed the disclaimer after the NOA was served, the Court is to assess the allegations of Hospira as at the date of hearing and not as at the date of the NOA. The allegations of Hospira ought to be assessed against the ‘778 Patent as disclaimed. Although Hosipra was unable to argue the validity of the disclaimer in its NOA, it was not estopped from arguing the validity of the disclaimer of the ‘778 Patent.

The disclaimer filed by Sanofi was invalid as it failed to meet the requirements of Section 48(6) of the Patent Act. Where the validity of the disclaimer is raised, then the patentee must establish on the balance of probabilities that it is a valid disclaimer. Sanofi failed to prove on a balance of probabilities that through mistake, accident or inadvertence its patent as filed was overly broad.

By: Mala Joshi, Ridout & Maybee LLP