October 22, 2009, docetaxel

The Court refused to grant an Order of Prohibition against Hospira regarding its docetaxel product.

After the NOA had been filed, but prior to the filing of the Application, Sanofi had disclaimed part of the claims of the patent at issue. The proceeding continued on the basis of the disclaimed claims until just before the hearing when Hospira raised the issue of whether it had to address them. Motions were brought before the Court resulting in the application being allowed to proceed. Sanofi and Hospira were also permitted to file further evidence on the disclaimer.

At the hearing, the Court held that previous jurisprudence in NOC proceedings regarding disclaimers had not considered the Supreme Court of Canada’s decision in Merck where it was held that the relevant date for assessing the justification of a NOA is the date of the hearing. The Court held that allowing a generic company to obtain a NOC despite a disclaimed patent does not meet the purpose of the NOC Regulations as the Court is not issuing a decision that prevents infringement when it ignores the reality of a disclaimed patent.

The Court then found that the disclaimer was not valid as once it was challenged, Sanofi failed to establish that through mistake or accidental inadvertence, its patent was overly broad. Thus, it failed to establish the disclaimer meets the prerequisites of section 46(1) of the Patent Act.

The Court held that the application would have to be dismissed based on the findings as to the invalidity of the disclaimer. However, in the event of appeal, the Court considered the remainder of the allegations in the NOA. The Court found that the claims would be infringed by Hospira’s formulation. The Court also found that the claims were not overly broad due to a failure to list every additional non-essential ingredient of the formulation in the claims. Furthermore, the allegations as to anticipation were not justified. The allegations as to material misstatement were found not to be justified as Hospira did not meet its evidential burden. The allegation as to insufficiency and non-patentable subject matter were also dismissed. However, the allegation to obviousness was justified on the basis of an obvious-to-try test.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2009/2009fc1077/2009fc1077.html