NOC Proceedings

Federal Court Grants Prohibition Order with Respect to a Use Patent
Eli Lilly Canada Inc. v. Apotex Inc., 2015 FC 875
Drug: tadalafil

The Federal Court considered and dismissed allegations relating to double patenting, insufficiency and lack of standing. The Court granted the prohibition order sought by Eli Lilly.

Patent Infringement Actions

Appeal Dismissed; Patent Claims Upheld as Invalid due to Obviousness
E. Mishan & Sons Inc. v. Supertek Canada Inc., 2015 FCA 163

The Federal Court of Appeal (FCA) dismissed an appeal from a trial decision finding the claims at issue in a patent infringement case to be invalid for obviousness (decision here; summary here).

The appellant argued that a particular document should not have been included in the prior art. In particular, the appellant argued that the fact that a document was found by a lawyer, should not lead to a conclusion that it would have been found by the skilled person. The FCA held that this issue was reviewable as a finding of mixed fact and law, and would not be overturned without a palpable and overriding error. The FCA refused to reweigh evidence in this analysis, and the finding stood.

The FCA then considered the appeal in relation to obviousness. It held that it was not convinced that the Federal Court misapplied the fourth step of the Sanofi test. Furthermore, the FCA held that there was evidence to support the factual findings made by the trial judge in coming to his conclusion that the claims were obvious. Thus, the appeal was dismissed.

Other Proceedings of Interest

FCA Finds Patent Should be Listed on the Patent Register for Combination Drug
Eli Lilly Canada Inc. v. Attorney General of Canada, 2015 FCA 166
Drug: spinosad; milbemycin oxime

In this case, the FCA overturned the Federal Court Decision dismissing Eli Lilly’s application for judicial review of a decision of the Minister of Health refusing to list a patent on the Patent Register (Decision here; summary here). The FCA returned the decision to the Minister for reconsideration.

The drug product contains two medicinal ingredients. The patent at issue claimed oral formulations specifically relating to one of the medicinal ingredients. The disclosure indicated that the formulation may include compounds with antiparasite activity such as milbemycins. The FCA held that the Federal Court misunderstood the requirements of paragraph 4(2)(b) of the NOC Regulations.

The FCA held that the Federal Court had not made an error when it overturned the Minister’s construction of the patent, finding it to claim a formulation which included both spinosad and milbemycin oxime. However, the Court had erred in not then overturning the decision not to list the patent on the Patent Register. Once the finding was made that the patent claimed a formulation containing the approved medicinal ingredients, it was eligible for listing on the Patent Register.

Court Upholds Minister’s Decision to Exclude Documents from an Access to Information Request on the Basis of Solicitor-Client Privilege
Information Commissioner of Canada v. The Minister of Health, 2015 FC 789
Drug: pantoprazole

The Office of the Information Commissioner of Canada (OICC) sought judicial review of the Minister of Health’s refusal to disclose information responsive to Apotex’s request for records related to the processing of an Abbreviated New Drug Submission (ANDS) and the issuance of a Notice of Compliance (NOC). The Judicial Review was largely dismissed.

Apotex had started litigation against the Government, claiming damages due to refusal or delay in approving drug submissions. It made an Access to Information (ATI) request relating to one of the drugs at issue. 47 pages were produced in their entirety, and 8 further pages were produced in redacted versions, based on solicitor-client privilege. Apotex filed a complaint with the OICC. The OICC investigated, reported the results to Apotex, and started this proceeding, with Apotex’s consent, after Health Canada maintained its position that the solicitor-client exemption applies.

The Court held that the question of whether the Minister properly applied the exemption of solicitor-client privilege is reviewable on a standard of correctness, and the question of whether the Minister’s discretionary decision to refuse disclosure is reasonable is reviewable on a standard of reasonableness. The Court then considered the solicitor-client exemption and found that it applied to all but one part of one of the documents. The Court held that there was no abuse of discretion, and that the severance was properly exercised. One further sentence was ordered disclosed.


Chantal Saunders

Beverley Moore

Adrian J. Howard


Intellectual Property